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

National Institutes of Health Nonprofit eligible

National Institutes of Health is funding health projects through this opportunity, which is open to nonprofits and other eligible applicants, with applications due Jul 20, 2028.

Open the official Grants.gov listing
Deadline
Jul 20, 2028
Posted
Sep 22, 2025
Opportunity number
PAR-25-450
CFDA
93.350, 93.865

Opportunity description

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.

Who can apply

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

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.

Agency contact

National Institutes of Health

NIH Grants Information grantsinfo@nih.gov

grantsinfo@nih.gov

Next steps to apply

You will apply through Grants.gov, the federal grants portal. Confirm every detail — eligibility, attachments, and the deadline — on the official page before you commit time to it.

Official Grants.gov listing

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