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 · United States government procurement

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February 08, 2028
Response Due
Active
Status

Opportunity Overview

<p><span style="color: rgb(51, 51, 51);">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.&nbsp;</span></p>

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Solicitation Details

Issuing agencyFood and Drug Administration
CountryUnited States
CategoryOther
NAICS93.103
PublishedJuly 11, 2025
Procurement stageRequest for Proposal (RFP)
Response dueFebruary 08, 2028
StatusOpen — accepting responses
Official sourceView original notice
Last verifiedAugust 10, 2026

Source: U.S. Government (Grants.gov) — public domain. Not affiliated with or endorsed by the United States Government.

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