agriculture · consumer_protection · food_and_nutrition · HHS-FDA

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

Food and Drug Administration · RFA-FD-25-020

629 days left

Award Range

$0 – $900K

Deadline

May 16, 2028

GRANTQUICK SUMMARYPlain-English Overview

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required). Food and Drug Administration. The purpose of this Notice of Funding Opportunity (NOFO) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally,... up to $900,000 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: 2028-05-16

💡 GrantQuick Tip

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 fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

Attachments

PDF

Notice of Funding Opportunity - Revised

Foa_Content_of_RFA-FD-25-020.pdf

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: $900K
Cost Sharing Required?: No
Funding Instrument: grant

Key Dates

Posted: July 11, 2025

Application Deadline: May 16, 2028 (629 days remaining)

Agency Contact

Patrick Johnson Grants Management Specialist

Patrick.Johnson@fda.hhs.gov

Ready to apply?

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

View on Grants.gov