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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.
Funding Opportunity Number: RFA-FD-25-020. Assistance Listing: 93.103. Funding Instrument: G. Category: AG,CP,FN. Award Amount: Up to $900K per award.
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Or search similar grants →According to the current listing, eligibility includes: Eligible applicants: Others (see text field entitled Additional Information on Eligibility for clarification). 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. Confirm the full requirements in the official notice before applying.
The current listing shows up to $900K per award. Verify award ceilings, matching requirements, and allowable costs in the official notice.
Applications for Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) are due May 16, 2028. Build your timeline backwards from this date to cover registrations, approvals, and final submission checks.
Yes — Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) is offered by Food and Drug Administration and this listing comes from Grants.gov, an official U.S. federal source. Federal applications generally require registrations (for example SAM.gov or an agency submission portal), so allow extra lead time.
Start from the official opportunity page linked in this listing — it carries the sponsor's submission instructions.
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