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NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)

Agency: National Institutes of Health

Assistance Listings: 93.847 -- Diabetes, Digestive, and Kidney Diseases Extramural Research

Last Updated: February 19, 2026

NIDDK supports investigator-initiated, high-risk multi-center (more than one center) clinical studies through a two-part process that may include an implementation planning cooperative agreement (U34). The U34 is designed to: 1) Permit early peer review of the rationale for the proposed clinical study; 2) Permit assessment of the design and protocol of the proposed study; 3) Provide support for the development of documents needed for the conduct of the study, including a manual of operations; and 4) Support the development of other essential elements required for the conduct of the clinical study. The proposed clinical study should be hypothesis-driven and focus on a disease in the mission of NIDDK. Consultation with NIDDK scientific staff is strongly encouraged prior to the submission of the U34 application.

Eligibility

Eligible applicants

Business

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

Government

  • City or township governments
  • Federally recognized Native American tribal governments
  • County governments
  • Public and Indian housing authorities
  • State governments
  • Special district governments

Miscellaneous

  • Other

Nonprofit

  • Nonprofits non-higher education with 501(c)(3)
  • Nonprofits non-higher education without 501(c)(3)
  • Other Native American tribal organizations

Education

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

Additional information

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.

Grantor contact information

Description

NIH Grants Information grantsinfo@nih.gov

Email

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

grantsinfo@nih.gov

Documents

File nameDescriptionLast updated
PAR-25-090-Full-Announcement.html
PAR-25-090 Full Announcement Text
Jan 10, 2025 07:22 PM UTC

Link to additional information

https://grants.nih.gov/grants/guide/pa-files/PAR-25-090.html

Archived: March 21, 2026

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates.

Award

$--

Program Funding

--

Expected awards

$--

Award Minimum

$225,000

Award Maximum

Funding opportunity number:

PAR-25-090

Cost sharing or matching requirement:

No

Funding instrument type:

Cooperative agreement

Opportunity Category:

Discretionary

Opportunity Category Explanation:

--

Category of Funding Activity:

Food and nutrition

Health

Category Explanation:

--

History

Version:

2

Posted date:

January 10, 2025

Archive date:

March 21, 2026

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