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

National Institutes of Health · Department of Health and Human Services · PAR-25-450

In plain English

National Institutes of Health (Department of Health and Human Services) is accepting applications for this grant until Jul 20, 2028 (617 days left).

The listing does not state award amounts or the number of awards.

Eligible applicant types include nonprofits, small businesses, for-profit companies, state governments, local governments, tribal governments & organizations, colleges & universities, school districts and public housing authorities, plus others described in the listing.

The listing says cost sharing or matching is not required.

Built only from the fields in the Grants.gov listing. Always confirm on the official listing.

Key facts

StatusPosted: open for applications
Close dateJul 20, 2028 · 617 days left
Posted dateSep 22, 2025
Opportunity numberPAR-25-450
AgencyNational Institutes of Health (Department of Health and Human Services)
Funding instrumentGrant
CategoryHealth, Income Security and Social Services
Opportunity categoryDiscretionary
Award ceiling (max per award)Not stated
Award floor (min per award)Not stated
Estimated total program fundingNot stated
Expected number of awardsNot stated
Cost sharing or matching requiredNo
Assistance listing (CFDA/ALN)93.350 – National Center for Advancing Translational Sciences
93.865 – Child Health and Human Development Extramural Research
Last updated on Grants.govSep 23, 2025
Archive dateAug 25, 2028

Who can apply

Browse similar: Nonprofits · Small businesses · For-profit companies · State governments · Local governments · Tribal governments & organizations · Colleges & universities · School districts · Public housing authorities

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and state-controlled institutions of higher education
  • Native American tribal governments (federally recognized)
  • Public housing authorities / Indian housing authorities
  • Native American tribal organizations (other than federally recognized tribal governments)
  • Nonprofits with 501(c)(3) status (other than institutions of higher education)
  • Nonprofits without 501(c)(3) status (other than institutions of higher education)
  • Private institutions of higher education
  • For-profit organizations other than small businesses
  • Small businesses
  • Others (see the eligibility details in the listing)

Additional eligibility information (excerpt from the listing):

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. …

Description

Excerpt from the official synopsis on Grants.gov (shortened; read the full text on the official listing):

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.

Read the full listing on Grants.gov → · Agency's announcement page

Before you apply: organizations applying through Grants.gov generally need an active SAM.gov registration (with a Unique Entity ID) and a Grants.gov account, and registration can take several weeks, so start early. Check the official listing for the exact requirements, deadline time and time zone. This page is a summary, not the official notice, and not legal or financial advice.

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