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

National Institutes of Health · PAR-25-450 · Deadline: July 20, 2028

Program-level history — this opportunity doesn't publish per-opportunity awards, so these numbers describe its parent program (CFDA 93.350, National Center for Advancing Translational Sciences), not this competition alone. Labeled that way on purpose.

Draw-down reality (program)

Across 263 completed awards in this program (FY2021+ sample, USAspending outlay records), grantees ultimately drew a median 99% of obligated funds. A median well under 100% means underspend or early closure is common here — worth knowing before promising a spend-down timeline.

Listing summary

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 …

Eligibility: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities, Native American tribal organizations (other), Nonprofits with 501(c)(3), other than higher education, Nonprofits without 501(c)(3), Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others · Categories: Health, Income Security and Social Services · official listing ↗

Sources: NIH RePORTER (opportunity-exact) and USAspending (program-level), labeled per section. GrantsDue computes summaries only; verify anything critical against the originals. Methodology.