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

FAQs: FDA OMHHE Health Equity Innovation Award (U01) - Enhance Equity (RFA-FD-23-011)

What is this grant opportunity?

This opportunity is the FDA Office of Minority Health and Health Equity (OMHHE) Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01), RFA-FD-23-011. It is a discretionary federal grant program administered by the U.S. Department of Health and Human Services (HHS) through the Food and Drug Administration (FDA).

What is the main goal of the program?

The central purpose 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. The focus is on generating approaches, methods, tools, analyses, and engagement strategies that can improve equity-relevant evidence generation and decision-making.

What funding mechanism is used (and what does it imply)?

The award uses a cooperative agreement mechanism (U01). This 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 serving only as a pass-through funder.

Are clinical trials allowed under this FOA?

No. The opportunity is explicitly labeled "Clinical Trials Not Allowed." Proposed work must not include prospective human subject intervention studies that meet the definition of a clinical trial.

If clinical trials are not allowed, what types of work can be proposed?

Applicants should focus on research and practical innovation that advance equity without conducting clinical trials. Examples described in the opportunity include developing or evaluating methods, tools, analyses, frameworks, and engagement approaches that address barriers to representativeness and equity in FDA-relevant evidence generation.

What are the priority areas highlighted in the announcement?

The FOA highlights three broad priority areas:

• Advancing equity in clinical trials (without running a clinical trial under this award)
• Equitable data efforts (improving the availability and quality of data on diverse groups)
• Equity of voices (increasing understanding of diverse patient perspectives, preferences, and unmet needs)

What does "advancing equity in clinical trials" mean if trials cannot be conducted?

It refers to work that improves diversity and inclusion in clinical research participation through non-trial activities. Based on the FOA description, this can include researching barriers to enrollment and retention, testing outreach and recruitment strategies in non-trial contexts, developing toolkits or frameworks for diverse participation, and evaluating policies and practices that influence representativeness in trials.

What does the FOA mean by "equitable data efforts"?

"Equitable data efforts" focuses on expanding the availability and quality of data on diverse groups so underrepresented populations are more visible in evidence generation and decision-making. The FOA signals interest in approaches that improve data capture, standardization, linkage, analysis, or reporting across demographic and contextual dimensions.

Which demographic and contextual dimensions are specifically called out?

The announcement specifically calls out ethnicity, race, age, disability, and geography as dimensions of interest for improving data availability and quality.

What does "equity of voices" focus on?

"Equity of voices" centers on increasing understanding of diverse patient perspectives, preferences, and unmet needs. It includes work that elevates patient input, improves methods for gathering lived experience across different communities, and develops approaches to ensure patient-centered insights are not limited to historically overrepresented groups.

How much funding is available per award?

Funding is capped at an award ceiling of $250,000.

How many awards did the FDA anticipate making?

The FDA anticipated making about four awards under this announcement.

What is the Assistance Listing (CFDA) number for this program?

The CFDA (Assistance Listing) number associated with the program is 93.103.

When was the FOA created and when did it close?

The FOA was created on March 9, 2023, and had an original closing date of May 8, 2023, indicating it was a time-limited competition.

Who is eligible to apply?

Eligibility is broad. 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
• Private institutions of higher education
• Federally recognized Native American tribal governments
• Other Native American tribal organizations
• Public housing authorities and Indian housing authorities
• Nonprofits with 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as stated)
• Nonprofits without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as stated)
• For-profit organizations other than small businesses
• Small businesses
• Other entities as further clarified in the announcement's additional eligibility information

Does the FOA appear limited to academic institutions?

No. The wide eligibility indicates the FDA intended to attract proposals not only from academia, but also from community-rooted organizations, public agencies, and private-sector groups that can develop scalable methods, data solutions, or patient-engagement innovations.

What kinds of project outputs would likely be considered strong under this FOA?

Based on the opportunity description, strong projects would emphasize actionable deliverables that can be used to improve equity, such as validated measures, analytic approaches, interoperable data elements, guidance-ready frameworks, or tested engagement models. The FOA framing suggests a preference for outputs that are usable by stakeholders, not solely publications.

What should a competitive proposal include, based on the FOA description?

A competitive proposal would likely:

• Frame a clear equity problem linked to FDA-relevant evidence generation (for example, 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
• Define the populations of interest and explain why current systems fall short for those groups
• Describe actionable deliverables and how they can be used to improve equity
• Explain how success will be evaluated in terms of improving equity, not only producing research outputs

What does "FDA-relevant evidence generation" imply in this context?

In the context provided, it refers to how the FDA-regulated ecosystem generates and uses evidence, including whether clinical research participation is representative, whether subgroup data are available and high quality, and whether patient perspectives from diverse communities are captured and incorporated into decision-making.

Can applicants propose research on barriers to enrollment and retention in clinical trials?

Yes, the FOA explicitly highlights research that addresses barriers to enrollment and retention as an example of work that can advance equity in clinical trials, as long as the proposed work itself does not conduct a clinical trial under this award.

Can applicants propose outreach and recruitment strategy testing?

Yes. The FOA indicates applicants may test outreach and recruitment strategies in non-trial contexts, consistent with the "Clinical Trials Not Allowed" restriction.

Can applicants propose policy and practice evaluations related to trial representativeness?

Yes. The FOA mentions evaluating policies and practices that influence representativeness in trials as an example of relevant work, provided it does not involve conducting a clinical trial.

What does it mean that this is a "discretionary" federal grant program?

It means the program is a discretionary federal grant opportunity (as opposed to a mandatory funding stream), and awards are made through a competitive process under the terms of the announcement.

What is the practical takeaway if this specific FOA was time-limited?

The FOA was created in March 2023 and originally closed in May 2023, but its design and priorities provide a clear blueprint for what FDA OMHHE considers high-value equity innovation, including the types of problems, methods, and deliverables the program sought to support.