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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 across FY2024–FY2026, from public federal spending records.

FY2024 obligated: $588.2M
FY2025 obligated: $599.3M
FY2026 (to date) obligated: $503.7M
Awards in window: 932

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, Icahn School of Medicine at Mount Sinai

Source: USAspending.gov · refreshed August 2026

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

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

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

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