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Grants.govALN 93.350PAR-25-450

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

National Institutes of Health

Amount not specifiedCloses in 729 days· Jul 20, 2028

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 rare disease to enable the design of upcoming clinical trials.

Related documents

Geography
US
Award range
Amount not specified
Cost share
Not required
Open date
Sep 22, 2025
Close date
Jul 20, 2028
Funding type
Grant
Opportunity type
Discretionary
Source
Grants.gov

Eligibility

NonprofitFor-profitGovernmentInstitution

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. | applicant types: State governments; Native American tribal governments (Federally recognized); Native American tribal organizations (other than Federally recognized tribal governments); Others (see text field entitled "Additional Information on Eligibility" for clarification); Public and State controlled institutions of higher education; Small businesses; Private institutions of higher education; 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; For profit organizations other than small businesses; City or township governments; County governments; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Independent school districts

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