Submission Deadline 02/08/2028
Fiscal Capacity $50,135,013
HHS-FDA Grant — Key Facts
Opportunity Number RFA-FD-25-017
Agency HHS-FDA
Application Deadline 02/08/2028
Award Amount $50,135,013
Status Posted
Sector Health
Cost Sharing Not Required

Fiscal Parameters & Taxonomy

Authority HHS-FDA
Status Posted

Who Can Apply

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

Eligibility Intelligence

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.

Program Description

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.

CFDA Programs

93.103 Food and Drug Administration Research

Agency Contact

Kimberly Pendleton Chief Grants Management Officer

✉ Kimberly.Pendleton@fda.hhs.gov

📞 3018276802

Related Intelligence Guides

In-depth editorial guides covering this agency's programs, eligibility requirements, and application strategies.

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