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

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 tha...

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National Institutes of Health Source published Sep 22, 2025 Verified 5 hours ago
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DeadlineThu Jul 20 12:00 AM 2028
Fundinggrant

Overview

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 t...

Complete grant details

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.

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

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.

Eligibility requirements

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

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.

Tips for this grant

Practical JobOpportunity guidance. These tips do not replace official rules or create new eligibility requirements.

  1. Check eligibility, funding coverage, study/project level and every required document before investing time in the application.
  2. Prepare transcripts, references, language tests, proposal/motivation statement and proof documents early.
  3. Separate the scholarship deadline from any university/program admission deadline; they may be different.
  4. Treat “fully funded” as a source fact only when the official provider explicitly confirms the covered costs.

Verification notes

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