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
Free. Verify your email, then we send one reminder only.
- Posted
- Dec 17, 2025
- Amount
- $600,000
- Closes
- Feb 8, 2028 (in 527 days)
Similar opportunities open now
- Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)Same funderOpenFood and Drug AdministrationCloses May 2028Up to $900K
- Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)OpenNational Institutes of HealthCloses Jul 2027
- Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)OpenNational Institutes of HealthCloses Jul 2028
- NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)OpenNational Institutes of HealthCloses in 75 daysUp to $350K
- NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)OpenNational Institutes of HealthCloses in 75 days
Classification and identifiers
- Solicitation number
- RFA-FD-25-017
- Assistance listing (CFDA)
- 93.103
Amount
$600,000
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 Hou...
About this opportunity
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.