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.Apply for PAR 18 406
- 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.
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Frequently Asked Questions (FAQs): NIH/NHLBI PAR-18-406 (R61/R33)
What is this funding opportunity (PAR-18-406) intended to support?
This NIH funding opportunity, issued through the National Heart, Lung, and Blood Institute (NHLBI), supports investigator-initiated, single-site clinical trials at phase II and beyond. It is designed for research teams that already have a strong scientific premise and are ready to conduct a controlled, later-stage clinical study at one primary study site.
Which NIH institute is sponsoring this opportunity?
The opportunity is issued by the National Institutes of Health (NIH) through the National Heart, Lung, and Blood Institute (NHLBI).
What types of research areas are considered a fit for this FOA?
The clinical study needs to clearly fit within NHLBI mission areas and research priorities, including heart, lung, blood, and sleep-related research.
Does the proposed study have to meet the NIH definition of a clinical trial?
Yes. The FOA is specifically for studies that meet the NIH definition of a clinical trial, as referenced in NOT-OD-15-015.
What trial stage is this opportunity focused on?
This FOA focuses on phase II and later-stage clinical trials ("phase II and beyond").
Is this FOA intended for single-site or multi-site clinical trials?
This program is intended for single-site clinical trials conducted at one primary study site, rather than establishing or operating a multi-site network.
What award mechanism does this FOA use?
The FOA uses the NIH R61/R33 mechanism, which is a two-stage, milestone-driven award structure.
How does the two-stage R61/R33 structure work?
The R61 phase functions as a supported launch period focused on completing key start-up activities and demonstrating readiness to begin or continue the trial. The R33 phase supports full implementation and conduct of the clinical trial, but only if the predefined R61 milestones are met.
What is the purpose of the R61 phase?
The R61 phase is meant to finalize start-up activities and demonstrate trial readiness using clearly specified milestones. Examples mentioned include start-up timelines, regulatory and IRB steps, recruitment activation, and other measurable indicators.
What is the purpose of the R33 phase?
The R33 phase supports the full implementation and conduct of the clinical trial, contingent upon successful achievement of the milestones established for the R61 phase.
Is progression from R61 to R33 automatic?
No. Progression is performance-based. Advancement to the R33 phase depends on meeting the predefined milestones during the R61 phase.
What does "milestone-driven" mean in practical terms for applicants?
Applicants are expected to define early, measurable indicators of success and explain how those milestones will be tracked and achieved. The FOA emphasizes being explicit about what success looks like early on, since continuation into the R33 phase depends on milestone performance.
How detailed should the application be?
The application is expected to go well beyond a basic protocol summary. NHLBI anticipates a complete scientific and operational plan, including rationale and objectives, trial design and analysis approach, and a clear description of day-to-day execution.
What operational planning elements does NHLBI expect to see?
NHLBI expects detailed planning for project management, participant recruitment and retention strategies tailored to the target population, and performance milestones reflecting both trial initiation and trial conduct.
What feasibility issues will reviewers focus on for a single-site trial?
Reviewers will look for evidence that the team has realistically addressed feasibility at one site, including enrollment capacity, staffing, timelines, data collection workflows, quality control, protocol adherence, and participant safety management.
Are recruitment and retention plans required?
Yes. The FOA specifically calls for participant recruitment and retention strategies tailored to the study population as part of the expected operational plan.
Does the FOA require a project management plan?
Yes. A detailed project management plan is explicitly included among the expected components of a complete scientific and operational plan.
Are dissemination plans expected?
Yes. Plans for dissemination of results are expected, and the FOA emphasizes producing actionable findings and communicating results responsibly after study completion.
Is the multiple PD/PI model required?
No. The FOA strongly encourages, but does not require, use of the multiple PD/PI model.
What types of expertise does NHLBI encourage applicants to include in leadership?
Applicants are encouraged to include leadership expertise in biostatistics, clinical trial design, and coordination, reflecting NHLBI's interest in strong methodological oversight as a core leadership function.
Should applicants contact NHLBI before submitting?
Yes. Prospective applicants are strongly encouraged to contact relevant NHLBI scientific/research staff before submission to help align the proposed trial with the FOA's goals and expectations and to reduce avoidable issues around fit, readiness, or operational planning.
Who is eligible to apply?
Eligibility is broad and includes many 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.
Does NHLBI explicitly call out any additional eligible applicant categories?
Yes. The FOA highlights additional eligible categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, regional organizations, non-domestic (non-U.S.) entities, and U.S. territories or possessions.
Are non-U.S. organizations eligible?
Yes. The FOA highlights that non-domestic (non-U.S.) entities are among the additional eligible applicant categories.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are included among the additional eligible applicant categories highlighted by the FOA.
Are for-profit organizations eligible?
Yes. The eligibility list includes for-profit organizations (other than small businesses) as well as small businesses.
What type of grant is this administratively?
It is described as a discretionary grant opportunity, with NIH as the issuing agency.
Which CFDA numbers are associated with this opportunity?
The opportunity is associated with CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840.
What is the FOA creation date and the listed closing date?
The FOA creation date is 2017-10-25, and the original closing date listed is 2019-08-05.
Does the provided summary include an award ceiling or the expected number of awards?
No. The summary information provided does not include an award ceiling or an expected number of awards.
What is the main "fit" takeaway for deciding whether to apply?
The mechanism is aimed at well-justified, later-stage, single-site trials that can be managed with clear milestones and demonstrate strong operational readiness, including credible plans for recruitment, trial conduct, analysis, and dissemination aligned with NHLBI priorities.
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