Opportunity Information: Apply for PAR 27 012
Apply for PAR 27 012
- 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 2026-03-18.
- Applicants must submit their applications by 2028-11-02.
- 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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Opportunity Summary:
The NIH, through the National Heart, Lung, and Blood Institute (NHLBI), is offering a cooperative agreement opportunity (PAR-27-012) to support the development and operation of a Clinical Coordinating Center (CCC) for investigator-initiated, multi-site clinical trials. The intent is to fund the coordinating infrastructure and leadership needed to run a complex, multi-center trial that fits within NHLBI's mission areas and meets the NIH definition of a clinical trial. The trials supported under this announcement can span efficacy studies, comparative effectiveness research, pragmatic clinical trials, and dissemination and implementation (D and I) science trials, including studies that evaluate therapeutic, behavioral, prevention, or implementation strategies. Applicants are also encouraged to propose innovative trial designs, including platform trials as well as adaptive and Bayesian approaches, which can make studies more efficient or better suited to real-world clinical settings.
A defining 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 begin with an initial phase focused on planning and feasibility (UG3), with clear, predefined milestones that must be met to transition to the implementation phase (UH3), where the trial is conducted. Because the award is a cooperative agreement, NHLBI is expected to have substantial involvement during the project, which typically includes collaboration on study oversight, milestone assessment, and major operational decisions. The application is expected to clearly articulate both the scientific rationale for the trial and a detailed operational blueprint for how the trial will be executed across multiple sites, including how progress will be measured and managed over time.
The CCC application is expected to be comprehensive and practical. It should lay out project management and governance plans, including how the coordinating center will communicate with clinical sites, manage timelines, and handle risk and problem-solving during recruitment and follow-up. Strong emphasis is placed on participant recruitment and retention strategies, since multi-site trials often succeed or fail based on whether they can enroll and keep participants representative of the populations most affected by the condition under study. The application should specify performance milestones and metrics, describe plans for ensuring high-quality scientific conduct (for example, standardization of intervention delivery across sites, protocol adherence, and oversight of trial operations), and present a strategy for disseminating results in ways that meaningfully reach clinicians, health systems, community organizations, and other end users.
NHLBI also signals that applications should go beyond conventional trial operations by incorporating authentic community engagement throughout the lifecycle of the study. That includes engagement from the earliest conceptual design of the intervention or strategy, through implementation, and into sustainability planning, especially when the intervention is intended for real-world delivery. The NOFO explicitly highlights closing gaps in health outcomes and improving health for all within the United States population, so applicants should be prepared to explain how their study design, site selection, recruitment approach, and intervention strategy will address inequities and produce results that are relevant and actionable for communities experiencing disproportionate burden.
This CCC funding opportunity is paired with a required companion application for a collaborating Data Coordinating Center (DCC) under PAR-27-013, and both applications must be submitted for the same due date in order to be considered. In other words, NHLBI is not funding a CCC in isolation; the model is a coordinated CCC plus DCC partnership, with the CCC generally leading clinical-site operations and the DCC typically managing data systems, statistical planning and analyses, data quality oversight, and related informatics. Applicants are strongly encouraged to contact the relevant NHLBI scientific/research program staff before applying, which is often important for confirming fit with NHLBI priorities and for troubleshooting complex design or eligibility questions ahead of submission.
Eligibility is broad and includes many types of U.S. organizations (state, county, and local governments; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations; and small businesses), as well as federally recognized tribal governments and other tribal organizations, public housing authorities, and other listed entities. International participation is permitted in specific ways: non-U.S. organizations can apply, and foreign components (as NIH defines them) may be included. However, there is a major restriction tied to NIH's policy effective May 1, 2025: NIH will not issue awards that include foreign subawards or subcontracts under this NOFO. Applications that propose foreign subawards/subcontracts are considered noncompliant and will not be reviewed for funding. This does not necessarily block all international involvement, because unfunded collaborations, foreign components (as allowable), foreign consultants, and purchasing unique equipment or supplies from foreign vendors can still be permissible, but any arrangement that functions as a funded foreign subaward/subcontract would disqualify the application under this announcement.
Administratively, the opportunity is listed as a discretionary funding program using the cooperative agreement instrument, categorized under health, with CFDA numbers 93.233 and 93.837 through 93.840. The posting indicates an original closing date of November 2, 2028, and while the notice does not specify an award ceiling or the expected number of awards in the provided excerpt, applicants should consult the full NOFO text for budget guidance, review criteria, required components, and the specific milestone expectations for the UG3 to UH3 transition.
FAQs: NIH/NHLBI Clinical Coordinating Center (CCC) Cooperative Agreement (PAR-27-012)
What is this funding opportunity?
This is an NIH National Heart, Lung, and Blood Institute (NHLBI) funding opportunity announcement (NOFO) to support the development and operation of a Clinical Coordinating Center (CCC) for an investigator-initiated, multi-site clinical trial. The mechanism is a cooperative agreement, meaning NHLBI will have substantial involvement in the project.
What is the NOFO number for the CCC opportunity?
The CCC opportunity is PAR-27-012.
Who is offering this opportunity?
The opportunity is offered by the National Institutes of Health (NIH) through NHLBI (the National Heart, Lung, and Blood Institute).
What is being funded: a clinical trial or a coordinating center?
This NOFO is designed to fund the coordinating infrastructure and leadership (the CCC) needed to run a complex, multi-center clinical trial that fits within NHLBI mission areas and meets the NIH definition of a clinical trial. The application should address both the scientific rationale for the trial and the operational blueprint for executing it across multiple sites.
What types of clinical trials are supported under this NOFO?
The NOFO supports investigator-initiated, multi-site clinical trials that meet NIH's definition of a clinical trial and align with NHLBI mission areas. Trials may include efficacy studies, comparative effectiveness research, pragmatic clinical trials, and dissemination and implementation (D and I) science trials. Studies may evaluate therapeutic, behavioral, prevention, or implementation strategies.
Are innovative trial designs allowed or encouraged?
Yes. Applicants are encouraged to propose innovative trial designs, including platform trials and adaptive and Bayesian approaches, particularly when such designs improve efficiency or better fit real-world clinical settings.
What is the award structure (UG3/UH3), and what does "bi-phasic" mean here?
This NOFO uses a bi-phasic, milestone-driven UG3/UH3 cooperative agreement structure. The project is expected to start with an initial planning and feasibility phase (UG3). Only after meeting clear, predefined milestones would the project transition to the implementation phase (UH3), where the trial is conducted.
How do milestones affect funding and project progression?
Milestones are central to this NOFO. The UG3 phase includes predefined milestones that are assessed to determine readiness to transition into the UH3 phase. The application is expected to specify performance milestones and metrics and describe how progress will be measured and managed over time.
What does it mean that this is a cooperative agreement?
A cooperative agreement indicates substantial involvement by NHLBI during the project. This typically includes collaboration on study oversight, milestone assessment, and major operational decisions.
What is the expected role of the Clinical Coordinating Center (CCC)?
The CCC is expected to provide the coordinating infrastructure and leadership to run the multi-site trial. The application is expected to be comprehensive and practical, laying out project management, governance, communication with clinical sites, timeline management, and risk/problem-solving approaches during recruitment and follow-up.
What operational plans should a CCC application include?
Based on the NOFO description, the CCC application should include plans for project management and governance, communication pathways with clinical sites, timeline management, risk management and problem-solving, recruitment and retention approaches, operational oversight, protocol adherence strategies, standardization of intervention delivery across sites, and performance milestones/metrics.
Why is recruitment and retention emphasized so strongly?
The NOFO highlights that multi-site trials often succeed or fail based on the ability to enroll and retain participants, especially participants who are representative of populations most affected by the condition under study. Accordingly, strong recruitment and retention strategies are a major emphasis.
What does the NOFO expect regarding scientific quality and trial conduct?
The application should describe plans to ensure high-quality scientific conduct. Examples noted include standardizing intervention delivery across sites, ensuring protocol adherence, and providing oversight of trial operations.
Is dissemination of results part of the CCC expectations?
Yes. The NOFO expects a strategy for disseminating results in ways that meaningfully reach clinicians, health systems, community organizations, and other end users.
What does NHLBI mean by "authentic community engagement" in this context?
The NOFO signals that applications should incorporate community engagement throughout the study lifecycle. This includes engagement from early conceptual design of the intervention or strategy, through implementation, and into sustainability planning, especially when the intervention is intended for real-world delivery.
How does the NOFO address health equity?
The NOFO explicitly highlights closing gaps in health outcomes and improving health for all within the United States population. Applicants should be prepared to explain how study design, site selection, recruitment approach, and intervention strategy will address inequities and produce results relevant and actionable for communities experiencing disproportionate burden.
Is a Data Coordinating Center (DCC) application required?
Yes. This CCC opportunity (PAR-27-012) is paired with a required companion application for a collaborating Data Coordinating Center (DCC) under PAR-27-013. Both applications must be submitted for the same due date in order to be considered.
What is the companion NOFO number for the Data Coordinating Center (DCC)?
The DCC companion NOFO is PAR-27-013.
Can an applicant apply for the CCC without a DCC partner?
No. The NOFO description indicates NHLBI is not funding a CCC in isolation. The model is a coordinated CCC plus DCC partnership, and both applications must be submitted on the same due date to be considered.
How are responsibilities generally divided between the CCC and DCC?
As described, the CCC generally leads clinical-site operations, while the DCC typically manages data systems, statistical planning and analyses, data quality oversight, and related informatics.
Should applicants contact NHLBI staff before applying?
Yes. Applicants are strongly encouraged to contact the relevant NHLBI scientific/research program staff before applying to confirm fit with NHLBI priorities and to help troubleshoot complex design or eligibility questions before submission.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. organizations, including state, county, and local governments; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations; and small businesses. It also includes federally recognized tribal governments and other tribal organizations, public housing authorities, and other listed entities.
Can non-U.S. organizations apply?
Yes. The NOFO description states that non-U.S. organizations can apply, and foreign components (as NIH defines them) may be included.
Are there restrictions on foreign participation or international partners?
Yes. A major restriction applies under an NIH policy effective May 1, 2025: NIH will not issue awards that include foreign subawards or subcontracts under this NOFO. Applications proposing foreign subawards/subcontracts are considered noncompliant and will not be reviewed for funding.
Does the foreign subaward restriction prohibit all international involvement?
No. The description notes that some forms of international involvement may still be permissible, such as unfunded collaborations, allowable foreign components, foreign consultants, and purchasing unique equipment or supplies from foreign vendors. However, any arrangement functioning as a funded foreign subaward/subcontract would disqualify the application.
What happens if an application includes a foreign subaward or foreign subcontract?
The application would be considered noncompliant and would not be reviewed for funding under this NOFO.
What is the general program category and instrument type?
The program is listed as a discretionary funding program in the health category, using the cooperative agreement instrument.
What CFDA numbers are associated with this opportunity?
The posting lists CFDA numbers 93.233 and 93.837 through 93.840.
What is the closing date shown in the posting excerpt?
The posting indicates an original closing date of November 2, 2028.
Does the provided excerpt state the award ceiling or number of awards?
No. The excerpt does not specify an award ceiling or the expected number of awards. Budget guidance and other details are expected to be in the full NOFO text.
Where should applicants look for budget guidance, review criteria, and detailed requirements?
The excerpt indicates that applicants should consult the full NOFO text for budget guidance, review criteria, required components, and the specific milestone expectations for the UG3 to UH3 transition.
What does the NOFO imply about the level of detail expected in the application?
The application is expected to be both comprehensive and practical, including a detailed operational blueprint for multi-site execution, governance and communication plans, performance milestones and metrics, and strategies for recruitment/retention, quality conduct, and dissemination.
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