GrantPostedDiscretionary

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
Application Deadline
Feb 8, 2028
593 days left
Days Remaining
593
Until deadline
Award Ceiling
$600,000
Total Program Funding

Grant Opportunity Analysis

The Food and Drug Administration (FDA) is offering a funding opportunity titled "Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)." This initiative aims to support innovative natural history studies that generate high-quality data to advance medical product development for rare diseases with significant unmet needs. The funding is crucial for addressing knowledge gaps and facilitating the development of treatments in this area. Eligible applicants include a wide range of organizations such as higher education institutions, nonprofits, and government entities, with grant amounts reaching up to $600,000. The application deadline is February 8, 2028, and interested parties can contact Kimberly Pendleton at Kimberly.Pendleton@fda.hhs.gov for further information.

Eligible Applicants

Others
Additional Eligibility Information

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.

Grant Documents

1 File

Related Grant Opportunities

Project Timeline

postedOriginal Opportunity PostedJul 11, 2025
deadlineApplication DeadlineFeb 8, 2028
expiryArchive DateMar 9, 2028

Funding Details

Award Ceiling
$600,000
No cost sharing required

Agency & Classification

Agency
Food and Drug Administration(HHS-FDA)
Funding Category
Food and Nutrition
Funding Instrument
Grant

Grantor Contact

CFDA Numbers

93.103

Official Sources