Opportunity Information: Apply for RFA FD 22 003
The Innovation Award: COVID-19 and Health Equity (U01) Clinical Trials Optional (RFA FD 22 003) is a discretionary federal grant opportunity from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). It uses a cooperative agreement mechanism (U01), which generally means the awardee conducts the research while the FDA maintains substantial involvement in the project, such as collaborating on key aspects of planning, execution, or oversight. The overall intent of the program is to fund innovative research that strengthens and advances COVID-19 health equity research, with an emphasis on generating evidence that improves how COVID-19 prevention, diagnosis, and treatment efforts reach and serve populations that have been disproportionately affected.
A central focus of the opportunity is improving the participation of racial and ethnic minority populations in COVID-19 and COVID-19 variant clinical trials. Projects can also be designed to support the continued evaluation of the safety and efficacy of FDA-approved medical products, including therapeutics, diagnostics, and vaccines, as well as products authorized under Emergency Use Authorizations (EUAs) or expansions of EUAs. In practical terms, the program is looking for research approaches that help ensure clinical evidence reflects the diversity of the people who use these products, and that any differences in performance, safety signals, or real-world outcomes across groups can be detected and addressed.
Another major area of interest is research that strengthens demographic analyses of COVID-19-related outcomes. The FOA highlights the importance of evaluating outcomes using demographic data such as ethnicity, race, age, disability status, and geography, while leaving room for applicants to include additional relevant variables. This could include studies that improve how demographic data are collected, linked, analyzed, or interpreted, or work that identifies disparities in access, uptake, adherence, effectiveness, adverse events, or other outcomes associated with COVID-19 products and interventions. The underlying theme is to produce clearer, more actionable evidence about who benefits, who is at risk, and where gaps persist.
The announcement also invites proposals that help the COVID-19 research ecosystem better understand diverse patient perspectives, preferences, and unmet needs. This includes work aimed at understanding barriers to participation in trials, reasons for hesitancy or mistrust, preferences around product characteristics or delivery models, and the lived experiences of different communities during the pandemic. The FOA is not limited to clinical trials, as indicated by "Clinical Trials Optional," meaning applicants can propose either clinical trial-related work or non-trial research, depending on the scientific question and approach.
Funding is offered under a cooperative agreement with an award ceiling of $1,000,000 per award, and the FDA expected to make about five awards under this announcement. The opportunity is listed under CFDA 93.103 and falls within activity areas tied to consumer protection and research and development, reflecting FDA's public health role in ensuring medical products are safe and effective for the public. Eligible applicants are broad and include public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), independent school districts, public housing authorities and Indian housing authorities, and certain Native American tribal organizations, among others as described in the eligibility text. The FOA was created on September 27, 2021, with an original closing date of November 29, 2021.
Overall, this opportunity is designed to generate practical, equity-centered evidence that can improve COVID-19 clinical research inclusivity, strengthen demographic outcome evaluation, and incorporate patient and community perspectives into the development, assessment, and use of COVID-19 diagnostics, therapeutics, and vaccines, including those authorized under EUAs.Apply for RFA FD 22 003
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, food and nutrition, science and technology and other research and development sector is offering a public funding opportunity titled "Innovation Award: COVID-19 and Health Equity (U01) Clinical Trials Optional" 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 Sep 27, 2021.
- Applicants must submit their applications by Nov 29, 2021. (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 $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: Independent school districts, Public and State controlled institutions of higher education, 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, Others (see text field entitled Additional Information on Eligibility for clarification).
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 22 003) also looked into and applied for these:
| Funding Opportunity |
|---|
| Deconstruction of data and standards to support harmonization and interoperability with real world data for clinical research and regulatory submissions. (U01 Clinical Trial Not Allowed) Apply for RFA FD 22 022 Funding Number: RFA FD 22 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $350,000 |
| Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24) Clinical Trials Not Allowed Apply for RFA FD 23 002 Funding Number: RFA FD 23 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $400,000 |
| Centers of Excellence in Regulatory Science and Innovation (CERSI) Apply for RFA FD 23 004 Funding Number: RFA FD 23 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
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