Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
This FDA award (up to $600,000) funds natural history studies that generate high-quality data to support medical product development for rare diseases with unmet needs. Eligibility is very broad, c…
- Deadline
- Feb 8, 2028
- Posted
- Jul 11, 2025
- Award amount
- Up to $600,000
Don’t miss this deadline
We’ll email you before Feb 8, 2028 so you have time to apply.
In plain English
This FDA award (up to $600,000) funds natural history studies that generate high-quality data to support medical product development for rare diseases with unmet needs. Eligibility is very broad, covering universities, nonprofits (with or without 501(c)(3) status), small and other for-profit businesses, tribal and local/state governments, and even foreign organizations and their non-U.S. components. No unusual disqualifiers are noted, and the deadline is not imminent.
AI-generated summary to help you decide quickly — verify the official eligibility rules before applying.
Who can apply
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.
About this grant
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.
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Source: public records via Grants.gov. UseGrants is an independent aggregator, not affiliated with any funding agency. Always confirm details on the official listing before applying.