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

Agency: National Institutes of Health

Assistance Listings: 93.350 -- National Center for Advancing Translational Sciences

Last Updated: June 9, 2025

Description

The National Center for Advancing Translational Sciences, with other NIH Institutes and Centers (ICs), intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for research on projects that address critical needs for clinical trial readiness in rare diseases. The initiative will seek 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. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the R21 activity code. Investigators with expertise and insights into this area of clinical trial readiness for rare diseases, disorders, and syndromes are encouraged to begin to consider applying for this new NOFO.

Eligibility

Eligible applicants

Government

  • County governments
  • Federally recognized Native American tribal governments
  • State governments
  • Public and Indian housing authorities

Education

  • Public and state institutions of higher education
  • Independent school districts
  • Private institutions of higher education

Business

  • Small businesses
  • For-profit organizations other than small businesses

Nonprofit

  • Nonprofits non-higher education with 501(c)(3)
  • Other Native American tribal organizations

Additional information

Grantor contact information

Description

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Email

alice.chen2@nih.gov

alice.chen2@nih.gov

Documents

No documents are currently available here

Link to additional information

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Forecasted

Estimated Post Date:

November 14, 2025

Estimated Application Due Date:

February 16, 2026

Estimated Due Date Description:

Not available

Estimated Award Date:

December 15, 2026

Estimated Project Start Date:

December 15, 2026

Fiscal Year:

2027

Application process

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Award

$--

Program Funding

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Expected awards

$--

Award Minimum

$--

Award Maximum

Funding opportunity number:

FOR-TR-27-001

Cost sharing or matching requirement:

No

Funding instrument type:

Grant

Opportunity Category:

Discretionary

Opportunity Category Explanation:

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Category of Funding Activity:

Health

Category Explanation:

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History

Version:

1

Forecast posted date:

June 9, 2025

Archive date:

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