Dept. of the Army -- USAMRAA logo

BROAD AGENCY ANNOUNCEMENT (BAA) for Extramural Biomedical and Human Performance Research and Development Department of Defense

Dept. of the Army -- USAMRAA

Funding Amount

$750,000 - $50,000,000

Deadline

July 31, 2028

845 days left

Grant Type

federal

Overview

BROAD AGENCY ANNOUNCEMENT (BAA) for Extramural Biomedical and Human Performance Research and Development Department of Defense

The FY23 -FY28 Broad Agency Announcement for Extramural Biomedical Research and Development - HT9425-23-S-SOC1.

Details

  • Agency: Dept. of the Army -- USAMRAA
  • Department: Department of Defense
  • Opportunity #: HT9425-23-S-SOC1
  • Total Funding: $10,000,000
  • Instrument: procurement_contract

Eligibility

Eligible Applicant Types

unrestricted

How to Apply

BAA

I. OVERVIEW OF THE FUNDING OPPORTUNITY
United States Special Operations Command
Department of Defense
BROAD AGENCY ANNOUNCEMENT (BAA)
for Extramural Biomedical and Human Performance
Research and Development
Funding Opportunity Number: HT9425-23-S-SOC1
Announcement Type: Initial
Catalog of Federal Domestic Assistance Number: 12.420
Military Medical Research and Development
KEY DATES
Release/Posted Date: Initial 01 August, 2023
Closing Date: 31 July, 2028, 11:59 p.m. Eastern Time
This Funding Opportunity Announcement is a BAA. It is continuously open for a 5-year period,
from 1 August 2023 closing 31 July 2028, 11:59 p.m. Eastern Time. Note: This BAA will be
updated annually.
This Broad Agency Announcement must be read in conjunction with the General Submission
FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
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Instructions, which are available for downloading from Grants.gov. The General Submission
Instructions are located under the “package” tab and can be downloaded by selecting the
“Download Instructions” icon when previewing the submission package.
TABLE OF CONTENTS
I. OVERVIEW OF THE FUNDING OPPORTUNITY ....................................................... 1
II. DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY ............... 3
II.A. Program Description ....................................................................................................... 3
II.A.1. Research Area of Interest .......................................................................................... 4
II.B. Federal Award Information .......................................................................................... 13
II.C. Eligibility Information ................................................................................................... 15
II.C.1. Eligible Applicants ................................................................................................... 15
II.C.2. Cost Sharing ............................................................................................................. 16
II.C.3. Other ......................................................................................................................... 16
II.D. Proposal/Application Submission Information ....................................................... 17
II.D.1. Where to Obtain the Proposal/Application Submission Package ............................ 17
II.D.2. Content and Form of the Proposal/Application Submission .................................... 17
II.D.3. Unique Entity Identifier (UEI) and System for Award Management (SAM) ........... 37
II.D.4. Submission Dates and Times ................................................................................... 39
II.D.5. Funding Restrictions ................................................................................................ 39
II.D.6. Other Submission Requirements .............................................................................. 41
II.E. Proposal/Application Review Information .................................................................... 41
II.E.1. Criteria ...................................................................................................................... 41
II.E.2. Proposal/Application Review and Selection Process ............................................... 42
II.E.3. Integrity and Performance Information .................................................................... 43
II.E.4. Anticipated Announcement and Federal Award Dates ............................................ 44
II.F. Federal Award Administration Information .................................................................. 44
II.F.1. Federal Award Notices ............................................................................................. 44
II.F.2. Administrative and National Policy Requirements .................................................. 44
II.F.3. Reporting .................................................................................................................. 45
II.G. Federal Awarding Agency Contacts ............................................................................. 46
II.G.1. eBRAP Help Desk.................................................................................................... 46
II.G.2. Grants.gov Contact Center ....................................................................................... 46
II.H. Other Information.......................................................................................................... 47
II.H.1. Administrative Actions ............................................................................................ 47
II.H.2. Proposal/Application Submission Checklist ............................................................ 49
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APPENDIX 1: ACRONYM LIST ............................................................................................ 50
II. DETAILED INFORMATION ABOUT THE FUNDING
OPPORTUNITY
The Fiscal Year 2023 – Fiscal Year 2028 (FY23-FY28) United States Special Operations
Command (USSOCOM), BAA for Extramural
Biomedical and Human Performance Research and Development contains several changes from
previous USSOCOM BAAs. Read each section carefully. Note the following:
• The total individual project estimated cost ceiling has been increased from $4,000,000 to
$5,000,000, and generally anticipated project cost has been increased from $700,000 to
$1,500,000.
• The “Program Description” that describes the “Research Areas of Interest (RAIs)” have
been updated.
II.A. Program Description
This BAA is intended to solicit extramural research and development ideas using the authority
provided by United States Code, Title 10, Section 4001. This BAA is issued under the provisions
of the Competition in Contracting Act of 1984 (Public Law 98-369), as implemented in Federal
Acquisition Regulation (FAR) 6.102(d)(2) and 35.016. In accordance with FAR 6.102, projects
funded under this BAA must be for basic and applied research to support scientific study and
experimentation directed toward advancing the state-of-the-art or increasing knowledge or
understanding rather than focusing on development of a specific system or hardware solution.
Research and development funding through this BAA is intended and expected to benefit and
inform both military and civilian medical practice and knowledge.
This BAA provides a general description of the USSOCOM’s research and development
programs, including RAIs, evaluation and selection criteria, pre-proposal/preapplication and full
proposal/application preparation instructions, and general administrative information.
Submission of a pre-proposal/pre-application is required. After review, if the USSOCOM is
interested in receiving a full proposal/application, the Applicant or Offeror will be invited to
submit a full proposal or full application. Specific submission information and additional
administrative requirements can be found in the document titled “General Submission
Instructions” available in Grants.gov along with this BAA.
The USSOCOM utilizes the tools and processes provided by the Congressionally Directed
Medical Research Programs (CDMRP). The CDMRP manages the electronic Biomedical
Research Application Portal (eBRAP) system and retrieval and processing of full
proposal/application submissions from Grants.gov. Refer to Section II.G, Agency Contacts, for
additional information.
The USSOCOM’s supporting contracting office, the U.S. Army Medical Research Acquisition
Activity (USAMRAA) will be the awarding and administering office for proposals selected for
funding.
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II.A.1. Research Area of Interest
A primary emphasis of the USSOCOM Biomedical, Human Performance, and Canine Research
Program is to identify and develop techniques, knowledge products, and materiel (medical devices,
drugs, and biologics) for early intervention in life-threatening injuries; prolonged field care (PFC);
human performance optimization; canine medicine/performance; brain health; immune response;
automation of systematic reviews and metanalysis; and novel post-traumatic stress, depression, and
anxiety treatment.. Special Operations Forces (SOF) medical personnel place a premium on medical
equipment that is small, lightweight, ruggedized, modular, multi-use, and designed for operation in
extreme environments. The equipment must be easy to use, require minimum maintenance, and have
low power consumption. Drugs and biologics should optimally not require refrigeration or other
special handling. All materiel and related techniques must be simple, effective, and easily modified
for commercialization. Research projects may apply existing scientific and technical knowledge for
which concept and/or patient care efficacy have already been demonstrated to meet SOF
requirements. The proposed research must be relevant to active-duty service members, veterans,
military beneficiaries, and/or the American public. Relevant research must be responsive to the
health care needs of the U.S. Armed Forces, family members of the U. S. Armed Forces, U.S.
Veterans, and civilian populations. Proposals must address a relevant health problem responsive to
one of the RAIs identified below. Additional RAIs may be added during the life of the BAA (FY23-
FY28). The following RAIs are in no particular order:
1. Damage Control Resuscitation:
SOF medical personnel require capabilities for far-forward medical care to reduce the mortality and
morbidity associated with critical wounds and injuries. The proposed research, application, and/or
development of medical techniques and materiel (medical devices and biologics) for optimal triage
and early intervention in critical life-threatening injuries when casualty evacuation is not possible or
is delayed. The project areas under “Damage Control Resuscitation” to which the USSOCOM will
give highest consideration are:
a. Global Treatment Strategies and Next Generation Wound Management:
The proposed project must research, apply, and/or develop effective treatment strategies that address
the following elements: hypotensive resuscitation, optimal fluid(s), uncomplicated shock,
noncompressible hemorrhaging, traumatic brain injuries, and austere damage control surgery. These
strategies must be optimized for medics in austere, far-forward areas, with minimal logistical or
specialty support, who must stabilize and treat patients for extended periods (days, not hours).
Projects that research and develop an all-in-one traumatic wound care treatment that can achieve
hemostasis, incorporate analgesia, deliver antibiotics, and start tissue regeneration are preferred.
b. Analgesia:
The proposed project must research, apply, and/or develop novel, safe, efficacious, peripherally, and
centrally acting analgesia that provide easy administration in the field, tolerance of extreme
environments, and effectiveness at the point of injury for a prolonged period of field care (days, not
hours) and does not sensitize the patient to topical analgesia. Maximum analgesia with minimal
sedation is preferred.
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c. Far Forward Blood, Blood Components, Blood Substitute, & Injectable Hemostatics:
The proposed project must research novel strategies to increase the ease, efficacy, and safety of blood
transfusions (i.e., person to person, pre-hospital blood banking, and blood substitutes) forward of
normal logistics support; (e.g., evaluating blood for type/cross matching and for the presence and/or
reduction of pathogens, leucocytes, and AB antibodies to improve safety of whole blood transfusion
at the point of injury). Projects that will be considered also include other blood components such as
freeze-dried plasma and platelets, cryoprecipitate, fibrinogen, prothrombin complex concentrate, and
injectable medications to address the coagulopathy of trauma such as Tranexamic acid. Research
should focus on extending shelf life of whole blood beyond current limitations. A long-term
objective is a blood substitute that is comparable in size, weight of traditional blood products, and
effectively functions like fresh whole blood without requiring refrigeration. Strategies to find the
delivery of these prototypes individually or in concert will also be considered. Priority will be given
towards projects that are oriented towards final solutions or prototypes that are shelf stable requiring
minimal to no refrigeration as well as those that can carry oxygen in quantities similar to healthy red
blood cells.
d. Austere Surgical Stabilization:
Future theatres where SOF personnel will operate are likely to be much less medically robust than
the past decade of fighting in our current theatres (this can translate to remote civilian areas). Rather
than sitting at hardened structures waiting on patients, surgical personnel may be increasingly asked
to go to the patient. Research should focus on mobility/portability of medical and surgical equipment,
including support equipment such as sterilization, with emphasis on equipment with greater
capabilities than currently fielded devices, smaller size and weight, low power demands, and
flexibility in power supplies. Additionally, research and development efforts should include
telehealth technologies linking forward surgical providers with higher medical authority consultation
and effective, relevant, and dynamic surgical training capabilities. Research may also include a
human systems approach to define limitations and mitigation strategies of surgical capability in
austere environments (i.e., low light, temperature variability, surgery in flight, etc.).
2. Prolonged Field Care (PFC):
SOF medical personnel require capabilities for far-forward medical care to reduce the mortality and
morbidity associated with critical wounds, injuries, diseases, and associated sepsis. PFC should focus
on novel treatments that support the ability to manage 3-5 patients across the spectrum of illness to
multi-system injury for a minimum of 5-7 days. Significant consideration will be given to proposals
focused on PFC that may also relate to Sections 1 (a-d) and 3(a) of this BAA.
a. Medical Sensors and Devices:
The primary emphasis is to research, apply and/or develop medical techniques, pharmaceuticals,
biologics, and field-sustainable, rapidly deployable medical sensors and/or devices for extended care
beyond initial trauma resuscitation, to include austere/forward surgery while operating in disease
endemic areas where casualty evacuation is delayed or unavailable. In addition, proposals that
investigate or develop wireless biosensors should demonstrate physiological monitoring capabilities
to include, but not limited to, heart rate, blood pressure, pulse oximetry, respiration rate,
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capnography, core temperature, heart rate variability and compensatory reserve index (CRI).
Research and development of devices and sensors should include or plan for the capability to
transmit (Bluetooth) to Android handheld devices and tablets. (NOTE: Ideally, sensor and equipment
technologies should be electronically readable, scannable, or transmittable to the Battlefield Assisted
Trauma Distributed Observation Kit (BATDOK), an Android-driven, multi-patient, point of injury
casualty monitoring capability being fielded by the U.S. Air Force (USAF) Pararescuemen and other
SOF Medics. Novel devices are required which aid in measuring physiologic decompensation and/or
adequacy of treatment/resuscitation in the field environment and/or provide a trigger for a pre-
hospital medical intervention (i.e., validation of tissue (muscle) oxygen saturation (StO2), CRI,
traumatic brain injury (TBI) measures, etc.
3. Portable Lab Assays and Diagnostics:
The proposed project must research, apply and/or develop novel concepts for portable and
environmentally stable far forward laboratory assays and diagnostics. Equipment should be
extremely portable, ruggedized, use limited or no external power, and any reagents should be self-
contained and stable in extreme environmental conditions. Preference will be given to proposals that
are field oriented, rugged, low weight/cube space and have little to no refrigeration requirements.
Additionally, novel wireless, transmittable or scannable solutions such as patches, scanner/readers or
other noninvasive technologies as described in paragraph 3.a. below are encouraged.
a. Occupational and Environmental Health (OEH) Hazards:
The proposed project must focus on development of novel methods and devices for rapid
identification and analysis of exposures to OEH hazards. Research must support the development
and analysis of handheld, field hardened, and environmentally stable analytical devices, monitoring
devices, dosimetry, assays for rapid on-site identification, and real-time analysis of OEH hazards in
air, water, and soil that could pose an acute or chronic health hazard to SOF personnel. Such OEH
hazards include toxic industrial chemicals/toxic industrial materials (TICs/TIMs), lead exposures,
food and water borne pathogens, toxins, biological agents, and radiological material exposures.
Research consideration should be given to development of small lightweight and programmable
unmanned underwater vehicles (UUV) and unmanned aerial vehicles (UAV) to conduct
environmental analysis of OEH hazards in water, air, and soil. UUVs and UAVs must be capable of
travel to designated locations, conduct point of collection analysis of OEH hazards, transmit data,
and return to originating base.
4. Force Health Protection and Environmental Medicine:
SOF personnel must often operate for extended periods of time in austere environments that expose
them to extremes in altitude, temperature, humidity, wind, kinetosis, infectious diseases, toxic
industrial chemicals, toxic industrial materials, and environmental hazards (including envenomation).
In addition, the environment may be compromised due to chemical, biological, and radiological
contamination. The primary emphasis of this research area is to research, apply, and develop
techniques, therapeutic measures, and materiel (personal protective equipment (PPE), medical
devices, drugs, and biologics) to ensure sustained human performance and effectiveness while
operating in harsh environmental conditions and/or wearing appropriate PPE. Additional research
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opportunities include identification and characterization of specific risk profiles/threats associated
with the SOF unique mission sets.
a. Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Rapid Diagnostics,
Treatment, and Prophylaxis:
The proposed projects must research, apply, and/or develop novel approaches that will diagnose,
treat, and protect SOF personnel from exposure to chemical, biological, radiological, nuclear, and
high yield explosives in near real time.
b. Operational Monitoring:
The proposed project must seek to develop wireless biosensors for monitoring SOF personnel in
extreme environments (i.e., high altitude, whether in-flight or the environment itself, excessive heat
or cold, etc.), and potentially hazardous material exposure. Sensors should address physiological
measurements and/or chemical, biological and/or radiological hazards. For hazards monitoring, a
personal dosimetry device is desired that can detect and alarm based on radiation and chemical
presence. The alarming function can be pre-determined to account for known environmental
conditions (i.e., natural occurring radiation levels that are below threshold/detrimental health levels)
and Parts Per Million (PPM) counts that would trigger an alert. This detection device needs to be able
to alarm differently to identify the "type" of hazard(s), and to trigger a back-off and/or donning of
additional PPE. Monitoring should be capable of wirelessly communicating via Bluetooth to Android
handheld devices, tablets, or compatible wrist-mounted displays.
5. Brain Health:
Brain Health research efforts include, but are not limited to: development and validation of fieldable
Neurocognitive Assessment Tools (NCATs) and baseline testing, Comprehensive Symptom History
(CASH) collection, blast exposure and impact monitoring, determination of safe acceptable limits for
blast exposure, development and validation of capabilities to easily identify/diagnose mild, moderate,
and severe TBI, methods to prevent, screen for, monitor, and correct neuroendocrine dysfunction,
methods to prevent TBI from impact and blast such as redesign of helmets, body armor, and
munitions, development of pharmaceuticals to prevent and/or treat brain injury, validation of brain
injury prevention strategies, and development of return to duty decision support tools.
a. Environmental Exposures:
Research that develops novel material and/or approaches to protect SOF personnel from the
neurological effects of single and repetitive auditory (impulse noise) and non- auditory
(overpressure) blast exposures and other environmental factors determined to affect nervous system
function.
b. Environmental Exposure Effects:
Research that determines the neurocognitive and nervous system effects from single and repetitive
blast exposures, impulse noise, and other potential hazardous environmental factors.
c. Biomarkers:
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Research to determine which biomarkers are indicative of mild, moderate, and severe TBI; sequelae
from TBI causing further injury; recovery status; and recovery rate from TBI. Testing and validating
diagnostic biomarkers for TBI. Proposals should also consider incorporation of validated biomarkers
onto existing or future diagnostic platforms. Use of machine learning and/or model development to
interpret and report biomarkers that are indicative of TBI are of interest.
d. Genetic Factors:
Research to determine if there are genetic predispositions, epigenetic changes and/or, genomic
modulators that affect the susceptibility to and recovery from TBI and neurotrauma.
e. Neuropsychological Testing:
Research to validate Neurocognitive Assessment Tools (NCATs) to determine baseline
neurocognitive status, readiness, neurocognitive degradation, sensitivity to various exposures, TBI
and recovery status post injury. Proposals to improve the speed, accuracy, specificity, and proximity
to injury for the use of NCATs, as well as to compare new technologies and/or modalities (including
passive assessment of cognition) to existing NCATs.
f. Affect testing. Research to develop and validate baseline and transient affect testing or
assessment tools to measure emotion and/or mood, to monitor change in emotion and/or mood
after TBI, and to investigate the effects of emotion or mood status on functional performance.
g. Olfactory, Oculomotor, Auditory, Vestibular, Cranial Nerve, and Vocal-Acoustic
Performance:
Research and proposals to perform and validate oculomotor, auditory, vestibular, cranial nerve, and
vocal acoustic assessments. Research and proposals to assess the effect of nervous system injury to
oculomotor, auditory, vestibular, cranial nerve, and vocal-acoustic performance and strategies to
restore their performance after injury and prevent injury or further decline.
h. Postural Stability:
Research to assess the effects of blast exposure on postural stability including the proprioceptive
component. Novel treatment strategies, therapies, and therapeutics to prevent and/or correct
detriment to postural stability from TBI and neurotrauma caused by blast, impact, and/or other
environmental exposures.
i. Neuroendocrine Dysfunction:
Methods to prevent, screen for, monitor, and correct neuroendocrine dysfunction.
j. Neuroimaging:
Research into novel imaging and imaging interpretation techniques including, but not limited to
Computed Axial Tomography (CAT), Magnetic Resonance Imaging (MRI), and Positron emission
tomography (PET) scans, to diagnose brain tissue pathologies including, but not limited to, axonal
injury, myelin injury, and astroglial scarring without the need for immunohistochemistry,
immunofluorescence, or histopathology testing.
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k. Analytics:
Research into analysis including Machine Learning, Natural Language Processing, and Artificial
Intelligence enabled analysis of data including, but not limited to, NCATs; environmental exposures
likely to affect brain health; blast, impact, and noise exposures; auditory, vestibular, and vocal
acoustic assessments; postural stability assessments; and neuroimaging.
l. Neuromodulation:
Research into the use of neuromodulation techniques for treating TBI, neurotrauma, pain, restoring
and improving function, and improving behavioral health.
m. Brain Lymphatics and Glymphatics:
Research into measuring the fluid dynamics of the brain lymph system, diagnosing dysfunction, and
validation for tools or techniques to improve brain lymph clearance.
n. Pupillometry, Pupillary Response and Microsacaades:
Research into field capable pupillary response measurement capture and analysis, with or without the
ability to capture microsacaades in order to assess central nervous system loading and/or damage.
6. Immune Response:
The use of modified and novel strategies to cause, strengthen, or supplement immunity through the
use of, but not limited to mRNA vaccines, nanolipoprotein particles (NLPs), polyvalent vaccines,
and phages.
7. Chronic Pain:
The proposed research must address the development of novel, non-opioid treatments for chronic
pain with or without the presence of migraines, allodynia, or fibromyalgia; but not with
accompanying myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) or cancer.
8. Automation of Systematic Reviews and Metanalysis:
Research into Automation of Systematic Reviews and Metanalysis using the Preferred Reporting
Items for Systematic Reviews and Meta Analyses (PRISMA) or a similar method.
9. Medical Simulation and Training Technologies:
The proposed project must research, apply and/or develop improved pre-hospital tactical combat
casualty care (TCCC) training with an emphasis on the SOF pre-hospital providers. Medical
simulations should replicate all phases of the pre-hospital combat environment, including care under
fire, tactical field care and casualty evacuation. Human-like simulators should bleed, breath, void,
have a physiologically relevant temperature, pulse, and response to medical care with little to no
operator/controller input, should be all-weather capable and should evoke an emotional response
from those with whom it interacts. Medical training simulations should capture and be capable of
providing a report on the timing, appropriateness, and effectiveness of medical treatment. All
material solutions should meet joint airworthiness standards. Additionally, there is interest in
research focused on validating or measuring the effectiveness of current medical simulation and
training technologies and in determining the best methods of acquiring and maintaining PFC skills as
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well as the impact of these skills on patient outcomes. In addition, the proposed project must research
the efficacy of using stress inoculation training (vs traditional didactics or other instructional
methods) to teach key TCCC skills (e.g., tourniquets, IV placement, etc.). Of particular interest are
the effects on stress response, performance, and decision making of the student as well as best
methods for optimizing performance in high stress situations as well as mitigating negative aspects of
stress.
10. Human Performance Optimization:
USSOCOM requires SOF personnel to withstand extraordinary physical demands and psychological
stress to complete their missions. The optimization of SOF personnel’s ability to perform at very
high levels for long durations, in addition to processing information and making critical decisions in
a timely manner, while operating in extreme environments, will significantly improve their overall
operational effectiveness. This research area explores alternatives and/or new approaches to sustain
and optimize SOF human performance.
a. Improved Sleep:
The proposed project must research, apply and/or develop novel approaches to achieve the
restorative effects of sleep. This may include methods to induce, maintain, or improve the quality of
sleep throughout the entire night. Additionally, the ability to accelerate the effects of sleep through
methods requiring less time (e.g., the effects of sleeping eight hours are realized in four hours’ time)
or enabling the SOF personnel to quickly reach and adequately cycle through the stages of sleep
where the highest restorative effects occur (i.e., Stage 3/ deep sleep, and Stage 4/rapid eye movement
sleep).
b. Optimal Acclimatization Strategies:
The proposed project must research, apply, and/or develop novel approaches and/or technologies that
provide rapid and sustainable human acclimatization in austere environments, to include fatigue
countermeasure, extremes in temperature, extremes in altitude, and time-zone change (i.e., circadian
acclimatization).
c. Wearables:
The proposed project must research , apply, and/or develop novel approaches and/or wearable
technologies that will monitor physiological measures of human performance to include, but not
limited to, caloric expenditure, heart rate/heart rate response, heart rate variability, body fat
percentage, sleep hygiene (deep and REM sleep duration) in real-time. Measures should be accurate
with low fixed bias, wirelessly communicated via Bluetooth, Near Field Magnetic Induction or
Radio Frequency technology in real-time and provide the command the capability to utilize the data
for analysis of individuals and/or team performance via the USSOCOM Human Performance Data
Management System (i.e., Smartabase). The device should be able to be turned on/off and/or have an
inactive mode, provide real-time feedback on a display screen, be capable of displaying time, and be
adjustable to fit users of different statures. Of parallel interest to address is a proposed project to track
aircrew sleep, fatigue, and performance degradations through a wearable device that provides
quantitative data (rather than qualitative surveys often seen in USAF Fatigue Studies), that in turn
will be gathered and amalgamated from entire units, in order to track individual performance, unit
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performance, mission impacts to performance levels, length of time for acclimatization (if it is ever
achieved), and potential risk of mishaps.
d. Diagnostics for Performance Sustainment:
The proposed project must research, apply, and/or develop minimally invasive diagnostic devices to
provide actionable information on nutritional gaps, hormonal response to training, physiological
response to performance interventions and recovery, and epigenetic predictors of potential injury.
e. Performance Nutrition:
The proposed projects must research, apply and/or develop methods to accurately measure nutritional
status of SOF personnel. The proposed project should focus on cost effectiveness, accuracy, and
end-user compatibility (i.e., user friendly) methods or devices for identifying and optimizing an
individual’s nutrient status. Consideration of alternative fuel (energy) sources, dietary
supplementation, and nutrient volume/timing are specific areas of interest.
f. Pharmaceutical and Nutritional Supplement Interactions:
The proposed project must research, apply, and/or develop novel approaches to determining what, if
any, meaningful interactions occur between and among SOF-common medications (i.e., over-the-
counter (OTC) or prescription (Rx) and commonly ingested/commercially available nutritional
supplements).
g. Physiological Performance:
The proposed project must research, apply, and/or develop novel approaches and/or technologies to
maximize the physiological performance of SOF personnel in austere and/or training environments,
to include increased endurance, enhanced senses, tolerance to environmental extremes, and enhanced
overall fitness, in order to maintain operational posture/ability in high stress scenarios without
noticeable augmentation, and without hampering personnel mobility.
h. Cognitive Performance:
The proposed project must research, apply, and/or develop novel approaches and/or technology that
provide greater mental acuity or neuroenhancement (i.e., targeted enhancement and extension of
cognitive and affective abilities). Encompasses pharmacological and non-pharmacological methods
of improving cognitive, affective, motor functionality and performance, to include neuromodulation.
i. Psychological Performance and Suicide Prevention:
The proposed project must research, apply, and/or develop novel approaches to the assessment and
improvement of behavioral health within the force. Examples include but are not limited to, novel
approaches to treatment and rehabilitation from acute and/or chronic post-traumatic stress,
depression, and anxiety, improved emotional and nervous system self-regulation, digital/virtual
engagement strategies, methods to measure behavioral health performance over time, and improved
suicide prevention tools/strategies.
j. Family Readiness and Social Connectedness:
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The proposed project must research, apply, and/or develop novel approaches to increase healthy SOF
family functioning. Family functioning includes positive interpersonal relationships, personal
resilience, self-efficacy, and the development of supportive social networks. Potential research could
determine what educational and didactic experiences best improve these factors of healthy SOF
family and relational functioning.
k. Spiritual Resilience:
The proposed project must research, apply, and/or develop innovative approaches to increase SOF
spiritual resilience or add scientific rigor to support current approaches. Spiritual resilience includes
religious practice, morals, ethics (such as just war tradition), connectedness, sense of purpose and
belonging. Potential research could determine what types of spiritual training or engagements best
improve these factors of spiritual resilience.
11. Canine Medicine and Performance:
SOF personnel rely on canines’ exceptional capabilities as combat multipliers. This research area
explores alternatives and/or new approaches to preserve and enhance SOF canine combat
performance. SOF medical personnel place a premium on canine-specific approaches that are
effective in extreme environments and do not require significant additional logistical support (i.e.,
maximize use of available SOF Medic materiel). The eight “Canine Medicine and Performance”
project areas, to which SOF will give consideration, in priority order, are:
a. Trauma Resuscitation:
The proposed project must support development of innovative techniques/strategies for canine
trauma resuscitation (e.g., hypotensive resuscitation, whole blood/blood component replacement, and
non-compressible hemorrhaging), particularly to address ballistic projectile injuries, in
diverse/austere environments that lack immediately available medical evacuation or restorative
surgical capacity.
Note: Research should minimize or refrain from utilizing canine specific equipment or devices; this
will allow treatment from existing trauma kits fielded by SOF Medics.
b. Non-Traditional Anesthesia Protocols:
The proposed project must develop novel approaches for routine and emergency/post- traumatic
canine field sedation and/or anesthesia in diverse environments and, utilizing pharmaceuticals
available to SOF Medics.
c. Canine Performance Optimization
The proposed project must research, apply, and/or develop novel approaches and/or technologies that
address optimization of canine performance through improved physical conditioning programs,
enhanced nutrition, and genetics research.
d. Sensory Optimization and Protection:
Research must be oriented toward innovative methods that enhance or conserve SOF canine
olfactory, visual, and/or auditory performance during combat operations.
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e. Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Canine Decontamination,
Treatment, and PPE Against Possible Exposure:
The proposed projects must research, apply, and/or develop novel approaches that will diagnose,
treat, decontaminate, and protect canines from exposure to chemical, biological, radiological,
nuclear, and high yield explosives.
f. Environmental Extremes:
Project proposals must research, apply, and/or develop novel strategies that address acclimatization
to acute extremes in temperature, altitude, and/or time zone change (circadian acclimatization),
and/or prolonged marine environmental exposure in SOF canines.
g. Brain Health and TBI
Brain health research efforts include but are not limited to development and validation of NCATs,
blast exposure and impact monitoring, determination of safe acceptable limits for blast exposure,
validation of neurocognitive baseline testing, capabilities to easily determine mild, moderate, and
severe TBI, pharmaceuticals to prevent or treat brain injury, validation of brain injury treatment
strategies, and procedures to determine safe return to duty decisions for SOF canines.
h. Pre- and Post-Trauma Training / Behavioral Issues:
The proposed project must address unique approaches to diagnosing and treating SOF-peculiar
training and post-traumatic canine behavioral issues, in order to optimize pre-purchase selection and
post-purchase training strategies across the enterprise and restore performance in canines with
behavioral and/or post-trauma issues.
i. Canine Simulation Technologies:
Develop improved pre-hospital canine combat casualty simulation training devices with an emphasis
on Special Operations Forces (SOF) pre-hospital providers. The proposed projects must research and
apply/or develop novel approaches for high-fidelity canine trauma training simulation devices with
physiologically relevant feedback to include temperature, pulse, lifelike size and weight, realistic fur,
active bleeding, anatomically accurate airways, and haptic technology. Canine training devices
should respond to medical treatments with little to no operator/trainer intervention and capture and
provide accurate casualty care feedback. All simulators/simulations should meet Joint Airworthiness
Standards.
II.B. Federal Award Information
The Anticipated total costs budgeted for the entire period of performance inclusive of all contract
awards made in response to this BAA, will not exceed $10 Million annually. The number of
awards is indeterminate and contingent upon funding availability. Any funding that is received
by the USSOCOM that is appropriate for a research area described within this BAA may be
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utilized to fund awards. Refer to Section II.D.5. Funding Restrictions, for detailed funding
information.
The USAMRAA will negotiate the contract awards for proposals selected for funding. A contract
is required when the principal purpose of the instrument is to acquire supplies or services for the
direct benefit or use of the U.S. Government. The contract type, along with the start date, will be
determined during the negotiation process.
Please see Appendix 2 of the General Submission Instructions for more information.
Research involving Human Anatomical Substances, Human Subjects, or Human Cadavers:
All DoD-funded research involving new and ongoing research with human anatomical
substances, human subjects, or human cadavers must be reviewed and approved by the
USAMRDC Office of Human Research Oversight (OHRO),, prior to research implementation.
This administrative review requirement is in addition to the local Institutional Review Board
(IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is
not required. The OHRO Human Research Protections Offiical (HRPO) review is mandated to
comply with specific laws and requirements governing all research involving human anatomical
substances, human subjects, or human cadavers that is supported by the DoD. These laws and
requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a
minimum of 2 to 3 months for OHRO HRPO regulatory review and approval processes.
Additional time for regulatory reviews may be needed for clinical studies taking place in
international settings. When possible, protocols should be written for research with human
subjects and/or human anatomical substances that are specific to the DoD-supported effort
outlined in the submitted proposal/application as a stand-alone study. Submission to OHRO of
protocols involving more than the scope of work in the DoD-funded award will require review of
the entire protocol (DoD and non-DoD funded). DoD human subjects protection requirements
may be applied to non-DoD funded work and necessitate extensive revisions to the protocol.
Refer to the General Submission Instructions, Appendix 1, and the Human Subject Resource
Document available on the eBRAP “Funding Opportunities & Forms” web page
(https://ebrap.org/eBRAP/public/Program.htm) for additional information.
Typically, a clinical trial is not associated with this BAA. A clinical trial is defined as a
prospective accrual of patients (human subjects) in which an intervention (e.g., device, drug,
biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested
for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome
represents a direct effect on the subject of that intervention or interaction.
Research Involving Animals: All DoD-funded research involving new and ongoing research
with animals must be reviewed and approved by the USSOCOM Veterinarian Review Office
(VRO) which ensures that research conducted, contracted, sponsored, supported, or managed by
the DoD involving animal care are conducted in accordance with federal, DoD, Army,
USSOCOM VRO, and international regulatory requirements. The USSOCOM VRO is
responsible for administrative review, approval, and oversight of all animal research protocols,
including all changes made during the life of the protocol.
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Specific documents relating to the use of animals in the proposed research will be requested if
the application is selected for funding. The VRO must review and approve all animal use prior
to the start of working with animals, including amendments to ongoing projects. PIs must
submit the institutional animal use protocol. Allow at least 1 to 2 months for regulatory review
and approval processes for animal studies.
Questions concerning animal use and review should be directed to the USSOCOM VRO:
Phone: 813-826-6031; Email: socom_vet@socom.mil.
Refer to the General Submission Instructions, Appendix 1, for additional information.
The USSOCOM intends that information, data, and research resources generated under awards
funded by this BAA be made available to the research community (which includes both
scientific and consumer advocacy communities) and to the public at large.
II.C. Eligibility Information
II.C.1. Eligible Applicants
II.C.1.a. Organizations:
Awards are made to organizations only. Organizations eligible to apply include national,
international, for-profit, non-profit, public, and private organizations. Refer to the General
Submission Instructions, Appendix 3.B, for general eligibility information.
NOTE: In accordance with FAR 35.017, Federally Funded Research and Development Centers
(FFRDCs) are not eligible to directly receive awards under this BAA. However, teaming
arrangements between FFRDCs and eligible organizations are allowed so long as they are
permitted under the sponsoring agreement between the Federal Government and the specific
FFRDC.
The USSOCOM is committed to supporting small businesses. Small business, Veteran-owned
small business, Service-disabled Veteran-owned small business, HUBZone small business, small
disadvantaged business, and woman-owned small business concerns must be given the
maximum practical opportunity to participate through subawards on research proposals
submitted through the BAA.
II.C.1.b. Eligible Investigators
Eligible investigators include all individuals, regardless of ethnicity, nationality, or citizenship
status, who are employed by, or affiliated with, an eligible organization.
There are no limitations on the number of proposals for which an investigator may be named as a
Principal Investigator (PI).
The USAMRAA makes awards to eligible organizations, not to individuals.
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In addition to other information provided herein, by submitting a proposal/application and
accepting an award, the organization is: (1) certifying that the investigators’ credentials have
been examined and; (2) verifying that the investigators are qualified to conduct the proposed
study and to use humans or animals as research subjects, if proposed.
II.C.2. Cost Sharing
Cost sharing/matching is not an eligibility requirement.
II.C.3. Other
Organizations must be able to access .gov and .mil websites in order to fulfill the financial and
technical deliverable requirements of the award and submit invoices for payment.
Refer to Section II.H.1, Administrative Actions, for a list of administrative actions that may be
taken if a pre-application or application does not meet the administrative, eligibility, or ethical
requirements defined in this BAA.
For general information on required qualifications for award recipients, refer to the General
Submission Instructions, Appendix 3.
Use of the System for Award Management (SAM) and the Responsibility/Qualification (R/Q):
To protect the public interest, the Federal Government ensures the integrity of Federal programs
by striving to conduct business only with responsible organizations. The USSOCOM uses the
“Exclusions” within the Performance Information functional area of the SAM and data from the
R/Q, a component within SAM, to verify that an organization is eligible to receive Federal
awards. More information about the SAM and the R/Q is available at https://www.sam.gov/.
Refer to the General Submission Instructions, Appendix 3, for additional information.
Conflicts of Interest: All awards must be free of conflicts of interest (COIs) that could bias the
research results. Prior to award of a contract, applicants will be required to disclose all potential
or actual COIs along with a plan to manage them. An award may not be made if it is determined
by the Contracting Officer that COIs cannot be adequately managed. Refer to the General
Submission Instructions, Appendix 3, for additional information.
Review of Risk: The following areas may be reviewed in evaluating the risk posed by an
applicant: Financial stability; quality of management systems and operational controls; history
of performance; reports and findings from audits; ability to effectively implement statutory,
regulatory, or other requirements imposed on non-Federal entities; degree of institutional
support; integrity; adequacy of facilities; and conformance with safety and environmental
statutes and regulations.
Subcontracting Plan: If the resultant award is a contract that exceeds $750,000 and the offeror
is other than a small business, the contractor will be required to submit a subcontracting plan for
small business and small disadvantaged business concerns, in accordance with FAR 19.704 and
DFARS 219.704. A mutually agreeable plan will be incorporated as part of the resultant
contract.
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II.D. Proposal/Application Submission Information
II.D.1. Where to Obtain the Proposal/Application Submission Package
To obtain the complete Grants.gov proposal/application package (hereinafter, submission
package), including all required forms, perform a Grants.gov (http://www.grants.gov/) basic
search using the Funding Opportunity Number HT9425-23-S-SOC1.
Submission is a two-step process requiring both (1) pre-proposal/pre-application submission
through eBRAP (https://eBRAP.org/) and (2) full proposal/application submission through
Grants.gov or eBRAP, depending on the type of application being submitted.
eBRAP is a multifunctional web-based system that allows PIs to submit their pre-applications
electronically through a secure connection, to view and edit the content of their pre-applications
and full applications, to receive communications from the USSOCOM, and to submit
documentation during award negotiations and period of performance.
Classified Submissions: Classified proposals are not expected. However, in an unusual
circumstance the applicant may be notified that access to classified information and/or controlled
unclassified information will occur under the work proposed. In those instances where a contract
is awarded requiring access to classified information and/or controlled unclassified information,
clause FAR 52.204-2 shall be in effect, as well as a DD Form 254, if issued.
Care must be exercised to ensure that classified, sensitive, and critical technologies are not
included in a proposal/ application package. If such information is required, appropriate
restrictive markings and procedures should be applied prior to submission of the proposal/
application package. Portions of the proposal/ application package may be subject to release
under terms of the Freedom of Information Act, 5 U.S.C. 552, as amended.
Pre-application content and forms must be accessed and submitted at eBRAP.org. Full
application packages must be accessed and submitted at Grants.gov.
Contact information for the eBRAP Help Desk and the Grants.gov Contact Center can be found
in Section II.G, Federal Awarding Agency Contacts.
II.D.2. Content and Form of the Proposal/Application Submission
Submission is a two-step process requiring both pre-application submission and full application
submission as indicated below. The submission process should be started early to avoid missing
deadlines. There are no grace periods.
Pre-Application Submission: All pre-applications for extramural organizations must be
submitted through eBRAP (https://eBRAP.org/).
Full Application Submission: Full applications must be submitted through the online portals as
described below.
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Submitting Organizations: Full applications from extramural organizations must be submitted
through a Grants.gov Workspace. Applications submitted by extramural organizations (e.g.,
research foundations) on behalf of intramural DoD or other Federal organizations or
investigators will be considered extramural submissions. Applications from extramural
organizations, including non-DoD Federal organizations, received through eBRAP will be
withdrawn. See definitions in Section II.C.1, Eligible Applicants.
A key feature of eBRAP is the ability of an organization’s representatives and PIs to view and
modify the full application submissions associated with them. eBRAP will validate full
application files against the specific BAA requirements, and discrepancies will be noted in an
email to the PI in the “Full Application Files” tab in eBRAP. It is the applicant’s responsibility
to review all application components for accuracy as well as ensure proper ordering as specified
in this BAA.
The application title, eBRAP log number, and all information for the PI, Business Official(s),
performing organization, and contracting organization must be consistent throughout the
entire pre-application and full application submission process. Inconsistencies may delay
application processing and limit or negate the ability to view, modify, and verify the application
in eBRAP. If any changes need to be made, the applicant should contact the eBRAP Help Desk
at help@eBRAP.org or 301-682-5507 prior to the application submission deadline.
II.D.2.a. Step 1: Pre-Proposal/Pre-Application Submission Content
Submission of a pre-proposal/pre-application is required and must be submitted through eBRAP
(https://eBRAP.org/). If the USSOCOM is interested in receiving a full proposal/application, the
PI will be sent an invitation to submit via eBRAP.
During the pre-proposal/pre-application process, each submission is assigned a unique log
number by eBRAP. This unique eBRAP log number is required during the full application
submission process. To begin the pre-application process, first select whether the submitting
organization is extramural or intramural, then confirm your selection or cancel. Incorrect
selection of extramural or intramural submission type will delay processing.
If an error has been made in the selection of extramural versus intramural and the pre-application
submission deadline has passed, the PI or Business Official must contact the eBRAP Help Desk
at help@eBRAP.org or 301-682-5507 to request a change in designation.
Because the invitation to submit a proposal/application is based on the contents of the pre-
proposal/pre-application, a PI should not change the title or research objectives after the pre-
proposal/pre-application is submitted. A PI and organization identified in the pre-proposal/pre-
application should be the same as those intended for the full proposal/application submission. If
any changes are necessary after submission of the pre-proposal/pre-application, the PI must
contact the eBRAP Help Desk via email at help@eBRAP.org or 301-682-5507. A change in PI
or organization after submission of the pre-proposal/pre-application will be allowed only at the
discretion of the USAMRAA Contracting Officer. Change in Principal Investigator during
contract performance unless otherwise restricted, will be allowed at the discretion of the
USAMRAA Contracting Officer, provided that the intent of the award is met.
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The organization, Business Official, and PI must register in eBRAP before submitting a pre-
proposal/pre-application. Upon completion of an organization’s registration in eBRAP and
approval by the eBRAP Help Desk, the organization name will be displayed in eBRAP to assist
the organization’s Business Officials and PIs as they register. The organization, Business
Officials, and PIs must all be registered and affiliated in eBRAP. (See eBRAP User Guide at
https://ebrap.org/eBRAP/public/UserGuide.pdf.)
Pre-proposals may be submitted at any time prior to the BAA closing date. Pre-proposals should
describe specific ideas or projects that pertain to any of the areas described under “Program
Description” in this BAA. A pre-proposal/pre-application must include a brief description of the
scientific methods and design to address the problem as described below. Brochures or other
descriptions of general organizational or individual capabilities will not be accepted as a pre-
proposal/pre-application. DO NOT include any proprietary information in the pre-
proposal/pre-application.
The pre-proposal/pre-application consists of the following components, which are organized in
eBRAP by separate tabs. Refer to the General Submission Instructions, Section II, for additional
information on the pre-proposal/pre-application submission.
• Tab 1 – Application Information: Enter the information as described in eBRAP before
continuing the pre-proposal/pre-application.
• Tab 2 – Application Contacts: Enter contact information for the PI and the
organization’s Business Official responsible for the sponsored program administration (or
equivalent). This is the individual listed as “person to be contacted on matters involving
this Application” in Block 5 of the Grants.gov SF424 form. The form is designed to fill in
common required fields across other forms, such as the applicant name, address, and
Unique Entity Identifier (UEI) Number. Once it is completed, the information will
transfer to the other forms.
The Business Official must either be named or invited in order for the pre-proposal/pre-
application to be submitted. If the organization’s Business Official is not in eBRAP, an
invitation to the Business Official to register in eBRAP must be sent. In addition, it is
recommended that the applicant identify an Alternate Submitter in the event that
assistance with pre- proposal/pre-application submission is needed.
NOTE: The eBRAP system does not require an approval of the pre-proposal/pre-
application by the PI’s organization.
• Tab 3 – Collaborators and Key Personnel:
Enter the name, organization, and role of all collaborators and key personnel associated
with the Application (including co-investigators, mentors, collaborators, consultants, and
subrecipients/subawardees) associated with the proposal/ application. Enter the
organization’s Business Official responsible for sponsored program administration (the
“person to be contacted on matters involving this Application” in Block 5 of the
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Grants.gov SF-424 form). The Business Official must either be selected from the eBRAP
list or invited in order for the pre- proposal/pre-application to be submitted.
• Tab 4 – Conflicts of Interest (COI):
List all individuals other than collaborators and key personnel who may have a conflict of
interest (COI) in the review of the pre-proposal/pre-application (including those with
whom the PI has a personal or professional relationship). Federal agency personnel
involved in the review process and/or with making funding recommendations are
prohibited from being involved in the research proposed or assisting in any pre-
proposal/pre-application, including, but not limited to, concept design, proposal/
application development, budget preparation, and the development of any supporting
documentation. If formal collaboration with Military Facility personnel is planned
(i.e., included in the proposal/application in performance of the research), this
prohibition is not applicable. Military Facility is defined as Military Health System
(MHS) facility, research laboratory, medical treatment facility, dental treatment
facility, or a DoD activity embedded with a civilian medical center. However, these
Military Facility personnel cannot be involved in the review process and/or with
making funding recommendations. Refer to the General Submission Instructions,
Appendix 3.D, for additional information. For questions related to COI, contact the
eBRAP Help Desk at help@eBRAP.org or 301-682-5507.
• Tab 5 – Pre-Application Files:
Note: Upload document(s) as individual PDF files unless otherwise noted. eBRAP will
not allow a file to be uploaded if the number of pages exceeds the limit specified below.
Pre-Proposal/Pre-Application Narrative (6-page limit): The pre-proposal/ pre-
application narrative page limit applies to text and non-text elements (e.g., figures, tables,
graphs, photographs, diagrams, chemical structures, drawings, etc.) used to describe the
project. Inclusion of URLs that provide additional information to expand the Narrative
and could confer an unfair competitive advantage is prohibited and may result in
administrative withdrawal of the pre-proposal/pre-application.
Include the following:
○ Problem to Be Studied: Describe the perceived issue(s) and the problems to be
studied. This section should serve as an abstract of the proposed work.
○ Theoretical Rationale, Scientific Methods, and Design: Describe how the
research approach for accomplishing the specific aims is feasible, will
accomplish the objectives, will provide information on proposed methods and
analysis/evaluation strategies, and is based on sound rationale. Describe how the
proposed work and research will create and produce a demonstration and
validation/proof of concept to meet the subject Topic Area.
– Background/Rationale: Clearly present the ideas and reasoning behind
the proposed research. Include relevant military and civilian literature
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citations, preliminary and/or pilot data, and/or other evidence that led to
the development of the proposed research. Any preliminary data should
be from the laboratory of the PI or member(s) of the collaborating team.
– Hypothesis/Objective and Specific Aims: State the proposed project’s
hypothesis and/or objectives and the specific aims/tasks of the proposed
research.
– Approach/Methodology: Describe the research approach. Include
research design, methods, and analysis/evaluation strategies as well as
materials anticipated to be used during the research. Include a description
of human use in the proposed project. For studies involving human
subjects, include a description of the size, characteristics, and partnering
organizations of the subject population that will be employed.
○ Significance, Relevance, and Innovation of the Proposed Effort:
– Significance and Relevance: Clearly articulate how the proposed research is
instrumental in addressing research gaps, meets military requirements, and has
military relevance to improving theater/operational medicine.
– Innovation: Explain how the proposed project is innovative and not an
incremental advancement of previous work.
○ Proposed Study Design/Plan: Provide the intended research methodology that
will support the study. Provide preliminary information such as description and
background of the technical solution, anticipated success criteria, research/test
plan(s), and statistical protocols. Refer to Section II.A., Program Description, for
additional information on the RAIs for this BAA.
○ Military Impact: Describe the anticipated short- and/or long-term outcomes of the
proposed project and their potential impact on improving technologies, data and/or
processes. Refer to Section II.A., Program Description, for additional information on
the anticipated outcomes sought by this BAA.
○ Personnel and Facilities: Describe the role of the PI, co-PIs (if applicable), key
personnel, sub-awards (if applicable), and consultants (if applicable) in the research
team, including the expertise each brings to the proposed project. Explain how the
team’s expertise is appropriate and complementary for achieving the research goals.
Also, briefly provide information on the primary facility where the research is
expected to be performed.
○ Open Source/License/Architecture: Describe the intellectual property that is
intended to be incorporated within the design/plan and identify any additional
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costs, such as licensing, which may be needed to ensure flexibility or adaption of
the research project for Government use.
Pre-Proposal/Pre-Application Supporting Documentation: The items to be included as
supporting documentation for the pre-proposal/pre-application must be uploaded as individual
PDF documents and are limited to:
○ References Cited (one-page limit): List the references cited (including URLs if
available) in the pre-proposal/pre-application narrative using a standard reference
format that includes the full citation (i.e., author[s], year published, title of reference,
source of reference, volume, chapter, page numbers, and publisher, as appropriate).
○ List of Abbreviations, Acronyms, and Symbols: Provide a list of abbreviations,
acronyms, and symbols used in the pre-proposal/pre-application narrative.
○ PI and Key Personnel Biographical Sketches (five-page limit per individual):
Upload as “Biosketch_LastName.pdf.” Bold or highlight publications relevant to the
proposed project.
○ Budget Summary: Upload as “BudgetSummary.pdf.” Complete the two-page Pre-
Application Budget Summary Form (available for download in eBRAP) as instructed.
○ Quad Chart: Upload as “QuadChart.pdf.” Complete the one-page Quad Chart
Form (available for download in eBRAP) as instructed.
 Submit Pre-Application – Tab 6: This tab must be completed for the pre-
proposal/preapplication to be accepted and processed.
II.D.2.b. Pre-Proposal/Pre-Application Screening Criteria
The USSOCOM scientists or outside experts will screen pre-proposals for technical merit and
programmatic considerations. Based on the screening of the preproposal, a PI may be invited to
submit a full proposal/application. Pre- proposal will be screened based on the following
criteria, listed in descending order of importance:
• Theoretical Rationale, Scientific Methods, and Research: To what degree the
research approach for accomplishing the specific aims is feasible, will accomplish
the objectives, will provide information on proposed methods and analysis/
evaluation strategies, and is based on sound rationale. To what degree the proposed
work and research will create and produce a demonstration and validation/proof of
concept to address the Topic Area.
• Significance, Relevance, and Innovation: To what degree the proposed research is
relevant and innovative, including whether the proposed research is duplicative of
existing research.
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• Study Design/Plan: To what degree the proposed demonstration and validation study
methodologies, anticipated sample and sample size, test plan(s), anticipated success
criteria, evaluation criteria/metrics, and statistical protocols will justify and support
the intended outcomes of the proposed research.
• Military Impact: To what degree the project’s anticipated short- and/or long-term
outcomes will impact the military and provide advancement in theater/operational
medicine in the military health system in a way that is consistent with the intent of
the award mechanism.
• Personnel, Facilities, Timelines, and Budget: To what degree the expertise,
experience, and knowledge of the key research personnel (including co-PIs if
applicable), sub-awards (if applicable), and consultants (if applicable) are
appropriate and complementary for achieving the research goals. To what degree
the prime facility will be able to perform the proposed research.
Following the pre-proposal/pre-application screening, PIs will be notified as to whether or not
they are invited to submit full proposals; however, they will not receive feedback (e.g., a critique
of strengths and weaknesses) on their pre-proposals. Within 180 days of submission, PIs should
receive email notification via eBRAP regarding disposition of their pre-proposals.
A. II.D.2.c. Step 2: Full Proposal/Application Submission Content
A Proposal/Application will not be accepted unless the PI has received an invitation to submit.
If the USSOCOM is interested in receiving a full proposal/application, the PI will receive an
invitation to submit via email from eBRAP. It should be submitted within 60 days of the PI’s
receipt of an invitation to submit, as directed in II.D.2. Agency receipt of a full
proposal/application will be acknowledged by an email sent to the PI via eBRAP. The
proposal/application log number for the full proposal/application will be the same number as
used for the pre-proposal/pre-application, e.g., SO23XX.
The USSOCOM cannot make allowances/exceptions to its policies for submission problems
encountered by the applicant organization using system-to-system interfaces with Grants.gov.
Each application submission must include the completed full application package for this BAA.
The full application package is submitted by the Authorized Organizational Representative
through Grants.gov (http://www.grants.gov/) for extramural organizations. See Table 1 below for
more specific guidelines. Proprietary information should only be included if necessary for
evaluation of the proposal/application. Conspicuously and legibly mark any proprietary
information that is included in the proposal/application.
II.D.2.c.i. Full Guidelines
Organizations must submit full applications through Grants.gov. Applicants must create a
Grants.gov Workspace for submission, which allows the application components to be
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completed online and routed through the applicant organization for review prior to submission.
Applicants may choose to download and save individual PDF forms rather than filling out
webforms in the Workspace. A compatible version of Adobe Reader must be used to view,
complete, and submit an application package consisting of PDF forms. If more than one person
is entering text into an application package, the same version of Adobe Reader software should
be used by each person. Check the version number of the Adobe software on each user’s
computer to make sure the versions match. Using different versions of Adobe Reader may cause
submission and/or save errors – even if each version is individually compatible with Grants.gov.
Refer to the General Submission Instructions, Section III, and the “Apply For Grants” page of
Grants.gov (https://www.grants.gov/web/grants/applicants/apply-for-grants.html) for further
information about the Grants.gov Workspace submission process. Submissions of extramural
applications through eBRAP may be withdrawn.
Table 1. Full Submission Guidelines
Submissions
Download application package components for
HT9425-23-S-SOC1 from Grants.gov
(http://www.grants.gov) and create a Grants.gov
Workspace. The Workspace allows online
completion of the application components and
routing of the application package through the
applicant organization for review prior to
submission.
SF424 Research & Related Forms (R&R)
Application for Federal
Assistance Form: Refer to the General
Submission Instructions, Section III.A.1, for
detailed information.
Submissions
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Descriptions of each required file can be found
under Full Application Submission Components:
• Attachments
• Research & Related Personal Data
• Research & Related Senior/Key Person
Profile (Expanded)
• Research & Related Budget
• Project/Performance Site Location(s) Form
• R&R Subaward Budget Attachment(s) Form
(if applicable)
• (if applicable) Additional Application
Component(s)
Complete a Grants.gov Workspace.
Add participants (investigators and Business
Officials) to the Workspace, complete all required
forms, and check for errors before submission. The
Workspace progress bar will display the state of
your application process as you apply. As you
apply using Workspace, you may click the blue
question mark icon near the upper-right corner of
each page to access context-sensitive help.
Mandatory Fields in Forms: In the forms, you
will note fields marked with an asterisk and a
different background color. These fields are
mandatory fields that must be completed to
successfully submit your application.
Submit a Grants.gov Workspace Package. An
application may be submitted through
Workspace by clicking the “Sign and Submit”
button on the “Manage Workspace” page, under the
“Forms” tab. Grants.gov recommends submission
of the application package at least 24-48 hours
prior to the close date to allow time to correct any
potential technical issues that may disrupt the
application submission.
Note: If either the Project Narrative or the budget
fails eBRAP validation or if the Project Narrative
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or the budget needs to be modified, an updated
Grants.gov application package must be submitted
via Grants.gov as a “Changed/Corrected
Application” with the previous Grants.gov
Tracking ID prior to the application submission
deadline.
Submissions
The full application package submitted to
Grants.gov may be viewed and modified in eBRAP
until the end of the application verification period.
During the application verification period, the full
application package, with the exception of the
Project Narrative and Budget Form, may be
modified.
Tracking a Grants.gov Workspace Package.
After successfully submitting a Workspace
package, a Grants.gov Tracking Number is
automatically assigned to the package. The
number will be listed on the “Confirmation” page
that is generated after submission.
Refer to the General Submission Instructions,
Section III, for further information regarding
Grants.gov requirements.
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Application viewing, modification, and verification in eBRAP are strongly recommended, but
not required. The Project Narrative and Budget cannot be changed after the application
submission deadline. Prior to the full application deadline, a corrected or modified full
application package may be submitted. Other application components may be changed until the
end of the application verification period. Verify that subaward budget(s) and budget
justification forms are present in eBRAP during the application verification period. If these
components are missing, upload them to eBRAP before the end of the application verification
period. After the end of the application verification period, the full application cannot be
modified.
Material submitted after the end of the application verification period, unless specifically
requested by the Government, will not be forwarded for processing.
II.D.2.c.ii. Full Proposal/Application Submission Components
The Grants.gov submission package includes the following components (refer to the General
Submission Instructions, Section III., for additional information on proposal/application
submission):
1. SF 424 (R&R) Application for Federal Assistance Form: Refer to the General
Submission Instructions, Section III for detailed information.
2. Attachments Form
Each attachment to the full proposal/application components must be uploaded as an
individual file in the format specified and in accordance with the formatting guidelines
listed in the General Submission Instructions, Appendix 4.
For all attachments, ensure that the file names are consistent with the guidance. Attachments
will be rejected if the file names are longer than 50 characters or have incorrect file names
that contain characters other than the following: A-Z, a-z, 0-9, underscore, hyphen, space,
and period. In addition, there are file size limits that may apply in some circumstances.
Individual attachments may not exceed 20 MB, and the file size for the entire full
proposal/application package may not exceed 200 MB.
 Attachment 1: Project Narrative (20-page limit): Upload as
“ProjectNarrative.pdf.” The page limit of the Project Narrative applies to text
and non-text elements (e.g., figures, tables, graphs, photographs, diagrams,
chemical structures, drawings, etc.) used to describe the project. Inclusion of
URLs that provide additional information to expand the Project Narrative and
could confer an unfair competitive advantage is prohibited and will result in
administrative withdrawal of the proposal/application.
Describe the proposed project in detail using the outline below.
○ Background: Present the ideas and reasoning behind the proposed
research; include relevant literature citations or preliminary data on the
proposed technical solution(s) and how they may have been utilized in
similar environment(s). Describe previous experience most pertinent to this
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project. Any preliminary data should be from the laboratory of the PI or
member(s) of the collaborating team.
○ Hypotheses/Objectives: State the hypotheses or research/evaluation
questions and overall objective(s) to be reached.
○ Specific Aims: Concisely explain the project’s specific aims to include
expected timeframe of each aim. If this proposal/application is part of a
larger study, present only tasks this award would fund.
○ Project Design: Describe and define the research design, methods, and
analyses/evaluations in sufficient detail for analysis.
— Clearly support the choice of study variables/metrics and explain the
basis for the research questions and/or study hypotheses. Establish the
relevance of the study and explain the applicability of the proposed
findings.
— Provide a detailed protocol, including but not limited to, proposed
methodologies, research/test plan(s) and criteria, intended medical
domain(s) or discipline(s), control groups, and defined statistical
models.
— Define the study variables (independent/dependent) and define how they
will be measured. Include a description of appropriate controls and the
endpoints to be tested. Describe how data will be collected and analyzed in
a manner that is consistent with the study objectives. Describe a plan for
data access and outcome dissemination.
— For development of devices and technologies, discuss the engineering/
technical design that will be used to achieve the project goals,
demonstrating the feasibility of the proposed product development. Discuss
the perceived engineering/design strengths and flaws and recommendations
for overcoming/preventing them.
— Address all potential barriers and provide plans for addressing potential
delays, unexpected events, changes in key personnel, and ongoing
adaptation of the Application. Provide a risk management plan to address
barriers to plans. As relevant, describe plans for addressing potential
issues unique to working within the military health system.
— Document the availability and accessibility of the study materials (including
data) needed as applicable.
○ Project Milestones: Identify timelines for critical events that must be
accomplished in order for the project to be successful in terms of cost,
schedule, and performance. For development of devices and technologies,
discuss the timelines and provide a commercial strategy plan for the
technology being developed.
○ Additional Information: If human subjects are involved in the research,
proposals may be submitted prior to human protocol institutional approvals.
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However, protocols with required institutional approvals must be submitted no
later than 60 days after award to demonstrate continued progress and ensure
continuation of payment. The Contracting Officer may make exceptions in
situations where human and/or animal use is not expected to begin until after
the first year of the research project. In such cases, a timeframe for submission
of the appropriate protocols and institutional approvals will be established
prior to award.
PIs and collaborating organizations may not use, employ, or subcontract for
the use of any human participants, including the use of human anatomical
substances, human data, and/or human cadavers, or laboratory animals until
applicable regulatory documents are approved by the OHRO and or
USSOCOM VRO to ensure that DoD regulations have been met.
– For studies with prospective accrual of human subjects, indicate
quarterly enrollment targets.
– Identify cell line(s) and commercial or organizational source(s) to be
used. If human anatomical substances (including cell lines) will be used,
specify whether or not identifiable information is accessible to the
research team by any means.
– If applicable, indicate time required for submission and/or approval of
documents (e.g., Investigational New Drug and Investigational Device
Exemption) to the U.S. Food and Drug Administration or appropriate
Government agency.
– For studies involving human subjects, allow at least 2 to 3 months for
regulatory review and approval by the USAMRDC OHRO; this does not
include the additional time required for local Institutional Review Board
(IRB)/Ethics Committee (EC) review and approval.
Refer to the General Submission Instructions, Appendix 5, for additional
regulatory information.
 Attachment 2: Supporting Documentation: Start each document on a new
page. Combine and upload as a single file named “Support.pdf.” If
documents are scanned to pdf, the lowest resolution (100 to 150 dpi) should be
used. The Supporting Documentation attachment should not include additional
information such as figures, tables, graphs, photographs, diagrams, chemical
structures, or drawings.
There are no page limits for any of these components unless otherwise noted.
Include only those components described below; items not requested will be
removed and may result in administrative withdrawal of the
proposal/application.
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○ Bibliography and References Cited: List the references in the order they
appear in the Project Narrative. Use a standard reference format that includes
the full citation (i.e., author[s], year published, title of reference, source of
reference, volume, chapter, page numbers, and publisher, as appropriate. Do
not send or attach copies of articles in print. There is no form for this
information. The attachments should be in PDF in accordance with the
formatting guidelines specified for full proposal/application preparation.
○ List of Abbreviations, Acronyms, and Symbols: Provide a list of
abbreviations, acronyms, and symbols.
○ Facilities, Existing Equipment, and Other Resources: Describe the
facilities and equipment available for performance of the proposed project
and any additional facilities or equipment proposed for acquisition at no cost
to the award. Indicate whether or not Government-furnished facilities or
equipment are proposed for use. If so, reference should be made to the
original or present Government award under which the facilities or equipment
items are now accountable. There is no form for this information.
Note: For researchers who will require access to the Defense Healthcare
Management Systems Modernization (DHMSM) Cerner Electronic
Health Record (EHR) solution for testing related to research workflows
and/or interfaces: Access will be provided through a research environment
within the Program Executive Office (PEO) Defense Healthcare
Management Systems (DHMS) Testing Infrastructure at Allegheny Ballistics
Laboratory (ABL). Users will follow the PEO DHMS Testing Infrastructure
Onboarding Guide to access the environment. Direct support from the
DHMSM vendor will not be provided through the DHMSM contract. No one
is authorized to engage the DHMSM contractor for this purpose. Research
must remain in these stated bounds.
○ Publications and/or Patent Abstracts (five-document limit): Include
relevant publication URLs and/or patent abstracts. If publications are not
publicly available, then a copy/copies of the published manuscript(s) must
be attached.
○ Letters of Organizational Support: Provide a letter (or letters, if applicable),
signed by the Department Chair or appropriate organization official,
confirming the laboratory space, equipment, and other resources available for
the project. A letter for each organization involved in the project should be
provided.
○ Letters of Collaboration: Provide a signed letter from each collaborating
individual or organization that will demonstrate that the PI has the support or
resources necessary for the proposed work. If an investigator at an
intramural organization is named as a collaborator on an application
submitted through an extramural organization, the application must include a
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letter from the collaborator’s Commander or Commanding Officer at the
intramural organization that authorizes the collaborator’s involvement.
Refer to the General Submission Instructions, Section III.A.8., Research &
Related Budget, for additional information.
○ Joint Sponsorship (if applicable): Describe present or prospective joint
sponsorship of any portion of the program outlined in the proposal/
application. In the absence of agreements among sponsors for joint support, the
proposal/application should be structured so that the research can be carried
out without the resources of any other sponsor. If, however, it is desirable to
request partial support from another agency, the proposed plan should be stated
and the reasons documented. If the plan cannot be formulated at the time the
proposal/application is submitted, information should be sent later as an
addendum to the proposal/application. Prior approval from both agencies must
be secured for research to be undertaken under joint sponsorship. Provide
letters of support related to recruitment, subject access, and data access plans.
○ Intellectual Property (if applicable): Refer to the General Submission
Instructions, Appendix 3, for additional information. Provide the following:
– Should the Applicant intend to use, in the performance of this program,
pre-existing, legally protected and perfected intangible property and for
which no Federal funds had been used in the development of said property,
the Applicant must:
1. Clearly identify all such property;
2. Identify the cost to the Federal government for use or license of such
property if applicable; or
3. Provide a statement that no property meeting this definition will be
used on this project.

  • Intellectual and Material Property Plan: If applicable, provide a plan for

  • resolving intellectual and material property issues among participating
    organizations.
     Attachment 3: Technical Abstract (one-page limit): Upload as
    “TechAbs.pdf.”
    The technical abstract is used by all reviewers. Abstracts of all funded research
    projects will be posted publicly. Do not include proprietary or confidential
    information. Use only characters available on a standard QWERTY keyboard.
    Spell out all Greek letters, other non-English letters, and symbols. Graphics are
    not allowed. Use the outline below.
    Background: Provide a brief statement of the ideas and theoretical
    o
    reasoning behind the proposed work. o Objective/Hypothesis: State the
    objective/hypothesis to be tested. Provide evidence or rationale that supports the
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    objective/hypothesis. o Specific Aims/Milestones: State concisely the specific
    aims/milestones of the project.
    Project Design: Briefly describe the project design. o Impact: Provide a
    o
    brief statement explaining the potential impact of the proposed work to advancing
    the standard of care for injured Service members and/or the general public. o
    Relevance: Provide a brief statement explaining the potential relevance of the
    proposed work to the specific topic area being addressed and its impact on health
    outcomes.
    • Attachment 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf.”
    The lay abstract is used by all reviewers. Do not include proprietary or
    confidential information. Use only characters available on a standard
    QWERTY keyboard. Spell out all Greek letters, other non-English letters, and
    symbols. Graphics are not allowed.
    Lay abstracts should be written using the following outline. Do not duplicate the
    technical abstract.
    ○ Describe the objectives and rationale for the proposal/application in a manner
    that will be readily understood by readers without a background in science or
    medicine.
    ○ Describe the ultimate applicability and potential impact of the research.
    — What types of patients will it help, and how will it help them? Include
    the current available statistics to the related injury/condition.
    — What are the potential clinical Applications, benefits, and risks?
    — What is the projected timeline it may take to achieve the expected patient-
    related outcome?
    ○ Briefly describe how the proposed project will benefit Service
    members, Veterans, and/or family members.
    • Attachment 5: Statement of Work (SOW) (two-page limit): Upload as
    “SOW.pdf.” The suggested SOW format and examples specific to different
    types of research projects are available on the eBRAP “Funding Opportunities
    & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm). The SOW
    outlines and establishes the PI’s and an organization’s performance expectations
    for the work to be funded under this award. The SOW in an assistance
    agreement award establishes general objectives. The SOW in a contract sets
    rather specific goals and conditions for each year of the contracted project; the
    PI and contractor are expected to meet the provisions and milestones of the SOW.
    The SOW for all award types will be incorporated into the award document and,
    as such, is subject to release under the Freedom of Information Act.
    A series of relatively short statements should be included that comprise the
    approach to each of the major goals or objectives of the proposed research. The
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    statements should outline the specific tasks, systems, and materials that are
    reasonable estimates for testing the proposed hypotheses of the study. An outline
    should be included that shows the work statements to be accomplished in each
    year of the award. If this proposal/application is part of a larger study, present
    only tasks that this award would fund. Allow at least 2 to 3 months for the
    USAMRDC OHRO’s regulatory review and approval processes for studies
    involving human subjects. Allow at least 1 to 2 months for the USSOCOM
    VRO regulatory review and approval processes for studies involving animals.
    • Attachment 6: Outcomes and Impact Statement (one-page limit): Upload as
    “Impact.pdf.” Explain in detail why the proposed research project is important,
    as follows:
    ○ Short-Term Impact: Describe the anticipated outcome(s), results, theoretical
    framework, design and or plan that will be directly attributed to the results of
    the proposed research.
    ○ Long-Term Impact: Describe the anticipated long-term clinical/patient
    gains or commercial end product from the proposed project. What is the
    indication and will the project lead toward transforming the standard of
    care? Are there non-trauma-related indications that would expand the
    market for the proposed product?
    ○ Military Relevance: Clearly articulate how the proposed project or product
    meets the needs of military medical providers and injured Service
    members.
    ○ Public Purpose: If appropriate, provide a concise, detailed description on
    how this project will benefit the general public.
    • Attachment 7: Innovation Statement (two-page limit): Upload as
    “Innovation.pdf.” Describe how the proposed project is innovative. Research
    deemed innovative may introduce a new paradigm, challenge current paradigms,
    look at existing problems from new perspectives, or exhibit other creative
    qualities. Investigating the next logical step or incremental advancement on
    published data is not considered innovative. This may include a proposed
    conceptual framework, design, and/or plan of key components and how they
    integrate/communicate with each other. Identify which potential components will
    be open source/open architecture vs. proprietary.
    • Attachment 8: Data and Research Resource-Sharing Plan (one-page limit):
    Upload as “Sharing.pdf.” Describe how unique and/or final research data will
    be shared with the research community, along with any resulting research
    resources. This includes cases where pre-existing data or research resources will
    be utilized and/or modified during the course of the proposed project. If there
    are limitations associated with a pre-existing agreement for the original data or
    research resources that preclude subsequent sharing, the Applicant should
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    explain this in the data- and/or research resource-sharing plan. For projects
    involving clinical trials, PIs may be required to register their clinical trials on
    Clinicaltrials.gov (https://clinicaltrials.gov/). For projects involving TBI, PIs
    may be required to report data to the Federal Interagency Traumatic Brain Injury
    Research (FITBIR) informatics system (http://fitbir.nih.gov/). If the project
    includes systems biology- related research, the PI may be required to make the
    systems biology data, generated via an award, available to the research
    community by depositing research data into the SysBioCube system
    (https://sysbiocube-abcc.ncifcrf.gov). Refer to the General Submission
    Instructions, Appendix 2, for additional information.
    • Attachment 9: Conflicts of Interest, if applicable: Upload as “COI.pdf.”
    Provide details with the proposal/application submission of all potential or
    actual COIs, along with a plan to resolve them. A contract or assistance
    agreement will not be awarded if it is determined by the respective Contracting
    Officer that a COI cannot be managed.
    Personnel involved in the review process and/or with making funding
    recommendations are prohibited from assisting in any proposal/application,
    including, but not limited to, concept design, Application development, budget
    preparation, and the development of any supporting documentation.
    Questions related to this topic should be directed to the eBRAP Help Desk via
    email at help@eBRAP.org or 301-682-5507. Refer to the General Submission
    Instructions, Appendix 3, for additional information.
    • Attachment 10: Data Management (no page limit): Upload as
    “DataManage.pdf.” The Data Management attachment should include the
    components listed below.
    Data Management: Describe all methods used for data collection to include the
    following:
    ○ Identifiers: Describe the unique identifiers or specific code system to be used
    to identify human subjects, if applicable.
    ○ Confidentiality: Explain measures taken to protect the privacy of studies
    conducted on human subjects and the ability to maintain confidentiality of
    study data. Strategies to protect the privacy and confidentiality of study
    records, particularly those containing identifying information, should be
    addressed.
    — Address who will have access to study records, data, and specimens,
    including an acknowledgment that representatives of USSOCOM
    are eligible to review study records.
    — Address requirements for reporting sensitive information to state or local
    authorities.
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    ○ Disposition of data: Describe where data (both electronic and hard copy) will
    be stored, who will keep the data, how the data will be stored, and the length
    of time data will be stored. For FDA-regulated studies, compliance with 21
    CFR 11 is required.
    ○ Sharing study results: In cases where the human subject could possibly
    benefit medically or otherwise from the information, explain whether or not
    the results of screening and/or study participation will be shared with human
    subjects or their primary care provider, to include results from any screening or
    diagnostic tests performed as part of the study.
    • Attachment 11: Post-Award Project Transition Plan (three-page limit).
    Upload as “Transition.pdf.” Provide information on the methods and
    strategies proposed to move the project or knowledge outcomes to the next
    project phase of studies, commercialization, and/or delivery to the civilian or
    military market after successful completion of the award. The transition plan
    should include the components listed below.
    a. The planned indication for the product label, if appropriate, and an outline of
    the development plan required to support that indication.
    b. The anticipated regulatory strategy (e.g., additional nonclinical or clinical
    studies anticipated/required, FDA or regulatory authority meetings desired,
    industry partnerships) for movement of the research into later phases of
    development and to support a potential marketing Application [e.g., New
    Drug Application, Biologics License Application, Premarket Approval
    Application, 510(k)].
    c. Details of the funding strategy that will be used to bring the outcomes to
    the next level of development and/or commercialization (e.g., specific
    potential industry partners, specific funding opportunities to be applied
    for).
    d. For knowledge products, a description of how the knowledge will be further
    developed, disseminated, and incorporated into clinical care.
    e. A description of collaborations and other resources that will be used to
    provide continuity of development.
    f. A brief schedule and milestones for bringing the outcome(s) to the next phase
    of studies, commercialization, and/or delivery to the military or civilian
    market, including when it can be anticipated to be transitioned to an industry
    partner or approved by the FDA, if applicable.
    g. A risk analysis for cost, schedule, manufacturability, and sustainability.
    • Attachment 12: Collaborating DoD Military Facility Budget Form(s), if
    applicable: Upload as “MFBudget.pdf.” If a Military Facility will be a
    collaborator in performance of the project complete the Collaborating DoD
    Military Facility Budget Form (available for download on eBRAP “Funding
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    Opportunities and Forms” web page), including a budget justification for each
    year. If more than one Military Facility is proposed, submit a separate budget
    form for each site. Refer to the General Submission Instructions, Section II.D.5.,
    Research & Related Budget, for detailed information.
     Extramural Applications
    To evaluate compliance with Title IX of the Education Amendments of 1972 (20 USC
    A§1681 et seq.), the DoD is collecting certain demographic and career information to be
    able to assess the success rates of women who are proposed for key roles in applications in
    science, technology, engineering, or mathematics (STEM) disciplines. To enable this
    assessment, each application must include the following forms completed as indicated.
    Research & Related Personal Data: For extramural submissions (via Grants.gov), refer to
    the General Submission Instructions, Section III.A.3.
    Research & Related Senior/Key Person Profile (Expanded): Refer to the General
    Submission Instructions, Section III for detailed information.
    • PI Biographical Sketch (five-page limit): Upload as “Biosketch_LastName.pdf.” 
    PI Previous/Current/Pending Support (three-page limit): Upload as
    “Support_LastName.pdf.”
    • Key Personnel Biographical Sketches (five-page limit each): Upload as
    “Biosketch_LastName.pdf.”
    • Key Personnel Previous/Current/Pending Support (three -page limit each): Upload
    as “Support_LastName.pdf.”
    Research & Related Budget: Refer to the General Submission Instructions, Section III for
    detailed information.
    • Budget Justification (no page limit): Upload as “BudgetJustification.pdf.” The budget
    justification for the entire period of performance must be uploaded to the Research &
    Related Budget after completion of the budget for Period 1.
    IAW FAR 35.016(e), “The primary basis for selecting proposals for
    o
    acceptance shall be technical, importance to agency programs, and fund
    availability. Cost realism and reasonableness shall also be considered to the
    extent appropriate”.
    For contracts, statutory limits for fees are specified in FAR 15.404-4(c)(4).
    o
    NOTE: For all Federal agencies or organizations collaborating with Military
    Facilities, special restrictions apply to the budget and are described below.
    • For Federal Agencies: Proposals from Federal agencies must include in their budget
    justifications a Federal Financial Plan. The Federal Financial Plan must address how
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    all funds will be obligated before their period for obligation expires, and how funds will
    be available to cover research costs over the entire award period. The Federal Financial
    Plan must include the funding mechanism(s) that will be used to carry over funds
    between fiscal years.
    • For Collaborating DoD Military Facilities: Proposals from organizations that include
    collaborations with DoD Military Facilities (military health system facility, research
    laboratory, treatment facility, dental treatment facility, or a DoD activity embedded with
    a civilian medical center) must submit Collaborating DoD Military Facility Budget
    Form(s) as instructed in Attachment 12.
    Project/Performance Site Location(s) Form: Refer to the General Submission Instructions,
    Section III. for detailed information.
    R & R Subaward Budget Attachment(s) Form (if applicable): Refer to the General
    Submission Instructions, Section III. for detailed information.
    R&R Subaward Budget Attachment(s) Form (if applicable): Refer to the General
    Application Instructions, Section III. for detailed information.
    Collaborating with DoD Military Facilities (if applicable): Refer to the General
    Application Instructions, Section III. for detailed information.
    II.D.3. Unique Entity Identifier (UEI) and System for Award Management (SAM)
    All organizations applying online through Grants.gov must register with the System for Award
    Management (SAM) and will receive a unique entity identifier (UEI) number. Failure to register
    with SAM will prevent your organization from applying through Grants.gov.
    Applicant organizations and all subrecipient organizations must have an active registration in the
    System for Award Management (SAM) number to submit proposals to Grants.gov. The
    applicant organization must also be registered in the Entity Management functional area of the
    SAM with an “Active” status to submit proposals through the Grants.gov portal. Verify the
    status of the applicant’s organization’s Entity registration in SAM well in advance of the
    proposal/application submission deadline. Allow several weeks to complete the entire SAM
    registration process. If an applicant has not fully complied with the requirements at the time the
    Federal awarding agency is ready to make a Federal award, the Federal awarding agency may
    determine that the applicant is not qualified to receive a Federal award and use that
    determination as a basis for making a Federal award to another applicant. Refer to the General
    Submission Instructions, Section III, for further information regarding Grants.gov requirements.
    Organizations must have an active System for Award Management (SAM) registration, and
    Grants.gov account to apply for contracts. If individual applicants are eligible to apply for this
    funding opportunity, then you may begin with step 3, Create a Grants.gov Account, listed below.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
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    Creating a Grants.gov account can be completed online in minutes, but SAM registrations may
    take additional time. Therefore, an organization's registration should be done in sufficient time to
    ensure it does not impact the entity's ability to meet required application submission deadlines.
    Complete organization instructions can be found on Grants.gov here:
    https://www.grants.gov/web/grants/applicants/organization-registration.html
    1) Register with SAM for all awards: SAM registration must be renewed annually. For more
    detailed instructions for registering with SAM, refer to:
    https://www.grants.gov/web/grants/applicants/organization-registration/step-2-register-with-
    sam.html
    2) Create a Grants.gov Account: The next step is to register an account with Grants.gov.
    Follow the on-screen instructions or refer to the detailed instructions here:
    https://www.grants.gov/web/grants/applicants/registration.html
    3) Add a Profile to a Grants.gov Account: A profile in Grants.gov corresponds to a single
    applicant organization the user represents (i.e., an applicant) or an individual applicant. If you
    work for or consult with multiple organizations and have a profile for each, you may log in to
    one Grants.gov account to access all of your grant applications. To add an organizational
    profile to your Grants.gov account, enter the UEI Number for the organization in the UEI field
    while adding a profile. For more detailed instructions about creating a profile on Grants.gov,
    refer to: https://www.grants.gov/web/grants/applicants/registration/add-profile.html
    4) EBiz POC Authorized Profile Roles: After you register with Grants.gov and create an
    Organization Applicant Profile, the organization applicant's request for Grants.gov roles and
    access is sent to the EBiz POC. The EBiz POC will then log in to Grants.gov and authorize the
    appropriate roles, which may include the AOR role, thereby giving you permission to complete
    and submit applications on behalf of the organization. You will be able to submit your
    application online any time after you have been assigned the AOR role. For more detailed
    instructions about creating a profile on Grants.gov, refer to:
    https://www.grants.gov/web/grants/applicants/registration/authorize-roles.html
    5) Track Role Status: To track your role request, refer to:
    https://www.grants.gov/web/grants/applicants/registration/track-role-status.html
    b. Electronic Signature: When applications are submitted through Grants.gov, the name of the
    organization applicant with the AOR role that submitted the application is inserted into the
    signature line of the application, serving as the electronic signature. The EBiz POC must
    authorize people who are able to make legally binding commitments on behalf of the
    organization as a user with the AOR role; this step is often missed and it is crucial for valid and
    timely submissions.
    For additional training resources, including video tutorials, refer to:
    https://www.grants.gov/web/grants/applicants/applicant-training.html
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    Applicant Support: If you are experiencing difficulties with your submission, it is best to call the
    Grants.gov Support Center and get a ticket number. The Support Center ticket number will assist
    the USSOCOM with tracking your issue and understanding background information on the
    issue. Grants.gov provides applicants 24/7 support via the toll-free number 1-800-518-4726 and
    email at support@grants.gov. For questions related to the specific grant opportunity, contact the
    number listed in the application package of the grant you are applying for.
    In March 2018, the General Services Administration (GSA) implemented fraud prevention
    security measures in the System for Award Management (SAM) which required every new
    contractor registrant to provide a written (hard copy), notarized letter confirming the entity's
    Administrator that is authorized to register the entity in the SAM database, or to make changes to
    its registration. Effective 29 April 2018, the notarized letter process is now mandatory on all
    CURRENT registrants at SAM who have a requirement to update data on their SAM record.
    The notarized letter is mandatory and is required before the GSA Federal Service
    Desk (FSD) will activate the entity's registration. The Office of the Secretary of Defense and GSA
    realizes the length of time needed to transmit, receive, process, and approve the notarized letters
    presents a significant impact on the ability of the contracting activity to make timely awards, but
    in order to mitigate the concern of fraud, these steps and the time needed for processing, is
    unavoidable. Notarized letters are required for all new and existing SAM registered Entities.
    The notarized letters must be postal service mailed (not emailed or faxed) to the "Federal Service
    Desk" and must contain the information outlined in the SAM posted FAQ at:
    (https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-
    systemsmanagement/integrated-award-environment-iae/sam-update). Instructions for domestic
    entities and instructions for international entities with embedded templates for use are also
    provided within the SAM Update notice with frequently asked questions at
    https://www.gsa.gov/aboutus/organization/federal-acquisition-service/office-of-systems-
    management/integrated-awardenvironment-iae/sam-update.
    II.D.4. Submission Dates and Times
    This is a continuously open announcement through 31 July 2028; therefore, reviews occur
    throughout the year. Pre-proposals may be submitted at any time throughout the 5-year period
    noted above. An invited full proposal/application should be submitted within
    60 days of the PI’s receipt of an invitation to submit. No pre-proposal/pre-application or full
    proposal/application may be submitted under this BAA after 31 July 2028, 11:59 p.m. Eastern
    Time. If an invited proposal/application is not submitted by 31 July 2028, 11:59 p.m. Eastern
    Time, the applicant must wait for the next available opportunity for submission, i.e., the release
    of the FY28 BAA (to be posted to Grants.gov 31 July 2028). No proposal/application received
    under this BAA will be considered for funding after 24 months from the date of submission.
    II.D.5. Funding Restrictions
    The following limits on the duration and cost of research projects apply:
    Proposed projects longer than five (5) years will not be considered.
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    Most projects are anticipated to have a total cost at or below $1,500,000 (including indirect
    costs). Projects that have a total cost higher than $1,500,000 (including Indirect costs) with
    outstanding scientific merit that meet a critical need may be accepted; however the total cost of
    these projects are not to exceed $5,000,000.00 (including Indirect costs).
    No budget will be approved by the Government exceeding $5,000,000.00 (including indirect
    costs).
    A budget should be commensurate with the nature and complexity of the proposed research.
    Researchers should submit budgets that include the entire period of performance of the research
    project. Budgets should include all direct and indirect costs, based on supportable, verifiable
    estimates. The budget for the full proposal/application should not differ significantly from the
    pre-proposal/pre-application budget summary form provided in the pre-proposal/pre-application
    submission.
    Offerors or Applicants seeking additional or continuation funding must submit new pre-
    proposals and be invited to submit full proposals.
    See the General Submission Instructions, Section III, for additional information regarding the
    research and related budget.
    All direct and indirect costs of any subaward, contract, or subcontract must be included in the
    costs of the primary award.
    The applicant may request the entire maximum funding amount for a project that may have a
    period of performance less than the maximum five years.
    For this award mechanism, direct costs may be requested for (not all inclusive):
    • Salary
    • Research – related subject costs
    • Research supplies
    • Support for multidisciplinary collaborations, including travel
    • Travel costs
    • Equipment
    For extramural awards with an intragovernmental component, direct transfer of funds from an
    extramural award recipient to a DoD or other Federal agency is not allowed. Funding to
    intramural DoD and other Federal agencies will be managed through a direct fund transfer.
    Intramural applicants are responsible for coordinating through their agency’s procedures the use
    of contractual or assistance funding awards or other appropriate agreements to support
    extramural collaborators.
    Refer to the General Submission Instructions, Section III. for budget regulations and instructions
    for the Research & Related Budget. For Federal agencies or organizations collaborating with
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    Federal agencies, budget restrictions apply as are noted in the General Submission
    Instructions, Section III.
    For additional information refer to Section II.F.1, Federal Award Notices.
    Funds to be obligated on any award resulting from this BAA will be available for use for a
    limited time period based on the fiscal year of the funds. Awards will identify expiration of the
    funds.
    Refer to the General Submission Instructions, “Research & Related Budget,” for discussion of
    allowable costs, including pre-award costs and collaborations with Military Facilities.
    II.D.6. Other Submission Requirements
    Refer to the General Submission Instructions, Appendix 4, for detailed formatting guidelines on
    submission.
    II.E. Proposal/Application Review Information
    II.E.1. Criteria
    II.E.1.a. Peer Review
    To determine technical merit, all proposals will be evaluated according to the following scored
    criteria, which are listed in descending order of importance:
    • Research Objectives: The degree to which the stated objectives are clear, valid, and logical.
    For development of devices and technologies, the degree to which the performance
    objectives are plausible; the proposed effort demonstrates familiarity with the historical
    background of the problem and previous/current solutions; and the awareness of similar
    projects previously undertaken and related activities. The extent that the proposed research
    projects demonstrate an innovative approach and relate to the Research Areas of Interest
    identified in Section II.A.
    • Scientific Design Excellence: The degree to which proposed plans, methods, techniques and
    procedures are feasible, clear, valid, adequately referenced, and state-of-the-art. The merit of
    the statistical features of the study. The extent to which literature searches were used to
    document the strengths of the proposed project. For development of devices and
    technologies, the feasibility of the proposed prototype/technology development plan; how
    well the engineering/technical design is likely to achieve the goals indicated; adequacy of the
    engineering/design solutions; and how well the perceived engineering/design strengths and
    flaws are addressed.
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    • Impact/Outcomes: The potential impact of the research in the field, the significance of this
    impact, and when it can be anticipated. For development of devices and technologies, the
    potential translation, implementation, and/or commercial use for the prototype/technology
    being developed.
    • Budget: The degree to which the budget reflects the actual needs of the proposed work, is
    thoroughly detailed and fully justified so that the government can evaluate and determine the
    cost commensurate with the complexity and nature of the research proposed.
    • PI and Key Personnel Qualifications: The qualifications, capabilities, and experience of
    the proposed PI and other key personnel to demonstrate that the proposed staff has the
    knowledge, technical expertise, and management skills to achieve the proposed objectives as
    well as the time available for the percentage of efforts indicated for the project.
    • Facilities: The proposed facilities and equipment, or unique combinations of these, to
    demonstrate that the organization has the necessary facilities required for the accomplishing
    the proposed objectives.
    II.E.1.b. Programmatic Review
    To make funding recommendations and select the proposal(s)/application(s) that, individually or
    collectively, will best achieve the program objectives, the following criteria are used by
    programmatic reviewers:
    • Scientific peer review results
    • SOF Relevance (mission, health, medicine, and beneficiaries)
    • Portfolio balance
    • Programmatic priorities
    II.E.2. Proposal/Application Review and Selection Process
    All invited proposals are evaluated by USSOCOM scientists, other federal agency
    representatives, outside scientists with diverse expertise, clinicians, consumers, or combinations
    thereof, using a two-tier review process. The first tier is peer review of proposals against
    established criteria for determining technical merit. Each proposal/application is evaluated for
    its own merit, independent of other proposals. The second tier is a programmatic review that
    makes recommendations for funding, based on established criteria for determining relevance to
    the mission of the USSOCOM and its programs. Programmatic review is a comparison-based
    process in which proposals with scientific and technical merit compete in a common pool. The
    highest-scoring proposals from the first tier of review are not automatically recommended for
    funding. Funding recommendations depend on various factors as described in Section II.E.
    Programmatic Review.
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    After the two-tier evaluation, proposals recommended for funding may be prioritized. A
    prioritized listing of alternates (deferred decisions) may also be prepared, when warranted.
    Subsequent awards depend upon the availability of funds and fulfillment of requirements and
    priorities determined to exist at the time of award. In some cases, funding priorities may change
    as certain scientific tasks are addressed and new mission assignments arise.
    If selected for funding, the award may also be dependent upon the organization providing
    adequate additional regulatory documentation, such as human subjects/anatomical
    substances/use of cadavers’ protocols and approvals, animal subjects’ protocols and approvals,
    and environmental information. The award may also be dependent upon additional supporting
    administrative and budgetary information.
    IAW FAR 35.016(e), “The primary basis for selecting proposals for acceptance shall be
    technical, importance to agency programs, and fund availability. Cost realism and
    reasonableness shall also be considered to the extent appropriate”.
    All USSOCOM review processes are conducted confidentially to maintain the integrity of the
    merit-based selection process. Panel members sign a statement that proposal/application and
    evaluation information will not be disclosed outside the panel. Violations of confidentiality can
    result in the dissolving of a panel(s) and other corrective actions. In addition, personnel at the
    Applicant or collaborating organizations are prohibited from contacting persons involved in the
    review and approval process to gain protected evaluation information or to influence the
    evaluation process. Violations of these prohibitions will result in the administrative withdrawal
    of the organization’s proposal/application. Violations by panel members or applicants that
    compromise the confidentiality of the review and approval process may also result in suspension
    or debarment from federal awards. Furthermore, the unauthorized disclosure of confidential
    information of one party to another third party is a crime in accordance with 18 USC 1905.
    II.E.3. Integrity and Performance Information
    Prior to making an award where the Federal share is expected to exceed the simplified
    acquisition threshold (currently $250,000) over the period of performance, the Federal awarding
    agency is required to review and consider any information about the applicant that is available in
    the SAM.gov Responsibility/Qualification (R/Q).
    An applicant organization may review R/Q, accessible through SAM, and submit comments to
    R/Q on any information about the organization that a Federal awarding agency previously
    entered and is currently available in R/Q.
    The Federal awarding agency will consider any comments by the applicant, in addition to other
    information in the designated integrity and performance system, in making a judgment about the
    applicant’s integrity, business ethics, and record of performance under Federal awards when
    determining an organization’s qualification prior to award, according to the qualification
    standards of the FAR.
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    II.E.4. Anticipated Announcement and Federal Award Dates
    Each PI and organization will receive email notification via eBRAP of the funding
    recommendation. Notifications should be sent within 180 days of submission. Each PI will
    receive a peer review summary statement on the strengths and weaknesses of the
    proposal/application.
    II.F. Federal Award Administration Information
    II.F.1. Federal Award Notices
    The PI should receive disposition regarding the full proposal/application via an email from
    eBRAP within 180 days of submission. A recommended for funding notification is NOT an
    authorization to begin performance nor a guarantee of an award.
    The awarding agency will be the USAMRAA. The USAMRAA Contracting Officers are the
    only individuals authorized to obligate funds and bind the Federal Government.
    Authorization to begin performance will be received via an award document (contract,) signed
    by the USAMRAA Contracting Officer. No commitment on the part of the Government should
    be inferred from discussions with any other individual.
    Awards will be made at any time throughout the year and are contingent upon availability of
    funding, adequacy of supporting documentation submitted, fulfillment of requirements, and
    completion of successful negotiations. No proposal/application submitted under this BAA will
    be considered for funding after 24 months from the date of submission to Grants.gov.
    Refer to the General Submission Instructions, Appendix 2, Section D, Award Notices, for
    additional information. Refer to the full text of the USAMRAA General Research Terms and
    Conditions for Institutions of Higher Education, Hospitals, and Non-Profit Organizations and the
    USAMRAA General Research Terms and Conditions for For-Profit Organizations available at
    http://www.usamraa.army.mil/Pages/Resources.aspx for further information.
    II.F.1.a. PI Changes and Award Transfers
    Refer to the General Submission Instructions, Appendix 2 for general information on changes to
    PIs and organizational transfers.
    Should the PI of a funded project leave the award organization, both the PI and organization
    must contact the USAMRAA Contracting Officer as soon as possible to discuss options for
    continued support of the research project. Every effort should be made to notify the USAMRAA
    prior to the PI leaving the organization. An organizational transfer of an Assistance Agreement
    award will not be allowed in the last year of the (original) period of performance or any
    extension thereof. An organizational transfer of a Contract award will not be allowed.
    II.F.2. Administrative and National Policy Requirements
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    Applicable requirements in the FAR, found in 48 CFR, Chapter 1, DFARS, found in 48 CFR
    Chapter 2, and AFARS, found in 48 CFR Chapter 51, apply to contracts resulting from this
    BAA.
    Refer to the General Submission Instructions, Appendix 2, for general information regarding
    administrative requirements.
    Refer to the General Submission Instructions, Appendix 5, for general information regarding
    national policy requirements.
    Refer to full text of the USAMRAA General Research Terms and Conditions with Institutions of
    Higher Education, Hospitals, and Non-Profit Organizations: Addendum to the DoD R&D Terms
    and Conditions and the USAMRAA General Research Terms and Conditions with For-Profit
    Organizations for further information.
    II.F.3. Reporting
    Refer to the General Submission Instructions, Appendix 2, Section A, for general information on
    reporting requirements. If there are technical reporting requirement delinquencies for any
    existing USSOCOM-sponsored awards at the applicant organization, no new awards will be
    issued to the applicant organization until all delinquent reports have been submitted.
    technical progress reports andquad charts will be required with frequency determined at the
    contract level.
    • quad charts including:
    ○ Objective, measurable, and easily independently verifiable assessment of metrics to
    measure progress regarding project cost, schedule, performance, risk, and opportunity.
    ○ Risk and opportunity assessment of project cost, schedule, and performance. Risk
    assessments will use objective, measurable, and easily independently verifiable metrics;
    mitigation plans; triggering event; latest potential successful mitigation date; and impacts
    of unmitigated risks. Opportunity assessments will use objective, measurable and easily
    independently verifiable metrics; exploitation plans; triggering event; latest potential
    successful exploitation; and impact of successful opportunity exploitation.
    ○ Integrated project Gantt chart with all progress to date, supported by the cost,
    performance, risk, and opportunity assessments.
    ○ Budget chart with burn rate, demonstrating funding expended against time, funds
    remaining, and planned expense plan through the rest of the project schedule against
    planned milestones.
    • technical reports including the following:
    ○ Full description of architecture and content of new interoperable component, description
    of scenarios developed, results and method of pilot study.
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    ○ A report, document, or list of the terminology and respective definitions used for the
    variables, metrics, and evaluation criteria and how they were deconstructed. It must
    provide the measuring tools and, if needed, how they were used to obtain the
    metric/evaluation criteria. Objective measurements are preferred, but subjective
    measurements that have rigorous reliability, repeatability, and robustness will be
    considered.
    ○ Explanation, including definitions and descriptions, of TRIAGE determinants of
    performance and agility. A report or document with the information and analyzed data of
    the actual postulated variables, metrics, and evaluation criteria.
    ○ Analyzed pilot study data and the specific aims, methodologies, sample and sample size,
    inter-rater reliability, assessment criteria, statistical methods, analyzed results,
    conclusions, and potential next-step recommendations.
    ○ Completion of preliminary/pilot empirical evaluation of the developed proof-of-concept;
    ○ A description of the components of the proof-of-concept that are proprietary and ones
    that are open source/open architecture. Explanation of Government rights and/or
    proposed pricing structure to the Government (if applicable).
    ○ Documentation of the translational parameters and the respective definitions (if
    applicable).
    ○ Description of the gaps that were uncovered during this research as it pertains to the
    success or improvement measured and an outline of anticipated next steps or
    recommendations.
    II.G. Federal Awarding Agency Contacts
    II.G.1. eBRAP Help Desk
    Questions related to BAA content or submission requirements as well as questions related to the
    submission of the pre-proposal/pre-application through eBRAP should be directed to the eBRAP
    Help Desk, which is available Monday through Friday from 8:00 a.m. to 5:00 p.m. Eastern Time.
    Response times may vary depending upon the volume of inquiries.
    Phone: 301-682-5507
    Email: help@eBRAP.org
    II.G.2. Grants.gov Contact Center
    Questions related to extramural full proposal/application submission through the Grants.gov
    portal should be directed to the Grants.gov Contact Center, which is available 24 hours a day, 7
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    days a week (closed on U.S. federal holidays). Note that the eBRAP Help Desk is unable to
    provide technical assistance with Grants.gov submission.
    Phone: 800-518-4726; International 1-606-545-5035
    Email: support@grants.gov
    Sign up on Grants.gov for “send me change notification emails” by following the link on the
    Synopsis page for the BAA or by responding to the prompt provided by Grants.gov when first
    downloading the submission package. If the submission package is updated or changed, the
    original version of the Application package may not be accepted by Grants.gov.
    II.H. Other Information
    II.H.1. Administrative Actions
    After agency receipt of pre-proposals or proposals, the following administrative actions may
    occur:
    II.H.1.a. Rejection
    The following will result in administrative rejection of the pre-proposal/pre-application:
    • Project narrative exceeds page limit.
    • Project narrative is missing.
    • Budget form contains only zeros.
    • Quad Chart is missing.
    The following will result in administrative rejection of the proposal/application:
    • Submission of an application for which a letter of invitation was not received.
    • Project Narrative exceeds page limit.
    • Project Narrative is missing.
    • Budget is missing.
    II.H.1.b. Modification
    • Pages exceeding the specific limits will be removed prior to review for all documents other
    than the pre-proposal narrative and project narrative.
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    • Documents not requested will be removed.
    • Following proposal/application submission to Grants.gov, the PI will receive an email
    request from eBRAP to review, modify, and verify the proposal/application submitted to
    Grants.gov. During this verification period, the PI may upload missing documents (refer to
    II.H.I.a, rejection), replace files, and re-categorize files. These modifications must be
    completed by the end of the application verification period; otherwise, the
    proposal/application will be reviewed as submitted
    II.H.1.c. Withdrawal
    The following may result in administrative withdrawal of the pre-proposal/pre-application or
    proposal/application:
    • Federal agency personnel involved in the review process and/or with making funding
    recommendations are named as being involved in the research proposed or found to
    have assisted in the pre-proposal/pre-application or proposal/application processes,
    including, but not limited to, concept design, proposal/application development, budget
    preparation, and the development of any supporting documentation. If formal
    collaboration with Military Facility personnel is planned (i.e., included in the
    proposal/application in performance of the research), this prohibition is not
    applicable. However, these Military Facility personnel are prohibited from being
    involved in the review process and/or with making funding recommendations.
    • Inclusion of URLs, with the exception of links in References Cited and Publication
    and/or Patent Abstract sections.
    • Page size is larger than 8.5 inches x 11.0 inches (approximately 21.59 cm x 27.94 cm).
    • Personnel from applicant or collaborating organizations are found to have contacted
    persons involved in the review process to gain protected evaluation information or to
    influence the evaluation process.
    • Full proposals from extramural organizations, including non-DoD Federal agencies,
    received through eBRAP may be withdrawn.
    • The full proposal/application does not propose the same research project as described in
    the pre-proposal/pre-application.
    • The full proposal/application budget differs significantly from the budget included in
    the pre-proposal/pre-application.
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    • A proposal submitted by a PI who does not meet the eligibility criteria will be
    withdrawn.
    II.H.1.d. Withhold
    Proposals that appear to involve research misconduct will be administratively withheld from
    further consideration pending organizational investigation. The organization will be required to
    provide the findings of the investigation to the USAMRAA Contracting
    Officer for a determination of the final disposition of the proposal/application.
    II.H.2. Proposal/Application Submission Checklist
    Grants.gov Submission Upload
    Action Completed
    Package Components Order
    SF-424 (R&R)
    Application for Federal Complete as instructed.
    Assistance
    Project Narrative: Upload as Attachment 1 with file name
    1
    “ProjectNarrative.pdf.”
    Supporting Documentation: Upload as Attachment 2 with
    2
    file name “Support.pdf.”
    Technical Abstract: Upload as Attachment 3 with file name
    3
    “TechAbs.pdf.”
    4
    Lay Abstract: Upload as Attachment 4 with file name
    “LayAbs.pdf.”
    Statement of Work: Upload as Attachment 5 with file name
    5
    “SOW.pdf.
    Outcomes and Impact Statement: Upload as Attachment 6
    6
    with file name “Impact.pdf.”
    Innovation Statement: Upload as Attachment 7 with file
    Attachments Form 7
    name “Innovation.pdf.”
    Data and Research Resource-Sharing Plan: Upload as
    8
    Attachment 8 with the file name “Sharing.pdf.”
    Conflicts of Interest: Upload as Attachment 9 with file name
    9
    “COI.pdf,” if applicable.
    Data Management: Upload as Attachment 10 with file
    10
    name “DataManage.pdf.”
    Post-Award Project Transition Plan: Upload as Attachment
    11
    11 with file name “Transition.pdf.”
    Collaborating DoD Military Facility Budget Form(s):
    12 Upload as Attachment 12 with the file name
    “MFBudget.pdf,” if applicable.
    Research & Related Complete as instructed.
    Personal Data
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    Attach PI Biographical Sketch (Biosketch_LastName.pdf)
    to the appropriate field.
    Attach PI Previous/Current/Pending Support
    Research & Related
    (Support_LastName.pdf) to the appropriate field.
    Senior/Key Person
    Attach Biographical Sketch (Biosketch_LastName.pdf) for
    Profile (Expanded)
    each senior/key person to the appropriate field.
    Attach Previous/Current/Pending (Support_LastName.pdf)
    for each senior/key person to the appropriate field.
    Research & Related Attach Budget Justification (BudgetJustification.pdf) to the
    Budget appropriate field. Complete form as instructed.
    Project/Performance Site
    Complete form as instructed.
    Location(s) Form
    R&R Subaward Budget
    Attachment(s) Form (if Complete form as instructed.
    applicable)
    Collaborating with DoD Complete form as instructed.
    Military Facilities
    APPENDIX 1: ACRONYM LIST
    BAA Broad Agency Announcement
    CDMRP Congressionally Directed Medical Research Programs
    CFR Code of Federal Regulations
    COI Conflict of Interest
    DHA Defense Health Agency
    DHP Defense Health Program
    DoD Department of Defense
    eBRAP Electronic Biomedical Research Application Portal
    EC Ethics Committee
    ET Eastern Time
    FAD Funding Authorization Document
    FY Fiscal Year
    HRPO Human Research Protection Office
    IRB Institutional Review Board
    LOI Letter of Intent
    M Million
    MIPR Military Interdepartmental Purchase Request
    NPC Non-Profit Corporation
    OASD(HA) Office of the Assistant Secretary of Defense for Health Affairs
    ORCID Open Researcher and Contributor ID, Inc.
    ORP Office of Research Protections
    PFC Prolonged Field Care
    PI Principal Investigator
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
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    General Submission Instructions

    General Submission Instructions for Funding
    Opportunity Number: HT9425-23-S-SOC1
    Broad Agency Announcement
    for Extramural Biomedical and Human
    Performance Research and Development
    Fiscal Year 2023 – Fiscal Year 2028
    Department of Defense
    United States Special Operations Command
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 1
    General Submission Instructions

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    Table of Contents
    I. HELPFUL INFORMATION ................................................................................................ 5
    A. Tips for Success .................................................................................................................. 5
    B. Current Funding Opportunity Announcement .................................................................... 5
    C. Receiving Emails from eBRAP, and Grants.gov ................................................................ 6
    D. Agency Contacts ................................................................................................................. 6
    II. REGISTRATION AND SUBMISSION INFORMATION ................................................ 7
    A. eBRAP Registration ............................................................................................................ 7
    B. Submission Dates and Times .............................................................................................. 8
    C. Content and Form of pre-application Submission .............................................................. 8
    III. Content and Form of Application Submission FOR RESEARCH pROPOSALS ........ 10
    A. Grants.gov Submission Package Components for Research Proposals ............................ 13
    B. Submission of a Grants.gov Workspace ........................................................................... 29
    C. Applicant Verification of Grants.gov Submission in eBRAP .......................................... 29
    D. Application Tracking ........................................................................................................ 30
    APPENDIX 1 Regulatory Requirements .................................................................................. 31
    A. Safety and Environmental Requirements .......................................................................... 31
    B. Research Protections Review Requirements .................................................................... 31
    C. Clinical Trial Registry....................................................................................................... 36
    D. Research Involving Recombinant DNA Molecules .......................................................... 37
    APPENDIX 2 Reporting Requirements and Administrative Information ........................... 38
    A. Reporting Requirements for Awards ................................................................................ 38
    B. Disclosure of Proprietary Information .............................................................................. 39
    C. Marking of Proprietary Information ................................................................................. 39
    D. Award Notices .................................................................................................................. 39
    E. Inquiry Review.................................................................................................................. 39
    F. Information Service .......................................................................................................... 40
    G. Freedom of Information Act Requests .............................................................................. 40
    H. Information Release .......................................................................................................... 40
    I. Contracted Fundamental Research ................................................................................... 41
    J. Sharing of Proposal Information ....................................................................................... 41
    K. Data Management and Sharing ......................................................................................... 42
    Purpose ..................................................................................................................................... 42
    Data sharing enables researchers to rigorously test the validity of research findings, strengthen
    analyses through combined datasets, reuse hard-to-generate data, and explore new
    frontiers of discovery. In addition, USSOCOM emphasizes the importance of good data
    management practices, which provide the foundation for effective data sharing and
    improve the reproducibility and reliability of research findings. USSOCOM encourages
    data management and data sharing practices consistent with the FAIR data principles
    (https://www.go-fair.org/fair-principles/) ......................................................................... 42
    USSOCOM expects researchers and institutions to implement data management and sharing
    practices as described. ....................................................................................................... 42
    Definitions ................................................................................................................................ 42
    For the purposes of this BAA, terms are defined as follows: .................................................. 42
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 2
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    Scientific Data: The recorded factual material commonly accepted in the scientific community
    as of sufficient quality to validate and replicate research findings, regardless of whether
    the data are used to support scholarly publications. Scientific data do not include
    laboratory notebooks, preliminary analyses, completed case report forms, drafts of
    scientific papers, plans for future research, peer reviews, communications with
    colleagues, or physical objects, such as laboratory specimens. ........................................ 42
    Data Management: The process of validating, organizing, protecting, maintaining, and
    processing scientific data to ensure the accessibility, reliability, and quality of the
    scientific data for its users................................................................................................. 42
    Data Sharing: The act of making scientific data available for use by others (e.g., the larger
    research community, institutions, the broader public), for example, via an established
    repository. ......................................................................................................................... 42
    Metadata: Data that provide additional information intended to make scientific data
    interpretable and reusable (e.g., date, independent sample and variable construction and
    description, methodology, data provenance, data transformations, any intermediate or
    descriptive observational variables). ................................................................................. 42
    Data Management and Sharing Plan (Plan): A plan describing the data management,
    preservation, and sharing of scientific data and accompanying metadata. ....................... 42
    Scope ........................................................................................................................................ 42
    This guidance applies to all research, funded or conducted in whole or in part by USSOCOM,
    that results in the generation of scientific data. This includes research funded or
    conducted by extramural grants, contracts, Intramural Research Projects, or other funding
    agreements regardless of USSOCOM funding level or funding mechanism. This guidance
    does not apply to research and other activities that do not generate scientific data,
    including training, infrastructure development, and non-research activities. ................... 42
    Managing and Sharing Scientific Data .................................................................................... 43
    USSOCOM expects that in drafting Plans, researchers will maximize the appropriate sharing
    of scientific data, acknowledging certain factors (i.e., legal, ethical, or technical) that may
    affect the extent to which scientific data are preserved and shared. Any potential
    limitations on subsequent data use should be communicated to individuals or entities
    (e.g., data repository managers) that will preserve and share the scientific data. ............. 43
    Considerations for Scientific Data Derived from Human Participants: USSOCOM prioritizes
    the responsible management and sharing of scientific data derived from human
    participants. Applicable federal, Tribal, state, and local laws, regulations, statutes,
    guidance, and institutional policies govern research involving human participants and the
    sharing and use of scientific data derived from human participants. USSOCOM also
    respects Tribal sovereignty in the absence of written Tribal laws or polices. This
    USSOCOM guidance is consistent with federal regulations for the protection of human
    research participants and other USSOCOM expectations for the use and sharing of
    scientific data derived from human participants, including the NIH’s 2014 Genomic Data
    Sharing (GDS) Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-
    124.html ) 2015 Intramural Research Program Human Data Sharing Policy
    (https://policymanual.nih.gov/3016), and 45 CFR 46
    (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html).
    Researchers proposing to generate scientific data derived from human participants should
    outline in their Plans how privacy, rights, and confidentiality of human research
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 3
    General Submission Instructions

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    participants will be protected (i.e., through de-identification, Certificates of
    Confidentiality (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html),
    and other protective measures). ........................................................................................ 43
    USSOCOM strongly encourages researchers to plan for how data management and sharing
    will be addressed in the informed consent process, including communicating with
    prospective participants how their scientific data are expected to be used and shared.
    Researchers should consider whether access to scientific data derived from humans, even
    if de-identified and lacking explicit limitations on subsequent use, should be controlled.
    ........................................................................................................................................... 43
    Data Repository Selection: USSOCOM strongly encourages the use of established
    repositories to the extent possible for preserving and sharing scientific data. The
    Supplemental Information to the NIH Policy for Data Management and Sharing:
    Selecting a Repository for Data Resulting from NIH-Supported Research
    (https://sharing.nih.gov/data-management-and-sharing-policy/sharing-scientific-
    data/selecting-a-data-repository) assists researchers in selecting a suitable data
    repository(ies) or cloud-computing platform. ................................................................... 43
    Data Preservation and Sharing Timelines: Shared scientific data should be made accessible as
    soon as possible, and no later than the time of an associated publication, or the end of
    performance period, whichever comes first. Researchers are encouraged to consider
    relevant requirements and expectations (e.g., data repository policies, award record
    retention requirements, journal policies) as guidance for the minimum time frame that
    scientific data should be made available, which researchers may extend. Depending on
    the research project, the PI may be required to participate in the following, which will be
    specified in the award: ...................................................................................................... 43
    L. Property/Equipment .......................................................................................................... 44
    M. Title to Inventions and Patents .......................................................................................... 44
    N. PI Changes and Award Transfers ..................................................................................... 44
    APPENDIX 3 Qualification Information.................................................................................. 46
    A. Contractor/Recipient Qualification ................................................................................... 46
    B. Eligibility Information ...................................................................................................... 46
    C. J-1 Visa Waiver................................................................................................................. 47
    D. Conflict of Interest ............................................................................................................ 47
    APPENDIX 4 Formatting Guidelines ....................................................................................... 48
    APPENDIX 5 National Policy Requirements ........................................................................... 49
    A. Certification ...................................................................................................................... 49
    B. Representations ................................................................................................................. 50
    APPENDIX 6 Acronym List ...................................................................................................... 52
    This General Submission Instructions document must be read in conjunction with the Broad
    Agency Announcement, available for downloading from Grants.gov.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 4
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    I. HELPFUL INFORMATION
    A. Tips for Success
    This symbol marks helpful hints throughout this document.
    This symbol refers to the Broad Agency Announcement for specific instructions.
    B. Current Funding Opportunity Announcement
    The Fiscal Year 2023 – Fiscal Year 2028 (FY23-FY28) U.S. Special Operations Command
    (USSOCOM) Broad Agency Announcement (BAA) can be found by searching Grants.gov
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 5
    General Submission Instructions

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    (http://www.grants.gov/) using the Funding Opportunity Number HT9425-23-S-SOC1 or the
    Catalog of Federal Domestic Assistance (CFDA) number 12.420 Military Medical Research
    and Development.
    USSOCOM utilizes the tools and processes provided by Congressionally Directed Medical
    Research Programs (CDMRP). Additional information may be found on the CDMRP’s
    electronic Biomedical Research Application Portal (eBRAP) website at
    https://ebrap.org/eBRAP/public/index.htm.
    The awarding agency will be the U.S. Army Medical Research Acquisition Activity
    (USAMRAA). The USAMRAA Contracting Officials are the only individuals authorized to
    obligate funds and bind the Federal Government for awards under this BAA.
    C. Receiving Emails from eBRAP, and Grants.gov
    To help ensure that all email correspondence is delivered correctly and is not treated as spam by
    email programs, keep your email address up to date in eBRAP and Grants.gov and place the
    following domains into your safe list: army.mil, us.army.mil, *.mail.mil, health.mil, eBRAP.org,
    and Grants.gov. Also, use the same email address when submitting both the pre-proposal/pre-
    application to eBRAP and the full proposal to Grants.gov.
    On occasion, the Grants.gov proposal package may be updated or changed. The applicant must
    use the latest version of the Grants.gov submission package; proposals submitted with a different
    version of the Grants.gov submission package will be rejected by Grants.gov. Sign up in
    Grants.gov (http://www.grants.gov/) for “Send me change notification emails” by following
    the link on the Synopsis page for the BAA or by responding to the prompt provided by
    Grants.gov when first downloading the Grants.gov submission package.
    D. Agency Contacts
    1. eBRAP Help Desk: Questions related to BAA content or submission requirements, as
    well as questions related to submission of Pre-proposals through eBRAP, should be
    directed to the eBRAP Help Desk, which is available Monday through Friday from
    8:00 a.m. to 5:00 p.m. Eastern time. Response times may vary depending upon the
    volume of inquiries. Be advised that the eBRAP Help Desk is unable to provide
    technical assistance with Grants.gov submission.
    Phone: 301-682-5507
    Email: HELP@EBRAP.ORG
    2. Grants.gov Contact Center: Questions related to proposal submission through the
    Grants.gov portal should be directed to the Grants.gov Contact Center, which is
    available 24 hours a day, 7 days a week (closed on U.S. Federal holidays).
    Phone: 800-518-4726; International: 1-606-545-5035
    Email: SUPPORT@GRANTS.GOV
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 6
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    II. REGISTRATION AND SUBMISSION INFORMATION
    Submission is a two-step process requiring both (1) Pre-proposal submission through eBRAP
    (https://eBRAP.org/) and (2) full proposal submission through a Grants.gov Workspace or
    eBRAP, depending on the type of application being submitted. General registration information
    is provided below. For detailed instructions, refer to the eBRAP User Guide
    (https://ebrap.org/eBRAP/public/UserGuide.pdf) for eBRAP registration, and www.grants.gov
    for Grants.gov registration.
    Submission of Proposals from U.S. Federal agencies and those proposing
    collaborations with Military Facilities have unique requirements. Budget requirements
    and restrictions apply. See Section III.A.5, Research & Related Budget.
    For specific guidance regarding changes to the Principal Investigator (PI) or
    organization, refer to the BAA.
    USSOCOM encourages all PIs to participate in a digital identifier initiative through Open
    Researcher and Contributor Identification (ORCID). Registration for a unique ORCID identifier
    can be done online at http://orcid.org/.
    A. eBRAP Registration
    eBRAP is a multifunctional web-based system that allows PIs to submit their pre-proposals
    electronically through a secure connection, to view and edit the content of their pre-proposals
    and full proposals, to receive communications from the USSOCOM, and to submit
    documentation during award negotiations and throughout the period of performance. A key
    feature of eBRAP is the ability of an organization’s representatives and PIs to view and modify
    the Grants.gov proposal submissions associated with them. eBRAP will validate Grants.gov
    proposal files against the specific BAA requirements, and discrepancies will be noted in an email
    to the PI and in the Full Application Files tab in eBRAP. It is the applicant’s responsibility to
    review all proposal components for accuracy as well as to ensure proper ordering as specified in
    the BAA.
    eBRAP does not confirm the accuracy of file content!
    To submit a pre-proposal, PIs must be registered in eBRAP.
    During eBRAP registration, the PI must request to be affiliated with his/her organization from
    the list of organizations already registered with eBRAP. If the PI’s organization is not already
    registered with eBRAP, then the PI must invite an Authorized Organizational Representative
    (AOR) to register the organization. The AOR does not need to complete the organization
    registration in eBRAP in order for the pre-proposal to be submitted. However, before the full
    proposal submission deadline, the organization’s eBRAP registration must be complete to allow
    for processing, viewing, and modifying of the Grants.gov submission package components.
    Specific information must be identical between the pre-proposal and the full proposal/application
    for eBRAP to process a proposal. Mismatched information may delay the availability of the
    proposal during the proposal/application verification period. For the PI to view/modify files, the
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 7
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    PI’s name and email address in the eBRAP pre-proposal/pre-application submission must match
    the information provided in Standard Form 424 (SF424) of the Grants.gov submission package.
    For the Business Official to view/modify files, the Business Official’s name and email address in
    the eBRAP pre-proposal submission must match the information provided in the SF424 of the
    Grants.gov submission package.
    During pre-proposal submission, the PI must identify a Business Official from the list of
    Business Officials registered with eBRAP. If the PI’s Business Official is not already registered
    with eBRAP, the PI must invite the Business Official to register. The Business Official’s
    registration must be completed prior to the full proposal deadline to allow the Business Official
    to view/modify the full proposal files in eBRAP after submission.
    During pre-proposal submission, the PI must select the performing organization (site at which
    the PI will perform the proposed work) and contracting organization (organization submitting on
    behalf of the PI) and click on “Add Organizations to this pre-application.” The organization(s)
    must be either selected from the eBRAP drop-down list or invited to allow submission of the pre-
    proposal.
    B. Submission Dates and Times
    This BAA is continuously open for a 5 year period, from 1 August, 2023 through 31 July, 2028,
    11:59 p.m. Eastern Time. Pre-proposals are required and may be submitted at any time
    throughout the 5-year period.
    C. Content and Form of pre-application Submission
    For specific instructions regarding content of the pre-proposal submission
    components, refer to the BAA.
    The pre-proposal consists of the following components, which are organized in eBRAP by
    separate tabs:
    Tab 1 – Application Information: Enter the information as described in eBRAP before
    continuing the pre-proposal. Submission of application information includes assignment of
    primary and secondary research classification codes which can be found at
    https://ebrap.org/eBRAP/public/program.htm. Note that the codes have recently been
    revised. Applicants are strongly encouraged to review and confirm the codes prior to
    making their selection. Click on “Save.”
    Tab 2 – Application Contacts: Enter contact information for the PI. Enter the
    organization’s Business Official responsible for sponsored program administration (the
    “person to be contacted on matters involving this application” in Block 5 of SF424 in the
    Grants.gov package). Depending on screen resolution, scrolling horizontally may be
    necessary to locate the box to invite an AOR to register the performing and/or contracting
    organization. Click on “Add Organizations to this pre-application.” The Business Official
    must be either selected from the eBRAP list or invited in order for the pre-proposal to be
    submitted.
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    If the organization’s Business Official is not in eBRAP, an invitation to the Business
    Official to register in eBRAP must be sent.
    Depending on the screen resolution, scrolling horizontally may be necessary to locate the
    box to invite an AOR to register the performing organization (site at which PI will perform
    the proposed work) and contracting organization (organization submitting on behalf of the
    PI; corresponds to Block 5 on SF424), and click on “Add Organizations to this pre-
    application.” The organization(s) must either be selected from the eBRAP drop-down list
    or invited to allow the pre-proposal to be submitted.
    Tab 3 – Collaborators and Key Personnel: Enter the name, organization, and role of all
    collaborators and key personnel associated with the proposal. Click on “Save.”
    Note: USSOCOM does not follow National Institutes of Health (NIH) guidelines for
    role designation of project participants. Unless otherwise noted, applicants should
    assign the role of each participant in accordance with the participant’s respective
    involvement in the project.
    Federal agency personnel involved in the review process and/or with making funding
    recommendations are prohibited from being involved in any pre-proposal and full proposal,
    including, but not limited to, concept design, proposal development, budget preparation,
    and the development of any supporting documentation.
    If formal collaboration with Military Facility personnel is planned (i.e., included in the
    proposal in performance of the research), this prohibition is not applicable; however, those
    Military Facility personnel are prohibited from being involved in the review process and/or
    with making funding recommendations.
    To preserve the integrity of its peer and programmatic review processes, the USSOCOM
    discourages employees or contracted personnel performing proposal review functions from
    participating or submitting proposals. For FY23-FY28, the peer review contractor is
    General Dynamics Information Technology (GDIT). The programmatic review contractor
    may vary. Proposals that include names of personnel from a review contractor may be
    administratively withdrawn unless plans to manage conflicts of interest (COIs) are
    provided and deemed appropriate by the Government. Questions related to this topic
    should be directed to the eBRAP Help Desk at help@eBRAP.org or 301-682-5507. Refer
    to Appendix 3 for additional information.
    Tab 4 – Conflicts of Interest (COI’s): To avoid COIs during the screening and review
    processes, list all individuals other than collaborators and key personnel who may have a
    COI in the review of the proposal (including those with whom the PI has a personal or
    professional relationship). Click on “Save.”
    Tab 5 – Required Files: Upload all documents as PDF as specified in the BAA.
    Documents should conform to the formatting guidelines outlined in Appendix 4. Click on
    “Upload.”
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 9
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    • eBRAP will truncate characters exceeding the limit specified for each data field as
    specified in the BAA.
    • eBRAP will not allow a document to be uploaded in the Required Files tab if the
    number of pages exceeds the limits specified in the BAA.
    Tab 6 – Submit pre-proposal: Enter eBRAP password and click the “Submit” button.
    Click the “Confirm Submission” button to complete the pre-proposal submission. This
    finalizes the pre-proposal process.
    The pre-proposal is not submitted until Tab 6 is complete.
    Pre-proposals not completed are left in DRAFT status.
    Following completion of pre-proposal/pre-application submission, the status of the pre-
    proposal in eBRAP will change from “DRAFT” to “SUBMITTED” and a confirmation
    email will be sent to the PI and named Business Official. A pre-proposal in DRAFT status
    will not be forwarded for review.
    III. CONTENT AND FORM OF APPLICATION SUBMISSION FOR RESEARCH
    PROPOSALS
    A PI must be invited to submit a full proposal. An invited full proposal must be submitted
    electronically through a Grants.gov Workspace (http://www.grants.gov). Proposals will not be
    accepted by mail or in person.
    Grants.gov applicants must apply online using Workspace. Workspace is a shared, online
    environment where members of a grant team (investigators and business officials) may
    simultaneously access and edit different webforms within an application. Applicants must create
    a Workspace, invite grant team members to join the Workspace, complete the required forms,
    and submit their application Workspace package.
    To apply through Grants.gov, an organization must first complete the Grants.gov registration
    process. Allow up to 8 weeks for the completion of the Grants.gov registration process.
    USSOCOM cannot make allowances/exceptions to its policies for submission problems
    encountered by the applicant organization using system-to-system interfaces with Grants.gov.
    Any modifications to the Project Narrative or Budget Form require submission of a
    changed/corrected Grants.gov submission package to Grants.gov. The Project Narrative and
    Budget Form cannot be modified during the proposal verification period.
    It is the applicant’s responsibility to verify his/her Adobe Reader’s compatibility with
    Grants.gov: http://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html. A
    no-cost compatible version of Adobe Reader can be downloaded at
    http://get.adobe.com/reader/otherversions/. Resubmission of a proposal prior to the Grants.gov
    deadline must be coded as a “Changed/Corrected Application.”
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 10
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    Foreign organizations doing business outside of the United States are also required to complete
    the Grants.gov registration process, in addition to fulfilling supplementary requirements for
    doing business with the U.S. Federal Government.
    If business is conducted with the Federal Government on a continuing basis, it is likely that some
    of the actions have already been completed, e.g., obtaining a Unique Entity Identifier (UEI)
    number via registration as an Entity in the System for Award Management (SAM).
    Detailed information, automated tools, and checklists are available at
    http://www.grants.gov/web/grants/applicants/organization-registration.html.
    The following steps are required as part of the Grants.gov registration process:
    1. UEI and SAM
    As of April 4, 2022, all organizations applying online through Grants.gov must register with the
    SAM and will receive a(UEI number. Failure to register with SAM will prevent your
    organization from applying through Grants.gov. Applicant organizations and all subrecipient
    organizations must have an active registration in the (SAM) number to submit proposals to
    Grants.gov. The applicant organization must also be registered in the Entity Management
    functional area of the SAM with an “Active” status to submit proposals through the Grants.gov
    portal. Verify the status of the applicant’s organization’s Entity registration in SAM well in
    advance of the proposal submission deadline. Allow several weeks to complete the entire SAM
    registration process. If an applicant has not fully complied with the requirements at the time the
    Federal awarding agency is ready to make a Federal award, the Federal awarding agency may
    determine that the applicant is not qualified to receive a Federal award and use that
    determination as a basis for making a Federal award to another applicant.
    2. SAM Registry
    The applicant organization must be registered as an entity for all awards in SAM
    (https://www.sam.gov) and receive confirmation of an “Active” status before submitting a
    proposal through Grants.gov. The SAM validates organization information and electronically
    shares the secure and encrypted data with Federal agencies’ finance offices to facilitate paperless
    payments through electronic funds transfer. An organization must identify an Accounts
    Receivable point of contact (POC), an Electronic Business (E-Biz) POC, and a Government
    Business POC during the SAM registration process. Entity registrations in SAM have an
    annual expiration. Verify the status of your organization’s Entity registration in SAM well in
    advance of the proposal submission deadline. An organization can register in SAM online at
    https://www.sam.gov/. If your organization does not have either an Employer Identification
    Number (EIN) or Tax Identification Number (TIN), allow at least 2 weeks to receive this
    information from the U.S. Internal Revenue Service. Allow several weeks to complete the entire
    SAM registration process. If an applicant has not fully complied with the requirements by the
    time the Federal awarding agency is ready to make a Federal award, the Federal awarding
    agency may determine that the applicant is not qualified to receive a Federal award and use that
    determination as a basis for making a Federal award to another applicant. Additional
    information and step-by-step registration directions are detailed in the SAM User Guide and
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 11
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    other General Services Administration (GSA) training materials in the Help area at
    https://www.sam.gov/.
    Applications will be rejected by Grants.gov if (1) the organization’s Entity registration in SAM
    is not active, or (2) if during the SAM registration process, the organization did not answer
    “Yes” when asked “Do you want to be eligible for grants and other Federal assistance?”
    3. Commercial and Government Entity (CAGE) Code
    The applicant organization must have a CAGE Code. The Defense Logistics Information
    Service in Battle Creek, Michigan, is the only authorized source of CAGE Codes. CAGE Codes
    will be assigned to registrants as their SAM registration advances through the validation process.
    Foreign registrants in SAM must be assigned a North Atlantic Treaty Organization (NATO)
    CAGE Code (NCAGE). An NCAGE code can be obtained by contacting the National
    Codification Bureau of the country where the organization is located or by visiting the website
    https://cage.dla.mil/Request. On average, CAGE Code or NCAGE Code validation in SAM
    occurs within 3 business days after the TIN is validated.
    4. Authorized Organizational Representative
    Each organization must have an AOR who is registered with Grants.gov (individual PIs do not
    register with Grants.gov). An AOR must be a member of the Grants.gov Workspace grant team
    as the business official authorized to submit the completed Workspace application package. An
    organization’s E-Biz POC must authorize an AOR. An individual may serve as both the E-Biz
    POC and the AOR. Before proposal submission, the AOR must be registered to submit on
    behalf of the organization at Grants.gov
    (https://www.grants.gov/web/grants/applicants/registration.html).
    An AOR must first register with the Grants.gov credential provider at
    https://www.grants.gov/web/grants/applicants/registration.html to obtain a username and
    password. Once an AOR has completed the Grants.gov registration process, Grants.gov will
    notify the E-Biz POC of the registration. The E-Biz POC will then log in to Grants.gov and
    assign and authorize the appropriate roles, which may include the AOR role, thereby giving the
    AOR permission to complete and submit applications on behalf of the organization. When an E-
    Biz POC approves an AOR, Grants.gov will send the AOR a confirmation email.
    At the time of proposal submission to Grants.gov, the AOR is certifying to the best of his/her
    knowledge that all information provided in the proposal is current, accurate, and complete.
    When applications are submitted through Grants.gov, the name of the organization’s AOR that
    submitted the application is inserted into the signature line of the application, serving as the
    electronic signature. The E-Biz POC must authorize individuals who are able to make legally
    binding commitments on behalf of the organization as an AOR; this step is often missed and it
    is crucial for valid and timely submissions.
    5. Grants.gov Workspace
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 12
    General Submission Instructions

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    Applicants must create a Workspace, which allows the application components to be completed
    online and routed through the applicant organization for review prior to submission. Once the
    Workspace has been created, participants (grant team members) can be added and the required
    forms can be completed and reviewed before submitting.
    Each proposal submission must include the completed Grants.gov submission package of forms
    associated with the BAA in Grants.gov (http://www.grants.gov/).
    If the applicant decides not to apply by filling out webforms within the Workspace, individual
    PDF forms can be downloaded, saved, and uploaded to the Workspace. A compatible version of
    Adobe Reader must be used to view, complete, and submit an application package consisting of
    PDF forms. If more than one person is entering text into an application package, the same
    version of Adobe Reader software should be used by each person. Check the version number of
    the Adobe software on each user’s computer to make sure the versions match. Using different
    versions of Adobe Reader may cause submission and/or save errors – even if each version is
    individually compatible with Grants.gov. Grants.gov will reject a submission package that is
    opened at any time by an individual with an incompatible version of Adobe Reader. Rejected
    proposals must be resubmitted using a new Grants.gov submission package and a supported
    version of Adobe Reader prior to the proposal submission deadline. It is the applicant’s
    responsibility to verify his/her Adobe Reader’s compatibility with Grants.gov:
    https://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html. A no-cost
    compatible version of Adobe Reader can be downloaded at
    http://get.adobe.com/reader/otherversions/. All contributors to the proposal must use matching
    compatible versions of Adobe software when editing and preparing proposal components outside
    the Workspace. The use of different software versions will result in corruption of the submitted
    file.
    Any modifications to the Project Narrative or Budget Form require submission of a changed/
    corrected Grants.gov submission package to Grants.gov prior to the proposal submission
    deadline.
    A. Grants.gov Submission Package Components for Research Proposals
    1. SF424 (R&R), Application for Federal Assistance Form
    All appropriate information must be entered into this form to allow for auto-population of
    subsequent forms in this Grants.gov submission package. See below for clarification to general
    instructions:
    Block 1 – Type of Submission. For original submissions, select the “Application” box. For
    changes that must be made after the original submission, the complete Grants.gov submission
    package must be resubmitted with the “Changed/Corrected Application” box selected.
    Block 2 – Date Submitted. Enter the date the proposal is submitted.
    Applicant Identifier. Enter the submitting organization’s Control Number, if applicable. If
    there is no Organization Control Number, leave this field blank.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 13
    General Submission Instructions

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    Block 3 – Date Received by State and State Application Identifier. Not applicable.
    Block 4a – Federal Identifier Box. Enter in your eBRAP log number assigned during
    pre-proposal submission.
    Figure 1. Enter your eBRAP log number in Block 4a.
    • Block 4b – Agency Routing Identifier. Not applicable.
    • Block 4c – Previous Grants.gov Tracking ID. For changed/correct proposal, enter
    the Grants.gov Tracking Number for the original proposal.
    • Block 5 – Applicant Information. Enter the information for the applicant
    organization. “Person to be contacted on matters involving this application” is the
    Business Official.
    • Block 6 – Employer Identification. Enter the EIN or TIN as assigned by the Internal
    Revenue Service. If applying from an organization outside the United States, enter
    44-4444444.
    • Block 7 – Type of Applicant. Enter the information for the applicant organization.
    • Block 8 – Type of Application. Select “New” for all submissions.
    • Block 9 – Name of Federal Agency. Populated by Grants.gov.
    • Block 10 – Catalog of Federal Domestic Assistance Number. Populated by
    Grants.gov.
    • Block 11 – Descriptive Title of Applicant’s Project. Enter the same project title as
    used for the pre-proposal.
    • Block 12 – Proposed Project. Enter the estimated start and end dates for the
    project. Actual start and end dates will be determined during negotiations if the
    proposal is recommended for funding.
    • Block 13 – Congressional District of Applicant. If the applicant organization is
    outside the United States, enter 00-000.
    • Block 14 – Project Director/Principal Investigator Contact Information. Enter
    information for the individual PI responsible for the overall scientific and technical
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 14
    General Submission Instructions

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    direction of the proposal. If outside the United States, select the appropriate
    country from the drop-down menu.
    • Block 15 – Estimated Project Funding. Enter the total funds (direct + indirect costs)
    requested for the entire performance period of the project. These figures should
    match those provided in the Research & Related Budget.
    • Block 16 – Is Application Subject to Review by State Executive Order 12372 Process?
    Select option b., “NO, program is not covered by E.O.12372.”
    • Block 17 – Complete Certification. Select the “I agree” box to provide the required
    certifications and assurances.
    • Block 18 – SFLLL (Disclosure of Lobbying Activities) or Other Explanatory
    Documentation. If applicable, complete and attach Standard Form LLL (SFLLL) to
    disclose lobbying activities pursuant to Title 31 of the United States Code,
    Section 1352 (31 USC 1352).
    • Block 19 – Authorized Representative. Enter the contact information for the
    applicant organization’s authorized representative. The “Signature of Authorized
    Representative” is automatically completed upon submission of the Grants.gov
    submission package.
    • Block 20 – pre-application. Not applicable.
    • Block 21 – Cover Letter Attachment. Not applicable.
    If a revised Project Narrative or Budget Form document is needed, an updated Grants.gov
    submission package must be submitted via Grants.gov as a “Changed/Corrected Application”
    with the previous Grants.gov Tracking ID found in Block 4.c. of the SF424 (R&R) Form prior
    to the full proposal submission deadline.
    2. Attachments Form
    Grants.gov does not validate for the presence of attachments on this Attachments Form.
    Following retrieval and processing of the Grants.gov proposal, eBRAP will notify the
    organizational representatives and PI by email to log into the eBRAP to view, modify, and verify
    the Grants.gov proposal submission. eBRAP will validate retrieved files against the BAA
    guidelines. Discrepancies will be noted in both the email and in the Full Application tab.
    eBRAP does not confirm the accuracy of file content. It is the applicant’s responsibility to
    review all proposal components and ensure proper ordering as specified in the BAA. See III.C.,
    Applicant Verification of Grants.gov Submission in eBRAP, for additional details.
    Each attachment in the Attachment Form must be uploaded as an individual PDF file in
    accordance with the formatting guidelines listed in Appendix 4. For all attachments, ensure that
    the file names are consistent with the guidance. Grants.gov will reject attachments with file
    names longer than 50 characters or incorrect file names that contain characters other than the
    following: A-Z, a-z, 0-9, underscore, hyphen, space, and period. In addition, Grants.gov has file
    size limits that may apply in some circumstances. Individual attachments may not exceed
    20 MB and the file size for the entire submission package may not exceed 200 MB. Applicants
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 15
    General Submission Instructions

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    must contact the Grants.gov Contact Center (support@grants.gov) for written confirmation that a
    file exceeding the maximum size will be accepted or for other guidance.
    For specific instructions regarding content and page limits of the Project Narrative,
    Supporting Documentation, and all other attachments to this Grants.gov form, refer to
    the BAA.
    All documents that require signatures must be signed. Both electronic and hand
    signatures will be accepted. Any document that is signed by hand should be scanned at a
    low resolution such as 100-150 dots per inch.
    The following must be included as attachments to this form:
    Attachment 1: Project Narrative: Attach as a PDF file named “ProjectNarrative.pdf.”
    The Project Narrative is the main body of the proposal. The page limit of the Project
    Narrative applies to text and non-text elements (e.g., figures, tables, graphs, photographs,
    diagrams, chemical structures, drawings, etc.) used to describe the project. Inclusion of
    URLs that provide additional information to expand on the Project Narrative and could
    confer an unfair competitive advantage is prohibited and may result in administrative
    withdrawal of the proposal. There is no form for this information. A detailed description
    of the research to be undertaken should be submitted. This should include the areas
    described in the BAA.
    Submission of a Project Narrative that exceeds the page limit specified in the BAA will
    result in administrative rejection of the proposal.
    Attachment 2: Supporting Documentation: Combine and attach as a single PDF file
    named “Support.pdf.” Include only supporting documentation as indicated in the BAA.
    Submitting material that is not requested may be viewed as an attempt to gain an unfair
    competitive advantage; such material will be removed or the proposal may be
    administratively withdrawn. The Supporting Documentation attachment should not
    include additional information such as figures, tables, graphs, photographs, diagrams,
    chemical structures, or drawings. These items should be included in the Project
    Narrative. Any additional material viewed as an extension of the Project Narrative will
    be removed or may result in administrative withdrawal of the proposal.
    All proposals are given fair and thorough reviews. Letters of support not requested in
    the BAA, such as those from members of Congress, do not impact proposal review or
    funding decisions.
    For a list and descriptions of required supporting documents, refer to the BAA.
    Attachment 3: Technical Abstract: Attach as a PDF file named “TechAbs.pdf.”
    Abstracts of all funded research projects will be posted on the CDMRP website at
    https://cdmrp.health.mil/. Do not include proprietary or confidential information. Use only
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 16
    General Submission Instructions

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    characters available on a standard QWERTY keyboard. Spell out all Greek letters, other
    non-English letters, and symbols. Graphics are not allowed.
    The Technical Abstract will be posted publicly and will be included in the award
    agreement.
    Attachment 4: Lay Abstract: Attach as a PDF file named “LayAbs.pdf.” Do not include
    proprietary or confidential information. Use only characters available on a standard
    QWERTY keyboard. Spell out all Greek letters, other non-English letters, and symbols.
    Graphics are not allowed.
    The Lay Abstract will be posted publicly and will be included in the award agreement.
    Attachment 5: Statement of Work (SOW): Attach as a PDF file named “SOW.pdf.”
    The SOW outlines and establishes the performance expectations and milestones for which
    USSOCOM may provide funding. The SOW for all award types will be incorporated into
    the award document and, as such, is subject to release under Freedom of Information Act
    (FOIA).
    SOW Format: There is no limit to the number of specific aims, tasks, or subtasks that are
    described within the SOW page limit. The suggested SOW format and examples specific
    to different types of research projects are available on the eBRAP “Funding
    Opportunities and Forms” web page (https://ebrap.org/eBRAP/public/Program.htm).
    The SOW must be in PDF format prior to attaching. The Government reserves the right
    to request a revised SOW format and/or additional information.
    The SOW should include a list of major tasks that support the proposed specific aims,
    followed by a series of subtasks outlined step-by-step as they relate to the major tasks and
    milestones within the period of performance. The SOW should describe only the work for
    which funding is being requested by this proposal and, as applicable, should also:
    • Include the following information for each study site/subaward site: Organization;
    organization address; investigator(s), collaborator(s), consultant(s); description of
    research with animals, human anatomical substances, and/or human subjects or
    cadavers to be conducted at the site; and key personnel responsible for each major
    task and each subtask to be performed at the site.
    • Indicate the number (and type, if applicable) of research subjects (animal or human)
    and/or human anatomical samples projected or required for each task and at each
    site. As applicable, estimated times to complete each task should include time for
    local USSOCOM and the U.S. Army Medical Research and Development Command
    (USAMRDC) regulatory review and approval, as shown below. Refer to Appendix 6
    for additional information regarding regulatory review.
    ○ For studies involving human subjects, include a subtask that allows at least 2 to 3
    months for regulatory review and approval by the USAMRDC Office of Human
    Research Oversight (OHRO); this does not include the additional time required
    for local Institutional Review Board (IRB) review and approval.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 17
    General Submission Instructions

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    For animal studies, include a subtask that allows at least 1 to 2 months for regulatory review and approval
    by the USSOCOM Veterinarian Review Office (VRO) and international regulatory requirements.
    Specific documents relating to the use of animals in the proposed research will be requested if
    the application is selected for funding. The VRO must review and approve all animal use prior
    to the start of working with animals, including amendments to ongoing projects. PIs must
    submit the institutional animal use protocol.
    Questions concerning animal use and review should be directed to the USSOCOM VRO:
    Phone: 813-826-6548; Email: socom_vet@socom.mil
    ○ Attachments 6-12: Additional Documents (as applicable): Attach each as a
    separate PDF file, named as indicated in the BAA (e.g., “Impact.pdf,”
    “Transition.pdf,” etc.).
    For specific instructions regarding content, titles, and page limits for the Additional
    Documents, refer to the BAA.
    3. Research & Related (R&R) Personal Data
    This form will be used by DoD as the source of demographic information, such as gender, race,
    ethnicity, and disability information, for the Project Director (PD)/PI and all other persons
    identified as Co-PD(s)/Co-PI(s).
    Each application must include this form with the name fields of the PD/PI and any Co-PD(s)/Co-
    PI(s) completed; however, provision of the demographic information in the form is voluntary. If
    completing the form for multiple individuals, each Co-PD/Co-PI can be added by selecting the
    “Next Person” button. The demographic information, if provided, will be used for statistical
    purposes only and will not be made available to merit reviewers. Applicants who do not wish to
    provide some or all of the information should check or select the “Do not wish to provide”
    option.
    4. Research & Related Senior/Key Person Profile (Expanded)
    Include the requested information for each person who will contribute significantly to the
    proposed research project.
    In the “PROFILE – Project Director/Principal Investigator” section, enter the PI’s username
    provided by eBRAP into the data field labeled “Credential, e.g., agency login” (Figure 2).
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 18
    General Submission Instructions

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    Figure 2. PI’s eBRAP User Name
    Biographical Sketch Suggested Format: The suggested biographical sketch format is available
    in a Microsoft Word document on the “Funding Opportunities and Forms” web page
    (https://ebrap.org/eBRAP/public/Program.htm) in eBRAP. Use of this document is optional.
    The NIH Biographical Sketch may also be used. Each biographical sketch must be in PDF
    format prior to attachment. Note the page limitation specified in the BAA. Biographical
    Sketches should also be used to demonstrate background and expertise through education,
    positions, publications, and previous work accomplished.
    • PI Biographical Sketch: This file must be titled “Biosketch_LastName.pdf,” where
    “LastName” is the last name of the PI.
    • PI Previous/Current/Pending Support: This file must be titled
    “Support_LastName.pdf,” where “LastName” is the last name of the PI.
    ○ For all previous (award period of performance ending within the past 5 years),
    current, and pending (includes period of time awaiting funding status and/or
    period of time awaiting start date) research support, include the title, time
    commitments, supporting agency, name and address of the funding agency’s
    procuring Contracting Officer, performance period, level of funding, brief
    description of the project’s goals, and list of the specific aims. If applicable,
    identify where the proposed project overlaps with other existing and pending
    research projects. Clearly state if there is no overlap.
    ○ List all positions and scientific appointments, both domestic and foreign, held by
    senior/key personnel that are relevant to an application, including affiliations with
    foreign entities or governments. This includes titled academic, professional, or
    institutional appointments whether or not remuneration is received, and whether
    full-time, part-time, or voluntary (including adjunct, visiting, or honorary).
    ○ Report all resources and other support for all individuals designated in an
    application as senior/key personnel – including for the PI and for other individuals
    who contribute to the scientific development or execution of a project in a
    substantive, measurable way, whether or not they request salaries or
    compensation. Information must be provided about all current support for
    ongoing projects, whether such support is provided through the applicant
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 19
    General Submission Instructions

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    organization, through another domestic or foreign organization, or is directly
    provided to an individual who supports the senior/key personnel’s research
    efforts.
    ○ Report all current projects and activities that involve senior/key personnel, even if
    the support received is only in-kind (e.g., office/laboratory space, equipment,
    supplies, employees). All research resources including, but not limited to, foreign
    financial support, research or laboratory personnel, lab space, scientific materials,
    selection to a foreign “talents” or similar-type program, or other foreign or
    domestic support must be reported.
    ○ Consistent with National Security Presidential Memoranda-33, individuals are
    required to disclose grants and contracts associated with participation in programs
    sponsored by foreign governments, instrumentalities, or entities, including foreign
    government- sponsored talent recruitment programs. Further, if individuals
    receive direct or indirect support that is funded by a foreign government-
    sponsored talent recruitment program, even where the support is provided through
    an intermediary and does not require membership in the foreign government-
    sponsored talent recruitment program, that support must be disclosed. Individuals
    must also report other foreign government sponsored or affiliated activity.
    Foreign government-sponsored talent recruitment program” is defined as an effort
    organized, managed, or funded by a foreign government, or a foreign government
    instrumentality or entity, to recruit science and technology professionals or
    students (regardless of citizenship or national origin, or whether having a full-time
    or part-time position).
    ○ Provide the total award amount for the entire award period covered (including
    facilities and administrative costs), as well as the number of person-months (or
    partial person- months) per year to be devoted to the project by the senior/key
    personnel involved.
    ○ If there is no previous, current, or pending support, enter “None.” An updated
    previous, current, and pending support document will be required if an award is
    recommended for funding.
    • Key Personnel Biographical Sketches: Each file must be titled
    “Biosketch_LastName.pdf,” where “LastName” is the last name of the respective
    individual.
    • Key Personnel Previous/Current/Pending Support: Each file must be titled
    “Support_LastName.pdf,” where “LastName” is the last name of the respective
    individual. Refer to content requirements under “PI Previous/Current/Pending
    Support” listed above.
    ○ Report all current projects and activities that involve senior/key personnel, even if
    the support received is only in-kind (e.g., office/laboratory space, equipment,
    supplies, employees). All research resources including, but not limited to, foreign
    financial support, research or laboratory personnel, laboratory space, scientific
    materials, selection to a foreign “talents” or similar-type program, or other foreign
    or domestic support must be reported.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 20
    General Submission Instructions

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    5. Research & Related Budget
    An estimate of the total proposed research project costs, with a breakdown of all cost categories
    for each year, must be submitted on the Grants.gov Research & Related Budget form. Include a
    sufficiently detailed budget and budget justification for each year so that the Government can
    determine the proposed costs to be allowable, allocable, and reasonable for the proposed
    research. The budget justification for the entire period of performance must be uploaded to
    the Research & Related Budget after completion of the budget for Period 1. At the time of
    proposal submission to Grants.gov, the AOR is certifying to the best of his/her knowledge that
    all costs are current, accurate, and complete.
    If the budget fails eBRAP validation or the budget needs to be modified, an updated Grants.gov
    submission package must be submitted via Grants.gov as a “Changed/Corrected Application”
    with the previous Grants.gov Tracking ID prior to proposal submission deadline.
    Budget Regulations and Restrictions:
    The following must be utilized in developing the budget:
    • Administrative and Cost Principles. Awardees are required to comply with the
    following, as applicable:
    ○ Federal Acquisition Regulation (FAR) Part 31
    ○ Defense FAR Supplement Part 231
    ○ 2 CFR Part 200, “Uniform Administrative Requirements, Cost Principles, and Audit
    Requirements for Federal Awards,” implemented by Chapter XI of Title 2, CFR.
    • Award Funding/Maximum Obligation:
    ○ Contract Awards: Reference contract funding regulations in FAR 32.7 and
    Defense Federal Acquisition Regulation Supplement (DFARS) 232.7.
    • Pre-Award Costs: Pre-award costs may be allowable as follows:
    ○ Contract Awards: An organization may request and negotiate pre-contract costs
    prior to contract award. An advanced agreement must be executed by the
    Contracting Officer prior to incurring any cost. Advanced Agreement Costs (Pre-
    Contract Costs) are referenced in FAR 31.205-32 and Advanced Agreements in
    31.109.
    • Cost of Preparing Proposals: The cost of preparing proposals in response to the BAA
    is not considered an allowable direct charge to any resultant award. However, the cost
    of preparing proposals may be an allowable expense included in the indirect/facilities
    and administrative cost as specified in the organizations applicable cost principles.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 21
    General Submission Instructions

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    • Currency: All costs must be entered in U.S. dollars. Recipients performing research
    outside of the United States should include the cost in local currency, the rate used for
    converting to U.S. dollars, and justification/basis for the conversion rate used. Foreign
    currency exchange rates for recipients performing research outside of the United States
    will be based on the official rate in effect at the time of submission.
    Submit a detailed budget and justification that covers the entire period of
    performance (not just the first year). The Government reserves the right to request a
    revised budget and budget justification and/or additional information.
    Budget Instructions: Complete the Research & Related Budget following the instructions
    below. Begin by entering the organizational UEI number, Budget Type, Name of Organization,
    and anticipated start and end dates. Ensure that the UEI number is entered accurately or
    Grants.gov will reject the proposal. For all Federal agencies or organizations collaborating
    with Military Facilities, special restrictions apply to the budget and are described below.
    For Federal Agencies (as applicant): A proposal from a Federal agency must include in
    the budget justification a Federal Financial Plan (Plan). The Plan must address how all
    funds will be obligated before their period for obligation expires, and how funds will be
    available to cover research costs over the entire award period. The Plan must include the
    funding mechanism(s) that will be used to carry over funds between fiscal years.
    For Collaborating Military Facilities: A proposal from an extramural organization that
    includes collaboration with a Military Facility (Military Health System facility, research
    laboratory, medical treatment facility, dental treatment facility, or a DoD activity
    embedded with a civilian medical center) must submit a Collaborating DoD Military
    Facility Budget Form(s). Include any Military Facility’s direct and indirect costs on this
    form. Also, include the Military Facility’s total costs (direct and indirect) on the
    Subaward/Consortium/Contractual Costs line of the Research & Related Budget Form
    (Section F.5.). See Section III.A.8, Collaborating with DoD Military Facilities, for
    additional information.
    Section A: Senior/Key Person
    • Prefix; First, Middle, and Last Name; and Suffix: Beginning with the PI, list all
    senior/key persons from the applicant organization who will be involved in the
    proposed research project, whether or not salaries are requested. Include all
    investigators, research associates, etc. If applicable, all investigators outside the
    applicant organization should be included on the R & R Subaward Budget
    Attachment(s) Form. Consultant costs should be listed under Section F.3.
    • Project Role: Identify the role of each senior/key person listed. Describe his/her
    specific functions in the budget justification.
    • Base Salary: Enter the current annual base salary (based on a full-time appointment)
    for each individual listed for the proposed research project. Establish labor costs using
    current labor rates or salaries. Labor rates or salaries may not be increased as a result
    of receiving an award. Identify and explain in the budget justification any proposed
    adjustments to rates or salaries. Any proposed increases in rates or salaries over the
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 22
    General Submission Instructions

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    period of the award must be consistent with the applicable cost principles and
    organization’s estimating procedures. For most Federal agencies, funding cannot be
    applied toward Federal salaries; therefore, these salaries should not be included in
    the requested budget.
    • Calendar, Academic, and Summer Months: For each senior/key person, including
    unpaid personnel, list the number of months to be devoted to the proposed research
    project in the appropriate box.
    • Requested Salary: Enter the amount of salary requested for this budget period.
    • Fringe Benefits: Enter the fringe benefits requested for each individual in accordance
    with organizational guidelines. If the proposal is recommended for funding, the
    organization will be required to provide documentation to support the fringe benefits
    (e.g., the current Department of Health and Human Services [DHHS] Rate Agreement
    or other policy document).
    • Funds Requested: Enter the total funds requested for each senior/key person listed for
    the proposed research project.
    • Project Role: Identify the role of each senior/key person listed. Describe his/her
    specific functions in the budget justification.
    Section B: Other Personnel
    • Number of Personnel: For each project role category, indicate the number of
    personnel for the proposed research project, including unpaid personnel.
    • Project Role: Identify each project role category. Within the budget justification,
    describe the specific functions of the personnel in each project role.
    • Calendar, Academic, and Summer Months: For each project role category, list the
    number of months to be devoted to the proposed research project in the appropriate
    box.
    • Requested Salary: Enter the amount of salary requested for this budget period. For
    most Federal agencies, funding cannot be applied toward Federal salaries; therefore,
    these salaries should not be included in the requested budget.
    • Fringe Benefits: Enter the fringe benefits requested for each project role category in
    accordance with organizational guidelines. If the proposal is recommended for
    funding, the organization will be required to provide documentation to support the
    fringe benefits (e.g., the current DHHS Rate Agreement, other federally approved rate
    agreement, or other policy document).
    • Funds Requested: Enter the total funds requested for each project role category listed
    for the proposed research project.
    Section C: Equipment Description: Equipment is tangible personal property (including
    information technology systems) having a useful life of more than 1 year and a per unit
    acquisition cost of (a) $5,000 or more per unit, or (b) the awardee’s or subawardees’
    capitalization threshold for financial statement purposes. Applicant organizations are
    encouraged to provide all equipment necessary to conduct the proposed research project. If
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 23
    General Submission Instructions

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    equipment is requested, provide a detailed list showing the cost of each item. The budget
    justification for any requested equipment must describe, as applicable:
    • Special test equipment to be fabricated for specific research purposes and its cost.
    • Standard equipment to be acquired and modified to meet specific requirements,
    including acquisition and modification costs; list separately.
    • Existing equipment to be modified to meet specific research requirements, including
    modification costs. Do not include as special test equipment those items of equipment
    that, if purchased by the contractor/awardee with award funds, would be capitalized for
    Federal income tax purposes.
    In addition, requests for equipment must include a rationale for estimated costs.
    Section D: Travel: Travel costs may include:
    • Costs to attend one scientific/technical meeting per year: Include the meeting name,
    purpose, location, and date, if known, in the budget justification. International travel
    may be requested but must be well justified and is subject to approval.
    • Costs for travel required for the execution of the proposed work (if applicable):
    Reasonable costs for travel between collaborating organizations should be included.
    International travel may be requested but must be well justified and is subject to
    approval.
    • The PI may be required to participate in an In-Progress Review (IPR). The PI should
    budget for an IPR yearly, lasting not more than 2 days and including up to two
    overnight stays, at the Contracting Officer’s Representative’s (COR) request. The
    invitation and format for the IPR will be provided by the COR at least 90 days prior to
    the meeting. The meetings will generally be held in the MacDill Airforce Base, Florida
    area but could occur elsewhere in the United States.
    Section E: Participant/Trainee Support Costs: Enter the funds requested for
    tuition/fees, health insurance, stipends, travel, subsistence, and other costs.
    Section F: Other Direct Costs
    • Materials and Supplies: Supplies means all tangible personal property, including a
    computing device, acquired under an award that does not meet the definition of
    equipment. The budget justification for supporting material and supply (consumable)
    costs should include a general description of expendable material and supplies for each
    year. For individual or total materials and supplies costing $5,000 or more per year,
    provide additional breakdown. If animals are to be purchased, state the species, strain
    (if applicable), number to be used, cost per animal and total costs, proposed vendor, and
    a copy of the animal per diem cost/rate agreement. If human cell lines are to be
    purchased, state the source, cost, and description.
    Computers and software are considered to be general office supplies and are not
    normally allowable direct cost charges unless the computer/software is essential and
    unique to the proposed research project.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 24
    General Submission Instructions

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    ○ If a computer/software purchase is requested, include the following in the budget
    justification:
    – Detailed explanation for why purchase of computer/software is required to
    complete the proposed research project.
    – Statement verifying that the requested computer/software is not currently
    available for use by the PI.
    – Statement assuring that the requested computer/software will be purchased in
    accordance with applicable cost principles.
    • Publication Costs: Estimate the costs of publishing and reporting research results,
    including direct charges for clerical preparation, illustrations, reprints, and distribution.
    • Consultant Services: Regardless of whether funds are requested, include in the budget
    justification the names and organizational affiliations of all consultants, and include the
    daily consultant fee, travel expenses, nature of the consulting effort, and why
    consultants are required for the proposed research project.
    • Automated Data Processing (ADP)/Computer Services: Include the cost of
    computer services, including computer-based retrieval of scientific, technical, and
    education information. Include in the budget justification the provider’s computer
    service rates.
    • Subaward/Consortium/Contractual Costs: Include the total funds (direct and
    indirect costs) requested for (1) all subaward/consortium organization(s) proposed for
    the research project and (2) any other contractual costs proposed for the research
    project. This amount should be supported in the subaward/consortium/contractual costs
    provided in the R & R Subaward Budget Attachment(s) Form.
    If a Military Facility (Military Health System facility, research laboratory, medical
    treatment facility, dental treatment facility, or a DoD activity embedded with a civilian
    medical center) will be a collaborator in performance of the project, complete the DoD
    Military Budget Form, available for download on the eBRAP “Funding Opportunities
    & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm), including a budget
    justification, for each Military Facility as instructed. The costs per year should be
    included on the Grants.gov Research and Related Budget form under subaward costs.
    See Section III.A.8., Collaborating with DoD Military Facilities below, for more
    information.
    Subcontracts shall be submitted in accordance with FAR 19.704 as necessary.
    • Equipment or Facility Rental/User Fees: List proposed equipment or facility
    rental/user fees. Include appropriate information (hours and rates) in the budget
    justification.
    • Alterations and Renovations: Alteration and renovation (A&R) costs can be
    requested if the costs are essential to accomplish the objectives of the research project
    and are a minor portion of the overall budget. A description of the existing facility
    and detailed description of the requested changes, along with a cost estimate, must be
    included in the budget justification. Costs for the construction of facilities are not
    allowable.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 25
    General Submission Instructions

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    • Other Expenses: Itemize other anticipated direct costs such as communication costs
    and organizationally provided services. These items should be described in detail and
    clearly justified in the budget justification. Organizationally provided services should
    be supported by the organization’s current cost/rate schedule.
    For research involving human subjects, include itemized research-related subject costs
    for the proposed research project. These costs are strictly limited to expenses
    specifically associated with the proposed research project.
    Section G: Direct Costs: Include the total direct costs (A-F).
    Section H: Indirect Costs: The indirect costs category may include Facilities and
    Administrative (F&A) costs, overhead, General and Administrative (G&A), and other. The
    most recent Federal agency approved rate(s) should be applied. If the rate(s) has been
    approved by other than a Federal agency, indicate the source of the approval.
    In accordance with 2 CFR 200.414, a non-Federal entity that has never received a
    negotiated indirect cost rate, may elect to charge a de minimis rate of 10% of modified total
    direct costs. If this methodology is chosen, it must be used consistently for all Federal
    awards until such time as the non-Federal entity chooses to negotiate for a rate. Costs must
    be consistently charged as either indirect or direct costs, but may not be double charged or
    inconsistently charged as both.
    Provide details of the direct cost base (modified total direct costs, salary and wage, or
    other). Identify any costs that have been excluded from the base (in accordance with the
    approved rate agreement). Also indicate if the rate(s) is an on- or off-site rate(s). If more
    than one rate is applicable, provide a breakdown of the calculation.
    Provide documentation to support the indirect cost rate (e.g., the current DHHS, Defense
    Contract Audit Agency [DCAA], Office of Naval Research [ONR] Rate Agreement, other
    Federally approved rate agreement, or other policy document) via eBRAP
    (https://eBRAP.org).
    Organizations can also visit the DHHS
    (https://www.hhs.gov/about/agencies/asa/psc/indirect-cost-negotiations/index.html), the
    ONR (https://www.nre.navy.mil/work-with-us/manage-your-award/manage-grant-award),
    and the DCAA (http://www.dcaa.mil/) for additional information on indirect rates.
    Section I: Total Direct and Indirect Costs: Include total costs for the proposed research
    project.
    Section J: Fee: Statutory limits for fees are specified in FAR 15.404-4(c)(4).
    Section K: Budget Justification: Provide a clear budget justification for each year and
    for each item in the budget over the entire period of performance and attach as a single
    PDF file to Section K of the Research & Related Budget.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 26
    General Submission Instructions

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    Proposals from Federal agencies must include in their budget justifications a Federal
    Financial Plan. The Plan must address how all funds will be obligated before their
    expiration for obligation, and how funds will be available to cover research costs over the
    entire award period. The Plan must include the funding mechanism(s) that will be used to
    carry over funds between fiscal years.
    Organizations must provide sufficient detail and justification to enable the Federal
    Government to determine that the proposed costs are allowable, allocable, and
    reasonable for the proposed research effort.
    6. Project/Performance Site Location(s) Form
    Indicate the primary site where the work will be performed. If a portion of the work will be
    performed at any other site(s), include the name and address for each collaborating location in
    the data fields provided. Add more sites as necessary using the “Next Site” button. If more than
    eight performance site locations are proposed, provide the requested information in a separate
    file and attach it to this form. Each additional research site requesting funds will require a
    subaward budget.
    7. R & R Subaward Budget Attachment(s) Form (if applicable)
    Complete a separate detailed Research & Related Budget (direct and indirect costs) including a
    budget justification for each subaward (subgrant or subcontract) in accordance with the
    instructions listed above. Title each individual subaward, “Research & Related Budget,” with
    the name of the subrecipient/subawardee organization and attach to the R & R Subaward Budget
    Attachment(s) Form.
    A description of services or materials that are to be provided under the subaward is required.
    Organizations must provide sufficient detail and justification to enable the Federal Government
    to determine that the proposed costs are allowable, allocable, and reasonable for the proposed
    research effort.
    If collaborating with a DoD Military Facility, do not complete this form; complete the
    Collaborating DoD Military Facility Budget Form. See Section III.A.8, Collaborating with DoD
    Military Facilities.
    8. Collaborating with DoD Military Facilities
    This section addresses requirements and procedures when a Military Facility will be a
    collaborator in performance of an extramural project.
    Budget Form: Complete a separate “Collaborating DoD Military Facility Budget Form,” for
    each Military Facility involved in the project. The form is available for download on the eBRAP
    “Funding Opportunities and Forms” web page (https://eBRAP.org). Do not complete the
    grants.gov R&R Subaward Budget Attachment Form.
    Direct Costs:
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 27
    General Submission Instructions

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    • Salaries: Include the positions/titles/ranks and levels of effort of all DoD civilian and
    military personnel expected to work on the extramural project, whether or not
    salaries/fringe benefits are proposed. Salaries/fringe benefits may be reimbursed,
    either directly by the Federal Government to the facility or through the extramural
    award to the facility, but only under certain limited circumstances, which will be
    discussed during negotiations. Extramural organizations may provide personnel to
    work at intramural DoD partnering organizations. The Extramural personnel costs
    should not be included here but on the organization’s Research and Related Budget
    Form.
    • Travel: Include costs to be incurred by DoD civilian and military personnel.
    However, note that these costs cannot be reimbursed through the extramural
    award. They can only be funded directly by the Federal Government to the facility.
    Some restrictions apply. Processes will be discussed during negotiations.
    • Consultants, Equipment, Materials, Supplies, Other, Etc.: Include all anticipated
    direct costs. The Military Facility should consider whether the applicant organization
    can purchase the items/resources and provide them to the facility. The organization
    may provide resources to the Military Facility, such as consultants, supplies,
    equipment, etc., acquired with award funds. If this is feasible, these funds should be
    included on the applicant organization’s Research & Related Budget Form and should
    not be included on this form. Title of all equipment will remain with the Government.
    • Rates/Fees (Other than Indirect Cost Rates and Profit): Where there are no DoD-
    established reimbursement rates (e.g., Institutional Review Board [IRB] fees), the
    Military Facility’s Resource Manager/Comptroller/Task Area Manager or equivalent
    Business Official must provide details of how the proposed rates/fees were determined.
    Rates/fees should be included in the Other Direct Costs line of the Research & Related
    Budget Form (Section F.8-10.).
    • Indirect Costs: If an indirect cost rate is proposed, include documentation to support
    the rate (i.e., cost pool(s) and what items are included in each pool). The Military
    Facility should consult with its RM office (or equivalent) for assistance in determining
    a rate.
    • Total Costs: Include the facility’s combined direct and indirect costs. Enter the total
    here and also include it in the Subaward/Consortium/Contractual Costs budget line on
    the Research & Related Budget Form (Section F.5).
    Budget Justification: Include a budget justification for each year, for each Military Facility. A
    description of services or materials that are to be provided by the collaborating Military Facility
    is required. The Military Facility researcher(s) should coordinate with his/her local RM office
    (or equivalent) to prepare a sound budget and justification for the estimated costs. Applicant
    organizations must provide sufficient detail and justification to enable the Federal Government to
    determine that the proposed costs are allowable, allocable, and reasonable for the proposed
    research effort. In addition, the Military Facilities’ direct and indirect costs to be supported
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 28
    General Submission Instructions

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    when performing collaborative research with the extramural organization must meet the
    requirements of the DoD’s Financial Management Regulation (FMR) 7000.14-R.
    Direct Fund by Federal Agency: The USSCOM’s RM office will “direct fund” (via a Funding
    Authorization Document [FAD], Military Interdepartmental Purchase Request [MIPR], or other
    authorized method) the collaborating Military Facility to support all costs to be incurred in
    performance of the Military Facility’s portion of the research project. When direct funded, these
    funds will not be included in the award amount to awardee.
    Technology Transfer: The Military Facility researcher(s) should also coordinate with his/her
    technology transfer office, when applicable. The facility may require that a Cooperative
    Research and Development Agreement (CRADA) or other instrument (as authorized by law or
    regulation) be executed between the facility and the awardee before work between the
    organizations can begin or funds can be provided to the Military Facility. The CRADA (or other
    instrument) is not required at the time of proposal submission. A timeline for execution of the
    document will be established during negotiations.
    B. Submission of a Grants.gov Workspace
    An application must be submitted through Workspace by clicking the “Sign and Submit” button
    on the Manage Workspace page, under the “Forms” tab. Grants.gov recommends submitting the
    application package at least 24-48 hours prior to the close date to provide time to correct any
    potential technical issues that may disrupt the application submission.
    All applications must be received by the deadline indicated on the title page of the respective
    BAA. Proof of timely submission is automatically recorded by Grants.gov. An electronic
    date/time stamp is generated within the system when the application is successfully received by
    Grants.gov. The applicant AOR will receive an acknowledgement of receipt and a Tracking
    Number (GRANTXXXXXXXX) from Grants.gov with the successful transmission of their
    application. Applicant AORs will also receive the official date/time stamp and Grants.gov
    Tracking Number in an email serving as proof of their timely submission.
    C. Applicant Verification of Grants.gov Submission in eBRAP
    The full application package submitted to Grants.gov may be viewed in eBRAP until the end of
    the application verification period. After eBRAP has processed the full application, PIs will
    receive an email notification of this status and will be able to view and modify application
    components in eBRAP. During the application verification period, the full application package,
    with the exception of the Project Narrative and Budget Form, may be modified. See the BAA
    for specific full application submission and application verification deadlines.
    Specific information must be identical between the pre-application and the full application for
    eBRAP to process an application. The application title, eBRAP log number, and all information
    for the PI, Business Official(s), performing organization, and contracting organization must be
    consistent for the entire pre-application and application submission process. Inconsistencies may
    delay application processing and limit or negate the ability to view, modify, and verify the
    application in eBRAP.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 29
    General Submission Instructions

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    Prior to the end of the application verification period, PIs and organizational representatives can
    review and modify in eBRAP certain components of an application submitted to Grants.gov.
    Following retrieval and processing of the Grants.gov application, eBRAP will notify the
    organizational representatives and PI by email to log into eBRAP to review, modify, and verify
    the Grants.gov application submission. eBRAP will validate retrieved files against the specific
    BAA requirements and discrepancies will be noted in both the email and in the “Full Application
    Files” tab in eBRAP. eBRAP does not confirm the accuracy of file content. It is the applicant’s
    responsibility to review all application components and ensure proper ordering as specified in the
    BAA. If either the Project Narrative or the budget fails eBRAP validation or if the Project
    Narrative or the budget need to be modified, an updated Grants.gov application package must
    be submitted via Grants.gov as a “Changed/Corrected Application” with the previous
    Grants.gov Tracking ID prior to the application submission deadline. The Project Narrative
    and Budget Form cannot be changed after the application submission deadline. The full
    application submission deadline and the end of the application verification period in eBRAP are
    stated in the specific BAA.
    D. Application Tracking
    After a Workspace package has been successfully submitted, a Grants.gov Tracking Number
    (GRANTXXXXXXXX) is automatically assigned to the package. The number will be listed on
    the Confirmation page that is generated after submission. Participants can also find the
    Grants.gov Tracking Number on the Manage Workspace page, under the “Details” tab. The
    submission of a Workspace package can be tracked from the Workspace or by visiting
    Grants.gov (https://www.grants.gov/web/grants/applicants/track-my-application.html) and
    entering the Tracking Number.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 30
    General Submission Instructions

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    APPENDIX 1
    REGULATORY REQUIREMENTS
    A. Safety and Environmental Requirements
    Based on changes to DoD compliance requirements (Department of the Army Pamphlet [DA
    PAM] 385-69, DA PAM 385-10, 32 CFR 651, 6 September 2012), provisions previously
    required for Safety and Environmental Compliance have been removed. However, in certain
    instances, compliance review may require submission of additional documentation prior to the
    awarding of any assistance agreement. Such instances may include use of Army-provided
    infectious agents or toxins, Biological Select Agents or Toxins, specific chemical agent(s), or
    pesticides outside of an established laboratory. The USAMRDC Office of Surety and
    Environment will identify any need for compliance review and documents must be submitted
    upon request.
    Additional information is available at:
    https://mrdc.health.mil/index.cfm/resources/researcher_resources/safety.
    B. Research Protections Review Requirements
    Use of Human Subjects, Human Anatomical Substances, Human Subject Data, Human
    Cadavers, and Animals
    The USAMRDC Office of Human Research Oversight (OHRO)and USSOCOM’s Veterinarian
    Review Office (VRO) ensures that research conducted, contracted, sponsored, supported, or
    managed by the DoD and involving human subjects, human anatomical substances, human
    subject data, human cadavers, and animals are conducted in accordance with Federal, DoD,
    Army, USAMRDC, USSOCOM, and international regulatory requirements.
    PIs and applicant organizations may not commence performance of research involving the
    above, or expend funding on such efforts, until regulatory documents are submitted and
    approved by the USAMRDC ORP to ensure that DoD regulations are met. All expectations
    described below are consistent with the DoD Instruction (DoDI) 3216.01, “USE OF ANIMALS
    IN DOD CONDUCTED AND SUPPORTED RESEARCH AND TRAINING,” as issued March
    20, 2019, available at https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/321601p.pdf
    and DoDI 3216.02, “PROTECTION OF HUMAN SUBJECTS AND ADHERENCE TO
    ETHICAL STANDARDS IN DOD-CONDUCTED AND -SUPPORTED RESEARCH,” as
    issued on April 15, 2020 with Change 1 Effective June 29, 2022, and available at
    www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/321602p.pdf
    The USSOCOM Veterinarian Review Office (VRO) is responsible for administrative review,
    approval, and oversight of all animal research protocols, including all changes made during the
    life of the protocol.
    The Office of Human Research Oversight (OHRO)is responsible for administrative review,
    approval, and oversight of research involving human subjects, human anatomical substances or
    data, and use of human cadavers. Research involving use of human subject data and/or
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 31
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    specimens that is anticipated to be exempt from human subjects protections regulations
    requires a determination from the PI’s institution as well as a determination from the Office
    of Human Research Oversight (OHRO) at USAMRDC. A timeframe for submission of the
    appropriate protocols and required approvals will be established during negotiations.
    1. Research Involving Animal Use
    Specific documents relating to the use of animals in the proposed research will be requested if
    the proposal is selected for funding. The USSOCOM VRO, must review and approve all
    animal use prior to the start of working with animals. All amendments or modifications must
    also be reviewed prior to initiation for the life of the award. PIs must submit the institutional
    animal use protocol, IACUC approval of that protocol, and a “VRO_Animal Research_Review”.
    The VRO review documents can be found on the USSOCOM Research Protections website at:
    https://www.socom.mil/SOF-ATL/Pages/HRPO.aspx
    Allow at least 1 to 2 months for regulatory review and approval processes for animal studies.
    For additional information, send questions via email to VRO (socom_vet@socom.mil).
    2. Use of Human Cadavers or Human Anatomical Substances Obtained from Human
    Cadavers
    Research, development, test and evaluation (RDT&E), education or training activities involving
    human cadavers or human anatomical substances obtained from cadavers shall not begin until
    approval is granted in accordance with the Army Policy for Use of Human Cadavers for
    Research, Development, Test and Evaluation, Education, or Training, November 05 2019
    (https://mrdc.health.mil/index.cfm/collaborate/research_protections/hrpo). The USAMRDC OHRO is
    the Action Office (usarmy.detrick.medcom-USAMRMC.other.hrpo@health.mil) for this policy.
    OHRO must review the use of postmortem specimens for compliance with the Army
    Cadaver Use Policy. Award recipients must coordinate with the supporting/funding Army
    organization to ensure that proper approvals are obtained. Written approvals to begin the activity
    will be issued under separate notification to the awardee. Questions regarding submission of
    human cadaver research for USAMRDC OHRO review and approval should be directed to the
    OHRO at usarmy.detrick.medcom-USAMRMC.other.hrpo@health.mil.
    3. Research Involving the Secondary Use of Data/Specimens
    All USSOCOM-supported research involving the secondary use of human data, records, human
    tissue, or human specimens (hereafter referred as data/specimens) must be reviewed for
    compliance with Federal and DoD human subjects protection requirements and approved by the
    USAMRDC ORP prior to implementation. USAMRDC OHRO review includes assessing the
    source of the data/specimens and whether the initial manner and consent for the data/specimen
    collection permits use in the DoD-funded research protocol. OHRO review, approvals, and
    determinations for specimen research are based upon the nature of the research, the source of the
    data/
    specimens, use and/or disclosure of identifiable health information, privacy and confidentiality
    protections, and whether the individual providing the data/specimens allowed the use of his/her
    data/specimens for research. For additional guidance and instructions on OHRO review of any
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 32
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    DoD-funded research activities involving access, use, and analysis of data/specimens,
    investigators should submit the OHRO Submission Form for Secondary research found on the
    OHRO website. https://mrdc.health.mil/index.cfm/collaborate/research_protections/hrpo.
    4. Research Involving Human Subjects
    In addition to local IRB review, investigators must submit all USSOCOM-funded
    research protocols involving human subjects for review and approval by the
    USAMRDC OHRO prior to implementation of the research. The focus of this review
    is to validate the IRB review as appropriate and ensure that DoD, Army, and
    USAMRDC and USSOCOM regulatory requirements have been met.
    Human subject research definitions, categories, and resource information may be found in the
    Human Subject Resource Document on the eBRAP website
    (https://ebrap.org/eBRAP/public/Program.htm). This information should only be used as a
    guide; it is not intended to be a source for human subjects protection regulations. Questions
    regarding applicable human subjects protection regulations, policies, and guidance should be
    directed to the local IRB, the OHRO (usarmy.detrick.medcom-
    USAMRMC.other.hrpo@health.mil), and/or the U.S. Food and Drug Administration (FDA) as
    appropriate. For in-depth information and to access HRPO protocol submission forms, refer to
    the OHRO website (https://mrdc.health.mil/index.cfm/collaborate/research_protections/hrpo).
    OHRO-required language must be inserted into the consent form, and compliance with
    DoD regulations may require that additional information be included in the protocol.
    The OHRO ensures that DoD-supported and/or -conducted research complies with
    specific DoD laws and requirements governing research involving human subjects. These laws
    and requirements may require information in addition to that supplied to the local IRB.
    During the regulatory review process for research involving human subjects, the ORP HRPO
    requirements must be addressed, and any changes to the already approved protocol must be
    approved as an amendment by the local IRB. It is strongly recommended that investigators
    carefully read the “Information for Investigators” found at
    https://mrdc.health.mil/index.cfm/collaborate/research_protections/hrpo. The time to approval
    depends greatly on adherence to the requirements described within. If the protocol has not been
    submitted to the local IRB at the time of award negotiation, these guidelines should be
    considered before submission.
    Documents related to the use of human subjects or human anatomical substances will be
    requested if the proposal is recommended for funding. Allow at least 2 to 3 months for
    regulatory review and approval processes for studies involving human subjects.
    Specific requirements for HRPO submission and review of research involving human subjects
    can be found at https://mrdc.health.mil/index.cfm/collaborate/research_protections/hrpo.
    (1) Assurance of Compliance: Each institution engaged in non-exempt human subjects
    research must have a current DHHS Office for Human Research Protection (OHRP)
    Federal Wide Assurance (FWA) or DoD Assurance.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 33
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    (2) Training: Personnel involved in human subjects research must have completed
    appropriate training in the protection of human subjects. Documentation confirming
    completion of appropriate training may be required during the regulatory review process.
    (3) Informed Consent Form: The following must appear in the consent form:
    • A statement that the U.S. DoD is providing funding for the study.
    • A statement that representatives of the DoD are authorized to review research
    records.
    • In the event that a Health Insurance Portability and Accountability Act (HIPAA)
    authorization is required, the DoD must be listed as one of the parties to whom
    private health information may be disclosed.
    (4) Intent to Benefit: The requirements of 10 USC 980, which are applicable to DoD-
    sponsored research, must be considered. 10 USC 980 requires that “Funds appropriated
    to the Department of Defense may not be used for research involving a human being as
    an experimental subject unless (1) the informed consent of the subject is obtained in
    advance; or (2) in the case of research intended to be beneficial to the subject, the
    informed consent may be obtained from a legal representative for the subject.”
    An individual not legally competent to provide informed consent (e.g., incapacitated
    individuals, cognitively impaired, minors) may not be enrolled as an experimental
    subject in a DoD-supported study unless the research is intended to benefit each subject
    enrolled in the study, to include subjects enrolled in study placebo arms. Studies
    designed in a manner that permits all subjects to potentially benefit directly from medical
    treatment or enhanced surveillance beyond the standard of care can meet the 10 USC 980
    requirements. Note that the definition of experimental subject as defined in the DoDI
    3216.02 is a much narrower definition of human subject. Research with experimental
    subjects must involve an intervention or interaction where the primary purpose of the
    research is to collect data regarding the effects of the intervention or interaction.
    10 USC 980 is only applicable to certain intervention studies. It does not apply to
    retrospective studies, observational studies, studies that involve only blood draws, and
    tissue collections. Contact the OHRO at usarmy.detrick.medcom-
    USAMRMC.other.hrpo@health.mil if further clarification regarding applicability of
    10 USC 980 to the proposed research project is required.
    Research Monitor Requirement: For research determined to be greater than minimal risk,
    DoDI 3216.02 requires that the IRB approve, by name, an independent research monitor with
    expertise consonant with the nature of risk(s) identified within the research protocol. The IRB
    must approve a written summary of the monitor’s duties, authorities, and responsibilities.
    The research monitor’s duties should be based on specific risks or concerns about the research.
    The research monitor may perform oversight functions and report his/her observations and
    findings to the IRB or a designated official. The research monitor may be identified from within
    or outside the PI’s institution. Research monitor functions may include:
    • Observing recruitment and enrollment procedures and the consent process for
    individuals, groups or units;
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 34
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    • Overseeing study interventions and interactions;
    • Reviewing monitoring plans and Unanticipated Problems Involving Risk to Subjects
    or Others (UPIRTSO) reports; and/or
    • Overseeing data matching, data collection, and analysis.
    There may be more than one research monitor (e.g., if different skills or experiences are
    necessary). The monitor may be an ombudsman or a member of the data safety monitoring
    board. At a minimum, the research monitor:
    • May discuss the research protocol with the investigators, interview human subjects,
    and consult with others outside of the study about the research;
    • Shall have authority to stop a research protocol in progress, remove individual human
    subjects from a research protocol, and take whatever steps are necessary to protect the
    safety and well-being of human subjects until the IRB can assess the monitor’s report;
    and
    • Shall have the responsibility for promptly reporting his or her observations and
    findings to the IRB or other designated official and the OHRO.
    A curriculum vitae or biographical sketch and documentation of human subjects protection
    training for the research monitor must be provided. There should be no apparent COI, and the
    research monitor cannot be under the supervision of the PI, other investigators, or research staff
    associated with the proposed research project. If the duties of the research monitor could require
    disclosure of subjects’ Protected Health Information outside a covered entity (i.e., the research
    monitor is not an agent of the covered entity), the PI’s institution may require the identity and
    location of the research monitor to be described in the study HIPAA authorization. It is
    acceptable to provide appropriate compensation to the research monitor for his or her services.
    1. Military Personnel Volunteers: The following is important information for research
    projects proposing to include military personnel as volunteers.
    • Recruitment of Military Personnel: Civilian investigators attempting to access
    military volunteer pools are advised to seek collaboration with a military investigator
    familiar with Service-specific requirements.
    A letter of support from Commanders of military units in which recruitment will
    occur or the study will be conducted will be requested by the OHRO. Some military
    sites may also require that each volunteer seek written permission from his/her
    supervisor prior to participation in research studies.
    Special consideration must be given to the recruitment process for military personnel.
    The Chain of Command must not be involved in the recruitment of military personnel
    and cannot encourage or order Service members to participate in a research study.
    For greater than minimal risk research, an ombudsman must be employed when
    conducting group briefings with active duty personnel to ensure that volunteers
    understand that participation is voluntary; this ombudsman may be recommended in
    other situations as well, especially when young enlisted Service members, who by
    virtue of their age and enlistment status are trained to follow orders, are being
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 35
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    recruited. Service members are trained to act as a unit, so peer pressure should also
    be considered and minimized, if possible.
    • Payment to Federal Employees and Military Personnel: Under 24 USC 30,
    payment to Federal employees and active duty military personnel for participation in
    research while on duty is limited to blood donation and may not exceed $50 per blood
    draw. These individuals may not receive any other payment or non-monetary
    compensation for participation in a research study unless they are off duty or on leave
    during the time they are participating in the protocol.
    • Confidentiality for Military Personnel: Confidentiality risk assessment for military
    personnel requires serious consideration of the potential to affect the military career.
    Medical and psychological diagnoses can lead to limitation of duties and/or discharge
    from active duty. Information regarding alcohol or drug abuse, drunk driving, and
    sexual or spousal abuse can lead to actions under the Uniform Code of Military
    Justice, including incarceration and dishonorable discharge.
    2. Site Visits: The USAMRDC OHRO conducts site visits as part of its responsibility for
    compliance oversight.
    Accurate and complete study records must be maintained and made available to
    representatives of the USAMRDC as a part of their responsibility to protect human
    subjects in research. Research records must be stored in a confidential manner so as to
    protect the confidentiality of subject information.
    Additional information pertaining to the human subjects regulatory review process,
    guidelines for developing protocols, and suggested language for specific issues can be
    found at: https://mrdc.health.mil/index.cfm/collaborate/research_protections/hrpo.
    3. Protocol Submission Format: The OHRO accepts protocol submissions in the format
    required by the local IRB. The IRB protocol application, if separate from the protocol
    itself, should be included with protocol submissions. A OHRO protocol submission form
    should be completed and submitted with each protocol.
    C. Clinical Trial Registry
    PIs are required to register clinical trials individually on https://clinicaltrials.gov/ using a
    Secondary Protocol ID number designation of “CDMRP-eBRAP Log Number” (e.g., CDMRP-
    BA23####). If several protocols exist under the same application, the Secondary Protocol ID
    number must be designated “CDMRP-eBRAP Log Number-A, B, C, etc.” (e.g., CDMRP-
    BA23####-A). Clinical trials must be registered prior to enrollment of the first patient. All trials
    that meet the definition on the NIH database (see http://prsinfo.clinicaltrials.gov/, click on
    “Support Materials (including data element definitions)”) are required to register. Failure to do
    so may result in a civil monetary penalty and/or the withholding or recovery of grant funds as per
    U.S. Public Law 110-85.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 36
    General Submission Instructions

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    D. Research Involving Recombinant DNA Molecules
    The awardee assures that all work involving the use of recombinant DNA will be in compliance
    with guidance provided at https://osp.od.nih.gov/biotechnology/nih-guidelines/.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 37
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    APPENDIX 2
    REPORTING REQUIREMENTS AND ADMINISTRATIVE INFORMATION
    A. Reporting Requirements for Awards
    The Government requires periodic reports to be submitted to continue the research and funding
    through the entire period of performance. Specific reports required by the Government will be
    described in each award and may include:
    • Technical/Scientific:
    ○ Monthly, quarterly, and/or annual progress reports
    ○ Final progress report
    ○ In-progress reviews
    ○ Quad charts: The Quad Chart template is a one-page Word document or
    PowerPoint file that must be downloaded from eBRAP at
    https://ebrap.org/eBRAP/public/ProgramFY.htm?programFYId=513103 and
    completed for submission and application.
    USAMRDC research progress reporting requirements and instructions can be found at
    https://mrdc.health.mil/index.cfm/resources/researcher_resources/reporting/technical.
    • Fiscal (SF 425 “Federal Financial Report”) (assistance agreements only):
    ○ Quarterly and/or annual reports
    ○ Final report
    • Regulatory:
    ○ Research with Human Subjects – For DoD awards that include funding to support
    research with human subjects, the USAMRDC’s OHRO requires submission of
    institutional continuing review reports and study event and modification reports.
    Instructions are found at
    https://mrdc.health.mil/index.cfm/collaborate/research_protections/hrpo. Questions
    related to OHRO review requirements should be directed to the OHRO mailbox at
    usarmy.detrick.medcom-USAMRMC.other.hrpo@health.mil.
    Research Involving Animals: Questions concerning animal use and review should
    o
    be directed to the USSOCOM VRO:
    Phone: 813-826-6548
    Email: socom_vet@socom.mil
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 38
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    B. Disclosure of Proprietary Information
    Do not include proprietary information in a pre-application/pre-proposal or abstract. Proprietary
    information should only be included in a full proposal if necessary for evaluation.
    Proprietary information submitted in a proposal may be disclosed outside the Government for the
    sole purpose of evaluation. Evaluators must agree that proprietary information in the proposal
    will be used for evaluation purposes only and will not be further disclosed or used. All proposal
    may be subject to public release under the FOIA.
    Proposals for funded projects will be subject to public release under the FOIA to the extent that
    they are incorporated into an award document; proposals that are not selected for funding will
    not be subject to public release.
    C. Marking of Proprietary Information
    Conspicuously and legibly mark any proprietary information that is included in the proposal.
    D. Award Notices
    Awards are made to organizations, not to individual PIs. The requiring activity executes its
    extramural research program primarily through the award of contracts. Any resultant award
    from this BAA will be issued as a research and development contract that will adhere to the
    FAR. Please familiarize yourself with the FAR at https://acquisition.gov/far/.
    A procurement contract is required when the principal purpose of the instrument is to acquire
    (by purchase, lease, or barter) supplies or services for the direct benefit or use of the U.S.
    Government (31 USC 6303). The contract type, along with the start date, will be determined
    during the negotiation process. After email notification that proposal review results can be found
    on eBRAP, and if the proposal is selected for funding, a representative from the USAMRAA will
    contact the Business Official authorized to negotiate on behalf of the PI’s organization.
    Only an appointed USAMRAA Contracting Officer may obligate the Government to the
    expenditure of funds. No commitment on the part of the Government should be inferred from
    discussions with any other individual. The award document signed by the Contracting is the
    official authorizing document.
    E. Inquiry Review
    If an application is not recommended for funding, the organization or PI may submit an inquiry
    within 15 business days after the notification email is sent. Inquiries submitted after 15 business
    days will not be considered.
    The inquiry must specifically address a factual or procedural error that is believed to have
    occurred during review of the proposal as defined below:
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 39
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    Inquiries in response to funding recommendations should be submitted to the USAMRAA
    Contracting Officers through the eBRAP Help Desk at help@eBRAP.org.
    The final determination of the IRP and the funding decision are not subject to appeal. Questions
    related to the IRP prior to or after submitting an inquiry should be directed to the eBRAP Help
    Desk at help@eBRAP.org.
    F. Information Service
    Applicants may use the technical reference facilities of Defense Technical Information Center
    (DTIC). DTIC or the National Technical Information Service (NTIS) to acquire information
    regarding existing research to avoid duplication of scientific and engineering effort. The DTIC
    physical address is 8725 John J. Kingman Road, Fort Belvoir, VA 22060-6218; the website is
    http://www.dtic.mil; and the telephone number is 800-225-3842. NTIS is located at 5285 Port
    Royal Road, Springfield, VA 22161; the website is www.ntis.gov; and the telephone number is
    703-605-6000.
    G. Freedom of Information Act Requests
    The FOIA (5 USC 552) provides a statutory basis for public access to official Government
    records. “Records” are defined to include documentation received by the Government in
    connection with the transaction of public business. Records must be made available to any
    person requesting them unless the records fall under one of nine exceptions to the Act
    (www.usdoj.gov/oip/index.html).
    When an FOIA request asks for information contained in a successful proposal that has been
    incorporated into an award document, the submitter will be contacted and given an opportunity
    to object to the release of all or part of the information that was incorporated. A valid legal basis
    must accompany each objection to release. Each objection will be evaluated by USAMRAA in
    making its final determination concerning which information is or is not releasable. If
    information requested is releasable, the submitter will be given notice of USAMRAA’s intent to
    release and will be provided a reasonable opportunity to assert available action.
    H. Information Release
    An awardee will be required to agree to the release of information pertaining to the research and
    development supported by the Federal agency. “Information” includes but is not limited to news
    releases, articles, manuscripts, brochures, advertisements, still and motion pictures, speeches,
    trade association meetings, and symposia. Certain research topics may require prior approval by
    the contracting officer prior to publishing, reference DFARS 252.204-7000.
    The following statements must be included in all information releases:
    (1) All releases shall identify the award number and include a statement acknowledging the
    Federal sponsoring agency. The release shall also contain the following disclaimer: “Any
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 40
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    opinions, findings and conclusions or recommendations expressed in this material are those of
    the author(s) and do not necessarily reflect the views of the (name of contracting agency(ies)).”
    “This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs
    and the Defense Health Agency J9, Research and Development Directorate, through the (insert
    program name) under Award No. (HT9425-23-X-XXXX). Any opinions, findings and
    conclusions or recommendations expressed in this material are those of the author(s) and do not
    necessarily reflect the views of the Department of Defense.”
    (2) “In conducting research using animals, the investigator(s) adheres to the laws of the
    United States and regulations of the Department of Agriculture.” Include required assurances,
    approvals, documents and information specified on the ACURO website.
    (https://mrdc.health.mil/index.cfm/collaborate/research_protections/acuro)
    (3) “In the conduct of research utilizing recombinant DNA, the investigator adhered to NIH
    Guidelines for research involving recombinant DNA molecules.” (http://www.nih.gov)
    (4) “In the conduct of research involving hazardous organisms or toxins, the investigator
    adhered to the CDC-NIH Guide for Biosafety in Microbiological and Biomedical Laboratories.”
    (https://www.cdc.gov/labs/BMBL.html)
    Failure to include the above statements and adhere to the above regulations, when required,
    may result in loss of funding.
    I. Contracted Fundamental Research
    Any awards to universities or industry and funded by Basic Research funds (6.1), or to
    universities for on-campus research and funded by Applied Research funds (6.2), meet the DoD
    definition of “Contracted Fundamental Research.” The results of this research are to be
    unrestricted to the maximum extent possible. It is at US Government discretion to fund research
    with Budget Activity 3 or higher funds without placing restrictions on publication or personnel.
    The research shall not be considered fundamental in those rare and exceptional circumstances
    where the effort presents a high likelihood of disclosing performance characteristics of military
    systems or manufacturing technologies that are unique and critical to defense, and where
    agreement on restrictions have been recorded in the award.
    J. Sharing of Proposal Information
    The USSOCOM shares proposal information with other Federal funding agencies (e.g., NIH,
    National Science Foundation, Department of Veterans Affairs) to inform funding priorities and
    decisions, and to increase transparency. By sharing and leveraging this information, duplication
    of efforts can be avoided, allowing for the support of more investigators with Federal funds. The
    USSOCOM believes that such sharing allows for a more expeditious translation of research
    results into knowledge, products, and procedures to improve human health. Updates on
    USSOCOM-funded awards including awardee information and published results are shared on
    DTIC. Additional information on DTIC can be found at https://discover.dtic.mil/
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 41
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    K. Data Management and Sharing
    Purpose
    Data sharing enables researchers to rigorously test the validity of research findings,
    strengthen analyses through combined datasets, reuse hard-to-generate data, and explore
    new frontiers of discovery. In addition, USSOCOM emphasizes the importance of good
    data management practices, which provide the foundation for effective data sharing and
    improve the reproducibility and reliability of research findings. USSOCOM encourages
    data management and data sharing practices consistent with the FAIR data principles
    (https://www.go-fair.org/fair-principles/)
    USSOCOM expects researchers and institutions to implement data management and
    sharing practices as described.
    Definitions
    For the purposes of this BAA, terms are defined as follows:
    Scientific Data: The recorded factual material commonly accepted in the scientific
    community as of sufficient quality to validate and replicate research findings, regardless
    of whether the data are used to support scholarly publications. Scientific data do not
    include laboratory notebooks, preliminary analyses, completed case report forms, drafts
    of scientific papers, plans for future research, peer reviews, communications with
    colleagues, or physical objects, such as laboratory specimens.
    Data Management: The process of validating, organizing, protecting, maintaining, and
    processing scientific data to ensure the accessibility, reliability, and quality of the
    scientific data for its users.
    Data Sharing: The act of making scientific data available for use by others (e.g., the
    larger research community, institutions, the broader public), for example, via an
    established repository.
    Metadata: Data that provide additional information intended to make scientific data
    interpretable and reusable (e.g., date, independent sample and variable construction and
    description, methodology, data provenance, data transformations, any intermediate or
    descriptive observational variables).
    Data Management and Sharing Plan (Plan): A plan describing the data management,
    preservation, and sharing of scientific data and accompanying metadata.
    Scope
    This guidance applies to all research, funded or conducted in whole or in part by
    USSOCOM, that results in the generation of scientific data. This includes research funded
    or conducted by extramural grants, contracts, Intramural Research Projects, or other
    funding agreements regardless of USSOCOM funding level or funding mechanism. This
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 42
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    guidance does not apply to research and other activities that do not generate scientific data,
    including training, infrastructure development, and non-research activities.
    Managing and Sharing Scientific Data
    USSOCOM expects that in drafting Plans, researchers will maximize the appropriate
    sharing of scientific data, acknowledging certain factors (i.e., legal, ethical, or technical)
    that may affect the extent to which scientific data are preserved and shared. Any potential
    limitations on subsequent data use should be communicated to individuals or entities (e.g.,
    data repository managers) that will preserve and share the scientific data.
    Considerations for Scientific Data Derived from Human Participants: USSOCOM
    prioritizes the responsible management and sharing of scientific data derived from human
    participants. Applicable federal, Tribal, state, and local laws, regulations, statutes,
    guidance, and institutional policies govern research involving human participants and the
    sharing and use of scientific data derived from human participants. USSOCOM also
    respects Tribal sovereignty in the absence of written Tribal laws or polices. This
    USSOCOM guidance is consistent with federal regulations for the protection of human
    research participants and other USSOCOM expectations for the use and sharing of
    scientific data derived from human participants, including the NIH’s 2014 Genomic Data
    Sharing (GDS) Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-
    124.html ) 2015 Intramural Research Program Human Data Sharing Policy
    (https://policymanual.nih.gov/3016), and 45 CFR 46
    (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html).
    Researchers proposing to generate scientific data derived from human participants should
    outline in their Plans how privacy, rights, and confidentiality of human research
    participants will be protected (i.e., through de-identification, Certificates of Confidentiality
    (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html), and other
    protective measures).
    USSOCOM strongly encourages researchers to plan for how data management and sharing
    will be addressed in the informed consent process, including communicating with
    prospective participants how their scientific data are expected to be used and shared.
    Researchers should consider whether access to scientific data derived from humans, even if
    de-identified and lacking explicit limitations on subsequent use, should be controlled.
    Data Repository Selection: USSOCOM strongly encourages the use of established
    repositories to the extent possible for preserving and sharing scientific data. The
    Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting
    a Repository for Data Resulting from NIH-Supported Research
    (https://sharing.nih.gov/data-management-and-sharing-policy/sharing-scientific-
    data/selecting-a-data-repository) assists researchers in selecting a suitable data
    repository(ies) or cloud-computing platform.
    Data Preservation and Sharing Timelines: Shared scientific data should be made accessible
    as soon as possible, and no later than the time of an associated publication, or the end of
    performance period, whichever comes first. Researchers are encouraged to consider
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 43
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    relevant requirements and expectations (e.g., data repository policies, award record
    retention requirements, journal policies) as guidance for the minimum time frame that
    scientific data should be made available, which researchers may extend. Depending on the
    research project, the PI may be required to participate in the following, which will be
    specified in the award:
    • Traumatic Brain Injury: If the project includes traumatic brain injury (TBI) research, the
    PI may be required to make TBI data generated via an award available to the research
    community by depositing de-identified research data into the Federal Interagency TBI
    Research (FITBIR) Informatics System (https://fitbir.nih.gov/content/policies-and-
    procedures).
    • Clinical Trials: If the project includes a clinical trial(s), the PI may be required to register
    the clinical trial(s) individually on the registry and database ClinicalTrials.gov
    (https://www.clinicaltrials.gov/).
    • Systems Biology: If the project includes systems biology (SB)-related research, the PI
    may be required to make SB data, generated via an award, available to the research
    community by depositing research data into the SysBioCube system (https://sysbiocube-
    abcc.ncifcrf.gov/).
    For additional information on USSOCOMS’s expectations and policies for data-sharing, refer to
    the document titled “Policy on Data & Resource Sharing”, available on eBRAP under Resources
    and Reference Material at https://ebrap.org/eBRAP/public/Program.htm. For unique data-
    sharing guidelines and requirements, refer to the instructions in the BAA.
    L. Property/Equipment
    Contracts: Reference FAR Part 45 and DFARS Part 245.
    M. Title to Inventions and Patents
    In accordance with the Bayh-Dole Act (Title 35, United States Code, Sections 200 et seq.), the
    contractor/recipient and collaborators may elect to retain title to their subject inventions and
    technical data, subject to meeting the reporting and patent filing requirements and retained rights
    to the Federal Government. The Federal Government shall, at a minimum, retain non-exclusive
    rights for the use of such inventions. Instructions in the assistance agreement concerning subject
    inventions must be followed. The FAR and DFARS govern the disposition of technical data
    rights, and generally the ownership of technical data is determined by the funding that governs it.
    For additional information, reference:
    Contracts: FAR part 27 and DFARS part 227
    N. PI Changes and Award Transfers
    Transfer of a Contract Award to New Organization: Unless restricted by the specific BAA, a
    change in organizational affiliation will be considered on a case-by-case basis by the
    USAMRAA Contacting Officer. If approved, the PI’s original organization will be required to
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 44
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    agree to relinquish the award. The new organization will be required to resubmit the entire
    application on behalf of the PI, including regulatory documentation. Extended times for transfer
    may put the award funding at risk. A transfer will not, unless under extraordinary circumstances,
    be allowed for any organization that includes a study site/clinical trial at its location.
    Change in Principal Investigator: Unless otherwise restricted, changes in PI will be allowed at
    the discretion of the USAMRAA Contracting Officer, provided that the intent of the award is
    met.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 45
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    APPENDIX 3
    QUALIFICATION INFORMATION
    A. Contractor/Recipient Qualification
    The USAMRAA utilizes the Exclusions within the Performance Information functional area of
    SAM to identify individuals and organizations unqualified to receive Federal awards. More
    information about Exclusions reported in SAM is available at https://www.sam.gov/portal. The
    USAMRAA also reviews and considers information about the applicant in the Office of
    Management and Budget (OMB)-designated integrity and performance system, currently the
    SAM.gov Responsibility/ Qualification (R/Q), prior to making an award, as described in the
    BAA, Section II.E.5.
    B. Eligibility Information
    Effective January 1, 2016, prior to making an award where the Federal share is expected to
    exceed the simplified acquisition threshold (currently $250,000) over the period of performance,
    the Federal awarding agency is required to review information regarding the recipient that is
    available through R/Q. The recipient may submit comments to R/Q about any information that
    the Federal awarding agency reported to R/Q, for consideration by the Federal awarding agency
    in making future Federal awards to the recipient.
    In accordance with OMB’s final guidance implementing the Duncan Hunter National Defense
    Authorization Act for Fiscal Year 2009 (hereafter referred to as “Section 872”), as that statute
    applies to grants, effective January 1, 2016, recipients that have Federal contract, grant, and
    cooperative agreement awards with a cumulative total value greater than $10,000,000, or for
    existing awards that are terminated on or after January 2, 2016 due to material failure to comply
    with the Federal awards terms and conditions, are required to provide information to R/Q about
    certain civil, criminal, and administrative proceedings that reached final disposition within the
    most recent five-year period and that were connected with performance of a Federal award.
    Recipients are required to disclose semiannually the information about the criminal, civil, and
    administrative proceedings that Section 872(c) describes. Reference Federal Register Notice,
    Vol. 80, No. 140, Wednesday, July 22, 2015. In addition, per NDAA 2021 Section 1062,
    beginning October 1, 2023, DoD may not fund institutions of higher education (as defined by 20
    USC 1002) that host a Confucius Institute, other than amounts provided directly to students as
    education assistance, unless a waiver is provided. A Confucius Institute is defined as a cultural
    institute directly or indirectly funded by the Government of the People’s of Republic of China
    General eligibility for investigators, organizations, and agencies:
    • Eligible Investigators: Includes all individuals, regardless of ethnicity, nationality, or
    citizenship status, who are employed by, or affiliated with, an eligible organization.
    Note: Awards are made to organizations only, not individuals. Investigators must
    meet the specific BAA requirements.
    • Eligible Organizations: Include national and international organizations. Eligible
    organizations include for-profit, non-profit, public, and private organizations, such as
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 46
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    universities and colleges (including historically black colleges and universities, and
    minority institutions), hospitals, laboratories, and companies.
    • Government Agencies within the United States: Local, state, and Federal Government
    agencies are eligible to the extent that proposals do not overlap with their fully funded
    intramural programs. Such agencies are required to explain how their proposals do not
    overlap with their intramural programs.
    C. J-1 Visa Waiver
    Each organization, including organizations located outside of the United States, is
    responsible for ensuring that the personnel associated with any proposal recommended for
    funding are able to complete the work without intercession by the DoD for a J-1 Visa
    Waiver on behalf of a foreign national in the United States under a J-1 Visa.
    Note: The Federal Government will not provide funds to support scientists from countries
    meeting the criteria for designation as a State Sponsor of Terrorism
    (http://www.state.gov/j/ct/list/c14151.htm). Additional information on J-1 Visa Waivers can be
    located at the following Department of State website: travel.state.gov/visa/temp.
    D. Conflict of Interest
    1. Contract Awards
    Organizational and Consultant (individual) Conflicts of Interest: Contracts must comply with the
    requirements found in FAR 9.5, Organizational and Consultant Conflicts of Interest. An
    organizational COI may result when factors create a potential or actual COI, or when the nature
    of the work to be performed creates a potential or actual COI on future acquisitions and some
    restrictions on future activities of the contractor may be required. FAR 9.5 will be used as a
    guide in analyzing and resolving organizational and consultant COIs relating to an award.
    All COIs on the part of an organization or individual investigators that could bias the research
    results must be disclosed in the proposal, along with a plan to resolve them. An award may not
    be made if it is determined by the Contracting Officer that a COI cannot be avoided or managed.
    2. Post-Employment Restrictions
    There are certain post-employment restrictions on former Federal officers and employees as
    defined in 18 USC 207. Post-employment restrictions may exist if a former Federal officer or
    employee participates in the proposed project; the situation should be discussed with the
    USSOCOM legal staff at (813) 826-9919, prior to expending time and effort in preparation of a
    proposal.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 47
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    APPENDIX 4
    FORMATTING GUIDELINES
    All Pre-proposal and proposal documents must be legible and should conform to the formatting
    guidelines described below. The font size, spacing, page size, and margins may differ among the
    word processing, PDF, and printed versions. These guidelines apply to the document properties
    of the electronic version of the PDF file(s) as viewed on a computer screen.
    • Document Format: Each attachment to the full proposal forms must be uploaded as an
    individual file in the format specified in the BAA. All contributors to the proposal must
    use matching compatible versions of Adobe software for all PDF documents when
    editing and preparing proposal components. The use of different software versions will
    result in corruption of the submitted file.
    • Font Size: 12 point, not condensed.
    • Font Type: Times New Roman.
    • Spacing: Single space or no more than six lines of type within a vertical inch (2.54 cm).
    • Page Size: No larger than 8.5 inches x 11.0 inches (21.59 cm x 27.94 cm).
    • Margins: At least 0.5 inch (1.27 cm) in all directions.
    • Print Area: 7.5 inches x 10.0 inches (19.05 cm x 25.40 cm).
    • Color, High-Resolution, and Multimedia Objects: Project narratives and pre-proposal
    files may include color, high-resolution, or multimedia objects (e.g., MPEG, WAV, or
    AVI files) embedded in the PDF files; however, these objects should not exceed 15
    seconds in length and a size of 10 MB. Photographs and illustrations must be submitted
    in JPEG format; bitmap and TIFF formats are not allowed. Please note that these types
    of objects are not allowed in the technical and public abstracts.
    • Scanning Resolution: 100 to 150 dots per inch.
    • Internet URLs: URLs directing reviewers to websites that contain additional
    information about the proposed research are not allowed in the proposal or its
    components. Inclusion of such URLs may be perceived as an attempt to gain an unfair
    competitive advantage. However, links to publications referenced in the proposal are
    encouraged.
    • Language: All documents must be submitted in English, unless otherwise specified in
    the BAA (e.g., foreign transcripts submitted with English translations).
    • Headers and Footers: Should not be used. Pre-existing headers and footers on required
    forms are allowed.
    • Page Numbering: Should not be used.
    • Recommended Attachment Size: Individual attachments should be no larger than
    20 MB. If the file size for the entire Grants.gov submission package will or may exceed
    200 MB, applicants should contact the Grants.gov Contact Center (support@grants.gov)
    for written confirmation that the file will be accepted or for other guidance.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 48
    General Submission Instructions

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    APPENDIX 5
    NATIONAL POLICY REQUIREMENTS
    The National Policy Requirements are available in full text at
    https://www.usamraa.army.mil/Pages/Resources.aspx. For additional regulatory requirements
    regarding safety, surety, and environmental requirements, and for use of animal and human
    subjects in research, refer to Appendix 1 of this General Submission Instructions.
    A. Certification
    Certification of compliance with the national policy requirement regarding lobbying activities is
    required from all recipients of awards over $100,000. Submission of this certification is required
    by 31 USC 1352 and is a prerequisite for making or entering into an award over $100,000.
    Complete SFLLL (Disclosure of Lobbying Activities), if applicable, and attach to Block 18 of
    SF424 (R&R) (Application for Federal Assistance) Form.
    Certification for Contracts, Grants, Loans, and Cooperative Agreements
    By signing a proposal, the applicant certifies, to the best of his or her knowledge and belief, that:
    (1) No Federally appropriated funds have been paid or will be paid, by or on behalf of the
    undersigned, to any person for influencing or attempting to influence an officer or
    employee of an agency, a Member of Congress, an officer or employee of Congress, or
    an employee of a Member of Congress in connection with the awarding of any Federal
    contract, the making of any Federal grant, and the making of any Federal loan, the
    entering into of any cooperative agreement, and the extension, continuation, renewal,
    amendment, or modification of any Federal contract, grant, loan, or cooperative
    agreement.
    (2) If any funds other than Federal appropriated funds have been paid or will be paid, to any
    person for influencing or attempting to influence an officer or employee of any agency, a
    Member of Congress, an officer or employee of Congress, or an employee of a Member
    of Congress in connection with this Federal contract, grant, loan, or cooperative
    agreement, the undersigned shall complete and submit SFLLL (Disclosure of Lobbying
    Activities), in accordance with its instructions.
    (3) The undersigned shall require that the language of this certification be included in the
    award documents for all subawards at all tiers (including subgrants, and contracts under
    grants, loans, and cooperative agreements) and that all subrecipients shall certify and
    disclose accordingly.
    This certification is a material representation of fact upon which reliance was placed when this
    transaction was made or entered into. Submission of this certification is a prerequisite for
    making or entering into this transaction imposed by 1352 USC 31. Any person who fails to file
    the required certification shall be subject to a civil penalty of not less than $10,000 and not more
    than $100,000 for each such failure.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 49
    General Submission Instructions

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    B. Representations
    All applicants are required to complete the representations below and submit with each proposal.
    The form for completion and submission is posted in eBRAP
    (https://ebrap.org/eBRAP/public/Program.htm) under the Organizational Forms Section,
    document titled “Required Representations”. Upload the form into Grants.gov under
    Attachments.
    Representations Regarding Unpaid Federal Tax Liabilities and Conviction of Felony
    Criminal Violations under Any Federal Law
    At the time of proposal submission, the applicant organization represents that it:
    (1) Is ___ is not _____ a Corporation (“Corporation” means any entity, including any
    institution of higher education, other nonprofit organization, or for-profit entity that has
    filed articles of incorporation). If the organization IS a corporation, complete (2) and
    (3) below.
    (2) Is_____is not______a Corporation that has any unpaid Federal tax liability that has
    been assessed, for which all judicial and administrative remedies have been exhausted
    or have lapsed, and that is not being paid in a timely manner pursuant to an agreement
    with the authority responsible for collecting the tax liability.
    (3) Is ______ is not ______ a Corporation that was convicted of a criminal violation under
    any Federal law within the preceding 24 months.
    NOTE: If the applicant organization responds in the affirmative to either (2) or (3) of the
    above representations, the applicant is ineligible to receive an award unless the agency
    suspension and debarment official has considered suspension or debarment and determined
    that further action is not required to protect the Government’s interests. The applicant
    organization therefore will be required to provide information about its tax liability and/or
    conviction, upon request, to the Grants Officer, to facilitate completion of the required
    consideration before award decisions are made.
    In accordance with DoD appropriations, the following representation is required. The applicant,
    by its signature on the SF424 (R&R) (Attachment 01) , represents:
    Representation Regarding the Prohibition on Using Funds Under Grants and Cooperative
    Agreements with Entities that Require Certain Internal Confidentiality Agreements.
    By submission of its proposal, the applicant represents that it does not require any of its
    employees, contractors, or subrecipients seeking to report fraud, waste, or abuse to sign or
    comply with internal confidentiality agreements or statements prohibiting or otherwise restricting
    those employees, contractors, or subrecipients from lawfully reporting that waste, fraud, or abuse
    to a designated investigative or law enforcement representative of a Federal department or
    agency authorized to receive such information. Note that (1) the basis for this representation is a
    prohibition in Section 743 of the Financial Services and General Government Appropriations
    Act, 2015 (Division E of the Consolidated and Further Continuing Appropriations Act, 2015,
    Public Law 113-235) and any successor provision of law on making funds available through
    grants and cooperative agreements to entities with certain internal confidentiality agreements or
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical Research and Development– 50
    General Submission Instructions

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    [Document continues — 3 more pages]

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    HT9425-23-S-SOC1-0002

    I. OVERVIEW OF THE FUNDING OPPORTUNITY
    United States Special Operations Command
    Department of Defense
    BROAD AGENCY ANNOUNCEMENT (BAA)
    for Extramural Biomedical and Human Performance
    Research and Development
    Funding Opportunity Number: HT9425-23-S-SOC1
    Announcement Type: Modified-0002
    Catalog of Federal Domestic Assistance Number: 12.420
    Military Medical Research and Development
    KEY DATES
    Release/Posted Date: Initial 01 August, 2023. Revised -0001: 11 AUG 2023. Revised -0002:
    14 JUN 2024.
    Closing Date: 31 July, 2028, 11:59 p.m. Eastern Time
    This Funding Opportunity Announcement is a BAA. It is continuously open for a 5-year period,
    from 1 August 2023 closing 31 July 2028, 11:59 p.m. Eastern Time. Note: This BAA will be
    updated annually.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    1

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    This Broad Agency Announcement must be read in conjunction with the General Submission
    Instructions, which are available for downloading from Grants.gov. The General Submission
    Instructions are located under the “package” tab and can be downloaded by selecting the
    “Download Instructions” icon when previewing the submission package.
    TABLE OF CONTENTS
    I. OVERVIEW OF THE FUNDING OPPORTUNITY ....................................................... 1
    II. DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY ............... 3
    II.A. Program Description ....................................................................................................... 3
    II.A.1. Research Area of Interest .......................................................................................... 4
    II.B. Federal Award Information .......................................................................................... 14
    II.C. Eligibility Information ................................................................................................... 16
    II.C.1. Eligible Applicants ................................................................................................... 16
    II.C.2. Cost Sharing ............................................................................................................. 17
    II.C.3. Other ......................................................................................................................... 17
    II.D. Proposal/Application Submission Information ....................................................... 18
    II.D.1. Where to Obtain the Proposal/Application Submission Package ............................ 18
    II.D.2. Content and Form of the Proposal/Application Submission .................................... 18
    II.D.3. Unique Entity Identifier (UEI) and System for Award Management (SAM) ........... 38
    II.D.4. Submission Dates and Times ................................................................................... 40
    II.D.5. Funding Restrictions ................................................................................................ 40
    II.D.6. Other Submission Requirements .............................................................................. 42
    II.E. Proposal/Application Review Information .................................................................... 42
    II.E.1. Criteria ...................................................................................................................... 42
    II.E.2. Proposal/Application Review and Selection Process ............................................... 43
    II.E.3. Integrity and Performance Information .................................................................... 44
    II.E.4. Anticipated Announcement and Federal Award Dates ............................................ 45
    II.F. Federal Award Administration Information .................................................................. 45
    II.F.1. Federal Award Notices ............................................................................................. 45
    II.F.2. Administrative and National Policy Requirements .................................................. 45
    II.F.3. Reporting .................................................................................................................. 46
    II.G. Federal Awarding Agency Contacts ............................................................................. 47
    II.G.1. eBRAP Help Desk ................................................................................................... 47
    II.G.2. Grants.gov Contact Center ....................................................................................... 47
    II.H. Other Information ......................................................................................................... 48
    II.H.1. Administrative Actions ............................................................................................ 48
    II.H.2. Proposal/Application Submission Checklist ............................................................ 50
    APPENDIX 1: ACRONYM LIST ............................................................................................ 52
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    2

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    II. DETAILED INFORMATION ABOUT THE FUNDING
    OPPORTUNITY
    The Fiscal Year 2023 – Fiscal Year 2028 (FY23-FY28) United States Special Operations
    Command (USSOCOM), BAA for Extramural
    Biomedical and Human Performance Research and Development contains several changes from
    previous USSOCOM BAAs. Read each section carefully. Note the following:
    • The total individual project estimated cost ceiling has been increased from $4,000,000 to
    $5,000,000, and generally anticipated project cost has been increased from $700,000 to
    $2,000,000.
    • The “Program Description” that describes the “Research Areas of Interest (RAIs)” have
    been updated.
    II.A. Program Description
    This BAA is intended to solicit extramural research and development ideas using the authority
    provided by United States Code, Title 10, Section 4001. This BAA is issued under the
    provisions of the Competition in Contracting Act of 1984 (Public Law 98-369), as implemented
    in Federal Acquisition Regulation (FAR) 6.102(d)(2) and 35.016. In accordance with FAR
    6.102, projects funded under this BAA must be for basic and applied research to support
    scientific study and experimentation directed toward advancing the state-of-the-art or increasing
    knowledge or understanding rather than focusing on development of a specific system or
    hardware solution. Research and development funding through this BAA is intended and
    expected to benefit and inform both military and civilian medical practice and knowledge.
    This BAA provides a general description of the USSOCOM’s research and development
    programs, including RAIs, evaluation and selection criteria, pre-proposal/preapplication and full
    proposal/application preparation instructions, and general administrative information.
    Submission of a pre-proposal/pre-application is required. After review, if the USSOCOM is
    interested in receiving a full proposal/application, the Applicant or Offeror will be invited to
    submit a full proposal or full application. Specific submission information and additional
    administrative requirements can be found in the document titled “General Submission
    Instructions” available in Grants.gov along with this BAA.
    The USSOCOM utilizes the tools and processes provided by the Congressionally Directed
    Medical Research Programs (CDMRP). The CDMRP manages the electronic Biomedical
    Research Application Portal (eBRAP) system and retrieval and processing of full
    proposal/application submissions from Grants.gov. Refer to Section II.G, Agency Contacts, for
    additional information.
    The USSOCOM’s supporting contracting office, the U.S. Army Medical Research Acquisition
    Activity (USAMRAA) will be the awarding and administering office for proposals selected for
    funding.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    3

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    II.A.1. Research Area of Interest
    A primary emphasis of the USSOCOM Biomedical, Human Performance, and Canine Research
    Program is to identify and develop techniques, knowledge products, and materiel (medical devices,
    drugs, and biologics) to support far-forward early intervention of life-threatening illnesses or injuries
    within an Irregular Warfare or asymmetric, mult-domain operational environment; Prolonged
    Casualty Care (PCC); human performance optimization; canine medicine/performance; brain health;
    immune response; automation of systematic reviews and metanalysis; and novel post-traumatic
    stress, depression, and anxiety treatment. Special Operations Forces (SOF) medical personnel place a
    premium on medical equipment that is small, lightweight, ruggedized, modular, multi-use, and
    designed for operation in extreme environments. The equipment must be simple to employ, require
    minimum maintenance, and have low power consumption. Drugs and biologics should optimally not
    require refrigeration or other special handling. All materiel and related techniques must be simple,
    effective, and easily modified for commercialization. Research projects may apply existing scientific
    and technical knowledge for which concept and/or patient care efficacy have already been
    demonstrated to meet SOF requirements. The proposed research must be relevant to active-duty
    service members, veterans, military beneficiaries, and/or the American public. Relevant research
    must be responsive to the health care needs of the U.S. Armed Forces, family members of the U. S.
    Armed Forces, and U.S. Veterans. Proposals must address a relevant health problem responsive to
    one of the RAIs identified below. Additional RAIs may be added during the life of the BAA (FY23-
    FY28). The following RAIs are in no particular order:
    1. Damage Control Resuscitation:
    SOF medical personnel require capabilities for far-forward medical care to reduce the mortality and
    morbidity associated with critical wounds and injuries. The proposed research, application, and/or
    development of medical techniques and materiel (medical devices and biologics) for optimal triage
    and early intervention in critical life-threatening injuries when casualty evacuation is not possible or
    is delayed. The project areas under “Damage Control Resuscitation” to which the USSOCOM will
    give highest consideration are:
    a. Global Treatment Strategies and Next Generation Wound Management:
    The proposed project must research, apply, and/or develop effective treatment strategies that address
    the following elements: hypotensive resuscitation, optimal fluid(s), uncomplicated shock,
    noncompressible hemorrhaging, traumatic brain injuries, and austere damage control surgery. These
    strategies must be optimized for medics in austere, far-forward areas, with minimal logistical or
    specialty support, who must stabilize and treat patients for extended periods (days, not hours).
    Projects that research and develop an all-in-one traumatic wound care treatment that can achieve
    hemostasis, incorporate analgesia, deliver antibiotics, and start tissue regeneration are preferred.
    b. Analgesia:
    The proposed project must research, apply, and/or develop novel, safe, efficacious, peripherally, and
    centrally acting analgesia that provide easy administration in the field, tolerance of extreme
    environments, and effectiveness at the point of injury for a prolonged period of field care (days, not
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    4

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    hours) and does not sensitize the patient to topical analgesia. Maximum analgesia with minimal
    sedation is preferred.
    c. Far Forward Blood, Blood Components, Blood Substitute, & Injectable Hemostatics:
    The proposed project must research novel strategies to increase the ease, efficacy, and safety of blood
    transfusions (i.e., person to person, pre-hospital blood banking, and blood substitutes) forward of
    normal logistics support; (e.g., evaluating blood for type/cross matching and for the presence and/or
    reduction of pathogens, leucocytes, and AB antibodies to improve safety of whole blood transfusion
    at the point of injury). Projects that will be considered also include other blood components such as
    freeze-dried plasma and platelets, cryoprecipitate, fibrinogen, prothrombin complex concentrate,
    injectable medications to address the coagulopathy of trauma such as Tranexamic acid, and novel
    strategies to improve tissue oxygen delivery in shock such as portable hyperbaric solutions. Research
    should focus on extending shelf life of whole blood beyond current limitations. A long-term
    objective is a blood substitute that is comparable in size, weight of traditional blood products, and
    effectively functions like fresh whole blood without requiring refrigeration. Strategies to find the
    delivery of these prototypes individually or in concert will also be considered. Priority will be given
    towards projects that are oriented towards final solutions or prototypes that are highly portable, shelf-
    stable requiring minimal to no refrigeration, and solutions that match the tissue oxygen delivery
    capacity of healthy red blood cells.
    d. Austere Surgical Stabilization:
    Future theatres where SOF personnel will operate are likely to be much less medically robust than
    the past decade of fighting in our current theatres (this can translate to remote civilian areas), and
    there will be a mismatch between capability and need. Rather than sitting at hardened structures
    waiting on patients, surgical personnel may be increasingly asked to go to the patient. Research
    should focus on mobility/portability of medical and surgical equipment, including support equipment
    such as sterilization, with emphasis on equipment with greater capabilities than currently fielded
    devices, smaller size and weight, low power demands, and flexibility in power supplies.
    Additionally, research and development efforts should include telehealth technologies linking
    forward surgical providers with higher medical authority consultation and effective, relevant, and
    dynamic surgical training capabilities. Lastly, research into future procedures and devices may also
    include a human systems approach to define limitations and mitigation strategies of surgical
    capability in austere environments (i.e., low light, temperature variability, improving surgical access
    in distributed maritime environment, surgery in flight, etc.) to bridge time to surgery when patient
    load exceeds surgical capability.
    2. Prolonged Casualty Care (PCC):
    SOF medical personnel require capabilities for far-forward medical care to reduce the mortality and
    morbidity associated with critical wounds, injuries, diseases, and associated sepsis. PFC should focus
    on novel treatments that support the ability to manage 3-5 patients across the spectrum of illness to
    multi-system injury for a minimum of 5-7 days. SOF medical personnel require capability to
    expedite evacuation and increase survivability with limited site of injury support in austere
    environments including: hyperbaric, mountainous, high-altitude, artic, and distributed maritime
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
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    operations. Significant consideration will be given to proposals focused on PFC that may also relate
    to Sections 1 (a-d) and 3(a) of this BAA.
    a. Medical Sensors and Devices:
    The primary emphasis is to research, apply and/or develop medical techniques, pharmaceuticals,
    biologics, and field-sustainable, rapidly deployable medical sensors and/or devices for extended care
    beyond initial trauma resuscitation, to include austere/forward surgery while operating in disease
    endemic areas where casualty evacuation is delayed or unavailable. In addition, proposals that
    investigate or develop wireless biosensors should demonstrate physiological monitoring capabilities
    to include, but not limited to, heart rate, blood pressure, pulse oximetry, respiration rate,
    capnography, core temperature, heart rate variability and compensatory reserve index (CRI).
    Research and development of devices and sensors should include or plan for the capability to
    transmit (Bluetooth) to Android handheld devices and be designed with an open architecture to allow
    for sensors to be incorporated into a family of sensors that may or may not report to a central
    handheld device. (NOTE: Ideally, sensor and equipment technologies should be electronically
    readable, scannable, or transmittable to the Battlefield Assisted Trauma Distributed Observation Kit
    (BATDOK), an Android-driven, multi-patient, point of injury casualty monitoring capability being
    fielded by the U.S. Air Force (USAF) Pararescuemen and other SOF Medics. Novel devices are
    required which aid in measuring physiologic decompensation and/or adequacy of
    treatment/resuscitation in the field environment and/or provide a trigger for a pre-hospital medical
    intervention (i.e., validation of tissue (muscle) oxygen saturation (StO2), CRI, traumatic brain injury
    (TBI) measures, etc.
    3. Portable Lab Assays and Diagnostics:
    The proposed project must research, apply and/or develop novel concepts for portable and
    environmentally stable far forward laboratory assays and diagnostics. Equipment should be
    extremely portable, ruggedized, use limited or no external power, and any reagents should be self-
    contained and stable in extreme environmental conditions. Preference will be given to proposals that
    are field oriented, rugged, low weight/cube space and have little to no refrigeration requirements.
    Additionally, novel wireless, transmittable or scannable solutions such as patches, scanner/readers or
    other noninvasive technologies as described in paragraph 3.a. below are encouraged.
    a. Occupational and Environmental Health (OEH) Hazards:
    The proposed project must focus on development of novel methods and devices for rapid
    identification and analysis of exposures to OEH hazards. Research must support the development
    and analysis of handheld, field hardened, and environmentally stable analytical devices, monitoring
    devices, dosimetry, assays for rapid on-site identification, and real-time analysis of OEH hazards in
    air, water, and soil that could pose an acute or chronic health hazard to SOF personnel. Such OEH
    hazards include toxic industrial chemicals/toxic industrial materials (TICs/TIMs), lead exposures,
    food and water borne pathogens, toxins, biological agents, and radiological material exposures.
    Research consideration should be given to development of small lightweight and programmable
    unmanned underwater vehicles (UUV) and unmanned aerial vehicles (UAV) to conduct
    environmental analysis of OEH hazards in water, air, and soil. UUVs and UAVs must be capable of
    travel to designated locations, conduct point of collection analysis of OEH hazards, transmit data,
    and return to originating base.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
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    4. Force Health Protection and Environmental Medicine:
    SOF personnel must often operate for extended periods of time in austere environments that expose
    them to extremes in altitude, temperature, humidity, wind, kinetosis, infectious diseases, toxic
    industrial chemicals, toxic industrial materials, and environmental hazards (including envenomation).
    In addition, the environment may be compromised due to chemical, biological, and radiological
    contamination. The primary emphasis of this research area is to research, apply, and develop
    techniques, therapeutic measures, and materiel (personal protective equipment (PPE), medical
    devices, drugs, and biologics) to ensure sustained human performance and effectiveness while
    operating in harsh environmental conditions and/or wearing appropriate PPE. Additional research
    opportunities include identification and characterization of specific risk profiles/threats associated
    with the SOF unique mission sets.
    a. Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Rapid Diagnostics,
    Treatment, and Prophylaxis:
    The proposed projects must research, apply, and/or develop novel approaches that will diagnose,
    treat, and protect SOF personnel from exposure to chemical, biological, radiological, nuclear, and
    high yield explosives in near real time.
    b. Operational Monitoring:
    The proposed project must seek to develop wireless biosensors for monitoring SOF personnel in
    extreme environments (i.e., high altitude, whether in-flight or the environment itself, excessive heat
    or cold, etc.), and potentially hazardous material exposure. Sensors should address physiological
    measurements and/or chemical, biological and/or radiological hazards. For hazards monitoring, a
    personal dosimetry device is desired that can detect and alarm based on radiation and chemical
    presence. The alarming function can be pre-determined to account for known environmental
    conditions (i.e., natural occurring radiation levels that are below threshold/detrimental health levels)
    and Parts Per Million (PPM) counts that would trigger an alert. This detection device needs to be able
    to alarm differently to identify the "type" of hazard(s), and to trigger a back-off and/or donning of
    additional PPE. Monitoring should be capable of wirelessly communicating via Bluetooth to Android
    handheld devices, tablets, or compatible wrist-mounted displays.
    5. Brain Health:
    Brain Health research efforts include, but are not limited to: development and validation of fieldable
    Neurocognitive Assessment Tools (NCATs) and baseline testing, Comprehensive Symptom History
    (CASH) collection, blast exposure and impact monitoring, determination of safe acceptable limits for
    blast exposure, development and validation of capabilities to easily identify/diagnose mild, moderate,
    and severe TBI, methods to prevent, screen for, monitor, and correct neuroendocrine dysfunction,
    methods to prevent TBI from impact and blast such as redesign of helmets, body armor, and
    munitions, development of pharmaceuticals to prevent and/or treat brain injury, validation of brain
    injury prevention strategies, and development of return to duty decision support tools.
    a. Environmental Exposures Protection:
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
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    Research that develops novel material and/or approaches to protect SOF personnel from the
    neurological effects of single and repetitive auditory (impulse noise) and non- auditory
    (overpressure) blast exposures and other environmental factors determined to affect nervous system
    function.
    b. Environmental Exposure Effects:
    Research that determines the neurocognitive and nervous system effects from single and repetitive
    (low-to-high) blast exposures, impulse noise, and other potential hazardous environmental factors.
    c. Biomarkers:
    Research to determine which biomarkers are indicative of mild, moderate, and severe TBI; sequelae
    from TBI causing further injury; recovery status; and recovery rate from TBI. Testing and validating
    diagnostic biomarkers for TBI. Proposals should also consider incorporation of validated biomarkers
    onto existing or future diagnostic platforms. Use of machine learning and/or model development to
    interpret and report biomarkers that are indicative of TBI are of interest.
    d. Genetic Factors:
    Research to determine if there are genetic predispositions, epigenetic changes and/or, genomic
    modulators that affect the susceptibility to and recovery from TBI and neurotrauma.
    e. Neuropsychological Testing:
    Research to validate Neurocognitive Assessment Tools (NCATs) to determine baseline
    neurocognitive status, readiness, neurocognitive degradation, sensitivity to various exposures, TBI
    and recovery status post injury. Proposals to improve the speed, accuracy, specificity, and proximity
    to injury for the use of NCATs, as well as to compare new technologies and/or modalities (including
    passive assessment of cognition) to existing NCATs.
    f. Affect testing:
    Research to develop and validate baseline and transient affect testing or assessment tools to
    measure emotion and/or mood, to monitor change in emotion and/or mood after TBI, and to
    investigate the effects of emotion or mood status on functional performance.
    g. Olfactory, Oculomotor, Auditory, Vestibular, Cranial Nerve, and Vocal-Acoustic
    Performance:
    Research and proposals to perform and validate oculomotor, auditory, vestibular, cranial nerve, and
    vocal acoustic assessments. Research and proposals to assess the effect of nervous system injury to
    oculomotor, auditory, vestibular, cranial nerve, and vocal-acoustic performance and strategies to
    restore their performance after injury and prevent injury or further decline.
    h. Postural Stability:
    Research to assess the effects of blast exposure on postural stability including the proprioceptive
    component. Novel treatment strategies, therapies, and therapeutics to prevent and/or correct
    detriment to postural stability from TBI and neurotrauma caused by blast, impact, and/or other
    environmental exposures.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
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    i. Neuroendocrine Dysfunction:
    Methods to prevent, screen for, monitor, and correct neuroendocrine dysfunction.
    j. Neuroimaging:
    Research into novel imaging and imaging interpretation techniques including, but not limited to
    Computed Axial Tomography (CAT), Magnetic Resonance Imaging (MRI), and Positron emission
    tomography (PET) scans, to diagnose brain tissue pathologies including, but not limited to, axonal
    injury, myelin injury, and astroglial scarring without the need for immunohistochemistry,
    immunofluorescence, or histopathology testing.
    k. Analytics:
    Research into analysis including Machine Learning, Natural Language Processing, and Artificial
    Intelligence enabled analysis of data including, but not limited to, NCATs; environmental exposures
    likely to affect brain health; blast, impact, and noise exposures; auditory, vestibular, and vocal
    acoustic assessments; postural stability assessments; and neuroimaging.
    l. Neuromodulation:
    Research into the use of neuromodulation techniques for treating TBI, neurotrauma, pain, restoring
    and improving function, and improving behavioral health.
    m. Brain Lymphatics and Glymphatics:
    Research into measuring the fluid dynamics of the brain lymph system, diagnosing dysfunction, and
    validation for tools or techniques to improve brain lymph clearance.
    n. Pupillometry, Pupillary Response and Microsaccades:
    Research into field capable pupillary response measurement capture and analysis, with or without the
    ability to capture microsaccades in order to assess central nervous system loading and/or damage.
    6. Immune Response:
    The use of modified and novel strategies to cause, strengthen, or supplement immunity through the
    use of, but not limited to mRNA vaccines, nanolipoprotein particles (NLPs), polyvalent vaccines,
    and phages.
    7. Chronic Pain:
    The proposed research must address the development of novel, non-opioid treatments for chronic
    pain with or without the presence of migraines, allodynia, or fibromyalgia; but not with
    accompanying myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) or cancer.
    8. Automation of Systematic Reviews and Metanalysis:
    Research into Automation of Systematic Reviews and Metanalysis using the Preferred Reporting
    Items for Systematic Reviews and Meta Analyses (PRISMA) or a similar method.
    9. Medical Simulation and Training Technologies:
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
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    The proposed project must research, apply and/or develop improved pre-hospital tactical combat
    casualty care (TCCC) training with an emphasis on the SOF pre-hospital providers. Medical
    simulations should replicate all phases of the pre-hospital combat environment, including care under
    fire, tactical field care and casualty evacuation. Human-like simulators should bleed, breath, void,
    have a physiologically relevant temperature, pulse, and response to medical care with little to no
    operator/controller input, should be all-weather capable and should evoke an emotional response
    from those with whom it interacts. Medical training simulations should capture and be capable of
    providing a report on the timing, appropriateness, and effectiveness of medical treatment. All
    material solutions should meet joint airworthiness standards. Additionally, there is interest in
    research focused on validating or measuring the effectiveness of current medical simulation and
    training technologies and in determining the best methods of acquiring and maintaining PCC skills as
    well as the impact of these skills on patient outcomes. In addition, the proposed project must research
    the efficacy of using stress inoculation training (vs traditional didactics or other instructional
    methods) to teach key TCCC skills (e.g., tourniquets, IV placement, etc.). Of particular interest are
    the effects on stress response, performance, and decision making of the student as well as best
    methods for optimizing performance in high stress situations as well as mitigating negative aspects of
    stress.
    10. Human Performance Optimization:
    USSOCOM requires SOF personnel to withstand extraordinary physical demands and psychological
    stress to complete their missions. The optimization of SOF personnel’s ability to perform at very
    high levels for long durations, in addition to processing information and making critical decisions in
    a timely manner, while operating in extreme environments, will significantly improve their overall
    operational effectiveness. This research area explores alternatives and/or new approaches to sustain
    and optimize SOF human performance both to increase mission capability and to extend the career
    longevity of SOF personnel.
    a. Improved Sleep:
    The proposed project must research, apply and/or develop novel approaches to achieve the
    restorative effects of sleep. This may include methods to induce, maintain, or improve the quality of
    sleep throughout the entire night. Additionally, the ability to accelerate the effects of sleep through
    methods requiring less time (e.g., the effects of sleeping eight hours are realized in four hours’ time)
    or enabling the SOF personnel to quickly reach and adequately cycle through the stages of sleep
    where the highest restorative effects occur (i.e., Stage 3/ deep sleep, and Stage 4/rapid eye movement
    sleep).
    b. Optimal Acclimatization Strategies:
    The proposed project must research, apply, and/or develop novel approaches and/or technologies that
    provide rapid and sustainable human acclimatization in austere environments, to include fatigue
    countermeasure, extremes in temperature, extremes in altitude, and time-zone change (i.e., circadian
    acclimatization).
    c. Wearables:
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    The proposed project must research, apply, and/or develop novel approaches and/or wearable
    technologies that will monitor physiological measures of human performance to include, but not
    limited to, caloric expenditure, heart rate/heart rate response, heart rate variability, body fat
    percentage, sleep hygiene (deep and REM sleep duration) in real-time. Measures should be accurate
    with low fixed bias, wirelessly communicated via Bluetooth, Near Field Magnetic Induction or
    Radio Frequency technology in real-time and provide the command the capability to utilize the data
    for analysis of individuals and/or team performance via the USSOCOM Human Performance Data
    Management System (i.e., Smartabase). The device should be able to be turned on/off and/or have an
    inactive mode, provide real-time feedback on a display screen, be capable of displaying time, and be
    adjustable to fit users of different statures. Of parallel interest to address is a proposed project to track
    sleep, fatigue, and performance degradations through a wearable device that provides quantitative
    data (rather than qualitative surveys often seen in USAF Fatigue Studies), that in turn will be
    gathered and amalgamated from entire units, in order to track individual performance, unit
    performance, mission impacts to performance levels, length of time for acclimatization (if it is ever
    achieved), and potential risk of mishaps.
    d. Diagnostics for Performance Sustainment:
    The proposed project must research, apply, and/or develop minimally invasive diagnostic devices to
    provide actionable information on nutritional gaps, hormonal response to training, physiological
    response to performance interventions and recovery, and epigenetic predictors of potential injury.
    e. Performance Nutrition:
    The proposed projects must research, apply and/or develop methods to accurately measure nutritional
    status of SOF personnel. The proposed project should focus on cost effectiveness, accuracy, and
    end-user compatibility (i.e., user friendly) methods or devices for identifying and optimizing an
    individual’s nutrient status. Consideration of alternative fuel (energy) sources, dietary
    supplementation, biomarkers, and nutrient volume/timing are specific areas of interest.
    f. Pharmaceutical and Nutritional Supplement Interactions:
    The proposed project must research, apply, and/or develop novel approaches to determining what, if
    any, meaningful interactions occur between and among SOF-common medications (i.e., over-the-
    counter (OTC) or prescription (Rx) and commonly ingested/commercially available nutritional
    supplements).
    g. Physiological Performance:
    The proposed project must research, apply, and/or develop novel approaches and/or technologies to
    maximize the physiological performance of SOF personnel in austere and/or training environments,
    to include increased endurance, enhanced senses, tolerance to environmental extremes, and enhanced
    overall fitness, in order to maintain operational posture/ability in high stress scenarios without
    noticeable augmentation, and without hampering personnel mobility.
    h. Cognitive Performance:
    The proposed project must research, apply, and/or develop novel approaches and/or technology that
    provide greater mental acuity or neuroenhancement (i.e., targeted enhancement and extension of
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    cognitive and affective abilities). Encompasses pharmacological and non-pharmacological methods
    of improving cognitive, affective, motor functionality and performance, to include neuromodulation.
    i. Psychological Performance and Suicide Prevention:
    The proposed project must research, apply, and/or develop novel approaches to the assessment and
    improvement of behavioral health within the force. Examples include but are not limited to, novel
    approaches to treatment and rehabilitation from acute and/or chronic post-traumatic stress,
    depression, and anxiety, improved emotional and nervous system self-regulation, digital/virtual
    engagement strategies, methods to measure behavioral health performance over time, and improved
    suicide prevention tools/strategies.
    j. Family Readiness and Social Connectedness:
    The proposed project must research, apply, and/or develop novel approaches to increase healthy SOF
    family functioning. Family functioning includes positive interpersonal relationships, personal
    resilience, self-efficacy, and the development of supportive social networks. Potential research could
    determine what educational and didactic experiences best improve these factors of healthy SOF
    family and relational functioning.
    k. Spiritual Resilience:
    The proposed project must research, apply, and/or develop innovative approaches to increase SOF
    spiritual resilience or add scientific rigor to support current approaches. Spiritual resilience includes
    religious practice, morals, ethics (such as just war tradition), connectedness, sense of purpose and
    belonging. Potential research could determine what types of spiritual training or engagements best
    improve these factors of spiritual resilience.
    11. Canine Medicine and Performance:
    SOF personnel rely on canines’ exceptional capabilities as combat multipliers. This research area
    explores alternatives and/or new approaches to preserve and enhance SOF canine combat
    performance. SOF medical personnel place a premium on canine-specific approaches that are
    effective in extreme environments and do not require significant additional logistical support (i.e.,
    maximize use of available SOF Medic materiel). The eight “Canine Medicine and Performance”
    project areas, to which SOF will give consideration, in priority order, are:
    a. Trauma Resuscitation:
    The proposed project must support development of innovative techniques/strategies for canine
    trauma resuscitation (e.g., hypotensive resuscitation, whole blood/blood component replacement, and
    non-compressible hemorrhaging), particularly to address ballistic projectile injuries, in
    diverse/austere environments that lack immediately available medical evacuation or restorative
    surgical capacity.
    Note: Research should minimize or refrain from utilizing canine specific equipment or devices; this
    will allow treatment from existing trauma kits fielded by SOF Medics.
    b. Non-Traditional Anesthesia Protocols:
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    The proposed project must develop novel approaches for routine and emergency/post- traumatic
    canine field sedation and/or anesthesia in diverse environments and, utilizing pharmaceuticals
    available to SOF Medics.
    c. Canine Performance Optimization
    The proposed project must research, apply, and/or develop novel approaches and/or technologies that
    address optimization of canine performance through improved physical conditioning programs,
    enhanced nutrition, and genetics research.
    d. Sensory Optimization and Protection:
    Research must be oriented toward innovative methods that enhance or conserve SOF canine
    olfactory, visual, and/or auditory performance during combat operations.
    e. Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Canine
    Decontamination, Treatment, and PPE Against Possible Exposure:
    The proposed projects must research, apply, and/or develop novel approaches that will diagnose,
    treat, decontaminate, and protect canines from exposure to chemical, biological, radiological,
    nuclear, and high yield explosives.
    f. Environmental Extremes:
    Project proposals must research, apply, and/or develop novel strategies that address acclimatization
    to acute extremes in temperature, altitude, and/or time zone change (circadian acclimatization),
    and/or prolonged marine environmental exposure in SOF canines.
    g. Brain Health and TBI
    Brain health research efforts include but are not limited to development and validation of NCATs,
    blast exposure and impact monitoring, determination of safe acceptable limits for blast exposure,
    validation of neurocognitive baseline testing, capabilities to easily determine mild, moderate, and
    severe TBI, pharmaceuticals to prevent or treat brain injury, validation of brain injury treatment
    strategies, and procedures to determine safe return to duty decisions for SOF canines.
    h. Pre- and Post-Trauma Training / Behavioral Issues:
    The proposed project must address unique approaches to diagnosing and treating SOF-peculiar
    training and post-traumatic canine behavioral issues, in order to optimize pre-purchase selection and
    post-purchase training strategies across the enterprise and restore performance in canines with
    behavioral and/or post-trauma issues.
    i. Canine Simulation Technologies:
    Develop improved pre-hospital canine combat casualty simulation training devices with an emphasis
    on Special Operations Forces (SOF) pre-hospital providers. The proposed projects must research and
    apply/or develop novel approaches for high-fidelity canine trauma training simulation devices with
    physiologically relevant feedback to include temperature, pulse, lifelike size and weight, realistic fur,
    active bleeding, anatomically accurate airways, and haptic technology. Canine training devices
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    should respond to medical treatments with little to no operator/trainer intervention and capture and
    provide accurate casualty care feedback. All simulators/simulations should meet Joint Airworthiness
    Standards.
    12. Medical Sustainment
    SOF medical personnel require sustainment capabilities to support far-forward medical
    requirements to reduce the patient and supply risk associated with operational medicine. The
    proposed research, application, and/or development of medical sustainment techniques and
    materiel must address unique approaches to optimizing supply management and safeguarding
    equipment requirements. The project areas under “Medical Sustainment” to which the
    USSOCOM will give highest consideration are:
    a. Power and Energy
    Project proposals must research, apply, and/or develop novel strategies that conserve or optimize
    medical equipment in-field use to reduce sustainment burden in prolonged, austere
    environments.
    b. Austere Medical Logistics Procurement
    SOF personnel, operating in austere environments, may not have the ability to receive
    conventional resupply efforts. Project proposals must research, apply, and/or develop novel
    approaches to assist SOF personnel in developing and receiving medical resupplies or repair
    parts to meet their needs while in the field. These efforts must meet shipping and handling
    considerations (i.e. temperature control) for a wide range of medical products from batteries to
    blood. Efforts may include, but are not limited to, fabrication, improvisation, and/or delivery
    methods from sea, ground, air, or suborbital domains.
    c. Equipment Protection
    Research that develops novel material and/or approaches to protect SOF medical equipment from
    environmental (i.e. CBRNE, freezing temperatures, etc.) and/or adversarial effects (i.e. jamming,
    electronicmagnetic pulse weapons, etc.).
    d. Supply Monitoring Capability
    Project proposals must research, apply, and/or develop novel approaches to rapidly forecasting
    and calculating supply requirements based on patient treatment requirements, shelf-life, and
    storage considerations.
    II.B. Federal Award Information
    The Anticipated total costs budgeted for the entire period of performance inclusive of all
    contract awards made in response to this BAA, will not exceed $20 Million annually. The
    number of awards is indeterminate and contingent upon funding availability. Any funding
    that is received by the USSOCOM that is appropriate for a research area described within this
    BAA may be utilized to fund awards. Refer to Section II.D.5. Funding Restrictions, for
    detailed funding information.
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    The USAMRAA will negotiate the contract awards for proposals selected for funding. A contract
    is required when the principal purpose of the instrument is to acquire supplies or services for the
    direct benefit or use of the U.S. Government. The contract type, along with the start date, will be
    determined during the negotiation process.
    Please see Appendix 2 of the General Submission Instructions for more information.
    Research involving Human Anatomical Substances, Human Subjects, or Human Cadavers:
    All DoD-funded research involving new and ongoing research with human anatomical
    substances, human subjects, or human cadavers must be reviewed and approved by the
    USAMRDC Office of Human Research Oversight (OHRO),, prior to research implementation.
    This administrative review requirement is in addition to the local Institutional Review Board
    (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is
    not required. The OHRO Human Research Protections Official (HRPO) review is mandated to
    comply with specific laws and requirements governing all research involving human anatomical
    substances, human subjects, or human cadavers that is supported by the DoD. These laws and
    requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a
    minimum of 2 to 3 months for OHRO HRPO regulatory review and approval processes.
    Additional time for regulatory reviews may be needed for clinical studies taking place in
    international settings. When possible, protocols should be written for research with human
    subjects and/or human anatomical substances that are specific to the DoD-supported effort
    outlined in the submitted proposal/application as a stand-alone study. Submission to OHRO of
    protocols involving more than the scope of work in the DoD-funded award will require review of
    the entire protocol (DoD and non-DoD funded). DoD human subjects' protection requirements
    may be applied to non-DoD funded work and necessitate extensive revisions to the protocol.
    Refer to the General Submission Instructions, Appendix 1, and the Human Subject Resource
    Document available on the eBRAP “Funding Opportunities & Forms” web page
    (https://ebrap.org/eBRAP/public/Program.htm) for additional information.
    Typically, a clinical trial is not associated with this BAA. A clinical trial is defined as a
    prospective accrual of patients (human subjects) in which an intervention (e.g., device, drug,
    biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested
    for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome
    represents a direct effect on the subject of that intervention or interaction.
    Research Involving Animals: All DoD-funded research involving new and ongoing research
    with animals must be reviewed and approved by the USSOCOM Veterinarian Review Office
    (VRO) which ensures that research conducted, contracted, sponsored, supported, or managed by
    the DoD involving animal care are conducted in accordance with federal, DoD, Army,
    USSOCOM VRO, and international regulatory requirements. The USSOCOM VRO is
    responsible for administrative review, approval, and oversight of all animal research protocols,
    including all changes made during the life of the protocol.
    Specific documents relating to the use of animals in the proposed research will be requested if
    the application is selected for funding. The VRO must review and approve all animal use prior
    to the start of working with animals, including amendments to ongoing projects. PIs must
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    submit the institutional animal use protocol. Allow at least 1 to 2 months for regulatory review
    and approval processes for animal studies.
    Questions concerning animal use and review should be directed to the USSOCOM VRO:
    Phone: 813-826-6031; Email: socom_vet@socom.mil.
    Refer to the General Submission Instructions, Appendix 1, for additional information.
    The USSOCOM intends that information, data, and research resources generated under awards
    funded by this BAA be made available to the research community (which includes both
    scientific and consumer advocacy communities) and to the public at large.
    II.C. Eligibility Information
    II.C.1. Eligible Applicants
    II.C.1.a. Organizations:
    Awards are made to organizations only. Organizations eligible to apply include national,
    international, for-profit, non-profit, public, and private organizations. Refer to the General
    Submission Instructions, Appendix 3.B, for general eligibility information.
    NOTE: In accordance with FAR 35.017, Federally Funded Research and Development Centers
    (FFRDCs) are not eligible to directly receive awards under this BAA. However, teaming
    arrangements between FFRDCs and eligible organizations are allowed so long as they are
    permitted under the sponsoring agreement between the Federal Government and the specific
    FFRDC.
    The USSOCOM is committed to supporting small businesses. Small business, Veteran-owned
    small business, Service-disabled Veteran-owned small business, HUBZone small business, small
    disadvantaged business, and woman-owned small business concerns must be given the
    maximum practical opportunity to participate through subawards on research proposals
    submitted through the BAA.
    II.C.1.b. Eligible Investigators
    Eligible investigators include all individuals, regardless of ethnicity, nationality, or citizenship
    status, who are employed by, or affiliated with, an eligible organization.
    There are no limitations on the number of proposals for which an investigator may be named as a
    Principal Investigator (PI).
    The USAMRAA makes awards to eligible organizations, not to individuals.
    In addition to other information provided herein, by submitting a proposal/application and
    accepting an award, the organization is: (1) certifying that the investigators’ credentials have
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    been examined and; (2) verifying that the investigators are qualified to conduct the proposed
    study and to use humans or animals as research subjects, if proposed.
    II.C.2. Cost Sharing
    Cost sharing/matching is not an eligibility requirement.
    II.C.3. Other
    Organizations must be able to access .gov and .mil websites in order to fulfill the financial and
    technical deliverable requirements of the award and submit invoices for payment.
    Refer to Section II.H.1, Administrative Actions, for a list of administrative actions that may be
    taken if a pre-application or application does not meet the administrative, eligibility, or ethical
    requirements defined in this BAA.
    For general information on required qualifications for award recipients, refer to the General
    Submission Instructions, Appendix 3.
    Use of the System for Award Management (SAM) and the Responsibility/Qualification (R/Q):
    To protect the public interest, the Federal Government ensures the integrity of Federal programs
    by striving to conduct business only with responsible organizations. The USSOCOM uses the
    “Exclusions” within the Performance Information functional area of the SAM and data from the
    R/Q, a component within SAM, to verify that an organization is eligible to receive Federal
    awards. More information about the SAM and the R/Q is available at https://www.sam.gov/.
    Refer to the General Submission Instructions, Appendix 3, for additional information.
    Conflicts of Interest: All awards must be free of conflicts of interest (COIs) that could bias the
    research results. Prior to award of a contract, applicants will be required to disclose all potential
    or actual COIs along with a plan to manage them. An award may not be made if it is determined
    by the Contracting Officer that COIs cannot be adequately managed. Refer to the General
    Submission Instructions, Appendix 3, for additional information.
    Review of Risk: The following areas may be reviewed in evaluating the risk posed by an
    applicant: Financial stability; quality of management systems and operational controls; history
    of performance; reports and findings from audits; ability to effectively implement statutory,
    regulatory, or other requirements imposed on non-Federal entities; degree of institutional
    support; integrity; adequacy of facilities; and conformance with safety and environmental
    statutes and regulations.
    Subcontracting Plan: If the resultant award is a contract that exceeds $750,000 and the offeror
    is other than a small business, the contractor will be required to submit a subcontracting plan for
    small business and small disadvantaged business concerns, in accordance with FAR 19.704 and
    DFARS 219.704. A mutually agreeable plan will be incorporated as part of the resultant
    contract.
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    II.D. Proposal/Application Submission Information
    II.D.1. Where to Obtain the Proposal/Application Submission Package
    To obtain the complete Grants.gov proposal/application package (hereinafter, submission
    package), including all required forms, perform a Grants.gov (http://www.grants.gov/) basic
    search using the Funding Opportunity Number HT9425-23-S-SOC1.
    Submission is a two-step process requiring both (1) pre-proposal/pre-application submission
    through eBRAP (https://eBRAP.org/) and (2) full proposal/application submission through
    Grants.gov or eBRAP, depending on the type of application being submitted.
    eBRAP is a multifunctional web-based system that allows PIs to submit their pre-applications
    electronically through a secure connection, to view and edit the content of their pre-applications
    and full applications, to receive communications from the USSOCOM, and to submit
    documentation during award negotiations and period of performance.
    Classified Submissions: Classified proposals are not expected. However, in an unusual
    circumstance the applicant may be notified that access to classified information and/or controlled
    unclassified information will occur under the work proposed. In those instances where a contract
    is awarded requiring access to classified information and/or controlled unclassified information,
    clause FAR 52.204-2 shall be in effect, as well as a DD Form 254, if issued.
    Care must be exercised to ensure that classified, sensitive, and critical technologies are not
    included in a proposal/ application package. If such information is required, appropriate
    restrictive markings and procedures should be applied prior to submission of the proposal/
    application package. Portions of the proposal/ application package may be subject to release
    under terms of the Freedom of Information Act, 5 U.S.C. 552, as amended.
    Pre-application content and forms must be accessed and submitted at eBRAP.org. Full
    application packages must be accessed and submitted at Grants.gov.
    Contact information for the eBRAP Help Desk and the Grants.gov Contact Center can be found
    in Section II.G, Federal Awarding Agency Contacts.
    II.D.2. Content and Form of the Proposal/Application Submission
    Submission is a two-step process requiring both pre-application submission and full application
    submission as indicated below. The submission process should be started early to avoid missing
    deadlines. There are no grace periods.
    Pre-Application Submission: All pre-applications for extramural organizations must be
    submitted through eBRAP (https://eBRAP.org/).
    Full Application Submission: Full applications must be submitted through the online portals as
    described below.
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    Submitting Organizations: Full applications from extramural organizations must be submitted
    through a Grants.gov Workspace. Applications submitted by extramural organizations (e.g.,
    research foundations) on behalf of intramural DoD or other Federal organizations or
    investigators will be considered extramural submissions. Applications from extramural
    organizations, including non-DoD Federal organizations, received through eBRAP will be
    withdrawn. See definitions in Section II.C.1, Eligible Applicants.
    A key feature of eBRAP is the ability of an organization’s representatives and PIs to view and
    modify the full application submissions associated with them. eBRAP will validate full
    application files against the specific BAA requirements, and discrepancies will be noted in an
    email to the PI in the “Full Application Files” tab in eBRAP. It is the applicant’s responsibility
    to review all application components for accuracy as well as ensure proper ordering as specified
    in this BAA.
    The application title, eBRAP log number, and all information for the PI, Business Official(s),
    performing organization, and contracting organization must be consistent throughout the
    entire pre-application and full application submission process. Inconsistencies may delay
    application processing and limit or negate the ability to view, modify, and verify the application
    in eBRAP. If any changes need to be made, the applicant should contact the eBRAP Help Desk
    at help@eBRAP.org or 301-682-5507 prior to the application submission deadline.
    II.D.2.a. Step 1: Pre-Proposal/Pre-Application Submission Content
    Submission of a pre-proposal/pre-application is required and must be submitted through eBRAP
    (https://eBRAP.org/). If the USSOCOM is interested in receiving a full proposal/application, the
    PI will be sent an invitation to submit via eBRAP.
    During the pre-proposal/pre-application process, each submission is assigned a unique log
    number by eBRAP. This unique eBRAP log number is required during the full application
    submission process. To begin the pre-application process, first select whether the submitting
    organization is extramural or intramural, then confirm your selection or cancel. Incorrect
    selection of extramural or intramural submission type will delay processing.
    If an error has been made in the selection of extramural versus intramural and the pre-application
    submission deadline has passed, the PI or Business Official must contact the eBRAP Help Desk
    at help@eBRAP.org or 301-682-5507 to request a change in designation.
    Because the invitation to submit a proposal/application is based on the contents of the pre-
    proposal/pre-application, a PI should not change the title or research objectives after the pre-
    proposal/pre-application is submitted. A PI and organization identified in the pre-proposal/pre-
    application should be the same as those intended for the full proposal/application submission. If
    any changes are necessary after submission of the pre-proposal/pre-application, the PI must
    contact the eBRAP Help Desk via email at help@eBRAP.org or 301-682-5507. A change in PI
    or organization after submission of the pre-proposal/pre-application will be allowed only at the
    discretion of the USAMRAA Contracting Officer. Change in Principal Investigator during
    contract performance unless otherwise restricted, will be allowed at the discretion of the
    USAMRAA Contracting Officer, provided that the intent of the award is met.
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    The organization, Business Official, and PI must register in eBRAP before submitting a pre-
    proposal/pre-application. Upon completion of an organization’s registration in eBRAP and
    approval by the eBRAP Help Desk, the organization name will be displayed in eBRAP to assist
    the organization’s Business Officials and PIs as they register. The organization, Business
    Officials, and PIs must all be registered and affiliated in eBRAP. (See eBRAP User Guide at
    https://ebrap.org/eBRAP/public/UserGuide.pdf.)
    Pre-proposals may be submitted at any time prior to the BAA closing date. Pre-proposals should
    describe specific ideas or projects that pertain to any of the areas described under “Program
    Description” in this BAA. A pre-proposal/pre-application must include a brief description of the
    scientific methods and design to address the problem as described below. Brochures or other
    descriptions of general organizational or individual capabilities will not be accepted as a pre-
    proposal/pre-application. DO NOT include any proprietary information in the pre-
    proposal/pre-application.
    The pre-proposal/pre-application consists of the following components, which are organized in
    eBRAP by separate tabs. Refer to the General Submission Instructions, Section II, for additional
    information on the pre-proposal/pre-application submission.
    • Tab 1 – Application Information: Enter the information as described in eBRAP before
    continuing the pre-proposal/pre-application.
    • Tab 2 – Application Contacts: Enter contact information for the PI and the
    organization’s Business Official responsible for the sponsored program administration (or
    equivalent). This is the individual listed as “person to be contacted on matters involving
    this Application” in Block 5 of the Grants.gov SF424 form. The form is designed to fill in
    common required fields across other forms, such as the applicant's name, address, and
    Unique Entity Identifier (UEI) Number. Once it is completed, the information will
    transfer to the other forms.
    The Business Official must either be named or invited in order for the pre-proposal/pre-
    application to be submitted. If the organization’s Business Official is not in eBRAP, an
    invitation to the Business Official to register in eBRAP must be sent. In addition, it is
    recommended that the applicant identify an Alternate Submitter in the event that
    assistance with pre- proposal/pre-application submission is needed.
    NOTE: The eBRAP system does not require an approval of the pre-proposal/pre-
    application by the PI’s organization.
    • Tab 3 – Collaborators and Key Personnel:
    Enter the name, organization, and role of all collaborators and key personnel associated
    with the Application (including co-investigators, mentors, collaborators, consultants, and
    subrecipients/subawardees) associated with the proposal/ application. Enter the
    organization’s Business Official responsible for sponsored program administration (the
    “person to be contacted on matters involving this Application” in Block 5 of the
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    Grants.gov SF-424 form). The Business Official must either be selected from the eBRAP
    list or invited in order for the pre- proposal/pre-application to be submitted.
    • Tab 4 – Conflicts of Interest (COI):
    List all individuals other than collaborators and key personnel who may have a conflict of
    interest (COI) in the review of the pre-proposal/pre-application (including those with
    whom the PI has a personal or professional relationship). Federal agency personnel
    involved in the review process and/or with making funding recommendations are
    prohibited from being involved in the research proposed or assisting in any pre-
    proposal/pre-application, including, but not limited to, concept design, proposal/
    application development, budget preparation, and the development of any supporting
    documentation. If formal collaboration with Military Facility personnel is planned
    (i.e., included in the proposal/application in performance of the research), this
    prohibition is not applicable. Military Facility is defined as Military Health System
    (MHS) facility, research laboratory, medical treatment facility, dental treatment
    facility, or a DoD activity embedded with a civilian medical center. However, these
    Military Facility personnel cannot be involved in the review process and/or with
    making funding recommendations. Refer to the General Submission Instructions,
    Appendix 3.D, for additional information. For questions related to COI, contact the
    eBRAP Help Desk at help@eBRAP.org or 301-682-5507.
    • Tab 5 – Pre-Application Files:
    Note: Upload document(s) as individual PDF files unless otherwise noted. eBRAP will
    not allow a file to be uploaded if the number of pages exceeds the limit specified below.
    Pre-Proposal/Pre-Application Narrative (6-page limit): The pre-proposal/ pre-
    application narrative page limit applies to text and non-text elements (e.g., figures, tables,
    graphs, photographs, diagrams, chemical structures, drawings, etc.) used to describe the
    project. Inclusion of URLs that provide additional information to expand the Narrative
    and could confer an unfair competitive advantage is prohibited and may result in
    administrative withdrawal of the pre-proposal/pre-application.
    Include the following:
    ○ Problem to Be Studied: Describe the perceived issue(s) and the problems to be
    studied. This section should serve as an abstract of the proposed work.
    ○ Theoretical Rationale, Scientific Methods, and Design: Describe how the
    research approach for accomplishing the specific aims is feasible, will
    accomplish the objectives, will provide information on proposed methods and
    analysis/evaluation strategies, and is based on sound rationale. Describe how the
    proposed work and research will create and produce a demonstration and
    validation/proof of concept to meet the subject Topic Area.
    – Background/Rationale: Clearly present the ideas and reasoning behind
    the proposed research. Include relevant military and civilian literature
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
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    citations, preliminary and/or pilot data, and/or other evidence that led to
    the development of the proposed research. Any preliminary data should
    be from the laboratory of the PI or member(s) of the collaborating team.
    – Hypothesis/Objective and Specific Aims: State the proposed project’s
    hypothesis and/or objectives and the specific aims/tasks of the proposed
    research.
    – Approach/Methodology: Describe the research approach. Include
    research design, methods, and analysis/evaluation strategies as well as
    materials anticipated to be used during the research. Include a description
    of human use in the proposed project. For studies involving human
    subjects, include a description of the size, characteristics, and partnering
    organizations of the subject population that will be employed.
    ○ Significance, Relevance, and Innovation of the Proposed Effort:
    – Significance and Relevance: Clearly articulate how the proposed research is
    instrumental in addressing research gaps, meets military requirements, and has
    military relevance to improving theater/operational medicine.
    – Innovation: Explain how the proposed project is innovative and not an
    incremental advancement of previous work.
    ○ Proposed Study Design/Plan: Provide the intended research methodology that
    will support the study. Provide preliminary information such as description and
    background of the technical solution, anticipated success criteria, research/test
    plan(s), and statistical protocols. Refer to Section II.A., Program Description, for
    additional information on the RAIs for this BAA.
    ○ Military Impact: Describe the anticipated short- and/or long-term outcomes of the
    proposed project and their potential impact on improving technologies, data and/or
    processes. Refer to Section II.A., Program Description, for additional information on
    the anticipated outcomes sought by this BAA.
    ○ Personnel and Facilities: Describe the role of the PI, co-PIs (if applicable), key
    personnel, sub-awards (if applicable), and consultants (if applicable) in the research
    team, including the expertise each brings to the proposed project. Explain how the
    team’s expertise is appropriate and complementary for achieving the research goals.
    Also, briefly provide information on the primary facility where the research is
    expected to be performed.
    ○ Open Source/License/Architecture: Describe the intellectual property that is
    intended to be incorporated within the design/plan and identify any additional
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    costs, such as licensing, which may be needed to ensure flexibility or adaption of
    the research project for Government use.
    Pre-Proposal/Pre-Application Supporting Documentation: The items to be included as
    supporting documentation for the pre-proposal/pre-application must be uploaded as individual
    PDF documents and are limited to:
    ○ References Cited (one-page limit): List the references cited (including URLs if
    available) in the pre-proposal/pre-application narrative using a standard reference
    format that includes the full citation (i.e., author[s], year published, title of reference,
    source of reference, volume, chapter, page numbers, and publisher, as appropriate).
    ○ List of Abbreviations, Acronyms, and Symbols: Provide a list of abbreviations,
    acronyms, and symbols used in the pre-proposal/pre-application narrative.
    ○ PI and Key Personnel Biographical Sketches (five-page limit per individual):
    Upload as “Biosketch_LastName.pdf.” Bold or highlight publications relevant to the
    proposed project.
    ○ Budget Summary: Upload as “BudgetSummary.pdf.” Complete the two-page Pre-
    Application Budget Summary Form (available for download in eBRAP) as instructed.
    ○ Quad Chart: Upload as “QuadChart.pdf.” Complete the one-page Quad Chart
    Form (available for download in eBRAP) as instructed.
     Submit Pre-Application – Tab 6: This tab must be completed for the pre-
    proposal/preapplication to be accepted and processed.
    II.D.2.b. Pre-Proposal/Pre-Application Screening Criteria
    The USSOCOM scientists or outside experts will screen pre-proposals for technical merit and
    programmatic considerations. Based on the screening of the preproposal, a PI may be invited to
    submit a full proposal/application. Pre- proposal will be screened based on the following
    criteria, listed in descending order of importance:
    • Theoretical Rationale, Scientific Methods, and Research: To what degree the
    research approach for accomplishing the specific aims is feasible, will accomplish
    the objectives, will provide information on proposed methods and analysis/
    evaluation strategies, and is based on sound rationale. To what degree the proposed
    work and research will create and produce a demonstration and validation/proof of
    concept to address the Topic Area.
    • Significance, Relevance, and Innovation: To what degree the proposed research is
    relevant and innovative, including whether the proposed research is duplicative of
    existing research.
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    • Study Design/Plan: To what degree the proposed demonstration and validation study
    methodologies, anticipated sample and sample size, test plan(s), anticipated success
    criteria, evaluation criteria/metrics, and statistical protocols will justify and support
    the intended outcomes of the proposed research.
    • Military Impact: To what degree the project’s anticipated short- and/or long-term
    outcomes will impact the military and provide advancement in theater/operational
    medicine in the military health system in a way that is consistent with the intent of
    the award mechanism.
    • Personnel, Facilities, Timelines, and Budget: To what degree the expertise,
    experience, and knowledge of the key research personnel (including co-PIs if
    applicable), sub-awards (if applicable), and consultants (if applicable) are
    appropriate and complementary for achieving the research goals. To what degree
    the prime facility will be able to perform the proposed research.
    Following the pre-proposal/pre-application screening, PIs will be notified as to whether or not
    they are invited to submit full proposals; however, they will not receive feedback (e.g., a critique
    of strengths and weaknesses) on their pre-proposals. Within 180 days of submission, PIs should
    receive email notification via eBRAP regarding disposition of their pre-proposals.
    A. II.D.2.c. Step 2: Full Proposal/Application Submission Content
    A Proposal/Application will not be accepted unless the PI has received an invitation to submit.
    If the USSOCOM is interested in receiving a full proposal/application, the PI will receive an
    invitation to submit via email from eBRAP. It should be submitted within 60 days of the PI’s
    receipt of an invitation to submit, as directed in II.D.2. Agency receipt of a full
    proposal/application will be acknowledged by an email sent to the PI via eBRAP. The
    proposal/application log number for the full proposal/application will be the same number as
    used for the pre-proposal/pre-application, e.g., SO23XX.
    The USSOCOM cannot make allowances/exceptions to its policies for submission problems
    encountered by the applicant organization using system-to-system interfaces with Grants.gov.
    Each application submission must include the completed full application package for this BAA.
    The full application package is submitted by the Authorized Organizational Representative
    through Grants.gov (http://www.grants.gov/) for extramural organizations. See Table 1 below for
    more specific guidelines. Proprietary information should only be included if necessary for
    evaluation of the proposal/application. Conspicuously and legibly mark any proprietary
    information that is included in the proposal/application.
    II.D.2.c.i. Full Guidelines
    Organizations must submit full applications through Grants.gov. Applicants must create a
    Grants.gov Workspace for submission, which allows the application components to be
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
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    completed online and routed through the applicant organization for review prior to submission.
    Applicants may choose to download and save individual PDF forms rather than filling out
    webforms in the Workspace. A compatible version of Adobe Reader must be used to view,
    complete, and submit an application package consisting of PDF forms. If more than one person
    is entering text into an application package, the same version of Adobe Reader software should
    be used by each person. Check the version number of the Adobe software on each user’s
    computer to make sure the versions match. Using different versions of Adobe Reader may cause
    submission and/or save errors – even if each version is individually compatible with Grants.gov.
    Refer to the General Submission Instructions, Section III, and the “Apply For Grants” page of
    Grants.gov (https://www.grants.gov/web/grants/applicants/apply-for-grants.html) for further
    information about the Grants.gov Workspace submission process. Submissions of extramural
    applications through eBRAP may be withdrawn.
    Table 1. Full Submission Guidelines
    Submissions
    Download application package components for
    HT9425-23-S-SOC1 from Grants.gov
    (http://www.grants.gov) and create a Grants.gov
    Workspace. The Workspace allows online completion
    of the application components and routing of the
    application package through the applicant organization
    for review prior to submission.
    SF424 Research & Related Forms (R&R)
    Application for Federal
    Assistance Form: Refer to the General Submission
    Instructions, Section III.A.1, for detailed information.
    Submissions
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    Descriptions of each required file can be found under
    Full Application Submission Components:
    • Attachments
    • Research & Related Personal Data
    • Research & Related Senior/Key Person
    Profile (Expanded)
    • Research & Related Budget
    • Project/Performance Site Location(s) Form
    • R&R Subaward Budget Attachment(s) Form
    (if applicable)
    • (if applicable) Additional Application
    Component(s)
    Complete a Grants.gov Workspace.
    Add participants (investigators and Business Officials)
    to the Workspace, complete all required forms, and
    check for errors before submission. The Workspace
    progress bar will display the state of your application
    process as you apply. As you apply using Workspace,
    you may click the blue question mark icon near the
    upper-right corner of each page to access context-
    sensitive help.
    Mandatory Fields in Forms: In the forms, you will
    note fields marked with an asterisk and a different
    background color. These fields are mandatory fields
    that must be completed to successfully submit your
    application.
    Submit a Grants.gov Workspace Package. An
    application may be submitted through
    Workspace by clicking the “Sign and Submit” button on
    the “Manage Workspace” page, under the “Forms” tab.
    Grants.gov recommends submission of the application
    package at least 24-48 hours prior to the close date to
    allow time to correct any potential technical issues that
    may disrupt the application submission.
    Note: If either the Project Narrative or the budget fails
    eBRAP validation or if the Project Narrative or the
    budget needs to be modified, an updated Grants.gov
    application package must be submitted via Grants.gov
    as a “Changed/Corrected Application” with the previous
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    Grants.gov Tracking ID prior to the application
    submission deadline.
    Submissions
    The full application package submitted to
    Grants.gov may be viewed and modified in eBRAP until
    the end of the application verification period. During
    the application verification period, the full application
    package, with the exception of the Project Narrative
    and Budget Form, may be modified.
    Tracking a Grants.gov Workspace Package. After
    successfully submitting a Workspace package, a
    Grants.gov Tracking Number is automatically assigned
    to the package. The number will be listed on the
    “Confirmation” page that is generated after submission.
    Refer to the General Submission Instructions, Section
    III, for further information regarding Grants.gov
    requirements.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
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    Application viewing, modification, and verification in eBRAP are strongly recommended, but
    not required. The Project Narrative and Budget cannot be changed after the application
    submission deadline. Prior to the full application deadline, a corrected or modified full
    application package may be submitted. Other application components may be changed until the
    end of the application verification period. Verify that subaward budget(s) and budget
    justification forms are present in eBRAP during the application verification period. If these
    components are missing, upload them to eBRAP before the end of the application verification
    period. After the end of the application verification period, the full application cannot be
    modified.
    Material submitted after the end of the application verification period, unless specifically
    requested by the Government, will not be forwarded for processing.
    II.D.2.c.ii. Full Proposal/Application Submission Components
    The Grants.gov submission package includes the following components (refer to the General
    Submission Instructions, Section III., for additional information on proposal/application
    submission):
    1. SF 424 (R&R) Application for Federal Assistance Form: Refer to the General
    Submission Instructions, Section III for detailed information.
    2. Attachments Form
    Each attachment to the full proposal/application components must be uploaded as an
    individual file in the format specified and in accordance with the formatting guidelines
    listed in the General Submission Instructions, Appendix 4.
    For all attachments, ensure that the file names are consistent with the guidance. Attachments
    will be rejected if the file names are longer than 50 characters or have incorrect file names
    that contain characters other than the following: A-Z, a-z, 0-9, underscore, hyphen, space,
    and period. In addition, there are file size limits that may apply in some circumstances.
    Individual attachments may not exceed 20 MB, and the file size for the entire full
    proposal/application package may not exceed 200 MB.
     Attachment 1: Project Narrative (20-page limit): Upload as
    “ProjectNarrative.pdf.” The page limit of the Project Narrative applies to text
    and non-text elements (e.g., figures, tables, graphs, photographs, diagrams,
    chemical structures, drawings, etc.) used to describe the project. Inclusion of
    URLs that provide additional information to expand the Project Narrative and
    could confer an unfair competitive advantage is prohibited and will result in
    administrative withdrawal of the proposal/application.
    Describe the proposed project in detail using the outline below.
    ○ Background: Present the ideas and reasoning behind the proposed
    research; include relevant literature citations or preliminary data on the
    proposed technical solution(s) and how they may have been utilized in
    similar environment(s). Describe previous experience most pertinent to this
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    project. Any preliminary data should be from the laboratory of the PI or
    member(s) of the collaborating team.
    ○ Hypotheses/Objectives: State the hypotheses or research/evaluation
    questions and overall objective(s) to be reached.
    ○ Specific Aims: Concisely explain the project’s specific aims to include
    expected timeframe of each aim. If this proposal/application is part of a
    larger study, present only tasks this award would fund.
    ○ Project Design: Describe and define the research design, methods, and
    analyses/evaluations in sufficient detail for analysis.
    — Clearly support the choice of study variables/metrics and explain the
    basis for the research questions and/or study hypotheses. Establish the
    relevance of the study and explain the applicability of the proposed
    findings.
    — Provide a detailed protocol, including but not limited to, proposed
    methodologies, research/test plan(s) and criteria, intended medical
    domain(s) or discipline(s), control groups, and defined statistical
    models.
    — Define the study variables (independent/dependent) and define how they
    will be measured. Include a description of appropriate controls and the
    endpoints to be tested. Describe how data will be collected and analyzed in
    a manner that is consistent with the study objectives. Describe a plan for
    data access and outcome dissemination.
    — For development of devices and technologies, discuss the engineering/
    technical design that will be used to achieve the project goals,
    demonstrating the feasibility of the proposed product development. Discuss
    the perceived engineering/design strengths and flaws and recommendations
    for overcoming/preventing them.
    — Address all potential barriers and provide plans for addressing potential
    delays, unexpected events, changes in key personnel, and ongoing
    adaptation of the Application. Provide a risk management plan to address
    barriers to plans. As relevant, describe plans for addressing potential
    issues unique to working within the military health system.
    — Document the availability and accessibility of the study materials (including
    data) needed as applicable.
    ○ Project Milestones: Identify timelines for critical events that must be
    accomplished in order for the project to be successful in terms of cost,
    schedule, and performance. For development of devices and technologies,
    discuss the timelines and provide a commercial strategy plan for the
    technology being developed.
    ○ Additional Information: If human subjects are involved in the research,
    proposals may be submitted prior to human protocol institutional approvals.
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    However, protocols with required institutional approvals must be submitted no
    later than 60 days after award to demonstrate continued progress and ensure
    continuation of payment. The Contracting Officer may make exceptions in
    situations where human and/or animal use is not expected to begin until after
    the first year of the research project. In such cases, a timeframe for submission
    of the appropriate protocols and institutional approvals will be established
    prior to award.
    PIs and collaborating organizations may not use, employ, or subcontract for
    the use of any human participants, including the use of human anatomical
    substances, human data, and/or human cadavers, or laboratory animals until
    applicable regulatory documents are approved by the OHRO and or
    USSOCOM VRO to ensure that DoD regulations have been met.
    – For studies with prospective accrual of human subjects, indicate
    quarterly enrollment targets.
    – Identify cell line(s) and commercial or organizational source(s) to be
    used. If human anatomical substances (including cell lines) will be used,
    specify whether or not identifiable information is accessible to the
    research team by any means.
    – If applicable, indicate time required for submission and/or approval of
    documents (e.g., Investigational New Drug and Investigational Device
    Exemption) to the U.S. Food and Drug Administration or appropriate
    Government agency.
    – For studies involving human subjects, allow at least 2 to 3 months for
    regulatory review and approval by the USAMRDC OHRO; this does not
    include the additional time required for local Institutional Review Board
    (IRB)/Ethics Committee (EC) review and approval.
    Refer to the General Submission Instructions, Appendix 5, for additional
    regulatory information.
     Attachment 2: Supporting Documentation: Start each document on a new
    page. Combine and upload as a single file named “Support.pdf.” If
    documents are scanned to pdf, the lowest resolution (100 to 150 dpi) should be
    used. The Supporting Documentation attachment should not include additional
    information such as figures, tables, graphs, photographs, diagrams, chemical
    structures, or drawings.
    There are no page limits for any of these components unless otherwise noted.
    Include only those components described below; items not requested will be
    removed and may result in administrative withdrawal of the
    proposal/application.
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    ○ Bibliography and References Cited: List the references in the order they
    appear in the Project Narrative. Use a standard reference format that includes
    the full citation (i.e., author[s], year published, title of reference, source of
    reference, volume, chapter, page numbers, and publisher, as appropriate. Do
    not send or attach copies of articles in print. There is no form for this
    information. The attachments should be in PDF in accordance with the
    formatting guidelines specified for full proposal/application preparation.
    ○ List of Abbreviations, Acronyms, and Symbols: Provide a list of
    abbreviations, acronyms, and symbols.
    ○ Facilities, Existing Equipment, and Other Resources: Describe the
    facilities and equipment available for performance of the proposed project
    and any additional facilities or equipment proposed for acquisition at no cost
    to the award. Indicate whether or not Government-furnished facilities or
    equipment are proposed for use. If so, reference should be made to the
    original or present Government award under which the facilities or equipment
    items are now accountable. There is no form for this information.
    Note: For researchers who will require access to the Defense Healthcare
    Management Systems Modernization (DHMSM) Cerner Electronic
    Health Record (EHR) solution for testing related to research workflows
    and/or interfaces: Access will be provided through a research environment
    within the Program Executive Office (PEO) Defense Healthcare
    Management Systems (DHMS) Testing Infrastructure at Allegheny Ballistics
    Laboratory (ABL). Users will follow the PEO DHMS Testing Infrastructure
    Onboarding Guide to access the environment. Direct support from the
    DHMSM vendor will not be provided through the DHMSM contract. No one
    is authorized to engage the DHMSM contractor for this purpose. Research
    must remain in these stated bounds.
    ○ Publications and/or Patent Abstracts (five-document limit): Include
    relevant publication URLs and/or patent abstracts. If publications are not
    publicly available, then a copy/copies of the published manuscript(s) must
    be attached.
    ○ Letters of Organizational Support: Provide a letter (or letters, if applicable),
    signed by the Department Chair or appropriate organization official,
    confirming the laboratory space, equipment, and other resources available for
    the project. A letter for each organization involved in the project should be
    provided.
    ○ Letters of Collaboration: Provide a signed letter from each collaborating
    individual or organization that will demonstrate that the PI has the support or
    resources necessary for the proposed work. If an investigator at an
    intramural organization is named as a collaborator on an application
    submitted through an extramural organization, the application must include a
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    letter from the collaborator’s Commander or Commanding Officer at the
    intramural organization that authorizes the collaborator’s involvement.
    Refer to the General Submission Instructions, Section III.A.8., Research &
    Related Budget, for additional information.
    ○ Joint Sponsorship (if applicable): Describe present or prospective joint
    sponsorship of any portion of the program outlined in the proposal/
    application. In the absence of agreements among sponsors for joint support, the
    proposal/application should be structured so that the research can be carried
    out without the resources of any other sponsor. If, however, it is desirable to
    request partial support from another agency, the proposed plan should be stated
    and the reasons documented. If the plan cannot be formulated at the time the
    proposal/application is submitted, information should be sent later as an
    addendum to the proposal/application. Prior approval from both agencies must
    be secured for research to be undertaken under joint sponsorship. Provide
    letters of support related to recruitment, subject access, and data access plans.
    ○ Intellectual Property (if applicable): Refer to the General Submission
    Instructions, Appendix 3, for additional information. Provide the following:
    – Should the Applicant intend to use, in the performance of this program,
    pre-existing, legally protected and perfected intangible property and for
    which no Federal funds had been used in the development of said property,
    the Applicant must:
    1. Clearly identify all such property;
    2. Identify the cost to the Federal government for use or license of such
    property if applicable; or
    3. Provide a statement that no property meeting this definition will be
    used on this project.

  • Intellectual and Material Property Plan: If applicable, provide a plan for

  • resolving intellectual and material property issues among participating
    organizations.
     Attachment 3: Technical Abstract (one-page limit): Upload as
    “TechAbs.pdf.”
    The technical abstract is used by all reviewers. Abstracts of all funded research
    projects will be posted publicly. Do not include proprietary or confidential
    information. Use only characters available on a standard QWERTY keyboard.
    Spell out all Greek letters, other non-English letters, and symbols. Graphics are
    not allowed. Use the outline below.
    Background: Provide a brief statement of the ideas and theoretical
    o
    reasoning behind the proposed work. o Objective/Hypothesis: State the
    objective/hypothesis to be tested. Provide evidence or rationale that supports the
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    objective/hypothesis. o Specific Aims/Milestones: State concisely the specific
    aims/milestones of the project.
    Project Design: Briefly describe the project design. o Impact: Provide a
    o
    brief statement explaining the potential impact of the proposed work to advancing
    the standard of care for injured Service members and/or the general public. o
    Relevance: Provide a brief statement explaining the potential relevance of the
    proposed work to the specific topic area being addressed and its impact on health
    outcomes.
    • Attachment 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf.”
    The lay abstract is used by all reviewers. Do not include proprietary or
    confidential information. Use only characters available on a standard
    QWERTY keyboard. Spell out all Greek letters, other non-English letters, and
    symbols. Graphics are not allowed.
    Lay abstracts should be written using the following outline. Do not duplicate the
    technical abstract.
    ○ Describe the objectives and rationale for the proposal/application in a manner
    that will be readily understood by readers without a background in science or
    medicine.
    ○ Describe the ultimate applicability and potential impact of the research.
    — What types of patients will it help, and how will it help them? Include
    the current available statistics to the related injury/condition.
    — What are the potential clinical Applications, benefits, and risks?
    — What is the projected timeline it may take to achieve the expected patient-
    related outcome?
    ○ Briefly describe how the proposed project will benefit Service
    members, Veterans, and/or family members.
    • Attachment 5: Statement of Work (SOW) (two-page limit): Upload as
    “SOW.pdf.” The suggested SOW format and examples specific to different
    types of research projects are available on the eBRAP “Funding Opportunities
    & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm). The SOW
    outlines and establishes the PI’s and an organization’s performance expectations
    for the work to be funded under this award. The SOW in an assistance
    agreement award establishes general objectives. The SOW in a contract sets
    rather specific goals and conditions for each year of the contracted project; the
    PI and contractor are expected to meet the provisions and milestones of the SOW.
    The SOW for all award types will be incorporated into the award document and,
    as such, is subject to release under the Freedom of Information Act.
    A series of relatively short statements should be included that comprise the
    approach to each of the major goals or objectives of the proposed research. The
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    statements should outline the specific tasks, systems, and materials that are
    reasonable estimates for testing the proposed hypotheses of the study. An outline
    should be included that shows the work statements to be accomplished in each
    year of the award. If this proposal/application is part of a larger study, present
    only tasks that this award would fund. Allow at least 2 to 3 months for the
    USAMRDC OHRO’s regulatory review and approval processes for studies
    involving human subjects. Allow at least 1 to 2 months for the USSOCOM
    VRO regulatory review and approval processes for studies involving animals.
    • Attachment 6: Outcomes and Impact Statement (one-page limit): Upload as
    “Impact.pdf.” Explain in detail why the proposed research project is important,
    as follows:
    ○ Short-Term Impact: Describe the anticipated outcome(s), results, theoretical
    framework, design and or plan that will be directly attributed to the results of
    the proposed research.
    ○ Long-Term Impact: Describe the anticipated long-term clinical/patient
    gains or commercial end product from the proposed project. What is the
    indication and will the project lead toward transforming the standard of
    care? Are there non-trauma-related indications that would expand the
    market for the proposed product?
    ○ Military Relevance: Clearly articulate how the proposed project or product
    meets the needs of military medical providers and injured Service
    members.
    ○ Public Purpose: If appropriate, provide a concise, detailed description on
    how this project will benefit the general public.
    • Attachment 7: Innovation Statement (two-page limit): Upload as
    “Innovation.pdf.” Describe how the proposed project is innovative. Research
    deemed innovative may introduce a new paradigm, challenge current paradigms,
    look at existing problems from new perspectives, or exhibit other creative
    qualities. Investigating the next logical step or incremental advancement on
    published data is not considered innovative. This may include a proposed
    conceptual framework, design, and/or plan of key components and how they
    integrate/communicate with each other. Identify which potential components will
    be open source/open architecture vs. proprietary.
    • Attachment 8: Data and Research Resource-Sharing Plan (one-page limit):
    Upload as “Sharing.pdf.” Describe how unique and/or final research data will
    be shared with the research community, along with any resulting research
    resources. This includes cases where pre-existing data or research resources will
    be utilized and/or modified during the course of the proposed project. If there
    are limitations associated with a pre-existing agreement for the original data or
    research resources that preclude subsequent sharing, the Applicant should
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    explain this in the data- and/or research resource-sharing plan. For projects
    involving clinical trials, PIs may be required to register their clinical trials on
    Clinicaltrials.gov (https://clinicaltrials.gov/). For projects involving TBI, PIs
    may be required to report data to the Federal Interagency Traumatic Brain Injury
    Research (FITBIR) informatics system (http://fitbir.nih.gov/). If the project
    includes systems biology- related research, the PI may be required to make the
    systems biology data, generated via an award, available to the research
    community by depositing research data into the SysBioCube system
    (https://sysbiocube-abcc.ncifcrf.gov). Refer to the General Submission
    Instructions, Appendix 2, for additional information.
    • Attachment 9: Conflicts of Interest, if applicable: Upload as “COI.pdf.”
    Provide details with the proposal/application submission of all potential or
    actual COIs, along with a plan to resolve them. A contract or assistance
    agreement will not be awarded if it is determined by the respective Contracting
    Officer that a COI cannot be managed.
    Personnel involved in the review process and/or with making funding
    recommendations are prohibited from assisting in any proposal/application,
    including, but not limited to, concept design, Application development, budget
    preparation, and the development of any supporting documentation.
    Questions related to this topic should be directed to the eBRAP Help Desk via
    email at help@eBRAP.org or 301-682-5507. Refer to the General Submission
    Instructions, Appendix 3, for additional information.
    • Attachment 10: Data Management (no page limit): Upload as
    “DataManage.pdf.” The Data Management attachment should include the
    components listed below.
    Data Management: Describe all methods used for data collection to include the
    following:
    ○ Identifiers: Describe the unique identifiers or specific code system to be used
    to identify human subjects, if applicable.
    ○ Confidentiality: Explain measures taken to protect the privacy of studies
    conducted on human subjects and the ability to maintain confidentiality of
    study data. Strategies to protect the privacy and confidentiality of study
    records, particularly those containing identifying information, should be
    addressed.
    — Address who will have access to study records, data, and specimens,
    including an acknowledgment that representatives of USSOCOM are
    eligible to review study records.
    — Address requirements for reporting sensitive information to state or local
    authorities.
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    ○ Disposition of data: Describe where data (both electronic and hard copy) will
    be stored, who will keep the data, how the data will be stored, and the length
    of time data will be stored. For FDA-regulated studies, compliance with 21
    CFR 11 is required.
    ○ Sharing study results: In cases where the human subject could possibly
    benefit medically or otherwise from the information, explain whether or not
    the results of screening and/or study participation will be shared with human
    subjects or their primary care provider, to include results from any screening or
    diagnostic tests performed as part of the study.
    • Attachment 11: Post-Award Project Transition Plan (three-page limit).
    Upload as “Transition.pdf.” Provide information on the methods and
    strategies proposed to move the project or knowledge outcomes to the next
    project phase of studies, commercialization, and/or delivery to the civilian or
    military market after successful completion of the award. The transition plan
    should include the components listed below.
    a. The planned indication for the product label, if appropriate, and an outline of
    the development plan required to support that indication.
    b. The anticipated regulatory strategy (e.g., additional nonclinical or clinical
    studies anticipated/required, FDA or regulatory authority meetings desired,
    industry partnerships) for movement of the research into later phases of
    development and to support a potential marketing Application [e.g., New
    Drug Application, Biologics License Application, Premarket Approval
    Application, 510(k)].
    c. Details of the funding strategy that will be used to bring the outcomes to
    the next level of development and/or commercialization (e.g., specific
    potential industry partners, specific funding opportunities to be applied
    for).
    d. For knowledge products, a description of how the knowledge will be further
    developed, disseminated, and incorporated into clinical care.
    e. A description of collaborations and other resources that will be used to
    provide continuity of development.
    f. A brief schedule and milestones for bringing the outcome(s) to the next phase
    of studies, commercialization, and/or delivery to the military or civilian
    market, including when it can be anticipated to be transitioned to an industry
    partner or approved by the FDA, if applicable.
    g. A risk analysis for cost, schedule, manufacturability, and sustainability.
    • Attachment 12: Collaborating DoD Military Facility Budget Form(s), if
    applicable: Upload as “MFBudget.pdf.” If a Military Facility will be a
    collaborator in performance of the project complete the Collaborating DoD
    Military Facility Budget Form (available for download on eBRAP “Funding
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    Opportunities and Forms” web page), including a budget justification for each
    year. If more than one Military Facility is proposed, submit a separate budget
    form for each site. Refer to the General Submission Instructions, Section II.D.5.,
    Research & Related Budget, for detailed information.
     Extramural Applications
    To evaluate compliance with Title IX of the Education Amendments of 1972 (20 USC
    A§1681 et seq.), the DoD is collecting certain demographic and career information to be
    able to assess the success rates of women who are proposed for key roles in applications in
    science, technology, engineering, or mathematics (STEM) disciplines. To enable this
    assessment, each application must include the following forms completed as indicated.
    Research & Related Personal Data: For extramural submissions (via Grants.gov), refer to
    the General Submission Instructions, Section III.A.3.
    Research & Related Senior/Key Person Profile (Expanded): Refer to the General
    Submission Instructions, Section III for detailed information.
    • PI Biographical Sketch (five-page limit): Upload as “Biosketch_LastName.pdf.” 
    PI Previous/Current/Pending Support (three-page limit): Upload as
    “Support_LastName.pdf.”
    • Key Personnel Biographical Sketches (five-page limit each): Upload as
    “Biosketch_LastName.pdf.”
    • Key Personnel Previous/Current/Pending Support (three -page limit each): Upload
    as “Support_LastName.pdf.”
    Research & Related Budget: Refer to the General Submission Instructions, Section III for
    detailed information.
    • Budget Justification (no page limit): Upload as “BudgetJustification.pdf.” The budget
    justification for the entire period of performance must be uploaded to the Research &
    Related Budget after completion of the budget for Period 1.
    IAW FAR 35.016(e), “The primary basis for selecting proposals for
    o
    acceptance shall be technical, importance to agency programs, and fund
    availability. Cost realism and reasonableness shall also be considered to the
    extent appropriate”.
    For contracts, statutory limits for fees are specified in FAR 15.404-4(c)(4).
    o
    NOTE: For all Federal agencies or organizations collaborating with Military
    Facilities, special restrictions apply to the budget and are described below.
    • For Federal Agencies: Proposals from Federal agencies must include in their budget
    justifications a Federal Financial Plan. The Federal Financial Plan must address how
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    all funds will be obligated before their period for obligation expires, and how funds will
    be available to cover research costs over the entire award period. The Federal Financial
    Plan must include the funding mechanism(s) that will be used to carry over funds
    between fiscal years.
    • For Collaborating DoD Military Facilities: Proposals from organizations that include
    collaborations with DoD Military Facilities (military health system facility, research
    laboratory, treatment facility, dental treatment facility, or a DoD activity embedded with
    a civilian medical center) must submit Collaborating DoD Military Facility Budget
    Form(s) as instructed in Attachment 12.
    Project/Performance Site Location(s) Form: Refer to the General Submission Instructions,
    Section III. for detailed information.
    R & R Subaward Budget Attachment(s) Form (if applicable): Refer to the General
    Submission Instructions, Section III. for detailed information.
    R&R Subaward Budget Attachment(s) Form (if applicable): Refer to the General
    Application Instructions, Section III. for detailed information.
    Collaborating with DoD Military Facilities (if applicable): Refer to the General
    Application Instructions, Section III. for detailed information.
    II.D.3. Unique Entity Identifier (UEI) and System for Award Management (SAM)
    All organizations applying online through Grants.gov must register with the System for Award
    Management (SAM) and will receive a unique entity identifier (UEI) number. Failure to register
    with SAM will prevent your organization from applying through Grants.gov.
    Applicant organizations and all subrecipient organizations must have an active registration in the
    System for Award Management (SAM) number to submit proposals to Grants.gov. The
    applicant organization must also be registered in the Entity Management functional area of the
    SAM with an “Active” status to submit proposals through the Grants.gov portal. Verify the
    status of the applicant’s organization’s Entity registration in SAM well in advance of the
    proposal/application submission deadline. Allow several weeks to complete the entire SAM
    registration process. If an applicant has not fully complied with the requirements at the time the
    Federal awarding agency is ready to make a Federal award, the Federal awarding agency may
    determine that the applicant is not qualified to receive a Federal award and use that
    determination as a basis for making a Federal award to another applicant. Refer to the General
    Submission Instructions, Section III, for further information regarding Grants.gov requirements.
    Organizations must have an active System for Award Management (SAM) registration, and
    Grants.gov account to apply for contracts. If individual applicants are eligible to apply for this
    funding opportunity, then you may begin with step 3, Create a Grants.gov Account, listed below.
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    Creating a Grants.gov account can be completed online in minutes, but SAM registrations may
    take additional time. Therefore, an organization's registration should be done in sufficient time to
    ensure it does not impact the entity's ability to meet required application submission deadlines.
    Complete organization instructions can be found on Grants.gov here:
    https://www.grants.gov/web/grants/applicants/organization-registration.html
    1) Register with SAM for all awards: SAM registration must be renewed annually. For more
    detailed instructions for registering with SAM, refer to:
    https://www.grants.gov/web/grants/applicants/organization-registration/step-2-register-with-
    sam.html
    2) Create a Grants.gov Account: The next step is to register an account with Grants.gov.
    Follow the on-screen instructions or refer to the detailed instructions here:
    https://www.grants.gov/web/grants/applicants/registration.html
    3) Add a Profile to a Grants.gov Account: A profile in Grants.gov corresponds to a single
    applicant organization the user represents (i.e., an applicant) or an individual applicant. If you
    work for or consult with multiple organizations and have a profile for each, you may log in to
    one Grants.gov account to access all of your grant applications. To add an organizational
    profile to your Grants.gov account, enter the UEI Number for the organization in the UEI field
    while adding a profile. For more detailed instructions about creating a profile on Grants.gov,
    refer to: https://www.grants.gov/web/grants/applicants/registration/add-profile.html
    4) EBiz POC Authorized Profile Roles: After you register with Grants.gov and create an
    Organization Applicant Profile, the organization applicant's request for Grants.gov roles and
    access is sent to the EBiz POC. The EBiz POC will then log in to Grants.gov and authorize the
    appropriate roles, which may include the AOR role, thereby giving you permission to complete
    and submit applications on behalf of the organization. You will be able to submit your
    application online any time after you have been assigned the AOR role. For more detailed
    instructions about creating a profile on Grants.gov, refer to:
    https://www.grants.gov/web/grants/applicants/registration/authorize-roles.html
    5) Track Role Status: To track your role request, refer to:
    https://www.grants.gov/web/grants/applicants/registration/track-role-status.html
    b. Electronic Signature: When applications are submitted through Grants.gov, the name of the
    organization applicant with the AOR role that submitted the application is inserted into the
    signature line of the application, serving as the electronic signature. The EBiz POC must
    authorize people who are able to make legally binding commitments on behalf of the
    organization as a user with the AOR role; this step is often missed and it is crucial for valid and
    timely submissions.
    For additional training resources, including video tutorials, refer to:
    https://www.grants.gov/web/grants/applicants/applicant-training.html
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    Applicant Support: If you are experiencing difficulties with your submission, it is best to call the
    Grants.gov Support Center and get a ticket number. The Support Center ticket number will assist
    the USSOCOM with tracking your issue and understanding background information on the
    issue. Grants.gov provides applicants 24/7 support via the toll-free number 1-800-518-4726 and
    email at support@grants.gov. For questions related to the specific grant opportunity, contact the
    number listed in the application package of the grant you are applying for.
    In March 2018, the General Services Administration (GSA) implemented fraud prevention
    security measures in the System for Award Management (SAM) which required every new
    contractor registrant to provide a written (hard copy), notarized letter confirming the entity's
    Administrator that is authorized to register the entity in the SAM database, or to make changes to
    its registration. Effective 29 April 2018, the notarized letter process is now mandatory on all
    CURRENT registrants at SAM who have a requirement to update data on their SAM record.
    The notarized letter is mandatory and is required before the GSA Federal Service
    Desk (FSD) will activate the entity's registration. The Office of the Secretary of Defense and
    GSA realizes the length of time needed to transmit, receive, process, and approve the notarized
    letters presents a significant impact on the ability of the contracting activity to make timely
    awards, but in order to mitigate the concern of fraud, these steps and the time needed for
    processing, is unavoidable. Notarized letters are required for all new and existing SAM
    registered Entities. The notarized letters must be postal service mailed (not emailed or faxed) to
    the "Federal Service Desk" and must contain the information outlined in the SAM posted FAQ
    at: (https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-
    management/integrated-award-environment-iae/sam-updatemanagement/integrated-award-
    environment-iae/sam-update). Instructions for domestic entities and instructions for
    international entities with embedded templates for use are also provided within the SAM Update
    notice with frequently asked questions at https://www.gsa.gov/about-us/organization/federal-
    acquisition-service/office-of-systems-management/integrated-award-environment-iae/sam-
    updateus/organization/federal-acquisition-service/office-of-systems-management/integrated-
    award
    II.D.4. Submission Dates and Times
    This is a continuously open announcement through 31 July 2028; therefore, reviews occur
    throughout the year. Pre-proposals may be submitted at any time throughout the 5-year period
    noted above. An invited full proposal/application should be submitted within
    60 days of the PI’s receipt of an invitation to submit. No pre-proposal/pre-application or full
    proposal/application may be submitted under this BAA after 31 July 2028, 11:59 p.m. Eastern
    Time. If an invited proposal/application is not submitted by 31 July 2028, 11:59 p.m. Eastern
    Time, the applicant must wait for the next available opportunity for submission, i.e., the release
    of the FY28 BAA (to be posted to Grants.gov 31 July 2028). No proposal/application received
    under this BAA will be considered for funding after 24 months from the date of submission.
    II.D.5. Funding Restrictions
    The following limits on the duration and cost of research projects apply:
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    Proposed projects longer than five (5) years will not be considered.
    Most projects are anticipated to have a total cost between $2,000,000 and $10,000,000
    (including indirect costs). Projects that have a total cost higher than $5,000,000 (including
    Indirect costs) with outstanding scientific merit that meet a critical need may be accepted;
    however, the total cost of these projects are not to exceed $10,000,000.00 (including Indirect
    costs).
    No budget will be approved by the Government exceeding $10,000,000.00 (including indirect
    costs).
    The total funding for this BAA will not exceed $50,000,000.00 (including indirect costs).
    A budget should be commensurate with the nature and complexity of the proposed research.
    Researchers should submit budgets that include the entire period of performance of the research
    project. Budgets should include all direct and indirect costs, based on supportable, verifiable
    estimates. The budget for the full proposal/application should not differ significantly from the
    pre-proposal/pre-application budget summary form provided in the pre-proposal/pre-application
    submission.
    Offerors or Applicants seeking additional or continuation funding must submit new pre-
    proposals and be invited to submit full proposals.
    See the General Submission Instructions, Section III, for additional information regarding the
    research and related budget.
    All direct and indirect costs of any subaward, contract, or subcontract must be included in the
    costs of the primary award.
    The applicant may request the entire maximum funding amount for a project that may have a
    period of performance less than the maximum five years.
    For this award mechanism, direct costs may be requested for (not all inclusive):
    • Salary
    • Research – related subject costs
    • Research supplies
    • Support for multidisciplinary collaborations, including travel
    • Travel costs
    • Equipment
    For extramural awards with an intragovernmental component, direct transfer of funds from an
    extramural award recipient to a DoD or other Federal agency is not allowed. Funding to
    intramural DoD and other Federal agencies will be managed through a direct fund transfer.
    Intramural applicants are responsible for coordinating through their agency’s procedures the use
    of contractual or assistance funding awards or other appropriate agreements to support
    extramural collaborators.
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    Refer to the General Submission Instructions, Section III. for budget regulations and instructions
    for the Research & Related Budget. For Federal agencies or organizations collaborating with
    Federal agencies, budget restrictions apply as are noted in the General Submission
    Instructions, Section III.
    For additional information refer to Section II.F.1, Federal Award Notices.
    Funds to be obligated on any award resulting from this BAA will be available for use for a
    limited time period based on the fiscal year of the funds. Awards will identify expiration of the
    funds.
    Refer to the General Submission Instructions, “Research & Related Budget,” for discussion of
    allowable costs, including pre-award costs and collaborations with Military Facilities.
    II.D.6. Other Submission Requirements
    Refer to the General Submission Instructions, Appendix 4, for detailed formatting guidelines on
    submission.
    II.E. Proposal/Application Review Information
    II.E.1. Criteria
    II.E.1.a. Peer Review
    To determine technical merit, all proposals will be evaluated according to the following scored
    criteria, which are listed in descending order of importance:
    • Research Objectives: The degree to which the stated objectives are clear, valid, and logical.
    For development of devices and technologies, the degree to which the performance
    objectives are plausible; the proposed effort demonstrates familiarity with the historical
    background of the problem and previous/current solutions; and the awareness of similar
    projects previously undertaken and related activities. The extent that the proposed research
    projects demonstrate an innovative approach and relate to the Research Areas of Interest
    identified in Section II.A.
    • Scientific Design Excellence: The degree to which proposed plans, methods, techniques and
    procedures are feasible, clear, valid, adequately referenced, and state-of-the-art. The merit of
    the statistical features of the study. The extent to which literature searches were used to
    document the strengths of the proposed project. For development of devices and
    technologies, the feasibility of the proposed prototype/technology development plan; how
    well the engineering/technical design is likely to achieve the goals indicated; adequacy of the
    engineering/design solutions; and how well the perceived engineering/design strengths and
    flaws are addressed.
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    • Impact/Outcomes: The potential impact of the research in the field, the significance of this
    impact, and when it can be anticipated. For development of devices and technologies, the
    potential translation, implementation, and/or commercial use for the prototype/technology
    being developed.
    • Budget: The degree to which the budget reflects the actual needs of the proposed work, is
    thoroughly detailed and fully justified so that the government can evaluate and determine the
    cost commensurate with the complexity and nature of the research proposed.
    • PI and Key Personnel Qualifications: The qualifications, capabilities, and experience of
    the proposed PI and other key personnel to demonstrate that the proposed staff has the
    knowledge, technical expertise, and management skills to achieve the proposed objectives as
    well as the time available for the percentage of efforts indicated for the project.
    • Facilities: The proposed facilities and equipment, or unique combinations of these, to
    demonstrate that the organization has the necessary facilities required for the accomplishing
    the proposed objectives.
    II.E.1.b. Programmatic Review
    To make funding recommendations and select the proposal(s)/application(s) that, individually or
    collectively, will best achieve the program objectives, the following criteria are used by
    programmatic reviewers:
    • Scientific peer review results
    • SOF Relevance (mission, health, medicine, and beneficiaries)
    • Portfolio balance
    • Programmatic priorities
    II.E.2. Proposal/Application Review and Selection Process
    All invited proposals are evaluated by USSOCOM scientists, other federal agency
    representatives, outside scientists with diverse expertise, clinicians, consumers, or combinations
    thereof, using a two-tier review process. The first tier is peer review of proposals against
    established criteria for determining technical merit. Each proposal/application is evaluated for
    its own merit, independent of other proposals. The second tier is a programmatic review that
    makes recommendations for funding, based on established criteria for determining relevance to
    the mission of the USSOCOM and its programs. Programmatic review is a comparison-based
    process in which proposals with scientific and technical merit compete in a common pool. The
    highest-scoring proposals from the first tier of review are not automatically recommended for
    funding. Funding recommendations depend on various factors as described in Section II.E.
    Programmatic Review.
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    After the two-tier evaluation, proposals recommended for funding may be prioritized. A
    prioritized listing of alternates (deferred decisions) may also be prepared, when warranted.
    Subsequent awards depend upon the availability of funds and fulfillment of requirements and
    priorities determined to exist at the time of award. In some cases, funding priorities may change
    as certain scientific tasks are addressed and new mission assignments arise.
    If selected for funding, the award may also be dependent upon the organization providing
    adequate additional regulatory documentation, such as human subjects/anatomical
    substances/use of cadavers’ protocols and approvals, animal subjects’ protocols and approvals,
    and environmental information. The award may also be dependent upon additional supporting
    administrative and budgetary information.
    IAW FAR 35.016(e), “The primary basis for selecting proposals for acceptance shall be
    technical, importance to agency programs, and fund availability. Cost realism and
    reasonableness shall also be considered to the extent appropriate”.
    All USSOCOM review processes are conducted confidentially to maintain the integrity of the
    merit-based selection process. Panel members sign a statement that proposal/application and
    evaluation information will not be disclosed outside the panel. Violations of confidentiality can
    result in the dissolving of a panel(s) and other corrective actions. In addition, personnel at the
    Applicant or collaborating organizations are prohibited from contacting persons involved in the
    review and approval process to gain protected evaluation information or to influence the
    evaluation process. Violations of these prohibitions will result in the administrative withdrawal
    of the organization’s proposal/application. Violations by panel members or applicants that
    compromise the confidentiality of the review and approval process may also result in suspension
    or debarment from federal awards. Furthermore, the unauthorized disclosure of confidential
    information of one party to another third party is a crime in accordance with 18 USC 1905.
    II.E.3. Integrity and Performance Information
    Prior to making an award where the Federal share is expected to exceed the simplified
    acquisition threshold (currently $250,000) over the period of performance, the Federal awarding
    agency is required to review and consider any information about the applicant that is available in
    the SAM.gov Responsibility/Qualification (R/Q).
    An applicant organization may review R/Q, accessible through SAM, and submit comments to
    R/Q on any information about the organization that a Federal awarding agency previously
    entered and is currently available in R/Q.
    The Federal awarding agency will consider any comments by the applicant, in addition to other
    information in the designated integrity and performance system, in making a judgment about the
    applicant’s integrity, business ethics, and record of performance under Federal awards when
    determining an organization’s qualification prior to award, according to the qualification
    standards of the FAR.
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    II.E.4. Anticipated Announcement and Federal Award Dates
    Each PI and organization will receive email notification via eBRAP of the funding
    recommendation. Notifications should be sent within 180 days of submission. Each PI will
    receive a peer review summary statement on the strengths and weaknesses of the
    proposal/application.
    II.F. Federal Award Administration Information
    II.F.1. Federal Award Notices
    The PI should receive disposition regarding the full proposal/application via an email from
    eBRAP within 180 days of submission. A recommended for funding notification is NOT an
    authorization to begin performance nor a guarantee of an award.
    The awarding agency will be the USAMRAA. The USAMRAA Contracting Officers are the
    only individuals authorized to obligate funds and bind the Federal Government.
    Authorization to begin performance will be received via an award document (contract,) signed
    by the USAMRAA Contracting Officer. No commitment on the part of the Government should
    be inferred from discussions with any other individual.
    Awards will be made at any time throughout the year and are contingent upon availability of
    funding, adequacy of supporting documentation submitted, fulfillment of requirements, and
    completion of successful negotiations. No proposal/application submitted under this BAA will
    be considered for funding after 24 months from the date of submission to Grants.gov.
    Refer to the General Submission Instructions, Appendix 2, Section D, Award Notices, for
    additional information. Refer to the full text of the USAMRAA General Research Terms and
    Conditions for Institutions of Higher Education, Hospitals, and Non-Profit Organizations and the
    USAMRAA General Research Terms and Conditions for For-Profit Organizations available at
    http://www.usamraa.army.mil/Pages/Resources.aspx for further information.
    II.F.1.a. PI Changes and Award Transfers
    Refer to the General Submission Instructions, Appendix 2 for general information on changes to
    PIs and organizational transfers.
    Should the PI of a funded project leave the award organization, both the PI and organization
    must contact the USAMRAA Contracting Officer as soon as possible to discuss options for
    continued support of the research project. Every effort should be made to notify the USAMRAA
    prior to the PI leaving the organization. An organizational transfer of an Assistance Agreement
    award will not be allowed in the last year of the (original) period of performance or any
    extension thereof. An organizational transfer of a Contract award will not be allowed.
    II.F.2. Administrative and National Policy Requirements
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    45

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    Applicable requirements in the FAR, found in 48 CFR, Chapter 1, DFARS, found in 48 CFR
    Chapter 2, and AFARS, found in 48 CFR Chapter 51, apply to contracts resulting from this
    BAA.
    Refer to the General Submission Instructions, Appendix 2, for general information regarding
    administrative requirements.
    Refer to the General Submission Instructions, Appendix 5, for general information regarding
    national policy requirements.
    Refer to full text of the USAMRAA General Research Terms and Conditions with Institutions of
    Higher Education, Hospitals, and Non-Profit Organizations: Addendum to the DoD R&D Terms
    and Conditions and the USAMRAA General Research Terms and Conditions with For-Profit
    Organizations for further information.
    II.F.3. Reporting
    Refer to the General Submission Instructions, Appendix 2, Section A, for general information on
    reporting requirements. If there are technical reporting requirement delinquencies for any
    existing USSOCOM-sponsored awards at the applicant organization, no new awards will be
    issued to the applicant organization until all delinquent reports have been submitted.
    technical progress reports and quad charts will be required with frequency determined at the
    contract level.
    • quad charts including:
    ○ Objective, measurable, and easily independently verifiable assessment of metrics to
    measure progress regarding project cost, schedule, performance, risk, and opportunity.
    ○ Risk and opportunity assessment of project cost, schedule, and performance. Risk
    assessments will use objective, measurable, and easily independently verifiable metrics;
    mitigation plans; triggering event; latest potential successful mitigation date; and impacts
    of unmitigated risks. Opportunity assessments will use objective, measurable and easily
    independently verifiable metrics; exploitation plans; triggering event; latest potential
    successful exploitation; and impact of successful opportunity exploitation.
    ○ Integrated project Gantt chart with all progress to date, supported by the cost,
    performance, risk, and opportunity assessments.
    ○ Budget chart with burn rate, demonstrating funding expended against time, funds
    remaining, and planned expense plan through the rest of the project schedule against
    planned milestones.
    • technical reports including the following:
    ○ Full description of architecture and content of new interoperable component, description
    of scenarios developed, results and method of pilot study.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    46

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    ○ A report, document, or list of the terminology and respective definitions used for the
    variables, metrics, and evaluation criteria and how they were deconstructed. It must
    provide the measuring tools and, if needed, how they were used to obtain the
    metric/evaluation criteria. Objective measurements are preferred, but subjective
    measurements that have rigorous reliability, repeatability, and robustness will be
    considered.
    ○ Explanation, including definitions and descriptions, of TRIAGE determinants of
    performance and agility. A report or document with the information and analyzed data of
    the actual postulated variables, metrics, and evaluation criteria.
    ○ Analyzed pilot study data and the specific aims, methodologies, sample and sample size,
    inter-rater reliability, assessment criteria, statistical methods, analyzed results,
    conclusions, and potential next-step recommendations.
    ○ Completion of preliminary/pilot empirical evaluation of the developed proof-of-concept;
    ○ A description of the components of the proof-of-concept that are proprietary and ones
    that are open source/open architecture. Explanation of Government rights and/or
    proposed pricing structure to the Government (if applicable).
    ○ Documentation of the translational parameters and the respective definitions (if
    applicable).
    ○ Description of the gaps that were uncovered during this research as it pertains to the
    success or improvement measured and an outline of anticipated next steps or
    recommendations.
    II.G. Federal Awarding Agency Contacts
    II.G.1. eBRAP Help Desk
    Questions related to BAA content or submission requirements as well as questions related to the
    submission of the pre-proposal/pre-application through eBRAP should be directed to the eBRAP
    Help Desk, which is available Monday through Friday from 8:00 a.m. to 5:00 p.m. Eastern Time.
    Response times may vary depending upon the volume of inquiries.
    Phone: 301-682-5507
    Email: help@eBRAP.org
    II.G.2. Grants.gov Contact Center
    Questions related to extramural full proposal/application submission through the Grants.gov
    portal should be directed to the Grants.gov Contact Center, which is available 24 hours a day, 7
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    47

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    days a week (closed on U.S. federal holidays). Note that the eBRAP Help Desk is unable to
    provide technical assistance with Grants.gov submission.
    Phone: 800-518-4726; International 1-606-545-5035
    Email: support@grants.gov
    Sign up on Grants.gov for “send me change notification emails” by following the link on the
    Synopsis page for the BAA or by responding to the prompt provided by Grants.gov when first
    downloading the submission package. If the submission package is updated or changed, the
    original version of the Application package may not be accepted by Grants.gov.
    II.H. Other Information
    II.H.1. Administrative Actions
    After agency receipt of pre-proposals or proposals, the following administrative actions may
    occur:
    II.H.1.a. Rejection
    The following will result in administrative rejection of the pre-proposal/pre-application:
    • Project narrative exceeds page limit.
    • Project narrative is missing.
    • Budget form contains only zeros.
    • Quad Chart is missing.
    The following will result in administrative rejection of the proposal/application:
    • Submission of an application for which a letter of invitation was not received.
    • Project Narrative exceeds page limit.
    • Project Narrative is missing.
    • Budget is missing.
    II.H.1.b. Modification
    • Pages exceeding the specific limits will be removed prior to review for all documents other
    than the pre-proposal narrative and project narrative.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    48

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    • Documents not requested will be removed.
    • Following proposal/application submission to Grants.gov, the PI will receive an email
    request from eBRAP to review, modify, and verify the proposal/application submitted to
    Grants.gov. During this verification period, the PI may upload missing documents (refer to
    II.H.I.a, rejection), replace files, and re-categorize files. These modifications must be
    completed by the end of the application verification period; otherwise, the
    proposal/application will be reviewed as submitted
    II.H.1.c. Withdrawal
    The following may result in administrative withdrawal of the pre-proposal/pre-application or
    proposal/application:
    • Federal agency personnel involved in the review process and/or with making funding
    recommendations are named as being involved in the research proposed or found to
    have assisted in the pre-proposal/pre-application or proposal/application processes,
    including, but not limited to, concept design, proposal/application development, budget
    preparation, and the development of any supporting documentation. If formal
    collaboration with Military Facility personnel is planned (i.e., included in the
    proposal/application in performance of the research), this prohibition is not
    applicable. However, these Military Facility personnel are prohibited from being
    involved in the review process and/or with making funding recommendations.
    • Inclusion of URLs, with the exception of links in References Cited and Publication
    and/or Patent Abstract sections.
    • Page size is larger than 8.5 inches x 11.0 inches (approximately 21.59 cm x 27.94 cm).
    • Personnel from applicant or collaborating organizations are found to have contacted
    persons involved in the review process to gain protected evaluation information or to
    influence the evaluation process.
    • Full proposals from extramural organizations, including non-DoD Federal agencies,
    received through eBRAP may be withdrawn.
    • The full proposal/application does not propose the same research project as described in
    the pre-proposal/pre-application.
    • The full proposal/application budget differs significantly from the budget included in
    the pre-proposal/pre-application.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    49

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    • A proposal submitted by a PI who does not meet the eligibility criteria will be
    withdrawn.
    II.H.1.d. Withhold
    Proposals that appear to involve research misconduct will be administratively withheld from
    further consideration pending organizational investigation. The organization will be required to
    provide the findings of the investigation to the USAMRAA Contracting
    Officer for a determination of the final disposition of the proposal/application.
    II.H.2. Proposal/Application Submission Checklist
    Grants.gov Submission Upload
    Action Completed
    Package Components Order
    SF-424 (R&R)
    Application for Federal Complete as instructed.
    Assistance
    Project Narrative: Upload as Attachment 1 with file name
    1
    “ProjectNarrative.pdf.”
    Supporting Documentation: Upload as Attachment 2 with
    2
    file name “Support.pdf.”
    Technical Abstract: Upload as Attachment 3 with file
    3
    name “TechAbs.pdf.”
    Lay Abstract: Upload as Attachment 4 with file name
    4
    “LayAbs.pdf.”
    Statement of Work: Upload as Attachment 5 with file
    5
    name “SOW.pdf.
    Outcomes and Impact Statement: Upload as Attachment 6
    6
    with file name “Impact.pdf.”
    Attachments Form
    Innovation Statement: Upload as Attachment 7 with file
    7
    name “Innovation.pdf.”
    Data and Research Resource-Sharing Plan: Upload as
    8
    Attachment 8 with the file name “Sharing.pdf.”
    Conflicts of Interest: Upload as Attachment 9 with file
    9
    name “COI.pdf,” if applicable.
    Data Management: Upload as Attachment 10 with file
    10
    name “DataManage.pdf.”
    Post-Award Project Transition Plan: Upload as Attachment
    11
    11 with file name “Transition.pdf.”
    Collaborating DoD Military Facility Budget
    12 Form(s): Upload as Attachment 12 with the file
    name “MFBudget.pdf,” if applicable.
    Research & Related Complete as instructed.
    Personal Data
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    50

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    [Document continues — 2 more pages]

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    HT9425-23-S-SOC1-0002 Sample Clause List

    DOCUMENT NUMBER SPECIAL NOTICE
    HT9425-23-S-SOC1 SAMPLE CLAUSE LIST
    CLAUSES INCORPORATED BY REFERENCE
    CLAUSE ALT NO/ YEAR-
    CLAUSE TITLE SECTION
    NO DEV NO MO
    252.201-7000 Contracting Officer's Representative. 1991-12 SEC G
    Requirements Relating to Compensation of Former DoD
    252.203-7000 2011-09 SEC I
    Officials.
    252.203-7002 Requirement to Inform Employees of Whistleblower Rights. 2013-09 SEC I
    Payment for Contract Line or Subline Items Not Separately
    252.204-7002 2020-04 SEC G
    Priced.
    252.204-7003 Control of Government Personnel Work Product. 1992-04 SEC I
    252.204-7004 Antiterrorism Awareness Training for Contractors. 2019-02 SEC I
    Safeguarding Covered Defense Information and Cyber
    252.204-7012 2019-12 SEC I
    Incident Reporting.
    Notice of Authorized Disclosure of Information for Litigation
    252.204-7015 2016-05 SEC I
    Support.
    Prohibition on the Acquisition of Covered Defense
    252.204-7018 2021-01 SEC I
    Telecommunications Equipment or Services.
    Prohibition on Storage, Treatment, and Disposal of Toxic or
    252.223-7006 2014-09 SEC I
    Hazardous Materials.
    252.225-7001 Buy American and Balance of Payments Program. Qualifying 2017-12 SEC I
    252.225-7002 Country Sources as Subcontractors. 2017-12 SEC I
    252.225-7048 Export-Controlled Items. 2013-06 SEC I
    252.227-7015 Technical Data--Commercial Items. 2014-02 SEC I
    252.227-7016 Rights in Bid or Proposal Information. 2011-01 SEC I
    252.227-7020 Rights in Special Works. 1995-06 SEC I
    252.227-7030 Technical Data--Withholding of Payment. 2000-03 SEC I
    252.227-7037 Validation of Restrictive Markings on Technical Data. 2016-09 SEC I
    252.227-7039 Patents--Reporting of Subject Inventions. 1990-04 SEC I
    Electronic Submission of Payment Requests and Receiving
    252.232-7003 2018-12 SEC G
    Reports.
    252.232-7010 Levies on Contract Payments. 2006-12 SEC I
    Accelerating Payments to Small Business Subcontractors-
    252.232-7017 2020-04 SEC I
    Prohibition on Fees and Consideration.
    252.235-7011 Final Scientific or Technical Report. 2019-12 SEC I
    Prohibition on Interrogation of Detainees by Contractor
    252.237-7010 2013-06 SEC I
    Personnel.
    252.243-7001 Pricing of Contract Modifications. 1991-12 SEC I
    252.244-7000 Subcontracts for Commercial Items. 2020-10 SEC I
    Prohibition on Requiring Certain Internal Confidentiality
    52.203-19 2017-01 SEC I
    Agreements or Statements.
    52.204-13 System for Award Management Maintenance. Incorporation 2018-10 SEC I
    by Reference of Representations and Certifications.
    52.204-19 2014-12 SEC I
    Prohibition on Contracting for Hardware, Software, and
    Services Developed or Provided by Kaspersky Lab and Other
    52.204-23 Covered Entities. 2018-07 SEC I
    Prohibition on Contracting for Certain Telecommunications
    and Video Surveillance Services or Equipment.
    52.204-25 2020-08 SEC I
    Personal Identity Verification of Contractor Personnel.
    52.204-9 Prohibition on Contracting with Inverted Domestic 2011-01 SEC I
    Corporations.
    52.209-10 2015-11 SEC I
    Order of Precedence-Uniform Contract Format.
    52.215-8 1997-10 SEC I
    Page 1 of 29

    ---

    52.222-21 Prohibition of Segregated Facilities. 2015-04 SEC I
    52.222-26 Equal Opportunity. 2016-09 SEC I
    52.222-50 Combating Trafficking in Persons. 2020-10 SEC I
    Exemption from Application of the Service Contract Labor
    52.222-51 Standards to Contracts for Maintenance, Calibration, or Repair 2014-05 SEC I
    of Certain Equipment-Requirements.
    Exemption from Application of the Service Contract Labor
    52.222-53 2014-05 SEC I
    Standards to Contracts for Certain Services-Requirements.
    Encouraging Contractor Policies to Ban Text Messaging While
    52.223-18 2020-06 SEC I
    Driving.
    52.223-19 Compliance with Environmental Management Systems. 2011-05 SEC I
    52.223-5 Pollution Prevention and Right-to-Know Information. 2011-05 SEC I
    52.225-13 Restrictions on Certain Foreign Purchases. 2021-02 SEC I
    52.230-2 Cost Accounting Standards. 2020-06 SEC I
    52.230-6 Administration of Cost Accounting Standards. 2010-06 SEC I
    Payment by Electronic Funds Transfer-System for Award
    52.232-33 2018-10 SEC I
    Management.
    52.232-39 Unenforceability of Unauthorized Obligations. 2013-06 SEC I
    Providing Accelerated Payments to Small Business
    52.232-40 2013-12 SEC I
    Subcontractors.
    52.233-1 Disputes. 2014-05 SEC I
    52.233-3 Protest after Award. 1996-08 SEC I
    52.233-4 Applicable Law for Breach of Contract Claim. 2004-10 SEC I
    52.242-15 Stop-Work Order. 1989-08 SEC F
    52.243-1 ALT I Changes-Fixed-Price. - (Alternate I) 1987-08 SEC I
    52.243-1 ALT V Changes-Fixed-Price. - (Alternate V) 1987-08 SEC I
    52.244-6 Subcontracts for Commercial Items. 2021-07 SEC I
    52.246-9 Inspection of Research and Development (Short Form). 1984-04 SEC E
    52.247-34 F.o.b. Destination. 1991-11 SEC F
    Termination for Convenience of the Government (Fixed-Price)
    52.249-1 1984-04 SEC I
    (Short Form).
    Notice of Price Evaluation Preference for HUBZone Small
    52.219-4 2021-09 SEC I
    Business Concerns.
    Ensuring Adequate COVID-19 Safety Protocols for Federal
    252.223-7999 DEV 2021-O0009 2021-10 SEC I
    Contractors (Deviation 2021-O0009)
    252.245-7005 Management and Reporting of Government Property 2024-01 SEC I
    252.225-7060 Prohibition on Certain Procurements from the Xinjiang 2023-06 SEC I
    Uyghur Autonomous Region
    CLAUSES IN FULL TEXT
    CLAUSE ALT NO/ YEAR-
    CLAUSE TITLE
    NO DEV NO MO
    CLAUSE TEXT
    52.232-1 Payments. 1984-04
    As prescribed in 32.111(a)(1), insert the following clause, appropriately modified with respect to
    payment due date in accordance with agency regulations, in solicitations and contracts when a fixed-
    price supply contract, a fixed-price service contract, or a contract for nonregulated communication
    services is contemplated:
    Payments (APR 1984)
    The Government shall pay the Contractor, upon the submission of proper invoices or vouchers, the
    prices stipulated in this contract for supplies delivered and accepted or services rendered and accepted,
    less any deductions provided in this contract. Unless otherwise specified in this contract, payment shall
    be made on partial deliveries accepted by the Government if-
    (a) The amount due on the deliveries warrants it; or
    Page 2 of 29

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    (b) The Contractor requests it and the amount due on the deliveries is at least $1,000 or 50 percent
    of the total contract price.
    (End of clause)
    52.232-11 Extras. 1984-04
    As prescribed in 32.111(c)(2), insert the following clause, appropriately modified with respect to
    payment due dates in accordance with agency regulations, in solicitations and contracts when a fixed-
    price supply contract, fixed-price service contract, or transportation contract is contemplated:
    Extras (APR 1984)
    Except as otherwise provided in this contract, no payment for extras shall be made unless such extras
    and the price therefor have been authorized in writing by the Contracting Officer.
    (End of clause)
    Payments under Fixed-Price Research and Development
    52.232-2 1984-04
    Contracts.
    As prescribed in 32.111(a)(2), insert the following clause, as appropriately modified with respect to
    payment due dates in accordance with agency regulations, in solicitations and contracts when a fixed-
    price research and development contract is contemplated:
    Payments under Fixed-Price Research and Development Contracts (APR 1984)
    The Government shall pay the Contractor, upon submission of proper invoices or vouchers, the prices
    stipulated in this contract for work delivered or rendered and accepted, less any deductions provided in
    this contract. Unless otherwise specified, payment shall be made upon acceptance of any portion of the
    work delivered or rendered for which a price is separately stated in the contract.
    (End of clause)
    52.232-25 Prompt Payment. 2017-01
    As prescribed in 32.908(c), insert the following clause:
    Prompt Payment (JAN 2017)
    Notwithstanding any other payment clause in this contract, the Government will make invoice
    payments under the terms and conditions specified in this clause. The Government considers payment as
    being made on the day a check is dated or the date of an electronic funds transfer (EFT). Definitions of
    pertinent terms are set forth in sections 2.101, 32.001, and 32.902 of the Federal Acquisition Regulation.
    All days referred to in this clause are calendar days, unless otherwise specified. (However, see paragraph
    (a)(4) of this clause concerning payments due on Saturdays, Sundays, and legal holidays.)
    Page 3 of 29

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    (a) Invoice payments-(1) Due date.(i) Except as indicated in paragraphs (a)(2) and (c) of this
    clause, the due date for making invoice payments by the designated payment office is the later of the
    following two events:
    (A) The 30 thday after the designated billing office receives a proper invoice from the
    Contractor (except as provided in paragraph (a)(1)(ii) of this clause).
    (B) The 30 thday after Government acceptance of supplies delivered or services
    performed. For a final invoice, when the payment amount is subject to contract settlement actions,
    acceptance is deemed to occur on the effective date of the contract settlement.
    (ii) If the designated billing office fails to annotate the invoice with the actual date of
    receipt at the time of receipt, the invoice payment due date is the 30 thday after the date of the
    Contractor’s invoice, provided the designated billing office receives a proper invoice and there is no
    disagreement over quantity, quality, or Contractor compliance with contract requirements.
    (2) Certain food products and other payments.(i) Due dates on Contractor invoices for meat,
    meat food products, or fish; perishable agricultural commodities; and dairy products, edible fats or oils,
    and food products prepared from edible fats or oils are-
    (A) For meat or meat food products, as defined in section 2(a)(3) of the Packers and
    Stockyard Act of1921 (7 U.S.C.182(3)), and as further defined in Pub.L.98-181, including any edible
    fresh or frozen poultry meat, any perishable poultry meat food product, fresh eggs, and any perishable
    egg product, as close as possible to, but not later than, the 7 thday after product delivery.
    (B) For fresh or frozen fish, as defined in section 204(3) of the Fish and Seafood
    Promotion Act of1986 (16 U.S.C.4003(3)), as close as possible to, but not later than, the 7 thday after
    product delivery.
    (C) For perishable agricultural commodities, as defined in section 1(4) of the Perishable
    Agricultural Commodities Act of1930 (7 U.S.C.499a(4)), as close as possible to, but not later than, the
    10 thday after product delivery, unless another date is specified in the contract.
    (D) For dairy products, as defined in section 111(e) of the Dairy Production Stabilization
    Act of1983 (7 U.S.C.4502(e)), edible fats or oils, and food products prepared from edible fats or oils, as
    close as possible to, but not later than, the 10 thday after the date on which a proper invoice has been
    received. Liquid milk, cheese, certain processed cheese products, butter, yogurt, ice cream, mayonnaise,
    salad dressings, and other similar products, fall within this classification. Nothing in the Act limits this
    classification to refrigerated products. When questions arise regarding the proper classification of a
    specific product, prevailing industry practices will be followed in specifying a contract payment due
    date. The burden of proof that a classification of a specific product is, in fact, prevailing industry practice
    is upon the Contractor making the representation.
    (ii) If the contract does not require submission of an invoice for payment (e.g., periodic
    lease payments), the due date will be as specified in the contract.
    (3) Contractor's invoice. The Contractor shall prepare and submit invoices to the designated
    billing office specified in the contract. A proper invoice must include the items listed in paragraphs (a)(3)
    (i) through (a)(3)(x) of this clause. If the invoice does not comply with these requirements, the
    designated billing office will return it within 7 days after receipt (3 days for meat, meat food products, or
    fish; 5 days for perishable agricultural commodities, dairy products, edible fats or oils, and food products
    prepared from edible fats or oils), with the reasons why it is not a proper invoice. The Government will
    take into account untimely notification when computing any interest penalty owed the Contractor.
    (i) Name and address of the Contractor.
    (ii) Invoice date and invoice number. (The Contractor should date invoices as close as
    possible to the date of the mailing or transmission.)
    Page 4 of 29

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    (iii) Contract number or other authorization for supplies delivered or services performed
    (including order number and line item number).
    (iv) Description, quantity, unit of measure, unit price, and extended price of supplies
    delivered or services performed.
    (v) Shipping and payment terms (e.g., shipment number and date of shipment, discount for
    prompt payment terms). Bill of lading number and weight of shipment will be shown for shipments on
    Government bills of lading.
    (vi) Name and address of Contractor official to whom payment is to be sent (must be the
    same as that in the contract or in a proper notice of assignment).
    (vii) Name (where practicable), title, phone number, and mailing address of person to notify
    in the event of a defective invoice.
    (viii) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the
    invoice only if required elsewhere in this contract.
    (ix) Electronic funds transfer (EFT) banking information.
    (A) The Contractor shall include EFT banking information on the invoice only if
    required elsewhere in this contract.
    (B) If EFT banking information is not required to be on the invoice, in order for the
    invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in
    accordance with the applicable solicitation provision (e.g., 52.232-38, Submission of Electronic Funds
    Transfer Information with Offer), contract clause (e.g., 52.232-33, Payment by Electronic Funds
    Transfer-System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer-Other
    Than System for Award Management), or applicable agency procedures.
    (C) EFT banking information is not required if the Government waived the requirement
    to pay by EFT.
    (x) Any other information or documentation required by the contract (e.g., evidence of
    shipment).
    (4) Interest penalty. The designated payment office will pay an interest penalty automatically,
    without request from the Contractor, if payment is not made by the due date and the conditions listed in
    paragraphs (a)(4)(i) through (a)(4)(iii) of this clause are met, if applicable. However, when the due date
    falls on a Saturday, Sunday, or legal holiday, the designated payment office may make payment on the
    following working day without incurring a late payment interest penalty.
    (i) The designated billing office received a proper invoice.
    (ii) The Government processed a receiving report or other Government documentation
    authorizing payment, and there was no disagreement over quantity, quality, or Contractor compliance
    with any contract term or condition.
    (iii) In the case of a final invoice for any balance of funds due the Contractor for supplies
    delivered or services performed, the amount was not subject to further contract settlement actions
    between the Government and the Contractor.
    (5) Computing penalty amount. The Government will compute the interest penalty in
    accordance with the Office of Management and Budget prompt payment regulations at 5 CFR Part 1315.
    Page 5 of 29

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    (i) For the sole purpose of computing an interest penalty that might be due the Contractor,
    Government acceptance is deemed to occur constructively on the 7 thday (unless otherwise specified in
    this contract) after the Contractor delivers the supplies or performs the services in accordance with the
    terms and conditions of the contract, unless there is a disagreement over quantity, quality, or Contractor
    compliance with a contract provision. If actual acceptance occurs within the constructive acceptance
    period, the Government will base the determination of an interest penalty on the actual date of
    acceptance. The constructive acceptance requirement does not, however, compel Government officials to
    accept supplies or services, perform contract administration functions, or make payment prior to
    fulfilling their responsibilities.
    (ii) The prompt payment regulations at 5 CFR1315.10(c) do not require the Government to
    pay interest penalties if payment delays are due to disagreement between the Government and the
    Contractor over the payment amount or other issues involving contract compliance, or on amounts
    temporarily withheld or retained in accordance with the terms of the contract. The Government and the
    Contractor shall resolve claims involving disputes and any interest that may be payable in accordance
    with the clause at FAR 52.233-1, Disputes.
    (6) Discounts for prompt payment. The designated payment office will pay an interest penalty
    automatically, without request from the Contractor, if the Government takes a discount for prompt
    payment improperly. The Government will calculate the interest penalty in accordance with the prompt
    payment regulations at 5 CFR Part 1315.
    (7) Additional interest penalty.(i) The designated payment office will pay a penalty amount,
    calculated in accordance with the prompt payment regulations at 5 CFR Part 1315 in addition to the
    interest penalty amount only if-
    (A) The Government owes an interest penalty of $1 or more;
    (B) The designated payment office does not pay the interest penalty within 10 days after
    the date the invoice amount is paid; and
    (C) The Contractor makes a written demand to the designated payment office for
    additional penalty payment, in accordance with paragraph (a)(7)(ii) of this clause, postmarked not later
    than 40 days after the invoice amount is paid.
    (ii) (A) The Contractor shall support written demands for additional penalty payments with the
    following data. The Government will not request any additional data. The Contractor shall-
    (1) Specifically assert that late payment interest is due under a specific invoice, and
    request payment of all overdue late payment interest penalty and such additional penalty as may be
    required;
    (2) Attach a copy of the invoice on which the unpaid late payment interest is due; and
    (3) State that payment of the principal has been received, including the date of receipt.
    (B) If there is no postmark or the postmark is illegible-
    (1) The designated payment office that receives the demand will annotate it with the
    date of receipt, provided the demand is received on or before the 40th day after payment was made; or
    (2) If the designated payment office fails to make the required annotation, the
    Government will determine the demand’s validity based on the date the Contractor has placed on the
    demand, provided such date is no later than the 40th day after payment was made.
    (iii) The additional penalty does not apply to payments regulated by other Government
    regulations (e.g., payments under utility contracts subject to tariffs and regulation).
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    (b) Contract financing payment. If this contract provides for contract financing, the Government
    will make contract financing payments in accordance with the applicable contract financing clause.
    (c) Fast payment procedure due dates. If this contract contains the clause at 52.213-1, Fast
    Payment Procedure, payments will be made within 15 days after the date of receipt of the invoice.
    (d) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice
    payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the
    Contractor shall-
    (1) Remit the overpayment amount to the payment office cited in the contract along with a
    description of the overpayment including the-
    (i) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment,
    liquidation errors, date(s) of overpayment);
    (ii) Affected contract number and delivery order number if applicable;
    (iii) Affected line item or subline item, if applicable; and
    (iv) Contractor point of contact.
    (2) Provide a copy of the remittance and supporting documentation to the Contracting Officer.
    (End of clause)
    52.232-8 Discounts for Prompt Payment. 2002-02
    As prescribed in 32.111(b)(1), insert the following clause:
    Discounts for Prompt Payment (FEB 2002)
    (a) Discounts for prompt payment will not be considered in the evaluation of offers. However, any
    offered discount will form a part of the award, and will be taken if payment is made within the discount
    period indicated in the offer by the offeror. As an alternative to offering a discount for prompt payment
    in conjunction with the offer, offerors awarded contracts may include discounts for prompt payment on
    individual invoices.
    (b) In connection with any discount offered for prompt payment, time shall be computed from the
    date of the invoice. If the Contractor has not placed a date on the invoice, the due date shall be calculated
    from the date the designated billing office receives a proper invoice, provided the agency annotates such
    invoice with the date of receipt at the time of receipt. For the purpose of computing the discount earned,
    payment shall be considered to have been made on the date that appears on the payment check or, for an
    electronic funds transfer, the specified payment date. When the discount date falls on a Saturday,
    Sunday, or legal holiday when Federal Government offices are closed and Government business is not
    expected to be conducted, payment may be made on the following business day.
    (End of clause)
    252.227-7013 Rights in Technical Data--Noncommercial Items. 2014-02
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    As prescribed in 227.7103-6(a), use the following clause:
    RIGHTS IN TECHNICAL DATA--NONCOMMERCIAL ITEMS (FEB 2014)
    (a) Definitions. As used in this clause-
    (1) "Computer data base" means a collection of data recorded in a form capable of being
    processed by a computer. The term does not include computer software.
    (2) "Computer program" means a set of instructions, rules, or routines recorded in a form that
    is capable of causing a computer to perform a specific operation or series of operations.
    (3) "Computer software" means computer programs, source code, source code listings, object
    code listings, design details, algorithms, processes, flow charts, formulae and related material that would
    enable the software to be reproduced, recreated, or recompiled. Computer software does not include
    computer data bases or computer software documentation.
    (4) "Computer software documentation" means owner's manuals, user's manuals, installation
    instructions, operating instructions, and other similar items, regardless of storage medium, that explain
    the capabilities of the computer software or provide instructions for using the software.
    (5) "Covered Government support contractor" means a contractor (other than a litigation
    support contractor covered by 252.204-7014) under a contract, the primary purpose of which is to furnish
    independent and impartial advice or technical assistance directly to the Government in support of the
    Government's management and oversight of a program or effort (rather than to directly furnish an end
    item or service to accomplish a program or effort), provided that the contractor-
    (i) Is not affiliated with the prime contractor or a first-tier subcontractor on the program
    or effort, or with any direct competitor of such prime contractor or any such first-tier subcontractor in
    furnishing end items or services of the type developed or produced on the program or effort; and
    (ii) Receives access to technical data or computer software for performance of a
    Government contract that contains the clause at 252.227-7025, Limitations on the Use or Disclosure of
    Government-Furnished Information Marked with Restrictive Legends.
    (6) "Detailed manufacturing or process data" means technical data that describe the steps,
    sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to
    produce an item or component or to perform a process.
    (7) "Developed" means that an item, component, or process exists and is workable. Thus, the
    item or component must have been constructed or the process practiced. Workability is generally
    established when the item, component, or process has been analyzed or tested sufficiently to demonstrate
    to reasonable people skilled in the applicable art that there is a high probability that it will operate as
    intended. Whether, how much, and what type of analysis or testing is required to establish workability
    depends on the nature of the item, component, or process, and the state of the art. To be considered
    "developed," the item, component, or process need not be at the stage where it could be offered for sale
    or sold on the commercial market, nor must the item, component, or process be actually reduced to
    practice within the meaning of Title 35 of the United States Code.
    (8) "Developed exclusively at private expense" means development was accomplished
    entirely with costs charged to indirect cost pools, costs not allocated to a government contract, or any
    combination thereof.
    (i) Private expense determinations should be made at the lowest practicable level.
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    (ii) Under fixed-price contracts, when total costs are greater than the firm-fixed-price or
    ceiling price of the contract, the additional development costs necessary to complete development shall
    not be considered when determining whether development was at government, private, or mixed expense.
    (9) "Developed exclusively with government funds" means development was not
    accomplished exclusively or partially at private expense.
    (10) "Developed with mixed funding" means development was accomplished partially with
    costs charged to indirect cost pools and/or costs not allocated to a government contract, and partially
    with costs charged directly to a government contract.
    (11) "Form, fit, and function data" means technical data that describes the required overall
    physical, functional, and performance characteristics (along with the qualification requirements, if
    applicable) of an item, component, or process to the extent necessary to permit identification of
    physically and functionally interchangeable items.
    (12) "Government purpose" means any activity in which the United States Government is a
    party, including cooperative agreements with international or multi-national defense organizations, or
    sales or transfers by the United States Government to foreign governments or international organizations.
    Government purposes include competitive procurement, but do not include the rights to use, modify,
    reproduce, release, perform, display, or disclose technical data for commercial purposes or authorize
    others to do so.
    (13) "Government purpose rights" means the rights to-
    (i) Use, modify, reproduce, release, perform, display, or disclose technical data within the
    Government without restriction; and
    (ii) Release or disclose technical data outside the Government and authorize persons to
    whom release or disclosure has been made to use, modify, reproduce, release, perform, display, or
    disclose that data for United States government purposes.
    (14) "Limited rights" means the rights to use, modify, reproduce, release, perform, display, or
    disclose technical data, in whole or in part, within the Government. The Government may not, without
    the written permission of the party asserting limited rights, release or disclose the technical data outside
    the Government, use the technical data for manufacture, or authorize the technical data to be used by
    another party, except that the Government may reproduce, release, or disclose such data or authorize the
    use or reproduction of the data by persons outside the Government if-
    (i) The reproduction, release, disclosure, or use is-
    (A) Necessary for emergency repair and overhaul; or
    (B) A release or disclosure to-
    (1) A covered Government support contractor in performance of its covered
    Government support contract for use, modification, reproduction, performance, display, or release or
    disclosure to a person authorized to receive limited rights technical data; or
    (2) A foreign government, of technical data other than detailed manufacturing
    or process data, when use of such data by the foreign government is in the interest of the Government
    and is required for evaluational or informational purposes;
    (ii) The recipient of the technical data is subject to a prohibition on the further
    reproduction, release, disclosure, or use of the technical data; and
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    (iii) The contractor or subcontractor asserting the restriction is notified of such
    reproduction, release, disclosure, or use.
    (15) "Technical data" means recorded information, regardless of the form or method of the
    recording, of a scientific or technical nature (including computer software documentation). The term
    does not include computer software or data incidental to contract administration, such as financial and/or
    management information.
    (16) "Unlimited rights" means rights to use, modify, reproduce, perform, display, release, or
    disclose technical data in whole or in part, in any manner, and for any purpose whatsoever, and to have
    or authorize others to do so.
    (b) Rights in technical data. The Contractor grants or shall obtain for the Government the
    following royalty free, world-wide, nonexclusive, irrevocable license rights in technical data other than
    computer software documentation (see the Rights in Noncommercial Computer Software and
    Noncommercial Computer Software Documentation clause of this contract for rights in computer
    software documentation):
    (1) Unlimited rights. The Government shall have unlimited rights in technical data that are-
    (i) Data pertaining to an item, component, or process which has been or will be
    developed exclusively with Government funds;
    (ii) Studies, analyses, test data, or similar data produced for this contract, when the study,
    analysis, test, or similar work was specified as an element of performance;
    (iii) Created exclusively with Government funds in the performance of a contract that
    does not require the development, manufacture, construction, or production of items, components, or
    processes;
    (iv) Form, fit, and function data;
    (v) Necessary for installation, operation, maintenance, or training purposes (other than
    detailed manufacturing or process data);
    (vi) Corrections or changes to technical data furnished to the Contractor by the
    Government;
    (vii) Otherwise publicly available or have been released or disclosed by the Contractor or
    subcontractor without restrictions on further use, release or disclosure, other than a release or disclosure
    resulting from the sale, transfer, or other assignment of interest in the technical data to another party or
    the sale or transfer of some or all of a business entity or its assets to another party;
    (viii) Data in which the Government has obtained unlimited rights under another
    Government contract or as a result of negotiations; or
    (ix) Data furnished to the Government, under this or any other Government contract or
    subcontract thereunder, with-
    (A) Government purpose license rights or limited rights and the restrictive condition
    (s) has/have expired; or
    (B) Government purpose rights and the Contractor's exclusive right to use such data
    for commercial purposes has expired.
    (2) Government purpose rights.
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    (i) The Government shall have government purpose rights for a five-year period, or such
    other period as may be negotiated, in technical data-
    (A) That pertain to items, components, or processes developed with mixed funding
    except when the Government is entitled to unlimited rights in such data as provided in paragraphs (b)(1)
    (ii) and (b)(1)(iv) through (b)(1)(ix) of this clause; or
    (B) Created with mixed funding in the performance of a contract that does not
    require the development, manufacture, construction, or production of items, components, or processes.
    (ii) The five-year period, or such other period as may have been negotiated, shall
    commence upon execution of the contract, subcontract, letter contract (or similar contractual instrument),
    contract modification, or option exercise that required development of the items, components, or
    processes or creation of the data described in paragraph (b)(2)(i)(B) of this clause. Upon expiration of
    the five-year or other negotiated period, the Government shall have unlimited rights in the technical data.
    (iii) The Government shall not release or disclose technical data in which it has
    government purpose rights unless-
    (A) Prior to release or disclosure, the intended recipient is subject to the non-
    disclosure agreement at 227.7103-7 of the Defense Federal Acquisition Regulation Supplement
    (DFARS); or
    (B) The recipient is a Government contractor receiving access to the data for
    performance of a Government contract that contains the clause at DFARS 252.227-7025, Limitations on
    the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends.
    (iv) The Contractor has the exclusive right, including the right to license others, to use
    technical data in which the Government has obtained government purpose rights under this contract for
    any commercial purpose during the time period specified in the government purpose rights legend
    prescribed in paragraph (f)(2) of this clause.
    (3) Limited rights.
    (i) Except as provided in paragraphs (b)(1)(ii) and (b)(1)(iv) through (b)(1)(ix) of this
    clause, the Government shall have limited rights in technical data-
    (A) Pertaining to items, components, or processes developed exclusively at private
    expense and marked with the limited rights legend prescribed in paragraph (f) of this clause; or
    (B) Created exclusively at private expense in the performance of a contract that does
    not require the development, manufacture, construction, or production of items, components, or
    processes.
    (ii) The Government shall require a recipient of limited rights data for emergency repair
    or overhaul to destroy the data and all copies in its possession promptly following completion of the
    emergency repair/overhaul and to notify the Contractor that the data have been destroyed.
    (iii) The Contractor, its subcontractors, and suppliers are not required to provide the
    Government additional rights to use, modify, reproduce, release, perform, display, or disclose technical
    data furnished to the Government with limited rights. However, if the Government desires to obtain
    additional rights in technical data in which it has limited rights, the Contractor agrees to promptly enter
    into negotiations with the Contracting Officer to determine whether there are acceptable terms for
    transferring such rights. All technical data in which the Contractor has granted the Government
    additional rights shall be listed or described in a license agreement made part of the contract. The license
    shall enumerate the additional rights granted the Government in such data.
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    (iv) The Contractor acknowledges that-
    (A) Limited rights data are authorized to be released or disclosed to covered
    Government support contractors;
    (B) The Contractor will be notified of such release or disclosure;
    (C) The Contractor (or the party asserting restrictions as identified in the limited
    rights legend) may require each such covered Government support contractor to enter into a non-
    disclosure agreement directly with the Contractor (or the party asserting restrictions) regarding the
    covered Government support contractor's use of such data, or alternatively, that the Contractor (or party
    asserting restrictions) may waive in writing the requirement for a non-disclosure agreement; and
    (D) Any such non-disclosure agreement shall address the restrictions on the covered
    Government support contractor's use of the limited rights data as set forth in the clause at 252.227-7025,
    Limitations on the Use or Disclosure of Government- Furnished Information Marked with Restrictive
    Legends. The non-disclosure agreement shall not include any additional terms and conditions unless
    mutually agreed to by the parties to the non-disclosure agreement.
    (4) Specifically negotiated license rights. The standard license rights granted to the
    Government under paragraphs (b)(1) through (b)(3) of this clause, including the period during which the
    Government shall have government purpose rights in technical data, may be modified by mutual
    agreement to provide such rights as the parties consider appropriate but shall not provide the
    Government lesser rights than are enumerated in paragraph (a)(14) of this clause. Any rights so
    negotiated shall be identified in a license agreement made part of this contract.
    (5) Prior government rights. Technical data that will be delivered, furnished, or otherwise
    provided to the Government under this contract, in which the Government has previously obtained rights
    shall be delivered, furnished, or provided with the pre-existing rights, unless-
    (i) The parties have agreed otherwise; or
    (ii) Any restrictions on the Government's rights to use, modify, reproduce, release,
    perform, display, or disclose the data have expired or no longer apply.
    (6) Release from liability. The Contractor agrees to release the Government from liability for
    any release or disclosure of technical data made in accordance with paragraph (a)(14) or (b)(2)(iii) of this
    clause, in accordance with the terms of a license negotiated under paragraph (b)(4) of this clause, or by
    others to whom the recipient has released or disclosed the data and to seek relief solely from the party
    who has improperly used, modified, reproduced, released, performed, displayed, or disclosed Contractor
    data marked with restrictive legends.
    (c) Contractor rights in technical data. All rights not granted to the Government are retained by
    the Contractor.
    (d) Third party copyrighted data. The Contractor shall not, without the written approval of the
    Contracting Officer, incorporate any copyrighted data in the technical data to be delivered under this
    contract unless the Contractor is the copyright owner or has obtained for the Government the license
    rights necessary to perfect a license or licenses in the deliverable data of the appropriate scope set forth
    in paragraph (b) of this clause, and has affixed a statement of the license or licenses obtained on behalf
    of the Government and other persons to the data transmittal document.
    (e) Identification and delivery of data to be furnished with restrictions on use, release, or
    disclosure.
    (1) This paragraph does not apply to restrictions based solely on copyright.
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    (2) Except as provided in paragraph (e)(3) of this clause, technical data that the Contractor
    asserts should be furnished to the Government with restrictions on use, release, or disclosure are
    identified in an attachment to this contract (the Attachment). The Contractor shall not deliver any data
    with restrictive markings unless the data are listed on the Attachment.
    (3) In addition to the assertions made in the Attachment, other assertions may be identified
    after award when based on new information or inadvertent omissions unless the inadvertent omissions
    would have materially affected the source selection decision. Such identification and assertion shall be
    submitted to the Contracting Officer as soon as practicable prior to the scheduled date for delivery of the
    data, in the following format, and signed by an official authorized to contractually obligate the
    Contractor:
    Identification and Assertion of Restrictions on the Government's Use, Release,
    or Disclosure of Technical Data.
    The Contractor asserts for itself, or the persons identified below, that the Government's
    rights to use, release, or disclose the following technical data should be restricted-
    Technical Data Name of Person
    to be Furnished Basis for Asserted Rights Asserting
    With Restrictions Assertion Category Restrictions**
    ____(LIST) ____(LIST) ____(LIST) ____(LIST)
    *If the assertion is applicable to items, components, or processes developed at private
    expense, identify both the data and each such item, component, or process.
    **Generally, the development of an item, component, or process at private expense, either
    exclusively or partially, is the only basis for asserting restrictions on the Government's rights to use,
    release, or disclose technical data pertaining to such items, components, or processes. Indicate whether
    development was exclusively or partially at private expense. If development was not at private expense,
    enter the specific reason for asserting that the Government's rights should be restricted.
    *Enter asserted rights category (e.g., government purpose license rights from a prior
    contract, rights in SBIR data generated under another contract, limited or government purpose rights
    under this or a prior contract, or specifically negotiated licenses).
    **Corporation, individual, or other person, as appropriate.
    Date ____
    Printed Name and Title ____
    ____
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    Signature ____
    (End of identification and assertion)
    (4) When requested by the Contracting Officer, the Contractor shall provide sufficient
    information to enable the Contracting Officer to evaluate the Contractor's assertions. The Contracting
    Officer reserves the right to add the Contractor's assertions to the Attachment and validate any listed
    assertion, at a later date, in accordance with the procedures of the Validation of Restrictive Markings on
    Technical Data clause of this contract.
    (f) Marking requirements. The Contractor, and its subcontractors or suppliers, may only assert
    restrictions on the Government's rights to use, modify, reproduce, release, perform, display, or disclose
    technical data to be delivered under this contract by marking the deliverable data subject to restriction.
    Except as provided in paragraph (f)(5) of this clause, only the following legends are authorized under
    this contract: the government purpose rights legend at paragraph (f)(2) of this clause; the limited rights
    legend at paragraph (f)(3) of this clause; or the special license rights legend at paragraph (f)(4) of this
    clause; and/or a notice of copyright as prescribed under 17 U.S.C. 401 or 402.
    (1) General marking instructions. The Contractor, or its subcontractors or suppliers, shall
    conspicuously and legibly mark the appropriate legend on all technical data that qualify for such
    markings. The authorized legends shall be placed on the transmittal document or storage container and,
    for printed material, each page of the printed material containing technical data for which restrictions are
    asserted. When only portions of a page of printed material are subject to the asserted restrictions, such
    portions shall be identified by circling, underscoring, with a note, or other appropriate identifier.
    Technical data transmitted directly from one computer or computer terminal to another shall contain a
    notice of asserted restrictions. Reproductions of technical data or any portions thereof subject to asserted
    restrictions shall also reproduce the asserted restrictions.
    (2) Government purpose rights markings. Data delivered or otherwise furnished to the
    Government with government purpose rights shall be marked as follows:
    GOVERNMENT PURPOSE RIGHTS
    Contract No.
    ____
    Contractor Name
    ____
    Contractor Address
    ____
    ____
    Expiration Date
    ____
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    The Government's rights to use, modify, reproduce, release, perform, display, or disclose
    these technical data are restricted by paragraph (b)(2) of the Rights in Technical Data-Noncommercial
    Items clause contained in the above identified contract. No restrictions apply after the expiration date
    shown above. Any reproduction of technical data or portions thereof marked with this legend must also
    reproduce the markings.
    (End of legend)
    (3) Limited rights markings. Data delivered or otherwise furnished to the Government with
    limited rights shall be marked with the following legend:
    LIMITED RIGHTS
    Contract No.
    ____
    Contractor Name
    ____
    Contractor Address
    ____
    ____
    The Government's rights to use, modify, reproduce, release, perform, display, or disclose
    these technical data are restricted by paragraph (b)(3) of the Rights in Technical Data--Noncommercial
    Items clause contained in the above identified contract. Any reproduction of technical data or portions
    thereof marked with this legend must also reproduce the markings. Any person, other than the
    Government, who has been provided access to such data must promptly notify the above named
    Contractor.
    (End of legend)
    (4) Special license rights markings.
    (i) Data in which the Government's rights stem from a specifically negotiated license
    shall be marked with the following legend:
    SPECIAL LICENSE RIGHTS
    The Government's rights to use, modify, reproduce, release, perform, display, or disclose these data
    are restricted by Contract No. ____(Insert contract number)____, License No. ____(Insert license
    identifier)____. Any reproduction of technical data or portions thereof marked with this legend must
    also reproduce the markings.
    (End of legend)
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    (ii) For purposes of this clause, special licenses do not include government purpose
    license rights acquired under a prior contract (see paragraph (b)(5) of this clause).
    (5) Pre-existing data markings. If the terms of a prior contract or license permitted the
    Contractor to restrict the Government's rights to use, modify, reproduce, release, perform, display, or
    disclose technical data deliverable under this contract, and those restrictions are still applicable, the
    Contractor may mark such data with the appropriate restrictive legend for which the data qualified under
    the prior contract or license. The marking procedures in paragraph (f)(1) of this clause shall be followed.
    (g) Contractor procedures and records. Throughout performance of this contract, the Contractor
    and its subcontractors or suppliers that will deliver technical data with other than unlimited rights, shall-
    (1) Have, maintain, and follow written procedures sufficient to assure that restrictive
    markings are used only when authorized by the terms of this clause; and
    (2) Maintain records sufficient to justify the validity of any restrictive markings on technical
    data delivered under this contract.
    (h) Removal of unjustified and nonconforming markings.
    (1) Unjustified technical data markings. The rights and obligations of the parties regarding
    the validation of restrictive markings on technical data furnished or to be furnished under this contract
    are contained in the Validation of Restrictive Markings on Technical Data clause of this contract.
    Notwithstanding any provision of this contract concerning inspection and acceptance, the Government
    may ignore or, at the Contractor's expense, correct or strike a marking if, in accordance with the
    procedures in the Validation of Restrictive Markings on Technical Data clause of this contract, a
    restrictive marking is determined to be unjustified.
    (2) Nonconforming technical data markings. A nonconforming marking is a marking placed
    on technical data delivered or otherwise furnished to the Government under this contract that is not in the
    format authorized by this contract. Correction of nonconforming markings is not subject to the
    Validation of Restrictive Markings on Technical Data clause of this contract. If the Contracting Officer
    notifies the Contractor of a nonconforming marking and the Contractor fails to remove or correct such
    marking within sixty (60) days, the Government may ignore or, at the Contractor's expense, remove or
    correct any nonconforming marking.
    (i) Relation to patents. Nothing contained in this clause shall imply a license to the Government
    under any patent or be construed as affecting the scope of any license or other right otherwise granted to
    the Government under any patent.
    (j) Limitation on charges for rights in technical data.
    (1) The Contractor shall not charge to this contract any cost, including, but not limited to,
    license fees, royalties, or similar charges, for rights in technical data to be delivered under this contract
    when-
    (i) The Government has acquired, by any means, the same or greater rights in the data; or
    (ii) The data are available to the public without restrictions.
    (2) The limitation in paragraph (j)(1) of this clause-
    (i) Includes costs charged by a subcontractor or supplier, at any tier, or costs incurred by
    the Contractor to acquire rights in subcontractor or supplier technical data, if the subcontractor or
    supplier has been paid for such rights under any other Government contract or under a license conveying
    the rights to the Government; and
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    (ii) Does not include the reasonable costs of reproducing, handling, or mailing the
    documents or other media in which the technical data will be delivered.
    (k) Applicability to subcontractors or suppliers.
    (1) The Contractor shall ensure that the rights afforded its subcontractors and suppliers under
    10 U.S.C. 2320, 10 U.S.C. 2321, and the identification, assertion, and delivery processes of paragraph (e)
    of this clause are recognized and protected.
    (2) Whenever any technical data for noncommercial items, or for commercial items
    developed in any part at Government expense, is to be obtained from a subcontractor or supplier for
    delivery to the Government under this contract, the Contractor shall use this same clause in the
    subcontract or other contractual instrument, including subcontracts or other contractual instruments for
    commercial items, and require its subcontractors or suppliers to do so, without alteration, except to
    identify the parties. This clause will govern the technical data pertaining to noncommercial items or to
    any portion of a commercial item that was developed in any part at Government expense, and the clause
    at 252.227-7015 will govern the technical data pertaining to any portion of a commercial item that was
    developed exclusively at private expense. No other clause shall be used to enlarge or diminish the
    Government's, the Contractor's, or a higher-tier subcontractor's or supplier's rights in a subcontractor's or
    supplier's technical data.
    (3) Technical data required to be delivered by a subcontractor or supplier shall normally be
    delivered to the next higher-tier contractor, subcontractor, or supplier. However, when there is a
    requirement in the prime contract for data which may be submitted with other than unlimited rights by a
    subcontractor or supplier, then said subcontractor or supplier may fulfill its requirement by submitting
    such data directly to the Government, rather than through a higher-tier contractor, subcontractor, or
    supplier.
    (4) The Contractor and higher-tier subcontractors or suppliers shall not use their power to
    award contracts as economic leverage to obtain rights in technical data from their subcontractors or
    suppliers.
    (5) In no event shall the Contractor use its obligation to recognize and protect subcontractor
    or supplier rights in technical data as an excuse for failing to satisfy its contractual obligation to the
    Government.
    (End of clause)
    252.232-7006 Wide Area WorkFlow Payment Instructions. 2018-12
    As prescribed in 232.7004(b), use the following clause:
    WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)
    (a) Definitions. As used in this clause-
    "Department of Defense Activity Address Code (DoDAAC)" is a six position code that uniquely
    identifies a unit, activity, or organization.
    "Document type" means the type of payment request or receiving report available for creation in
    Wide Area WorkFlow (WAWF).
    "Local processing office (LPO)" is the office responsible for payment certification when payment
    certification is done external to the entitlement system.
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    "Payment request" and "receiving report" are defined in the clause at 252.232-7003, Electronic
    Submission of Payment Requests and Receiving Reports.
    (b) Electronic invoicing. The WAWF system provides the method to electronically process
    vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation
    Supplement (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving
    Reports.
    (c) WAWF access. To access WAWF, the Contractor shall-
    (1) Have a designated electronic business point of contact in the System for Award
    Management at https://www.sam.gov; and
    (2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures
    for self-registration available at this web site.
    (d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-
    Based Training Course and use the Practice Training Site before submitting payment requests through
    WAWF. Both can be accessed by selecting the "Web Based Training" link on the WAWF home page at
    https://wawf.eb.mil/
    (e) WAWF methods of document submission. Document submissions may be via web entry,
    Electronic Data Interchange, or File Transfer Protocol.
    (f) WAWF payment instructions. The Contractor shall use the following information when
    submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:
    (1) Document type. The Contractor shall submit payment requests using the following
    document type(s):
    (i) For cost-type line items, including labor-hour or time-and-materials, submit a cost
    voucher.
    (ii) For fixed price line items-
    (A) That require shipment of a deliverable, submit the invoice and receiving report
    specified by the Contracting Officer.
    ____
    (Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price
    line items that require shipment of a deliverable.)
    (B) For services that do not require shipment of a deliverable, submit either the
    Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable
    invoice and receiving report, as specified by the Contracting Officer.
    ____
    (Contracting Officer: Insert either "Invoice 2in1" or the applicable invoice and receiving
    report document type(s) for fixed price line items for services.)
    (iii) For customary progress payments based on costs incurred, submit a progress
    payment request.
    (iv) For performance based payments, submit a performance based payment request.
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    (v) For commercial item financing, submit a commercial item financing request.
    (2) ) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR)
    52.213-1 is included in the contract.
    (f) [Note: The Contractor may use a WAWF "combo" document type to create some combinations
    of invoice and receiving report in one step.]
    (3) Document routing. The Contractor shall use the information in the Routing Data Table
    below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in
    the system.
    Routing Data Table*
    Field Name in WAWF Data to be entered in WAWF
    Pay Official DoDAAC ____
    Issue By DoDAAC ____
    Admin DoDAAC ____
    Inspect By DoDAAC ____
    Ship To Code ____
    Ship From Code ____
    Mark For Code ____
    Service Approver (DoDAAC) ____
    Service Acceptor (DoDAAC) ____
    Accept at Other DoDAAC ____
    LPO DoDAAC ____
    DCAA Auditor DoDAAC ____
    Other DoDAAC(s) ____
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    (*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance
    locations apply, insert "See Schedule" or "Not applicable.")
    (**Contracting Officer: If the contract provides for progress payments or performance-based
    payments, insert the DoDAAC for the contract administration office assigned the functions under FAR
    42.302(a)(13).)
    (4) Payment request. The Contractor shall ensure a payment request includes documentation
    appropriate to the type of payment request in accordance with the payment clause, contract financing
    clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.
    (5) Receiving report. The Contractor shall ensure a receiving report meets the requirements
    of DFARS Appendix F.
    (g) WAWF point of contact.
    (1) The Contractor may obtain clarification regarding invoicing in WAWF from the
    following contracting activity's WAWF point of contact.
    ____
    (Contracting Officer: Insert applicable information or "Not applicable.")
    (2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.
    (End of clause)
    252.232-7007 Limitation of Government's Obligation. 2014-04
    As prescribed in 232.705-70, use the following clause:
    LIMITATION OF GOVERNMENT'S OBLIGATION (APR 2014)
    (a) Contract line item(s) [Contracting Officer insert after negotiations] is/are incrementally
    funded. For this/these item(s), the sum of $ [Contracting Officer insert after negotiations] of the total
    price is presently available for payment and allotted to this contract. An allotment schedule is set forth in
    paragraph (j) of this clause.
    (b) For item(s) identified in paragraph (a) of this clause, the Contractor agrees to perform up to the
    point at which the total amount payable by the Government, including reimbursement in the event of
    termination of those item(s) for the Government's convenience, approximates the total amount currently
    allotted to the contract. The Contractor is not authorized to continue work on those item(s) beyond that
    point. The Government will not be obligated in any event to reimburse the Contractor in excess of the
    amount allotted to the contract for those item(s) regardless of anything to the contrary in the clause
    entitled "Termination for Convenience of the Government." As used in this clause, the total amount
    payable by the Government in the event of termination of applicable contract line item(s) for
    convenience includes costs, profit, and estimated termination settlement costs for those item(s).
    (c) Notwithstanding the dates specified in the allotment schedule in paragraph (j) of this clause,
    the Contractor will notify the Contracting Officer in writing at least ninety days prior to the date when, in
    the Contractor's best judgment, the work will reach the point at which the total amount payable by the
    Page 20 of 29

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    Government, including any cost for termination for convenience, will approximate 85 percent of the total
    amount then allotted to the contract for performance of the applicable item(s). The notification will state
    (1) the estimated date when that point will be reached and (2) an estimate of additional funding, if any,
    needed to continue performance of applicable line items up to the next scheduled date for allotment of
    funds identified in paragraph (j) of this clause, or to a mutually agreed upon substitute date. The
    notification will also advise the Contracting Officer of the estimated amount of additional funds that will
    be required for the timely performance of the item(s) funded pursuant to this clause, for a subsequent
    period as may be specified in the allotment schedule in paragraph (j) of this clause or otherwise agreed to
    by the parties. If after such notification additional funds are not allotted by the date identified in the
    Contractor's notification, or by an agreed substitute date, the Contracting Officer will terminate any item
    (s) for which additional funds have not been allotted, pursuant to the clause of this contract entitled
    "Termination for Convenience of the Government."
    (d) When additional funds are allotted for continued performance of the contract line item(s)
    identified in paragraph (a) of this clause, the parties will agree as to the period of contract performance
    which will be covered by the funds. The provisions of paragraphs (b) through (d) of this clause will
    apply in like manner to the additional allotted funds and agreed substitute date, and the contract will be
    modified accordingly.
    (e) If, solely by reason of failure of the Government to allot additional funds, by the dates
    indicated below, in amounts sufficient for timely performance of the contract line item(s) identified in
    paragraph (a) of this clause, the Contractor incurs additional costs or is delayed in the performance of the
    work under this contract and if additional funds are allotted, an equitable adjustment will be made in the
    price or prices (including appropriate target, billing, and ceiling prices where applicable) of the item(s),
    or in the time of delivery, or both. Failure to agree to any such equitable adjustment hereunder will be a
    dispute concerning a question of fact within the meaning of the clause entitled "Disputes."
    (f) The Government may at any time prior to termination allot additional funds for the
    performance of the contract line item(s) identified in paragraph (a) of this clause.
    (g) The termination provisions of this clause do not limit the rights of the Government under the
    clause entitled "Default." The provisions of this clause are limited to the work and allotment of funds for
    the contract line item(s) set forth in paragraph (a) of this clause. This clause no longer applies once the
    contract is fully funded except with regard to the rights or obligations of the parties concerning equitable
    adjustments negotiated under paragraphs (d) and (e) of this clause.
    (h) Nothing in this clause affects the right of the Government to terminate this contract pursuant to
    the clause of this contract entitled "Termination for Convenience of the Government."
    (i) Nothing in this clause shall be construed as authorization of voluntary services whose
    acceptance is otherwise prohibited under 31 U.S.C. 1342.
    (j) The parties contemplate that the Government will allot funds to this contract in accordance
    with the following schedule:
    On execution of contract $ ____
    (month) (day), (year) $ ____
    (month) (day), (year) $ ____
    (month) (day), (year) $ ____
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    (End of clause)
    252.235-7010 Acknowledgment of Support and Disclaimer. 1995-05
    As prescribed in 235.072(c), use the following clause:
    ACKNOWLEDGMENT OF SUPPORT AND DISCLAIMER (MAY 1995)
    (a) The Contractor shall include an acknowledgment of the Government's support in the
    publication of any material based on or developed under this contract, stated in the following terms:
    This material is based upon work supported by the ____(name of contracting agency(ies)) under
    Contract No. ____(Contracting agency(ies) contract number(s)).
    (b) All material, except scientific articles or papers published in scientific journals, must, in
    addition to any notices or disclaimers by the Contractor, also contain the following disclaimer: Any
    opinions, findings and conclusions or recommendations expressed in this material are those of the author
    (s) and do not necessarily reflect the views of the ____(name of contracting agency(ies)).
    (End of clause)
    52.227-11 Patent Rights-Ownership by the Contractor. 2014-05
    As prescribed in 27.303(b)(1), insert the following clause:
    Patent Rights-Ownership by the Contractor (MAY 2014)
    (a) As used in this clause-
    Invention means any invention or discovery that is or may be patentable or otherwise protectable
    under title 35 of the U.S. Code, or any variety of plant that is or may be protectable under the Plant
    Variety Protection Act (7 U.S.C. 2321, et seq.)
    Made means-
    (1) When used in relation to any invention other than a plant variety, the conception or first
    actual reduction to practice of the invention; or
    (2) When used in relation to a plant variety, that the Contractor has at least tentatively
    determined that the variety has been reproduced with recognized characteristics.
    Nonprofit organization means a university or other institution of higher education or an
    organization of the type described in section 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C.
    501(c)) and exempt from taxation under section 501(a) of the Internal Revenue Code (26 U.S.C. 501(a)),
    or any nonprofit scientific or educational organization qualified under a State nonprofit organization
    statute.
    "Practical application" means to manufacture, in the case of a composition of product; to
    practice, in the case of a process or method; or to operate, in the case of a machine or system; and, in
    each case, under such conditions as to establish that the invention is being utilized and that its benefits
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    are, to the extent permitted by law or Government regulations, available to the public on reasonable
    terms.
    Subject invention means any invention of the Contractor made in the performance of work
    under this contract.
    (b) Contractor's rights. (1) Ownership. The Contractor may retain ownership of each subject
    invention throughout the world in accordance with the provisions of this clause.
    (2) License. (i) The Contractor shall retain a nonexclusive royalty-free license throughout the
    world in each subject invention to which the Government obtains title, unless the Contractor fails to
    disclose the invention within the times specified in paragraph (c) of this clause. The Contractor's license
    extends to any domestic subsidiaries and affiliates within the corporate structure of which the Contractor
    is a part, and includes the right to grant sublicenses to the extent the Contractor was legally obligated to
    do so at contract award. The license is transferable only with the written approval of the agency, except
    when transferred to the successor of that part of the Contractor's business to which the invention pertains.
    (ii) The Contractor's license may be revoked or modified by the agency to the extent
    necessary to achieve expeditious practical application of the subject invention in a particular country in
    accordance with the procedures in FAR 27.302(i)(2) and 27.304-1(f).
    (c) Contractor's obligations. (1) The Contractor shall disclose in writing each subject invention to
    the Contracting Officer within 2 months after the inventor discloses it in writing to Contractor personnel
    responsible for patent matters. The disclosure shall identify the inventor(s) and this contract under which
    the subject invention was made. It shall be sufficiently complete in technical detail to convey a clear
    understanding of the subject invention. The disclosure shall also identify any publication, on sale (i.e.,
    sale or offer for sale), or public use of the subject invention, or whether a manuscript describing the
    subject invention has been submitted for publication and, if so, whether it has been accepted for
    publication. In addition, after disclosure to the agency, the Contractor shall promptly notify the
    Contracting Officer of the acceptance of any manuscript describing the subject invention for publication
    and any on sale or public use.
    (2) The Contractor shall elect in writing whether or not to retain ownership of any subject
    invention by notifying the Contracting Officer within 2 years of disclosure to the agency. However, in
    any case where publication, on sale, or public use has initiated the 1-year statutory period during which
    valid patent protection can be obtained in the United States, the period for election of title may be
    shortened by the agency to a date that is no more than 60 days prior to the end of the statutory period.
    (3) The Contractor shall file either a provisional or a nonprovisional patent application or a
    Plant Variety Protection Application on an elected subject invention within 1 year after election.
    However, in any case where a publication, on sale, or public use has initiated the 1-year statutory period
    during which valid patent protection can be obtained in the United States, the Contractor shall file the
    application prior to the end of that statutory period. If the Contractor files a provisional application, it
    shall file a nonprovisional application within 10 months of the filing of the provisional application. The
    Contractor shall file patent applications in additional countries or international patent offices within
    either 10 months of the first filed patent application (whether provisional or nonprovisional) or 6 months
    from the date permission is granted by the Commissioner of Patents to file foreign patent applications
    where such filing has been prohibited by a Secrecy Order.
    (4) The Contractor may request extensions of time for disclosure, election, or filing under
    paragraphs (c)(1), (c)(2), and (c)(3) of this clause.
    (d) Government's rights- (1) Ownership. The Contractor shall assign to the agency, on written
    request, title to any subject invention-
    (i) If the Contractor fails to disclose or elect ownership to the subject invention within the
    times specified in paragraph (c) of this clause, or elects not to retain ownership; provided, that the agency
    may request title only within 60 days after learning of the Contractor's failure to disclose or elect within
    the specified times.
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    (ii) In those countries in which the Contractor fails to file patent applications within the
    times specified in paragraph (c) of this clause; provided, however, that if the Contractor has filed a patent
    application in a country after the times specified in paragraph (c) of this clause, but prior to its receipt of
    the written request of the agency, the Contractor shall continue to retain ownership in that country.
    (iii) In any country in which the Contractor decides not to continue the prosecution of any
    application for, to pay the maintenance fees on, or defend in reexamination or opposition proceeding on,
    a patent on a subject invention.
    (2) License. If the Contractor retains ownership of any subject invention, the Government shall
    have a nonexclusive, nontransferable, irrevocable, paid-up license to practice, or have practiced for or on
    its behalf, the subject invention throughout the world.
    (e) Contractor action to protect the Government's interest. (1) The Contractor shall execute or have
    executed and promptly deliver to the agency all instruments necessary to-
    (i) Establish or confirm the rights the Government has throughout the world in those subject
    inventions in which the Contractor elects to retain ownership; and
    (ii) Assign title to the agency when requested under paragraph (d) of this clause and to
    enable the Government to obtain patent protection and plant variety protection for that subject invention
    in any country.
    (2) The Contractor shall require, by written agreement, its employees, other than clerical and
    nontechnical employees, to disclose promptly in writing to personnel identified as responsible for the
    administration of patent matters and in the Contractor's format, each subject invention in order that the
    Contractor can comply with the disclosure provisions of paragraph (c) of this clause, and to execute all
    papers necessary to file patent applications on subject inventions and to establish the Government's rights
    in the subject inventions. The disclosure format should require, as a minimum, the information required
    by paragraph (c)(1) of this clause. The Contractor shall instruct such employees, through employee
    agreements or other suitable educational programs, as to the importance of reporting inventions in
    sufficient time to permit the filing of patent applications prior to U.S. or foreign statutory bars.
    (3) The Contractor shall notify the Contracting Officer of any decisions not to file a
    nonprovisional patent application, continue the prosecution of a patent application, pay maintenance
    fees, or defend in a reexamination or opposition proceeding on a patent, in any country, not less than 30
    days before the expiration of the response or filing period required by the relevant patent office.
    (4) The Contractor shall include, within the specification of any United States nonprovisional
    patent or plant variety protection application and any patent or plant variety protection certificate issuing
    thereon covering a subject invention, the following statement, "This invention was made with
    Government support under (identify the contract) awarded by (identify the agency). The Government has
    certain rights in the invention."
    (f) Reporting on utilization of subject inventions. The Contractor shall submit, on request, periodic
    reports no more frequently than annually on the utilization of a subject invention or on efforts at
    obtaining utilization of the subject invention that are being made by the Contractor or its licensees or
    assignees. The reports shall include information regarding the status of development, date of first
    commercial sale or use, gross royalties received by the Contractor, and other data and information as the
    agency may reasonably specify. The Contractor also shall provide additional reports as may be requested
    by the agency in connection with any march-in proceeding undertaken by the agency in accordance with
    paragraph (h) of this clause. The Contractor also shall mark any utilization report as confidential
    /proprietary to help prevent inadvertent release outside the Government. As required by 35 U.S.C. 202(c)
    (5), the agency will not disclose that information to persons outside the Government without the
    Contractor's permission.
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    (g) Preference for United States industry. Notwithstanding any other provision of this clause,
    neither the Contractor nor any assignee shall grant to any person the exclusive right to use or sell any
    subject invention in the United States unless the person agrees that any products embodying the subject
    invention or produced through the use of the subject invention will be manufactured substantially in the
    United States. However, in individual cases, the requirement for an agreement may be waived by the
    agency upon a showing by the Contractor or its assignee that reasonable but unsuccessful efforts have
    been made to grant licenses on similar terms to potential licensees that would be likely to manufacture
    substantially in the United States, or that under the circumstances domestic manufacture is not
    commercially feasible.
    (h) March-in rights. The Contractor acknowledges that, with respect to any subject invention in
    which it has retained ownership, the agency has the right to require licensing pursuant to 35 U.S.C. 203
    and 210(c), and in accordance with the procedures in 37 CFR 401.6 and any supplemental regulations of
    the agency in effect on the date of contract award.
    (i) Special provisions for contracts with nonprofit organizations. If the Contractor is a nonprofit
    organization, it shall-
    (1) Not assign rights to a subject invention in the United States without the written approval of
    the agency, except where an assignment is made to an organization that has as one of its primary
    functions the management of inventions, provided, that the assignee shall be subject to the same
    provisions as the Contractor;
    (2) Share royalties collected on a subject invention with the inventor, including Federal
    employee co-inventors (but through their agency if the agency deems it appropriate) when the subject
    invention is assigned in accordance with 35U.S.C.202(e) and 37 CFR 401.10;
    (3) Use the balance of any royalties or income earned by the Contractor with respect to subject
    inventions, after payment of expenses (including payments to inventors) incidental to the administration
    of subject inventions for the support of scientific research or education; and
    (4) Make efforts that are reasonable under the circumstances to attract licensees of subject
    inventions that are small business concerns, and give a preference to a small business concern when
    licensing a subject invention if the Contractor determines that the small business concern has a plan or
    proposal for marketing the invention which, if executed, is equally as likely to bring the invention to
    practical application as any plans or proposals from applicants that are not small business concerns;
    provided, that the Contractor is also satisfied that the small business concern has the capability and
    resources to carry out its plan or proposal. The decision whether to give a preference in any specific case
    will be at the discretion of the Contractor.
    (5) Allow the Secretary of Commerce to review the Contractor's licensing program and
    decisions regarding small business applicants, and negotiate changes to its licensing policies, procedures,
    or practices with the Secretary of Commerce when the Secretary's review discloses that the Contractor
    could take reasonable steps to more effectively implement the requirements of paragraph (i)(4) of this
    clause.
    (j) Communications. ____[Complete according to agency instructions.]
    (k) Subcontracts. (1) The Contractor shall include the substance of this clause, including this
    paragraph (k), in all subcontracts for experimental, developmental, or research work to be performed by
    a small business concern or nonprofit organization.
    (2) The Contractor shall include in all other subcontracts for experimental, developmental, or
    research work the substance of the patent rights clause required by FAR subpart 27.3.
    (3) At all tiers, the patent rights clause must be modified to identify the parties as follows:
    references to the Government are not changed, and the subcontractor has all rights and obligations of the
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    Contractor in the clause. The Contractor shall not, as part of the consideration for awarding the
    subcontract, obtain rights in the subcontractor's subject inventions.
    (4) In subcontracts, at any tier, the agency, the subcontractor, and the Contractor agree that the
    mutual obligations of the parties created by this clause constitute a contract between the subcontractor
    and the agency with respect to the matters covered by the clause; provided, however, that nothing in this
    paragraph is intended to confer any jurisdiction under the Contract Disputes statute in connection with
    proceedings under paragraph (h) of this clause.
    (End of clause)
    52.252-2 Clauses Incorporated by Reference. 1998-02
    As prescribed in 52.107(b), insert the following clause:
    Clauses Incorporated By Reference (FEB 1998)
    This contract incorporates one or more clauses by reference, with the same force and effect as if they
    were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the
    full text of a clause may be accessed electronically at this/these address(es):
    ____ ____ ____[Insert one or more Internet addresses]
    (End of clause)
    52.252-4 Alterations in Contract. 1984-04
    As prescribed in 52.107(d), insert the following clause in solicitations and contracts in order to revise
    or supplement, as necessary, other parts of the contract, or parts of the solicitation that apply after
    contract award, except for any clause authorized for use with a deviation. Include clear identification of
    what is being altered.
    Alterations in Contract (APR 1984)
    Portions of this contract are altered as follows:
    ____ ____ ____
    (End of clause)
    52.252-6 Authorized Deviations in Clauses. 2020-11
    As prescribed in 52.107(f), insert the following clause in solicitations and contracts that include any
    FAR or supplemental clause with an authorized deviation. Whenever any FAR or supplemental clause is
    used with an authorized deviation, the contracting officer shall identify it by the same number, title, and
    date assigned to the clause when it is used without deviation, include regulation name for any
    supplemental clause, except that the contracting officer shall insert "(DEVIATION)" after the date of the
    clause.
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    Authorized Deviations in Clauses (Nov 2020)
    (a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter
    1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of
    the clause.
    (b) The use in this solicitation or contract of any ____[insert regulation name] (48 CFR ____)
    clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the
    regulation.
    (End of clause)
    52.204-1 Approval of Contract. 1989-12
    As prescribed in 4.103 , insert the following clause:
    Approval of Contract (DEC 1989)
    This contract is subject to the written approval of ____[identify title of designated agency official
    here] and shall not be binding until so approved.
    (End of clause)
    52.219-14 DEV 2021-O0008 Limitations on Subcontracting (DEVIATION 2021-O0008) 2021-09
    As prescribed in 19.507(e), insert the following clause:
    LIMITATIONS ON SUBCONTRACTING (SEP 2021) (DEVIATION 2021-O0008)
    (a) This clause does not apply to the unrestricted portion of a partial set-aside.
    (b) Definition. “Similarly situated entity,” as used in this clause, means a first-tier subcontractor,
    including an independent contractor, that--
    (1) Has the same small business program status as that which qualified the prime contractor for the
    award (e.g., for a small business set-aside contract, any small business concern, without regard to its
    socioeconomic status); and
    (2) Is considered small for the size standard under the North American Industry Classification
    System (NAICS) code the prime contractor assigned to the subcontract.
    (c) Applicability. This clause applies only to--
    (1) Contracts that have been set aside for any of the small business concerns identified in 19.000(a)
    (3);
    (2) Part or parts of a multiple-award contract that have been set aside for any of the small business
    concerns identified in 19.000(a)(3);
    (3) Contracts that have been awarded on a sole-source basis in accordance with subparts 19.8,
    19.13, 19.14, and 19.15;
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    (4) Orders expected to exceed the simplified acquisition threshold and that are--
    (i) Set aside for small business concerns under multiple-award contracts, as described in
    8.405-5 and 16.505(b)(2)(i)(F); or
    (ii) Issued directly to small business concerns under multiple-award contracts as described in
    19.504(c)(1)(ii);
    (5) Orders, regardless of dollar value, that are--
    (i) Set aside in accordance with subparts 19.8, 19.13, 19.14, or 19.15 under multiple-award
    contracts, as described in 8.405-5 and 16.505(b)(2)(i)(F); or
    (ii) Issued directly to concerns that qualify for the programs described in subparts 19.8, 19.13,
    19.14, or 19.15 under multiple-award contracts, as described in 19.504(c)(1)(ii); and
    (6) Contracts using the HUBZone price evaluation preference to award to a HUBZone small
    business concern unless the concern waived the evaluation preference.
    (d) Independent contractors. An independent contractor shall be considered a subcontractor.
    (e) Limitations on subcontracting. By submission of an offer and execution of a contract, the
    Contractor agrees that in performance of a contract assigned a North American Industry Classification
    System (NAICS) code for--
    (1) Services (except construction), it will not pay more than 50 percent of the amount paid by the
    Government for contract performance, excluding certain other direct costs and certain work performed
    outside the United States (see paragraph (e)(1)(i)), to subcontractors that are not similarly situated
    entities. Any work that a similarly situated entity further subcontracts will count towards the prime
    contractor’s 50 percent subcontract amount that cannot be exceeded. When a contract includes both
    services and supplies, the 50 percent limitation shall apply only to the service portion of the contract. The
    following services may be excluded from the 50 percent limitation:
    (i) Other direct costs, to the extent they are not the principal purpose of the acquisition and small
    business concerns do not provide the service. Examples include airline travel, work performed by a
    transportation or disposal entity under a contract assigned the environmental remediation NAICS code
    562910), cloud computing services, or mass media purchases.
    (ii) Work performed outside the United States on awards made pursuant to the Foreign
    Assistance Act of 1961, or work performed outside the United States required to be performed by a local
    contractor.
    (2) Supplies (other than procurement from a nonmanufacturer of such supplies), it will not pay
    more than 50 percent of the amount paid by the Government for contract performance, excluding the cost
    of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated
    entity further subcontracts will count towards the prime contractor’s 50 percent subcontract amount that
    cannot be exceeded. When a contract includes both supplies and services, the 50 percent limitation shall
    apply only to the supply portion of the contract;
    (3) General construction, it will not pay more than 85 percent of the amount paid by the
    Government for contract performance, excluding the cost of materials, to subcontractors that are not
    similarly situated entities. Any work that a similarly situated entity further subcontracts will count
    towards the prime contractor’s 85 percent subcontract amount that cannot be exceeded; or
    (4) Construction by special trade contractors, it will not pay more than 75 percent of the amount
    paid by the Government for contract performance, excluding the cost of materials, to subcontractors that
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    are not similarly situated entities. Any work that a similarly situated entity further subcontracts will
    count towards the prime contractor’s 75 percent subcontract amount that cannot be exceeded.
    (f) The Contractor shall comply with the limitations on subcontracting as follows:
    (1) For contracts, in accordance with paragraphs (c)(1), (2), (3) and (6) of this clause --
    [Contracting Officer check as appropriate.]
    By the end of the base term of the contract and then by the end of each subsequent option period; or
    By the end of the performance period for each order issued under the contract.
    (2) For orders, in accordance with paragraphs (c)(4) and (5) of this clause, by the end of the
    performance period for the order.
    (g) A joint venture agrees that, in the performance of the contract, the applicable percentage specified
    in paragraph (e) of this clause will be performed by the aggregate of the joint venture participants.
    (End of clause)
    Page 29 of 29

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    HT9425-23-S-SOC1-0003

    I. OVERVIEW OF THE FUNDING OPPORTUNITY
    United States Special Operations Command
    Department of Defense
    BROAD AGENCY ANNOUNCEMENT (BAA)
    for Extramural Biomedical and Human Performance
    Research and Development
    Funding Opportunity Number: HT9425-23-S-SOC1
    Announcement Type: Revised-0003
    Catalog of Federal Domestic Assistance Number: 12.420
    Military Medical Research and Development
    KEY DATES
    Release/Posted Date: Initial 27 July 2023. Revised -0001: 11 AUG 2023. Revised -0002: 29
    APR 2024. Revised 0003: 23 July 2025.
    Closing Date: 31 July, 2028, 11:59 p.m. Eastern Time
    This Funding Opportunity Announcement is a BAA. It is continuously open for a 5-year period,
    from 1 August 2023 closing 31 July 2028, 11:59 p.m. Eastern Time. Note: This BAA will be
    updated annually.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    1

    ---

    This Broad Agency Announcement must be read in conjunction with the General Submission
    Instructions, which are available for downloading from Grants.gov. The General Submission
    Instructions are located under the “package” tab and can be downloaded by selecting the
    “Download Instructions” icon when previewing the submission package.
    TABLE OF CONTENTS
    I. OVERVIEW OF THE FUNDING OPPORTUNITY ....................................................... 1
    II. DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY ............... 3
    II.A. Program Description ....................................................................................................... 3
    II.A.1. Research Area of Interest .......................................................................................... 4
    II.B. Federal Award Information .......................................................................................... 12
    II.C. Eligibility Information ................................................................................................... 14
    II.C.1. Eligible Applicants ................................................................................................... 14
    II.C.2. Cost Sharing ............................................................................................................. 15
    II.C.3. Other ......................................................................................................................... 15
    II.D. Proposal/Application Submission Information ....................................................... 16
    II.D.1. Where to Obtain the Proposal/Application Submission Package ............................ 16
    II.D.2. Content and Form of the Proposal/Application Submission .................................... 16
    II.D.3. Unique Entity Identifier (UEI) and System for Award Management (SAM) ........... 36
    II.D.4. Submission Dates and Times ................................................................................... 40
    II.D.5. Funding Restrictions ................................................................................................ 40
    II.D.6. Other Submission Requirements .............................................................................. 40
    II.E. Proposal/Application Review Information .................................................................... 40
    II.E.1. Criteria ...................................................................................................................... 40
    II.E.2. Proposal/Application Review and Selection Process ............................................... 41
    II.E.3. Integrity and Performance Information .................................................................... 42
    II.E.4. Anticipated Announcement and Federal Award Dates ............................................ 43
    II.F. Federal Award Administration Information .................................................................. 43
    II.F.1. Federal Award Notices ............................................................................................. 43
    II.F.2. Administrative and National Policy Requirements .................................................. 44
    II.F.3. Reporting .................................................................................................................. 44
    II.G. Federal Awarding Agency Contacts ............................................................................. 45
    II.G.1. eBRAP Help Desk ................................................................................................... 45
    II.G.2. Grants.gov Contact Center ....................................................................................... 46
    II.H. Other Information ......................................................................................................... 46
    II.H.1. Administrative Actions ............................................................................................ 46
    II.H.2. Proposal/Application Submission Checklist ............................................................ 50
    APPENDIX 1: ACRONYM LIST ............................................................................................ 50
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    2

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    II. DETAILED INFORMATION ABOUT THE FUNDING
    OPPORTUNITY
    The Fiscal Year 2023 – Fiscal Year 2028 (FY23-FY28) United States Special Operations
    Command (USSOCOM), BAA for Extramural
    Biomedical and Human Performance Research and Development contains several changes from
    previous USSOCOM BAAs. Read each section carefully. Note the following:
    • The total individual project estimated cost ceiling has been increased from $4,000,000 to
    $5,000,000, and generally anticipated project cost has been increased from $700,000 to
    $2,000,000.
    • The “Program Description” that describes the “Research Areas of Interest (RAIs)” have
    been updated.
    II.A. Program Description
    This BAA is intended to solicit extramural research and development ideas using the authority
    provided by United States Code, Title 10, Section 4001. This BAA is issued under the
    provisions of the Competition in Contracting Act of 1984 (Public Law 98-369), as implemented
    in Federal Acquisition Regulation (FAR) 6.102(d)(2) and 35.016. In accordance with FAR
    6.102, projects funded under this BAA must be for basic and applied research to support
    scientific study and experimentation directed toward advancing the state-of-the-art or increasing
    knowledge or understanding rather than focusing on development of a specific system or
    hardware solution. Research and development funding through this BAA is intended and
    expected to benefit and inform both military and civilian medical practice and knowledge.
    This BAA provides a general description of the USSOCOM’s research and development
    programs, including RAIs, evaluation and selection criteria, pre-proposal/preapplication and full
    proposal/application preparation instructions, and general administrative information.
    Submission of a pre-proposal/pre-application is required. After review, if the USSOCOM is
    interested in receiving a full proposal/application, the Applicant or Offeror will be invited to
    submit a full proposal or full application. Specific submission information and additional
    administrative requirements can be found in the document titled “General Submission
    Instructions” available in Grants.gov along with this BAA.
    The USSOCOM utilizes the tools and processes provided by the Congressionally Directed
    Medical Research Programs (CDMRP). The CDMRP manages the electronic Biomedical
    Research Application Portal (eBRAP) system and retrieval and processing of full
    proposal/application submissions from Grants.gov. Refer to Section II.G, Agency Contacts, for
    additional information.
    The USSOCOM’s supporting contracting office, the U.S. Army Medical Research Acquisition
    Activity (USAMRAA) will be the awarding and administering office for proposals selected for
    funding.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    3

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    II.A.1. Research Area of Interest
    A primary emphasis of the USSOCOM Biomedical, Human Performance, and Canine Research
    Program is to identify and develop techniques, knowledge products, and materiel (medical devices,
    drugs, and biologics) to support far-forward early intervention of life-threatening illnesses or injuries
    within an Irregular Warfare or asymmetric, multi-domain operational environment. Special
    Operations Forces (SOF) medical personnel place a premium on medical equipment that is small,
    lightweight, ruggedized, modular, multi-use, and designed for operation in extreme environments.
    The equipment must be simple to employ, require minimum maintenance, and have low power
    consumption. Drugs and biologics should optimally not require refrigeration or other special
    handling. All materiel solutions must be capable of commercialization. Research projects may apply
    existing scientific and technical knowledge for which concept and/or patient care efficacy have
    already been demonstrated to meet SOF requirements. The proposed research must be relevant to
    active-duty service members, veterans, military beneficiaries, and/or the American public. Relevant
    research must be responsive to the health care needs of the U.S. Armed Forces, family members of
    the U. S. Armed Forces, and U.S. Veterans. Proposals must address a relevant health problem
    responsive to one of the RAIs identified below. Additional RAIs may be added during the life of the
    BAA (FY23-FY28). The following RAIs are in no particular order:
    1. Damage Control Resuscitation (DCR):
    SOF medical personnel require capabilities for far-forward medical care to reduce the mortality and
    morbidity associated with critical wounds and injuries. The proposed research, application, and/or
    development of medical techniques and materiel (medical devices, drugs, and biologics) for optimal
    triage and early intervention in critical life-threatening injuries when casualty evacuation is not
    possible or is delayed. The project areas under DCR to which the USSOCOM will give highest
    consideration are:
    a. Global Treatment Strategies and Next Generation Wound Management:
    The proposed project must research, apply, and/or develop effective treatment strategies that address
    the following elements: resuscitation, optimal resuscitation fluid(s), uncomplicated shock,
    noncompressible hemorrhaging, traumatic brain injuries, and austere damage control surgery. These
    strategies must be optimized for medics in austere, far-forward areas, with minimal logistical or
    specialty support, who must stabilize and treat patients for extended periods (days, not hours).
    Projects that research and develop an all-in-one traumatic wound care treatment that can achieve
    hemostasis, and incorporate analgesia are preferred.
    b. Analgesia:
    The proposed project must research, apply, and/or develop novel, safe, efficacious, peripherally, and
    centrally acting analgesia that provide easy administration in the field, tolerance of extreme
    environments, and effectiveness at the point of injury for a prolonged period of field care (days, not
    hours) and does not sensitize the patient to topical analgesia. Maximum analgesia with minimal
    sedation is preferred.
    c. Far Forward Blood, Blood Components, Blood Substitute, & Injectable Hemostatics:
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
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    The proposed project must research novel strategies to increase the ease, efficacy, and safety of blood
    transfusions (i.e., person to person, pre-hospital blood banking, rolling blood banks, and blood
    substitutes) forward of normal logistics support; (e.g., evaluating blood for type/cross matching and
    for the presence and/or reduction of pathogens, leucocytes, and AB antibodies to improve safety of
    whole blood transfusion at the point of injury). Projects that will be considered also include injectable
    medications to address the coagulopathy of trauma and novel strategies to improve tissue
    oxygenation.
    d. Austere Surgical Stabilization:
    Future theatres where SOF personnel will operate are likely to be much less medically robust than the
    past decade of fighting in our current theatres (this can translate to remote civilian areas), and there
    will be a mismatch between capability and need. Rather than sitting at hardened structures waiting on
    patients, surgical personnel may be increasingly asked to go to the patient. Research should focus on
    mobility/portability of medical and surgical equipment, including support equipment such as
    sterilization, with emphasis on equipment with greater capabilities than currently fielded devices,
    smaller size and weight, low power demands, and flexibility in power supplies. Additionally,
    research and development efforts should include telehealth technologies linking forward surgical
    providers with higher medical authority consultation and effective, relevant, and dynamic surgical
    training capabilities. Lastly, research into future procedures and devices may also include a human
    systems approach to define limitations and mitigation strategies of surgical capability in austere
    environments (i.e., low light, temperature variability, improving surgical access in distributed
    maritime environment, surgery in flight, etc.) to bridge time to surgery when patient load exceeds
    surgical capability.
    2. Prolonged Field Care (PFC):
    SOF medical personnel require capabilities for far-forward medical care to reduce the mortality and
    morbidity associated with critical wounds, injuries, diseases, and associated sepsis. PFC should focus
    on novel treatments that support the ability to manage 3-5 patients across the spectrum of illness to
    multi-system injury for a minimum of 5-7 days. SOF medical personnel require capability to
    expedite evacuation and increase survivability with limited site of injury support in austere
    environments including: hyperbaric, mountainous, high-altitude, arctic, and distributed maritime
    operations. Significant consideration will be given to proposals focused on PCC that may also relate
    to Sections 1.a. through 1.d. and 5.b. of this BAA.
    3. Medical Sensors and Devices:
    The primary emphasis is to research, apply and/or develop field-sustainable, rapidly deployable
    medical sensors and/or devices for extended care beyond initial trauma resuscitation, to include
    austere/forward surgery while operating in areas where casualty evacuation is delayed or unavailable.
    In addition, proposals that investigate or develop wireless biosensors should demonstrate
    physiological monitoring capabilities to include, but not limited to, heart rate, blood pressure, pulse
    oximetry, respiration rate, capnography, core temperature, heart rate variability and compensatory
    reserve index (CRI). Research and development of devices and sensors should include or plan for the
    capability to transmit (Bluetooth 4.2) to Android handheld devices and be designed with an open
    architecture to allow for sensors to be incorporated into a family of sensors that may or may not
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
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    report to a central handheld device. (NOTE: Ideally, sensor and equipment technologies should be
    electronically readable, scannable, or transmittable to the Battlefield Assisted Trauma Distributed
    Observation Kit (BATDOK), an Android-driven, multi-patient, point of injury casualty monitoring
    capability being fielded by U.S. Air Force (USAF) Pararescuemen and other SOF Medics. Novel
    devices are required which aid in measuring physiologic decompensation and/or adequacy of
    treatment/resuscitation in the field environment and/or provide a trigger for a pre-hospital medical
    intervention (i.e., validation of tissue (muscle) oxygen saturation (StO2), CRI, traumatic brain injury
    (TBI) measures, etc.
    4. Portable Lab Assays and Diagnostics:
    The proposed project must research, apply and/or develop novel concepts for portable and
    environmentally stable far forward laboratory assays and diagnostics. Equipment should be
    extremely portable, ruggedized, use limited or no external power, and any reagents should be self-
    contained and stable in extreme environmental conditions. Preference will be given to proposals that
    are field oriented, rugged, low weight/cube space and have little to no refrigeration requirements.
    Additionally, novel wireless, transmittable or scannable solutions such as patches, scanner/readers or
    other noninvasive technologies as described in paragraph 5.a. below are encouraged.
    5. Force Health Protection and Environmental Medicine:
    SOF personnel must often operate for extended periods of time in austere environments that expose
    them to extremes in altitude, temperature, humidity, wind, kinetosis, infectious diseases, toxic
    industrial chemicals, toxic industrial materials, and environmental hazards (including envenomation).
    In addition, the environment may be compromised due to chemical, biological, and radiological
    contamination. The primary emphasis of this research area is to research, apply, and develop
    techniques, therapeutic measures, and materiel (personal protective equipment (PPE), medical
    devices, drugs, and biologics) to ensure sustained human performance and effectiveness while
    operating in harsh environmental conditions and/or wearing appropriate PPE.
    a. Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Rapid Diagnostics,
    Treatment, and Prophylaxis:
    The proposed projects must research, apply, and/or develop novel approaches that will diagnose,
    treat, and protect SOF personnel from exposure to chemical, biological, radiological, nuclear, and
    high yield explosives in near real time.
    b. Occupational and Environmental Health (OEH) Hazards:
    The proposed project must focus on development of novel methods and devices for rapid
    identification and analysis of exposures to OEH hazards. Research must support the development
    and analysis of handheld, field hardened, and environmentally stable analytical devices, monitoring
    devices, dosimetry, assays for rapid on-site identification, and real-time analysis of OEH hazards in
    air, water, and soil that could pose an acute or chronic health hazard to SOF personnel. Such OEH
    hazards include toxic industrial chemicals/toxic industrial materials (TICs/TIMs), lead exposures,
    food and water borne pathogens, toxins, biological agents, and radiological material exposures.
    c. Operational Exposure Monitoring:
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
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    The proposed project must seek to develop wireless biosensors for monitoring SOF personnel in
    extreme environments (i.e., high altitude, whether in-flight or the environment itself, excessive heat
    or cold, etc.), and potentially hazardous material exposure. Sensors should address physiological
    measurements and/or chemical, biological and/or radiological hazards. For hazards monitoring, a
    personal dosimetry device is desired that can detect and alarm based on radiation and chemical
    presence. The alarming function can be pre-determined to account for known environmental
    conditions (i.e., natural occurring radiation levels that are below threshold/detrimental health levels)
    and parts per million (PPM) counts that would trigger an alert. This detection device needs to be able
    to alarm differently to identify the "type" of hazard(s), and to trigger a back-off and/or donning of
    additional PPE. Monitoring should be capable of wirelessly communicating via Bluetooth 4.2 to
    Android handheld devices, tablets, or compatible wrist-mounted displays.
    6. Brain Health:
    Brain Health research efforts include, but are not limited to: determining if repeated low-level blast
    exposure (rLLBE) causes brain injury or repeated blast brain injury (rBBI), development and
    validation of fieldable Neurocognitive Assessment Tools (NCATs) and baseline testing,
    Comprehensive Symptom History (CASH) collection, blast exposure and impact monitoring,
    determination of safe acceptable limits for blast exposure, development and validation of capabilities
    to easily identify/diagnose rBBI, methods to prevent, screen for, monitor, and correct neuroendocrine
    dysfunction. Additionally, Brain Health research efforts include, but are not limited to: methods to
    prevent TBI from impact and blast such as redesign of helmets, body armor, and munitions,
    development of pharmaceuticals to prevent and/or treat brain injury, validation of brain injury
    prevention strategies, and development of return to duty decision support tools.
    a. Environmental Exposures Protection:
    Research that develops novel material and/or approaches to protect SOF personnel from the
    neurological effects of single and repetitive auditory (impulse noise) and non-auditory (overpressure)
    blast exposures and other environmental factors determined to affect nervous system function.
    b. Environmental Exposure Effects:
    Research that determines the neurocognitive, nervous system, and auditory effects from single and
    repeated low- and high-level blast exposures, impulse noise, and other potential hazardous
    environmental factors.
    c. Biomarkers:
    Research to determine which biomarkers are indicative of rBBI; sequelae from rBBI causing further
    injury; recovery status; and recovery rate from rBBI. Testing and validating diagnostic biomarkers
    for rBBI. Proposals should also consider incorporation of validated biomarkers onto existing or
    future diagnostic platforms. Use of machine learning and/or model development to interpret and
    report biomarkers that are indicative of rBBI are of interest.
    d. Neuropsychological Testing:
    Research to validate neurocognitive assessment tools (NCATs) to determine baseline neurocognitive
    status, readiness, neurocognitive degradation, sensitivity to various exposures, TBI and recovery
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
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    status post injury. Proposals to improve the speed, accuracy, specificity, and proximity to injury for
    the use of NCATs, as well as to compare new technologies and/or modalities (including passive
    assessment of cognition) to existing NCATs.
    e. Olfactory, Oculomotor, Auditory, Vestibular, Cranial Nerve, and Vocal-Acoustic
    Performance:
    Research and proposals to perform and validate oculomotor, auditory, vestibular, cranial nerve, and
    vocal acoustic assessments. Research and proposals to assess the effect of nervous system injury to
    oculomotor, auditory, vestibular, cranial nerve, and vocal-acoustic performance and strategies to
    restore their performance after injury and prevent injury or further decline.
    f. Postural Stability:
    Research to assess the effects of blast exposure on postural stability including the proprioceptive
    component. Novel treatment strategies, therapies, and therapeutics to prevent and/or correct
    detriment to postural stability from TBI and neurotrauma caused by blast, impact, and/or other
    environmental exposures.
    g. Neuroendocrine Dysfunction:
    Methods to prevent, screen for, monitor, and correct neuroendocrine dysfunction.
    h. Neuroimaging:
    Research into novel imaging and imaging interpretation techniques including, but not limited to
    computed axial tomography (CAT), magnetic resonance imaging (MRI), and positron emission
    tomography (PET) scans, to diagnose brain tissue pathologies including, but not limited to, axonal
    injury, myelin injury, and interface astroglial scarring without the need for immunohistochemistry,
    immunofluorescence, or histopathology testing.
    i. Analytics:
    Research into analysis including machine learning, natural language processing, and artificial
    intelligence enabled analysis of data including, but not limited to, NCATs; environmental exposures
    likely to affect brain health; blast, impact, and noise exposures; auditory, vestibular, and vocal
    acoustic assessments; postural stability assessments; and neuroimaging.
    j. Neuromodulation:
    Research into the use of neuromodulation techniques for treating TBI, neurotrauma, pain, restoring
    and improving function, improving behavioral health, and cognitive performance.
    k. Brain Lymphatics and Glymphatics:
    Research into measuring the fluid dynamics of the brain lymphatic system, diagnosing dysfunction,
    and validation for tools or techniques to improve brain lymphatic clearance.
    l. Pupillometry, Pupillary Response, and Microsaccades:
    Research into field capable pupillary response measurement capture and analysis, with or without the
    ability to capture Microsaccades to assess central nervous system loading and/or damage.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
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    7. Automation of Systematic Reviews and Metanalysis:
    Research into Automation of Systematic Reviews and Metanalysis using the Preferred Reporting
    Items for Systematic Reviews and Meta Analyses (PRISMA) or a similar method
    8. Human Performance:
    USSOCOM requires SOF personnel to withstand extraordinary physical demands and psychological
    stress to complete their missions. The optimization of SOF personnel’s ability to perform at very
    high levels for long durations, in addition to processing information and making critical decisions in
    a timely manner, while operating in extreme environments, will significantly improve their overall
    operational effectiveness. This research area explores alternatives and/or new approaches to sustain
    and optimize SOF human performance both to increase mission capability and to extend the career
    longevity of SOF personnel.
    a. Improved Sleep:
    The proposed project must research, apply and/or develop novel approaches to achieve the
    restorative effects of sleep. This may include methods to induce, maintain, or improve the quality of
    sleep throughout the entire night. Additionally, the ability to accelerate the effects of sleep through
    methods requiring less time (e.g., the effects of sleeping eight hours are realized in four hours’ time)
    or enabling the SOF personnel to quickly reach and adequately cycle through the stages of sleep
    where the highest restorative effects occur (i.e., Stage 3/ deep sleep, and Stage 4/rapid eye movement
    sleep).
    b. Optimal Acclimatization Strategies:
    The proposed project must research, apply, and/or develop novel approaches and/or technologies that
    provide rapid and sustainable human acclimatization in austere environments, to include fatigue
    countermeasure, extremes in temperature, extremes in altitude, and time-zone change (i.e., circadian
    acclimatization).
    c. Wearables:
    The proposed project must research, apply, and/or develop novel approaches and/or wearable
    technologies, and/or leverage commercial-off-the-shelf wearable technologies that will monitor
    physiological measures of human performance to include, but not limited to, caloric expenditure,
    heart rate/heart rate response, heart rate variability, body fat percentage, sleep hygiene (deep and
    REM sleep duration) in real-time. Measures should be accurate with low fixed bias, wirelessly
    communicated via Bluetooth, Near Field Magnetic Induction or Radio Frequency technology in real-
    time and provide the command the capability to utilize the data for analysis of individuals and/or
    team performance via the USSOCOM Human Performance Data Management System. The device
    should be able to be turned on/off and/or have an inactive mode, provide real-time feedback on a
    display screen, be capable of displaying time, and be adjustable to fit users of different statures. Of
    parallel interest to address is a proposed project to track sleep, fatigue, and performance degradations
    through a wearable device that provides quantitative data (rather than qualitative surveys often seen
    in Fatigue Studies), that in turn will be gathered and amalgamated from entire units, in order to track
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
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    individual performance, unit performance, mission impacts to performance levels, length of time for
    acclimatization (if it is ever achieved), and potential risk of mishaps.
    d. Diagnostics for Performance Sustainment:
    The proposed project must research, apply, and/or develop minimally invasive diagnostic devices to
    provide actionable information on nutritional gaps, hormonal response to training, physiological
    response to performance interventions and recovery, and epigenetic predictors of potential injury.
    e. Performance Nutrition:
    The proposed projects must research, apply and/or develop methods to accurately measure nutritional
    status of SOF personnel. The proposed project should focus on cost effectiveness, accuracy, and
    end-user compatibility (i.e., user friendly) methods or devices for identifying and optimizing an
    individual’s nutrient status. Consideration of alternative fuel (energy) sources, dietary
    supplementation, biomarkers, and nutrient volume/timing are specific areas of interest.
    f. Physiological Performance:
    The proposed project must research, apply, and/or develop novel approaches and/or technologies to
    maximize the physiological performance of SOF personnel in austere and/or training environments,
    to include increased endurance, enhanced senses, tolerance to environmental extremes, and enhanced
    overall fitness, to maintain operational posture/ability in high stress scenarios without noticeable
    augmentation, and without hampering personnel mobility.
    g. Cognitive Performance:
    The proposed project must research, apply, and/or develop novel approaches and/or technology that
    provide greater mental acuity or neuroenhancement (i.e., targeted enhancement and extension of
    cognitive and affective abilities). Encompasses pharmacological and non-pharmacological methods
    of improving cognitive, affective, motor functionality and performance, to include neuromodulation.
    h. Psychological Performance and Suicide Prevention:
    The proposed project must research, apply, and/or develop novel approaches to the assessment and
    improvement of behavioral health within the force. Examples include but are not limited to, novel
    approaches to treatment and rehabilitation from acute and/or chronic post-traumatic stress,
    depression, and anxiety, improved emotional and nervous system self-regulation, digital/virtual
    engagement strategies, methods to measure behavioral health performance over time, and improved
    suicide prevention tools/strategies.
    9. Canine Medicine and Performance:
    SOF personnel rely on canines’ exceptional capabilities as combat multipliers. This research area
    explores alternatives and/or new approaches to preserve and enhance SOF canine combat
    performance. SOF medical personnel place a premium on canine-specific approaches that are
    effective in extreme environments and do not require significant additional logistical support (i.e.,
    maximize use of available SOF Medic materiel). The eight “Canine Medicine and Performance”
    project areas, to which SOF will give consideration, in priority order, are:
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
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    a. Trauma Resuscitation:
    The proposed project must support development of innovative techniques/strategies for canine
    trauma resuscitation (e.g., hypotensive resuscitation, whole blood/blood component replacement, and
    non-compressible hemorrhaging), particularly to address ballistic projectile injuries, in
    diverse/austere environments that lack immediately available medical evacuation or restorative
    surgical capacity.
    Note: Research should minimize or refrain from utilizing canine specific equipment or devices; this
    will allow treatment from existing trauma kits fielded by SOF Medics.
    b. Non-Traditional Anesthesia Protocols:
    The proposed project must develop novel approaches for routine and emergency/post- traumatic
    canine field sedation and/or anesthesia in diverse environments and, utilizing pharmaceuticals
    available to SOF Medics.
    c. Canine Performance:
    The proposed project must research, apply, and/or develop novel approaches and/or technologies that
    address optimization of canine performance through improved physical conditioning programs,
    reduction of cognitive decline, enhanced nutrition, and genetics research.
    d. Sensory Optimization and Protection:
    Research must be oriented toward innovative methods that enhance or conserve SOF canine
    olfactory, visual, and/or auditory performance during combat operations.
    e. Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Canine
    Decontamination, Treatment, and PPE Against Possible Exposure:
    The proposed projects must research, apply, and/or develop novel approaches that will diagnose,
    treat, decontaminate, and protect canines from exposure to chemical, biological, radiological,
    nuclear, and high yield explosives.
    f. Environmental Extremes:
    Project proposals must research, apply, and/or develop novel strategies that address acclimatization
    to acute extremes in temperature, altitude, and/or time zone change (circadian acclimatization),
    and/or prolonged marine environmental exposure in SOF canines.
    g. Brain Health and TBI
    Brain health research efforts include but are not limited to development and validation of NCATs,
    blast exposure and impact monitoring, determination of safe acceptable limits for blast exposure,
    validation of neurocognitive baseline testing, capabilities to easily determine mild, moderate, and
    severe TBI, pharmaceuticals to prevent or treat brain injury, validation of brain injury treatment
    strategies, and procedures to determine safe return to duty decisions for SOF canines.
    h. Pre- and Post-Trauma Training / Behavioral Issues:
    The proposed project must address unique approaches to diagnosing and treating SOF-peculiar
    training and post-traumatic canine behavioral issues, to optimize pre-purchase selection and post-
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
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    purchase training strategies across the enterprise and restore performance in canines with behavioral
    and/or post-trauma issues.
    10. Medical Sustainment
    SOF medical personnel require sustainment capabilities to support far-forward medical
    requirements to reduce the patient and supply risk associated with operational medicine. The
    proposed research, application, and/or development of medical sustainment techniques and
    materiel must address unique approaches to optimizing supply management and safeguarding
    equipment requirements. The project areas under “Medical Sustainment” to which the
    USSOCOM will give highest consideration are:
    a. Power and Energy
    Project proposals must research, apply, and/or develop novel strategies that conserve or optimize
    medical equipment in-field use to reduce sustainment burden in prolonged, austere
    environments.
    b. Austere Medical Logistics Procurement
    SOF personnel, operating in austere environments, may not have the ability to receive
    conventional resupply efforts. Project proposals must research, apply, and/or develop novel
    approaches to assist SOF personnel in developing and receiving medical resupplies or repair
    parts to meet their needs while in the field. These efforts must meet shipping and handling
    considerations (i.e. temperature control) for a wide range of medical products from batteries to
    blood. Efforts may include, but are not limited to, fabrication, improvisation, and/or delivery
    methods from sea, ground, air, or suborbital domains.
    c. Equipment Protection
    Research that develops novel material and/or approaches to protect SOF medical equipment from
    environmental (i.e. CBRNE, freezing temperatures, etc.) and/or adversarial effects (i.e. jamming,
    electromagnetic pulse weapons, etc.).
    d. Supply Monitoring Capability
    Project proposals must research, apply, and/or develop novel approaches to rapidly forecasting
    and calculating supply requirements based on patient treatment requirements, shelf-life, and
    storage considerations.
    II.B. Federal Award Information
    The Anticipated total costs budgeted for the entire period of performance inclusive of all
    contract awards made in response to this BAA, will not exceed $20 Million annually. The
    number of awards is indeterminate and contingent upon funding availability. Any funding
    that is received by the USSOCOM that is appropriate for a research area described within this
    BAA may be utilized to fund awards. Refer to Section II.D.5. Funding Restrictions, for
    detailed funding information.
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    The USAMRAA will negotiate the contract awards for proposals selected for funding. A contract
    is required when the principal purpose of the instrument is to acquire supplies or services for the
    direct benefit or use of the U.S. Government. The contract type, along with the start date, will be
    determined during the negotiation process.
    Please see Appendix 2 of the General Submission Instructions for more information.
    Research involving Human Anatomical Substances, Human Subjects, or Human Cadavers:
    All DoD-funded research involving new and ongoing research with human anatomical
    substances, human subjects, or human cadavers must be reviewed and approved by the
    USAMRDC Office of Human Research Oversight (OHRO),, prior to research implementation.
    This administrative review requirement is in addition to the local Institutional Review Board
    (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is
    not required. The OHRO Human Research Protections Official (HRPO) review is mandated to
    comply with specific laws and requirements governing all research involving human anatomical
    substances, human subjects, or human cadavers that is supported by the DoD. These laws and
    requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a
    minimum of 2 to 3 months for OHRO HRPO regulatory review and approval processes.
    Additional time for regulatory reviews may be needed for clinical studies taking place in
    international settings. When possible, protocols should be written for research with human
    subjects and/or human anatomical substances that are specific to the DoD-supported effort
    outlined in the submitted proposal/application as a stand-alone study. Submission to OHRO of
    protocols involving more than the scope of work in the DoD-funded award will require review of
    the entire protocol (DoD and non-DoD funded). DoD human subjects' protection requirements
    may be applied to non-DoD funded work and necessitate extensive revisions to the protocol.
    Refer to the General Submission Instructions, Appendix 1, and the Human Subject Resource
    Document available on the eBRAP “Funding Opportunities & Forms” web page
    (https://ebrap.org/eBRAP/public/Program.htm) for additional information.
    Typically, a clinical trial is not associated with this BAA. A clinical trial is defined as a
    prospective accrual of patients (human subjects) in which an intervention (e.g., device, drug,
    biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested
    for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome
    represents a direct effect on the subject of that intervention or interaction.
    Research Involving Animals: All DoD-funded research involving new and ongoing research
    with animals must be reviewed and approved by the USSOCOM Veterinarian Review Office
    (VRO) which ensures that research conducted, contracted, sponsored, supported, or managed by
    the DoD involving animal care are conducted in accordance with federal, DoD, Army,
    USSOCOM VRO, and international regulatory requirements. The USSOCOM VRO is
    responsible for administrative review, approval, and oversight of all animal research protocols,
    including all changes made during the life of the protocol.
    Specific documents relating to the use of animals in the proposed research will be requested if
    the application is selected for funding. The VRO must review and approve all animal use prior
    to the start of working with animals, including amendments to ongoing projects. PIs must
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    submit the institutional animal use protocol. Allow at least 1 to 2 months for regulatory review
    and approval processes for animal studies.
    Questions concerning animal use and review should be directed to the USSOCOM VRO:
    Phone: 813-826-6031; Email: socom_vet@socom.mil.
    Refer to the General Submission Instructions, Appendix 1, for additional information.
    The USSOCOM intends that information, data, and research resources generated under awards
    funded by this BAA be made available to the research community (which includes both
    scientific and consumer advocacy communities) and to the public at large.
    II.C. Eligibility Information
    II.C.1. Eligible Applicants
    II.C.1.a. Organizations:
    Awards are made to organizations only. Organizations eligible to apply include national,
    international, for-profit, non-profit, public, and private organizations. Refer to the General
    Submission Instructions, Appendix 3.B, for general eligibility information.
    NOTE: In accordance with FAR 35.017, Federally Funded Research and Development Centers
    (FFRDCs) are not eligible to directly receive awards under this BAA. However, teaming
    arrangements between FFRDCs and eligible organizations are allowed so long as they are
    permitted under the sponsoring agreement between the Federal Government and the specific
    FFRDC.
    The USSOCOM is committed to supporting small businesses. Small business, Veteran-owned
    small business, Service-disabled Veteran-owned small business, HUBZone small business,
    disadvantaged small business, and woman-owned small business concerns must be given the
    maximum practical opportunity to participate through subawards on research proposals
    submitted through the BAA.
    II.C.1.b. Eligible Investigators
    Eligible investigators include all individuals, regardless of ethnicity, nationality, or citizenship
    status, who are employed by, or affiliated with, an eligible organization.
    There are no limitations on the number of proposals for which an investigator may be named as a
    Principal Investigator (PI).
    The USAMRAA makes awards to eligible organizations, not to individuals.
    In addition to other information provided herein, by submitting a proposal/application and
    accepting an award, the organization is: (1) certifying that the investigators’ credentials have
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    been examined and; (2) verifying that the investigators are qualified to conduct the proposed
    study and to use humans or animals as research subjects, if proposed.
    II.C.2. Cost Sharing
    Cost sharing/matching is not an eligibility requirement.
    II.C.3. Other
    Organizations must be able to access .gov and .mil websites in order to fulfill the financial and
    technical deliverable requirements of the award and submit invoices for payment.
    Refer to Section II.H.1, Administrative Actions, for a list of administrative actions that may be
    taken if a pre-application or application does not meet the administrative, eligibility, or ethical
    requirements defined in this BAA.
    For general information on required qualifications for award recipients, refer to the General
    Submission Instructions, Appendix 3.
    Use of the System for Award Management (SAM) and the Responsibility/Qualification (R/Q):
    To protect the public interest, the Federal Government ensures the integrity of Federal programs
    by striving to conduct business only with responsible organizations. The USSOCOM uses the
    “Exclusions” within the Performance Information functional area of the SAM and data from the
    R/Q, a component within SAM, to verify that an organization is eligible to receive Federal
    awards. More information about the SAM and the R/Q is available at https://www.sam.gov/.
    Refer to the General Submission Instructions, Appendix 3, for additional information.
    Conflicts of Interest: All awards must be free of conflicts of interest (COIs) that could bias the
    research results. Prior to award of a contract, applicants will be required to disclose all potential
    or actual COIs along with a plan to manage them. An award may not be made if it is determined
    by the Contracting Officer that COIs cannot be adequately managed. Refer to the General
    Submission Instructions, Appendix 3, for additional information.
    Review of Risk: The following areas may be reviewed in evaluating the risk posed by an
    applicant: Financial stability; quality of management systems and operational controls; history
    of performance; reports and findings from audits; ability to effectively implement statutory,
    regulatory, or other requirements imposed on non-Federal entities; degree of institutional
    support; integrity; adequacy of facilities; and conformance with safety and environmental
    statutes and regulations.
    Subcontracting Plan: If the resultant award is a contract that exceeds $750,000 and the offeror
    is other than a small business, the contractor will be required to submit a subcontracting plan for
    small business and small disadvantaged business concerns, in accordance with FAR 19.704 and
    DFARS 219.704. A mutually agreeable plan will be incorporated as part of the resultant
    contract.
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    II.D. Proposal/Application Submission Information
    II.D.1. Where to Obtain the Proposal/Application Submission Package
    To obtain the complete Grants.gov proposal/application package (hereinafter, submission
    package), including all required forms, perform a Grants.gov (http://www.grants.gov/) basic
    search using the Funding Opportunity Number HT9425-23-S-SOC1.
    Submission is a two-step process requiring both (1) pre-proposal/pre-application submission
    through eBRAP (https://eBRAP.org/) and (2) full proposal/application submission through
    Grants.gov or eBRAP, depending on the type of application being submitted.
    eBRAP is a multifunctional web-based system that allows PIs to submit their pre-applications
    electronically through a secure connection, to view and edit the content of their pre-applications
    and full applications, to receive communications from the USSOCOM, and to submit
    documentation during award negotiations and period of performance.
    Classified Submissions: Classified proposals are not expected. However, in an unusual
    circumstance the applicant may be notified that access to classified information and/or controlled
    unclassified information will occur under the work proposed. In those instances where a contract
    is awarded requiring access to classified information and/or controlled unclassified information,
    clause FAR 52.204-2 shall be in effect, as well as a DD Form 254, if issued.
    Care must be exercised to ensure that classified, sensitive, and critical technologies are not
    included in a proposal/ application package. If such information is required, appropriate
    restrictive markings and procedures should be applied prior to submission of the proposal/
    application package. Portions of the proposal/ application package may be subject to release
    under terms of the Freedom of Information Act, 5 U.S.C. 552, as amended.
    Pre-application content and forms must be accessed and submitted at eBRAP.org. Full
    application packages must be accessed and submitted at Grants.gov.
    Contact information for the eBRAP Help Desk and the Grants.gov Contact Center can be found
    in Section II.G, Federal Awarding Agency Contacts.
    II.D.2. Content and Form of the Proposal/Application Submission
    Submission is a two-step process requiring both pre-application submission and full application
    submission as indicated below. The submission process should be started early to avoid missing
    deadlines. There are no grace periods.
    Pre-Application Submission: All pre-applications for extramural organizations must be
    submitted through eBRAP (https://eBRAP.org/).
    Full Application Submission: Full applications must be submitted through the online portals as
    described below.
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    Submitting Organizations: Full applications from extramural organizations must be submitted
    through a Grants.gov Workspace. Applications submitted by extramural organizations (e.g.,
    research foundations) on behalf of intramural DoD or other Federal organizations or
    investigators will be considered extramural submissions. Applications from extramural
    organizations, including non-DoD Federal organizations, received through eBRAP will be
    withdrawn. See definitions in Section II.C.1, Eligible Applicants.
    A key feature of eBRAP is the ability of an organization’s representatives and PIs to view and
    modify the full application submissions associated with them. eBRAP will validate full
    application files against the specific BAA requirements, and discrepancies will be noted in an
    email to the PI in the “Full Application Files” tab in eBRAP. It is the applicant’s responsibility
    to review all application components for accuracy as well as ensure proper ordering as specified
    in this BAA.
    The application title, eBRAP log number, and all information for the PI, Business Official(s),
    performing organization, and contracting organization must be consistent throughout the
    entire pre-application and full application submission process. Inconsistencies may delay
    application processing and limit or negate the ability to view, modify, and verify the application
    in eBRAP. If any changes need to be made, the applicant should contact the eBRAP Help Desk
    at help@eBRAP.org or 301-682-5507 prior to the application submission deadline.
    II.D.2.a. Step 1: Pre-Proposal/Pre-Application Submission Content
    Submission of a pre-proposal/pre-application is required and must be submitted through eBRAP
    (https://eBRAP.org/). If the USSOCOM is interested in receiving a full proposal/application, the
    PI will be sent an invitation to submit via eBRAP.
    During the pre-proposal/pre-application process, each submission is assigned a unique log
    number by eBRAP. This unique eBRAP log number is required during the full application
    submission process. To begin the pre-application process, first select whether the submitting
    organization is extramural or intramural, then confirm your selection or cancel. Incorrect
    selection of extramural or intramural submission type will delay processing.
    If an error has been made in the selection of extramural versus intramural and the pre-application
    submission deadline has passed, the PI or Business Official must contact the eBRAP Help Desk
    at help@eBRAP.org or 301-682-5507 to request a change in designation.
    Because the invitation to submit a proposal/application is based on the contents of the pre-
    proposal/pre-application, a PI should not change the title or research objectives after the pre-
    proposal/pre-application is submitted. A PI and organization identified in the pre-proposal/pre-
    application should be the same as those intended for the full proposal/application submission. If
    any changes are necessary after submission of the pre-proposal/pre-application, the PI must
    contact the eBRAP Help Desk via email at help@eBRAP.org or 301-682-5507. A change in PI
    or organization after submission of the pre-proposal/pre-application will be allowed only at the
    discretion of the USAMRAA Contracting Officer. Change in Principal Investigator during
    contract performance unless otherwise restricted, will be allowed at the discretion of the
    USAMRAA Contracting Officer, provided that the intent of the award is met.
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    The organization, Business Official, and PI must register in eBRAP before submitting a pre-
    proposal/pre-application. Upon completion of an organization’s registration in eBRAP and
    approval by the eBRAP Help Desk, the organization name will be displayed in eBRAP to assist
    the organization’s Business Officials and PIs as they register. The organization, Business
    Officials, and PIs must all be registered and affiliated in eBRAP. (See eBRAP User Guide at
    https://ebrap.org/eBRAP/public/UserGuide.pdf.)
    Pre-proposals may be submitted at any time prior to the BAA closing date. Pre-proposals should
    describe specific ideas or projects that pertain to any of the areas described under “Program
    Description” in this BAA. A pre-proposal/pre-application must include a brief description of the
    scientific methods and design to address the problem as described below. Brochures or other
    descriptions of general organizational or individual capabilities will not be accepted as a pre-
    proposal/pre-application. DO NOT include any proprietary information in the pre-
    proposal/pre-application.
    The pre-proposal/pre-application consists of the following components, which are organized in
    eBRAP by separate tabs. Refer to the General Submission Instructions, Section II, for additional
    information on the pre-proposal/pre-application submission.
    • Tab 1 – Application Information: Enter the information as described in eBRAP before
    continuing the pre-proposal/pre-application.
    • Tab 2 – Application Contacts: Enter contact information for the PI and the
    organization’s Business Official responsible for the sponsored program administration (or
    equivalent). This is the individual listed as “person to be contacted on matters involving
    this Application” in Block 5 of the Grants.gov SF424 form. The form is designed to fill in
    common required fields across other forms, such as the applicant's name, address, and
    Unique Entity Identifier (UEI) Number. Once it is completed, the information will
    transfer to the other forms.
    The Business Official must either be named or invited in order for the pre-proposal/pre-
    application to be submitted. If the organization’s Business Official is not in eBRAP, an
    invitation to the Business Official to register in eBRAP must be sent. In addition, it is
    recommended that the applicant identify an Alternate Submitter in the event that
    assistance with pre- proposal/pre-application submission is needed.
    NOTE: The eBRAP system does not require an approval of the pre-proposal/pre-
    application by the PI’s organization.
    • Tab 3 – Collaborators and Key Personnel:
    Enter the name, organization, and role of all collaborators and key personnel associated
    with the Application (including co-investigators, mentors, collaborators, consultants, and
    subrecipients/subawardees) associated with the proposal/ application. Enter the
    organization’s Business Official responsible for sponsored program administration (the
    “person to be contacted on matters involving this Application” in Block 5 of the
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    Grants.gov SF-424 form). The Business Official must either be selected from the eBRAP
    list or invited in order for the pre- proposal/pre-application to be submitted.
    • Tab 4 – Conflicts of Interest (COI):
    List all individuals other than collaborators and key personnel who may have a conflict of
    interest (COI) in the review of the pre-proposal/pre-application (including those with
    whom the PI has a personal or professional relationship). Federal agency personnel
    involved in the review process and/or with making funding recommendations are
    prohibited from being involved in the research proposed or assisting in any pre-
    proposal/pre-application, including, but not limited to, concept design, proposal/
    application development, budget preparation, and the development of any supporting
    documentation. If formal collaboration with Military Facility personnel is planned
    (i.e., included in the proposal/application in performance of the research), this
    prohibition is not applicable. Military Facility is defined as Military Health System
    (MHS) facility, research laboratory, medical treatment facility, dental treatment
    facility, or a DoD activity embedded with a civilian medical center. However, these
    Military Facility personnel cannot be involved in the review process and/or with
    making funding recommendations. Refer to the General Submission Instructions,
    Appendix 3.D, for additional information. For questions related to COI, contact the
    eBRAP Help Desk at help@eBRAP.org or 301-682-5507.
    • Tab 5 – Pre-Application Files:
    Note: Upload document(s) as individual PDF files unless otherwise noted. eBRAP will
    not allow a file to be uploaded if the number of pages exceeds the limit specified below.
    Pre-Proposal/Pre-Application Narrative (6-page limit): The pre-proposal/ pre-
    application narrative page limit applies to text and non-text elements (e.g., figures, tables,
    graphs, photographs, diagrams, chemical structures, drawings, etc.) used to describe the
    project. Inclusion of URLs that provide additional information to expand the Narrative
    and could confer an unfair competitive advantage is prohibited and may result in
    administrative withdrawal of the pre-proposal/pre-application.
    Include the following:
    ○ Problem to Be Studied: Describe the perceived issue(s) and the problems to be
    studied. This section should serve as an abstract of the proposed work.
    ○ Theoretical Rationale, Scientific Methods, and Design: Describe how the
    research approach for accomplishing the specific aims is feasible, will
    accomplish the objectives, will provide information on proposed methods and
    analysis/evaluation strategies, and is based on sound rationale. Describe how the
    proposed work and research will create and produce a demonstration and
    validation/proof of concept to meet the subject Topic Area.
    – Background/Rationale: Clearly present the ideas and reasoning behind
    the proposed research. Include relevant military and civilian literature
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    citations, preliminary and/or pilot data, and/or other evidence that led to
    the development of the proposed research. Any preliminary data should
    be from the laboratory of the PI or member(s) of the collaborating team.
    – Hypothesis/Objective and Specific Aims: State the proposed project’s
    hypothesis and/or objectives and the specific aims/tasks of the proposed
    research.
    – Approach/Methodology: Describe the research approach. Include
    research design, methods, and analysis/evaluation strategies as well as
    materials anticipated to be used during the research. Include a description
    of human use in the proposed project. For studies involving human
    subjects, include a description of the size, characteristics, and partnering
    organizations of the subject population that will be employed.
    ○ Significance, Relevance, and Innovation of the Proposed Effort:
    – Significance and Relevance: Clearly articulate how the proposed research is
    instrumental in addressing research gaps, meets military requirements, and has
    military relevance to improving theater/operational medicine.
    – Innovation: Explain how the proposed project is innovative and not an
    incremental advancement of previous work.
    ○ Proposed Study Design/Plan: Provide the intended research methodology that
    will support the study. Provide preliminary information such as description and
    background of the technical solution, anticipated success criteria, research/test
    plan(s), and statistical protocols. Refer to Section II.A., Program Description, for
    additional information on the RAIs for this BAA.
    ○ Military Impact: Describe the anticipated short- and/or long-term outcomes of the
    proposed project and their potential impact on improving technologies, data and/or
    processes. Refer to Section II.A., Program Description, for additional information on
    the anticipated outcomes sought by this BAA.
    ○ Personnel and Facilities: Describe the role of the PI, co-PIs (if applicable), key
    personnel, sub-awards (if applicable), and consultants (if applicable) in the research
    team, including the expertise each brings to the proposed project. Explain how the
    team’s expertise is appropriate and complementary for achieving the research goals.
    Also, briefly provide information on the primary facility where the research is
    expected to be performed.
    ○ Open Source/License/Architecture: Describe the intellectual property that is
    intended to be incorporated within the design/plan and identify any additional
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    costs, such as licensing, which may be needed to ensure flexibility or adaption of
    the research project for Government use.
    Pre-Proposal/Pre-Application Supporting Documentation: The items to be included as
    supporting documentation for the pre-proposal/pre-application must be uploaded as individual
    PDF documents and are limited to:
    ○ References Cited (one-page limit): List the references cited (including URLs if
    available) in the pre-proposal/pre-application narrative using a standard reference
    format that includes the full citation (i.e., author[s], year published, title of reference,
    source of reference, volume, chapter, page numbers, and publisher, as appropriate).
    ○ List of Abbreviations, Acronyms, and Symbols: Provide a list of abbreviations,
    acronyms, and symbols used in the pre-proposal/pre-application narrative.
    ○ PI and Key Personnel Biographical Sketches (five-page limit per individual):
    Upload as “Biosketch_LastName.pdf.” Bold or highlight publications relevant to the
    proposed project.
    ○ Budget Summary: Upload as “BudgetSummary.pdf.” Complete the two-page Pre-
    Application Budget Summary Form (available for download in eBRAP) as instructed.
    ○ Quad Chart: Upload as “QuadChart.pdf.” Complete the one-page Quad Chart
    Form (available for download in eBRAP) as instructed.
     Submit Pre-Application – Tab 6: This tab must be completed for the pre-
    proposal/preapplication to be accepted and processed.
    II.D.2.b. Pre-Proposal/Pre-Application Screening Criteria
    The USSOCOM scientists or outside experts will screen pre-proposals for technical merit and
    programmatic considerations. Based on the screening of the preproposal, a PI may be invited to
    submit a full proposal/application. Pre- proposal will be screened based on the following
    criteria, listed in descending order of importance:
    • Theoretical Rationale, Scientific Methods, and Research: To what degree the
    research approach for accomplishing the specific aims is feasible, will accomplish
    the objectives, will provide information on proposed methods and analysis/
    evaluation strategies, and is based on sound rationale. To what degree the proposed
    work and research will create and produce a demonstration and validation/proof of
    concept to address the Topic Area.
    • Significance, Relevance, and Innovation: To what degree the proposed research is
    relevant and innovative, including whether the proposed research is duplicative of
    existing research.
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    • Study Design/Plan: To what degree the proposed demonstration and validation study
    methodologies, anticipated sample and sample size, test plan(s), anticipated success
    criteria, evaluation criteria/metrics, and statistical protocols will justify and support
    the intended outcomes of the proposed research.
    • Military Impact: To what degree the project’s anticipated short- and/or long-term
    outcomes will impact the military and provide advancement in theater/operational
    medicine in the military health system in a way that is consistent with the intent of
    the award mechanism.
    • Personnel, Facilities, Timelines, and Budget: To what degree the expertise,
    experience, and knowledge of the key research personnel (including co-PIs if
    applicable), sub-awards (if applicable), and consultants (if applicable) are
    appropriate and complementary for achieving the research goals. To what degree
    the prime facility will be able to perform the proposed research.
    Following the pre-proposal/pre-application screening, PIs will be notified as to whether or not
    they are invited to submit full proposals; however, they will not receive feedback (e.g., a critique
    of strengths and weaknesses) on their pre-proposals. Within 180 days of submission, PIs should
    receive email notification via eBRAP regarding disposition of their pre-proposals.
    A. II.D.2.c. Step 2: Full Proposal/Application Submission Content
    A Proposal/Application will not be accepted unless the PI has received an invitation to submit.
    If the USSOCOM is interested in receiving a full proposal/application, the PI will receive an
    invitation to submit via email from eBRAP. It should be submitted within 60 days of the PI’s
    receipt of an invitation to submit, as directed in II.D.2. Agency receipt of a full
    proposal/application will be acknowledged by an email sent to the PI via eBRAP. The
    proposal/application log number for the full proposal/application will be the same number as
    used for the pre-proposal/pre-application, e.g., SO23XX.
    The USSOCOM cannot make allowances/exceptions to its policies for submission problems
    encountered by the applicant organization using system-to-system interfaces with Grants.gov.
    Each application submission must include the completed full application package for this BAA.
    The full application package is submitted by the Authorized Organizational Representative
    through Grants.gov (http://www.grants.gov/) for extramural organizations. See Table 1 below for
    more specific guidelines. Proprietary information should only be included if necessary for
    evaluation of the proposal/application. Conspicuously and legibly mark any proprietary
    information that is included in the proposal/application.
    II.D.2.c.i. Full Guidelines
    Organizations must submit full applications through Grants.gov. Applicants must create a
    Grants.gov Workspace for submission, which allows the application components to be
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    completed online and routed through the applicant organization for review prior to submission.
    Applicants may choose to download and save individual PDF forms rather than filling out
    webforms in the Workspace. A compatible version of Adobe Reader must be used to view,
    complete, and submit an application package consisting of PDF forms. If more than one person
    is entering text into an application package, the same version of Adobe Reader software should
    be used by each person. Check the version number of the Adobe software on each user’s
    computer to make sure the versions match. Using different versions of Adobe Reader may cause
    submission and/or save errors – even if each version is individually compatible with Grants.gov.
    Refer to the General Submission Instructions, Section III, and the “Apply For Grants” page of
    Grants.gov (https://www.grants.gov/web/grants/applicants/apply-for-grants.html) for further
    information about the Grants.gov Workspace submission process. Submissions of extramural
    applications through eBRAP may be withdrawn.
    Table 1. Full Submission Guidelines
    Submissions
    Download application package components for
    HT9425-23-S-SOC1 from Grants.gov
    (http://www.grants.gov) and create a Grants.gov
    Workspace. The Workspace allows online completion
    of the application components and routing of the
    application package through the applicant organization
    for review prior to submission.
    SF424 Research & Related Forms (R&R)
    Application for Federal
    Assistance Form: Refer to the General Submission
    Instructions, Section III.A.1, for detailed information.
    Submissions
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    Descriptions of each required file can be found under
    Full Application Submission Components:
    • Attachments
    • Research & Related Personal Data
    • Research & Related Senior/Key Person
    Profile (Expanded)
    • Research & Related Budget
    • Project/Performance Site Location(s) Form
    • R&R Subaward Budget Attachment(s) Form
    (if applicable)
    • (if applicable) Additional Application
    Component(s)
    Complete a Grants.gov Workspace.
    Add participants (investigators and Business Officials)
    to the Workspace, complete all required forms, and
    check for errors before submission. The Workspace
    progress bar will display the state of your application
    process as you apply. As you apply using Workspace,
    you may click the blue question mark icon near the
    upper-right corner of each page to access context-
    sensitive help.
    Mandatory Fields in Forms: In the forms, you will
    note fields marked with an asterisk and a different
    background color. These fields are mandatory fields
    that must be completed to successfully submit your
    application.
    Submit a Grants.gov Workspace Package. An
    application may be submitted through
    Workspace by clicking the “Sign and Submit” button on
    the “Manage Workspace” page, under the “Forms” tab.
    Grants.gov recommends submission of the application
    package at least 24-48 hours prior to the close date to
    allow time to correct any potential technical issues that
    may disrupt the application submission.
    Note: If either the Project Narrative or the budget fails
    eBRAP validation or if the Project Narrative or the
    budget needs to be modified, an updated Grants.gov
    application package must be submitted via Grants.gov
    as a “Changed/Corrected Application” with the previous
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    Grants.gov Tracking ID prior to the application
    submission deadline.
    Submissions
    The full application package submitted to
    Grants.gov may be viewed and modified in eBRAP until
    the end of the application verification period. During
    the application verification period, the full application
    package, with the exception of the Project Narrative
    and Budget Form, may be modified.
    Tracking a Grants.gov Workspace Package. After
    successfully submitting a Workspace package, a
    Grants.gov Tracking Number is automatically assigned
    to the package. The number will be listed on the
    “Confirmation” page that is generated after submission.
    Refer to the General Submission Instructions, Section
    III, for further information regarding Grants.gov
    requirements.
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    Application viewing, modification, and verification in eBRAP are strongly recommended, but
    not required. The Project Narrative and Budget cannot be changed after the application
    submission deadline. Prior to the full application deadline, a corrected or modified full
    application package may be submitted. Other application components may be changed until the
    end of the application verification period. Verify that subaward budget(s) and budget
    justification forms are present in eBRAP during the application verification period. If these
    components are missing, upload them to eBRAP before the end of the application verification
    period. After the end of the application verification period, the full application cannot be
    modified.
    Material submitted after the end of the application verification period, unless specifically
    requested by the Government, will not be forwarded for processing.
    II.D.2.c.ii. Full Proposal/Application Submission Components
    The Grants.gov submission package includes the following components (refer to the General
    Submission Instructions, Section III., for additional information on proposal/application
    submission):
    1. SF 424 (R&R) Application for Federal Assistance Form: Refer to the General
    Submission Instructions, Section III for detailed information.
    2. Attachments Form
    Each attachment to the full proposal/application components must be uploaded as an
    individual file in the format specified and in accordance with the formatting guidelines
    listed in the General Submission Instructions, Appendix 4.
    For all attachments, ensure that the file names are consistent with the guidance. Attachments
    will be rejected if the file names are longer than 50 characters or have incorrect file names
    that contain characters other than the following: A-Z, a-z, 0-9, underscore, hyphen, space,
    and period. In addition, there are file size limits that may apply in some circumstances.
    Individual attachments may not exceed 20 MB, and the file size for the entire full
    proposal/application package may not exceed 200 MB.
     Attachment 1: Project Narrative (20-page limit): Upload as
    “ProjectNarrative.pdf.” The page limit of the Project Narrative applies to text
    and non-text elements (e.g., figures, tables, graphs, photographs, diagrams,
    chemical structures, drawings, etc.) used to describe the project. Inclusion of
    URLs that provide additional information to expand the Project Narrative and
    could confer an unfair competitive advantage is prohibited and will result in
    administrative withdrawal of the proposal/application.
    Describe the proposed project in detail using the outline below.
    ○ Background: Present the ideas and reasoning behind the proposed
    research; include relevant literature citations or preliminary data on the
    proposed technical solution(s) and how they may have been utilized in
    similar environment(s). Describe previous experience most pertinent to this
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    project. Any preliminary data should be from the laboratory of the PI or
    member(s) of the collaborating team.
    ○ Hypotheses/Objectives: State the hypotheses or research/evaluation
    questions and overall objective(s) to be reached.
    ○ Specific Aims: Concisely explain the project’s specific aims to include
    expected timeframe of each aim. If this proposal/application is part of a
    larger study, present only tasks this award would fund.
    ○ Project Design: Describe and define the research design, methods, and
    analyses/evaluations in sufficient detail for analysis.
    — Clearly support the choice of study variables/metrics and explain the
    basis for the research questions and/or study hypotheses. Establish the
    relevance of the study and explain the applicability of the proposed
    findings.
    — Provide a detailed protocol, including but not limited to, proposed
    methodologies, research/test plan(s) and criteria, intended medical
    domain(s) or discipline(s), control groups, and defined statistical
    models.
    — Define the study variables (independent/dependent) and define how they
    will be measured. Include a description of appropriate controls and the
    endpoints to be tested. Describe how data will be collected and analyzed in
    a manner that is consistent with the study objectives. Describe a plan for
    data access and outcome dissemination.
    — For development of devices and technologies, discuss the engineering/
    technical design that will be used to achieve the project goals,
    demonstrating the feasibility of the proposed product development. Discuss
    the perceived engineering/design strengths and flaws and recommendations
    for overcoming/preventing them.
    — Address all potential barriers and provide plans for addressing potential
    delays, unexpected events, changes in key personnel, and ongoing
    adaptation of the Application. Provide a risk management plan to address
    barriers to plans. As relevant, describe plans for addressing potential
    issues unique to working within the military health system.
    — Document the availability and accessibility of the study materials (including
    data) needed as applicable.
    ○ Project Milestones: Identify timelines for critical events that must be
    accomplished in order for the project to be successful in terms of cost,
    schedule, and performance. For development of devices and technologies,
    discuss the timelines and provide a commercial strategy plan for the
    technology being developed.
    ○ Additional Information: If human subjects are involved in the research,
    proposals may be submitted prior to human protocol institutional approvals.
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    However, protocols with required institutional approvals must be submitted no
    later than 60 days after award to demonstrate continued progress and ensure
    continuation of payment. The Contracting Officer may make exceptions in
    situations where human and/or animal use is not expected to begin until after
    the first year of the research project. In such cases, a timeframe for submission
    of the appropriate protocols and institutional approvals will be established
    prior to award.
    PIs and collaborating organizations may not use, employ, or subcontract for
    the use of any human participants, including the use of human anatomical
    substances, human data, and/or human cadavers, or laboratory animals until
    applicable regulatory documents are approved by the OHRO and or
    USSOCOM VRO to ensure that DoD regulations have been met.
    – For studies with prospective accrual of human subjects, indicate
    quarterly enrollment targets.
    – Identify cell line(s) and commercial or organizational source(s) to be
    used. If human anatomical substances (including cell lines) will be used,
    specify whether or not identifiable information is accessible to the
    research team by any means.
    – If applicable, indicate time required for submission and/or approval of
    documents (e.g., Investigational New Drug and Investigational Device
    Exemption) to the U.S. Food and Drug Administration or appropriate
    Government agency.
    – For studies involving human subjects, allow at least 2 to 3 months for
    regulatory review and approval by the USAMRDC OHRO; this does not
    include the additional time required for local Institutional Review Board
    (IRB)/Ethics Committee (EC) review and approval.
    Refer to the General Submission Instructions, Appendix 5, for additional
    regulatory information.
     Attachment 2: Supporting Documentation: Start each document on a new
    page. Combine and upload as a single file named “Support.pdf.” If
    documents are scanned to pdf, the lowest resolution (100 to 150 dpi) should be
    used. The Supporting Documentation attachment should not include additional
    information such as figures, tables, graphs, photographs, diagrams, chemical
    structures, or drawings.
    There are no page limits for any of these components unless otherwise noted.
    Include only those components described below; items not requested will be
    removed and may result in administrative withdrawal of the
    proposal/application.
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    ○ Bibliography and References Cited: List the references in the order they
    appear in the Project Narrative. Use a standard reference format that includes
    the full citation (i.e., author[s], year published, title of reference, source of
    reference, volume, chapter, page numbers, and publisher, as appropriate. Do
    not send or attach copies of articles in print. There is no form for this
    information. The attachments should be in PDF in accordance with the
    formatting guidelines specified for full proposal/application preparation.
    ○ List of Abbreviations, Acronyms, and Symbols: Provide a list of
    abbreviations, acronyms, and symbols.
    ○ Facilities, Existing Equipment, and Other Resources: Describe the
    facilities and equipment available for performance of the proposed project
    and any additional facilities or equipment proposed for acquisition at no cost
    to the award. Indicate whether or not Government-furnished facilities or
    equipment are proposed for use. If so, reference should be made to the
    original or present Government award under which the facilities or equipment
    items are now accountable. There is no form for this information.
    Note: For researchers who will require access to the Defense Healthcare
    Management Systems Modernization (DHMSM) Cerner Electronic
    Health Record (EHR) solution for testing related to research workflows
    and/or interfaces: Access will be provided through a research environment
    within the Program Executive Office (PEO) Defense Healthcare
    Management Systems (DHMS) Testing Infrastructure at Allegheny Ballistics
    Laboratory (ABL). Users will follow the PEO DHMS Testing Infrastructure
    Onboarding Guide to access the environment. Direct support from the
    DHMSM vendor will not be provided through the DHMSM contract. No one
    is authorized to engage the DHMSM contractor for this purpose. Research
    must remain in these stated bounds.
    ○ Publications and/or Patent Abstracts (five-document limit): Include
    relevant publication URLs and/or patent abstracts. If publications are not
    publicly available, then a copy/copies of the published manuscript(s) must
    be attached.
    ○ Letters of Organizational Support: Provide a letter (or letters, if applicable),
    signed by the Department Chair or appropriate organization official,
    confirming the laboratory space, equipment, and other resources available for
    the project. A letter for each organization involved in the project should be
    provided.
    ○ Letters of Collaboration: Provide a signed letter from each collaborating
    individual or organization that will demonstrate that the PI has the support or
    resources necessary for the proposed work. If an investigator at an
    intramural organization is named as a collaborator on an application
    submitted through an extramural organization, the application must include a
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    letter from the collaborator’s Commander or Commanding Officer at the
    intramural organization that authorizes the collaborator’s involvement.
    Refer to the General Submission Instructions, Section III.A.8., Research &
    Related Budget, for additional information.
    ○ Joint Sponsorship (if applicable): Describe present or prospective joint
    sponsorship of any portion of the program outlined in the proposal/
    application. In the absence of agreements among sponsors for joint support, the
    proposal/application should be structured so that the research can be carried
    out without the resources of any other sponsor. If, however, it is desirable to
    request partial support from another agency, the proposed plan should be stated
    and the reasons documented. If the plan cannot be formulated at the time the
    proposal/application is submitted, information should be sent later as an
    addendum to the proposal/application. Prior approval from both agencies must
    be secured for research to be undertaken under joint sponsorship. Provide
    letters of support related to recruitment, subject access, and data access plans.
    ○ Intellectual Property (if applicable): Refer to the General Submission
    Instructions, Appendix 3, for additional information. Provide the following:
    – Should the Applicant intend to use, in the performance of this program,
    pre-existing, legally protected and perfected intangible property and for
    which no Federal funds had been used in the development of said property,
    the Applicant must:
    1. Clearly identify all such property;
    2. Identify the cost to the Federal government for use or license of such
    property if applicable; or
    3. Provide a statement that no property meeting this definition will be
    used on this project.

  • Intellectual and Material Property Plan: If applicable, provide a plan for

  • resolving intellectual and material property issues among participating
    organizations.
     Attachment 3: Technical Abstract (one-page limit): Upload as
    “TechAbs.pdf.”
    The technical abstract is used by all reviewers. Abstracts of all funded research
    projects will be posted publicly. Do not include proprietary or confidential
    information. Use only characters available on a standard QWERTY keyboard.
    Spell out all Greek letters, other non-English letters, and symbols. Graphics are
    not allowed. Use the outline below.
    Background: Provide a brief statement of the ideas and theoretical
    o
    reasoning behind the proposed work. o Objective/Hypothesis: State the
    objective/hypothesis to be tested. Provide evidence or rationale that supports the
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    objective/hypothesis. o Specific Aims/Milestones: State concisely the specific
    aims/milestones of the project.
    Project Design: Briefly describe the project design. o Impact: Provide a
    o
    brief statement explaining the potential impact of the proposed work to advancing
    the standard of care for injured Service members and/or the general public. o
    Relevance: Provide a brief statement explaining the potential relevance of the
    proposed work to the specific topic area being addressed and its impact on health
    outcomes.
    • Attachment 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf.”
    The lay abstract is used by all reviewers. Do not include proprietary or
    confidential information. Use only characters available on a standard
    QWERTY keyboard. Spell out all Greek letters, other non-English letters, and
    symbols. Graphics are not allowed.
    Lay abstracts should be written using the following outline. Do not duplicate the
    technical abstract.
    ○ Describe the objectives and rationale for the proposal/application in a manner
    that will be readily understood by readers without a background in science or
    medicine.
    ○ Describe the ultimate applicability and potential impact of the research.
    — What types of patients will it help, and how will it help them? Include
    the current available statistics to the related injury/condition.
    — What are the potential clinical Applications, benefits, and risks?
    — What is the projected timeline it may take to achieve the expected patient-
    related outcome?
    ○ Briefly describe how the proposed project will benefit Service
    members, Veterans, and/or family members.
    • Attachment 5: Statement of Work (SOW) (two-page limit): Upload as
    “SOW.pdf.” The suggested SOW format and examples specific to different
    types of research projects are available on the eBRAP “Funding Opportunities
    & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm). The SOW
    outlines and establishes the PI’s and an organization’s performance expectations
    for the work to be funded under this award. The SOW in an assistance
    agreement award establishes general objectives. The SOW in a contract sets
    rather specific goals and conditions for each year of the contracted project; the
    PI and contractor are expected to meet the provisions and milestones of the SOW.
    The SOW for all award types will be incorporated into the award document and,
    as such, is subject to release under the Freedom of Information Act.
    A series of relatively short statements should be included that comprise the
    approach to each of the major goals or objectives of the proposed research. The
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    statements should outline the specific tasks, systems, and materials that are
    reasonable estimates for testing the proposed hypotheses of the study. An outline
    should be included that shows the work statements to be accomplished in each
    year of the award. If this proposal/application is part of a larger study, present
    only tasks that this award would fund. Allow at least 2 to 3 months for the
    USAMRDC OHRO’s regulatory review and approval processes for studies
    involving human subjects. Allow at least 1 to 2 months for the USSOCOM
    VRO regulatory review and approval processes for studies involving animals.
    • Attachment 6: Outcomes and Impact Statement (one-page limit): Upload as
    “Impact.pdf.” Explain in detail why the proposed research project is important,
    as follows:
    ○ Short-Term Impact: Describe the anticipated outcome(s), results, theoretical
    framework, design and or plan that will be directly attributed to the results of
    the proposed research.
    ○ Long-Term Impact: Describe the anticipated long-term clinical/patient
    gains or commercial end product from the proposed project. What is the
    indication and will the project lead toward transforming the standard of
    care? Are there non-trauma-related indications that would expand the
    market for the proposed product?
    ○ Military Relevance: Clearly articulate how the proposed project or product
    meets the needs of military medical providers and injured Service
    members.
    ○ Public Purpose: If appropriate, provide a concise, detailed description on
    how this project will benefit the general public.
    • Attachment 7: Innovation Statement (two-page limit): Upload as
    “Innovation.pdf.” Describe how the proposed project is innovative. Research
    deemed innovative may introduce a new paradigm, challenge current paradigms,
    look at existing problems from new perspectives, or exhibit other creative
    qualities. Investigating the next logical step or incremental advancement on
    published data is not considered innovative. This may include a proposed
    conceptual framework, design, and/or plan of key components and how they
    integrate/communicate with each other. Identify which potential components will
    be open source/open architecture vs. proprietary.
    • Attachment 8: Data and Research Resource-Sharing Plan (one-page limit):
    Upload as “Sharing.pdf.” Describe how unique and/or final research data will
    be shared with the research community, along with any resulting research
    resources. This includes cases where pre-existing data or research resources will
    be utilized and/or modified during the course of the proposed project. If there
    are limitations associated with a pre-existing agreement for the original data or
    research resources that preclude subsequent sharing, the Applicant should
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    explain this in the data- and/or research resource-sharing plan. For projects
    involving clinical trials, PIs may be required to register their clinical trials on
    Clinicaltrials.gov (https://clinicaltrials.gov/). For projects involving TBI, PIs
    may be required to report data to the Federal Interagency Traumatic Brain Injury
    Research (FITBIR) informatics system (http://fitbir.nih.gov/). If the project
    includes systems biology- related research, the PI may be required to make the
    systems biology data, generated via an award, available to the research
    community by depositing research data into the SysBioCube system
    (https://sysbiocube-abcc.ncifcrf.gov). Refer to the General Submission
    Instructions, Appendix 2, for additional information.
    • Attachment 9: Conflicts of Interest, if applicable: Upload as “COI.pdf.”
    Provide details with the proposal/application submission of all potential or
    actual COIs, along with a plan to resolve them. A contract or assistance
    agreement will not be awarded if it is determined by the respective Contracting
    Officer that a COI cannot be managed.
    Personnel involved in the review process and/or with making funding
    recommendations are prohibited from assisting in any proposal/application,
    including, but not limited to, concept design, Application development, budget
    preparation, and the development of any supporting documentation.
    Questions related to this topic should be directed to the eBRAP Help Desk via
    email at help@eBRAP.org or 301-682-5507. Refer to the General Submission
    Instructions, Appendix 3, for additional information.
    • Attachment 10: Data Management (no page limit): Upload as
    “DataManage.pdf.” The Data Management attachment should include the
    components listed below.
    Data Management: Describe all methods used for data collection to include the
    following:
    ○ Identifiers: Describe the unique identifiers or specific code system to be used
    to identify human subjects, if applicable.
    ○ Confidentiality: Explain measures taken to protect the privacy of studies
    conducted on human subjects and the ability to maintain confidentiality of
    study data. Strategies to protect the privacy and confidentiality of study
    records, particularly those containing identifying information, should be
    addressed.
    — Address who will have access to study records, data, and specimens,
    including an acknowledgment that representatives of USSOCOM are
    eligible to review study records.
    — Address requirements for reporting sensitive information to state or local
    authorities.
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    ○ Disposition of data: Describe where data (both electronic and hard copy) will
    be stored, who will keep the data, how the data will be stored, and the length
    of time data will be stored. For FDA-regulated studies, compliance with 21
    CFR 11 is required.
    ○ Sharing study results: In cases where the human subject could possibly
    benefit medically or otherwise from the information, explain whether or not
    the results of screening and/or study participation will be shared with human
    subjects or their primary care provider, to include results from any screening or
    diagnostic tests performed as part of the study.
    • Attachment 11: Post-Award Project Transition Plan (three-page limit).
    Upload as “Transition.pdf.” Provide information on the methods and
    strategies proposed to move the project or knowledge outcomes to the next
    project phase of studies, commercialization, and/or delivery to the civilian or
    military market after successful completion of the award. The transition plan
    should include the components listed below.
    a. The planned indication for the product label, if appropriate, and an outline of
    the development plan required to support that indication.
    b. The anticipated regulatory strategy (e.g., additional nonclinical or clinical
    studies anticipated/required, FDA or regulatory authority meetings desired,
    industry partnerships) for movement of the research into later phases of
    development and to support a potential marketing Application [e.g., New
    Drug Application, Biologics License Application, Premarket Approval
    Application, 510(k)].
    c. Details of the funding strategy that will be used to bring the outcomes to
    the next level of development and/or commercialization (e.g., specific
    potential industry partners, specific funding opportunities to be applied
    for).
    d. For knowledge products, a description of how the knowledge will be further
    developed, disseminated, and incorporated into clinical care.
    e. A description of collaborations and other resources that will be used to
    provide continuity of development.
    f. A brief schedule and milestones for bringing the outcome(s) to the next phase
    of studies, commercialization, and/or delivery to the military or civilian
    market, including when it can be anticipated to be transitioned to an industry
    partner or approved by the FDA, if applicable.
    g. A risk analysis for cost, schedule, manufacturability, and sustainability.
    • Attachment 12: Collaborating DoD Military Facility Budget Form(s), if
    applicable: Upload as “MFBudget.pdf.” If a Military Facility will be a
    collaborator in performance of the project complete the Collaborating DoD
    Military Facility Budget Form (available for download on eBRAP “Funding
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    Opportunities and Forms” web page), including a budget justification for each
    year. If more than one Military Facility is proposed, submit a separate budget
    form for each site. Refer to the General Submission Instructions, Section II.D.5.,
    Research & Related Budget, for detailed information.
     Extramural Applications
    To evaluate compliance with Title IX of the Education Amendments of 1972 (20 USC
    A§1681 et seq.), the DoD is collecting certain demographic and career information to be
    able to assess the success rates of women who are proposed for key roles in applications in
    science, technology, engineering, or mathematics (STEM) disciplines. To enable this
    assessment, each application must include the following forms completed as indicated.
    Research & Related Personal Data: For extramural submissions (via Grants.gov), refer to
    the General Submission Instructions, Section III.A.3.
    Research & Related Senior/Key Person Profile (Expanded): Refer to the General
    Submission Instructions, Section III for detailed information.
    • PI Biographical Sketch (five-page limit): Upload as “Biosketch_LastName.pdf.” 
    PI Previous/Current/Pending Support (three-page limit): Upload as
    “Support_LastName.pdf.”
    • Key Personnel Biographical Sketches (five-page limit each): Upload as
    “Biosketch_LastName.pdf.”
    • Key Personnel Previous/Current/Pending Support (three -page limit each): Upload
    as “Support_LastName.pdf.”
    Research & Related Budget: Refer to the General Submission Instructions, Section III for
    detailed information.
    • Budget Justification (no page limit): Upload as “BudgetJustification.pdf.” The budget
    justification for the entire period of performance must be uploaded to the Research &
    Related Budget after completion of the budget for Period 1.
    IAW FAR 35.016(e), “The primary basis for selecting proposals for
    o
    acceptance shall be technical, importance to agency programs, and fund
    availability. Cost realism and reasonableness shall also be considered to the
    extent appropriate”.
    For contracts, statutory limits for fees are specified in FAR 15.404-4(c)(4).
    o
    NOTE: For all Federal agencies or organizations collaborating with Military
    Facilities, special restrictions apply to the budget and are described below.
    • For Federal Agencies: Proposals from Federal agencies must include in their budget
    justifications a Federal Financial Plan. The Federal Financial Plan must address how
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    all funds will be obligated before their period for obligation expires, and how funds will
    be available to cover research costs over the entire award period. The Federal Financial
    Plan must include the funding mechanism(s) that will be used to carry over funds
    between fiscal years.
    • For Collaborating DoD Military Facilities: Proposals from organizations that include
    collaborations with DoD Military Facilities (military health system facility, research
    laboratory, treatment facility, dental treatment facility, or a DoD activity embedded with
    a civilian medical center) must submit Collaborating DoD Military Facility Budget
    Form(s) as instructed in Attachment 12.
    Project/Performance Site Location(s) Form: Refer to the General Submission Instructions,
    Section III. for detailed information.
    R & R Subaward Budget Attachment(s) Form (if applicable): Refer to the General
    Submission Instructions, Section III. for detailed information.
    R&R Subaward Budget Attachment(s) Form (if applicable): Refer to the General
    Application Instructions, Section III. for detailed information.
    Collaborating with DoD Military Facilities (if applicable): Refer to the General
    Application Instructions, Section III. for detailed information.
    II.D.3. Unique Entity Identifier (UEI) and System for Award Management (SAM)
    All organizations applying online through Grants.gov must register with the System for Award
    Management (SAM) and will receive a unique entity identifier (UEI) number. Failure to register
    with SAM will prevent your organization from applying through Grants.gov.
    Applicant organizations and all subrecipient organizations must have an active registration in the
    System for Award Management (SAM) number to submit proposals to Grants.gov. The
    applicant organization must also be registered in the Entity Management functional area of the
    SAM with an “Active” status to submit proposals through the Grants.gov portal. Verify the
    status of the applicant’s organization’s Entity registration in SAM well in advance of the
    proposal/application submission deadline. Allow several weeks to complete the entire SAM
    registration process. If an applicant has not fully complied with the requirements at the time the
    Federal awarding agency is ready to make a Federal award, the Federal awarding agency may
    determine that the applicant is not qualified to receive a Federal award and use that
    determination as a basis for making a Federal award to another applicant. Refer to the General
    Submission Instructions, Section III, for further information regarding Grants.gov requirements.
    Organizations must have an active System for Award Management (SAM) registration, and
    Grants.gov account to apply for contracts. If individual applicants are eligible to apply for this
    funding opportunity, then you may begin with step 3, Create a Grants.gov Account, listed below.
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    Creating a Grants.gov account can be completed online in minutes, but SAM registrations may
    take additional time. Therefore, an organization's registration should be done in sufficient time to
    ensure it does not impact the entity's ability to meet required application submission deadlines.
    Complete organization instructions can be found on Grants.gov here:
    https://www.grants.gov/web/grants/applicants/organization-registration.html
    1) Register with SAM for all awards: SAM registration must be renewed annually. For more
    detailed instructions for registering with SAM, refer to:
    https://www.grants.gov/web/grants/applicants/organization-registration/step-2-register-with-
    sam.html
    2) Create a Grants.gov Account: The next step is to register an account with Grants.gov.
    Follow the on-screen instructions or refer to the detailed instructions here:
    https://www.grants.gov/web/grants/applicants/registration.html
    3) Add a Profile to a Grants.gov Account: A profile in Grants.gov corresponds to a single
    applicant organization the user represents (i.e., an applicant) or an individual applicant. If you
    work for or consult with multiple organizations and have a profile for each, you may log in to
    one Grants.gov account to access all of your grant applications. To add an organizational
    profile to your Grants.gov account, enter the UEI Number for the organization in the UEI field
    while adding a profile. For more detailed instructions about creating a profile on Grants.gov,
    refer to: https://www.grants.gov/web/grants/applicants/registration/add-profile.html
    4) EBiz POC Authorized Profile Roles: After you register with Grants.gov and create an
    Organization Applicant Profile, the organization applicant's request for Grants.gov roles and
    access is sent to the EBiz POC. The EBiz POC will then log in to Grants.gov and authorize the
    appropriate roles, which may include the AOR role, thereby giving you permission to complete
    and submit applications on behalf of the organization. You will be able to submit your
    application online any time after you have been assigned the AOR role. For more detailed
    instructions about creating a profile on Grants.gov, refer to:
    https://www.grants.gov/web/grants/applicants/registration/authorize-roles.html
    5) Track Role Status: To track your role request, refer to:
    https://www.grants.gov/web/grants/applicants/registration/track-role-status.html
    b. Electronic Signature: When applications are submitted through Grants.gov, the name of the
    organization applicant with the AOR role that submitted the application is inserted into the
    signature line of the application, serving as the electronic signature. The EBiz POC must
    authorize people who are able to make legally binding commitments on behalf of the
    organization as a user with the AOR role; this step is often missed and it is crucial for valid and
    timely submissions.
    For additional training resources, including video tutorials, refer to:
    https://www.grants.gov/web/grants/applicants/applicant-training.html
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    Applicant Support: If you are experiencing difficulties with your submission, it is best to call the
    Grants.gov Support Center and get a ticket number. The Support Center ticket number will assist
    the USSOCOM with tracking your issue and understanding background information on the
    issue. Grants.gov provides applicants 24/7 support via the toll-free number 1-800-518-4726 and
    email at support@grants.gov. For questions related to the specific grant opportunity, contact the
    number listed in the application package of the grant you are applying for.
    In March 2018, the General Services Administration (GSA) implemented fraud prevention
    security measures in the System for Award Management (SAM) which required every new
    contractor registrant to provide a written (hard copy), notarized letter confirming the entity's
    Administrator that is authorized to register the entity in the SAM database, or to make changes to
    its registration. Effective 29 April 2018, the notarized letter process is now mandatory on all
    CURRENT registrants at SAM who have a requirement to update data on their SAM record.
    The notarized letter is mandatory and is required before the GSA Federal Service
    Desk (FSD) will activate the entity's registration. The Office of the Secretary of Defense and
    GSA realizes the length of time needed to transmit, receive, process, and approve the notarized
    letters presents a significant impact on the ability of the contracting activity to make timely
    awards, but in order to mitigate the concern of fraud, these steps and the time needed for
    processing, is unavoidable. Notarized letters are required for all new and existing SAM
    registered Entities. The notarized letters must be postal service mailed (not emailed or faxed) to
    the "Federal Service Desk" and must contain the information outlined in the SAM posted FAQ
    at: (https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-
    systemshttps://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-
    systems-management/integrated-award-environment-iae/sam-updatemanagement/integrated-
    award-environment-iae/sam-update). Instructions for domestic entities and instructions for
    international entities with embedded templates for use are also provided within the SAM Update
    notice with frequently asked questions at https://www.gsa.gov/abouthttps://www.gsa.gov/about-
    us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-
    environment-iae/sam-updateus/organization/federal-acquisition-service/office-of-systems-
    management/integrated-awardhttps://www.gsa.gov/about-us/organization/federal-acquisition-
    service/office-of-systems-management/integrated-award-environment-iae/sam-
    updateenvironment-iae/sam-update.
    II.D.4. Submission Dates and Times
    This is a continuously open announcement through 31 July 2028; therefore, reviews occur
    throughout the year. Pre-proposals may be submitted at any time throughout the 5-year period
    noted above. An invited full proposal/application should be submitted within
    60 days of the PI’s receipt of an invitation to submit. No pre-proposal/pre-application or full
    proposal/application may be submitted under this BAA after 31 July 2028, 11:59 p.m. Eastern
    Time. If an invited proposal/application is not submitted by 31 July 2028, 11:59 p.m. Eastern
    Time, the applicant must wait for the next available opportunity for submission, i.e., the release
    of the FY28 BAA (to be posted to Grants.gov 31 July 2028). No proposal/application received
    under this BAA will be considered for funding after 24 months from the date of submission.
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    II.D.5. Funding Restrictions
    The following limits on the duration and cost of research projects apply:
    Proposed projects longer than five (5) years will not be considered.
    Most projects are anticipated to have a total cost between $2,000,000 and $10,000,000
    (including indirect costs). Projects that have a total cost higher than $5,000,000 (including
    Indirect costs) with outstanding scientific merit that meet a critical need may be accepted;
    however, the total cost of these projects are not to exceed $10,000,000.00 (including Indirect
    costs).
    No budget will be approved by the Government exceeding $10,000,000.00 (including indirect
    costs).
    A budget should be commensurate with the nature and complexity of the proposed research.
    Researchers should submit budgets that include the entire period of performance of the research
    project. Budgets should include all direct and indirect costs, based on supportable, verifiable
    estimates. The budget for the full proposal/application should not differ significantly from the
    pre-proposal/pre-application budget summary form provided in the pre-proposal/pre-application
    submission.
    Offerors or Applicants seeking additional or continuation funding must submit new pre-
    proposals and be invited to submit full proposals.
    See the General Submission Instructions, Section III, for additional information regarding the
    research and related budget.
    All direct and indirect costs of any subaward, contract, or subcontract must be included in the
    costs of the primary award.
    The applicant may request the entire maximum funding amount for a project that may have a
    period of performance less than the maximum five years.
    For this award mechanism, direct costs may be requested for (not all inclusive):
    • Salary
    • Research – related subject costs
    • Research supplies
    • Support for multidisciplinary collaborations, including travel
    • Travel costs
    • Equipment
    For extramural awards with an intragovernmental component, direct transfer of funds from an
    extramural award recipient to a DoD or other Federal agency is not allowed. Funding to
    intramural DoD and other Federal agencies will be managed through a direct fund transfer.
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    Intramural applicants are responsible for coordinating through their agency’s procedures the use
    of contractual or assistance funding awards or other appropriate agreements to support
    extramural collaborators.
    Refer to the General Submission Instructions, Section III. for budget regulations and instructions
    for the Research & Related Budget. For Federal agencies or organizations collaborating with
    Federal agencies, budget restrictions apply as are noted in the General Submission
    Instructions, Section III.
    For additional information refer to Section II.F.1, Federal Award Notices.
    Funds to be obligated on any award resulting from this BAA will be available for use for a
    limited time period based on the fiscal year of the funds. Awards will identify expiration of the
    funds.
    Refer to the General Submission Instructions, “Research & Related Budget,” for discussion of
    allowable costs, including pre-award costs and collaborations with Military Facilities.
    II.D.6. Other Submission Requirements
    Refer to the General Submission Instructions, Appendix 4, for detailed formatting guidelines on
    submission.
    II.E. Proposal/Application Review Information
    II.E.1. Criteria
    II.E.1.a. Peer Review
    To determine technical merit, all proposals will be evaluated according to the following scored
    criteria, which are listed in descending order of importance:
    • Research Objectives: The degree to which the stated objectives are clear, valid, and logical.
    For development of devices and technologies, the degree to which the performance
    objectives are plausible; the proposed effort demonstrates familiarity with the historical
    background of the problem and previous/current solutions; and the awareness of similar
    projects previously undertaken and related activities. The extent that the proposed research
    projects demonstrate an innovative approach and relate to the Research Areas of Interest
    identified in Section II.A.
    • Scientific Design Excellence: The degree to which proposed plans, methods, techniques and
    procedures are feasible, clear, valid, adequately referenced, and state-of-the-art. The merit of
    the statistical features of the study. The extent to which literature searches were used to
    document the strengths of the proposed project. For development of devices and
    technologies, the feasibility of the proposed prototype/technology development plan; how
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    well the engineering/technical design is likely to achieve the goals indicated; adequacy of the
    engineering/design solutions; and how well the perceived engineering/design strengths and
    flaws are addressed.
    • Impact/Outcomes: The potential impact of the research in the field, the significance of this
    impact, and when it can be anticipated. For development of devices and technologies, the
    potential translation, implementation, and/or commercial use for the prototype/technology
    being developed.
    • Budget: The degree to which the budget reflects the actual needs of the proposed work, is
    thoroughly detailed and fully justified so that the government can evaluate and determine the
    cost commensurate with the complexity and nature of the research proposed.
    • PI and Key Personnel Qualifications: The qualifications, capabilities, and experience of
    the proposed PI and other key personnel to demonstrate that the proposed staff has the
    knowledge, technical expertise, and management skills to achieve the proposed objectives as
    well as the time available for the percentage of efforts indicated for the project.
    • Facilities: The proposed facilities and equipment, or unique combinations of these, to
    demonstrate that the organization has the necessary facilities required for the accomplishing
    the proposed objectives.
    II.E.1.b. Programmatic Review
    To make funding recommendations and select the proposal(s)/application(s) that, individually or
    collectively, will best achieve the program objectives, the following criteria are used by
    programmatic reviewers:
    • Scientific peer review results
    • SOF Relevance (mission, health, medicine, and beneficiaries)
    • Portfolio balance
    • Programmatic priorities
    II.E.2. Proposal/Application Review and Selection Process
    All invited proposals are evaluated by USSOCOM scientists, other federal agency
    representatives, outside scientists with diverse expertise, clinicians, consumers, or combinations
    thereof, using a two-tier review process. The first tier is peer review of proposals against
    established criteria for determining technical merit. Each proposal/application is evaluated for
    its own merit, independent of other proposals. The second tier is a programmatic review that
    makes recommendations for funding, based on established criteria for determining relevance to
    the mission of the USSOCOM and its programs. Programmatic review is a comparison-based
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    process in which proposals with scientific and technical merit compete in a common pool. The
    highest-scoring proposals from the first tier of review are not automatically recommended for
    funding. Funding recommendations depend on various factors as described in Section II.E.
    Programmatic Review.
    After the two-tier evaluation, proposals recommended for funding may be prioritized. A
    prioritized listing of alternates (deferred decisions) may also be prepared, when warranted.
    Subsequent awards depend upon the availability of funds and fulfillment of requirements and
    priorities determined to exist at the time of award. In some cases, funding priorities may change
    as certain scientific tasks are addressed and new mission assignments arise.
    If selected for funding, the award may also be dependent upon the organization providing
    adequate additional regulatory documentation, such as human subjects/anatomical
    substances/use of cadavers’ protocols and approvals, animal subjects’ protocols and approvals,
    and environmental information. The award may also be dependent upon additional supporting
    administrative and budgetary information.
    IAW FAR 35.016(e), “The primary basis for selecting proposals for acceptance shall be
    technical, importance to agency programs, and fund availability. Cost realism and
    reasonableness shall also be considered to the extent appropriate”.
    All USSOCOM review processes are conducted confidentially to maintain the integrity of the
    merit-based selection process. Panel members sign a statement that proposal/application and
    evaluation information will not be disclosed outside the panel. Violations of confidentiality can
    result in the dissolving of a panel(s) and other corrective actions. In addition, personnel at the
    Applicant or collaborating organizations are prohibited from contacting persons involved in the
    review and approval process to gain protected evaluation information or to influence the
    evaluation process. Violations of these prohibitions will result in the administrative withdrawal
    of the organization’s proposal/application. Violations by panel members or applicants that
    compromise the confidentiality of the review and approval process may also result in suspension
    or debarment from federal awards. Furthermore, the unauthorized disclosure of confidential
    information of one party to another third party is a crime in accordance with 18 USC 1905.
    II.E.3. Integrity and Performance Information
    Prior to making an award where the Federal share is expected to exceed the simplified
    acquisition threshold (currently $250,000) over the period of performance, the Federal awarding
    agency is required to review and consider any information about the applicant that is available in
    the SAM.gov Responsibility/Qualification (R/Q).
    An applicant organization may review R/Q, accessible through SAM, and submit comments to
    R/Q on any information about the organization that a Federal awarding agency previously
    entered and is currently available in R/Q.
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    The Federal awarding agency will consider any comments by the applicant, in addition to other
    information in the designated integrity and performance system, in making a judgment about the
    applicant’s integrity, business ethics, and record of performance under Federal awards when
    determining an organization’s qualification prior to award, according to the qualification
    standards of the FAR.
    II.E.4. Anticipated Announcement and Federal Award Dates
    Each PI and organization will receive email notification via eBRAP of the funding
    recommendation. Notifications should be sent within 180 days of submission. Each PI will
    receive a peer review summary statement on the strengths and weaknesses of the
    proposal/application.
    II.F. Federal Award Administration Information
    II.F.1. Federal Award Notices
    The PI should receive disposition regarding the full proposal/application via an email from
    eBRAP within 180 days of submission. A recommended for funding notification is NOT an
    authorization to begin performance nor a guarantee of an award.
    The awarding agency will be the USAMRAA. The USAMRAA Contracting Officers are the
    only individuals authorized to obligate funds and bind the Federal Government.
    Authorization to begin performance will be received via an award document (contract,) signed
    by the USAMRAA Contracting Officer. No commitment on the part of the Government should
    be inferred from discussions with any other individual.
    Awards will be made at any time throughout the year and are contingent upon availability of
    funding, adequacy of supporting documentation submitted, fulfillment of requirements, and
    completion of successful negotiations. No proposal/application submitted under this BAA will
    be considered for funding after 24 months from the date of submission to Grants.gov.
    Refer to the General Submission Instructions, Appendix 2, Section D, Award Notices, for
    additional information. Refer to the full text of the USAMRAA General Research Terms and
    Conditions for Institutions of Higher Education, Hospitals, and Non-Profit Organizations and the
    USAMRAA General Research Terms and Conditions for For-Profit Organizations available at
    http://www.usamraa.army.mil/Pages/Resources.aspx for further information.
    II.F.1.a. PI Changes and Award Transfers
    Refer to the General Submission Instructions, Appendix 2 for general information on changes to
    PIs and organizational transfers.
    Should the PI of a funded project leave the award organization, both the PI and organization
    must contact the USAMRAA Contracting Officer as soon as possible to discuss options for
    continued support of the research project. Every effort should be made to notify the USAMRAA
    prior to the PI leaving the organization. An organizational transfer of an Assistance Agreement
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    award will not be allowed in the last year of the (original) period of performance or any
    extension thereof. An organizational transfer of a Contract award will not be allowed.
    II.F.2. Administrative and National Policy Requirements
    Applicable requirements in the FAR, found in 48 CFR, Chapter 1, DFARS, found in 48 CFR
    Chapter 2, and AFARS, found in 48 CFR Chapter 51, apply to contracts resulting from this
    BAA.
    Refer to the General Submission Instructions, Appendix 2, for general information regarding
    administrative requirements.
    Refer to the General Submission Instructions, Appendix 5, for general information regarding
    national policy requirements.
    Refer to full text of the USAMRAA General Research Terms and Conditions with Institutions of
    Higher Education, Hospitals, and Non-Profit Organizations: Addendum to the DoD R&D Terms
    and Conditions and the USAMRAA General Research Terms and Conditions with For-Profit
    Organizations for further information.
    II.F.3. Reporting
    Refer to the General Submission Instructions, Appendix 2, Section A, for general information on
    reporting requirements. If there are technical reporting requirement delinquencies for any
    existing USSOCOM-sponsored awards at the applicant organization, no new awards will be
    issued to the applicant organization until all delinquent reports have been submitted.
    technical progress reports and quad charts will be required with frequency determined at the
    contract level.
    • quad charts including:
    ○ Objective, measurable, and easily independently verifiable assessment of metrics to
    measure progress regarding project cost, schedule, performance, risk, and opportunity.
    ○ Risk and opportunity assessment of project cost, schedule, and performance. Risk
    assessments will use objective, measurable, and easily independently verifiable metrics;
    mitigation plans; triggering event; latest potential successful mitigation date; and impacts
    of unmitigated risks. Opportunity assessments will use objective, measurable and easily
    independently verifiable metrics; exploitation plans; triggering event; latest potential
    successful exploitation; and impact of successful opportunity exploitation.
    ○ Integrated project Gantt chart with all progress to date, supported by the cost,
    performance, risk, and opportunity assessments.
    ○ Budget chart with burn rate, demonstrating funding expended against time, funds
    remaining, and planned expense plan through the rest of the project schedule against
    planned milestones.
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    • technical reports including the following:
    ○ Full description of architecture and content of new interoperable component, description
    of scenarios developed, results and method of pilot study.
    ○ A report, document, or list of the terminology and respective definitions used for the
    variables, metrics, and evaluation criteria and how they were deconstructed. It must
    provide the measuring tools and, if needed, how they were used to obtain the
    metric/evaluation criteria. Objective measurements are preferred, but subjective
    measurements that have rigorous reliability, repeatability, and robustness will be
    considered.
    ○ Explanation, including definitions and descriptions, of TRIAGE determinants of
    performance and agility. A report or document with the information and analyzed data of
    the actual postulated variables, metrics, and evaluation criteria.
    ○ Analyzed pilot study data and the specific aims, methodologies, sample and sample size,
    inter-rater reliability, assessment criteria, statistical methods, analyzed results,
    conclusions, and potential next-step recommendations.
    ○ Completion of preliminary/pilot empirical evaluation of the developed proof-of-concept;
    ○ A description of the components of the proof-of-concept that are proprietary and ones
    that are open source/open architecture. Explanation of Government rights and/or
    proposed pricing structure to the Government (if applicable).
    ○ Documentation of the translational parameters and the respective definitions (if
    applicable).
    ○ Description of the gaps that were uncovered during this research as it pertains to the
    success or improvement measured and an outline of anticipated next steps or
    recommendations.
    II.G. Federal Awarding Agency Contacts
    II.G.1. eBRAP Help Desk
    Questions related to BAA content or submission requirements as well as questions related to the
    submission of the pre-proposal/pre-application through eBRAP should be directed to the eBRAP
    Help Desk, which is available Monday through Friday from 8:00 a.m. to 5:00 p.m. Eastern Time.
    Response times may vary depending upon the volume of inquiries.
    Phone: 301-682-5507
    Email: help@eBRAP.org
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    II.G.2. Grants.gov Contact Center
    Questions related to extramural full proposal/application submission through the Grants.gov
    portal should be directed to the Grants.gov Contact Center, which is available 24 hours a day, 7
    days a week (closed on U.S. federal holidays). Note that the eBRAP Help Desk is unable to
    provide technical assistance with Grants.gov submission.
    Phone: 800-518-4726; International 1-606-545-5035
    Email: support@grants.gov
    Sign up on Grants.gov for “send me change notification emails” by following the link on the
    Synopsis page for the BAA or by responding to the prompt provided by Grants.gov when first
    downloading the submission package. If the submission package is updated or changed, the
    original version of the Application package may not be accepted by Grants.gov.
    II.H. Other Information
    II.H.1. Administrative Actions
    After agency receipt of pre-proposals or proposals, the following administrative actions may
    occur:
    II.H.1.a. Rejection
    The following will result in administrative rejection of the pre-proposal/pre-application:
    • Project narrative exceeds page limit.
    • Project narrative is missing.
    • Budget form contains only zeros.
    • Quad Chart is missing.
    The following will result in administrative rejection of the proposal/application:
    • Submission of an application for which a letter of invitation was not received.
    • Project Narrative exceeds page limit.
    • Project Narrative is missing.
    • Budget is missing.
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    II.H.1.b. Modification
    • Pages exceeding the specific limits will be removed prior to review for all documents other
    than the pre-proposal narrative and project narrative.
    • Documents not requested will be removed.
    • Following proposal/application submission to Grants.gov, the PI will receive an email
    request from eBRAP to review, modify, and verify the proposal/application submitted to
    Grants.gov. During this verification period, the PI may upload missing documents (refer to
    II.H.I.a, rejection), replace files, and re-categorize files. These modifications must be
    completed by the end of the application verification period; otherwise, the
    proposal/application will be reviewed as submitted
    II.H.1.c. Withdrawal
    The following may result in administrative withdrawal of the pre-proposal/pre-application or
    proposal/application:
    • Federal agency personnel involved in the review process and/or with making funding
    recommendations are named as being involved in the research proposed or found to
    have assisted in the pre-proposal/pre-application or proposal/application processes,
    including, but not limited to, concept design, proposal/application development, budget
    preparation, and the development of any supporting documentation. If formal
    collaboration with Military Facility personnel is planned (i.e., included in the
    proposal/application in performance of the research), this prohibition is not
    applicable. However, these Military Facility personnel are prohibited from being
    involved in the review process and/or with making funding recommendations.
    • Inclusion of URLs, with the exception of links in References Cited and Publication
    and/or Patent Abstract sections.
    • Page size is larger than 8.5 inches x 11.0 inches (approximately 21.59 cm x 27.94 cm).
    • Personnel from applicant or collaborating organizations are found to have contacted
    persons involved in the review process to gain protected evaluation information or to
    influence the evaluation process.
    • Full proposals from extramural organizations, including non-DoD Federal agencies,
    received through eBRAP may be withdrawn.
    • The full proposal/application does not propose the same research project as described in
    the pre-proposal/pre-application.
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    • The full proposal/application budget differs significantly from the budget included in
    the pre-proposal/pre-application.
    • A proposal submitted by a PI who does not meet the eligibility criteria will be
    withdrawn.
    II.H.1.d. Withhold
    Proposals that appear to involve research misconduct will be administratively withheld from
    further consideration pending organizational investigation. The organization will be required to
    provide the findings of the investigation to the USAMRAA Contracting
    Officer for a determination of the final disposition of the proposal/application.
    II.H.2. Proposal/Application Submission Checklist
    Grants.gov Submission Upload
    Action Completed
    Package Components Order
    SF-424 (R&R)
    Application for Federal Complete as instructed.
    Assistance
    Project Narrative: Upload as Attachment 1 with file name
    1
    “ProjectNarrative.pdf.”
    Supporting Documentation: Upload as Attachment 2 with
    2
    file name “Support.pdf.”
    Technical Abstract: Upload as Attachment 3 with file
    3
    name “TechAbs.pdf.”
    Lay Abstract: Upload as Attachment 4 with file name
    4
    “LayAbs.pdf.”
    Statement of Work: Upload as Attachment 5 with file
    5
    name “SOW.pdf.
    Outcomes and Impact Statement: Upload as Attachment 6
    6
    with file name “Impact.pdf.”
    Attachments Form
    Innovation Statement: Upload as Attachment 7 with file
    7
    name “Innovation.pdf.”
    Data and Research Resource-Sharing Plan: Upload as
    8
    Attachment 8 with the file name “Sharing.pdf.”
    Conflicts of Interest: Upload as Attachment 9 with file
    9
    name “COI.pdf,” if applicable.
    Data Management: Upload as Attachment 10 with file
    10
    name “DataManage.pdf.”
    Post-Award Project Transition Plan: Upload as Attachment
    11
    11 with file name “Transition.pdf.”
    Collaborating DoD Military Facility Budget
    12 Form(s): Upload as Attachment 12 with the file
    name “MFBudget.pdf,” if applicable.
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    48

    ---

    Research & Related Complete as instructed.
    Personal Data
    Attach PI Biographical Sketch (Biosketch_LastName.pdf)
    to the appropriate field.
    Attach PI Previous/Current/Pending Support
    Research & Related
    (Support_LastName.pdf) to the appropriate field.
    Senior/Key Person
    Attach Biographical Sketch (Biosketch_LastName.pdf) for
    Profile (Expanded)
    each senior/key person to the appropriate field.
    Attach Previous/Current/Pending (Support_LastName.pdf)
    for each senior/key person to the appropriate field.
    Research & Related Attach Budget Justification (BudgetJustification.pdf) to the
    Budget appropriate field. Complete form as instructed.
    Project/Performance Site
    Complete form as instructed.
    Location(s) Form
    R&R Subaward Budget
    Attachment(s) Form (if Complete form as instructed.
    applicable)
    Collaborating with DoD Complete form as instructed.
    Military Facilities
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    49

    ---

    APPENDIX 1: ACRONYM LIST
    BAA Broad Agency Announcement
    CDMRP Congressionally Directed Medical Research Programs
    CFR Code of Federal Regulations
    COI Conflict of Interest
    DHA Defense Health Agency
    DHP Defense Health Program
    DoD Department of Defense
    eBRAP Electronic Biomedical Research Application Portal
    EC Ethics Committee
    ET Eastern Time
    FAD Funding Authorization Document
    FY Fiscal Year
    HRPO Human Research Protection Office
    IRB Institutional Review Board
    LOI Letter of Intent
    M Million
    MIPR Military Interdepartmental Purchase Request
    NPC Non-Profit Corporation
    OASD(HA) Office of the Assistant Secretary of Defense for Health Affairs
    ORCID Open Researcher and Contributor ID, Inc.
    ORP Office of Research Protections
    PFC Prolonged Field Care
    PI Principal Investigator
    RAI Research Area of Interest
    R/Q Sam.Gov Responsibility/Qualification
    RDT&E Research, Development, Test, and Evaluation
    SAM System for Award Management
    SCR Service Contract Reporting
    SOF Special Operations Forces
    SOW Statement of Work
    UEI Unique Entity Identifier
    USAMRAA U.S. Army Medical Research Acquisition Activity
    USAMRDC U.S. Army Medical Research and Development Command
    USC United States Code
    USSOCOM United States Special Operations Command
    VRO Veterinarian Review Office
    FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance
    Research and Development
    50

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    1_2

    ATTACHMENTS FORM
    Instructions: On this form, you will attach the various files that make up your grant application. Please consult with the appropriate
    Agency Guidelines for more information about each needed file. Please remember that any files you attach must be in the document format
    and named as specified in the Guidelines.
    Important: Please attach your files in the proper sequence. See the appropriate Agency Guidelines for details.
    1) Please attach Attachment 1 Add Attachment Delete Attachment View Attachment
    2) Please attach Attachment 2 Add Attachment Delete Attachment View Attachment
    3) Please attach Attachment 3 Add Attachment Delete Attachment View Attachment
    4) Please attach Attachment 4 Add Attachment Delete Attachment View Attachment
    5) Please attach Attachment 5 Add Attachment Delete Attachment View Attachment
    6) Please attach Attachment 6 Add Attachment Delete Attachment View Attachment
    7) Please attach Attachment 7 Add Attachment Delete Attachment View Attachment
    8) Please attach Attachment 8 Add Attachment Delete Attachment View Attachment
    9) Please attach Attachment 9 Add Attachment Delete Attachment View Attachment
    10) Please attach Attachment 10 Add Attachment Delete Attachment View Attachment
    11) Please attach Attachment 11 Add Attachment Delete Attachment View Attachment
    12) Please attach Attachment 12 Add Attachment Delete Attachment View Attachment
    13) Please attach Attachment 13 Add Attachment Delete Attachment View Attachment
    14) Please attach Attachment 14 Add Attachment Delete Attachment View Attachment
    15) Please attach Attachment 15 Add Attachment Delete Attachment View Attachment

    ---

    Performance Site

    OMB Number: 4040-0010
    Expiration Date: 11/30/2025
    Project/Performance Site Location(s)
    I am submitting an application as an individual, and not on behalf of a company, state,
    Project/Performance Site Primary Location local or tribal government, academia, or other type of organization.
    Organization Name:
    UEI:
    * Street1:
    Street2:
    * City: County:
    * State:
    Province:
    * Country: USA: UNITED STATES
    ZIP / Postal Code: Project/ Performance Site Congressional District:
    I am submitting an application as an individual, and not on behalf of a company, state,
    Project/Performance Site Location 1
    local or tribal government, academia, or other type of organization.
    Organization Name:
    UEI:
    * Street1:
    Street2:
    * City: County:
    * State:
    Province:
    * Country: USA: UNITED STATES
    ZIP / Postal Code: Project/ Performance Site Congressional District:
    Additional Location(s) Add Attachment Delete Attachment View Attachment

    ---

    RR Budget

    RESEARCH & RELATED BUDGET - Budget Period 1 OMB Number: 4040-0001
    Expiration Date: 11/30/2025
    UEI: Enter name of Organization:
    Budget Type: Project Subaward/Consortium Budget Period: 1 Start Date: End Date:
    A.Senior/Key Person
    Months
    Requested Fringe Funds
    Prefix First Middle Last Suffix Base Salary ($) Cal. Acad. Sum. Salary ($) Benefits ($) Requested ($)
    Project Role: PD/PI
    Total Funds requested for all Senior
    Add Attachment Delete Attachment View Attachment
    Additional Senior Key Persons: Key Persons in the attached file
    Total Senior/Key Person
    B.Other Personnel
    Months
    Number of Requested Fringe Funds
    Personnel Project Role Cal. Acad. Sum. Salary ($) Benefits ($) Requested ($)
    Post Doctoral Associates
    Graduate Students
    Undergraduate Students
    Secretarial/Clerical
    Total Number Other Personnel Total Other Personnel
    Total Salary, Wages and Fringe Benefits (A+B)

    ---

    C. Equipment Description
    List items and dollar amount for each item exceeding $5,000
    Equipment item Funds Requested ($)
    Additional Equipment: Add Attachment Delete Attachment View Attachment
    Total funds requested for all equipment listed in the attached file
    Total Equipment
    D. Travel Funds Requested ($)
    1. Domestic Travel Costs ( Incl. Canada, Mexico and U.S. Possessions)
    2. Foreign Travel Costs
    Total Travel Cost
    E. Participant/Trainee Support Costs Funds Requested ($)
    1. Tuition/Fees/Health Insurance
    2. Stipends
    3. Travel
    4. Subsistence
    5. Other
    Number of Participants/Trainees Total Participant/Trainee Support Costs

    ---

    F. Other Direct Costs
    Funds Requested ($)
    1. Materials and Supplies
    2. Publication Costs
    3. Consultant Services
    4. ADP/Computer Services
    5. Subawards/Consortium/Contractual Costs
    6. Equipment or Facility Rental/User Fees
    7. Alterations and Renovations
    8.
    9.
    10.
    11.
    12.
    13.
    14.
    15.
    16.
    17.
    Total Other Direct Costs
    G. Direct Costs Funds Requested ($)
    Total Direct Costs (A thru F)
    H. Indirect Costs
    Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) Funds Requested ($)
    Total Indirect Costs
    Cognizant Federal Agency
    (Agency Name, POC Name, and
    POC Phone Number)
    I. Total Direct and Indirect Costs Funds Requested ($)
    Total Direct and Indirect Institutional Costs (G + H)
    J. Fee Funds Requested ($)
    K. Total Costs and Fee Funds Requested ($)
    Total Costs and Fee (I + J)
    L. Budget Justification
    (Only attach one file.) Add Attachment Delete Attachment View Attachment

    ---

    RESEARCH & RELATED BUDGET - Cumulative Budget
    Totals ($)
    Section A, Senior/Key Person
    Section B, Other Personnel
    Total Number Other Personnel
    Total Salary, Wages and Fringe Benefits (A+B)
    Section C, Equipment
    Section D, Travel
    1. Domestic
    2. Foreign
    Section E, Participant/Trainee Support Costs
    1. Tuition/Fees/Health Insurance
    2. Stipends
    3. Travel
    4. Subsistence
    5. Other
    6. Number of Participants/Trainees
    Section F, Other Direct Costs
    1. Materials and Supplies
    2. Publication Costs
    3. Consultant Services
    4. ADP/Computer Services
    5. Subawards/Consortium/Contractual Costs
    6. Equipment or Facility Rental/User Fees
    7. Alterations and Renovations
    8. Other 1
    9. Other 2
    10.Other 3
    11.Other 4
    12.Other 5
    13.Other 6
    14.Other 7
    15.Other 8
    16.Other 9
    17.Other 10

    ---

    Section G, Direct Costs (A thru F)
    Section H, Indirect Costs
    Section I, Total Direct and Indirect Costs (G + H)
    Section J, Fee
    Section K, Total Costs and Fee (I + J)

    ---

    RR Key Personal

    OMB Number: 4040-0001
    Expiration Date: 11/30/2025
    RESEARCH & RELATED Senior/Key Person Profile (Expanded)
    PROFILE - Project Director/Principal Investigator
    Prefix: *First Name: Middle Name:
    *Last Name: Suffix:
    Position/Title:
    Department:
    Organization Name:
    Division:
    *Street1:
    Street2:
    *City: County/ Parish:
    *State: Province:
    Country: Zip / Postal Code:
    *Phone Number: Fax Number:
    *E-Mail:
    Credential, e.g., agency login:
    *Project Role: PD/PI Other Project Role Category:
    Degree Type:
    Degree Year:
    *Attach Biographical Sketch Add Attachment Delete Attachment View Attachment
    Attach Current & Pending Support Add Attachment Delete Attachment View Attachment
    PROFILE - Senior/Key Person 1
    Prefix: *First Name: Middle Name:
    *Last Name: Suffix:
    Position/Title:
    Department:
    Organization Name:
    Division:
    *Street1:
    Street2:
    *City: County/ Parish:
    *State: Province:
    Country: USA: UNITED STATES Zip / Postal Code:
    *Phone Number: Fax Number:
    *E-Mail:
    Credential, e.g., agency login:
    *Project Role: Other Project Role Category:
    Degree Type:
    Degree Year:
    Attach Biographical Sketch Add Attachment Delete Attachment View Attachment
    Attach Current & Pending Support Add Attachment Delete Attachment View Attachment
    Delete Entry Next Person
    To ensure proper performance of this form; after adding 20 additional Senior/ Key Persons; please save your application, close the Adobe
    Reader, and reopen it.

    ---

    RR Personal data

    OMB Number: 4040-0001
    Expiration Date: 11/30/2025
    RESEARCH & RELATED PERSONAL DATA
    Project Director/Principal Investigator and Co-Project Director(s)/Co-Principal Investigator(s)
    The Federal Government has a continuing commitment to monitor the operation of its review and award processes to identify and address any inequities
    based on gender, race, ethnicity, or disability of its proposed PDs/PIs and co-PDs/PIs. To gather information needed for this important task, the
    applicant should submit the requested information for each identified PD/PI and co-PDs/PIs with each proposal. Submission of the requested
    information is voluntary and is not a precondition of award. However, information not submitted will seriously undermine the statistical validity, and
    therefore the usefulness, of information received from others. Any individual not wishing to submit some or all the information should check the box
    provided for this purpose. Upon receipt of the application, this form will be separated from the application. This form will not be duplicated, and it will not
    be a part of the review process. Data will be confidential.
    Project Director/Principal Investigator
    Prefix: *First Name: Middle Name:
    *Last Name: Suffix:
    Gender:
    Race (check all that apply): Ethnicity: Disability Status (check all that apply):
    American Indian or Alaska Native Hearing
    Asian Visual
    Black or African American Mobility/Orthopedic Impairment
    Native Hawaiian or Other Pacific Islander Other
    White None
    Do Not Wish to Provide Do Not Wish to Provide
    Citizenship:

    ---

    RR SF424

    OMB Number: 4040-0001
    Expiration Date: 11/30/2025
    APPLICATION FOR FEDERAL ASSISTANCE
    3. DATE RECEIVED BY STATE State Application Identifier
    SF 424 (R&R)
    1. TYPE OF SUBMISSION 4. a. Federal Identifier
    Pre-application Application Changed/Corrected Application b. Agency Routing Identifier
    2. DATE SUBMITTED Applicant Identifier
    c. Previous Grants.gov
    Tracking ID
    5. APPLICANT INFORMATION UEI:
    Legal Name:
    Department:
    Division:
    Street1:
    Street2:
    City: County / Parish:
    State: Province:
    Country: USA: UNITED STATES ZIP / Postal Code:
    Person to be contacted on matters involving this application
    Prefix: First Name: Middle Name:
    Last Name: Suffix:
    Position/Title:
    Street1:
    Street2:
    City: County / Parish:
    State: Province:
    Country: USA: UNITED STATES ZIP / Postal Code:
    Phone Number: Fax Number:
    Email:
    6. EMPLOYER IDENTIFICATION (EIN) or (TIN):
    7. TYPE OF APPLICANT: Please select one of the following
    Other (Specify):
    Small Business Organization Type Women Owned Socially and Economically Disadvantaged
    8. TYPE OF APPLICATION: If Revision, mark appropriate box(es).
    New Resubmission A. Increase Award B. Decrease Award C. Increase Duration D. Decrease Duration
    Renewal Continuation Revision E. Other (specify):
    Is this application being submitted to other agencies? Yes No What other Agencies?
    9. NAME OF FEDERAL AGENCY: 10. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:
    TITLE:
    11. DESCRIPTIVE TITLE OF APPLICANT'S PROJECT:
    12. PROPOSED PROJECT: 13. CONGRESSIONAL DISTRICT OF APPLICANT
    Start Date Ending Date

    ---

    SF 424 (R&R) Page 2
    APPLICATION FOR FEDERAL ASSISTANCE
    14. PROJECT DIRECTOR/PRINCIPAL INVESTIGATOR CONTACT INFORMATION
    Prefix: First Name: Middle Name:
    Last Name: Suffix:
    Position/Title:
    Organization Name:
    Department:
    Division:
    Street1:
    Street2:
    City: County / Parish:
    State: Province:
    Country: ZIP / Postal Code:
    USA: UNITED STATES
    Phone Number: Fax Number:
    Email:
    15. ESTIMATED PROJECT FUNDING 16. IS APPLICATION SUBJECT TO REVIEW BY STATE EXECUTIVE ORDER
    12372 PROCESS?
    a. YES THIS PREAPPLICATION/APPLICATION WAS MADE
    a. Total Federal Funds Requested
    AVAILABLE TO THE STATE EXECUTIVE ORDER 12372
    b. Total Non-Federal Funds PROCESS FOR REVIEW ON:
    DATE:
    c. Total Federal & Non-Federal Funds
    b. NO PROGRAM IS NOT COVERED BY E.O. 12372; OR
    d. Estimated Program Income
    PROGRAM HAS NOT BEEN SELECTED BY STATE FOR
    REVIEW
    17. By signing this application, I certify (1) to the statements contained in the list of certifications* and (2) that the statements herein are
    true, complete and accurate to the best of my knowledge. I also provide the required assurances * and agree to comply with any resulting
    terms if I accept an award. I am aware that any false, fictitious. or fraudulent statements or claims may subject me to criminal, civil, or
    administrative penalties. (U.S. Code, Title 18, Section 1001)
    I agree
    *The list of certifications and assurances, or an Internet site where you may obtain this list, is contained in the announcement or agency specific instructions.
    18. SFLLL (Disclosure of Lobbying Activities) or other Explanatory Documentation
    Add Attachment Delete Attachment View Attachment
    19. Authorized Representative
    Prefix: First Name: Middle Name:
    Last Name: Suffix:
    Position/Title:
    Organization:
    Department:
    Division:
    Street1:
    Street2:
    City: County / Parish:
    State: Province:
    Country: ZIP / Postal Code:
    USA: UNITED STATES
    Phone Number: Fax Number:
    Email:
    Signature of Authorized Representative Date Signed
    Completed on submission to Grants.gov Completed on submission to Grants.gov
    20. Pre-application Add Attachment Delete Attachment View Attachment
    21. Cover Letter Attachment Add Attachment Delete Attachment View Attachment

    ---

    RR Subaward budget

    OMB Number: 4040-0001
    Expiration Date: 11/30/2025
    R&R SUBAWARD BUDGET ATTACHMENT(S) FORM
    Instructions: On this form, you will attach the R&R Subaward Budget files for your grant application. Complete the subawardee budget(s) in
    accordance with the R&R budget instructions. Please remember that any files you attach must be a PDF document.
    Click here to extract the R&R Subaward Budget Attachment
    Important: Please attach your subawardee budget file(s) with the file name of the subawardee organization. Each file name must be unique.
    1)Please attach Attachment 1 Add Attachment Delete Attachment View Attachment
    2)Please attach Attachment 2 Add Attachment Delete Attachment View Attachment
    3)Please attach Attachment 3 Add Attachment Delete Attachment View Attachment
    4)Please attach Attachment 4 Add Attachment Delete Attachment View Attachment
    5)Please attach Attachment 5 Add Attachment Delete Attachment View Attachment
    6)Please attach Attachment 6 Add Attachment Delete Attachment View Attachment
    7)Please attach Attachment 7 Add Attachment Delete Attachment View Attachment
    8)Please attach Attachment 8 Add Attachment Delete Attachment View Attachment
    9)Please attach Attachment 9 Add Attachment Delete Attachment View Attachment
    10)Please attach Attachment 10 Add Attachment Delete Attachment View Attachment
    11)Please attach Attachment 11 Add Attachment Delete Attachment View Attachment
    12)Please attach Attachment 12 Add Attachment Delete Attachment View Attachment
    13)Please attach Attachment 13 Add Attachment Delete Attachment View Attachment
    14)Please attach Attachment 14 Add Attachment Delete Attachment View Attachment
    15)Please attach Attachment 15 Add Attachment Delete Attachment View Attachment
    16)Please attach Attachment 16 Add Attachment Delete Attachment View Attachment
    17)Please attach Attachment 17 Add Attachment Delete Attachment View Attachment
    18)Please attach Attachment 18 Add Attachment Delete Attachment View Attachment
    19)Please attach Attachment 19 Add Attachment Delete Attachment View Attachment
    20)Please attach Attachment 20 Add Attachment Delete Attachment View Attachment
    21)Please attach Attachment 21 Add Attachment Delete Attachment View Attachment
    22)Please attach Attachment 22 Add Attachment Delete Attachment View Attachment
    23)Please attach Attachment 23 Add Attachment Delete Attachment View Attachment
    24)Please attach Attachment 24 Add Attachment Delete Attachment View Attachment
    25)Please attach Attachment 25 Add Attachment Delete Attachment View Attachment
    26)Please attach Attachment 26 Add Attachment Delete Attachment View Attachment
    27)Please attach Attachment 27 Add Attachment Delete Attachment View Attachment
    28)Please attach Attachment 28 Add Attachment Delete Attachment View Attachment
    29)Please attach Attachment 29 Add Attachment Delete Attachment View Attachment
    30)Please attach Attachment 30 Add Attachment Delete Attachment View Attachment

    ---

    Sample Clause list

    DOCUMENT NUMBER SPECIAL NOTICE
    HT9425-23-S-SOC1 SAMPLE CLAUSE LIST
    CLAUSES INCORPORATED BY REFERENCE
    CLAUSE ALT NO/ YEAR-
    CLAUSE TITLE SECTION
    NO DEV NO MO
    252.201-7000 Contracting Officer's Representative. 1991-12 SEC G
    Requirements Relating to Compensation of Former DoD
    252.203-7000 2011-09 SEC I
    Officials.
    252.203-7002 Requirement to Inform Employees of Whistleblower Rights. 2013-09 SEC I
    Payment for Contract Line or Subline Items Not Separately
    252.204-7002 2020-04 SEC G
    Priced.
    252.204-7003 Control of Government Personnel Work Product. 1992-04 SEC I
    252.204-7004 Antiterrorism Awareness Training for Contractors. 2019-02 SEC I
    Safeguarding Covered Defense Information and Cyber
    252.204-7012 2019-12 SEC I
    Incident Reporting.
    Notice of Authorized Disclosure of Information for Litigation
    252.204-7015 2016-05 SEC I
    Support.
    Prohibition on the Acquisition of Covered Defense
    252.204-7018 2021-01 SEC I
    Telecommunications Equipment or Services.
    Prohibition on Storage, Treatment, and Disposal of Toxic or
    252.223-7006 2014-09 SEC I
    Hazardous Materials.
    252.225-7001 Buy American and Balance of Payments Program. 2017-12 SEC I
    252.225-7002 Qualifying Country Sources as Subcontractors. 2017-12 SEC I
    252.225-7048 Export-Controlled Items. 2013-06 SEC I
    252.227-7015 Technical Data--Commercial Items. 2014-02 SEC I
    252.227-7016 Rights in Bid or Proposal Information. 2011-01 SEC I
    252.227-7020 Rights in Special Works. 1995-06 SEC I
    252.227-7030 Technical Data--Withholding of Payment. 2000-03 SEC I
    252.227-7037 Validation of Restrictive Markings on Technical Data. 2016-09 SEC I
    252.227-7039 Patents--Reporting of Subject Inventions. 1990-04 SEC I
    Electronic Submission of Payment Requests and Receiving
    252.232-7003 2018-12 SEC G
    Reports.
    252.232-7010 Levies on Contract Payments. 2006-12 SEC I
    Accelerating Payments to Small Business Subcontractors-
    252.232-7017 2020-04 SEC I
    Prohibition on Fees and Consideration.
    252.235-7011 Final Scientific or Technical Report. 2019-12 SEC I
    Prohibition on Interrogation of Detainees by Contractor
    252.237-7010 2013-06 SEC I
    Personnel.
    252.243-7001 Pricing of Contract Modifications. 1991-12 SEC I
    252.244-7000 Subcontracts for Commercial Items. 2020-10 SEC I
    Prohibition on Requiring Certain Internal Confidentiality
    52.203-19 2017-01 SEC I
    Agreements or Statements.
    52.204-13 System for Award Management Maintenance. 2018-10 SEC I
    Incorporation by Reference of Representations and
    52.204-19 2014-12 SEC I
    Certifications.
    Prohibition on Contracting for Hardware, Software, and
    52.204-23 Services Developed or Provided by Kaspersky Lab and Other 2018-07 SEC I
    Covered Entities.
    Prohibition on Contracting for Certain Telecommunications
    52.204-25 2020-08 SEC I
    and Video Surveillance Services or Equipment.
    52.204-9 Personal Identity Verification of Contractor Personnel. 2011-01 SEC I
    Prohibition on Contracting with Inverted Domestic
    52.209-10 2015-11 SEC I
    Corporations.
    52.215-8 Order of Precedence-Uniform Contract Format. 1997-10 SEC I
    Page 1 of 29

    ---

    52.222-21 Prohibition of Segregated Facilities. 2015-04 SEC I
    52.222-26 Equal Opportunity. 2016-09 SEC I
    52.222-50 Combating Trafficking in Persons. 2020-10 SEC I
    Exemption from Application of the Service Contract Labor
    52.222-51 Standards to Contracts for Maintenance, Calibration, or Repair 2014-05 SEC I
    of Certain Equipment-Requirements.
    Exemption from Application of the Service Contract Labor
    52.222-53 2014-05 SEC I
    Standards to Contracts for Certain Services-Requirements.
    Encouraging Contractor Policies to Ban Text Messaging While
    52.223-18 2020-06 SEC I
    Driving.
    52.223-19 Compliance with Environmental Management Systems. 2011-05 SEC I
    52.223-5 Pollution Prevention and Right-to-Know Information. 2011-05 SEC I
    52.225-13 Restrictions on Certain Foreign Purchases. 2021-02 SEC I
    52.230-2 Cost Accounting Standards. 2020-06 SEC I
    52.230-6 Administration of Cost Accounting Standards. 2010-06 SEC I
    Payment by Electronic Funds Transfer-System for Award
    52.232-33 2018-10 SEC I
    Management.
    52.232-39 Unenforceability of Unauthorized Obligations. 2013-06 SEC I
    Providing Accelerated Payments to Small Business
    52.232-40 2013-12 SEC I
    Subcontractors.
    52.233-1 Disputes. 2014-05 SEC I
    52.233-3 Protest after Award. 1996-08 SEC I
    52.233-4 Applicable Law for Breach of Contract Claim. 2004-10 SEC I
    52.242-15 Stop-Work Order. 1989-08 SEC F
    52.243-1 ALT I Changes-Fixed-Price. - (Alternate I) 1987-08 SEC I
    52.243-1 ALT V Changes-Fixed-Price. - (Alternate V) 1987-08 SEC I
    52.244-6 Subcontracts for Commercial Items. 2021-07 SEC I
    52.246-9 Inspection of Research and Development (Short Form). 1984-04 SEC E
    52.247-34 F.o.b. Destination. 1991-11 SEC F
    Termination for Convenience of the Government (Fixed-Price)
    52.249-1 1984-04 SEC I
    (Short Form).
    Notice of Price Evaluation Preference for HUBZone Small
    52.219-4 2021-09 SEC I
    Business Concerns.
    Ensuring Adequate COVID-19 Safety Protocols for Federal
    252.223-7999 DEV 2021-O0009 2021-10 SEC I
    Contractors (Deviation 2021-O0009)
    CLAUSES IN FULL TEXT
    CLAUSE ALT NO/ YEAR-
    CLAUSE TITLE
    NO DEV NO MO
    CLAUSE TEXT
    52.232-1 Payments. 1984-04
    As prescribed in 32.111(a)(1), insert the following clause, appropriately modified with respect to
    payment due date in accordance with agency regulations, in solicitations and contracts when a fixed-
    price supply contract, a fixed-price service contract, or a contract for nonregulated communication
    services is contemplated:
    Payments (APR 1984)
    The Government shall pay the Contractor, upon the submission of proper invoices or vouchers, the
    prices stipulated in this contract for supplies delivered and accepted or services rendered and accepted,
    less any deductions provided in this contract. Unless otherwise specified in this contract, payment shall
    be made on partial deliveries accepted by the Government if-
    (a) The amount due on the deliveries warrants it; or
    Page 2 of 29

    ---

    (b) The Contractor requests it and the amount due on the deliveries is at least $1,000 or 50 percent
    of the total contract price.
    (End of clause)
    52.232-11 Extras. 1984-04
    As prescribed in 32.111(c)(2), insert the following clause, appropriately modified with respect to
    payment due dates in accordance with agency regulations, in solicitations and contracts when a fixed-
    price supply contract, fixed-price service contract, or transportation contract is contemplated:
    Extras (APR 1984)
    Except as otherwise provided in this contract, no payment for extras shall be made unless such extras
    and the price therefor have been authorized in writing by the Contracting Officer.
    (End of clause)
    Payments under Fixed-Price Research and Development
    52.232-2 1984-04
    Contracts.
    As prescribed in 32.111(a)(2), insert the following clause, as appropriately modified with respect to
    payment due dates in accordance with agency regulations, in solicitations and contracts when a fixed-
    price research and development contract is contemplated:
    Payments under Fixed-Price Research and Development Contracts (APR 1984)
    The Government shall pay the Contractor, upon submission of proper invoices or vouchers, the prices
    stipulated in this contract for work delivered or rendered and accepted, less any deductions provided in
    this contract. Unless otherwise specified, payment shall be made upon acceptance of any portion of the
    work delivered or rendered for which a price is separately stated in the contract.
    (End of clause)
    52.232-25 Prompt Payment. 2017-01
    As prescribed in 32.908(c), insert the following clause:
    Prompt Payment (JAN 2017)
    Notwithstanding any other payment clause in this contract, the Government will make invoice
    payments under the terms and conditions specified in this clause. The Government considers payment as
    being made on the day a check is dated or the date of an electronic funds transfer (EFT). Definitions of
    pertinent terms are set forth in sections 2.101, 32.001, and 32.902 of the Federal Acquisition Regulation.
    All days referred to in this clause are calendar days, unless otherwise specified. (However, see paragraph
    (a)(4) of this clause concerning payments due on Saturdays, Sundays, and legal holidays.)
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    (a) Invoice payments-(1) Due date.(i) Except as indicated in paragraphs (a)(2) and (c) of this
    clause, the due date for making invoice payments by the designated payment office is the later of the
    following two events:
    (A) The 30 thday after the designated billing office receives a proper invoice from the
    Contractor (except as provided in paragraph (a)(1)(ii) of this clause).
    (B) The 30 thday after Government acceptance of supplies delivered or services
    performed. For a final invoice, when the payment amount is subject to contract settlement actions,
    acceptance is deemed to occur on the effective date of the contract settlement.
    (ii) If the designated billing office fails to annotate the invoice with the actual date of
    receipt at the time of receipt, the invoice payment due date is the 30 thday after the date of the
    Contractor’s invoice, provided the designated billing office receives a proper invoice and there is no
    disagreement over quantity, quality, or Contractor compliance with contract requirements.
    (2) Certain food products and other payments.(i) Due dates on Contractor invoices for meat,
    meat food products, or fish; perishable agricultural commodities; and dairy products, edible fats or oils,
    and food products prepared from edible fats or oils are-
    (A) For meat or meat food products, as defined in section 2(a)(3) of the Packers and
    Stockyard Act of1921 (7 U.S.C.182(3)), and as further defined in Pub.L.98-181, including any edible
    fresh or frozen poultry meat, any perishable poultry meat food product, fresh eggs, and any perishable
    egg product, as close as possible to, but not later than, the 7 thday after product delivery.
    (B) For fresh or frozen fish, as defined in section 204(3) of the Fish and Seafood
    Promotion Act of1986 (16 U.S.C.4003(3)), as close as possible to, but not later than, the 7 thday after
    product delivery.
    (C) For perishable agricultural commodities, as defined in section 1(4) of the Perishable
    Agricultural Commodities Act of1930 (7 U.S.C.499a(4)), as close as possible to, but not later than, the
    10 thday after product delivery, unless another date is specified in the contract.
    (D) For dairy products, as defined in section 111(e) of the Dairy Production Stabilization
    Act of1983 (7 U.S.C.4502(e)), edible fats or oils, and food products prepared from edible fats or oils, as
    close as possible to, but not later than, the 10 thday after the date on which a proper invoice has been
    received. Liquid milk, cheese, certain processed cheese products, butter, yogurt, ice cream, mayonnaise,
    salad dressings, and other similar products, fall within this classification. Nothing in the Act limits this
    classification to refrigerated products. When questions arise regarding the proper classification of a
    specific product, prevailing industry practices will be followed in specifying a contract payment due
    date. The burden of proof that a classification of a specific product is, in fact, prevailing industry practice
    is upon the Contractor making the representation.
    (ii) If the contract does not require submission of an invoice for payment (e.g., periodic
    lease payments), the due date will be as specified in the contract.
    (3) Contractor's invoice. The Contractor shall prepare and submit invoices to the designated
    billing office specified in the contract. A proper invoice must include the items listed in paragraphs (a)(3)
    (i) through (a)(3)(x) of this clause. If the invoice does not comply with these requirements, the
    designated billing office will return it within 7 days after receipt (3 days for meat, meat food products, or
    fish; 5 days for perishable agricultural commodities, dairy products, edible fats or oils, and food products
    prepared from edible fats or oils), with the reasons why it is not a proper invoice. The Government will
    take into account untimely notification when computing any interest penalty owed the Contractor.
    (i) Name and address of the Contractor.
    (ii) Invoice date and invoice number. (The Contractor should date invoices as close as
    possible to the date of the mailing or transmission.)
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    (iii) Contract number or other authorization for supplies delivered or services performed
    (including order number and line item number).
    (iv) Description, quantity, unit of measure, unit price, and extended price of supplies
    delivered or services performed.
    (v) Shipping and payment terms (e.g., shipment number and date of shipment, discount for
    prompt payment terms). Bill of lading number and weight of shipment will be shown for shipments on
    Government bills of lading.
    (vi) Name and address of Contractor official to whom payment is to be sent (must be the
    same as that in the contract or in a proper notice of assignment).
    (vii) Name (where practicable), title, phone number, and mailing address of person to notify
    in the event of a defective invoice.
    (viii) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the
    invoice only if required elsewhere in this contract.
    (ix) Electronic funds transfer (EFT) banking information.
    (A) The Contractor shall include EFT banking information on the invoice only if
    required elsewhere in this contract.
    (B) If EFT banking information is not required to be on the invoice, in order for the
    invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in
    accordance with the applicable solicitation provision (e.g., 52.232-38, Submission of Electronic Funds
    Transfer Information with Offer), contract clause (e.g., 52.232-33, Payment by Electronic Funds
    Transfer-System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer-Other
    Than System for Award Management), or applicable agency procedures.
    (C) EFT banking information is not required if the Government waived the requirement
    to pay by EFT.
    (x) Any other information or documentation required by the contract (e.g., evidence of
    shipment).
    (4) Interest penalty. The designated payment office will pay an interest penalty automatically,
    without request from the Contractor, if payment is not made by the due date and the conditions listed in
    paragraphs (a)(4)(i) through (a)(4)(iii) of this clause are met, if applicable. However, when the due date
    falls on a Saturday, Sunday, or legal holiday, the designated payment office may make payment on the
    following working day without incurring a late payment interest penalty.
    (i) The designated billing office received a proper invoice.
    (ii) The Government processed a receiving report or other Government documentation
    authorizing payment, and there was no disagreement over quantity, quality, or Contractor compliance
    with any contract term or condition.
    (iii) In the case of a final invoice for any balance of funds due the Contractor for supplies
    delivered or services performed, the amount was not subject to further contract settlement actions
    between the Government and the Contractor.
    (5) Computing penalty amount. The Government will compute the interest penalty in
    accordance with the Office of Management and Budget prompt payment regulations at 5 CFR Part 1315.
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    (i) For the sole purpose of computing an interest penalty that might be due the Contractor,
    Government acceptance is deemed to occur constructively on the 7 thday (unless otherwise specified in
    this contract) after the Contractor delivers the supplies or performs the services in accordance with the
    terms and conditions of the contract, unless there is a disagreement over quantity, quality, or Contractor
    compliance with a contract provision. If actual acceptance occurs within the constructive acceptance
    period, the Government will base the determination of an interest penalty on the actual date of
    acceptance. The constructive acceptance requirement does not, however, compel Government officials to
    accept supplies or services, perform contract administration functions, or make payment prior to
    fulfilling their responsibilities.
    (ii) The prompt payment regulations at 5 CFR1315.10(c) do not require the Government to
    pay interest penalties if payment delays are due to disagreement between the Government and the
    Contractor over the payment amount or other issues involving contract compliance, or on amounts
    temporarily withheld or retained in accordance with the terms of the contract. The Government and the
    Contractor shall resolve claims involving disputes and any interest that may be payable in accordance
    with the clause at FAR 52.233-1, Disputes.
    (6) Discounts for prompt payment. The designated payment office will pay an interest penalty
    automatically, without request from the Contractor, if the Government takes a discount for prompt
    payment improperly. The Government will calculate the interest penalty in accordance with the prompt
    payment regulations at 5 CFR Part 1315.
    (7) Additional interest penalty.(i) The designated payment office will pay a penalty amount,
    calculated in accordance with the prompt payment regulations at 5 CFR Part 1315 in addition to the
    interest penalty amount only if-
    (A) The Government owes an interest penalty of $1 or more;
    (B) The designated payment office does not pay the interest penalty within 10 days after
    the date the invoice amount is paid; and
    (C) The Contractor makes a written demand to the designated payment office for
    additional penalty payment, in accordance with paragraph (a)(7)(ii) of this clause, postmarked not later
    than 40 days after the invoice amount is paid.
    (ii) (A) The Contractor shall support written demands for additional penalty payments with the
    following data. The Government will not request any additional data. The Contractor shall-
    (1) Specifically assert that late payment interest is due under a specific invoice, and
    request payment of all overdue late payment interest penalty and such additional penalty as may be
    required;
    (2) Attach a copy of the invoice on which the unpaid late payment interest is due; and
    (3) State that payment of the principal has been received, including the date of receipt.
    (B) If there is no postmark or the postmark is illegible-
    (1) The designated payment office that receives the demand will annotate it with the
    date of receipt, provided the demand is received on or before the 40th day after payment was made; or
    (2) If the designated payment office fails to make the required annotation, the
    Government will determine the demand’s validity based on the date the Contractor has placed on the
    demand, provided such date is no later than the 40th day after payment was made.
    (iii) The additional penalty does not apply to payments regulated by other Government
    regulations (e.g., payments under utility contracts subject to tariffs and regulation).
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    (b) Contract financing payment. If this contract provides for contract financing, the Government
    will make contract financing payments in accordance with the applicable contract financing clause.
    (c) Fast payment procedure due dates. If this contract contains the clause at 52.213-1, Fast
    Payment Procedure, payments will be made within 15 days after the date of receipt of the invoice.
    (d) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice
    payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the
    Contractor shall-
    (1) Remit the overpayment amount to the payment office cited in the contract along with a
    description of the overpayment including the-
    (i) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment,
    liquidation errors, date(s) of overpayment);
    (ii) Affected contract number and delivery order number if applicable;
    (iii) Affected line item or subline item, if applicable; and
    (iv) Contractor point of contact.
    (2) Provide a copy of the remittance and supporting documentation to the Contracting Officer.
    (End of clause)
    52.232-8 Discounts for Prompt Payment. 2002-02
    As prescribed in 32.111(b)(1), insert the following clause:
    Discounts for Prompt Payment (FEB 2002)
    (a) Discounts for prompt payment will not be considered in the evaluation of offers. However, any
    offered discount will form a part of the award, and will be taken if payment is made within the discount
    period indicated in the offer by the offeror. As an alternative to offering a discount for prompt payment
    in conjunction with the offer, offerors awarded contracts may include discounts for prompt payment on
    individual invoices.
    (b) In connection with any discount offered for prompt payment, time shall be computed from the
    date of the invoice. If the Contractor has not placed a date on the invoice, the due date shall be calculated
    from the date the designated billing office receives a proper invoice, provided the agency annotates such
    invoice with the date of receipt at the time of receipt. For the purpose of computing the discount earned,
    payment shall be considered to have been made on the date that appears on the payment check or, for an
    electronic funds transfer, the specified payment date. When the discount date falls on a Saturday,
    Sunday, or legal holiday when Federal Government offices are closed and Government business is not
    expected to be conducted, payment may be made on the following business day.
    (End of clause)
    252.227-7013 Rights in Technical Data--Noncommercial Items. 2014-02
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    As prescribed in 227.7103-6(a), use the following clause:
    RIGHTS IN TECHNICAL DATA--NONCOMMERCIAL ITEMS (FEB 2014)
    (a) Definitions. As used in this clause-
    (1) "Computer data base" means a collection of data recorded in a form capable of being
    processed by a computer. The term does not include computer software.
    (2) "Computer program" means a set of instructions, rules, or routines recorded in a form that
    is capable of causing a computer to perform a specific operation or series of operations.
    (3) "Computer software" means computer programs, source code, source code listings, object
    code listings, design details, algorithms, processes, flow charts, formulae and related material that would
    enable the software to be reproduced, recreated, or recompiled. Computer software does not include
    computer data bases or computer software documentation.
    (4) "Computer software documentation" means owner's manuals, user's manuals, installation
    instructions, operating instructions, and other similar items, regardless of storage medium, that explain
    the capabilities of the computer software or provide instructions for using the software.
    (5) "Covered Government support contractor" means a contractor (other than a litigation
    support contractor covered by 252.204-7014) under a contract, the primary purpose of which is to furnish
    independent and impartial advice or technical assistance directly to the Government in support of the
    Government's management and oversight of a program or effort (rather than to directly furnish an end
    item or service to accomplish a program or effort), provided that the contractor-
    (i) Is not affiliated with the prime contractor or a first-tier subcontractor on the program
    or effort, or with any direct competitor of such prime contractor or any such first-tier subcontractor in
    furnishing end items or services of the type developed or produced on the program or effort; and
    (ii) Receives access to technical data or computer software for performance of a
    Government contract that contains the clause at 252.227-7025, Limitations on the Use or Disclosure of
    Government-Furnished Information Marked with Restrictive Legends.
    (6) "Detailed manufacturing or process data" means technical data that describe the steps,
    sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to
    produce an item or component or to perform a process.
    (7) "Developed" means that an item, component, or process exists and is workable. Thus, the
    item or component must have been constructed or the process practiced. Workability is generally
    established when the item, component, or process has been analyzed or tested sufficiently to demonstrate
    to reasonable people skilled in the applicable art that there is a high probability that it will operate as
    intended. Whether, how much, and what type of analysis or testing is required to establish workability
    depends on the nature of the item, component, or process, and the state of the art. To be considered
    "developed," the item, component, or process need not be at the stage where it could be offered for sale
    or sold on the commercial market, nor must the item, component, or process be actually reduced to
    practice within the meaning of Title 35 of the United States Code.
    (8) "Developed exclusively at private expense" means development was accomplished
    entirely with costs charged to indirect cost pools, costs not allocated to a government contract, or any
    combination thereof.
    (i) Private expense determinations should be made at the lowest practicable level.
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    (ii) Under fixed-price contracts, when total costs are greater than the firm-fixed-price or
    ceiling price of the contract, the additional development costs necessary to complete development shall
    not be considered when determining whether development was at government, private, or mixed expense.
    (9) "Developed exclusively with government funds" means development was not
    accomplished exclusively or partially at private expense.
    (10) "Developed with mixed funding" means development was accomplished partially with
    costs charged to indirect cost pools and/or costs not allocated to a government contract, and partially
    with costs charged directly to a government contract.
    (11) "Form, fit, and function data" means technical data that describes the required overall
    physical, functional, and performance characteristics (along with the qualification requirements, if
    applicable) of an item, component, or process to the extent necessary to permit identification of
    physically and functionally interchangeable items.
    (12) "Government purpose" means any activity in which the United States Government is a
    party, including cooperative agreements with international or multi-national defense organizations, or
    sales or transfers by the United States Government to foreign governments or international organizations.
    Government purposes include competitive procurement, but do not include the rights to use, modify,
    reproduce, release, perform, display, or disclose technical data for commercial purposes or authorize
    others to do so.
    (13) "Government purpose rights" means the rights to-
    (i) Use, modify, reproduce, release, perform, display, or disclose technical data within the
    Government without restriction; and
    (ii) Release or disclose technical data outside the Government and authorize persons to
    whom release or disclosure has been made to use, modify, reproduce, release, perform, display, or
    disclose that data for United States government purposes.
    (14) "Limited rights" means the rights to use, modify, reproduce, release, perform, display, or
    disclose technical data, in whole or in part, within the Government. The Government may not, without
    the written permission of the party asserting limited rights, release or disclose the technical data outside
    the Government, use the technical data for manufacture, or authorize the technical data to be used by
    another party, except that the Government may reproduce, release, or disclose such data or authorize the
    use or reproduction of the data by persons outside the Government if-
    (i) The reproduction, release, disclosure, or use is-
    (A) Necessary for emergency repair and overhaul; or
    (B) A release or disclosure to-
    (1) A covered Government support contractor in performance of its covered
    Government support contract for use, modification, reproduction, performance, display, or release or
    disclosure to a person authorized to receive limited rights technical data; or
    (2) A foreign government, of technical data other than detailed manufacturing
    or process data, when use of such data by the foreign government is in the interest of the Government
    and is required for evaluational or informational purposes;
    (ii) The recipient of the technical data is subject to a prohibition on the further
    reproduction, release, disclosure, or use of the technical data; and
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    (iii) The contractor or subcontractor asserting the restriction is notified of such
    reproduction, release, disclosure, or use.
    (15) "Technical data" means recorded information, regardless of the form or method of the
    recording, of a scientific or technical nature (including computer software documentation). The term
    does not include computer software or data incidental to contract administration, such as financial and/or
    management information.
    (16) "Unlimited rights" means rights to use, modify, reproduce, perform, display, release, or
    disclose technical data in whole or in part, in any manner, and for any purpose whatsoever, and to have
    or authorize others to do so.
    (b) Rights in technical data. The Contractor grants or shall obtain for the Government the
    following royalty free, world-wide, nonexclusive, irrevocable license rights in technical data other than
    computer software documentation (see the Rights in Noncommercial Computer Software and
    Noncommercial Computer Software Documentation clause of this contract for rights in computer
    software documentation):
    (1) Unlimited rights. The Government shall have unlimited rights in technical data that are-
    (i) Data pertaining to an item, component, or process which has been or will be
    developed exclusively with Government funds;
    (ii) Studies, analyses, test data, or similar data produced for this contract, when the study,
    analysis, test, or similar work was specified as an element of performance;
    (iii) Created exclusively with Government funds in the performance of a contract that
    does not require the development, manufacture, construction, or production of items, components, or
    processes;
    (iv) Form, fit, and function data;
    (v) Necessary for installation, operation, maintenance, or training purposes (other than
    detailed manufacturing or process data);
    (vi) Corrections or changes to technical data furnished to the Contractor by the
    Government;
    (vii) Otherwise publicly available or have been released or disclosed by the Contractor or
    subcontractor without restrictions on further use, release or disclosure, other than a release or disclosure
    resulting from the sale, transfer, or other assignment of interest in the technical data to another party or
    the sale or transfer of some or all of a business entity or its assets to another party;
    (viii) Data in which the Government has obtained unlimited rights under another
    Government contract or as a result of negotiations; or
    (ix) Data furnished to the Government, under this or any other Government contract or
    subcontract thereunder, with-
    (A) Government purpose license rights or limited rights and the restrictive condition
    (s) has/have expired; or
    (B) Government purpose rights and the Contractor's exclusive right to use such data
    for commercial purposes has expired.
    (2) Government purpose rights.
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    (i) The Government shall have government purpose rights for a five-year period, or such
    other period as may be negotiated, in technical data-
    (A) That pertain to items, components, or processes developed with mixed funding
    except when the Government is entitled to unlimited rights in such data as provided in paragraphs (b)(1)
    (ii) and (b)(1)(iv) through (b)(1)(ix) of this clause; or
    (B) Created with mixed funding in the performance of a contract that does not
    require the development, manufacture, construction, or production of items, components, or processes.
    (ii) The five-year period, or such other period as may have been negotiated, shall
    commence upon execution of the contract, subcontract, letter contract (or similar contractual instrument),
    contract modification, or option exercise that required development of the items, components, or
    processes or creation of the data described in paragraph (b)(2)(i)(B) of this clause. Upon expiration of
    the five-year or other negotiated period, the Government shall have unlimited rights in the technical data.
    (iii) The Government shall not release or disclose technical data in which it has
    government purpose rights unless-
    (A) Prior to release or disclosure, the intended recipient is subject to the non-
    disclosure agreement at 227.7103-7 of the Defense Federal Acquisition Regulation Supplement
    (DFARS); or
    (B) The recipient is a Government contractor receiving access to the data for
    performance of a Government contract that contains the clause at DFARS 252.227-7025, Limitations on
    the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends.
    (iv) The Contractor has the exclusive right, including the right to license others, to use
    technical data in which the Government has obtained government purpose rights under this contract for
    any commercial purpose during the time period specified in the government purpose rights legend
    prescribed in paragraph (f)(2) of this clause.
    (3) Limited rights.
    (i) Except as provided in paragraphs (b)(1)(ii) and (b)(1)(iv) through (b)(1)(ix) of this
    clause, the Government shall have limited rights in technical data-
    (A) Pertaining to items, components, or processes developed exclusively at private
    expense and marked with the limited rights legend prescribed in paragraph (f) of this clause; or
    (B) Created exclusively at private expense in the performance of a contract that does
    not require the development, manufacture, construction, or production of items, components, or
    processes.
    (ii) The Government shall require a recipient of limited rights data for emergency repair
    or overhaul to destroy the data and all copies in its possession promptly following completion of the
    emergency repair/overhaul and to notify the Contractor that the data have been destroyed.
    (iii) The Contractor, its subcontractors, and suppliers are not required to provide the
    Government additional rights to use, modify, reproduce, release, perform, display, or disclose technical
    data furnished to the Government with limited rights. However, if the Government desires to obtain
    additional rights in technical data in which it has limited rights, the Contractor agrees to promptly enter
    into negotiations with the Contracting Officer to determine whether there are acceptable terms for
    transferring such rights. All technical data in which the Contractor has granted the Government
    additional rights shall be listed or described in a license agreement made part of the contract. The license
    shall enumerate the additional rights granted the Government in such data.
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    (iv) The Contractor acknowledges that-
    (A) Limited rights data are authorized to be released or disclosed to covered
    Government support contractors;
    (B) The Contractor will be notified of such release or disclosure;
    (C) The Contractor (or the party asserting restrictions as identified in the limited
    rights legend) may require each such covered Government support contractor to enter into a non-
    disclosure agreement directly with the Contractor (or the party asserting restrictions) regarding the
    covered Government support contractor's use of such data, or alternatively, that the Contractor (or party
    asserting restrictions) may waive in writing the requirement for a non-disclosure agreement; and
    (D) Any such non-disclosure agreement shall address the restrictions on the covered
    Government support contractor's use of the limited rights data as set forth in the clause at 252.227-7025,
    Limitations on the Use or Disclosure of Government- Furnished Information Marked with Restrictive
    Legends. The non-disclosure agreement shall not include any additional terms and conditions unless
    mutually agreed to by the parties to the non-disclosure agreement.
    (4) Specifically negotiated license rights. The standard license rights granted to the
    Government under paragraphs (b)(1) through (b)(3) of this clause, including the period during which the
    Government shall have government purpose rights in technical data, may be modified by mutual
    agreement to provide such rights as the parties consider appropriate but shall not provide the
    Government lesser rights than are enumerated in paragraph (a)(14) of this clause. Any rights so
    negotiated shall be identified in a license agreement made part of this contract.
    (5) Prior government rights. Technical data that will be delivered, furnished, or otherwise
    provided to the Government under this contract, in which the Government has previously obtained rights
    shall be delivered, furnished, or provided with the pre-existing rights, unless-
    (i) The parties have agreed otherwise; or
    (ii) Any restrictions on the Government's rights to use, modify, reproduce, release,
    perform, display, or disclose the data have expired or no longer apply.
    (6) Release from liability. The Contractor agrees to release the Government from liability for
    any release or disclosure of technical data made in accordance with paragraph (a)(14) or (b)(2)(iii) of this
    clause, in accordance with the terms of a license negotiated under paragraph (b)(4) of this clause, or by
    others to whom the recipient has released or disclosed the data and to seek relief solely from the party
    who has improperly used, modified, reproduced, released, performed, displayed, or disclosed Contractor
    data marked with restrictive legends.
    (c) Contractor rights in technical data. All rights not granted to the Government are retained by
    the Contractor.
    (d) Third party copyrighted data. The Contractor shall not, without the written approval of the
    Contracting Officer, incorporate any copyrighted data in the technical data to be delivered under this
    contract unless the Contractor is the copyright owner or has obtained for the Government the license
    rights necessary to perfect a license or licenses in the deliverable data of the appropriate scope set forth
    in paragraph (b) of this clause, and has affixed a statement of the license or licenses obtained on behalf
    of the Government and other persons to the data transmittal document.
    (e) Identification and delivery of data to be furnished with restrictions on use, release, or
    disclosure.
    (1) This paragraph does not apply to restrictions based solely on copyright.
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    (2) Except as provided in paragraph (e)(3) of this clause, technical data that the Contractor
    asserts should be furnished to the Government with restrictions on use, release, or disclosure are
    identified in an attachment to this contract (the Attachment). The Contractor shall not deliver any data
    with restrictive markings unless the data are listed on the Attachment.
    (3) In addition to the assertions made in the Attachment, other assertions may be identified
    after award when based on new information or inadvertent omissions unless the inadvertent omissions
    would have materially affected the source selection decision. Such identification and assertion shall be
    submitted to the Contracting Officer as soon as practicable prior to the scheduled date for delivery of the
    data, in the following format, and signed by an official authorized to contractually obligate the
    Contractor:
    Identification and Assertion of Restrictions on the Government's Use, Release,
    or Disclosure of Technical Data.
    The Contractor asserts for itself, or the persons identified below, that the Government's
    rights to use, release, or disclose the following technical data should be restricted-
    Technical Data Name of Person
    to be Furnished Basis for Asserted Rights Asserting
    With Restrictions Assertion Category Restrictions**
    ____(LIST) ____(LIST) ____(LIST) ____(LIST)
    *If the assertion is applicable to items, components, or processes developed at private
    expense, identify both the data and each such item, component, or process.
    **Generally, the development of an item, component, or process at private expense, either
    exclusively or partially, is the only basis for asserting restrictions on the Government's rights to use,
    release, or disclose technical data pertaining to such items, components, or processes. Indicate whether
    development was exclusively or partially at private expense. If development was not at private expense,
    enter the specific reason for asserting that the Government's rights should be restricted.
    *Enter asserted rights category (e.g., government purpose license rights from a prior
    contract, rights in SBIR data generated under another contract, limited or government purpose rights
    under this or a prior contract, or specifically negotiated licenses).
    **Corporation, individual, or other person, as appropriate.
    Date ____
    Printed Name and Title ____
    ____
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    Signature ____
    (End of identification and assertion)
    (4) When requested by the Contracting Officer, the Contractor shall provide sufficient
    information to enable the Contracting Officer to evaluate the Contractor's assertions. The Contracting
    Officer reserves the right to add the Contractor's assertions to the Attachment and validate any listed
    assertion, at a later date, in accordance with the procedures of the Validation of Restrictive Markings on
    Technical Data clause of this contract.
    (f) Marking requirements. The Contractor, and its subcontractors or suppliers, may only assert
    restrictions on the Government's rights to use, modify, reproduce, release, perform, display, or disclose
    technical data to be delivered under this contract by marking the deliverable data subject to restriction.
    Except as provided in paragraph (f)(5) of this clause, only the following legends are authorized under
    this contract: the government purpose rights legend at paragraph (f)(2) of this clause; the limited rights
    legend at paragraph (f)(3) of this clause; or the special license rights legend at paragraph (f)(4) of this
    clause; and/or a notice of copyright as prescribed under 17 U.S.C. 401 or 402.
    (1) General marking instructions. The Contractor, or its subcontractors or suppliers, shall
    conspicuously and legibly mark the appropriate legend on all technical data that qualify for such
    markings. The authorized legends shall be placed on the transmittal document or storage container and,
    for printed material, each page of the printed material containing technical data for which restrictions are
    asserted. When only portions of a page of printed material are subject to the asserted restrictions, such
    portions shall be identified by circling, underscoring, with a note, or other appropriate identifier.
    Technical data transmitted directly from one computer or computer terminal to another shall contain a
    notice of asserted restrictions. Reproductions of technical data or any portions thereof subject to asserted
    restrictions shall also reproduce the asserted restrictions.
    (2) Government purpose rights markings. Data delivered or otherwise furnished to the
    Government with government purpose rights shall be marked as follows:
    GOVERNMENT PURPOSE RIGHTS
    Contract No.
    ____
    Contractor Name
    ____
    Contractor Address
    ____
    ____
    Expiration Date
    ____
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    The Government's rights to use, modify, reproduce, release, perform, display, or disclose
    these technical data are restricted by paragraph (b)(2) of the Rights in Technical Data-Noncommercial
    Items clause contained in the above identified contract. No restrictions apply after the expiration date
    shown above. Any reproduction of technical data or portions thereof marked with this legend must also
    reproduce the markings.
    (End of legend)
    (3) Limited rights markings. Data delivered or otherwise furnished to the Government with
    limited rights shall be marked with the following legend:
    LIMITED RIGHTS
    Contract No.
    ____
    Contractor Name
    ____
    Contractor Address
    ____
    ____
    The Government's rights to use, modify, reproduce, release, perform, display, or disclose
    these technical data are restricted by paragraph (b)(3) of the Rights in Technical Data--Noncommercial
    Items clause contained in the above identified contract. Any reproduction of technical data or portions
    thereof marked with this legend must also reproduce the markings. Any person, other than the
    Government, who has been provided access to such data must promptly notify the above named
    Contractor.
    (End of legend)
    (4) Special license rights markings.
    (i) Data in which the Government's rights stem from a specifically negotiated license
    shall be marked with the following legend:
    SPECIAL LICENSE RIGHTS
    The Government's rights to use, modify, reproduce, release, perform, display, or disclose these data
    are restricted by Contract No. ____(Insert contract number)____, License No. ____(Insert license
    identifier)____. Any reproduction of technical data or portions thereof marked with this legend must
    also reproduce the markings.
    (End of legend)
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    (ii) For purposes of this clause, special licenses do not include government purpose
    license rights acquired under a prior contract (see paragraph (b)(5) of this clause).
    (5) Pre-existing data markings. If the terms of a prior contract or license permitted the
    Contractor to restrict the Government's rights to use, modify, reproduce, release, perform, display, or
    disclose technical data deliverable under this contract, and those restrictions are still applicable, the
    Contractor may mark such data with the appropriate restrictive legend for which the data qualified under
    the prior contract or license. The marking procedures in paragraph (f)(1) of this clause shall be followed.
    (g) Contractor procedures and records. Throughout performance of this contract, the Contractor
    and its subcontractors or suppliers that will deliver technical data with other than unlimited rights, shall-
    (1) Have, maintain, and follow written procedures sufficient to assure that restrictive
    markings are used only when authorized by the terms of this clause; and
    (2) Maintain records sufficient to justify the validity of any restrictive markings on technical
    data delivered under this contract.
    (h) Removal of unjustified and nonconforming markings.
    (1) Unjustified technical data markings. The rights and obligations of the parties regarding
    the validation of restrictive markings on technical data furnished or to be furnished under this contract
    are contained in the Validation of Restrictive Markings on Technical Data clause of this contract.
    Notwithstanding any provision of this contract concerning inspection and acceptance, the Government
    may ignore or, at the Contractor's expense, correct or strike a marking if, in accordance with the
    procedures in the Validation of Restrictive Markings on Technical Data clause of this contract, a
    restrictive marking is determined to be unjustified.
    (2) Nonconforming technical data markings. A nonconforming marking is a marking placed
    on technical data delivered or otherwise furnished to the Government under this contract that is not in the
    format authorized by this contract. Correction of nonconforming markings is not subject to the
    Validation of Restrictive Markings on Technical Data clause of this contract. If the Contracting Officer
    notifies the Contractor of a nonconforming marking and the Contractor fails to remove or correct such
    marking within sixty (60) days, the Government may ignore or, at the Contractor's expense, remove or
    correct any nonconforming marking.
    (i) Relation to patents. Nothing contained in this clause shall imply a license to the Government
    under any patent or be construed as affecting the scope of any license or other right otherwise granted to
    the Government under any patent.
    (j) Limitation on charges for rights in technical data.
    (1) The Contractor shall not charge to this contract any cost, including, but not limited to,
    license fees, royalties, or similar charges, for rights in technical data to be delivered under this contract
    when-
    (i) The Government has acquired, by any means, the same or greater rights in the data; or
    (ii) The data are available to the public without restrictions.
    (2) The limitation in paragraph (j)(1) of this clause-
    (i) Includes costs charged by a subcontractor or supplier, at any tier, or costs incurred by
    the Contractor to acquire rights in subcontractor or supplier technical data, if the subcontractor or
    supplier has been paid for such rights under any other Government contract or under a license conveying
    the rights to the Government; and
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    (ii) Does not include the reasonable costs of reproducing, handling, or mailing the
    documents or other media in which the technical data will be delivered.
    (k) Applicability to subcontractors or suppliers.
    (1) The Contractor shall ensure that the rights afforded its subcontractors and suppliers under
    10 U.S.C. 2320, 10 U.S.C. 2321, and the identification, assertion, and delivery processes of paragraph (e)
    of this clause are recognized and protected.
    (2) Whenever any technical data for noncommercial items, or for commercial items
    developed in any part at Government expense, is to be obtained from a subcontractor or supplier for
    delivery to the Government under this contract, the Contractor shall use this same clause in the
    subcontract or other contractual instrument, including subcontracts or other contractual instruments for
    commercial items, and require its subcontractors or suppliers to do so, without alteration, except to
    identify the parties. This clause will govern the technical data pertaining to noncommercial items or to
    any portion of a commercial item that was developed in any part at Government expense, and the clause
    at 252.227-7015 will govern the technical data pertaining to any portion of a commercial item that was
    developed exclusively at private expense. No other clause shall be used to enlarge or diminish the
    Government's, the Contractor's, or a higher-tier subcontractor's or supplier's rights in a subcontractor's or
    supplier's technical data.
    (3) Technical data required to be delivered by a subcontractor or supplier shall normally be
    delivered to the next higher-tier contractor, subcontractor, or supplier. However, when there is a
    requirement in the prime contract for data which may be submitted with other than unlimited rights by a
    subcontractor or supplier, then said subcontractor or supplier may fulfill its requirement by submitting
    such data directly to the Government, rather than through a higher-tier contractor, subcontractor, or
    supplier.
    (4) The Contractor and higher-tier subcontractors or suppliers shall not use their power to
    award contracts as economic leverage to obtain rights in technical data from their subcontractors or
    suppliers.
    (5) In no event shall the Contractor use its obligation to recognize and protect subcontractor
    or supplier rights in technical data as an excuse for failing to satisfy its contractual obligation to the
    Government.
    (End of clause)
    252.232-7006 Wide Area WorkFlow Payment Instructions. 2018-12
    As prescribed in 232.7004(b), use the following clause:
    WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)
    (a) Definitions. As used in this clause-
    "Department of Defense Activity Address Code (DoDAAC)" is a six position code that uniquely
    identifies a unit, activity, or organization.
    "Document type" means the type of payment request or receiving report available for creation in
    Wide Area WorkFlow (WAWF).
    "Local processing office (LPO)" is the office responsible for payment certification when payment
    certification is done external to the entitlement system.
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    "Payment request" and "receiving report" are defined in the clause at 252.232-7003, Electronic
    Submission of Payment Requests and Receiving Reports.
    (b) Electronic invoicing. The WAWF system provides the method to electronically process
    vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation
    Supplement (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving
    Reports.
    (c) WAWF access. To access WAWF, the Contractor shall-
    (1) Have a designated electronic business point of contact in the System for Award
    Management at https://www.sam.gov; and
    (2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures
    for self-registration available at this web site.
    (d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-
    Based Training Course and use the Practice Training Site before submitting payment requests through
    WAWF. Both can be accessed by selecting the "Web Based Training" link on the WAWF home page at
    https://wawf.eb.mil/
    (e) WAWF methods of document submission. Document submissions may be via web entry,
    Electronic Data Interchange, or File Transfer Protocol.
    (f) WAWF payment instructions. The Contractor shall use the following information when
    submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:
    (1) Document type. The Contractor shall submit payment requests using the following
    document type(s):
    (i) For cost-type line items, including labor-hour or time-and-materials, submit a cost
    voucher.
    (ii) For fixed price line items-
    (A) That require shipment of a deliverable, submit the invoice and receiving report
    specified by the Contracting Officer.
    ____
    (Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price
    line items that require shipment of a deliverable.)
    (B) For services that do not require shipment of a deliverable, submit either the
    Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable
    invoice and receiving report, as specified by the Contracting Officer.
    ____
    (Contracting Officer: Insert either "Invoice 2in1" or the applicable invoice and receiving
    report document type(s) for fixed price line items for services.)
    (iii) For customary progress payments based on costs incurred, submit a progress
    payment request.
    (iv) For performance based payments, submit a performance based payment request.
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    (v) For commercial item financing, submit a commercial item financing request.
    (2) ) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR)
    52.213-1 is included in the contract.
    (f) [Note: The Contractor may use a WAWF "combo" document type to create some combinations
    of invoice and receiving report in one step.]
    (3) Document routing. The Contractor shall use the information in the Routing Data Table
    below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in
    the system.
    Routing Data Table*
    Field Name in WAWF Data to be entered in WAWF
    Pay Official DoDAAC ____
    Issue By DoDAAC ____
    Admin DoDAAC ____
    Inspect By DoDAAC ____
    Ship To Code ____
    Ship From Code ____
    Mark For Code ____
    Service Approver (DoDAAC) ____
    Service Acceptor (DoDAAC) ____
    Accept at Other DoDAAC ____
    LPO DoDAAC ____
    DCAA Auditor DoDAAC ____
    Other DoDAAC(s) ____
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    (*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance
    locations apply, insert "See Schedule" or "Not applicable.")
    (**Contracting Officer: If the contract provides for progress payments or performance-based
    payments, insert the DoDAAC for the contract administration office assigned the functions under FAR
    42.302(a)(13).)
    (4) Payment request. The Contractor shall ensure a payment request includes documentation
    appropriate to the type of payment request in accordance with the payment clause, contract financing
    clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.
    (5) Receiving report. The Contractor shall ensure a receiving report meets the requirements
    of DFARS Appendix F.
    (g) WAWF point of contact.
    (1) The Contractor may obtain clarification regarding invoicing in WAWF from the
    following contracting activity's WAWF point of contact.
    ____
    (Contracting Officer: Insert applicable information or "Not applicable.")
    (2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.
    (End of clause)
    252.232-7007 Limitation of Government's Obligation. 2014-04
    As prescribed in 232.705-70, use the following clause:
    LIMITATION OF GOVERNMENT'S OBLIGATION (APR 2014)
    (a) Contract line item(s) [Contracting Officer insert after negotiations] is/are incrementally
    funded. For this/these item(s), the sum of $ [Contracting Officer insert after negotiations] of the total
    price is presently available for payment and allotted to this contract. An allotment schedule is set forth in
    paragraph (j) of this clause.
    (b) For item(s) identified in paragraph (a) of this clause, the Contractor agrees to perform up to the
    point at which the total amount payable by the Government, including reimbursement in the event of
    termination of those item(s) for the Government's convenience, approximates the total amount currently
    allotted to the contract. The Contractor is not authorized to continue work on those item(s) beyond that
    point. The Government will not be obligated in any event to reimburse the Contractor in excess of the
    amount allotted to the contract for those item(s) regardless of anything to the contrary in the clause
    entitled "Termination for Convenience of the Government." As used in this clause, the total amount
    payable by the Government in the event of termination of applicable contract line item(s) for
    convenience includes costs, profit, and estimated termination settlement costs for those item(s).
    (c) Notwithstanding the dates specified in the allotment schedule in paragraph (j) of this clause,
    the Contractor will notify the Contracting Officer in writing at least ninety days prior to the date when, in
    the Contractor's best judgment, the work will reach the point at which the total amount payable by the
    Page 20 of 29

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    Government, including any cost for termination for convenience, will approximate 85 percent of the total
    amount then allotted to the contract for performance of the applicable item(s). The notification will state
    (1) the estimated date when that point will be reached and (2) an estimate of additional funding, if any,
    needed to continue performance of applicable line items up to the next scheduled date for allotment of
    funds identified in paragraph (j) of this clause, or to a mutually agreed upon substitute date. The
    notification will also advise the Contracting Officer of the estimated amount of additional funds that will
    be required for the timely performance of the item(s) funded pursuant to this clause, for a subsequent
    period as may be specified in the allotment schedule in paragraph (j) of this clause or otherwise agreed to
    by the parties. If after such notification additional funds are not allotted by the date identified in the
    Contractor's notification, or by an agreed substitute date, the Contracting Officer will terminate any item
    (s) for which additional funds have not been allotted, pursuant to the clause of this contract entitled
    "Termination for Convenience of the Government."
    (d) When additional funds are allotted for continued performance of the contract line item(s)
    identified in paragraph (a) of this clause, the parties will agree as to the period of contract performance
    which will be covered by the funds. The provisions of paragraphs (b) through (d) of this clause will
    apply in like manner to the additional allotted funds and agreed substitute date, and the contract will be
    modified accordingly.
    (e) If, solely by reason of failure of the Government to allot additional funds, by the dates
    indicated below, in amounts sufficient for timely performance of the contract line item(s) identified in
    paragraph (a) of this clause, the Contractor incurs additional costs or is delayed in the performance of the
    work under this contract and if additional funds are allotted, an equitable adjustment will be made in the
    price or prices (including appropriate target, billing, and ceiling prices where applicable) of the item(s),
    or in the time of delivery, or both. Failure to agree to any such equitable adjustment hereunder will be a
    dispute concerning a question of fact within the meaning of the clause entitled "Disputes."
    (f) The Government may at any time prior to termination allot additional funds for the
    performance of the contract line item(s) identified in paragraph (a) of this clause.
    (g) The termination provisions of this clause do not limit the rights of the Government under the
    clause entitled "Default." The provisions of this clause are limited to the work and allotment of funds for
    the contract line item(s) set forth in paragraph (a) of this clause. This clause no longer applies once the
    contract is fully funded except with regard to the rights or obligations of the parties concerning equitable
    adjustments negotiated under paragraphs (d) and (e) of this clause.
    (h) Nothing in this clause affects the right of the Government to terminate this contract pursuant to
    the clause of this contract entitled "Termination for Convenience of the Government."
    (i) Nothing in this clause shall be construed as authorization of voluntary services whose
    acceptance is otherwise prohibited under 31 U.S.C. 1342.
    (j) The parties contemplate that the Government will allot funds to this contract in accordance
    with the following schedule:
    On execution of contract $ ____
    (month) (day), (year) $ ____
    (month) (day), (year) $ ____
    (month) (day), (year) $ ____
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    (End of clause)
    252.235-7010 Acknowledgment of Support and Disclaimer. 1995-05
    As prescribed in 235.072(c), use the following clause:
    ACKNOWLEDGMENT OF SUPPORT AND DISCLAIMER (MAY 1995)
    (a) The Contractor shall include an acknowledgment of the Government's support in the
    publication of any material based on or developed under this contract, stated in the following terms:
    This material is based upon work supported by the ____(name of contracting agency(ies)) under
    Contract No. ____(Contracting agency(ies) contract number(s)).
    (b) All material, except scientific articles or papers published in scientific journals, must, in
    addition to any notices or disclaimers by the Contractor, also contain the following disclaimer: Any
    opinions, findings and conclusions or recommendations expressed in this material are those of the author
    (s) and do not necessarily reflect the views of the ____(name of contracting agency(ies)).
    (End of clause)
    52.227-11 Patent Rights-Ownership by the Contractor. 2014-05
    As prescribed in 27.303(b)(1), insert the following clause:
    Patent Rights-Ownership by the Contractor (MAY 2014)
    (a) As used in this clause-
    Invention means any invention or discovery that is or may be patentable or otherwise protectable
    under title 35 of the U.S. Code, or any variety of plant that is or may be protectable under the Plant
    Variety Protection Act (7 U.S.C. 2321, et seq.)
    Made means-
    (1) When used in relation to any invention other than a plant variety, the conception or first
    actual reduction to practice of the invention; or
    (2) When used in relation to a plant variety, that the Contractor has at least tentatively
    determined that the variety has been reproduced with recognized characteristics.
    Nonprofit organization means a university or other institution of higher education or an
    organization of the type described in section 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C.
    501(c)) and exempt from taxation under section 501(a) of the Internal Revenue Code (26 U.S.C. 501(a)),
    or any nonprofit scientific or educational organization qualified under a State nonprofit organization
    statute.
    "Practical application" means to manufacture, in the case of a composition of product; to
    practice, in the case of a process or method; or to operate, in the case of a machine or system; and, in
    each case, under such conditions as to establish that the invention is being utilized and that its benefits
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    are, to the extent permitted by law or Government regulations, available to the public on reasonable
    terms.
    Subject invention means any invention of the Contractor made in the performance of work
    under this contract.
    (b) Contractor's rights. (1) Ownership. The Contractor may retain ownership of each subject
    invention throughout the world in accordance with the provisions of this clause.
    (2) License. (i) The Contractor shall retain a nonexclusive royalty-free license throughout the
    world in each subject invention to which the Government obtains title, unless the Contractor fails to
    disclose the invention within the times specified in paragraph (c) of this clause. The Contractor's license
    extends to any domestic subsidiaries and affiliates within the corporate structure of which the Contractor
    is a part, and includes the right to grant sublicenses to the extent the Contractor was legally obligated to
    do so at contract award. The license is transferable only with the written approval of the agency, except
    when transferred to the successor of that part of the Contractor's business to which the invention pertains.
    (ii) The Contractor's license may be revoked or modified by the agency to the extent
    necessary to achieve expeditious practical application of the subject invention in a particular country in
    accordance with the procedures in FAR 27.302(i)(2) and 27.304-1(f).
    (c) Contractor's obligations. (1) The Contractor shall disclose in writing each subject invention to
    the Contracting Officer within 2 months after the inventor discloses it in writing to Contractor personnel
    responsible for patent matters. The disclosure shall identify the inventor(s) and this contract under which
    the subject invention was made. It shall be sufficiently complete in technical detail to convey a clear
    understanding of the subject invention. The disclosure shall also identify any publication, on sale (i.e.,
    sale or offer for sale), or public use of the subject invention, or whether a manuscript describing the
    subject invention has been submitted for publication and, if so, whether it has been accepted for
    publication. In addition, after disclosure to the agency, the Contractor shall promptly notify the
    Contracting Officer of the acceptance of any manuscript describing the subject invention for publication
    and any on sale or public use.
    (2) The Contractor shall elect in writing whether or not to retain ownership of any subject
    invention by notifying the Contracting Officer within 2 years of disclosure to the agency. However, in
    any case where publication, on sale, or public use has initiated the 1-year statutory period during which
    valid patent protection can be obtained in the United States, the period for election of title may be
    shortened by the agency to a date that is no more than 60 days prior to the end of the statutory period.
    (3) The Contractor shall file either a provisional or a nonprovisional patent application or a
    Plant Variety Protection Application on an elected subject invention within 1 year after election.
    However, in any case where a publication, on sale, or public use has initiated the 1-year statutory period
    during which valid patent protection can be obtained in the United States, the Contractor shall file the
    application prior to the end of that statutory period. If the Contractor files a provisional application, it
    shall file a nonprovisional application within 10 months of the filing of the provisional application. The
    Contractor shall file patent applications in additional countries or international patent offices within
    either 10 months of the first filed patent application (whether provisional or nonprovisional) or 6 months
    from the date permission is granted by the Commissioner of Patents to file foreign patent applications
    where such filing has been prohibited by a Secrecy Order.
    (4) The Contractor may request extensions of time for disclosure, election, or filing under
    paragraphs (c)(1), (c)(2), and (c)(3) of this clause.
    (d) Government's rights- (1) Ownership. The Contractor shall assign to the agency, on written
    request, title to any subject invention-
    (i) If the Contractor fails to disclose or elect ownership to the subject invention within the
    times specified in paragraph (c) of this clause, or elects not to retain ownership; provided, that the agency
    may request title only within 60 days after learning of the Contractor's failure to disclose or elect within
    the specified times.
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    (ii) In those countries in which the Contractor fails to file patent applications within the
    times specified in paragraph (c) of this clause; provided, however, that if the Contractor has filed a patent
    application in a country after the times specified in paragraph (c) of this clause, but prior to its receipt of
    the written request of the agency, the Contractor shall continue to retain ownership in that country.
    (iii) In any country in which the Contractor decides not to continue the prosecution of any
    application for, to pay the maintenance fees on, or defend in reexamination or opposition proceeding on,
    a patent on a subject invention.
    (2) License. If the Contractor retains ownership of any subject invention, the Government shall
    have a nonexclusive, nontransferable, irrevocable, paid-up license to practice, or have practiced for or on
    its behalf, the subject invention throughout the world.
    (e) Contractor action to protect the Government's interest. (1) The Contractor shall execute or have
    executed and promptly deliver to the agency all instruments necessary to-
    (i) Establish or confirm the rights the Government has throughout the world in those subject
    inventions in which the Contractor elects to retain ownership; and
    (ii) Assign title to the agency when requested under paragraph (d) of this clause and to
    enable the Government to obtain patent protection and plant variety protection for that subject invention
    in any country.
    (2) The Contractor shall require, by written agreement, its employees, other than clerical and
    nontechnical employees, to disclose promptly in writing to personnel identified as responsible for the
    administration of patent matters and in the Contractor's format, each subject invention in order that the
    Contractor can comply with the disclosure provisions of paragraph (c) of this clause, and to execute all
    papers necessary to file patent applications on subject inventions and to establish the Government's rights
    in the subject inventions. The disclosure format should require, as a minimum, the information required
    by paragraph (c)(1) of this clause. The Contractor shall instruct such employees, through employee
    agreements or other suitable educational programs, as to the importance of reporting inventions in
    sufficient time to permit the filing of patent applications prior to U.S. or foreign statutory bars.
    (3) The Contractor shall notify the Contracting Officer of any decisions not to file a
    nonprovisional patent application, continue the prosecution of a patent application, pay maintenance
    fees, or defend in a reexamination or opposition proceeding on a patent, in any country, not less than 30
    days before the expiration of the response or filing period required by the relevant patent office.
    (4) The Contractor shall include, within the specification of any United States nonprovisional
    patent or plant variety protection application and any patent or plant variety protection certificate issuing
    thereon covering a subject invention, the following statement, "This invention was made with
    Government support under (identify the contract) awarded by (identify the agency). The Government has
    certain rights in the invention."
    (f) Reporting on utilization of subject inventions. The Contractor shall submit, on request, periodic
    reports no more frequently than annually on the utilization of a subject invention or on efforts at
    obtaining utilization of the subject invention that are being made by the Contractor or its licensees or
    assignees. The reports shall include information regarding the status of development, date of first
    commercial sale or use, gross royalties received by the Contractor, and other data and information as the
    agency may reasonably specify. The Contractor also shall provide additional reports as may be requested
    by the agency in connection with any march-in proceeding undertaken by the agency in accordance with
    paragraph (h) of this clause. The Contractor also shall mark any utilization report as confidential
    /proprietary to help prevent inadvertent release outside the Government. As required by 35 U.S.C. 202(c)
    (5), the agency will not disclose that information to persons outside the Government without the
    Contractor's permission.
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    (g) Preference for United States industry. Notwithstanding any other provision of this clause,
    neither the Contractor nor any assignee shall grant to any person the exclusive right to use or sell any
    subject invention in the United States unless the person agrees that any products embodying the subject
    invention or produced through the use of the subject invention will be manufactured substantially in the
    United States. However, in individual cases, the requirement for an agreement may be waived by the
    agency upon a showing by the Contractor or its assignee that reasonable but unsuccessful efforts have
    been made to grant licenses on similar terms to potential licensees that would be likely to manufacture
    substantially in the United States, or that under the circumstances domestic manufacture is not
    commercially feasible.
    (h) March-in rights. The Contractor acknowledges that, with respect to any subject invention in
    which it has retained ownership, the agency has the right to require licensing pursuant to 35 U.S.C. 203
    and 210(c), and in accordance with the procedures in 37 CFR 401.6 and any supplemental regulations of
    the agency in effect on the date of contract award.
    (i) Special provisions for contracts with nonprofit organizations. If the Contractor is a nonprofit
    organization, it shall-
    (1) Not assign rights to a subject invention in the United States without the written approval of
    the agency, except where an assignment is made to an organization that has as one of its primary
    functions the management of inventions, provided, that the assignee shall be subject to the same
    provisions as the Contractor;
    (2) Share royalties collected on a subject invention with the inventor, including Federal
    employee co-inventors (but through their agency if the agency deems it appropriate) when the subject
    invention is assigned in accordance with 35U.S.C.202(e) and 37 CFR 401.10;
    (3) Use the balance of any royalties or income earned by the Contractor with respect to subject
    inventions, after payment of expenses (including payments to inventors) incidental to the administration
    of subject inventions for the support of scientific research or education; and
    (4) Make efforts that are reasonable under the circumstances to attract licensees of subject
    inventions that are small business concerns, and give a preference to a small business concern when
    licensing a subject invention if the Contractor determines that the small business concern has a plan or
    proposal for marketing the invention which, if executed, is equally as likely to bring the invention to
    practical application as any plans or proposals from applicants that are not small business concerns;
    provided, that the Contractor is also satisfied that the small business concern has the capability and
    resources to carry out its plan or proposal. The decision whether to give a preference in any specific case
    will be at the discretion of the Contractor.
    (5) Allow the Secretary of Commerce to review the Contractor's licensing program and
    decisions regarding small business applicants, and negotiate changes to its licensing policies, procedures,
    or practices with the Secretary of Commerce when the Secretary's review discloses that the Contractor
    could take reasonable steps to more effectively implement the requirements of paragraph (i)(4) of this
    clause.
    (j) Communications. ____[Complete according to agency instructions.]
    (k) Subcontracts. (1) The Contractor shall include the substance of this clause, including this
    paragraph (k), in all subcontracts for experimental, developmental, or research work to be performed by
    a small business concern or nonprofit organization.
    (2) The Contractor shall include in all other subcontracts for experimental, developmental, or
    research work the substance of the patent rights clause required by FAR subpart 27.3.
    (3) At all tiers, the patent rights clause must be modified to identify the parties as follows:
    references to the Government are not changed, and the subcontractor has all rights and obligations of the
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    Contractor in the clause. The Contractor shall not, as part of the consideration for awarding the
    subcontract, obtain rights in the subcontractor's subject inventions.
    (4) In subcontracts, at any tier, the agency, the subcontractor, and the Contractor agree that the
    mutual obligations of the parties created by this clause constitute a contract between the subcontractor
    and the agency with respect to the matters covered by the clause; provided, however, that nothing in this
    paragraph is intended to confer any jurisdiction under the Contract Disputes statute in connection with
    proceedings under paragraph (h) of this clause.
    (End of clause)
    52.252-2 Clauses Incorporated by Reference. 1998-02
    As prescribed in 52.107(b), insert the following clause:
    Clauses Incorporated By Reference (FEB 1998)
    This contract incorporates one or more clauses by reference, with the same force and effect as if they
    were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the
    full text of a clause may be accessed electronically at this/these address(es):
    ____ ____ ____[Insert one or more Internet addresses]
    (End of clause)
    52.252-4 Alterations in Contract. 1984-04
    As prescribed in 52.107(d), insert the following clause in solicitations and contracts in order to revise
    or supplement, as necessary, other parts of the contract, or parts of the solicitation that apply after
    contract award, except for any clause authorized for use with a deviation. Include clear identification of
    what is being altered.
    Alterations in Contract (APR 1984)
    Portions of this contract are altered as follows:
    ____ ____ ____
    (End of clause)
    52.252-6 Authorized Deviations in Clauses. 2020-11
    As prescribed in 52.107(f), insert the following clause in solicitations and contracts that include any
    FAR or supplemental clause with an authorized deviation. Whenever any FAR or supplemental clause is
    used with an authorized deviation, the contracting officer shall identify it by the same number, title, and
    date assigned to the clause when it is used without deviation, include regulation name for any
    supplemental clause, except that the contracting officer shall insert "(DEVIATION)" after the date of the
    clause.
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    ---

    Authorized Deviations in Clauses (Nov 2020)
    (a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter
    1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of
    the clause.
    (b) The use in this solicitation or contract of any ____[insert regulation name] (48 CFR ____)
    clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the
    regulation.
    (End of clause)
    52.204-1 Approval of Contract. 1989-12
    As prescribed in 4.103 , insert the following clause:
    Approval of Contract (DEC 1989)
    This contract is subject to the written approval of ____[identify title of designated agency official
    here] and shall not be binding until so approved.
    (End of clause)
    52.219-14 DEV 2021-O0008 Limitations on Subcontracting (DEVIATION 2021-O0008) 2021-09
    As prescribed in 19.507(e), insert the following clause:
    LIMITATIONS ON SUBCONTRACTING (SEP 2021) (DEVIATION 2021-O0008)
    (a) This clause does not apply to the unrestricted portion of a partial set-aside.
    (b) Definition. “Similarly situated entity,” as used in this clause, means a first-tier subcontractor,
    including an independent contractor, that--
    (1) Has the same small business program status as that which qualified the prime contractor for the
    award (e.g., for a small business set-aside contract, any small business concern, without regard to its
    socioeconomic status); and
    (2) Is considered small for the size standard under the North American Industry Classification
    System (NAICS) code the prime contractor assigned to the subcontract.
    (c) Applicability. This clause applies only to--
    (1) Contracts that have been set aside for any of the small business concerns identified in 19.000(a)
    (3);
    (2) Part or parts of a multiple-award contract that have been set aside for any of the small business
    concerns identified in 19.000(a)(3);
    (3) Contracts that have been awarded on a sole-source basis in accordance with subparts 19.8,
    19.13, 19.14, and 19.15;
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    (4) Orders expected to exceed the simplified acquisition threshold and that are--
    (i) Set aside for small business concerns under multiple-award contracts, as described in
    8.405-5 and 16.505(b)(2)(i)(F); or
    (ii) Issued directly to small business concerns under multiple-award contracts as described in
    19.504(c)(1)(ii);
    (5) Orders, regardless of dollar value, that are--
    (i) Set aside in accordance with subparts 19.8, 19.13, 19.14, or 19.15 under multiple-award
    contracts, as described in 8.405-5 and 16.505(b)(2)(i)(F); or
    (ii) Issued directly to concerns that qualify for the programs described in subparts 19.8, 19.13,
    19.14, or 19.15 under multiple-award contracts, as described in 19.504(c)(1)(ii); and
    (6) Contracts using the HUBZone price evaluation preference to award to a HUBZone small
    business concern unless the concern waived the evaluation preference.
    (d) Independent contractors. An independent contractor shall be considered a subcontractor.
    (e) Limitations on subcontracting. By submission of an offer and execution of a contract, the
    Contractor agrees that in performance of a contract assigned a North American Industry Classification
    System (NAICS) code for--
    (1) Services (except construction), it will not pay more than 50 percent of the amount paid by the
    Government for contract performance, excluding certain other direct costs and certain work performed
    outside the United States (see paragraph (e)(1)(i)), to subcontractors that are not similarly situated
    entities. Any work that a similarly situated entity further subcontracts will count towards the prime
    contractor’s 50 percent subcontract amount that cannot be exceeded. When a contract includes both
    services and supplies, the 50 percent limitation shall apply only to the service portion of the contract. The
    following services may be excluded from the 50 percent limitation:
    (i) Other direct costs, to the extent they are not the principal purpose of the acquisition and small
    business concerns do not provide the service. Examples include airline travel, work performed by a
    transportation or disposal entity under a contract assigned the environmental remediation NAICS code
    562910), cloud computing services, or mass media purchases.
    (ii) Work performed outside the United States on awards made pursuant to the Foreign
    Assistance Act of 1961, or work performed outside the United States required to be performed by a local
    contractor.
    (2) Supplies (other than procurement from a nonmanufacturer of such supplies), it will not pay
    more than 50 percent of the amount paid by the Government for contract performance, excluding the cost
    of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated
    entity further subcontracts will count towards the prime contractor’s 50 percent subcontract amount that
    cannot be exceeded. When a contract includes both supplies and services, the 50 percent limitation shall
    apply only to the supply portion of the contract;
    (3) General construction, it will not pay more than 85 percent of the amount paid by the
    Government for contract performance, excluding the cost of materials, to subcontractors that are not
    similarly situated entities. Any work that a similarly situated entity further subcontracts will count
    towards the prime contractor’s 85 percent subcontract amount that cannot be exceeded; or
    (4) Construction by special trade contractors, it will not pay more than 75 percent of the amount
    paid by the Government for contract performance, excluding the cost of materials, to subcontractors that
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    are not similarly situated entities. Any work that a similarly situated entity further subcontracts will
    count towards the prime contractor’s 75 percent subcontract amount that cannot be exceeded.
    (f) The Contractor shall comply with the limitations on subcontracting as follows:
    (1) For contracts, in accordance with paragraphs (c)(1), (2), (3) and (6) of this clause --
    [Contracting Officer check as appropriate.]
    By the end of the base term of the contract and then by the end of each subsequent option period; or
    By the end of the performance period for each order issued under the contract.
    (2) For orders, in accordance with paragraphs (c)(4) and (5) of this clause, by the end of the
    performance period for the order.
    (g) A joint venture agrees that, in the performance of the contract, the applicable percentage specified
    in paragraph (e) of this clause will be performed by the aggregate of the joint venture participants.
    (End of clause)
    Page 29 of 29

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