Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed
🏛 Food and Drug Administration (HHS-FDA)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for organizations seeking to advance health equity through innovative research and programs. Eligible applicants include nonprofits, academic institutions, health systems, and community-based organizations. The grant supports U01 cooperative agreement awards, which involve FDA collaboration on research projects. Clinical trials are explicitly not allowed under this funding opportunity. Projects must demonstrate clear alignment with FDA's health equity priorities and have capacity for multi-year partnership with the agency.
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Program description
The purpose of this notice of funding opportunity (NOFO) is to fund innovative research that will strengthen and advance minority health and health equity objectives.
Areas of interest include:
Proposals that focus on advancing equity in clinical trials by supporting efforts to advance diversity in clinical trials, equitable data efforts by increasing data available on diverse groups including, but not limited to, ethnicity, race, age, disability and geography, and equity of voices by increasing understanding of diverse patient perspectives, preferences, and unmet needs.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&R) Federal Application Form
- Project Narrative and Specific Aims
- Budget and Budget Justification
- Biosketches of Key Personnel
- Organizational Capability Statement
- Letters of Support/Commitment
- IRB/IACUC Documentation (if applicable)
- Data Management Plan
Program contact
- 👤 Terrin Brown Grantor
- 📧 terrin.brown@fda.hhs.gov
- 📞 2404027610
Funding track record
Recent awards under CFDA 93.103 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$121,795,918
-
$76,105,626
-
$50,217,964
-
$47,940,304
-
$36,000,000
-
$35,573,997
-
$35,391,995
-
$30,732,300
-
$23,332,999
-
$21,347,288
Top States by Funding
- AZ 3 awards $131.4M
- MD 7 awards $108.7M
- CA 9 awards $106.5M
- VA 5 awards $96.6M
- PA 10 awards $77.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.103). How funding has trended year over year.
| 2016 | $170,482,435 | |
| 2017 est. | $208,900,832 | |
| 2018 | $173,077,408 | |
| 2019 | $198,507,896 | |
| 2020 | $212,448,590 | |
| 2021 | $218,918,739 | |
| 2022 est. | $255,910,458 | |
| 2023 est. | $246,894,600 |
FAQ
Who can apply for this Health Equity Innovation Award?
Nonprofits, universities, hospitals, health systems, and community-based organizations with 501(c)(3) status. Smaller organizations and those serving underrepresented populations are encouraged to apply.
Are clinical trials eligible under this grant?
No. Clinical trials are explicitly prohibited. Focus on research, programs, or initiatives that advance health equity outside of clinical trial settings.
What does a U01 cooperative agreement involve?
U01 awards require collaborative partnership with FDA throughout the project period. Expect regular communication, reporting, and alignment with FDA health equity goals.
How competitive is this funding?
Very competitive. Applications must demonstrate innovation, clear equity impact, and strong organizational capacity. Preliminary data or evidence of community need strengthens competitiveness.
What is the typical funding range?
Federal R&D grants typically range from $250,000 to $2 million annually, but verify current NOFO for exact amounts.
💡 Tips for applicants
- Clearly articulate the health equity problem your organization is addressing and why FDA partnership matters to solve it. Avoid vague equity language—be specific about the population and disparity.
- Since clinical trials are excluded, focus on implementation research, health systems improvement, workforce development, or community-based interventions that advance equity.
- Demonstrate existing relationships with FDA or equivalent agency partners; U01s require close collaboration, so show readiness for an active grant partnership.
- Include letters of support from community partners and affected populations, not just institutional partners. Authentic community voice strengthens equity proposals.
- Budget realistically for FDA collaboration costs (meetings, reporting, evaluation). Many applicants underestimate the administrative burden of cooperative agreements.
⚠️ Common mistakes
Submitting clinical trial proposals when explicitly prohibited. Treating equity as a checkbox rather than core project focus. Insufficient detail on FDA partnership expectations and regular engagement points.
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