FDA OMHHE Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed | RFA FD 23 011

Opportunity Information: Apply for RFA FD 23 011

The FDA Office of Minority Health and Health Equity (OMHHE) Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01), RFA-FD-23-011, is a discretionary federal grant program run by the U.S. Department of Health and Human Services through the Food and Drug Administration. It uses a cooperative agreement mechanism (U01), which generally means the FDA expects to have substantial involvement during the project period, such as collaborating on technical direction, milestones, or project management, rather than functioning only as a pass-through funder. The opportunity is explicitly labeled "Clinical Trials Not Allowed," so proposed work must not include prospective human subject intervention studies that meet the definition of a clinical trial; instead, applicants should focus on research, methods, tools, analyses, and engagement approaches that advance equity without conducting clinical trials.

The central purpose of the award is to fund innovative research that strengthens and advances minority health and health equity research, with a practical emphasis on improving how the FDA-regulated ecosystem understands, measures, and incorporates equity. In particular, the FOA highlights three broad priority areas. First is advancing equity in clinical trials by supporting efforts that improve diversity and inclusion in clinical research participation. While applicants cannot run clinical trials under this FOA, they can propose research that addresses barriers to enrollment and retention, tests outreach and recruitment strategies in non-trial contexts, develops toolkits or frameworks for diverse participation, or evaluates policies and practices that influence representativeness in trials. Second is equitable data efforts, with a focus on expanding the availability and quality of data on diverse groups. The announcement specifically calls out demographic and contextual dimensions such as ethnicity, race, age, disability, and geography, signaling interest in approaches that improve data capture, standardization, linkage, analysis, or reporting so that underrepresented populations are more visible in evidence generation and decision-making. Third is equity of voices, which centers on increasing understanding of diverse patient perspectives, preferences, and unmet needs. This can include work that elevates patient input, improves methods for gathering lived experience across different communities, or develops approaches to ensure that patient-centered insights are not limited to historically overrepresented groups.

Funding is capped at an award ceiling of $250,000, and the FDA anticipated making about four awards under this announcement. The CFDA (Assistance Listing) number associated with the program is 93.103. The FOA was created on March 9, 2023, with an original closing date of May 8, 2023, indicating it was a time-limited competition; however, the program’s design and priorities provide a useful blueprint for what the FDA OMHHE considers high-value equity innovation.

Eligibility is broad and includes many types of organizations that could credibly conduct or support health equity research. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those specific nonprofit categories); for-profit organizations other than small businesses; small businesses; and other entities as further clarified in the announcement’s additional eligibility information. This wide eligibility suggests the FDA intended to attract proposals not only from academia, but also from community-rooted organizations, public agencies, and private-sector groups with the capability to develop scalable methods, data solutions, or patient-engagement innovations.

In practical terms, a competitive proposal under this FOA would likely frame a clear equity problem linked to FDA-relevant evidence generation (such as representativeness, subgroup data gaps, or systematic under-capture of certain communities’ experiences), propose an innovative and feasible research approach that does not cross into clinical trial territory, and demonstrate how the outputs could be used by stakeholders to improve equity. Strong projects would typically define the populations of interest, justify why current systems fall short for those groups, describe how the research will produce actionable deliverables (for example, validated measures, analytic approaches, interoperable data elements, guidance-ready frameworks, or tested engagement models), and explain how success will be evaluated in terms of improving equity, not just producing publications.

• The Department of Health and Human Services, Food and Drug Administration in the science and technology and other research and development 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 Mar 09, 2023.
• Applicants must submit their applications by May 08, 2023. (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, Others (see text field entitled Additional Information on Eligibility for clarification).

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