Data / Federal grants / PAR-27-011

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

National Institutes of Health (Department of Health and Human Services) is accepting applications until November 2, 2028.

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Key facts

Opportunity number: PAR-27-011
Status: Posted, open
Posted: March 18, 2026
Closes: November 2, 2028
Cost sharing: Not required
Funding instrument: Grant
Category: Health
Assistance listing: 93.233 National Center on Sleep Disorders Research; 93.837 Cardiovascular Diseases Research; 93.838 Lung Diseases Research; 93.839 Blood Diseases and Resources Research; 93.840 Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders; None None
Contact: National Institutes of Health · [email protected] · 301-402-2541

Who can apply

Public housing authorities/Indian housing authorities
City or township governments
Native American tribal governments (Federally recognized)
State governments
Public and State controlled institutions of higher education
For profit organizations other than small businesses
Others (see text field entitled "Additional Information on Eligibility" for clarification)
County governments
Native American tribal organizations (other than Federally recognized tribal governments)
Special district governments
Private institutions of higher education
Small businesses
Independent school districts
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment

What the agency says

This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and implementation science clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, dissemination and implementation science clinical trials 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, participant 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. The application should also describe its approaches to increase community engagement from conceptual design of the intervention through implementation and sustainability, close gaps in health outcomes within the US population, and increase health for all.

The notice on Grants.gov

Other open grants from the Department of Health and Human Services

Opportunity	Status	Closes	Award ceiling	Total funding	Record
Long-term health outcomes of people living with spina bifida CDC-RFA-DD-26-0222	Open	Oct 26	$300,000	$3,000,000	grants.gov
GREGoRi Data Coordination and Outreach Center (U01, Clinical Trials Not Allowed) RFA-HG-27-011	Open	Oct 30	$1,250,000	$2,000,000	grants.gov
GREGoRi Innovation Projects (U01 Clinical Trial Optional) RFA-HG-27-013	Open	Oct 30	$500,000	$7,500,000	grants.gov
GREGoRi Technology Integration Center (U01, Clinical Trials Optional) RFA-HG-27-012	Open	Oct 30	$2,250,000	$3,000,000	grants.gov
HEAL Initiative: Whole Joint Health Program (R61/R33 Clinical Trial Required) PAR-27-045	Open	Oct 30			grants.gov
Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed) PAR-24-280	Open	Nov 2			grants.gov

All grants open to Public housing authorities/Indian housing authorities · All grants open to City or township governments · All grants open to Tribal governments · Everything closing in November 2028

Read from the Grants.gov API, last updated 2026-10-23. The agency's notice on Grants.gov is the official record; check it before you apply.