The purpose of this notice of funding opportunity (NOFO) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development.
Open for applications
Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
Food and Drug Administration · Opportunity number RFA-FD-25-017
View the official notice on Grants.gov
480 days left
(deadline Feb 8, 2028)
Details summarized from the official notice as of Oct 16, 2026. Always confirm eligibility, deadlines and requirements in the official notice before applying.
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Key facts
| Opportunity number | RFA-FD-25-017 |
|---|---|
| Agency | Food and Drug Administration Department of Health and Human Services |
| Assistance listing (ALN, formerly CFDA) | 93.103 |
| Posted | Jul 11, 2025 |
| Deadline | Feb 8, 2028 |
| Award ceiling | $600,000 |
| Cost sharing or matching required | No |
| Funding type | Grant |
| Category | Agriculture |
| Last updated here | Oct 16, 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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