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

Source: https://welltoldgrants.com/grants/rfa-fd-25-017-reissue-of-rfa-fd-22-001-efficient-and/  
Official notice: https://www.grants.gov/search-results-detail/360007

> Food and Drug Administration is offering grants of up to $600,000 to the applicants described in the notice. Applications close on February 8, 2028.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-25-017 |
| Agency | Food and Drug Administration |
| Status | Open |
| Deadline | February 8, 2028 |
| Award ceiling | $600,000 |
| Award floor | not stated |
| Expected awards | not stated |
| Total funding | not stated |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

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

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.

## What the 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.

## Questions people ask

### Who can apply for 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 accepts applications from the applicants described in the notice. The notice adds further conditions, so read its eligibility section.

### What is the deadline for Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)?

Closes February 8, 2028 (465 days left). Confirm the date and time in the official notice on Grants.gov.

### How much funding is available?

Awards of up to $600,000 each.