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Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)

Open. Closes February 8, 2028, 474 days from October 22, 2026, as posted on Grants.gov. Posted by Food and Drug Administration, opportunity number RFA-FD-25-017.

February 8Closes, 474 days left
Up to $600,000Award range, as stated
Not requiredCost sharing, per the notice

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Notice facts

AgencyFood and Drug Administration
Opportunity numberRFA-FD-25-017
Assistance listing93.103
Funding instrumentGrant
CategoryAgriculture, Consumer Protection, Food and Nutrition
PostedJuly 11, 2025
ClosesFebruary 8, 2028
Award rangeUp to $600,000
Expected number of awardsNot stated
Total program fundingNot stated
Cost sharing or matchingNot required, per the notice
Applicant types listedOthers (see the notice's eligibility text)
Additional eligibility informationFrom 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…
Where to applyCheck the notice for where and how to submit.

As posted on Grants.gov, checked October 21, 2026. CedarGrant lists what the notice states; it does not judge whether an organization is eligible. The official notice and its modifications control.

Summary from the notice

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.

Official notice and documents

Open the official noticeGrants.gov page

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