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OpenOpportunity PAR-27-011

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

National Institutes of Health · Department of Health and Human Services

At a glance

Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) is an open federal grant opportunity from the National Institutes of Health (Department of Health and Human Services). Applications are due November 2, 2028. Applicant types listed as eligible include state governments, county governments, city or township governments, special district governments, independent school districts and 10 more. Cost sharing is not required. It is funded under Assistance Listing 93.233 (National Center on Sleep Disorders Research) and 4 other listings.

Summary assembled from the official notice's fields. The official notice governs.

Key facts

Posted
Mar 18, 2026
Close date
Nov 2, 2028
Archive date
Jan 2, 2029
Est. award date
Oct 1, 2026
Award floor
Not specified
Award ceiling
Not specified
Est. total funding
Not specified
Expected awards
Not specified
Cost sharing
Not required
Funding instrument
Grant
Opportunity category
Discretionary

Who can apply

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public colleges & universities
  • Federally recognized tribal governments
  • Public & Indian housing authorities
  • Native American tribal organizations
  • 501(c)(3) nonprofits
  • Nonprofits without 501(c)(3) status
  • Private colleges & universities
  • For-profit organizations (not small businesses)
  • Small businesses
  • Others (see notice)

Additional information on eligibility (from the notice)

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 or supplies from foreign vendors.

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

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.

Assistance Listings

What is an ALN?

Reported obligations under ALN 93.233

Historical data · not a prediction
FY24$105M
FY25$116M
FY26— est.
Source: SAM.gov Assistance Listing 93.233. Program-wide totals, not awards from this specific opportunity.

Agency contact (as published)

National Institutes of Health
NHLBIDCVSClinical@mail.nih.gov
301-402-2541

Quick answers

When is the deadline for “Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)”?

According to the official notice, applications are due November 2, 2028. Confirm the deadline and submission time on Grants.gov before applying.

Who is eligible to apply for “Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)”?

The official notice lists these applicant types as eligible: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public colleges & universities, Federally recognized tribal governments, Public & Indian housing authorities, Native American tribal organizations, 501(c)(3) nonprofits, Nonprofits without 501(c)(3) status, Private colleges & universities and 3 more. Additional restrictions may apply; review the full notice.

How do I apply for “Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)”?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity PAR-27-011), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.