DOD Defense Health Agency (DHA) Research & Development FY23-FY27 BROAD AGENCY ANNOUNCEMENT for Extramural Medical Research

FY25 MRDC BAA HT942523SBAA1

I. OVERVIEW OF THE FUNDING OPPORTUNITY
Defense Health Agency Research & Development
BROAD AGENCY ANNOUNCEMENT
for Extramural Medical Research
Funding Opportunity Number: HT942523SBAA1
Announcement Type: Initial
Assistance Listing Number: 12.420
Military Medical Research and Development
KEY DATES
Release/Posted Date: October 1, 2022
Closing Date: September 30, 2027, 11:59 p.m. Eastern Time
This funding opportunity announcement is a broad agency announcement (BAA). It is
continuously open for a 5-year period, from October 1, 2022, through September 30, 2027,
11:59 p.m. Eastern Time.
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.
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Table of Contents
I. OVERVIEW OF THE FUNDING OPPORTUNITY ........................................................1
I.A. New for Fiscal Year 2023 – Fiscal Year 2027 ..................................................................5
II. DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY ..................6
II.A. Program Descriptions ........................................................................................................7
II.A.1. Military Infectious Diseases ....................................................................................7
II.A.2. Combat Casualty Care .............................................................................................8
II.A.3. Traumatic Brain Injury ..........................................................................................11
II.A.4. Psychological Health .............................................................................................13
II.A.5. Sensory Systems ....................................................................................................14
II.A.6. Musculoskeletal Injury...........................................................................................15
II.A.7. Environmental Exposures ......................................................................................16
II.A.8. Directed Energy/Radiation Health .........................................................................17
II.A.9. DOD Working Dogs ..............................................................................................17
II.B. Award Information ..........................................................................................................18
II.B.1. Clinical Trial Support ............................................................................................19
II.B.2. Use of Military and Department of Veterans Affairs Populations or Resources ...19
II.B.3. Technology Requirements and Standards ..............................................................20
II.B.4. Data Sharing ...........................................................................................................21
II.B.5. Funds Available and Anticipated Number of Awards ...........................................22
II.B.6. Award Amounts and Periods of Performance .......................................................23
II.B.7. Mechanisms of Support .........................................................................................23
II.C. Eligibility Information .....................................................................................................25
II.C.1. Eligible Applicants .................................................................................................25
II.C.2. Cost-Sharing ..........................................................................................................26
II.C.3. Other ......................................................................................................................27
II.D. Proposal/Application Submission Information ...............................................................28
II.D.1. Where to Obtain the Proposal/Application Submission Package ..........................28
II.D.2. Content and Form of Proposal/Application Submission .......................................28
II.D.3. Unique Entity Identifier (UEI) and System for Award Management ....................50
II.D.4. Submission Dates and Times .................................................................................51
II.D.5. Intergovernmental Review .....................................................................................51
II.D.6. Funding Restrictions ..............................................................................................52
II.D.7. Other Submission Requirements ............................................................................52
II.E. Proposal/Application Review and Selection Information ...............................................52
II.E.1. Criteria for Research Proposals/Applications Without a Clinical Trial .................52
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II.E.2. Proposal/Application Selection Process ................................................................55
II.E.3. Integrity and Performance Information .................................................................56
II.E.4. Notification of Proposal/Application Review Results ...........................................56
II.F. Federal Award Administration Information ....................................................................57
II.F.1. Federal Award Notices ..........................................................................................57
II.F.2. Administrative and National Policy Requirements ................................................57
II.F.3. Reporting Requirements ........................................................................................58
II.G. Federal Awarding Agency Contacts ................................................................................59
II.G.1. eBRAP Help Desk .................................................................................................59
II.G.2. Grants.gov Contact Center .....................................................................................59
II.H. Other Information ............................................................................................................59
II.H.1. Contractor/Recipient Qualification ........................................................................60
II.H.2. Proprietary Information .........................................................................................60
II.H.3. Administrative Actions ..........................................................................................60
II.I. Checklist for Research Proposal/Application Submission Without a Clinical Trial .......63
APPENDIX I. RESEARCH AREAS OF INTEREST ..............................................................65
I. Military Infectious Diseases ............................................................................................65
II. Combat Casualty Care .....................................................................................................67
III. Traumatic Brain Injury ....................................................................................................69
IV. Psychological Health .......................................................................................................71
V. Sensory Systems ..............................................................................................................72
VI. Musculoskeletal Injury ....................................................................................................72
VII. Environmental Exposures ................................................................................................73
VIII. Directed Energy/Radiation Health ..................................................................................73
IX. DOD Working Dogs ........................................................................................................74
APPENDIX II. CLINICAL TRIALS .........................................................................................75
I. Important Aspects of Clinical Trials ...............................................................................75
II. Full Proposal/Application Submission Components for Studies with a Clinical Trial ...77
III. Review Criteria for Research Proposals/Applications with a Clinical Trial ...................95
IV. Checklist for Research Proposal/Application Submission with a Clinical Trial ...........100
APPENDIX III. DOD AND VA WEBSITES ..........................................................................102
APPENDIX IV. PROCEDURES FOR ACQUISITION, PROCESSING, STORAGE,
AND SHIPMENT OF BIO-FLUIDS ........................................................................................104
APPENDIX V. NATIONAL INSTITUTE OF MENTAL HEALTH DATA ARCHIVE –
INFORMED CONSENT ...........................................................................................................105
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APPENDIX VI. TECHNOLOGY READINESS LEVELS AND KNOWLEDGE
READINESS LEVELS ..............................................................................................................106
APPENDIX VII. ACRONYMS AND ABBREVIATIONS ....................................................107
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I.A. New for Fiscal Year 2023 – Fiscal Year 2027
The fiscal year 2023 – 2027 (FY23 – FY27) U.S. Army Medical Research and Development
Command’s (USAMRDC) BAA for Extramural Medical Research contains several changes
from previous USAMRDC BAAs. Read each section carefully. Note the following:
• The open period of the BAA is 5 years and will be amended annually with any updates.
• The “Research Areas of Interest” can be found in Appendix I.
• The type of instrument used to reflect the business relationship between the organization and
the government is at the discretion of the government, in accordance with the Federal Grant
and Cooperative Agreement Act of 1977, as amended, United States Code, Title 31, Sections
6301-6308 (31 USC 6301-6308), which provides the legal criteria to select a procurement
contract or an assistance agreement. The award type, along with the start date, will be
determined during the negotiation process.
• For assistance agreements:
○ The total period of performance may be proposed for up to a maximum of 4 years in
length; additional periods may be considered.
○ Any assistance agreement (grant or cooperative agreement) awarded under this BAA will
be governed by the award terms and conditions that conform to the Department of
Defense’s (DOD) implementation of Office of Management and Budget guidance in Code
of Federal Regulations, Title 2, Part 200 (2 CFR 200), “Uniform Administrative
Requirements, Cost Principles, and Audit Requirements for Federal Awards.” DOD
implementation is located in Chapter XI of 2 CFR.
• For contract awards:
○ The total period of performance may be proposed for up to 5 years in length; additional
periods may be considered.
○ Any contract awarded under this BAA will be governed by the various provisions of the
Federal Acquisition Regulation (FAR) and the Defense Federal Acquisition Regulation
Supplement (DFARS).
• For other transactions:
○ Regarding Other Transaction Agreements (OTAs) that utilize the authority within 10 USC
4021 or 4022, the period of performance will be dependent upon each specific award
made.
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II. DETAILED INFORMATION ABOUT THE FUNDING
OPPORTUNITY
The USAMRDC’s mission is to provide solutions to medical problems of importance to the
American Service Member at home and abroad, as well as to the general public at large. The
scope of this effort and the priorities attached to specific projects are influenced by changes in
military and civilian medical science and technology (S&T), operational requirements, military
threat assessments, and national defense strategies. Extramural research and development
programs play a vital role in the fulfillment of the objectives established by the USAMRDC.
General information on the USAMRDC can be obtained at https://mrdc.health.mil/.
This BAA is intended to solicit extramural research and development ideas using the authority
provided by 10 USC 4001. The BAA is issued under the provisions of the Competition in
Contracting Act of 1984 (Public Law 98-369), as implemented in FAR 6.102(d)(2) and 35.016
and in Department of Defense Grant and Agreement Regulations (DoDGARs) 22.315. In
accordance with FAR 35.016, 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 funded through this BAA are
intended and expected to benefit and inform both military and civilian medical practice and
knowledge. This BAA utilizes competitive procedures in accordance with 10 USC 3012 for the
selection for award of S&T proposals/applications. For the purposes of this BAA, S&T includes
activities involving basic research, applied research, advanced technology development, and,
under certain conditions, may include activities involving advanced component development and
prototypes.
The selection process is highly competitive, and the quantity of meaningful submissions (both
pre-proposals/pre-applications and full proposals/applications) received typically exceeds the
number of awards that available funding can support.
This BAA provides a general description of USAMRDC’s research and development programs,
including Research Areas of Interest, evaluation and selection criteria, pre-proposal/pre-
application and full proposal/application preparation instructions, and general administrative
information. Specific submission information and additional administrative requirements can be
found in the document titled, “General Submission Instructions,” which is available on
Grants.gov along with this BAA.
Proposal/application submission by extramural organizations through Grants.gov requires
use of the Workspace interface, which separates the proposal/application package into
individual forms. Applicants must create a Workspace in Grants.gov, complete the
required forms, and submit their proposal/application Workspace package.
The management agent for this BAA is the Congressionally Directed Medical Research
Programs (CDMRP). The CDMRP manages the electronic Biomedical Research Application
Portal (eBRAP) system, pre-proposal/pre-application and full proposal/application receipt and
review, and other key process oversight. Refer to Section II.G, Federal Awarding Agency
Contacts, for additional information.
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The USAMRDC’s supporting acquisition office, the U.S. Army Medical Research Acquisition
Activity (USAMRAA), will be the awarding and administering office for proposals/applications
selected for funding, unless approval is obtained from the USAMRAA Senior Contracting
Official to allow another federal acquisition office to execute and administer an award.
II.A. Program Descriptions
II.A.1. Military Infectious Diseases
The Joint Force operates in areas of the world where endemic and emerging infectious diseases
present substantial and immediate health risks to U.S. personnel. Future operational scenarios, to
include large scale combat operations (LSCOs), pose an increased risk of infectious diseases due
to degraded natural environmental disease barriers and public health infrastructure, as well as the
potential for delayed evacuation times. Current national, military, and biodefense strategies and
subsequent requirements documents specify a worldwide force protection capability to prevent,
diagnose, and treat endemic and emerging infectious disease threats to protect the Joint Force.
Likewise, wound infection resulting from complex traumatic injuries in a prolonged care
environment poses a substantial threat to the operational effectiveness of deployed forces.
During prolonged care scenarios to include LSCO environments, infection and complications
secondary to injury will develop in the prehospital setting through Role 3. While recent conflicts
typically managed infection at higher roles of care, future conflicts in contested environments
with near-peer adversaries will require management in-theater due to delayed casualty
evacuation and/or treatment. While most infected wounds during insurgency operations over the
last 20 years were not initially colonized with multidrug-resistant organisms (MDROs), the
prevalence of MDRO infections significantly increased as casualties moved through higher roles
of care. The inability to prevent, delay, or treat wound infections in a prolonged care
environment will increase the prevalence and severity of infected wounds. Similarly, a
concomitant increase in MDRO wound infections will occur across the continuum of care.
Therefore, closing the gap on the impact of wound infections on the Joint Force requires
countermeasures to prevent, diagnose, and treat both initial wound infections and MDRO
infections across the continuum of care.
The scope of the DHA Military Infectious Diseases (MID) portfolio relates to the prevention,
diagnosis, and treatment of military relevant infectious diseases, to include combat-associated
wound infections to serve the overall goal of maintaining unit and individual readiness,
preserving operational effectiveness, and accelerating return to duty following infection.
The MID portfolio priority research areas are organized into the following capability areas:
• Prevent: Develop solutions to prevent endemic and emerging infectious diseases, to include
combat-associated wound infections, to maintain readiness and preserve operational
effectiveness. Prevention is the most desirable infectious disease countermeasure because it
prevents disease from occurring (versus treatment post-infection), is the most cost-effective
approach, and reduces unit loss rate.
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• Diagnose: Develop solutions to diagnose endemic and emerging infectious diseases, to
include combat-associated wound infections, to maintain readiness, preserve operational
effectiveness, and accelerate return to duty.
• Treat: Develop solutions to treat endemic and emerging infectious diseases, to include
combat-associated wound infections, to maintain readiness, preserve operational
effectiveness, and accelerate return to duty.
Research Areas of Interest for the MID portfolio are found in Appendix I.I. Applicants are urged
to read and consider these before preparing their proposals/applications.
II.A.2. Combat Casualty Care
Combat Casualty Care (CCC) encompasses the assessment, diagnosis, treatment, stabilization,
and disposition (return to duty or evacuation) of Service Members at point of need (PON),
including far-forward, en route, and extended pre-hospital environments. The scope of the CCC
portfolio includes capability requirements that will optimize recovery from combat-related
injuries to decrease the burden of survivorship, reduce morbidity and mortality across the
continuum of CCC, and accelerate return to duty, when possible. Capability requirements within
the CCC portfolio focus on Immediate Casualty Care, Medical Care in Operational
Environments, Patient Movement, and Enabling Medical System Technologies.
The CCC portfolio offers a plan for identifying, developing (when necessary), evaluating,
transitioning methods, therapeutics and technologies aimed at improving acute and early combat-
related trauma management solutions. The continuum of care is defined as an integrated system
that guides care at PON and tracks wounded, ill, or injured (WII) Service Members through the
various roles of care (ROC; 1, 2, and 3) by facilitating seamless movement using comprehensive
health service through discharge from definitive care.
The capability requirements have been identified based on assessment of the current and future
medical and operational needs and/or existing research gaps of the military medical community.
The CCC portfolio places an emphasis on the following capability requirements:
• Tactical Combat Casualty Care (TCCC): TCCC encompasses advanced medical solutions
to assess, treat, and stabilize combat-related injuries needed at PON through ROC 1, and the
ability to hold patients longer when evacuation is challenged. Future large-scale, multi-
domain combat operations will significantly contest the military’s “Golden Hour” or “Golden
Day” paradigm used to date. Responding to this challenge and taking measures to maintain
high rates of survival and recovery among wounded Service Members will require innovative
solutions that sustain/build medical capabilities as far forward as possible to support and
immediately stabilize the injured Service Member in addition to continuing that care when
evacuation is delayed or unavailable.
• Resuscitative Strategies and Care: Advanced resuscitative care is paramount for battlefield
survivability at PON and anywhere along the continuum of care. Delays in evacuation and
high casualty rates in the future battlespace will place further demands on advanced trauma
care if casualties deteriorate and need to be resuscitated again anywhere in the evacuation
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chain. Effective hemorrhage control and replacement of lost blood volume are the lifesaving,
battle-proven treatments most likely to mitigate hemorrhagic shock and blood failure. The
ability to provide enough resuscitative products, such as whole blood, at the point of need in
the future battlespace for large numbers of casualties remains a critical medical challenge for
operational forces. The Resuscitative Strategies and Care capability requirement outlines
forward resuscitative and augmenting solutions (blood, blood products, and substitutes) to
wounded Service Members experiencing complications from trauma, shock, or other life-
threatening conditions in austere and resource-limited environments.
• Care of Complex Injuries and Organ Support: Providers in the future battlespace will be
challenged with managing large casualty volumes with a need for high acuity care with
limited resources. Across the continuum of care, far forward providers will need to have
adaptable medical solutions to help manage complex injuries and further address the
respiratory, cardiovascular, metabolic, and immunologic consequences of trauma, shock,
organ failure, and burn in contested and isolated environments. Prolonged and resource-
limited settings further drive the need to develop tools that support the wounded across
various operational platforms in diverse environments of the future battlespace. Activities
within this Care of Complex Injuries and Organ Support capability requirement seek to
resolve critically identified Joint deficiencies associated with casualty care for WII Service
Members in a complex and resource-limited operational environment.
• Forward Surgical Care: In the future battlespace, contested and resource-limiting
environments will hinder evacuation and access to larger medical elements closest to PON. It
will be incumbent upon medical, evacuation, and logistics elements to position surgical
assets further forward and in greater isolation than in recent theaters. Forward surgical care,
also known as damage control surgery (DCS), is a principal component of military medicine,
enabling medical personnel to provide lifesaving surgical interventions to injured Service
Members. Activities within the Forward Surgical Care capability requirement include
identifying and developing new or leveraging existing knowledge and materiel solutions
needed to surgically stabilize life-threatening injuries closest to PON. Performance of these
critical surgical interventions promotes survivability of injured Service Members and helps to
further prevent or mitigate a casualty's irreversible physiologic deterioration. As we prepare
for the future fight without the benefits of the “Golden Hour,” the battlefield medical system
must be modernized to maximize the further-forward surgery paradigm and bring with it
medical solutions that will ensure expeditious surgical care to wounded Service Members in
theatre.
• Functional Recovery from Traumatic Wound and Burn Injuries: Significant increases to
the frequency and severity of traumatic wound and burn injuries are predicted to challenge
capability and capacity in a future battlespace. Urban dense terrain and multi-domain
operations of the future are expected to generate complex wounds and burn injuries that will
require advanced prolonged care and stabilization when tactical evacuations to robust rear
element medical care infrastructures are delayed. Under current doctrine, these wound and
burn casualties will quickly overwhelm providers and available resources in an already
strained and complex operational environment. Moreover, the specialized care needed for
burn patients comes with significant challenges as even a small number of burn casualties
can deplete a large number of resources quickly. As a result, the need for aggressive
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battlefield wound and burn care technologies are paramount to providing advanced care to
wounded Service Members. Activities within the Functional Recovery from Traumatic
Wound and Burn Injuries capability requirement focus on yielding knowledge and advanced
materiel solutions needed to assess, treat, and manage complex wounds and burn injuries in
any pre-hospital, resource-limited battlespace environment.
• Effects of Transport on Complex Injuries: As the military engages in future multi-domain
operations, contested air, land, and sea superiority will result in significantly extended
evacuation times for WII Service Members. Distinct from previous research and
development efforts, the future battlespace will require military en route care research to
focus on the intersection of the patient, their injury or illness, the stresses of transport, and
the environment of care in addition to the multimodal transport platform that may be used.
Casualty care providers will need to better understand the effects of prolonged transport time,
mode(s) of transport, and environmental factors that can negatively impact Service Members
with complex/polytraumatic injuries under these extended and diverse conditions. Activities
within the Effects of Transport on Complex Injuries capability requirement focus on
understanding and advancing knowledge to better enable effective casualty support and
treatment during transportation from PON to more advanced ROCs, in between ROCs via
various evacuation platforms, and scalability. Understanding the physiological response to
transport is not only needed to inform future practice guidelines and policy decisions for
anticipated conflicts, but provides necessary operational and medical data, highlights
important deficiencies in the current system, and offers information that can be used to create
robust solutions for medical evacuation support in the future battlespace.
• En Route Care: According to military doctrine, patient movement throughout the continuum
of medical care is termed “en route care,” an important element of which is providing the
appropriate medical capability during the transport so that the patient’s clinical condition is
not compromised. In this SRP, en route care includes (1) ground transport at point of injury
through both unregulated and regulated means; (2) ground, maritime, and rotary and fixed-
wing tactical transport; (3) strategic intercontinental air transport; (4) maritime transport from
surface and underwater ships out at sea; and (5) nontraditional space medical mobility
systems. Effective en route care throughout the continuum is a critical element needed during
combat operations to ensure optimal patient outcomes and maintain operational advantage.
Activities within the En Route Care capability requirement include focus on modalities to
increase care provider capability and capacity during transportation of casualties and
solutions that enhance patient movement efforts in pre-hospital and mass evacuations
scenarios. A Joint approach to research efforts will be key to advancing solutions with a
consideration that each Service has distinct needs within their respective domain of
operations that will continue to be discussed and deconflicted as necessary.
• Virtual Health and Monitoring: To meet the challenges of the future battlespace, the DOD
will need technological advancements that will enhance provider capabilities that decrease
cognitive load, aid decision-making through artificial intelligence (AI), or offer
telementoring/telemedicine support to improve patient outcomes and enhance the combat
health system across the continuum of care. The Virtual Health and Monitoring capability
requirement focuses on decision support tools that assist care providers in providing
enhanced assessment, diagnosis, intervention, treatment, and continued monitoring of a
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patient’s physiological and injury status. Furthermore, these Joint capabilities will target
enabling critical care expertise earlier into far forward environments and interfacing
seamlessly with Joint tactical networks in denied, degraded, intermittent, and limited
environments (DDIL). Each of the services and their respective cyber security offices have
operational requirements for implementation of virtual medical systems that will continue to
be discussed and deconflicted as necessary to develop Joint capabilities.
• Scalable Triage: Optimizing casualty care requires a coordinated, real-time, common
operating platform to extend the capacity of the MHS to multi-domain operations.
Developing a Joint, forward-deployed intelligent trauma system is needed to support the
medical care team’s ability to efficiently triage, communicate, and care for wounded Service
Members across ROCs; improve operational planning efforts for evacuation; and promote
overall survivability in the future battlespace. Moreover, these force-multiplying capabilities
are crucial for mitigating resource and medical team constraints experienced during mass
casualty events. This Scalable Triage capability requirement seeks to resolve deficiencies for
effective triage through the use of fast and accurate screening, diagnostic, and
communication tools that can be used across the Services; and effective protocols suited for
the tactical environment that adapt to the limitations of the operational environment, the
mission, and available resources (e.g., time, equipment, supplies, personnel, and evacuation
capabilities).
• Autonomous Systems: As the military prepares for a future conflict where air superiority
and freedom of movement is limited or contested across an active battlespace, access to
advanced systems that utilize clinical decision support through AI, autonomous medical
technologies, and robotics to enhance casualty care and evacuation, when necessary, will be
vital. Autonomous systems have the potential to provide the medical support needed in
contested environments at the PON and during transport across the operational continuum of
care; but must be further developed in order to create an unmanned evacuation capability that
can reliably care for combat casualties in the future. These solutions must include biosensors,
AI, and machine learning (ML) to enable the development of closed-loop/autonomous
medical systems capable of providing critical care. The Autonomous System capability
requirement seeks to resolve deficiencies in knowledge and materiel solutions associated
with integrated/interfaced medical system technologies using semi-autonomous, autonomous,
and unmanned capabilities to help augment medical providers in operational environments,
reducing task saturation, and to perform care and evacuation needs in situations that are
unsafe.
The Research Areas of Interest for the CCC portfolio are found in Appendix I.II. Applicants are
urged to read and consider these before preparing their proposals/applications.
II.A.3. Traumatic Brain Injury
Traumatic Brain Injury (TBI) is a collective term used for multiple different physiological states
that are consequences of physical damage to the brain. This type of damage typically arises from
an external force and can be penetrating, contact non-penetrating closed-head, effects from blast
and blast overpressure, as well as other energies and forces; TBI is also seen with polytrauma.
The human brain is among the most heterogeneous organs in the body, and trauma can cause the
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most varying source of disease, making brain injury a very complex medical issue to solve,
especially rapidly. The earlier brain injury can be addressed, the better outcome is expected of
the patient. The two main overarching gaps existing with TBI in combat and early management
are objective diagnosis/prognosis and treatment. Both of these can vary depending on the injury
types; however, it may be possible that the diverse types of injuries share common objectives,
rapid biomarkers, and treatment interventions. Some injuries are quite different from others; for
instance, mild TBI (mTBI) in theater may yield no physical impairments yet lead to cognitive
and psychological issues which can greatly reduce unit readiness and combat effectiveness.
The scope of the DHA TBI program relates to the diagnosis and treatment of military-relevant
brain injury, to include combat-associated TBI, polytrauma, blast and blast overpressure,
recognizing the vast diversity of the injury types. Both early diagnosis/prognosis and treatment
can serve to prevent further damage seen in repetitive mTBI and blast overpressure, and more
severe injuries.
Focus areas for the TBI program are:
• TBI assessment and diagnosis:
Development of noninvasive far forward TBI assessment tools
o
Fluid-based biomarker tools to identify and assess TBI far forward
o
Advanced analytic tools for TBI management and diagnosis
o
• TBI point-of-injury stabilization:
Minimally invasive intracranial access for Role 2 and mobile medical care
o
Therapeutic interventions to treat/stabilize penetrating and severe TBI
o
Therapeutic interventions to treat mild/moderate TBI
o
• TBI countermeasures to prevent adverse brain health effects and performance degradation
resulting from hazardous/injurious exposures:
Modulating concussion dosimetry health performance criteria, particularly for blast
o
injuries
Modulating concussion dosimetry health performance criteria, particularly for impact
o
injuries
• TBI monitoring and return-to-duty:
Biomarkers to detect long-term effects
o
Validation and implementation of clinical findings related to return-to-duty
o
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Targeted strategies to prevent/treat TBI
o
TBI contributions to other injuries that prolong recovery and return-to-duty (e.g.,
o
musculoskeletal injury)
Models to predict health problems associated with mTBI
o
Out-of-scope areas include training for forward responders, management of chronic effects of
TBI, neurodegenerative disease, epilepsy, and spinal cord injuries.
Diagnose/prognose and monitor: Develop solutions to objectively diagnose the injury, prognose
and monitor to inform treatment options and to maintain readiness, preserve operational
effectiveness, and accelerate return to duty.
Treat: Develop solutions to initiate early treatment for the spectrum of TBI categories including
interventions for milder injuries to maintain readiness, preserve operational effectiveness, and
accelerate return to duty. Interventions for more moderate and severe injuries at Roles 1 and 2 to
improve outcomes in prolong care scenarios.
Prevent: Develop capabilities to prevent further brain damage by providing early warnings and
management of potential injury arising from blast overpressure in training and combat, and
combat environments.
This DOD funded program requires that all TBI-related clinical research data with at least
50 subjects funded by this program be shared through the jointly supported DOD-National
Institutes of Health (NIH) Federal Interagency TBI Research (FITBIR) Informatics System.
Recipients will be required to upload study data annually and in accordance with the FITBIR
data submission policies. There is no fee to use the FITBIR, and detailed guidance and policies,
including a cost estimator tool for budgeting considerations, can be found at the FITBIR website.
The Research Areas of Interest for the Traumatic Brain Injury portfolio are found in Appendix
I.III. Applicants are urged to read and consider these before preparing their
proposals/applications.
II.A.4. Psychological Health
The mission of the Psychological Health (PH) portfolio is to assess, protect, sustain, and
optimize the readiness and performance of Service Members, their Families, and the military
community by developing effective biomedical countermeasures against operational stressors, as
well as to prevent and mitigate physical and psychological injuries and threats during training
and operations. This mission is made up of seven capability requirements relating to the
advancement of psychological health research for the military community. Psychological health
encompasses multiple domains including clinical conditions and psychological readiness, and
therefore these capability requirements capture psychological health across domains that are not
necessarily targeting a specific psychological health clinical condition.
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The PH portfolio places an emphasis on the following capability requirements:1
• Development of Assessment Tools: Identify objective non-self-report factors that can
provide the basis for the development of tools that assess, monitor, and document an
individual’s current psychological state which would provide a comparison across relevant
time points and enable decision-support interventions.
• Countermeasures for Military Community Needs and Vulnerabilities: Develop
psychological health support and prevention solutions for Service Members, their Families,
and the military community that match their needs; and enable the scaling up and adoption of
these solutions.
• Countermeasures Against Current and Emerging Threats: Identify evidence-based
prevention strategies and develop prevention services that protect Service Member
psychological health, readiness, and performance.
• Models of Care for Efficient Interventions: Develop recognition, triage, and referral
protocols, effective psychological health models, and/or models incorporating non-specialty
medical personnel for early intervention of psychological health conditions.
• Models of Care for Tailored Intervention: Deliver tailored psychological health care for
Service Members, their Families, and the military community which would restore and
maintain psychological health, readiness, and performance across their lifecycle.
• Medically Appropriate Return-to-Duty Guidelines: Develop and validate core elements of
Joint Services return to duty criteria.
• Solutions to Optimize Psychological Readiness: Develop Service Member, unit, and
leadership tools to improve and maximize psychological readiness and performance.
The Research Areas of Interest for the Psychological Health portfolio are found in Appendix
I.IV. Applicants are urged to read and consider these before preparing their
proposals/applications.
II.A.5. Sensory Systems
The Sensory Systems program focuses on military-related injuries and illnesses to sensory
modalities, such as pain, ocular, auditory, and vestibular. The program is structured into
modalities to cover a range of distinct research areas within medical S&T research. Capability
requirements within the Sensory Systems Program focus to characterize basic mechanisms and
advance assessment, diagnosing, monitoring, and treatment of sensory injuries, dysfunctions, or
illnesses.
The capability requirements have been identified based on assessment of the current and future
medical and operational needs and/or existing research gaps of the military medical community.
The Sensory Systems program places an emphasis on the following capability requirements:
1 Capability requirements are not listed in order of priority
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• Mechanistic Characterization: Develop improved models of sensory injury or illness,
describing the etiology, mechanism(s), progression, and potential targets for prevention.
• Assessment Tool Development: Develop knowledge and materiel solutions for diagnosing
and quantifying sensory injury or illness (in clinical testing and operationally relevant
function).
• Stabilization Took Development: Optimize stabilization solutions and point-of-injury care
of sensory injury to preserve function and readiness.
• Treatment Tool Development: Develop knowledge and materiel solutions for the repair or
mitigation of sensory injury or illness.
Focus areas for the Sensory Systems program are:
• Improved pain control or anesthesia
Stabilization and treatment tool development to improve pain control or anesthesia (e.g.,
o
reduce care demand)
Development of therapeutics with minimal impairment of Service Member operational
o
capabilities
• Ocular injury stabilization
Temporary corneal repair
o
• Auditory injury assessment
Tool development and mechanistic characterization for the assessment of auditory injury
o
• Ocular injury assessment
Tool development for assessment of ocular injuries and associated operational
o
performance effects
Out of scope areas include: polymorbidities and injury associated with TBI; training medical
providers to examine, assess, and treat injuries/illness; regenerative, restorative, and transplant
capabilities; enhancing sensory system capabilities; longitudinal care for sensory injury/illness;
peripheral nerve and spinal cord damage; chronic pain.
The Research Areas of Interest for the Sensory Systems portfolio are found in Appendix I.V.
Applicants are urged to read and consider these before preparing their proposals/applications.
II.A.6. Musculoskeletal Injury
The Musculoskeletal Injury program advances medical solutions to prevent, diagnose, treat, and
rehabilitate musculoskeletal injuries (MSKI). By addressing critical research gaps, it develops
innovative, data-driven strategies to reduce injury risk, enhance recovery, and improve long-term
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outcomes, ensuring Service Member readiness and resilience. The program delivers scalable
solutions that support rapid assessment, effective treatment, and seamless reintegration into
active duty. Through cutting-edge medical technologies, regenerative medicine, and
comprehensive rehabilitation approaches, the Musculoskeletal Injury program empowers
military healthcare providers and operational leaders to enhance force readiness and sustain the
health of the Joint Force.
Capability requirements within the Musculoskeletal Injury program focus to reduce the risk of
injury while advancing the diagnosing, monitoring, and treatment of musculoskeletal injuries,
and optimizing return-to-duty decisions.
The Capability requirements have been identified based on assessment of the current and future
medical and operational needs and/or existing research gaps of the military medical community.
• Assess and Diagnose Musculoskeletal Injuries
• Musculoskeletal Injury Risk Mitigation: Musculoskeletal injury risk mitigation programs
• Return to Duty and Reintegration: Solutions to determine fitness for duty following
musculoskeletal injury.
Focus areas for the MSKI program are:
• MSKI rehabilitation interventions, technologies, and techniques to treat MSKI in pre-hospital
interventions
• Therapeutic interventions to accelerate recovery from MSKI
• Preservation of musculoskeletal health
Out of scope areas include: treatment of spinal cord injury.
The Research Areas of Interest for the Musculoskeletal Injury portfolio are found in Appendix
I.VI. Applicants are urged to read and consider these before preparing their
proposals/applications.
II.A.7. Environmental Exposures
The purpose of the Environmental Exposures program is to counter health threats, disease, and
non-battle injury through prevention, assessment, and treatment of military relevant
environmental exposures. The following environmental exposures are included in the scope of
the overall program: extreme heat, cold, high terrestrial altitude, military diving, toxic exposures,
aviation medicine, and vibration/acceleration. Weaponized chemical, biological radiological and
nuclear (CBRN), blast, infectious disease, and noise are not within the program’s scope. The
program supports basic (6.1), applied (6.2), and advanced technology development (6.3) research
efforts.
The Research Areas of Interest for the Environmental Exposures portfolio are found in Appendix
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I.VII. Applicants are urged to read and consider these before preparing their
proposals/applications.
II.A.8. Directed Energy/Radiation Health
Directed Energy and Radiation Health address injuries and adverse health effects from exposure
to non-ionizing radiation and ionizing radiation.
Directed Energy: The term directed energy is defined for military applications as the ability to
project non-ionizing electromagnetic energy either broadly for communication and surveillance
or in a focused manner to produce defensive or offensive effect(s) at militarily relevant distances.
Given the non-kinetic nature of directed energy threats, the elicitation of a bioeffect may
compromise well-being resulting in an adverse health effect, prompting healthcare assessment
and treatment. This area of research should add clarity to discriminators in which bioeffects
become health effects following radiofrequency, optical, or acoustic exposures in an operational
environment. The overarching focus is to improve capabilities and knowledge available to
distinguish between a “bioeffect” and injurious “adverse health effect” resulting from directed
energy exposures via established mechanisms. Research deliverables should have direct
applications to relevant directed energy safety standards and/or clinical practice guidelines.
Radiation Health: Radiation health promotes warfighter health and readiness through activities
that support the discovery and development of medical capabilities to counter threats from acute
ionizing radiation exposure. Research efforts to be considered include discovery and
development of: radiation pre-exposure prophylaxis candidates; biomarkers to support diagnosis
or to inform effective treatment modalities; characterization of the mechanism(s) of radiation
injury and/or the mechanism(s) of action of medical countermeasures; and characterization of
combined injuries resulting from CBRN exposures in the presence of trauma injuries (e.g.,
hemorrhage, severe burn). Capabilities are intended to be for use in operational military
environments, including Roles of Care 1 through 3.
The Research Areas of Interest for the Directed Energy/Radiation Health portfolio are found in
Appendix I.VIII. Applicants are urged to read and consider these before preparing their
proposals/applications.
II.A.9. DOD Working Dogs
The DoD Working Dog portfolio supports the development of health readiness solutions for
canine injury prevention, wound recovery, therapeutics, and pain management emphasizing
return to duty. Injury prevention research identifies and characterizes occupational risk factors
for MSKI and probability of MSKI occurrence based on breed, genetics, or body conformation.
Wound recovery and therapeutics research delivers optimal protocols and therapies for injuries
and return-to-duty plans for military working dogs (MWD)s. Pain management research leads to
solutions that effectively recognize, prevent, and treat pain in MWDs, including acute and
chronic pain, field analgesia, and sedation/anesthesia and their associated effects.
The Research Areas of Interest for the DOD Working Dog portfolio are found in Appendix I.IX.
Applicants are urged to read and consider these before preparing their proposals/applications.
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II.B. Award Information
This BAA may be used to support applied research, preclinical research, clinical research,
and clinical trials/testing (or equivalent). BAA proposals/applications that include a clinical
trial have additional proposal/application and review requirements (see Appendix II). The
proposed research must be relevant to active-duty Service Members, Veterans, military
beneficiaries, and/or the American public.
Clinical research is defined as: (1) Patient-oriented research. Research conducted with human
subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena)
for which an investigator (or colleague) directly interacts with human subjects. Excluded from
this definition are in vitro studies that utilize human tissues that cannot be linked to a living
individual. Patient-oriented research includes (a) mechanisms of human disease, (b) therapeutic
interventions, (c) clinical trials, and (d) development of new technologies. (2) Epidemiologic and
behavioral studies. (3) Outcomes research and health services research.
A clinical trial is defined as a research study in which one or more human subjects are
prospectively assigned to one or more interventions (which may include placebo or other
control) to evaluate the effects of the interventions on biomedical or behavioral health-related
outcomes. Funded trials are required to post a copy of the Institutional Review Board (IRB)-
approved informed consent form used to enroll subjects on a publicly available federal website in
accordance with federal requirements described in 32 CFR 219. Note: A Food and Drug
Administration (FDA)-regulated clinical investigation is always a clinical trial, but not all
clinical trials are FDA-regulated clinical investigations.
Research Involving Human Anatomical Substances, Human Data, Human Subjects, or
Human Cadavers: All DOD-funded research involving new and ongoing research with human
anatomical substances, human data human subjects, or human cadavers must be reviewed and
approved by the USAMRDC Office of Human and Animal Research Oversight (OHARO),
Office of Human Research Oversight (OHRO), prior to research implementation. This
administrative review requirement is in addition to the local IRB or Ethics Committee (EC)
review. Local IRB/EC approval at the time of submission is not required. Allow up to 3 months
to complete the OHRO regulatory review and approval processes following submission of all
required and complete documents to the OHRO. Refer to the General Submission Instructions,
Appendix 1, and the Office for Human Research Protections Office Resources and Overview
document available on the eBRAP “Funding Opportunities & Forms” web page
(https://ebrap.org/eBRAP/public/Program.htm) for additional information.
If the proposed research involves more than one institution, plans for the multi-institutional
structure governing the research protocol(s) should be outlined. In addition, a written plan for
single IRB review arrangements must be provided for research conducted in the United States
involving more than one institution. The lead institution responsible for developing the master
protocol and master consent form should be identified and should be the single point of contact
for regulatory submissions and requirements. Communication and data transfer between or
among the collaborating institutions, as well as how specimens and/or imaging products obtained
during the study will be handled, should be included in the appropriate sections of the
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application. A separate intellectual and material property plan agreed on by all participating
institutions is also required for multi-institutional clinical research/trials.
Research Involving Animals: All research funded by the BAA involving new and ongoing
research with animals must be reviewed and approved by the USAMRDC OHARO Animal Care
and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use
Committee (IACUC) of record. IACUC approval at the time of submission is not required. Allow
at least 2 to 3 months for ACURO regulatory review and approval processes for animal
studies. Refer to the General Application Instructions, Appendix 1, for additional information.
Rigor of Experimental Design: All projects should adhere to accepted standards for rigorous
study design and reporting to maximize the reproducibility and translational potential of
preclinical research. Core standards are described in S.C. Landis et al., “A call for transparent
reporting to optimize the predictive value of preclinical research,” Nature 2012, 490:187-191
(https://www.nature.com/articles/nature11556). While these standards are written for preclinical
studies, the basic principles of randomization, blinding, sample-size estimation, and data
handling derive from well-established best practices in clinical studies. Applicants should consult
the Animal Research: Reporting In Vivo Experiments (ARRIVE) guidelines 2.0 to ensure
relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported.
The ARRIVE guidelines 2.0 can be found at https://arriveguidelines.org/arrive-guidelines.
II.B.1. Clinical Trial Support
Investigator(s) proposing a clinical trial should refer to Appendix II for a detailed description of
the requirements for such a proposal/application. The pre-proposal/pre-application submission
process should be performed as described in Section II.D.2.a. Full proposal/application
submission is described in Appendix II. Refer to Appendix II, Section IV, Checklist for Research
Proposal/Application Submission With a Clinical Trial, in preparing the full
proposal/application.
For projects proposing a clinical trial:
• If an Investigational New Drug (IND) or Investigational Device Exemption (IDE) is
required for the study, the IND/IDE application must be submitted to the FDA by the
proposal/application submission. It is the responsibility of the applicant to provide
evidence from the IRB of record or the FDA if an IND/IDE is not required. Refer to
Attachment 12, Regulatory Strategy (Appendix II), for further details.
• If the clinical trial of an investigational product will be conducted at international sites,
evidence that an application has been submitted to the relevant national regulatory agency of
the host country(ies) is required by the above deadlines.
• Clinical trials must be initiated no later than 12 months after the award date.
Note: The government reserves the right to withhold or withdraw funding if an IND or IDE
is necessary to conduct the study but has not been obtained within 6 months of the award
date.
II.B.2. Use of Military and Department of Veterans Affairs Populations or Resources
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Principal Investigators (PIs) are encouraged to integrate and/or align their research projects with
DOD and/or Department of Veterans Affairs (VA) research laboratories and programs and
existing clinical trial networks. Collaboration with the DOD and/or VA is also encouraged. A list
of websites that may be useful in identifying additional information about ongoing DOD and VA
areas of research interest or potential opportunities for collaboration can be found in Appendix
III.
Use of DOD or VA Resources: If the proposed research involves access to active-duty military
and/or Veteran patient populations and/or DOD or VA resources or databases, the
proposal/application must describe the access at the time of submission and include a plan for
maintaining access as needed throughout the proposed research. Use Attachment 2: Supporting
Documentation, to provide relevant documentation to demonstrate access to DOD and/or VA
populations or resources. Refer to the General Submission Instructions, Appendix 1, for
additional information.
45 CFR Section 46.114 (Cooperative Research) of the Common Rule requires any institution
located in the United States that is engaged in cooperative research to rely upon approval by a
single IRB for that portion of the research that is conducted in the United States. For multi-site
studies with collaborating VA institutions engaged in non-exempt human subjects research, and
for which the use of a single IRB is determined to be not appropriate for the particular research
context, a memorandum from the VA Office of Research and Development approving exception
of the single IRB requirement must be sought and provided to the OHARO OHRO during the
human research protection official review of the project.
Access to certain DOD or VA patient populations, resources, or databases may only be obtained
by collaboration with a DOD or VA investigator who has a substantial role in the research and
may not be available to a non-DOD or non-VA investigator if the resource is restricted to DOD
or VA personnel. Investigators should be aware of which resources are available to them if the
proposed research involves a non-DOD or non-VA investigator collaborating with the DOD
and/or VA. If the proposal/application is recommended for funding, the government reserves
the right to withdraw or revoke funding until the PI has demonstrated support for and access
to the relevant population(s) and/or resource(s).
Conducting DOD-Funded Human Research with Military Populations: There are unique
requirements and prohibitions for compensating DOD-affiliated personnel for study participation
and for conducting research with military Service Members or their Families/children and
research with populations from U.S. Special Operations Command may require additional
reviews and approvals. Additional information regarding conducting DOD-funded human
research with military populations can be found at
https://mrdc.health.mil/assets/docs/orp/conducting_research_military_Pop_dod_may_2021.pdf.
II.B.3. Technology Requirements and Standards
Any technology-based research products/prototypes (such as devices, mobile apps, software,
information technology (IT) infrastructure, etc.) that expect to interact with military health IT
systems should conform with accepted industry and DOD Information Management/IT standards
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for interoperability, cybersecurity, as well as the DOD Architecture Framework (DoDAF) and
viewpoints, as follows:
a. DoDAF and viewpoints
b. DoDI 8500.01 March, 14, 2014, “Cybersecurity”
c. DoDI 8510.01 July 19, 2022, “Risk Management Framework (RMF) for DoD Information
Technology (IT)”
d. Any products expected to provide data to Military Health System (MHS) Genesis, the DOD
Military Electronic Health Record system (which is the military version of Cerner
Millennium commercial-off-the-shelf electronic health record), should be aimed toward
meeting the Health Level 7 and Fast Healthcare Interoperability Resources standards in order
to ultimately provide integration with MHS Genesis.
e. All software-based research products, including computer code, software code, data, and
metadata, should be provided as deliverables, and electronic versions need to be able to be
uploaded to standards-based electronic repositories. Metadata (i.e., the data dictionary and
data model) as well as data (i.e., cases) generated in the research should be provided in an
industry standard format for access by the government in an open source data repository of
electronic deliverables.
f. Any information systems that are owned or operated by the contractor that processes, stores,
or transmits Federal contraction information, not intended for public release, is subject to the
basic safeguarding requirements detailed under the FAR and DFARS.
g. OTAs may establish non-standard requirements.
II.B.4. Data Sharing
The USAMRDC intends that information, data, and research resources generated under awards
funded by this BAA be made available to the research community and to the public at large. The
government reserves the right to identify repositories for submission of data for archive. For
additional guidance, refer to the General Submission Instructions, Appendix 2, Section K.
A number of research areas utilize Common Data Elements (CDEs) to facilitate the sharing of
data to promote collaboration, accelerate research, and advance knowledge in specific topic
areas. In accordance with the White House Office of Science and Technology Policy
memorandum, “Increasing Access to the Results of Federally Funded Research,” and Executive
Order (EO) 13625 and the National Research Action Plan (NRAP) responding to the EO,
“Improving Access to Mental Health Services for Veterans, Service Members, and Families”
(August 31, 2012), federally funded research is required to be conducted in a manner that
promotes public access to scientific data. In cases of psychological health and TBI, use of CDEs
continues to be required. The USAMRDC strongly encourages applicants to incorporate CDE
measures appropriate to each field of study, such as:
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• PhenX Core and Specialty collections, which are available in the Mental Health Research,
Substance Abuse and Addiction, and Research Domains Collections of the PhenX Toolkit
(https://www.phenxtoolkit.org/index.php) in all studies involving human subjects, as
applicable.
• Spinal cord injury research CDEs developed through the collaboration of the International
Spinal Cord Society, the American Spinal Injury Association, and the National Institute of
Neurological Disorders and Stroke CDE team, as referenced at Spinal Cord Injury | National
Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (nih.gov).
• Military Suicide Research Consortium CDEs were developed across two consortium phases
and can be found here at the VA
(https://www.hsrd.research.va.gov/centers/core/sprint/msrc.cfm).
TBI research data elements must be reported using the NINDS TBI CDEs or entered into the
FITBIR data dictionary as new, unique data elements (UDEs). For the most current version of
the NINDS TBI CDEs, go to http://www.commondataelements.ninds.nih.gov. Assistance will be
available to help the researchers map their study variables to specific CDEs and ensure the
formats of the CDEs collected are compatible with the FITBIR. Use of the TBI CDEs is required
wherever possible in an effort to create standardized definitions and guidelines about the kinds of
data to collect and the data collection methods that should be used in clinical studies of TBI. Use
of UDEs is strongly discouraged and subject to program approval.
If the project includes the collection of bio-fluids, such as blood, saliva, urine, etc., the PI may be
required to include a set of collection variables and patient phenotypic data in order to
standardize the quality of bio-fluid studies. The suggested procedures for acquisition, processing,
storage, and shipment of bio-fluids can be found in Appendix IV.
For projects involving TBI, PIs may be required to report data to the FITBIR
(https://fitbir.nih.gov/).
For studies that will enroll subjects with psychological health disorders, awardees may be
requested to submit data to the National Institute of Mental Health Data Archive (NDA)
https://nda.nih.gov/. The NDA is a data repository run by the National Institute of Mental Health
(NIMH) that allows researchers studying mental illness to collect and share de-identified
information with each other. Such studies may require the inclusion of specific language in the
informed consent form which references the NDA (see Appendix V).
OTAs may establish unique data sharing requirements.
II.B.5. Funds Available and Anticipated Number of Awards
The funding amount for this BAA is unspecified, and the number of awards is indeterminate and
contingent upon funding availability. Selection of research projects is a highly competitive
process and is based on the evaluation of the proposal/application’s technical merit,
programmatic considerations, and the availability of funds. The quantity of meaningful
submissions received normally exceeds the number of awards that the available funding can
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support. Any funding that is received by the USAMRDC and is appropriate for a research area
described within this BAA may be utilized to fund proposals/applications.
II.B.6. Award Amounts and Periods of Performance
There are no specified funding limitations identified for a proposal/application submitted under
this BAA. 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-Application Budget Summary Form provided in the pre-proposal/pre-application
submission.
Period of performance may differ depending upon the type of funding mechanism awarded under
this BAA. For an assistance agreement, the total period of performance may be proposed for up
to 4 years in length; additional periods may be considered. For research and development
contract awards, the total period of performance may be proposed for up to 5 years in length;
additional periods may be considered. For OTAs that utilize the authority within 10 USC 4021 or
4022, the period of performance will be dependent upon each specific award made. Because the
nature and scope of each proposed research project will vary, it is anticipated that the size and
duration of each award will vary. Start dates will vary, depending on when
proposals/applications were submitted and reviewed and the negotiation process. However, no
proposal/application submitted under this BAA will be considered for funding after 24 months
from the date of submission.
Organizations seeking additional or continuation funding must work with their respective
PIs to submit new pre-proposals/pre-applications and be invited to submit full
proposals/applications.
Refer to the General Submission Instructions, Section III.A.5, for additional information
regarding the Research & Related Budget.
II.B.7. Mechanisms of Support
The USAMRDC executes its extramural research program primarily through the awarding of
contracts and assistance agreements (grants and cooperative agreements). The type of instrument
used to reflect the business relationship between the organization and the government is at the
discretion of the government, in accordance with the Federal Grant and Cooperative Agreement
Act of 1977, as amended (31 USC 6301-6308), which provides the legal criteria to select a
procurement contract or an assistance agreement. Refer to the General Submission Instructions,
Appendix 2, Section D, for additional information.
Proposers awarded a Grant, Cooperative Agreement, Procurement Contract or Other Transaction
for Research or Prototypes, based on their response to this BAA, shall follow the applicable rules
and regulations governing these various award instruments but, in all cases, should appropriately
identify any potential restrictions on the government’s use of any Intellectual Property
contemplated under the award instrument in question; refer to Attachment 8: Data and Research
Resource Sharing Plan. This includes both noncommercial Items and commercial Items.
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II.B.7.a. Procurement Contract: A legal instrument that, consistent with 31 USC 6303, reflects
a relationship between the federal government and a state government, local government, or
other entity/contractor when the principal purpose of the instrument is to acquire (by purchase,
lease, or barter) property or services for the direct benefit or use of the federal government.
Contracts are primarily governed by the following regulations:
a. FAR
b. DFARS
II.B.7.b. Grant: A legal instrument that, consistent with 31 USC 6304, is used to enter into a
relationship:
a. The principal purpose is to transfer a thing of value to the recipient to carry out a public
purpose of support or stimulation authorized by a law or the United States, rather than to
acquire property or services for the federal government’s direct benefit or use;
b. In which substantial involvement is not expected between the federal government and the
recipient when carrying out the activity contemplated by the grant; and
c. No fee or profit is allowed.
II.B.7.c. Cooperative Agreement: A legal instrument that, consistent with 31 USC 6305, is
used to enter into the same kind of relationship as a grant (see definition “grant”), except that
substantial involvement (collaboration, participation, or intervention in the research) is expected
between the federal government and the recipient when carrying out the activity contemplated by
the cooperative agreement. The term does not include “cooperative research and development
agreements” as defined in 15 USC 3710a. No fee or profit is allowed.
II.B.7.d. Other Transactions for Research: The USAMRDC will also consider the use of
Other Transactions for Research as a vehicle for award under this BAA. In accordance
with 10 USC 4021, “Research projects: transactions other than contracts and grants,” such
other transactions shall not be entered into unless the following conditions are satisfied:
a. To the maximum extent practicable, no other transaction entered into shall provide for
research that duplicates research being conducted under existing programs carried out by
DOD.
b. The funds provided by the government under another transaction authorization shall not
exceed, to the extent that the Secretary of Defense determines practicable, the total amount
provided by other parties to the other transaction.
II.B.7.e. Other Transactions for Prototypes: The USAMRDC will also consider the use of
Other Transactions for Prototypes as a vehicle for award under this BAA. In accordance
with 10 USC 4022, “Authority of the Department of Defense to carry out certain prototype
projects”: No official of an agency shall enter into a transaction (other than a contract,
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grant, or cooperative agreement) for a prototype project under the authority of 10
USC 4022 unless one of the following conditions is met:
a. There is at least one nontraditional defense contractor or nonprofit research institution
participating to a significant extent in the prototype project.
b. All significant participants in the transaction other than the Federal Government are small
businesses (including small businesses participating in a program described in section 9 of the
Small Business Act (15 U.S.C. 638)) or nontraditional defense contractors.
c. At least one-third of the total cost of the prototype project is to be paid out of funds provided
by sources other than the federal government.
d. The senior procurement executive for the agency determines in writing that exceptional
circumstances justify the use of a transaction that provides for innovative business
arrangements or structures that would not be feasible or appropriate under a contract, or
would provide an opportunity to expand the defense supply base in a manner that would not
be practical or feasible under a contract.
In accordance with 10 USC 4022(f), any other transaction for prototypes awarded under this
BAA may provide for the award of a follow-on production contract or transaction to the
participants in the transaction without the use of competitive procedures.
Additional information can be found in the most current version of the Other Transactions Guide
for Prototype Projects at TAB A1 – DoD OT Guide JUL 2023_final.pdf (osd.mil).
II.C. Eligibility Information
II.C.1. Eligible Applicants
II.C.1.a. Organizations
Awards are made to eligible organizations, not to individuals. Organizations eligible to apply
include national, international, for-profit, non-profit, public, and private organizations. Refer to
the General Submission Instructions, Appendix 3, Section B, for general eligibility information.
Note: In accordance with FAR 35.017-1(c)(4), 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 USAMRDC 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 will be given the maximum
practical opportunity to participate through subawards on research proposals/applications
submitted through this BAA.
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Government Agencies Within the United States: Local, state, and federal government
agencies are eligible to the extent that proposals/applications do not overlap with their fully
funded internal programs. Such agencies are required to explain how their proposals/
applications do not overlap with their internal programs.
Proposals/applications for this BAA may only be submitted by extramural organizations.
Submissions from intramural DOD organizations to this BAA will be withdrawn. These terms
are defined below.
Extramural Organization: An eligible non-DOD organization. Examples of extramural
organizations include academic institutions, biotechnology companies, foundations, federal
government organizations other than the DOD, and research institutes.
Intramural DOD Organization: A DOD laboratory, DOD military treatment facility, and/or
DOD activity embedded within a civilian medical center. Intramural Submission: A proposal/
application submitted by a DOD organization for an intramural investigator working within a
DOD laboratory or military treatment facility or in a DOD activity embedded within a civilian
medical center.
Proposals/applications from intramural investigators may be submitted extramurally through a
research foundation. It is permissible, however, for an intramural investigator to be named as a
collaborator on a proposal/application submitted through an extramural organization. In this
case, the proposal/application must include a letter from the collaborator’s Commander or
Commanding Officer at the intramural organization that authorizes the collaborator’s
involvement. For more information, refer to the General Submission Instructions, Section III.
II.C.1.b. Investigator(s)
Eligible investigators include all individuals, regardless of ethnicity, nationality, or citizenship
status, who are employed by or affiliated with an eligible organization.
Investigators are cautioned that awards are made to organizations only, not individuals.
II.C.2. Cost-Sharing
Generally, there is no requirement for cost-sharing, matching, or cost participation to be eligible
for award under this BAA. Cost-sharing and matching is not an evaluation factor used under this
BAA. Exceptions may exist if the applicant is proposing the use of a Research OTA or Prototype
OTA as an award instrument. Cost-sharing requirements may be found at 32 CFR 37 for TIAs.
Cost-sharing requirements for OTAs are stated in 10 USC 4021 for Research OTAs and 10 USC
4022 for Prototype OTAs.
In addition, if cost-sharing is proposed on a grant or cooperative agreement proposal/
application submitted by a nonprofit or institution of higher education, the award will be
subject to the restrictions at 2 CFR 200.306. If cost-sharing is proposed on a contract
proposal/application, the award will be subject to the restrictions at FAR 35.003(b).
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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.
Use of the System for Award Management (SAM) and the Federal Awardee Performance and
Integrity Information System (FAPIIS): To protect the public interest, the federal government
ensures the integrity of federal programs by conducting business with qualified recipients only.
The USAMRDC 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/SAM/. The
USAMRDC also reviews and considers information about the applicant in the Office of
Management and Budget-designated integrity and performance system, currently FAPIIS, prior
to making an award. Refer to the General Submission Instructions, Appendix 3, for additional
information.
Conflict of Interest (COI): All awards must be free of COIs that could bias the research results.
Prior to award of a contract, grant, or agreement, 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, Grants, or Agreements 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.
For general information on required qualifications for award recipients, refer to the General
Submission Instructions, Appendix 3.
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. The
subcontracting plan will have to comply with the requirements in FAR 19.704 and DFARS
219.704. A mutually agreeable plan will be developed during award negotiation process and
incorporated as part of the resultant contract. This requirement is not applicable to assistance
agreements or OTAs.
Refer to Section II.H.3, Administrative Actions, for a list of administrative actions that may be
taken if a pre-proposal/pre-application or proposal/application does not meet the administrative,
eligibility, or ethical requirements defined in this BAA.
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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 (https://www.grants.gov/) basic
search using the Funding Opportunity Number HT942523SBAA1.
eBRAP (https://ebrap.org) is a secure web-based system that allows PIs to submit their pre-
proposals/pre-applications, view and verify extramural full proposals/applications submitted to
Grants.gov (https://www.grants.gov), receive communications from the CDMRP, and submit
documentation during award negotiations and throughout the period of performance.
Grants.gov is a federal system required to be utilized by agencies to receive and process
extramural grant proposals/applications. Full proposals/applications may only be submitted to
Grants.gov after submission of a pre-proposal/pre-application through eBRAP.
Contact information for the eBRAP Help Desk and the Grants.gov Contact Center can be found
in Section II.G, Federal Awarding Agency Contacts.
Extramural Submission:
• Pre-proposal/pre-application content and forms must be accessed and submitted at
eBRAP.org.
• Full proposal/application packages must be accessed and submitted at Grants.gov.
II.D.2. Content and Form of Proposal/Application Submission
Submission is a two-step process requiring both pre-proposal/pre-application (eBRAP.org) and
full proposal/application (Grants.gov) as indicated below. Refer to Table 1, Full Application
Guidelines for full proposal/application submission guidelines. Note: Investigator(s) proposing a
clinical trial should refer to Appendix II for a detailed description of the requirements for such a
proposal/application.
Pre-Proposal/Pre-Application Submission: Submission of a pre-proposal/pre-application is
required and must be submitted through eBRAP. If the USAMRDC is interested in receiving a
full proposal/application, the PI will be sent an invitation via eBRAP to submit.
The proposal/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-proposal/pre-application and proposal/application submission
process. Inconsistencies may delay proposal/application processing and limit or negate the
ability to view, modify, and verify the proposal/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 proposal/application deadline.
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Pre-proposals/pre-applications may be submitted at any time prior to the BAA closing date. Pre-
proposals/pre-applications 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.
II.D.2.a Step 1: Pre-Proposal/Pre-Application Submission Content
During the pre-proposal/pre-application process, eBRAP assigns each submission is assigned
a unique log number. This unique eBRAP log number is required during the full proposal/
application submission process.
To begin the pre-proposal/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.
Note: Proposals/applications for this BAA may only be submitted by extramural organizations.
Submissions from intramural DOD organizations to this BAA will be withdrawn.
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.
All pre-proposal/pre-application components must be submitted by the PI through eBRAP
(https://eBRAP.org/). Because the invitation to submit a proposal/application is based on the
contents of the pre-proposal/pre-application, investigators should not change the title or research
objectives after the pre-proposal/pre-application is submitted.
The applicant organization and associated PI identified in the pre-proposal/pre-application
should be the same as those intended for the subsequent proposal/application submission. If any
changes are necessary after submission of the pre-proposal/pre-application, the PI must contact
the eBRAP Help Desk at help@eBRAP.org or 301-682-5507. A change in PI or organization
after submission of the pre-proposal/pre-application may be allowed after review of a submitted
written appeal (contact the eBRAP Help Desk at help@eBRAP.org or 301-682-5507) and at the
discretion of the USAMRAA Contracting, Agreements, or Grants Officer.
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.B, for
additional information on pre-proposal/pre-application submission):
• Tab 1 – Application Information
Submission of proposal/application information includes assignment of primary and
secondary research classification codes, which may be found at
https://ebrap.org/eBRAP/public/Program.htm. Applicants are strongly encouraged to review
and confirm the codes prior to making their selection.
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• Tab 2 – Application Contact
Enter contact information for the PI. Enter the organization’s Business Official responsible
for the sponsored program administration (the “person to be contacted on matters involving
this application” in Block 5 of the Grants.gov SF424 Research & Related Form). The
Business Official must either be selected from the eBRAP list or invited for the pre-
proposal/pre-application to be submitted.
Select the performing organization (site at which the PI will perform the proposed work) and
the contracting organization (organization submitting on behalf of the PI, which corresponds
to Block 5 on the Grants.gov SF424 [R&R]), and click on “Add Organizations to this Pre-
application.” The organization(s) must be either selected from the eBRAP drop-down list or
invited in order for the pre-proposal/pre-application to be submitted.
It is recommended that PIs identify an Alternate Submitter in the event that assistance with
pre-proposal/pre-application submission is needed.
• Tab 3 – Collaborators and Key Personnel
Enter the name, organization, and role of all collaborators and key personnel associated with
the pre-proposal/pre-application.
• Tab 4 – Conflicts of Interest
List all individuals other than collaborators and key personnel who may have a COI in the
review of the pre-proposal/pre-application (including those with whom the PI has a personal
or professional relationship).
• Tab 5 – Required Files
Note: No figures, charts, graphs, or other additional material will be accepted during the pre-
proposal/pre-application process.
Provide responses in the appropriate data fields for the following in eBRAP. EVERY DATA
FIELD MUST CONTAIN COMPLETE INFORMATION. eBRAP will truncate
characters exceeding the limit specified for each data field. Enter “none” if there is no
information to be included.
○ Problem To Be Studied (4,000 character limit, including spaces).
○ Theoretical Rationale, Scientific Methods, and Design (4,000 character limit, including
spaces).
○ Significance and/or Uniqueness of the Proposed Effort (4,000 character limit, including
spaces).
○ Military Relevance and Impact (4,000 character limit, including spaces).
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○ Brief Description of Research Involving Animals, Human Anatomical Substances,
Human Data, and/or Human Subjects (4,000 character limit, including spaces).
○ Plans and Strategy for Translation, Implementation, and/or Commercialization (4,000
character limit, including spaces).
Upload document(s) as individual PDF file(s). eBRAP will not allow a document to be
uploaded in the Required Files tab if the number of pages exceeds the limits specified
below.
○ Budget Summary: Upload as “BudgetSummary.pdf”. Complete the two-page Pre-
application Budget Summary Form (available for download in eBRAP) as instructed.
○ PI and Key Personnel Biographical Sketches (five-page limit per individual): Use
boldfaced type or highlight titles of publications relevant to the proposed project. All
biographical sketches should be uploaded as a single combined file.
• Tab 6 – Submit Pre-Application
This tab must be completed for the pre-proposal/pre-application to be accepted and processed.
Pre-Proposal/Pre-Application Screening
USAMRDC scientists and/or contracted, non-governmental subject matter experts will screen
pre-proposals/pre-applications for technical merit and programmatic considerations. Based on
the screening of the pre-proposal/pre-application, a PI may be invited to submit a full
proposal/application.
Notification of Pre-Proposal/Pre-Application Screening Results
Following the pre-proposal/pre-application screening, PIs will be notified as to whether or not
they are invited to submit full proposals/applications; however, they will not receive feedback
(e.g., a critique of strengths and weaknesses) on their pre-proposals/pre-applications. Within
120 calendar days of submission, PIs should receive email notification via eBRAP regarding
disposition of their pre-proposals/pre-applications.
II.D.2.b. Step 2: Full Proposal/Application Submission Content
Proposals/applications will not be accepted unless notification of invitation has been received.
The USAMRDC cannot make allowances/exceptions to its policies for submission problems
encountered by the applicant organization using system-to-system interfaces with Grants.gov.
Each proposal/application submission must include the completed full submission package for
this BAA. The full submission package is submitted by the Authorized Organizational
Representative through Grants.gov (https://www.grants.gov/). See Table 1 below for more
specific guidelines.
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II.D.2.b.i. Full Proposal/Application Submission Guidelines
Extramural organizations must submit full proposals/applications through Grants.gov. Applicants
must create a Grants.gov Workspace for submission, which allows the proposal/ application
components to be 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 Workspace. A compatible version of Adobe Reader must be used to
view, complete, and submit a proposal/application package consisting of PDF forms. If more
than one person is entering text into a proposal/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/applicants/grant-
applications/how-to-apply-for-grants) for further information about the Grants.gov Workspace
submission process.
Submissions of extramural applications through eBRAP may be withdrawn.
Do not password protect any files of the proposal/application package, including the Project
Narrative.
Table 1. Full Proposal/Application Submission Guidelines
Proposal/Application Package Location
Download proposal/application package components for HT942523SBAA1 from Grants.gov
(https://grants.gov) and create a Grants.gov Workspace. Workspace allows online completion of
the proposal/application components and routing of the proposal/application package through
the applicant organization for review prior to submission.
Full Proposal/Application Package Components
SF424 Research & Related Application for Federal Assistance Form: Refer to the General
Submission Instructions, Section III.A.1, for detailed information.
Descriptions of each required file can be found under Full Proposal/Application Submission
Components:
• Attachments (for submissions without clinical trial)
• Research & Related Personal Data (for submissions without clinical trial)
• Research & Related Senior/Key Person Profile (Expanded) (for submissions without
clinical trial)
• Research & Related Budget (for submissions without clinical trial)
• Project/Performance Site Location(s) Form (for submissions without clinical trial)
• Research & Related Subaward Budget Attachment(s) Form (for submissions without
clinical trial)
• Attachments (for submissions with clinical trial)
• Research & Related Personal Data (for submissions with clinical trial)
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• Research & Related Senior/Key Person Profile (Expanded) (for submissions with clinical
trial)
• Research & Related Budget (for submissions with clinical trial)
• Project/Performance Site Location(s) Form (for submissions with clinical trial)
• Research & Related Subaward Budget Attachment(s) Form (for submissions with clinical
trial)
Proposal/Application Package Submission
Create a Grants.gov Workspace.
Add participants (investigators and Business Officials) to Workspace, complete all required
forms, and check for errors before submission.
Submit a Grants.gov Workspace Package.
A proposal/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 proposal/application package at least 24-48 hours prior to the BAA closing
date to allow time to correct any potential technical issues that may disrupt the
proposal/application submission.
Note: If either the Project Narrative or the budget fails eBRAP validation or needs to be
modified, an updated Grants.gov proposal/application package must be submitted via
Grants.gov as a “Changed/Corrected Application” with the previous Grants.gov Tracking
Identification prior to the proposal/application submission deadline. Do not password protect
any files of the application package, including the Project Narrative.
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.
Proposal/Application Verification Period
The full proposal/application package submitted to Grants.gov may be viewed and modified in
eBRAP until the end of the 5-day proposal/application verification period. During the
proposal/application verification period, the full proposal/application package may be modified
with the exception of the Project Narrative and Research & Related Budget Form.
Further Information
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.
The full proposal/application package must be submitted using the unique eBRAP log number to
avoid delays in proposal/application processing.
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II.D.2.b.ii. Full Proposal/Application Submission Components Without a Clinical Trial
The Grants.gov Workspace submission package includes the following components (refer to the
General Submission Instructions, Section III, for additional information on proposal/application
submission).
• SF424 Research & Related Application for Federal Assistance Form: Refer to the
General Submission Instructions, Section III.A.1, for detailed information.
Attachments for Proposals/Applications Without a Clinical Trial
Note: Components and attachments for a proposal/application with a clinical trial are
provided in Appendix II.
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,
i.e., 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 submission
package may not exceed 200 MB.
○ Attachment 1: Project Narrative (15-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) used to describe
the project. Inclusion of URLs (uniform resource locators; web addresses) that provide
additional information to expand the Project Narrative and could confer an unfair
competitive advantage is prohibited and may result in administrative withdrawal of the
proposal/application.
A detailed innovative/state of the art description of the research (relating to the Research
Areas of Interest identified in Section II.A and Appendix I) to be undertaken should be
submitted. This should include the areas provided below and address their relationship to
the state of knowledge in the field and to comparable work in progress elsewhere.
Evaluation of the proposed research will be influenced by the adequacy of this
information.
Literature references and curriculum vitae will be shown in separate addenda entries. The
following general outline should be followed:
– Background: Provide a brief statement of ideas and theoretical reasoning behind the
proposed study. Describe previous experience most pertinent to this proposal/
application. Cite relevant literature references. Include discussion of any findings (if
available) from relevant pilot or preliminary work or any related work underway. For
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development of devices and technologies, provide an intellectual property plan as part
of the supporting documentation.
– Hypothesis: State the hypothesis to be tested and the expected results. For
development of devices and technologies, discuss the technical feasibility of the
proposed project including historical background of the problem, previous and
current solutions, similar projects previously undertaken, and related development
activities.
– Technical Objectives: State concisely the question to be answered by each research
objective.
– 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
commercialization strategy/plan for the technology being developed.
– Military Significance: State precisely the estimates as to the immediate and/or long-
range usefulness of this study to the U.S. Armed Forces, as distinguished from
general advancement of knowledge in medicine.
– Public Purpose: If appropriate, provide a concise, detailed description of how this
research project will benefit the general public.
– Methods: Give details about the experimental design and methodology. If the
methodology is new or unusual, describe it in sufficient detail for evaluation.
 Describe how the proposed research is designed to achieve reproducible and
rigorous results, including controls, sample size estimation, randomization,
statistical analysis, and data handling.
 For synthetic chemistry applications, include a clear statement of the rationale for
the proposed syntheses. Outline and document the routes to the syntheses.
 For development of devices and technologies, discuss the engineering/technical
design 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.
 For clinical research studies involving human subjects, describe the recruitment
plan to include relevant support and justification for sample size, study inclusion
criteria, and data collection instruments, as well as access to populations. The
proposal/application should describe a plan for data access and sharing. (Access
to subjects and data is the sole responsibility of the investigator.) As relevant,
describe plans for addressing issues unique to working with military populations.
 For studies involving human and animal research, provide a statistical and data
analysis plan. Include a complete power analysis to demonstrate that the sample
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size is appropriate to meet the objectives of the study. Describe the statistical
model and data analysis plan with respect to the study objectives as appropriate to
the type of study. Specify the approximate number of human subjects that will be
enrolled. If multiple study sites are involved, state the approximate number to be
enrolled at each site. Investigators must develop protocols for research with
human subjects and/or human anatomical substances that are specific to the DOD-
supported effort outlined in the submitted proposal/application. The research
protocol submitted for OHRO review MUST only include those activities funded
by the DOD, as referenced in the Statement of Work (SOW). The OHRO will
NOT review protocols submitted for DOD-funded activities if such studies have
been added to an ongoing/existing protocol.
 For studies with prospective accrual of human subjects, indicate quarterly
enrollment targets. For clinical research studies, further details of clinical research
components (including the required strategy for the inclusion of women and
minorities appropriate to the objectives of the study, see Senate Report 115-290
(S. 3159), 2019) will be required in see Attachment 10: Human Subject
Recruitment and Safety Procedures, as applicable.
 For use of human anatomical substances, identify the commercial or
organizational source(s) of the material. For cell lines, identify cell line(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., IND and IDE) to the FDA or appropriate government regulatory 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 IRB review and approval, as stated above.
 For animal studies, allow at least 2 to 3 months for regulatory review and
approval by the USAMRDC ACURO; this does not include the additional time
required for local IACUC review and approval, as stated above.
 Refer to the General Submission Instructions, Appendix 1, for additional
regulatory information.
○ Attachment 2: Supporting Documentation: Combine and upload as a single file
named “Support.pdf”. Start each document on a new page. 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. These items
should be included in the Project Narrative.
There are no page limits for any of these components unless otherwise noted. Include
only those components described below; inclusion of items not requested or viewed as
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an extension of the Project Narrative will result in the removal of those items or may
result in administrative withdrawal of the proposal/application.
– References Cited: List the references cited (including URLs, if available) in the
Project 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.
– Facilities, Existing Equipment, and Other Resources: Describe the facilities and
existing 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 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 are now accountable. There is no form for this
information.
– Publications and/or Patent Abstracts: Include a list of relevant publication URLs
and/or patent abstracts. If articles are not publicly available, then copies of up to five
published manuscripts may be included in Attachment 2. Extra items will not be
reviewed
– 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
from each organization involved in the project should be provided. Letters of support
not requested in this BAA, such as those from members of Congress, do not impact
proposal/application review or funding decisions.
– Letters of Collaboration (if applicable): Provide a signed letter from each
collaborating individual or organization that demonstrates that the investigator has the
support of resources necessary for the proposed work. If an investigator at an
intramural organization is named as a collaborator on a proposal/application
submitted through an extramural organization, the proposal/application must include
a letter from the collaborator’s Commander or Commanding Officer at the intramural
organization that authorizes the collaborator’s involvement.
– Letters of Commitment (if applicable, two-page limit per letter is
recommended): If the proposed study involves use of a commercially produced
investigational drug, device, or biologic, provide a letter of commitment from the
commercial entity indicating availability of the product for the duration of the study,
support for the proposed phase of research, and support for the indication to be tested.
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– Use of DOD Resources (if applicable): Provide a letter of support signed by the
lowest-ranking person with approval authority confirming access to active-duty
military populations and/or DOD resources or databases.
– Use of VA Resources (if applicable): Provide a letter of support from the VA
Facility Director(s) or individual designated by the VA Facility Director(s), such as
the Associate Chief of Staff for Research and Development (ACOS/R&D) or Clinical
Service Chief confirming access to VA patients, resources, and/or VA research space.
For VA PIs, if the VA Non-Profit Corporation (NPC) is not identified as the applicant
institution for administering the funds, include a letter from the VA ACOS/R&D
confirming this arrangement and identifying the institution that will administer the
funds associated with the proposed research.
– Collaboration with Military Facility (if applicable): If the project involves
collaboration with a Military Facility, special requirements apply. A DOD
researcher, to include collaborating DOD PIs, must obtain a letter from his/her
Commanding Officer or Military Facility Director authorizing his/her participation in
the research project. This letter must be included with the proposal/application.
– 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 between/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/all 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: Information can be found in 2 CFR 200.315, “Intangible
Property.”
 Background and Proprietary Information: All software and data first produced
under the award are subject to a federal purpose license. A term of the award
requires the recipient to grant the government all necessary and appropriate
licenses, which could include licenses to background and proprietary information
that have been developed at private expense. Refer to the General Submission
Instructions, Appendix 2, Sections C and D, for more information about
disclosure of proprietary information.
Therefore, it is important to disclose/list any intellectual property (software, data,
patents, etc.) that will be used in performance of the project or provide a statement
that none will be used. If applicable, all proprietary information to be provided to
the government should be stated and identified; the applicant should indicate
whether a waiver of the federal purpose license will be required.
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 Intellectual and Material Property Plan (if applicable): Provide a plan for
resolving intellectual and material property issues among participating
organizations. Address any impact of intellectual property issues on product
development and subsequent government access to products supported by this
BAA. Demonstrate access to all intellectual property rights necessary for
development and commercialization and evidence that the government has the
ability to access such products or technologies.
○ 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.
The structured technical abstract should be clear and concise and, at a minimum, provide
the following information:
– Background: Provide a brief statement of the ideas and theoretical reasoning behind
the proposed work.
– Objective/Hypothesis: State the objective/hypothesis to be tested. Provide evidence or
rationale that supports the objective/hypothesis.
– Specific Aims: State concisely the specific aims of the study.
– Study Design: Briefly describe the study design.
– 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. 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.
Lay abstracts should be written using the outline below. Do not duplicate the technical
abstract.
– Clearly describe the objectives and theoretical reasoning behind the proposed work in
a manner readily understood by readers without a background in science or medicine.
– Clearly describe the problem or question to be addressed and the ultimate
applicability and 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.
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 What are the potential clinical applications, benefits, and risks?
 What is the projected timeline it may take to achieve the expected patient-related
outcome?
 Describe how the proposed project will benefit Service Members, Veterans,
and/or their Family members.
○ Attachment 5: Statement of Work (two-page limit): Upload as “SOW.pdf”. The
SOW outlines and establishes the performance expectations and milestones for which the
USAMRDC may provide funding. The SOW will be incorporated into the award
document and, as such, is subject to release under the Freedom of Information Act. The
SOW should identify all collaborating research sites involved in the performance of the
research. 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). Recommended strategies for assembling
the SOW can be found at https://ebrap.org/eBRAP/public/Program.htm. Refer to either
the “Example: Assembling a Clinical Research and/or Clinical Trial Statement of
Work” or “Example: Assembling a Generic Statement of Work”, whichever format is
most appropriate for the proposed effort, and use the blank SOW format titled “Suggested
SOW Format”. The SOW must be in PDF format prior to attaching.
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 statements should
outline the specific tasks, systems, key assessments/techniques, and materials that are
reasonable estimates for testing the proposed hypotheses of the study. A timeline should
be included that shows the work statements to be accomplished in each year of the award.
Any animal use and/or human subjects recruitment should be included. Allow at least
2 to 3 months for the USAMRDC OHARO regulatory review and approval processes for
studies involving human subjects and 2 to 3 months for studies involving animal subjects.
○ Attachment 6: Impact/Outcomes Statement (one-page limit): Upload as
“Impact.pdf”. Explain the potential impact of the research in the field, the significance
of this impact, and when it can be anticipated. Explain how the results of this research are
expected to impact the intended beneficiaries. Describe how the anticipated outcomes
could be implanted in a dual-use capacity to address the healthcare needs of military
Service Members, Veterans, and/or their beneficiaries, as well as the civilian population,
as appropriate.
○ Attachment 7: Military Relevance Statement (one-page limit): Upload as
“MilRel.pdf”.
– Describe how the proposed study is responsive to the healthcare needs of military
Service Members, Veterans, and/or beneficiaries. Provide information about the
incidence and/or prevalence of the disease or condition in the general population as
well as in military Service Members, Veterans, and/or beneficiaries.
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– If active-duty military, military families, and/or Veteran population(s) will be used in
the proposed research project, describe the population(s) and the appropriateness of
the population(s) for the proposed study. If a non-military population will be used for
the proposed research project, explain how the population simulates the targeted
population (i.e., military Service Members, Veterans, and/or beneficiaries).
– As applicable, show how the proposed research project aligns with DOD and VA
areas of research interests. Provide a description of how the knowledge or technology
gained from the research could be implemented in a dual-use capacity to benefit the
civilian population and address a military need, as appropriate.
○ Attachment 8: Data and Research Resource Sharing Plan (one-page limit): All data
must be shared while ensuring appropriate protection of information. 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 explain this in the data and/or research resource sharing plan.
Refer to the General Submission Instructions, Appendix 2, Section K, for additional
information.
○ Attachment 9: Post-Award Transition Plan (two-page limit): Upload as
“Transition.pdf”. Describe the methods and strategies proposed to move the anticipated
research outcomes to the next phase of development or clinical application (clinical trials,
commercialization, and/or delivery to the civilian or military market) after successful
completion of the award. Applicants are encouraged to work with their organization’s
Technology Transfer Office (or equivalent) to develop the transition plan. Applicants are
encouraged to explore developing relationships with industry and/or other funding
agencies to facilitate moving the product into the next phase of development. The post-
award transition plan should include the components listed below:
The project’s anticipated research outcomes including knowledge products, clinical
-
products for development, etc.
Using Appendix VI as a guide, describe the maturity of the product and provide the
-
current and projected research technology or knowledge readiness level (as
appropriate) at the end of the proposed project or knowledge outcome.
– A description of the scientific or technical requirements needed to advance the
research findings. Include steps necessary for FDA regulatory approval for the
planning indication, and compliance with Good Manufacturing Practice (GMP),
Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) guidelines as
appropriate.
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– A timeline with defined milestones and deliverables describing the expected post-
award progress of the results toward the next phase of development and eventual
clinical impact.
– An assessment of the opportunities available and potential barriers that would impact
the progress of commercializing and/or translating the study results into clinical
practice.
– A plan for management of intellectual property.
– Details of the funding strategy to transition to the next level of investigation,
development, and/or commercialization (e.g., partners, internal/external funding
opportunities to be applied for).
– A description of collaborations and other resources that will be used to provide
continuity of development.
– A plan to distribute the findings or intervention to the civilian and/or military
communities.
○ Attachment 10: Human Subject Recruitment and Safety Procedures for Clinical
Research (no page limit), if applicable; required for all studies recruiting human
subjects: Upload as “HumSubProc.pdf”. The Human Subject Recruitment and Safety
Procedures attachment should include the components listed below, where applicable.
Applicants 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 until applicable regulatory documents are
reviewed and approved by the USAMRDC OHARO to ensure that applicable
regulations have been met.
– Study Population: Describe the availability of the target population (to whom the
study findings will be generalized) and the nature, approximate number, and pertinent
demographic characteristics of the accessible population at the study site(s)
(population from whom the sample will be recruited/drawn). Provide a table of
anticipated enrollment counts at each study site. Demonstrate that the research team
has access to the proposed study population at each site, and describe the efforts that
will be made to achieve accrual goals. Furthermore, discuss past efforts in recruiting
human subjects from the target population for previous clinical studies (if applicable).
Address any potential barriers to accrual and plans for addressing unanticipated
delays, including a mitigation plan for slow or low enrollment or poor retention.
Identify ongoing clinical studies that may compete for the same patient population
and how they may impact enrollment progress. Provide justification related to the
scientific goals of the proposed study for limiting inclusion of any group by age, race,
ethnicity, or sex. For clinical research proposing to include military personnel,
refer to the General Submission Instructions, Appendix 1, for more information.
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– Inclusion/Exclusion Criteria: List the inclusion and exclusion criteria for the
proposed clinical study. Inclusion/exclusion criteria should take into consideration the
specific risk profile of the studies to be conducted and the standard of care for that
patient population. Provide detailed justification for exclusions.
– Women and Minorities in the Study: Consistent with the Belmont Report, “Ethical
Principles and Guidelines for the Protection of Human Subjects,” and congressional
legislation in Senate Report 115-290 (S. 3159), 2019, special attention is given to
inclusion of women and/or minorities in studies funded or supported by the
USAMRDC. Describe the strategy for the inclusion of women and minorities
appropriate to the objectives of the study, including a description of the composition
of the proposed study population in terms of sex, race, and ethnicity, and an
accompanying rationale for the selection of subjects. Provide a planned enrollment
table(s) with the proposed enrollment distributed on the basis of sex, race, and
ethnicity. The Public Health Service (PHS) Inclusion Enrollment Report may be
downloaded from eBRAP at https://ebrap.org/eBRAP/public/Program.htm.
– Description of the Recruitment Process: Explain methods for identification of
potential human subjects (e.g., medical record review, healthcare provider
identification of potential subjects, recruitment databases, advertising).
 Describe the recruitment process in detail. Address who will identify potential
human subjects, who will recruit them, and what methods will be used to recruit
them.
 If human subjects will be compensated for participation in the study, include a
detailed description of and justification for the compensation plan.
 Describe the recruitment and advertisement materials. The recruitment materials
should not be coercive or offer undue inducements and should accurately reflect
the study.
– Description of the Informed Consent Process: Specifically describe the plan for
obtaining informed consent from human subjects.
 For the proposed study, provide a draft, in English, of the Informed Consent
Form.
 Identify who is responsible for explaining the study, answering questions, and
obtaining informed consent. Include a plan for ensuring that human subjects’
questions will be addressed during the consent process and throughout the study.
 Include information regarding the timing and location of the consent process.
 Address issues relevant to the mental capacity of the potential human subject
(e.g., altered capacity due to administration of any mind-altering substances such
as tranquilizers, conscious sedation or anesthesia, brain injury, stress/life
situations, or human subject age), if applicable.
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 Address how privacy and time for decision-making will be provided and whether
or not the potential human subject will be allowed to discuss the study with
anyone before making a decision.
 Consider the need for obtaining ongoing consent or for reassessing capacity over
the course of a long-term study and describe any relevant procedures to assure
continued consent.
 Describe the plan for the consent of the individual’s Legally Authorized
Representative (LAR) to be obtained prior to the human subject’s participation in
the study. State law defines who may act as the LAR. The performance site’s IRB
office should be consulted for guidance regarding who can serve as LAR for
research at the study site. Note: In compliance with 10 USC 980
(https://www.govinfo.gov/content/pkg/USCODE-2011-title10/pdf/USCODE-
2011-title10-subtitleA-partII-chap49-sec980.pdf), if the research will include an
intervention or interaction with subjects for the primary purpose of obtaining data
regarding the effect of the intervention or interaction, the application must
describe a clear intent to benefit all for human subjects who cannot give their own
consent to participate in the proposed study. If applicable, please refer to the
General Submission Instructions, Appendix 1, for more information.
 Assent: If minors or other populations that cannot provide informed consent are
included in the proposed clinical study, a plan to obtain assent (agreement) from
those with capacity to provide it or a justification for a waiver of assent should be
provided. PIs should consult with their IRB office to identify the conditions
necessary for obtaining assent.
– Screening Procedures: List and describe any evaluations (e.g., laboratory
procedures, history, or physical examination) that are required to determine
eligibility/suitability for study participation and the diagnostic criteria for entry. Note:
Some screening procedures may require a separate consent or a two-stage consent
process. Informed consent must be obtained prior to initiation of any procedures for
the purpose of determining eligibility.
– Risks/Benefits Assessment:
 Foreseeable risks: Clearly identify all study risks, including potential safety
concerns and adverse events. Study risks include any risks that the human subject
is exposed to as a result of participation in the study. Consider psychological,
legal, social, and economic risks as well as physical risks. If the risks are
unknown, this should be stated. If applicable, any potential risk to the study
personnel should be identified.
 Risk management and emergency response:
 Appropriate to the study’s level of risk, describe how safety monitoring and
reporting to the IRB and FDA (if applicable) will be managed and conducted.
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 Describe all safety measures to minimize and/or eliminate risks to human
subjects and study personnel or to manage unpreventable risks. Include
safeguards and planned responses such as dose reduction or stopping criteria
based on toxicity grading scales or other predetermined alert values.
 Discuss the overall plan for provision of emergency care or treatment for an
adverse event for study-related injuries, including who will be responsible for
the cost of such care.
 Address any special precautions to be taken by the human subjects before,
during, and after the study (e.g., medication washout periods, dietary
restrictions, hydration, fasting, and pregnancy prevention).
 Describe any special care (e.g., wound dressing assistance, transportation due
to side effects of study intervention impairing ability to drive) or equipment
(e.g., thermometers, telemedicine equipment) needed for human subjects
enrolled in the study.
 Potential benefits: Describe known and potential benefits of the study to the
human subjects who will participate in the study. Articulate the importance of
the knowledge to be gained as a result of the proposed research. Discuss why the
potential risks to human subjects are reasonable in relation to the anticipated
benefits to the human subjects and others that may be expected to result.
○ Attachment 11: Data Management (no page limit), if applicable; required for all
studies recruiting human subjects: Upload as “Data_Manage.pdf”. The Data
Management attachment should include the components listed below.
– Data Management: Describe all methods used for data collection, including 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 human subjects and 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 the DOD are eligible to review
study records.
 Address requirements for reporting sensitive information to state or local
authorities.
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 Data capture, verification, and disposition: Describe how data will be
captured and verified. Describe where data (both electronic and hard copy) will
be stored, who will keep the data, how the data will be stored, the process for
locking the database at study completion, and the length of time the data will be
stored. Describe the proposed database, how it will be developed and validated,
and its capability to safeguard and maintain the integrity of the data. Describe the
database lock process. For FDA-regulated studies, compliance with 21 CFR 11
and appropriate data standards (such as those established by the Clinical Data
Interchange Standards Consortium) is required.
 Data reporting: Describe how data will be reported and how it will be assured
that the documentation will support a regulatory filing with the FDA, if
applicable.
 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, including results from any screening or diagnostic
tests performed as part of the study.
– Laboratory Evaluations:
 Specimens to be collected, schedule, and amount: All specimens that will be
collected for study purposes must be clearly stated. The collection schedule and
amount of material collected must also be clearly described.
 Evaluations to be made: Describe all evaluations that will be made for study
purposes. Explain how the results of laboratory evaluations will be used to meet
the objectives of the study (or to monitor safety of human subjects).
 Storage: Describe specimen storage, including location of storage, how long
specimens will be stored, any special conditions required, labeling, and specimen
disposition. Outline the plan to store specimens for future use including
considerations for informed consent and providing human subjects with an
opportunity to decline participation in the study.
 Laboratories performing evaluations and special precautions: Identify the
laboratory performing each evaluation, the applicable quality standard, and any
special precautions that should be taken in handling the samples. Special
precautions that should be taken by the human subject before, during, or after the
laboratory procedure should be clearly defined. If transport of samples is required,
describe provisions for ensuring proper storage during transport.
○ Attachment 12: Regulatory Strategy (no page limit): If submitting multiple
documents, start each document on a new page. Combine and upload as a single file
named “Regulatory.pdf”. (Attachment 12 is required for human subjects studies using
an investigational drug or device.) Provide the information requested below and provide
supporting documentation as applicable.
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Will data collected under this proposal be submitted to the FDA (or submitted later to, or
held for inspection by, the FDA), as part of an application for a research or marketing
permit?
– If yes, describe how the planned data will contribute to a research or marketing
application with the FDA.
Clinical trials must be initiated no later than 12 months after the award date. Note: The
government reserves the right to withhold or withdraw funding if an IND or IDE is
necessary to conduct the clinical trial but has not been obtained within 6 months of the
award date.
– State the product/intervention name.
For products/interventions that do not require regulation by the FDA or an
international regulatory agency:
– Explain why the product/intervention is exempt from FDA oversight. Provide
evidence that the proposed study does not require regulation by the FDA. If the
proposed study will be conducted at international sites, provide equivalent
information relevant to the host country(ies) regulatory requirements.
For products/interventions that require regulation by the FDA and/or an international
regulatory agency:
– State whether the product is FDA-approved, -licensed, or -cleared, and marketed in
the United States.
– If the product is marketed in the United States, state the product label indication. State
whether the proposed research involves a change to the approved label indication for
the route of administration, dosage level, and/or subject population. Indicate whether
the proposed research involves a change that increases the risks associated with using
the product. State whether the product is being promoted for an off-label use (where
promotion involves the sale of a marketed product).
– If the product is not currently FDA-approved, -licensed, or -cleared, state the planned
indication/use. Indicate whether the product would be classified as a drug, device,
biologic, or combination product. Indicate whether the FDA has confirmed the
proposed classification. Identify the regulatory sponsor. Include a signed sponsor
commitment letter acknowledging the regulatory sponsor’s understanding of all
sponsor responsibilities and commitment to oversee execution of the study.
– If an IND or IDE is required for the work proposed, the IND/IDE application
must be submitted to the FDA prior to submission of the full
proposal/application. The IND or IDE should be specific for the investigational
product (i.e., not a derivative or alternate version of the product) and indication to be
tested in the proposed clinical study. Provide the date of submission, the application
number, and existing copy of the FDA letter acknowledging the submission. If there
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are any existing cross-references in place, provide the application number(s) and
associated sponsor(s). Provide an explanation of the status of the application (e.g.,
past the critical 30-day period, pending response to questions raised by the FDA, on
clinical hold, on partial clinical hold). If the IND or IDE application has been placed
on clinical hold or partial hold, explain the conditions that must be met for release of
the hold. Provide a summary of any previous meetings with the FDA on development
of this product. A copy of the Agency meeting minutes should be included if
available. Provide copies of communications from the FDA relevant to the most
recent status of the IND or IDE application.
– If available, provide a copy of the communication from the FDA indicating the IND
or IDE application is active/safe to proceed.
– If an active IND or IDE for the investigational product is in effect, but the amendment
is needed to include the proposed study, describe the type and nature of the
amendments(s) and timeline for submission. Indicate whether the amendment
increases the risk of the intervention.
– If the study will be conducted at international sites, provide equivalent information
and supporting documentation relevant to the product indication/label and regulatory
approval and/or filings in the host country(ies).
– Provide the current status for manufacturing development (e.g., manufacturer’s name,
GMP-compliant lots available, status of stability testing.), non-clinical development
(e.g., test facility name, status of pivotal GLP toxicology studies to support phase 1
testing), and clinical development (e.g., clinical site name, safety profile, status of any
completed or ongoing clinical trials).
– Describe the overall regulatory strategy and product development plan that will
support the planned product indication/label. Include a description of the numbers and
types of studies proposed to reach approval, licensure, or clearance, the types of FDA
meetings that will be held/planned, and the submission filing strategy. Include
considerations for compliance with current GMP, GLP, and GCP guidelines.
○ Attachment 13: Representations: Upload as “RequiredReps.pdf”. All extramural
applicants must complete and submit the Required Representations template available on
eBRAP (https://ebrap.org/eBRAP/public/Program.htm). For more information, see the
General Submission Instructions, Appendix 5, Section B, Representations.
○ Attachment 14: Suggested Intragovernmental/Intramural Budget, if applicable:
Upload as “IGBudget.pdf”. If a Military Facility (MHS facility, research laboratory,
medical treatment facility, dental treatment facility, or a DOD activity embedded within a
civilian medical center) will be a collaborator in performance of the project, complete a
separate budget using, “Suggested Intragovernmental/Intramural Budget,” 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
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Research & Related Budget Form under subaward costs. Refer to the General Submission
Instructions, Section III.A.8, for detailed information.
To evaluate compliance with Title IX of the Education Amendments of 1972 (20 USC
1681(a) 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 proposals/applications
in science, technology, engineering, and/or mathematics (STEM) disciplines. To enable this
assessment, each proposal/application must include the following forms completed as
indicated.
Research & Related Personal Data: Refer to the General Submission Instructions,
Section III.A.3, for detailed information.
Research & Related Senior/Key Person Profile (Expanded): Refer to the General
Submission Instructions, Section III.A.4, for detailed information. Complete a Profile for
each person who will contribute in a substantive, meaningful way to the scientific
development or execution of the proposed research project. A biographical sketch and
full description of each PI and senior/key person’s current/pending support information
must be attached to the individual’s profile in the Attach Biographical Sketch and Attach
Current & Pending Support fields, respectively.
– Biographical Sketch: Upload as “Biosketch_LastName.pdf”.
 The USAMRDC staff and reviewers use biosketches to evaluate whether research
teams are equipped with the expertise necessary to carry out the proposed
research.
 Biosketches must conform to the federal-wide Biographical Sketch Common
Form. To prepare their biosketch attachments, applicants may use the instructions
provided in the General Application Instructions, Section IV.C.(b), for Grants.gov
submissions; or General Application Instructions, Section V.B.(b), for eBRAP
submissions; or may use a pdf form created in SciENcv for the NIH or the U.S.
National Science Foundation (NSF).
– Current/Pending Support: Upload as “Support_LastName.pdf”.
 Current and pending (other) support information are used to assess the capacity or
any conflicts of commitment that may impact the ability of the individual to carry
out the research effort as proposed. The information also helps to assess any
potential scientific and budgetary overlap/duplication with the project being
proposed.
 Current and pending support documentation must conform to the federal wide
format. To prepare their Current and Pending Support form, applicants may use
the instructions provided in the General Application Instructions, Section
IV.C.(b), for Grants.gov submissions; or General Application Instructions,
Section V.B.(b), for eBRAP submissions; or may use a pdf form created
in SciENcv for NIH or NSF.
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Research & Related Budget: Refer to the General Submission Instructions, Section
III.A.5, 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.
Project/Performance Site Location(s) Form: Refer to the General Submission
Instructions, Section III.A.6, for detailed information.
Research & Related Subaward Budget Attachment(s) Form (if applicable): Refer to
the General Submission Instructions, Section III.A.7, for detailed information.
Extramural Subaward: Complete the Research & Related Subaward Budget Form
through Grants.gov. (Refer to the General Submission Instructions, Section III.A.7, for
detailed information.) Verify subaward budget(s) and budget justification forms are
present in eBRAP during the proposal/application verification period. If these
components are missing, upload them to eBRAP before the end of the proposal/
application verification period.
Note: Proposals/applications from federal agencies must include in their budget
justifications a Federal Financial Plan. Proposals/applications from organizations that
include collaborations with DOD Military Facilities must comply with special
requirements. Refer to the General Submission Instructions, Section III.A.5, Research &
Related Budget, for detailed information.
Intramural DOD Collaborator(s): Complete the Suggested
Intragovernmental/Intramural Budget and upload to Grants.gov attachment form as
Attachment 14. (Refer to the General Application Instructions, Section IV.A.4, for
detailed information.) Each Intramural DOD Collaborator should include costs per year
on the Grants.gov Research & Related Budget Form under subaward costs.
II.D.3. Unique Entity Identifier (UEI) and System for Award Management
The applicant organization must be registered as an entity in SAM (https://www.sam.gov/SAM/)
and receive confirmation of an “Active” status before submitting a proposal/application through
Grants.gov. As published in the Federal Register, July 10, 2019,
(https://www.federalregister.gov/documents/2019/07/10/2019-14665/unique-entity-id-standard-
for-awards-management), the UEI for awards management generated through SAM will be used
instead of the Data Universal Numbering System (DUNS) number as of April 2022. All federal
awards including, but not limited to, contracts, grants, and cooperative agreements will use the
UEI. USAMRDC will transition to use of the UEI beginning with FY22 announcements and
utilize the latest SF424, which includes the UEI. The DUNS will no longer be accepted.
Applicant organizations will not go to a third-party website to obtain an identifier. During the
transition, your SAM registration will automatically be assigned a new UEI displayed in SAM.
(For more information, visit the General Services Administration: Unique Entity Identifier
update | GSA) Current SAM.gov registrants are assigned their UEI and can view it within
FY23 – FY27 DOD USAMRDC Broad Agency Announcement 50
for Extramural Medical Research

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