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

Federal funding opportunity PAR-25-450 from National Institutes of Health (Department of Health and Human Services).

Apply on Grants.gov →Application closes July 20, 2028

Posted
September 22, 2025
Closes
July 20, 2028
Cost sharing
No
Instrument
Grant
Assistance listing
93.350, 93.865
Category
Health, Income Security and Social Services
Archives
August 25, 2028

Program funding history

Awards made under Assistance Listing 93.350 (one of 2 on this opportunity) across FY2025–FY2027, from public federal spending records.

FY2025 obligated
$599.3M
FY2026 obligated
$627.8M
FY2027 (to date) obligated
$0
Awards in window
772

Top recipients: Vanderbilt University Medical Center, University of Pittsburgh - of the Commonwealth System of Higher Education, Regents of the University of Michigan, Trustees of the University of Pennsylvania, the, The Johns Hopkins University

Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →

Synopsis

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

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.

How to apply

Applications go through the official government listing. Grants Radar links you straight to the source — applying is free.

View on Grants.gov   Full announcement

Agency contact: National Institutes of Health · [email protected] · 301-402-2541

New to federal funding? How to read an announcement · Who can apply · How grants work

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