Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)
NIH supports readiness-focused rare disease clinical research that develops biomarkers, outcome measures, or natural history data to enable future clinical trials, but does not allow clinical trials in this R21.
⚑ R21 Clinical Trial Not Allowed · Foreign organizations not eligible; foreign components not allowed · Standard NIH grants policy exclusions apply to non-U.S. components
Unit fits — one characterization, each unit's own rules
| Physical Sciences & Engineering (demo) | 70 strong | technical depth: substantial; funds applied research |
| IPPRA | 58 good | peripheral portfolio topic: public_health; social/behavioral work is minor; funds applied research; biomedical core — IPPRA health lane is communication/crisis/policy (capped) |
| Tom Love Innovation Hub | 30 weak | funds applied research; deep-tech content |
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.
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.
Apply
View on Grants.gov → CONTACT: National Institutes of Health <grantsinfo@nih.gov>
Proposal brief SEE AN EXAMPLE →
A one-page internal memo: fit assessment, submission requirements, document scaffold, and next steps dated back from the deadline — tailored to your project idea if you add one.
Proposal shell · National Institutes of Health conventions SEE AN NIH EXAMPLE →
Funder-faithful document skeletons — National Institutes of Health's document set with section headings, page limits, reviewer guidance, and writing prompts; add a project idea to get [DRAFT] starter bullets. Download as .md for Word or Overleaf.