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.
Open for applications
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 · Opportunity number RFA-FD-25-020
View the official notice on Grants.gov
578 days left
(deadline May 16, 2028)
Details summarized from the official notice as of Oct 15, 2026. Always confirm eligibility, deadlines and requirements in the official notice before applying.
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Key facts
| Opportunity number | RFA-FD-25-020 |
|---|---|
| Agency | Food and Drug Administration Department of Health and Human Services |
| Assistance listing (ALN, formerly CFDA) | 93.103 |
| Posted | Jul 11, 2025 |
| Deadline | May 16, 2028 |
| Award ceiling | $900,000 |
| Cost sharing or matching required | No |
| Funding type | Grant |
| Category | Agriculture |
| Last updated here | Oct 15, 2026 |
Summary from the notice
Who can apply
The official notice lists these applicant types as eligible:
- Others named in the notice (see the eligibility text)
Not listed as eligible
- Small businesses
- Nonprofits
- Colleges and universities
- State governments
- Local governments
- Tribal governments and organizations
- Larger for-profit companies
- Individuals
Unless the eligibility text in the notice names you, this opportunity is probably not for you.
Eligibility details from the notice
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.
Registrations you will likely need
Most applications submitted through Grants.gov need the following. Registration can take several weeks, so start early. The notice lists the exact requirements.
- SAM.gov registration for your organization, which also gives you a Unique Entity ID (UEI). Registration is free.
- A Login.gov account, which Grants.gov uses for sign-in.
- A Grants.gov applicant registration linked to your organization's UEI.
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