Open RFA-FD-25-017 CFDA 93.103 Discretionary

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

Posted by Food and Drug Administration

Opportunity snapshot. This Grants.gov announcement — Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) — is cataloged under number RFA-FD-25-017 and tied to CFDA assistance listing 93.103, posted by Food and Drug Administration. Grants.gov currently shows the opportunity as open, first posted on July 11, 2025. The funding category is Discretionary, delivered as a grant.

Award economics. The award range on file is Up to $600,000. Cost sharing is not required, so applicants do not need to commit matching funds to be competitive on this opportunity. Federal award ranges are often upper bounds; actual allocations reflect program appropriations, the strength of the applicant pool, and the evaluation committee's scoring.

Deadline and action path. Applications close on February 8, 2028 — roughly 613 days from today. Every Grants.gov submission requires an active SAM.gov registration and a Unique Entity ID. Review the Eligibility section below carefully — federal eligibility categories (nonprofit, state or local government, tribal, individual, educational institution, small business) have distinct registration and reporting requirements. Pre-application outreach to the listed agency contact is permitted and often welcomed — it helps clarify scope and scoring priorities.

Award Range

Up to $600,000

Close Date

February 8, 2028

Posted

July 11, 2025

Instrument

Grant

Description

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.

Eligibility

25

Official Listing on Grants.gov

View full details, application forms, and submission instructions.

View on Grants.gov

Agency Contact

Kimberly Pendleton <br/>Chief Grants Management Officer

Key Dates

Posted July 11, 2025
Close Date February 8, 2028
Archive Date March 9, 2028
Last Updated July 11, 2025

Frequently Asked Questions

What is this grant opportunity?
This is a federal funding opportunity titled "Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)", offered by Food and Drug Administration. It is associated with CFDA program 93.103. 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 ...
Is this opportunity still open?
Yes, this opportunity is currently open for applications. The closing date is February 8, 2028.
How much funding is available?
The award range for this opportunity is Up to $600,000.
How do I apply?
Applications for federal grant opportunities are typically submitted through Grants.gov. Visit the official listing at grants.gov for application instructions, required documents, and submission deadlines.

Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.

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