Open PAR-27-011 CFDA 93.233;93.837;93.838;93.839;93.840 Discretionary

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

Posted by National Institutes of Health

Opportunity snapshot. This Grants.gov announcement — Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) — is cataloged under number PAR-27-011 and tied to CFDA assistance listing 93.233;93.837;93.838;93.839;93.840, posted by National Institutes of Health. Grants.gov currently shows the opportunity as open, first posted on March 18, 2026. The funding category is Discretionary, delivered as a grant.

Award economics. The award range on file is Varies by applicant. Cost sharing is not required, so applicants do not need to commit matching funds to be competitive on this opportunity. Federal award ranges are often upper bounds; actual allocations reflect program appropriations, the strength of the applicant pool, and the evaluation committee's scoring.

Deadline and action path. Applications close on November 2, 2028 — roughly 881 days from today. Every Grants.gov submission requires an active SAM.gov registration and a Unique Entity ID. Review the Eligibility section below carefully — federal eligibility categories (nonprofit, state or local government, tribal, individual, educational institution, small business) have distinct registration and reporting requirements. Pre-application outreach to the listed agency contact is permitted and often welcomed — it helps clarify scope and scoring priorities.

Award Range

Varies by applicant

Close Date

November 2, 2028

Posted

March 18, 2026

Instrument

Grant

Description

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.

Eligibility

00;01;02;04;05;06;07;08;11;12;13;20;22;23;25

Official Listing on Grants.gov

View full details, application forms, and submission instructions.

View on Grants.gov

Agency Contact

Division of Cardiovascular Sciences<br/>NHLBIDCVSClinical@mail.nih.gov

Key Dates

Posted March 18, 2026
Close Date November 2, 2028
Archive Date January 2, 2029
Last Updated March 18, 2026

Frequently Asked Questions

What is this grant opportunity?
This is a federal funding opportunity titled "Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)", offered by National Institutes of Health. It is associated with CFDA program 93.233;93.837;93.838;93.839;93.840. This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/o...
Is this opportunity still open?
Yes, this opportunity is currently open for applications. The closing date is November 2, 2028.
How much funding is available?
The award range for this opportunity is Varies by applicant.
How do I apply?
Applications for federal grant opportunities are typically submitted through Grants.gov. Visit the official listing at grants.gov for application instructions, required documents, and submission deadlines.

More from National Institutes of Health

Open Closes November 2, 2028

Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)

View →
Open Closes November 2, 2028

Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)

View →
Open Closes January 25, 2028

Development of Collaborative Research Facilities or Research-Resource Facilities (C06 Clinical Trial Not Allowed)

View →
Open Closes March 5, 2029

Research Grants in Clinical Informatics (R01 Clinical Trial Optional)

View →
Open Closes March 5, 2029

Advancing Bioinformatics, Translational Bioinformatics and Computational Biology Research (R01 Clinical Trial Optional)

View →

Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.

Read our methodology — how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainGrants Editorial