Grants / Department of Health and Human Services / Food and Drug Administration

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

Closed Closed October 30, 2024 Opportunity RFA-FD-23-001 ☆ Save

This grant is closed. A newer notice from the same program is forecast: Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) (FOR-FD-25-020). Status: Forecast, no dates yet. It is in our archive of Food and Drug Administration notices from 2022.

• Award ceiling$650,000
• Award floor$200,000
• Expected awards20
• Cost sharingNot required
• Funding typeGrant

Key dates

Who can apply

This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.

Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits 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)GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)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 Institutions)Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses.

Is this a realistic fit?

• Past Food and Drug Administration Research awards averaged $1.3 million; this notice allows up to $650,000 per award.
• Most of the program's money (35% over five years) went to nonprofits.
• No cost sharing or match is required.

What the grant funds

The purpose of this funding opportunity announcement (FOA) 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.

Category: Consumer Protection, Science and Technology and other Research and Development.

Applying now

This notice no longer takes applications. Apply under the newer notice, FOR-FD-25-020, which is forecast.

The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.