Pathways for Regulatory Innovation and Strategic Modernization (PRISM)

Notice of Funding Opportunity Announcement (NOFO)

Department of Health and Human Services
Part 1. Overview Information
U.S. Food and Drug Administration (FDA)
Participating
Organization(s) NOTE: The policies, guidelines, terms, and conditions stated in this
Notice of Funding Opportunity (NOFO) may differ from those used by
the NIH. Where this NOFO provides specific written guidance that may
differ from the general guidance provided in the grant application form,
please follow the instructions given in this NOFO.
The FDA does not follow the NIH Page Limitation Guidelines or the NIH
Review Criteria. Applicants are encouraged to consult with FDA
Agency Contacts for additional information regarding page limits and
the FDA Objective Review Process.
Center for Biologics Evaluation & Research (CBER)
Components of
Participating Center for Devices & Radiological Health (CDRH)
Organizations
Center for Drug Evaluation & Research (CDER)
Center for Tobacco Products (CTP)
Center for Veterinary Medicine (CVM)
Human Foods Program (HFP)
Office of the Chief Scientist (OCS)
Office of the Commissioner (OC)
Office of Inspections & Investigations (OII)
Funding Opportunity Pathways for Regulatory Innovation and Strategic Modernization
Title (PRISM)
U01
Activity Code
Announcement Type New
None
Related Notices
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Funding Opportunity RFA-FD-26-007
Number (FON)
Companion Funding None
Opportunity
See Part 2, Section III. 3. Additional Information on Eligibility.
Number of Applications
Assistance Listing 93.103
Number(s)
The Pathways for Regulatory Innovation and Strategic Modernization
Funding Opportunity
(PRISM) cooperative agreement is intended to advance public health by
Purpose
strengthening the scientific, collaborative, and operational foundations
needed to modernize regulatory oversight in an increasingly complex
and rapidly evolving public health landscape. As innovation in medical
products, diagnostics, foods, and digital health accelerates, our nation
must continuously adapt its regulatory science approaches to ensure
timely access to safe, effective, and high-quality products for the
American public. PRISM is designed to support this modernization by
enabling forward-looking, non-regulatory collaborations that align with
the Commissioner’s strategic priorities and the Administration’s
broader public health goals.
PRISM provides a flexible, scalable approach to patient, consumer,
industry, academia, and healthcare workforce engagement to generate
applied scientific knowledge, tools, and approaches that enhance
regulatory predictability, efficiency, and transparency. By leveraging
independent expertise and real-world insights, PRISM bridges gaps
between innovation and regulation to optimize uptake of emerging
technologies, evolving consumer needs, and new sources of evidence
such as real-world data and real-world evidence.
The goals of FDA's Pathways for Regulatory Innovation and Strategic
Funding Opportunity
Modernization (PRISM) project are to:
Goals
1. Advance the Use of Real-World Data, Real-World Evidence, and
Artificial Intelligence to Inform Public Health and Regulatory Science.
2. Strengthen Pathways for Patient Access to Investigational
Therapies, Including Expanded Access.
3. Advance Transparency and Public Trust in Regulatory Science.
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4. Support Gold-Standard Science–Based Approaches Across
Regulatory Science, Food Safety, and Nutrition.
Key Dates
Posted Date March 31, 2026
Open Date (Earliest March 31, 2026
Submission Date)
Not Applicable.
Letter of Intent Due
Date(s)
Application Due Date(s)
April 30, 2026
All applications are due by 11:59 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found
in the application during the submission process by the due date.
No late applications will be accepted for this Notice of Funding Opportunity (NOFO).
AIDS Application Due Date(s)
Not Applicable
Expiration Date May 01, 2026
Advisory Council Review
Not Applicable
Not Applicable
Due Dates for E.O.
12372
Required Application Instructions
Conformance to all requirements, both in the the Research (R) Instructions How to Apply - Application
Guide and in the NOFO, is required and strictly enforced. Applicants must read and follow all application
instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in
Section IV of this NOFO or an applicable related Notice posted to the Guide for Grants and Contracts.
When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow
the program-specific instructions.
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Applications that do not comply with these instructions may be delayed or not accepted for review.
Table of Contents
Part 1. Overview Information ............................................................................................................................... 1
Key Dates ......................................................................................................................................................... 3
Part 2. Full Text of Announcement ..................................................................................................................... 4
Section I. Notice of Funding Opportunity Description ................................................................................... 4
Section II. Award Information.......................................................................................................................... 6
Section III. Eligibility Information .................................................................................................................... 7
Section IV. Application and Submission Information .................................................................................... 9
Section V. Application Review Information .................................................................................................. 11
Section VI. Award Administration Information ............................................................................................ 15
Section VII. Agency Contacts ........................................................................................................................ 17
Section VIII. Other Information ...................................................................................................................... 18
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Background
Rapid advances in medical products, diagnostics, foods, nutrition science, and digital health are
transforming how public health is protected and promoted in the United States. These innovations
increasingly rely on complex data sources, novel technologies, and evolving scientific methodologies that
challenge traditional regulatory approaches. To effectively protect public health, we must continuously
modernize regulatory science, engagement models, and operational frameworks to ensure timely access
to safe, effective, and high-quality FDA-regulated products while maintaining public trust.
Engagement with a regulatory agency such as FDA can be complex for patients, consumers, healthcare
professionals, academia, and regulated industry—particularly when collaboration requires shared
scientific expertise, financial resources, or data. Transparent, neutral, and trusted mechanisms for
engagement are essential to ensure advances in science and technology are translated efficiently into
public health benefits. Non-regulatory collaborative approaches play a critical role in enabling cooperation
among public- and private-sector stakeholders while preserving FDA’s regulatory independence.
The Pathways for Regulatory Innovation and Strategic Modernization (PRISM) project is intended to
enable forward-looking collaboration, applied research, and convening activities that strengthen scientific
foundations and support the modernization of regulatory oversight to enhance the safety and
effectiveness of FDA-regulated products in an increasingly complex and rapidly evolving public health
landscape.
Purpose and Research Objectives
The purpose of the PRISM project is to advance public health by strengthening the scientific,
collaborative, and operational foundations needed to modernize regulatory oversight across FDA-
regulated products. PRISM will support non-regulatory, science-driven activities that align with FDA's
public health goals and priorities.
Through applied research, stakeholder engagement, and evidence generation, PRISM seeks to:
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• Enhance the use of advanced scientific methods, real-world data, and emerging technologies to
improve the development, safety, and/or efficacy of FDA-regulated products.
• Improve pathways for patient access to investigational therapies, including expanded access
mechanisms, while preserving appropriate safeguards.
• Increase transparency, predictability, and public understanding of FDA’s science-based
approaches to enable more effective and efficient product development, evaluation, and
oversight.
• Promote gold-standard, evidence-based approaches across regulatory science domains,
including food safety, nutrition, and population health.
The cooperative agreement will support the generation of applied scientific knowledge, tools,
frameworks, and best practices that help bridge gaps between innovation and regulation. The recipient
will not participate in regulatory decision-making or provide policy advice to FDA.
Program Scope and Approach
PRISM provides a flexible and scalable platform for engaging a broad range of stakeholders, including
patients, consumers, healthcare professionals, industry, academia, and public health experts. Activities
supported under this cooperative agreement may include, but are not limited to:
• Convenings, workshops, and public forums to share expertise and identify emerging scientific
and operational challenges.
• Applied research and methodological exploration to support modern regulatory science
approaches.
• Development and dissemination of tools, frameworks, and best practices that enhance regulatory
predictability, efficiency, and transparency.
• Analysis of real-world experiences and data to inform improvements in regulatory science and
public health outcomes.
Specific Areas of Research Interest
Research and programmatic activities supported under this project may address a broad range of
regulatory science and public health priorities. Appropriate topics include, but are not limited to, the areas
described below.
1. Advancing the Use of Real-World Data, Real-World Evidence, and Artificial Intelligence
PRISM will support the development, evaluation, and dissemination of approaches that leverage real-
world data (RWD), real-world evidence (RWE), and advanced analytical technologies, including artificial
intelligence (AI) and computational modeling, to improve understanding of product performance, safety,
and effectiveness across the product lifecycle. Activities may include convenings, applied research, and
methodological exploration focused on enhancing post-market surveillance, strengthening causal
inference, and improving the use of large-scale and complex data sources to detect safety signals,
assess real-world effectiveness, and increase the efficiency and consistency of evidence generation.
These efforts will complement FDA’s existing data infrastructure and support a transition toward more
timely, scalable, and informative approaches to regulatory science that better protect and promote public
health.
2. Strengthening Pathways for Patient Access to Investigational Therapies, Including Expanded Access
PRISM will support research and stakeholder engagement aimed at improving pathways for patients with
serious or life-threatening conditions to access investigational medical products outside of clinical trials
when no comparable alternatives exist. This includes examining barriers, operational challenges, and
patient and provider experiences associated with expanded access (compassionate use) mechanisms.
By identifying opportunities to streamline processes, improve transparency, and enhance navigation for
patients, healthcare providers, and manufacturers, PRISM will contribute to more predictable access to
investigational therapies while preserving appropriate safeguards.
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3. Advancing Transparency and Public Trust in Regulatory Science
PRISM will support activities that enhance transparency, clarity, and public understanding of FDA’s
science-based approaches to product evaluation and oversight. Through convenings, research, and
evidence-sharing, the project will explore methods to improve communication of regulatory science
concepts, data sources, assumptions, and limitations to a variety of audiences, including patients,
consumers, healthcare providers, and product developers. By promoting openness and accessibility in
how evidence is generated and interpreted—while preserving regulatory independence—PRISM will help
strengthen public confidence in FDA-regulated products and enable more effective and efficient product
development.
4. Supporting Gold-Standard Science–Based Approaches Across Regulatory Science, Food Safety, and
Nutrition
PRISM will support applied research and stakeholder engagement grounded in gold-standard scientific
methods to advance modern, evidence-based approaches across FDA’s regulatory science portfolio,
including food safety, nutrition, and dietary exposures that affect population health. Activities may include
rigorous examination of emerging and large-scale data sources, real-world use and consumption
patterns, and validated analytical, computational, and causal inference methods to strengthen
understanding of the relationships among regulated products, exposures, and health outcomes. By
fostering collaboration across public health, regulatory science, epidemiology, nutrition science, and data
analytics communities, PRISM will contribute to the generation of high-quality, reproducible evidence that
supports proactive, prevention-oriented strategies, enhances product safety and effectiveness, and
promotes healthier outcomes, particularly for children and other vulnerable populations.
5. Advancing Competition and Domestic Innovation
PRISM will support proposals for innovative research and implementation projects that will advance a
faster, more efficient early-stage clinical ecosystem and promote domestic medical innovation. Proposed
activities should address the preclinical and first phase of clinical trials, and will target 1) chemistry,
manufacturing, and controls requirements, 2) toxicology expectations, and 3) streamlining data
standards for investigator-initiated trials. Successful projects will foster collaboration between IRBs,
CROs, and institutions while generating evidence and validating expedited approaches for advancing
regulatory reform and onshoring clinical development in the U.S.
Relationship to Other Funding Opportunities
This cooperative agreement is distinct from investigator-initiated or product-specific research programs
in that it emphasizes non-regulatory collaboration, convening, and applied regulatory science across
multiple FDA-regulated domains. PRISM focuses on cross-cutting scientific and operational challenges
that affect regulatory modernization broadly, rather than on individual product approvals or policy
development.
See Section VIII. Other Information for award authorities and regulations.
Section II. Award Information
Cooperative Agreement: A financial assistance mechanism used when
Funding Instrument
there will be substantial Federal scientific or programmatic
involvement. See Section VI.2 for additional information about the
substantial involvement for this NOFO.
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Application Types New
Allowed The OER Glossary and the How to Apply - Application Guide provide
details on these application types. Only those application types listed
here are allowed for this NOFO.
Need help determining whether you are doing a clinical trial?
Clinical Trial?
FDA intends to commit $1,300,000 for fiscal year 2026.
Funds Available and
Anticipated Number of The number of awards is contingent upon FDA appropriations and the
Awards submission of a sufficient number of meritorious applications.
Award(s) will provide one (1) year of support and include future
recommended support for FOUR (4) additional year(s) contingent upon
annual appropriations, availability of funding and satisfactory awardee
performance.
It is anticipated that up to one (1) award will be made, not to exceed
$1,300,000 in total costs (direct plus indirect).
Application budgets need to reflect the actual needs of the proposed
Award Budget
project and should not exceed the following in total costs (direct and
indirect):
YR 01: $1,300,000
YR 02: $1,300,000
YR 03: $1,300,000
YR 04: $1,300,000
YR 05: $1,300,000
The scope of the proposed project should determine the project period.
Award Project Period
The maximum project period is 5 (five) years.
HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications
submitted and awards made from this NOFO.
Section III. Eligibility Information
Eligible Organizations
Only the following applicant is eligible to apply for this single source funding: Reagan-Udall Foundation for
the Food and Drug Administration.
Foreign Organizations
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
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Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Required Registrations
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How
to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants
should begin the registration process as soon as possible. Failure to complete registrations in advance of
a due date is not a valid reason for a late submission, please reference the HHS Grants Policy Statement
for additional information
• System for Award Management (SAM) Applicants must complete and maintain an active
registration, which requires renewal at least annually. The renewal process may require as much
time as the initial registration. SAM registration includes the assignment of a Commercial and
Government Entity (CAGE) Code for domestic organizations which have not already been
assigned a CAGE Code.
o NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must
obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
o Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process.
The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register
with eRA Commons in tandem with completing their Grants.gov registrations; all registrations
must be in place by time of submission. eRA Commons requires organizations to identify at least
one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI)
account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov
registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational
officials to either create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two
distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2
weeks.
Eligible Individuals (Program Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research
as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization
to develop an application for support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal
Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the
How to Apply - Application Guide.
The PD/PI should be an established investigator in the scientific area in which the application is targeted
and capable of providing both administrative and scientific leadership to the development and
implementation of the proposed program. The PD/PI will be expected to monitor and assess the program
and submit all documents and reports as required.
2. Cost Sharing
This NOFO does not require cost sharing.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application, provided that each application is
scientifically distinct.
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The FDA will not accept duplicate or highly overlapping applications under review at the same time.
Section IV. Application and Submission Information
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov
Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov
Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply -
Application Guide except where instructed in this notice of funding opportunity to do otherwise.
Conformance to the requirements in the How to Apply - Application Guide is required and strictly
enforced. Applications that are out of compliance with these instructions may be delayed or not accepted
for review.
Page Limitations
All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must
be followed.
Instructions for Application Submission
The following section supplements the instructions found in the How to Apply - Application Guide and
should be used for preparing an application to this NOFO.
SF424(R&R) Cover
All instructions in the How to Apply - Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the How to Apply - Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the How to Apply - Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the How to Apply - Application Guide must be followed.
R&R Budget
All instructions in the How to Apply - Application Guide must be followed.
R&R Subaward Budget
All instructions in the How to Apply - Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the How to Apply - Application Guide must be followed.
PHS 398 Research Plan
All instructions in the How to Apply - Application Guide must be followed, with the following additional
instructions:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing
Plans as provided in the How to Apply - Application Guide.
Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and
Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.
All instructions in the How to Apply - Application Guide must be followed, with the following additional
instructions:
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All applicants planning research (funded or conducted in whole or in part by the FDA) that results in the
generation of scientific data are required to comply with the instructions for the Data Management and
Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must
address a Data Management and Sharing Plan.
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as
described in the How to Apply - Application Guide.
• No publications or other material, with the exception of blank questionnaires or blank surveys,
may be included in the Appendix.
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research, and/or FDA-defined clinical trials (and when
applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and
Clinical Trials Information form in the How to Apply - Application Guide, with the following additional
instructions:
If you answered "Yes" to the question “Are Human Subjects Involved?” on the R&R Other Project
Information form, you must include at least one human subjects study record using the Study Record:
PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e.,
delayed start). All instructions in the How to Apply - Application Guide must be followed.
PHS Assignment Request Form
All instructions in the How to Apply - Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier
and for completing and maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
4. Submission Dates and Times
Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application corrections that might be necessary
for successful submission. When a submission date falls on a weekend or Federal holiday, the application
deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, FDA's electronic system for grants administration. FDA
and Grants.gov systems check the application against many of the application instructions upon
submission. Errors must be corrected and a changed/corrected application must be submitted to
Grants.gov on or before the application due date and time. If a Changed/Corrected application is
submitted after the deadline, the application will be considered late. Applications that miss the due date
and time are subjected to the FDA Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to
ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the How to
Apply - Application Guide.
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6. Funding Restrictions
All FDA awards are subject to the terms and conditions, cost principles, and other considerations
described in the HHS Grants Policy Statement.
Pre-award costs are allowable only as described in the HHS Grants Policy Statement.
• Recipients must comply with all applicable federal anti-discrimination laws material to the government’s
payment decisions for purposes of 31 U.S.C. § 3729(b)(4).
• Discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate:
▪ racial preferences or other forms of racial discrimination by the recipient, including activities
where race or intentional proxies for race will be used as a selection criterion for employment or
program participation.
▪ denial by the recipient of the sex binary in humans or the notion that sex is a chosen or mutable
characteristic.
▪ harm reduction
▪ illegal immigration; or
▪ any other initiatives that compromise public safety or promote anti-American values.
All activities proposed in your application and budget narrative must align with the current Executive Orders,
and where applicable, demonstrably advance the President’s policy priorities. If an application does not
align, the application will not receive funding.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the How to Apply -
Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility
Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission
process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must follow the Dealing with
System Issues guidance. For assistance with application submission, contact the Application Submission
Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile
form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to the FDA. See Section III of this
NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the
same identifier used in the organization's profile in the eRA Commons and for the System for Award
Management. Additional information may be found in the How to Apply - Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application
instructions by the assigned FDA Grants Management Specialist and responsiveness by components of
participating organizations. Applications that are incomplete, non-compliant and/or nonresponsive will
not be reviewed.
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Post Submission Materials
Not applicable.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted
to the FDA in support of the FDA mission are evaluated for scientific and technical merit through the FDA
objective review system.
Overall Impact
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit and give
a separate score for each. An application does not need to be strong in all categories to be judged likely
to have major scientific impact. For example, a project that by its nature is not innovative may be
essential to advance a field.
Significance Maximum Points: 10
Does the project address an important problem or a critical barrier to progress in the field? Is the prior
research that serves as the key support for the proposed project rigorous? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How
will successful completion of the aims change the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Investigator(s) Maximum Points: 10
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage
Investigators or those in the early stages of independent careers, do they have appropriate experience
and training? If established, have they demonstrated an ongoing record of accomplishments that have
advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach, governance, and organizational
structure appropriate for the project?
Innovation Maximum Points: 30
Does the application challenge and seek to shift current research or clinical practice paradigms by
utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of
research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical
concepts, approaches or methodologies, instrumentation, or interventions proposed?
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Approach Maximum Points: 25
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of
prior research that serves as the key support for the proposed project? Have the investigators presented
strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential
problems, alternative strategies, and benchmarks for success presented? If the project is in the early
stages of development, will the strategy establish feasibility and will particularly risky aspects be
managed? Have the investigators presented adequate plans to address relevant biological variables, such
as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or FDA-defined clinical research, are the plans to address 1)
the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the
basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages
(including children and older adults), justified in terms of the scientific goals and research strategy
proposed?
Environment Maximum Points: 25
Will the scientific environment in which the work will be done contribute to the probability of success? Are
the institutional support, equipment, and other physical resources available to the investigators adequate
for the project proposed? Will the project benefit from unique features of the scientific environment,
subject populations, or collaborative arrangements?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while
determining scientific and technical merit, and in providing an overall impact score, but will not give
separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that
are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of
human subjects and the proposed protections from research risk relating to their participation
according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against
risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained,
and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for
the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to the Guidelines for the
Review of Human Subjects.
Vertebrate Animals
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The committee will evaluate the involvement of live vertebrate animals as part of the scientific
assessment according to the following three points: (1) a complete description of all proposed
procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2)
justifications that the species is appropriate for the proposed research and why the research goals
cannot be accomplished using an alternative non-animal model; and (3) interventions including
analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any
unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research.
Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA
Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the
application. For additional information on review of the Vertebrate Animals Section, please refer to
the Worksheet for Review of the Vertebrate Animals Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to
research personnel and/or the environment, and if needed, determine whether adequate protection is
proposed.
Resubmissions
Not applicable.
Renewals
Not applicable.
Revisions
Not applicable.
Additional Review Considerations
As applicable for the project proposed, reviewers will consider each of the following items, but will not
give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where
Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and
transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of
the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or
the rationale for not sharing the resources, is reasonable.
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief
plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and
reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review
Committee convened by the FDA, using the stated review criteria. Assignment to an Objective Review
Committee will be shown in eRA Commons.
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As part of the objective review, all applications will receive a written critique.
Appeals of objective review will not be accepted for applications submitted in response to this NOFO.
The following will be considered in making funding decisions:
• Scientific and technical merit of the proposed project as determined by objective review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates
Successful applicants will be notified of additional information that may be required or other actions
leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is
discretionary and is not subject to appeal to any FDA or HHS official or board.
Information regarding the disposition of applications is available in the HHS Grants Policy Statement.
Section VI. Award Administration Information
1. Award Notices
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has
been made and that funds may be requested from the designated HHS payment system or office. The
NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all
provisions currently in effect or implemented during the period of the award, other Department
regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any
pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information
on the Notice of Award, please refer to the HHS Grants Policy Statement.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure
that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-
funded studies, the recipient must provide FDA copies of documents related to all major changes in the
status of ongoing protocols.
2. Administrative and National Policy Requirements
The following Federal wide and HHS-specific policy requirements apply to awards funded through FDA:
• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and
Audit Requirements for Federal Awards.
• All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as
part of the terms and conditions in the Notice of Award (NoA). The NoA includes the
requirements of this NOFO.
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in
the HHS Grants Policy Statement.
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.
FDA may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and HHS
Grants Policy Statement.
Successful recipients under this NOFO agree that:
Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any
funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and
implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and
implementation specifications can support the activity. Visit https://www.ecfr.gov/current/title-
45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.
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Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible
clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the
HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology
can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to
learn more.
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS
Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best
practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
1. ongoing and consistent access to HHS owned or operated information or operational technology
systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable
information (PII) or personal health information (PHI) obtained from the awarding HHS agency
for the purposes of executing the award.
Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to
protect HHS systems and data. Please refer to HHS Grants Policy Statement for additional information.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office
of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human
Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and FDA grant
administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an
"assistance" mechanism (rather than an "acquisition" mechanism), in which substantial FDA
programmatic involvement with the recipients is anticipated during the performance of the activities.
Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by
involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the
dominant role and prime responsibility resides with the recipients for the project as a whole, although
specific tasks and activities may be shared among the recipients and the FDA as defined below.
To assist recipients in achieving the purpose of this award, FDA will conduct the following activities
above and beyond normal programmatic oversight, monitoring, and stewardship of awards:
• FDA staff from Components of Participating Organizations will collaborate with recipients in the
planning, execution, and evaluation of project activities to ensure alignment with goals and
priorities of this NOFO.
3. Data Management and Sharing
Consistent with the FDA Policy for Data Management and Sharing, when data management and sharing is
applicable to the award, recipients will be required to adhere to the Data Management and Sharing
requirements as outlined in the HHS Grants Policy Statement. Upon the approval of a Data Management
and Sharing Plan, it is required for recipients to implement the plan as described.
4. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance
Progress Report (RPPR) annually and financial statements as required in the HHS Grants Policy
Statement.
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A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the HHS Grants Policy Statement. . FDA NOFOs outline
intended research goals and objectives. Post award, the FDA will review and measure performance based
on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a
requirement for recipients of Federal grants to report information about first-tier subawards and executive
compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable
FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System
(FSRS) available at www.fsrs.gov on all subawards over the threshold. See the HHS Grants Policy
Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR
Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for
any period of time during the period of performance of a Federal award, must report and maintain the
currency of information reported in the System for Award Management (SAM) about civil, criminal, and
administrative proceedings in connection with the award or performance of a Federal award that reached
final disposition within the most recent five-year period. The recipient must also make semiannual
disclosures regarding such proceedings. Proceedings information will be made publicly available in the
designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS).
This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).
As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and
performance system on or after April 15, 2011, except past performance reviews required for Federal
procurement contracts, will be publicly available. Full reporting requirements and procedures are found in
Appendix XII to 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance
Matters.
5. Evaluation
Enter text here.
Section VII. Agency Contacts
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings,
documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Scientific/Research Contact(s)
Luke Hall
Office of the Commissioner (OC)
Email: Luke.hall@fda.hhs.gov
Peer Review Contact(s)
Examine your eRA Commons account for review assignment and contact information (information
appears two weeks after the submission due date).
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Financial/Grants Management Contact(s)
Patrick Johnson
Office of Acquisitions and Grants Services (OAGS)
Email: patrick.johnson@fda.hhs.gov
Section VIII. Other Information
Recently issued policy notices may affect your application submission. A full list of policy notices is
provided in the Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the HHS Grants Policy Statement.
Authority and Regulations
Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended
(42 USC 241) and subject to 2 CFR Parts 200 and 300.
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