OpenFederal grantOpen to for-profit businessesRFA-FD-25-020

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

Food and Drug AdministrationCloses May 16, 2028(581 days left)Up to $900,000

Does this fit your business?

This FDA program funds clinical trials testing whether orphan products work for rare diseases, either for a new indication or a labeling change. It is for organizations that can actually run a clinical trial — universities, nonprofits, for-profits including small businesses, governments, tribes, and even foreign entities. If you are not running clinical research on a rare disease treatment, do not apply; nothing in this notice supports general business costs, product development outside trials,或

Best for
Biotech and pharma companies running clinical trials of orphan products, Universities and academic medical centers with rare disease trial programs, Nonprofits and hospitals sponsoring clinical research, Contract research organizations and small businesses developing rare disease therapies
Not for
Businesses outside clinical research, such as retail, construction, or finance firms, Organizations without the capacity to run a clinical trial, Applicants seeking general operating or product commercialization funding
Estimated fit by industry, best first
IndustryEstimated fit
Healthcare & BiotechMatches your industry (clinical)
66
Good Match
Environment & ConservationLimit: Primarily for minority-owned businesses
54
Possible Match
Education & TrainingLimit: Primarily for minority-owned businesses
53
Possible Match
Technology & SoftwareLimit: Primarily for minority-owned businesses
51
Possible Match
Energy & Clean TechLimit: Primarily for minority-owned businesses
50
Possible Match
Social Services & NonprofitLimit: Primarily for minority-owned businesses
50
Possible Match
Show all 15 industries
Estimated fit by industry, best first
IndustryEstimated fit
Arts & CultureLimit: Primarily for minority-owned businesses
47
Possible Match
Food & BeverageLimit: Primarily for minority-owned businesses
47
Possible Match
Agriculture & FarmingLimit: Primarily for minority-owned businesses
45
Possible Match
ManufacturingLimit: Primarily for minority-owned businesses
44
Possible Match
Housing & Real EstateLimit: Primarily for minority-owned businesses
43
Possible Match
Finance & BankingLimit: Primarily for minority-owned businesses
42
Possible Match
Retail & E-CommerceLimit: Primarily for minority-owned businesses
42
Possible Match
Transportation & LogisticsLimit: Primarily for minority-owned businesses
42
Possible Match
Construction & InfrastructureLimit: Primarily for minority-owned businesses
36
Possible Match

These are our matcher’s estimates for a typical business in each industry. A real match depends on your size, your state and what you need the money for — check your own fit.

What this funds

Money can be used for
Research, Clinical trials, R&D
Who can apply
Small businesses, For-profit companies, Nonprofits, State and local governments, Tribal governments and organizations, Colleges and universities, Other applicants (see eligibility)
Award range
Up to $900,000

Questions about this grant

When is the application deadline?
May 16, 2028.
How much funding can an applicant receive?
Awards range up to $900,000. The smallest listed award is $0, so the notice does not publish a meaningful minimum.
Who can apply for this grant?
Higher education institutions, nonprofits (with or without 501(c)(3) status), for-profit organizations including small businesses, state, local, county, city, and tribal governments, federal entities, independent school districts, public housing authorities, faith-based and community-based organizations, regional organizations, and foreign organizations. Non-U.S. components of U.S. organizations and foreign components are also allowed.
Can a sole proprietor or single-member LLC apply?
The notice does not say. It lists for-profit organizations and small businesses as eligible, but does not specifically address sole proprietors or single-member LLCs, so you would need to check with the FDA or the full NOFO.
Can a nonprofit apply?
Yes. Nonprofits other than institutions of higher education are eligible, both those with 501(c)(3) IRS status and those without.

Summary

FDA funds clinical trials evaluating efficacy/safety of orphan products for new indications or labeling changes for rare diseases. Open to universities, nonprofits, for-profits including small businesses, governments, tribes, and even foreign organizations. Awards up to $900,000; no cost share.

About this grant

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

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.

Topics and uses of funds

Topics

  • Health
  • Science
  • Rare diseases
  • Clinical trials
  • Pharmaceuticals

Program contact

Stephanie Bogan GrantorPatrick.Johnson@fda.hhs.gov3018276802

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