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

National Institutes of Health

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 effici

Funding
Varies
Category
Health & Medical
Status
OPEN
Deadline
7/21/2028

About

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.

Eligibility

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.

Applicant types

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Notice-specific evidence check

What an applicant must verify for Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)

Applicant evidence

  • Applicant type: State governments
  • Applicant type: County governments
  • Applicant type: City or township governments
  • Applicant type: Special district governments
  • Applicant type: Independent school districts
  • Applicant type: Public and state-controlled institutions of higher education
  • Applicant type: Federally recognized tribal governments
  • Applicant type: Public housing authorities and Indian housing authorities

Opportunity boundaries

  • Recorded deadline: July 21, 2028; confirm time zone and submission system.
  • Recorded focus: Health
  • Recorded focus: Information and statistics
Do not infer missing fields: award amount. Absence from this directory record is not evidence that a restriction does not exist.
Before investing in an application, connect every eligibility claim, required registration, submission component and deadline to the current official notice. Open the recorded official source →

Application checklist

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

The steps below turn the recorded grant fields into a pre-submission check. They do not replace the current Notice of Funding Opportunity or its amendments.

Recorded eligibility

  • Applicant types: Grants.gov eligibility code 00, Grants.gov eligibility code 01, Grants.gov eligibility code 02, Grants.gov eligibility code 04, Grants.gov eligibility code 05, Grants.gov eligibility code 06.
  • Geographic scope is not structured in this record.
  • Notice summary: 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.

Focus areas: HL, ISS

Recorded deadline

July 20, 2028 — confirm the time zone and submission system

A missing or rolling date is not permission to assume an open application window.

  1. 1. Confirm fitMatch your applicant type, location, project scope and any cost-share or registration rule to the official notice.
  2. 2. Read the noticeCollect the current guidelines, amendments, budget rules, required attachments and submission instructions.
  3. 3. Check timingRecord the deadline time zone, internal review date and any earlier registration or portal cut-off.
  4. 4. Submit thereUse the official application route and save the confirmation or submission reference.

Official sources

Recorded source: https://www.grants.gov/xml-extract

Last directory verification: Sep 13, 2026.