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Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)

Agency: National Institutes of Health

Assistance Listings: 93.838 -- Lung Diseases Research

93.233 -- National Center on Sleep Disorders Research

93.840 -- Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders

93.837 -- Cardiovascular Diseases Research

93.839 -- Blood Diseases and Resources Research

Last Updated: May 21, 2025

This Notice of Funding Opportunity (NOFO) supports applications to develop and implement investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination.

Eligibility

Eligible applicants

Education

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

Nonprofit

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

Government

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

Business

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

Miscellaneous

  • Other

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.

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-25-028-Full-Announcement.html
PAR-25-028 Full Announcement Text
Dec 11, 2024 05:43 PM UTC

Link to additional information

https://grants.nih.gov/grants/guide/pa-files/PAR-25-028.html

Closing: January 11, 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 Floor

$--

Award Ceiling

Funding opportunity number:

PAR-25-028

Cost sharing or matching requirement:

No

Funding instrument type:

Grant

Opportunity Category:

Discretionary

Opportunity Category Explanation:

--

Category of Funding Activity:

Health

Category Explanation:

--

History

Version:

2

Posted date:

December 11, 2024

Archive date:

February 10, 2026

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