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

Key facts

Copied from the official Grants.gov record. Last verified October 29, 2026.

Program name

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

Issuing agency

Food and Drug Administration (Department of Health and Human Services)

Opportunity number

RFA-FD-25-020

Funding type

Grant

Funding purpose

Agriculture, Consumer Protection, Food and Nutrition

Status

Open (posted)

Application deadline

Closes May 16, 2028

Published award range

Up to $900,000

Cost sharing or match required

No

Eligible applicants (official categories)

• Others (see Additional Information on Eligibility)

Relevant to

Businesses and NonprofitsHow we determined this: Listed as 'Others'; the agency's eligibility text mentions businesses (flagged for review). Listed as 'Others'; the agency's eligibility text mentions nonprofits (flagged for review).

Geographic restrictions

None stated in structured data (federal opportunities are often nationwide). Check the eligibility details and full announcement for any limits.

Assistance Listing (CFDA)

93.103

Official source

View on Grants.gov ↗

Application URL

www.grants.gov/search-results-detail/360008 ↗Apply through Grants.gov (Workspace) using the application package on the official listing, unless the full announcement names a different submission system.

Source identifier

Grants.gov opportunity ID 360008 · Funding opportunity number RFA-FD-25-020

Posted

July 11, 2025 · Source last updated April 13, 2026

Last verified

October 29, 2026 (against Grants.gov)

Data completeness

100% of key fields published by the source

Record confidence

loweligibility described only in free text (in review).

Eligibility details (from the agency)

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.

Description (from the official listing)

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.

Agency contact

Patrick Johnson Grants Management Specialist
Patrick.Johnson@fda.hhs.gov