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agriculture · consumer_protection · food_and_nutrition · HHS-FDA

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

540 days left

Award Range

$0$600K

Deadline

February 8, 2028

GRANTQUICK SUMMARYPlain-English Overview

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. 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... up to $600,000 per award.

Who Should Apply

Other eligible entities

Who Should NOT Apply

Individuals and organizations outside the specified eligible types

Key Requirements (Plain English)

  • Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher Education...
  • Deadline: 2028-02-08

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Focus your proposal on clear outcomes, alignment with agency priorities, and demonstrate organizational capacity.

Competitiveness: Moderate to high — federal grants are always competitive

What This Grant Funds

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. 

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.

Eligible Applicant Types

Other (see NOFO for details)

Funding Details

Maximum Award
$600K
Cost Sharing Required?
No
Funding Instrument
grant

Key Dates

Posted: July 11, 2025
Application Deadline: February 8, 2028 (540 days remaining)

Agency Contact

Kimberly Pendleton Chief Grants Management Officer

Kimberly.Pendleton@fda.hhs.gov

Ready to apply?

View the full NOFO and submit your application on Grants.gov