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Data / Federal grants / PAR-25-450

Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)

National Institutes of Health (Department of Health and Human Services) is accepting applications until July 20, 2028.

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Key facts

Opportunity number
PAR-25-450
Status
Posted, open
Posted
September 22, 2025
Closes
July 20, 2028
Cost sharing
Not required
Funding instrument
Grant
Category
Health, Income Security and Social Services
Assistance listing
93.350 National Center for Advancing Translational Sciences; 93.865 Child Health and Human Development Extramural Research; None None
Contact
National Institutes of Health · [email protected] · 301-402-2541

Who can apply

  • Private institutions of higher education
  • County governments
  • Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
  • Others (see text field entitled "Additional Information on Eligibility" for clarification)
  • City or township governments
  • Public and State controlled institutions of higher education
  • Public housing authorities/Indian housing authorities
  • Native American tribal governments (Federally recognized)
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Small businesses
  • State governments
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
  • For profit organizations other than small businesses
  • Special district governments
  • Independent school districts

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

What the agency says

This Notice of Funding Opportunity (NOFO) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in rare diseases. The initiative seeks applications that are intended to facilitate rare diseases research by enabling efficient and effective movement of candidate therapeutics or diagnostics toward clinical trials, and to increase their likelihood of success. This could be through the development and testing of rigorous biomarkers and clinical outcome assessment measures, or by defining the presentation and course of a rare disease to enable the design of upcoming clinical trials.

The notice on Grants.gov Full announcement

Other open grants from the Department of Health and Human Services

All grants open to Private colleges and universities · All grants open to County governments · All grants open to Nonprofits without 501(c)(3) status · Everything closing in July 2028

Read from the Grants.gov API, last updated 2026-10-23. The agency's notice on Grants.gov is the official record; check it before you apply.