Innovation Award: COVID-19 and Health Equity (U01) Clinical Trials Not Allowed | RFA FD 23 009

Opportunity Information: Apply for RFA FD 23 009

The Innovation Award: COVID-19 and Health Equity (U01) is a discretionary research funding opportunity from the U.S. Food and Drug Administration (FDA), administered through the FDA Office of Minority Health and Health Equity (OMHHE). It uses a cooperative agreement mechanism (U01), which typically means the FDA expects to have substantial involvement in the project after award, such as collaborating on project direction, milestones, or deliverables. The central goal is to support COVID-19 research that strengthens the evidence base around minority health and health equity, improves understanding of health disparities, and produces findings that can help shape future research priorities and inform FDA regulatory decision making.

This opportunity specifically targets research that advances understanding of COVID-19 and long COVID (also described as post-COVID conditions) among racial and ethnic minority populations, or research that helps inform the continued evaluation of FDA-approved medical products used for COVID-19. Those products can include therapeutics, diagnostics, and vaccines. A key expectation is that proposed studies do more than report overall outcomes; they should evaluate outcomes using demographic data, explicitly including (but not limited to) ethnicity, race, age, disability status, and geography. In practice, this emphasis pushes applicants to design analyses that can reveal inequities, differential impacts, and subgroup-specific outcomes that might otherwise be hidden in aggregated results.

Clinical trials are not allowed under this FOA, so projects should be framed as non-trial research activities. That can include work such as secondary analyses of existing datasets, observational or epidemiologic studies that do not meet the definition of a clinical trial, real-world evidence generation and analysis, methods development, modeling, community-informed research approaches, surveillance-oriented analyses, or other research strategies that can contribute to understanding disparities and informing product evaluation without prospectively assigning interventions. The FDA interest in “regulatory decision making” signals that outputs should be policy- and evidence-relevant, for example by clarifying how safety, effectiveness, performance, or access may differ across populations, or by improving the quality of demographic data and analytic approaches used to assess these issues.

Eligibility is broad and includes a wide range of organization types. Higher education institutions may apply, including public/state-controlled and private institutions, and OMHHE explicitly encourages applications from institutions that have historically served underrepresented groups, such as Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). Beyond academia, eligible applicants include nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses and other for-profits), and multiple levels of government (state, county, city/township, special districts). It also includes independent school districts, public housing authorities and Indian housing authorities, federally recognized and non-federally recognized tribal governments, other Native American tribal organizations, U.S. territories or possessions, faith-based and community-based organizations, and regional organizations. This breadth indicates the FDA is open to multidisciplinary teams and community-connected entities that can access relevant data, populations, and expertise to study equity-focused COVID outcomes.

Key administrative details from the source information include the funding opportunity number RFA-FD-23-009 and CFDA number 93.103. The award ceiling is listed as $500,000. The opportunity was created on 2022-11-09, with an original closing date of 2023-02-12. The activity category is Science and Technology and other Research and Development, consistent with the expectation of producing rigorous evidence and actionable insights rather than delivering direct clinical care.

• The Food and Drug Administration in the 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 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 2022-11-09.
• Applicants must submit their applications by 2023-02-12. (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 $500,000.00 in funding.
• 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, Others.

Apply for RFA FD 23 009

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