Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) | PAR 18 406

Opportunity Information: Apply for PAR 18 406

The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), issued this funding opportunity (PAR-18-406) to support investigator-initiated, single-site clinical trials at phase II and beyond. The focus is on clinical studies that clearly fit the NHLBI mission areas (heart, lung, blood, and sleep-related research priorities) and that meet the NIH definition of a clinical trial (as referenced in NOT-OD-15-015). In practical terms, this program is meant for research teams that already have a strong scientific premise and are ready to run a controlled, later-stage clinical study at one primary study site, rather than building a multi-site network.

A defining feature of this opportunity is its two-stage, milestone-driven award structure using the R61/R33 mechanism. The R61 phase functions like a supported “launch” period where the team finalizes key start-up activities and demonstrates readiness to begin or continue the trial under clearly specified milestones. The R33 phase supports the full implementation and conduct of the clinical trial, contingent on meeting the predefined milestones from the first phase. Because progression is performance-based, applicants need to be very explicit about what success looks like early on (for example, startup timelines, regulatory and IRB steps, recruitment activation, or other measurable indicators) and how those milestones will be tracked and achieved.

Applications are expected to go well beyond a basic protocol summary. NHLBI anticipates a complete scientific and operational plan that lays out the rationale and objectives for the trial, the design and analysis approach, and a clear description of how the study will be executed day to day. That includes a detailed project management plan, participant recruitment and retention strategies tailored to the study population, and performance milestones that reflect both trial initiation and trial conduct. Reviewers will be looking for evidence that the team has realistically thought through feasibility at a single site, including enrollment capacity, staffing, timelines, data collection workflows, quality control, and how protocol adherence and participant safety will be managed. Plans for dissemination of results are also expected, emphasizing that this mechanism is intended to produce actionable findings and communicate them responsibly after the study is completed.

The FOA strongly encourages (but does not require) use of the multiple PD/PI model, reflecting how complex clinical trials tend to be. Applicants are encouraged to include leadership with expertise in biostatistics, clinical trial design, and coordination, which signals that NHLBI wants strong methodological oversight built into the project leadership rather than treated as a supporting afterthought. Given the complexity and the milestone-based structure, prospective applicants are also strongly encouraged to contact the relevant NHLBI scientific/research staff before submitting. The intent is that NHLBI staff can help investigators align the proposed trial with the FOA’s goals and expectations and reduce avoidable problems around fit, trial readiness, or operational planning.

Eligibility is broad and includes many types of U.S. organizations and governmental entities, such as state, county, city/township, and special district governments; public and state-controlled and private institutions of higher education; independent school districts; Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other qualifying entities. The FOA also highlights additional eligible applicant categories including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, non-domestic (non-U.S.) entities, and U.S. territories or possessions. This emphasis suggests NHLBI’s openness to a wide range of applicants, including institutions serving underrepresented communities and organizations positioned to reach specific patient populations.

Administratively, this is a discretionary grant opportunity with NIH as the issuing agency. It is associated with CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840, reflecting NHLBI’s program areas. The original closing date listed is 2019-08-05, and the FOA creation date is 2017-10-25. While the summary data do not provide an award ceiling or expected number of awards, the key takeaway is that the mechanism is designed for well-justified, later-stage, single-site trials that can be managed with clear milestones, strong operational readiness, and a credible plan for recruitment, trial conduct, analysis, and dissemination aligned with NHLBI priorities.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840.
• This funding opportunity was created on 2017-10-25.
• Applicants must submit their applications by 2019-08-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), 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, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 18 406

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