OpenFederal grantOpen to for-profit businessesRFA-FD-25-017

Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)

Food and Drug AdministrationCloses Feb 8, 2028(483 days left)Up to $600,000

Does this fit your business?

This is an FDA research grant for natural history studies of rare diseases with unmet needs, meant to fill knowledge gaps and support medical product development. It fits healthcare and biotech organizations that can run a research study; our engine scores it 89/100 for Healthcare & Biotech and only 54/100 for technology, education, retail, finance, and housing. If your business is not in medical research, do not bother applying.

Best for
Biotech and life-science companies running rare-disease natural history studies, Universities and academic medical centers with rare-disease research programs, Nonprofits and patient foundations focused on a specific rare disease, Research teams studying medical product development for rare conditions
Not for
Retail, e-commerce, finance, housing, or other businesses outside healthcare and biotech, Companies looking for general business funding rather than research support, Organizations without the capacity to run a clinical-grade research study
Estimated fit by industry, best first
IndustryEstimated fit
Healthcare & BiotechMatches your industry (medical, clinical)
89
Strong Match
Agriculture & FarmingLimit: Nothing in this notice points to agriculture & farming
54
Possible Match
Arts & CultureLimit: Nothing in this notice points to arts & culture
54
Possible Match
Construction & InfrastructureLimit: Not clearly about your industry or what you need funding for; check the…
54
Possible Match
Education & TrainingLimit: Nothing in this notice points to education & training
54
Possible Match
Energy & Clean TechLimit: Nothing in this notice points to energy & clean tech
54
Possible Match
Show all 15 industries
Estimated fit by industry, best first
IndustryEstimated fit
Environment & ConservationLimit: Nothing in this notice points to environment & conservation
54
Possible Match
Finance & BankingLimit: Nothing in this notice points to finance & banking
54
Possible Match
Food & BeverageLimit: Nothing in this notice points to food & beverage
54
Possible Match
Housing & Real EstateLimit: Nothing in this notice points to housing & real estate
54
Possible Match
ManufacturingLimit: Nothing in this notice points to manufacturing
54
Possible Match
Retail & E-CommerceLimit: Nothing in this notice points to retail & e-commerce
54
Possible Match
Social Services & NonprofitLimit: Nothing in this notice points to social services & nonprofit
54
Possible Match
Technology & SoftwareLimit: Nothing in this notice points to technology & software
54
Possible Match
Transportation & LogisticsLimit: Nothing in this notice points to transportation & logistics
54
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
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 $600,000

Questions about this grant

When is the application deadline?
The application deadline is February 8, 2028.
How much funding can an applicant receive?
Awards range from $0 to $600,000. The facts do not say how many awards will be made or whether the full $600,000 is typical.
Who can apply for this grant?
Higher education institutions, nonprofits (with or without 501(c)(3) status), for-profit organizations including small businesses, local, state, county, city, tribal, and federal governments, independent school districts, public housing authorities, faith-based and community-based organizations, regional organizations, and foreign organizations may apply. Foreign components of U.S. organizations are also allowed.
Can a sole proprietor or single-member LLC apply?
The facts do not specifically address sole proprietors or single-member LLCs. For-profit organizations and small businesses are listed as eligible, but the notice does not break eligibility down to that level of detail.
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 it.

Summary

FDA funds natural history studies of rare diseases with unmet needs to fill knowledge gaps and support medical product development. Eligible applicants include universities, nonprofits, for-profits and small businesses, governments, tribes, and foreign organizations.

About this grant

The purpose of this notice of funding opportunity (NOFO) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product 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

Program contact

Stephanie Bogan GrantorKimberly.Pendleton@fda.hhs.gov3018276802

Related grants

Open opportunities funding similar work, from the same funder or in the same place.

All grantsGrants by stateGrants by industry