Data / Federal grants / RFA-FD-25-020
Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Food and Drug Administration (Department of Health and Human Services) is accepting applications until May 16, 2028. It lists awards of up to $900,000.
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Key facts
- Opportunity number
- RFA-FD-25-020
- Status
- Posted, open
- Posted
- July 11, 2025
- Closes
- May 16, 2028
- Award ceiling
- $900,000
- Cost sharing
- Not required
- Funding instrument
- Grant
- Category
- Agriculture, Consumer Protection, Food and Nutrition
- Assistance listing
- 93.103 Food and Drug Administration Research
- Contact
- Stephanie Bogan Grantor · [email protected] · 3018276802
Who can apply
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationNonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)For-Profit OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)Local GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)Federal Governments U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations)Foreign OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Org
What the agency says
The purpose of this Notice of Funding Opportunity (NOFO) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.
Other open grants from the Department of Health and Human Services
| Opportunity | Status | Closes | Award ceiling | Total funding | Record |
|---|---|---|---|---|---|
| Long-term health outcomes of people living with spina bifida CDC-RFA-DD-26-0222 | Open | Oct 26 | $300,000 | $3,000,000 | grants.gov |
| GREGoRi Data Coordination and Outreach Center (U01, Clinical Trials Not Allowed) RFA-HG-27-011 | Open | Oct 30 | $1,250,000 | $2,000,000 | grants.gov |
| GREGoRi Innovation Projects (U01 Clinical Trial Optional) RFA-HG-27-013 | Open | Oct 30 | $500,000 | $7,500,000 | grants.gov |
| GREGoRi Technology Integration Center (U01, Clinical Trials Optional) RFA-HG-27-012 | Open | Oct 30 | $2,250,000 | $3,000,000 | grants.gov |
| HEAL Initiative: Whole Joint Health Program (R61/R33 Clinical Trial Required) PAR-27-045 | Open | Oct 30 | grants.gov | ||
| Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed) PAR-24-280 | Open | Nov 2 | grants.gov |
· Everything closing in May 2028
Read from the Grants.gov API, last updated 2026-10-23. The agency's notice on Grants.gov is the official record; check it before you apply.