View Grant Opportunity

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

Food and Drug Administration

RFA-FD-25-020

HHS-FDA

General Information

N/a

Est. Program Funding:

May 16, 2028

Closing Date:

N/a

Expected No. of Awards

$900,000

Award Ceiling

Opportunity Number:
RFA-FD-25-020

Owning Agency:
HHS-FDA

Opportunity Category:
Discretionary (D)

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.
Response Date	May 16, 2028 12:00:00 AM EDT
Posting Date	Jul 11, 2025 12:00:00 AM EDT
Archive Date	Jun 15, 2028 12:00:00 AM EDT
Award Ceiling	900,000
Award Floor	N/a
Cost Sharing	No

Eligibility

Eligible Applicants

Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Info on Eligibility:

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.

Additional Information

Agency Name	Stephanie Bogan Grantor
Link to Additional Information:	RFA-FD-25-020 Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Grantor Contact Information:	If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk Phone: 3018276802

CFDA Program(s)

93.103: Food and Drug Administration Research

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