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OpenOpportunity PAR-25-450

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

National Institutes of Health · Department of Health and Human Services

At a glance

Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed) is an open federal grant opportunity from the National Institutes of Health (Department of Health and Human Services). Applications are due July 20, 2028. Applicant types listed as eligible include state governments, county governments, city or township governments, special district governments, independent school districts and 10 more. Cost sharing is not required. It is funded under Assistance Listing 93.350 (National Center for Advancing Translational Sciences) and 1 other listing.

Summary assembled from the official notice's fields. The official notice governs.

Key facts

  1. Sep 22, 2025Posted
  2. Jul 20, 2028Application deadlinenext date
  3. Dec 15, 2026 (est.)Est. award date
  4. Aug 25, 2028Archived
Posted
Sep 22, 2025
Close date
Jul 20, 2028
Archive date
Aug 25, 2028
Est. award date
Dec 15, 2026
Award floor
Not specified
Award ceiling
Not specified
Est. total funding
Not specified
Expected awards
Not specified
Cost sharing
Not required
Funding instrument
Grant
Opportunity category
Discretionary

Who can apply

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public colleges & universities
  • Federally recognized tribal governments
  • Public & Indian housing authorities
  • Native American tribal organizations
  • 501(c)(3) nonprofits
  • Nonprofits without 501(c)(3) status
  • Private colleges & universities
  • For-profit organizations (not small businesses)
  • Small businesses
  • Others (see notice)

Additional information on eligibility (from the notice)

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.

A quick check against the listed applicant types — other requirements in the notice still apply.

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

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.

Additional information from the agency ↗

How to apply

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Assistance Listings

What is an ALN?

Reported obligations under ALN 93.350

Historical data · not a prediction
FY24$596M
FY25$626M
FY26— est.
Source: SAM.gov Assistance Listing 93.350. Program-wide totals, not awards from this specific opportunity.

Agency contact (as published)

National Institutes of Health
grantsinfo@nih.gov
301-402-2541

Quick answers

When is the deadline for this opportunity?

According to the official notice, applications are due July 20, 2028. Confirm the deadline and submission time on Grants.gov before applying.

Who is eligible to apply for this opportunity?

The official notice lists these applicant types as eligible: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public colleges & universities, Federally recognized tribal governments, Public & Indian housing authorities, Native American tribal organizations, 501(c)(3) nonprofits, Nonprofits without 501(c)(3) status, Private colleges & universities and 3 more. Additional restrictions may apply; review the full notice.

How do I apply for this opportunity?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity PAR-25-450), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.