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

Official funding announcement — preliminary draft

Funder: National Institutes of Health

Opportunity number: PAR-25-450

Official listed status: posted

Closing information: 2028-07-20 (official deadline clock time and time zone must be checked in NOFO)

Award disclosure: Applicant-level ceiling not stated in the retrieved federal synopsis; verify in full NOFO.

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

Federal 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.

Draft intake record. Eligibility, program terms, current amendments and applicant ceiling must be independently verified before publishing.

Official Grants.gov opportunity and NOFO