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Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

Apply on Grants.gov →Application closes May 16, 2028

Posted
July 11, 2025
Closes
May 16, 2028
Award ceiling
$900,000
Cost sharing
No
Instrument
Grant
Assistance listing
93.103
Category
Agriculture, Consumer Protection, Food and Nutrition
Archives
June 15, 2028

Program funding history

Awards made under Assistance Listing 93.103 across FY2025–FY2027, from public federal spending records.

FY2025 obligated
$213M
FY2026 obligated
$215.3M
FY2027 (to date) obligated
$0
Awards in window
849

Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, Yale Univ, Food & Agriculture, California Department of

Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →

Synopsis

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.

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 Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)Federal Governments U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations)Foreign OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

How to apply

Applications go through the official government listing. Grants Radar links you straight to the source — applying is free.

View on Grants.gov

Agency contact: Stephanie Bogan Grantor · [email protected] · 3018276802

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