ACCEPTING APPLICATIONS · GRANT
Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
- Deadline
- May 16, 2028 (570 days left)
- Who can apply
- Others
- Award range
- $0 to $900,000
- Expected awards
- Not stated
- Total program funding
- Not stated
- Your own money required
- No cost sharing or matching required
- Opportunity number
- RFA-FD-25-020
- Posted
- Jul 11, 2025
- Assistance listing
- 93.103
More on who can apply
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 GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal
What it funds
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.
Open the official notice on Grants.gov ↗What to do next
- Open the official notice on Grants.gov and download the full announcement (the NOFO) and any attachments.
- Check you can apply: the eligible applicants above, and any detail in the notice's eligibility section.
- Register your organization in SAM.gov (choose "all awards") and create a Grants.gov account; allow several weeks the first time.
- Apply through Grants.gov exactly as the notice says, before May 16, 2028. Late applications are usually not accepted.
New to this? Applying for a federal grant, step by step · Register to apply · How to read the notice · Write the narrative · Build the budget · Agency contact: Patrick.Johnson@fda.hhs.gov
From Grants.gov's official daily extract of Oct 25, 2026. The notice on Grants.gov and its attachments are what count. UX Contract is independent and not a government website.