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

National Institutes of Health · HHS

CFDA Numbers

93.350, 93.865

Award Ceiling

—

Award Floor

—

Expected Awards

—

Close Date

Jul 20, 2028

Section I

How to Apply

Apply Online ↗

View on grants_gov ↗

Program Contact

NIH Grants Information<br/>grantsinfo@nih.gov
grantsinfo@nih.gov

Section II

Eligibility

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.

Eligible Applicant Types

00, 01, 02, 04, 05, 06, 07, 08, 11, 12, 13, 20, 22, 23, 25

Section III

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.

Section IV

Key Dates

Posted: Sep 22, 2025
Closes: Jul 20, 2028
Archive: Aug 25, 2028