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

Agency: National Institutes of Health

Assistance Listings: 93.865 -- Child Health and Human Development Extramural Research

93.350 -- National Center for Advancing Translational Sciences

Last Updated: September 23, 2025
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.

Eligibility

Eligible applicants

Government

  • Special district governments
  • Federally recognized Native American tribal governments
  • County governments
  • City or township governments
  • State governments
  • Public and Indian housing authorities

Business

  • Small businesses
  • For-profit organizations other than small businesses

Miscellaneous

  • Other

Education

  • Public and state institutions of higher education
  • Independent school districts
  • Private institutions of higher education

Nonprofit

  • Nonprofits non-higher education with 501(c)(3)
  • Nonprofits non-higher education without 501(c)(3)
  • Other Native American tribal organizations

Additional information

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.

Grantor contact information

Description

NIH Grants Information grantsinfo@nih.gov

Email

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

grantsinfo@nih.gov

Documents

File nameDescriptionLast updated
PAR-25-450-Full-Announcement.html
PAR-25-450 Full Announcement Text
Sep 23, 2025 02:03 PM UTC

Link to additional information

https://grants.nih.gov/grants/guide/pa-files/PAR-25-450.html

Closing: July 20, 2028

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates.

Award

$--

Program Funding

--

Expected awards

$--

Award Minimum

$--

Award Maximum

Funding opportunity number:

PAR-25-450

Cost sharing or matching requirement:

No

Funding instrument type:

Grant

Opportunity Category:

Discretionary

Opportunity Category Explanation:

--

Category of Funding Activity:

Health

Income security and social services

Category Explanation:

--

History

Version:

1

Posted date:

September 22, 2025

Archive date:

August 25, 2028

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