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
- 613d
- 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 613 days. PlainGrants indexes 481 other opportunities from Food and Drug Administration.
- up to $900K
- award range
- Open
- 613 days left
- 93.103
- CFDA program
- 481
- other opportunities from Food and Drug Administration
Open desk with published close date
Reissue of RFA-FD-23-001- Clinical Studies of… remains open until May 16, 2028 (613 days out). Award range Up to $900,000 without a cost-share requirement. Parent CFDA 93.103 may carry future cycles if this NOFO closes unfunded.
According to Grants.gov (extract vintage 2026-08-10), this record reflects the officially published listing. See methodology.
Deadline tracker
613 days left to apply
Posted Jul 11 → closes May 16, 2028
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.
Catch-all / unrestricted eligibility mark · RFA-FD-25-020
Grants.gov marks Reissue of RFA-FD-23-001- Clinical Studies of… with a catch-all / unrestricted eligibility code (Others (see official listing text)). Read the official announcement text for the real applicant filter — the code alone is not a door list. The extract does not mark applicant cost-sharing as required. Instrument: Grant. Funding-activity codes span Agriculture · Consumer Protection · Food and Nutrition (AG;CP;FN). 119 other Food and Drug Administration listings share this eligibility-code string (25% of 482).
- Code 25
- Others (see official listing text)
Codes are Grants.gov eligibility category values from the extract vintage 2026-08-10. Confirm the full eligibility statement on the official listing or the Grants.gov eligibility reference.
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
Patrick Johnson Grants Management Specialist
More from Food and Drug Administration
Federal and University Partnership to Improve the Safety of Seafood from the Gulf of America
Research, Education, and Outreach on Botanical Natural Products
Cooperative Agreement to Support Shellfish Safety Assistance Project
Education and Outreach to Tribal Producers through the Tribal Food Safety Alliance
Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional
What to do next
Reissue of RFA-FD-23-001- Clinical Studies of… is open with Up to $900,000 awards and 613 days left on the clock.
- Submit through Grants.gov (RFA-FD-25-020) - verify SAM.gov registration and the current NOFO before drafting. Official listing
- Food and Drug Administration Research indexes 42 Grants.gov listings in this extract. Program profile
- Food and Drug Administration lists 481 other indexed opportunities on PlainGrants. Agency catalog
Opportunity deadlines and eligibility change on Grants.gov; PlainGrants mirrors the extract and is not the submission system.
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.
| Publisher | PlainGrants |
| Sources | the SAM.gov Assistance Listings and Grants.gov |