Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
Apply on Grants.gov →Application closes February 8, 2028
- Posted
- July 11, 2025
- Closes
- February 8, 2028
- Award ceiling
- $600,000
- Cost sharing
- No
- Instrument
- Grant
- Assistance listing
- 93.103
- Category
- Agriculture, Consumer Protection, Food and Nutrition
- Archives
- March 9, 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
- $65.5M
- Awards in window
- 920
Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, The Medical Device Innovation Consortium, Food & Agriculture, California Department of
Source: USAspending.gov · refreshed August 2026
Synopsis
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.
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 — applying is free.
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