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

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Key Information

Due Date: July 20, 2028


Agency: United States Department of Health and Human Services


Source: Federal


Website: View Website


Funding Categories:

Funding Amount: Not Specified


Funding Type: Grant


Match Required: No


Status: Posted


Contact Info: grantsinfo@nih.gov
NIH Grants Information grantsinfo@nih.gov

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 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.
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Additional Info

Posted Date: September 22, 2025


Application Due Date: July 20, 2028


Estimated Award Date: Not Specified


Eligible Applicants:

  • Special district governments
  • Native American tribal governments (Federally recognized)
  • Small businesses
  • County governments
  • City or township governments
  • Others
  • Public and State controlled institutions of higher education
  • 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
  • Independent school districts
  • For profit organizations other than small businesses
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • State governments
  • Private institutions of higher education
  • Public housing authorities/Indian housing authorities
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