Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed

US Food and Drug Administration (HHS-FDA) grant unknown #FOR-FD-25-011

Summary

This is a forecasted federal funding opportunity (U01 cooperative agreement) issued by the FDA under HHS. It is focused on health equity innovation, specifically aimed at enhancing equity in health-related research or programs. Clinical trials are explicitly not allowed under this funding mechanism. The opportunity was forecasted as of August 2024 and full details are pending formal publication.

What they want

This funding opportunity (number FOR-FD-25-011) is a U01 cooperative agreement mechanism administered by the FDA. It targets health equity innovation with an explicit prohibition on clinical trials. The opportunity is in forecasted/pre-solicitation status as of its open date of August 14, 2024. Full scope, eligibility requirements, award amounts, and application instructions are to be provided upon formal publication of the Notice of Funding Opportunity (NOFO).

Technical requirements

Clinical trials are not allowed under this funding mechanism
U01 cooperative agreement mechanism required
Must align with health equity and innovation objectives

How they evaluate

Submission: Grants.gov federal grants portal (grants.gov)

Risks & flags

Opportunity is in 'forecasted' status — full solicitation details, eligibility, and evaluation criteria have not yet been published
Scope of work is extremely limited in detail, making competitive preparation difficult at this stage

Market context

inferred from NAICS

Professional, Scientific & Technical Services

NAICS 541714

US market size: $2.0T
Typical award: $25K – $50M

Typical buyers

All federal civilianDoDStates

Commonly required

8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Health Care & Social Assistance

NAICS 621999

US market size: $2.7T
Typical award: $50K – $100M

Typical buyers

VAHHSDoD MHSIHS

Commonly required

Joint CommissionCMS

Sector-level estimate — full code lookup not yet in catalog.

Health Equity Innovation Award: Enhance Eq…

$unknown

Onboard ↗