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

National Institutes of Health · Opportunity number PAR-25-450

View the official notice on Grants.gov
643 days left (deadline Jul 20, 2028)

Details summarized from the official notice as of Oct 16, 2026. Always confirm eligibility, deadlines and requirements in the official notice before applying.

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Key facts

Opportunity numberPAR-25-450
AgencyNational Institutes of Health
Department of Health and Human Services
Assistance listing (ALN, formerly CFDA)93.350, 93.865
PostedSep 22, 2025
DeadlineJul 20, 2028
Cost sharing or matching requiredNo
Funding typeGrant
CategoryHealth
Last updated hereOct 16, 2026

Summary from the notice

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

The official notice lists these applicant types as eligible:

  • Special district governments
  • Federally recognized tribal governments
  • Small businesses
  • County governments
  • City or township governments
  • Others named in the notice (see the eligibility text)
  • Public and state colleges and universities
  • Nonprofits with 501(c)(3) status (other than colleges)
  • Nonprofits without 501(c)(3) status (other than colleges)
  • Independent school districts
  • For-profit organizations other than small businesses
  • Other Native American tribal organizations
  • State governments
  • Private colleges and universities
  • Public and Indian housing authorities

Who should take a closer look

  • Small businesses
  • Nonprofits
  • Colleges and universities
  • State governments
  • Local governments
  • Tribal governments and organizations
  • Larger for-profit companies

Not listed as eligible

  • Individuals

Unless the eligibility text in the notice names you, this opportunity is probably not for you.

Eligibility details from the notice

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.

Registrations you will likely need

Most applications submitted through Grants.gov need the following. Registration can take several weeks, so start early. The notice lists the exact requirements.

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