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Food and Drug Administration · United States

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

Full title in the source: Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

Open

Food and Drug Administration expects to make awards of up to $900,000 each. Applications close on 16 May 2028. Eligible applicant types include others (see text field entitled "Additional Information on Eligibility" for clarification).

About this call

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.

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.

Applicant categories are a starting point. The official call decides eligibility.

Topics

Agriculture Consumer Protection Food and Nutrition

How to apply

1. Read the full notice of funding opportunity (NOFO) linked from the official page: eligibility, cost sharing and evaluation criteria.
2. Make sure your organisation has an active SAM.gov registration and Unique Entity ID (UEI); registration can take several weeks.
3. Register with Grants.gov and set up a Workspace for this opportunity, with the right roles for your organisation.
4. Prepare the required forms, narrative, budget and attachments exactly as the NOFO specifies.
5. Submit before the deadline and keep the tracking number. Check for amendments before you submit.

From the call text

Who can apply

Not stated in the call text we hold — check the official page

Company stage

Not stated in the call text we hold — check the official page

Single applicant or consortium

Not stated in the call text we hold — check the official page

Where applicants must be based

Not stated in the call text we hold — check the official page

Where to apply

Not stated in the call text we hold — check the official page

Contact

Stephanie Bogan · Patrick.Johnson@fda.hhs.gov · 3018276802

Where these facts come from

Official sources

Official call page

Facts on this page come from the funder’s official data, taken on 13 Nov 2026. The funder's own documents, including later amendments, always take precedence.

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