View Grant Opportunity

Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)

Food and Drug Administration

RFA-FD-25-017

HHS-FDA

General Information

N/a

Est. Program Funding:

February 8, 2028

Closing Date:

N/a

Expected No. of Awards

$600,000

Award Ceiling

Opportunity Number:
RFA-FD-25-017

Owning Agency:
HHS-FDA

Opportunity Category:
Discretionary (D)

Synopsis

The purpose of this notice of funding opportunity (NOFO) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development.
Response Date	Feb 08, 2028 12:00:00 AM EST
Posting Date	Jul 11, 2025 12:00:00 AM EDT
Archive Date	Mar 09, 2028 12:00:00 AM EST
Award Ceiling	600,000
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-25-017 Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
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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