Open · RFA-FD-25-020 · CFDA 93.103 · Discretionary
Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- up to $900K
- Award range
- Open
- Status
- 658d
- Days left
- -
- Expected awards
The verdict
Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) is an open discretionary opportunity from Food and Drug Administration, offering Up to $900,000. Applications close in 658 days.
- up to $900K
- award range
- Open
- 658 days left
- 93.103
- CFDA program
Opportunity snapshot. This Grants.gov announcement - Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) - is cataloged under number RFA-FD-25-020 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 $900,000. 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 May 16, 2028 - roughly 658 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. Before acting on the deadline or award figures above, verify them directly on the official Grants.gov listing, amendments can change dates and amounts after this page was last refreshed.
Award Range
Up to $900,000
Close Date
May 16, 2028
Posted
July 11, 2025
Instrument
Grant
Description
The purpose of this Notice of Funding Opportunity (NOFO) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.
Eligibility
Grants.gov lists this opportunity under eligibility category code 25. These codes correspond to applicant types (state/local government, tribal organization, nonprofit, educational institution, individual, small business, etc.) defined in Grants.gov's own eligibility reference. See the current Grants.gov eligibility categories or check the official listing below for this opportunity's exact eligibility statement.
Official Listing on Grants.gov
View full details, application forms, and submission instructions.
Parent Grant Program
Food and Drug Administration Research
U.S. Department of Health and Human Services
Agency Contact
Kimberly Pendleton Chief Grants Management Officer
Key Dates
Frequently Asked Questions
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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.
Read our methodology - how this data is sourced, computed, and verified.
Related
| Publisher | PlainGrants |
| Sources | the SAM.gov Assistance Listings and Grants.gov |