Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Federal funding opportunity RFA-FD-25-020 from Food and Drug Administration (Department of Health and Human Services).
Apply on Grants.gov →Application closes May 16, 2028
- Posted
- July 11, 2025
- Closes
- May 16, 2028
- Award ceiling
- $900,000
- Cost sharing
- No
- Instrument
- Grant
- Assistance listing
- 93.103
- Category
- Agriculture, Consumer Protection, Food and Nutrition
- Archives
- June 15, 2028
Program funding history
Awards made under Assistance Listing 93.103 across FY2024–FY2026, from public federal spending records.
- FY2024 obligated
- $250.8M
- FY2025 obligated
- $213M
- FY2026 (to date) obligated
- $15M
- Awards in window
- 911
Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, The Medical Device Innovation Consortium, Duke University
Source: USAspending.gov · refreshed July 2026
Synopsis
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.
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. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
How to apply
Applications go through the official government listing. Grants Radar links you straight to the source.
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