Opportunity Information: Apply for RFA FD 24 022

The FDA Office of Minority Health and Health Equity (OMHHE) Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01), Funding Opportunity Number RFA-FD-24-022, is a discretionary federal grant program designed to support innovative research that strengthens and advances minority health and broader health equity goals. The award uses a cooperative agreement mechanism (U01), which typically means that funded projects will involve substantial FDA involvement during the project period, such as collaboration on milestones, coordination, or programmatic input, rather than operating as a fully independent research grant. Clinical trials are not allowed under this announcement, so proposed work should focus on research, methods, tools, infrastructure, engagement, or analyses that advance equity without conducting a clinical trial.

The core purpose of the opportunity is to generate practical, scalable innovations that help reduce inequities in the evidence and decision-making ecosystem that surrounds FDA-regulated medical products and public health. The FOA highlights three main interest areas. First is advancing equity in clinical trials, specifically by supporting efforts that improve diversity and representation in clinical research participation. While you cannot run a clinical trial under this FOA, projects can still address barriers to participation, develop recruitment and retention strategies, improve site readiness, create community-engaged approaches, build sustainable partnerships, or evaluate and refine operational practices that make trial participation more inclusive and accessible.

The second priority area is equitable data efforts, with an emphasis on increasing the availability, quality, and usefulness of data on diverse populations. The announcement explicitly references demographic dimensions such as ethnicity, race, age, disability, and geography, and also leaves room for other relevant factors that shape health experiences and outcomes. In practice, this can include developing improved approaches to data collection, harmonization, linkage, and governance; creating frameworks to fill data gaps for underrepresented groups; improving measurement consistency; and producing analytic methods that better reflect real-world diversity. The intent is to strengthen the evidence base so it more accurately captures variation across populations and can better inform equitable policy, product development, and healthcare decisions.

The third highlighted area is equity of voices, which centers on understanding diverse patient perspectives, preferences, and unmet needs. Projects aligned with this area might use qualitative and mixed methods research, patient-centered outcomes approaches, community-based participatory research, preference elicitation, or structured listening efforts to capture perspectives that are often underrepresented. The goal is to ensure that patient experiences and needs from diverse communities are better understood and appropriately reflected in research agendas, product development pathways, and broader health decision-making.

Eligibility is broad and includes state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations (including entities other than small businesses); small businesses; and the program is listed as unrestricted, indicating wide eligibility as long as applicants meet federal requirements and the FOA specifications.

Key administrative details include a total award ceiling of $250,000 per award and an expectation of approximately 4 awards. The opportunity was created on December 21, 2023, with an original application closing date of March 11, 2024. The program is associated with CFDA number 93.103 and is administered by the Food and Drug Administration. Overall, the funding opportunity is positioned to support research and implementation-oriented innovations that make clinical research participation more inclusive, improve the representativeness and completeness of data on diverse groups, and elevate patient voices to better identify preferences and unmet needs, all while staying outside the scope of conducting clinical trials.

  • The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "FDA OMHHE Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
  • This funding opportunity was created on 2023-12-21.
  • Applicants must submit their applications by 2024-03-11. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $250,000.00 in funding.
  • The number of recipients for this funding is limited to 4 candidate(s).
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Unrestricted.
Apply for RFA FD 24 022

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Funding Opportunity
Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed Apply for RFA FD 24 020

Funding Number: RFA FD 24 020
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $350,000
Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 026

Funding Number: RFA FD 24 026
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $150,000
OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 023

Funding Number: RFA FD 24 023
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $250,000
Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required) Apply for RFA FD 24 025

Funding Number: RFA FD 24 025
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $2,000,000
Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional Apply for RFA FD 24 029

Funding Number: RFA FD 24 029
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $5,000,000
Critical Path Public Private Partnerships Clinical Trials Optional Apply for RFA FD 24 027

Funding Number: RFA FD 24 027
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $20,000,000
Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed Apply for RFA FD 24 007

Funding Number: RFA FD 24 007
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $300,000
Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional Apply for RFA FD 24 006

Funding Number: RFA FD 24 006
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $300,000
Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required) Apply for RFA FD 24 008

Funding Number: RFA FD 24 008
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $250,000
Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 005

Funding Number: RFA FD 24 005
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $300,000
Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed Apply for RFA FD 24 011

Funding Number: RFA FD 24 011
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $300,000
Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed Apply for RFA FD 24 010

Funding Number: RFA FD 24 010
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $250,000
Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers (U01) Clinical Trial Optional Apply for RFA FD 24 038

Funding Number: RFA FD 24 038
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $500,000
Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by State, Local, Tribal, and Territorial (SLTT) Retail Food Regulatory Agencies (U19) Clinical Trials Not Allowed Apply for RFA FD 24 033

Funding Number: RFA FD 24 033
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $15,000,000
Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed Apply for RFA FD 24 032

Funding Number: RFA FD 24 032
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $360,000
Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U19) Clinical Trials Not Allowed Apply for RFA FD 24 039

Funding Number: RFA FD 24 039
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $340,000
Drug Development Tools Research Grants (U01) Clinical Trials Optional Apply for RFA FD 24 030

Funding Number: RFA FD 24 030
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $500,000
Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) Clinical Trial Not Allowed Apply for RFA FD 24 031

Funding Number: RFA FD 24 031
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $200,000
Alliance to Support the Activities of the Integrated Food Safety System (IFSS), including the Grade “A” Milk Safety and National Shellfish Sanitation Programs (U01) Clinical Trials Not Allowed Apply for RFA FD 24 034

Funding Number: RFA FD 24 034
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $6,000,000
Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01) Clinical Trials Not Allowed Apply for RFA FD 24 016

Funding Number: RFA FD 24 016
Agency: Food and Drug Administration
Category: Agriculture, Consumer Protection, Food and Nutrition
Funding Amount: $750,000

 

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