Opportunity Information: Apply for PAR 25 029
The NIH, through the National Heart, Lung, and Blood Institute (NHLBI), is offering a cooperative agreement opportunity (PAR-25-029) to support the development and operation of a Clinical Coordinating Center (CCC) for an investigator-initiated, multi-site clinical trial. The trial must fit squarely within NHLBI's mission areas (heart, lung, blood, and sleep-related research priorities) and must meet the NIH definition of a clinical trial. The intent is not to fund a general coordinating infrastructure in the abstract, but to fund a CCC that is built around a clearly justified, well-designed multi-site trial, whether the trial focuses on efficacy, comparative effectiveness, pragmatic approaches, and/or implementation research in real-world settings.
A key feature of this NOFO is that it uses a bi-phasic, milestone-driven UG3/UH3 cooperative agreement structure. In practice, that means the project is expected to start with a planning and start-up phase (UG3) with specific, NHLBI-approved milestones that demonstrate readiness to launch. If those milestones are met, the award transitions to the implementation phase (UH3) to conduct and manage the trial. Because it is a cooperative agreement rather than a standard grant, NHLBI will have substantial programmatic involvement during the project, particularly around milestone assessment and major operational decisions that affect trial integrity, feasibility, and deliverables.
This NOFO runs in parallel with a companion opportunity for a Data Coordinating Center (DCC) (referenced as PAR-22-193). Applicants are expected to submit both a CCC application and a collaborating DCC application by the same due date, and both applications are required for NHLBI consideration. The CCC and DCC are meant to function as a paired set: the CCC typically leads trial operations and site coordination, while the DCC leads data systems, statistical design/analysis support, data quality, and related functions. The requirement to submit both applications on the same deadline is meant to ensure the full trial coordinating ecosystem is in place from the start and that responsibilities are clearly defined and integrated across the two coordinating entities.
From an application content standpoint, the CCC proposal must do more than describe a clinical question. It must present a strong scientific rationale for the proposed multi-site trial and provide a comprehensive operational plan for executing it. NHLBI is explicitly looking for detail on project management structures, site management and communication plans, recruitment and retention strategies (often the make-or-break component of multi-site trials), and clear performance milestones. The application should also explain how the trial will be conducted scientifically and ethically, how protocol adherence and quality will be maintained across sites, and how results will be disseminated in a credible and timely way once the study is complete. In other words, reviewers will expect to see both the "why this trial matters" argument and the "how this will actually work across multiple sites" blueprint, with enough operational specificity to inspire confidence that the team can launch and run the study.
The funding instrument is a discretionary NIH cooperative agreement under health-related activity categories, with CFDA listings that align with NHLBI programs (93.233, 93.837, 93.838, 93.839, 93.840). The opportunity is broadly open to a wide range of eligible applicants, including state, county, and local governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; and eligible tribal entities. The NOFO also highlights inclusion of organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, faith-based and community-based organizations, regional organizations, U.S. territories or possessions, and even non-U.S. entities where eligible. This breadth signals that NHLBI is open to diverse organizational models for trial coordination, including community-connected and regionally networked approaches, as long as the applicant can credibly deliver the required coordinating functions for a complex multi-site trial.
Operationally important details include the original closing date of September 11, 2025, and the strong encouragement for applicants to contact the relevant NHLBI Scientific/Research contact before submission. That pre-submission communication is especially important in milestone-driven cooperative agreements, where early alignment on fit with NHLBI priorities, trial scope, feasibility expectations, and coordination plans with the DCC can prevent avoidable missteps and clarify what NHLBI will consider a fundable and executable trial-coordinating proposal. The award ceiling and expected number of awards are not specified in the provided listing, which means applicants should rely on the full NOFO text, budget guidelines, and any NHLBI program staff guidance to shape a realistic budget and staffing plan for both the UG3 and UH3 phases.
Overall, this opportunity is best understood as NHLBI support for a full, coordinated trial operations hub that can reliably launch and manage a multi-site investigator-initiated clinical trial, with explicit accountability through milestones and with required partnership to a separately applied-for but tightly collaborating Data Coordinating Center. The strongest applications will typically pair a compelling, NHLBI-relevant clinical question with a highly practical execution plan that shows the CCC can manage sites, participants, timelines, quality, and communications, while also demonstrating that the CCC and DCC together form a coherent, end-to-end trial management team.Apply for PAR 25 029
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 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 2024-12-11.
- Applicants must submit their applications by 2025-09-11. (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 Clinical Coordinating Center (CCC) Cooperative Agreement (PAR-25-029)
1. What is PAR-25-029 funding?
PAR-25-029 is an NIH cooperative agreement opportunity from the National Heart, Lung, and Blood Institute (NHLBI) to support the development and operation of a Clinical Coordinating Center (CCC) for an investigator-initiated, multi-site clinical trial.
2. What does NHLBI mean by a Clinical Coordinating Center (CCC) in this opportunity?
In this program, the CCC is the trial operations hub. It is expected to coordinate and manage multi-site trial execution, including operational planning, site coordination, communications, recruitment/retention strategy implementation, and maintaining protocol adherence and quality across sites.
3. Is this opportunity intended to fund a general coordinating center infrastructure?
No. The intent is not to fund a general coordinating infrastructure in the abstract. NHLBI is looking to fund a CCC that is built around a clearly justified, well-designed, specific multi-site clinical trial.
4. What types of studies are responsive to this NOFO?
The proposed study must be a multi-site clinical trial that fits squarely within NHLBI mission areas (heart, lung, blood, and sleep-related research priorities) and must meet the NIH definition of a clinical trial. The trial may focus on efficacy, comparative effectiveness, pragmatic approaches, and/or implementation research in real-world settings.
5. Does the proposed trial have to meet the NIH definition of a clinical trial?
Yes. A key requirement stated in the opportunity summary is that the proposed study must meet the NIH definition of a clinical trial.
6. What funding mechanism is used (grant vs cooperative agreement)?
This is a discretionary NIH cooperative agreement. That structure is different from a standard grant because NHLBI will have substantial programmatic involvement during the project, particularly around milestone assessment and major operational decisions affecting trial integrity, feasibility, and deliverables.
7. What does "UG3/UH3 bi-phasic, milestone-driven" mean in practice?
The project is expected to begin with a planning and start-up phase (UG3) with specific milestones that must be approved by NHLBI. If those milestones are met, the award transitions to the implementation phase (UH3), where the trial is conducted and managed.
8. Can the project move from UG3 to UH3 automatically?
No. Transition is milestone-driven. The award is expected to transition to UH3 only if the NHLBI-approved UG3 milestones demonstrating readiness to launch are met.
9. What kinds of milestones is NHLBI looking for?
The listing emphasizes NHLBI-approved milestones that demonstrate readiness to launch the trial. It also highlights the importance of clear performance milestones tied to project management, site operations, recruitment/retention, adherence, and overall feasibility and deliverables.
10. What role will NHLBI play during the project?
Because this is a cooperative agreement, NHLBI will have substantial programmatic involvement, particularly regarding milestone assessment and major operational decisions that affect trial integrity, feasibility, and deliverables.
11. Is a companion Data Coordinating Center (DCC) required?
Yes. This NOFO runs in parallel with a companion opportunity for a Data Coordinating Center (DCC), referenced as PAR-22-193. Applicants are expected to submit both a CCC application and a collaborating DCC application by the same due date, and both are required for NHLBI consideration.
12. Do the CCC and DCC applications need to be submitted on the same deadline?
Yes. The opportunity summary states that applicants are expected to submit both applications by the same due date, and that requirement is meant to ensure the full trial coordinating ecosystem is in place from the start.
13. What happens if only the CCC (or only the DCC) application is submitted?
Based on the information provided, both applications are required for NHLBI consideration. Submitting only one would not meet the stated requirement.
14. How are responsibilities typically split between the CCC and the DCC?
The CCC typically leads trial operations and site coordination. The DCC typically leads data systems, statistical design and analysis support, data quality, and related functions. The two centers are intended to function as a paired set with integrated responsibilities.
15. What does NHLBI expect to see in the CCC application besides the clinical question?
The CCC proposal must present a strong scientific rationale for the trial and a comprehensive operational plan for executing it. NHLBI is explicitly looking for detailed plans for project management structures, site management and communications, recruitment and retention strategies, and clear performance milestones.
16. Why are recruitment and retention emphasized?
The opportunity summary describes recruitment and retention as "often the make-or-break component of multi-site trials," signaling that NHLBI expects a credible and detailed plan in this area.
17. What operational topics should be addressed for running a multi-site trial?
Based on the provided listing, reviewers will expect operational specificity around management structures, site coordination and communication, recruitment/retention, protocol adherence, quality maintenance across sites, ethical and scientific conduct, and dissemination of results.
18. How should applicants address scientific and ethical conduct in the application?
The summary indicates the application should explain how the trial will be conducted scientifically and ethically, and how protocol adherence and quality will be maintained across sites.
19. What does NHLBI want regarding dissemination of trial results?
The application should describe how results will be disseminated in a credible and timely way once the study is complete.
20. What are the eligible applicant organization types?
The opportunity is broadly open to many eligible applicants, including state, county, and local governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; and eligible tribal entities. The listing also highlights a wide range of institution types and organizations (including certain minority-serving institutions and community-based organizations) and notes that non-U.S. entities may be eligible where allowed.
21. Are small businesses eligible to apply?
Yes. The eligibility list includes small businesses.
22. Are for-profit organizations eligible to apply?
Yes. The eligibility list includes for-profit organizations (other than small businesses) and also separately includes small businesses.
23. Are nonprofits required to have 501(c)(3) status?
No. The listing states that nonprofit organizations with or without 501(c)(3) status are included among eligible applicants.
24. Are tribal entities eligible?
Yes. Eligible tribal entities are explicitly listed among eligible applicants, and the NOFO highlights Tribal Colleges and Universities and other related institution types.
25. Are non-U.S. entities allowed to apply?
The listing indicates that non-U.S. entities may be eligible where eligible. Applicants should confirm details in the full NOFO.
26. What are the CFDA listings associated with this opportunity?
The provided information lists CFDA numbers aligned with NHLBI programs: 93.233, 93.837, 93.838, 93.839, and 93.840.
27. When is the closing date?
The listing states an original closing date of September 11, 2025.
28. Is pre-submission contact with NHLBI encouraged?
Yes. The listing strongly encourages applicants to contact the relevant NHLBI Scientific/Research contact before submission.
29. Why is contacting NHLBI before submission particularly important for this NOFO?
The summary notes that this is especially important in a milestone-driven cooperative agreement, where early alignment on fit with NHLBI priorities, trial scope, feasibility expectations, and coordination plans with the DCC can prevent avoidable missteps and clarify NHLBI expectations.
30. Are the award ceiling and number of awards specified in the provided information?
No. The award ceiling and expected number of awards are not specified in the provided listing. The summary advises relying on the full NOFO text, budget guidelines, and NHLBI program staff guidance.
31. What is the overall purpose of this opportunity in plain terms?
It is NHLBI support for a full, coordinated trial operations center that can reliably launch and manage a multi-site investigator-initiated clinical trial, with accountability through milestones and a required partnership with a separately applied-for but tightly collaborating Data Coordinating Center.
32. What will likely distinguish stronger applications, based on the listing?
The summary indicates that stronger applications will pair a compelling NHLBI-relevant clinical question with a highly practical execution plan showing the CCC can manage sites, participants, timelines, quality, and communications, and that the CCC and DCC together form a coherent end-to-end trial management team.
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