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OpenDeadline extended (was Jun 2, 2026)Research announcementOpportunity RFA-TR-25-002

Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)

National Institutes of Health · Department of Health and Human Services

At a glance

Preclinical Proof of Concept Studies for Rare Diseases (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 2, 2027. 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).

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

Key facts

  1. Dec 6, 2024Posted
  2. Jul 2, 2027Application deadlinenext date
  3. Aug 1, 2027Archived
Posted
Dec 6, 2024
Close date
Jul 2, 2027
Archive date
Aug 1, 2027
Award floor
Not specified
Award ceiling
Not specified
Est. total funding
Not specified
Original deadline (extended)
Jun 2, 2026
Expected awards
Not specified
Cost sharing
Not required
Funding instrument
Grant
Opportunity category
Discretionary

Typical awards for this program (SAM.gov listing for ALN 93.350, not this notice): NCATS Assistance: $1 - $11,215,948, average: $1,718,935

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); Non-domestic (non-U.S.) Entities (Foreign Organizations); 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 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) provides funding to conduct efficacy studies in an established rare disease preclinical model to demonstrate that a proposed therapeutic agent warrants further development. In addition to preclinical efficacy, accompanying pharmacodynamic and pharmacokinetic studies would be supported. Therapeutic agents include small molecules, biologics or biotechnology-derived products. The goal of this NOFO is to spur therapeutic development for a variety of rare diseases by advancing projects to the point where they would attract subsequent investment supporting full Investigational New Drug (IND) application development or progression to clinical trials in the case of repurposing or repositioning.

Additional information from the agency ↗

Full announcement & documents

The full announcement has the complete rules — page limits, required attachments, evaluation criteria and any letter-of-intent dates. Files download directly from Grants.gov.

How to apply

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Assistance Listing

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 “Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)”?

According to the official notice, applications are due July 2, 2027. Confirm the deadline and submission time on Grants.gov before applying.

Who is eligible to apply for “Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)”?

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 “Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)”?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity RFA-TR-25-002), 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.