Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required) | PAR 24 090

Opportunity Information: Apply for PAR 24 090

The NIH National Center for Complementary and Integrative Health (NCCIH) is offering a cooperative agreement opportunity (PAR-24-090) to support a Clinical Coordinating Center (CCC) for an investigator-initiated, fully powered, multi-site clinical trial focused on complementary and integrative health approaches. The trial must study mind and body interventions, meaning approaches that use physical and/or psychological therapeutic inputs, and it may also include broader multicomponent interventions that combine physical, psychological, and/or nutritional elements. NCCIH is aiming for projects in its designated high-priority research areas, and applicants are expected to align the proposed clinical question and study design with NCCIHs mission, strategic vision, and research priorities described on the NCCIH website.

This NOFO is specifically about the Clinical Coordinating Center role, which is responsible for building and running the operational and scientific backbone of the multi-site trial. The CCC application needs to do more than describe an idea; it must present a clear scientific rationale and a complete scientific and operational plan for carrying out a Phase III (and beyond) trial. In practice, that means the CCC should lay out how the study will be organized across sites, how the intervention will be delivered consistently, how protocol adherence and quality will be monitored, and how the trial will be executed in a way that produces credible, generalizable results. The CCC is also expected to propose concrete project management structures, detailed recruitment and retention strategies suited to the target population and settings, and plans for responsible scientific conduct, including oversight and performance tracking.

A central feature of this opportunity is the milestone-driven, two-phase UG3/UH3 cooperative agreement mechanism. Under this structure, the project begins in an initial UG3 phase that supports time-limited planning and start-up activities tied to specific milestones, followed by a UH3 phase that supports full implementation once those milestones are met. This arrangement is designed to reduce the risk of launching large, expensive multi-site trials before readiness is demonstrated. As a result, applicants should be prepared to define measurable milestones and decision points, such as finalizing study protocols and manuals of procedures, obtaining regulatory approvals, confirming site readiness, demonstrating feasible recruitment pipelines, and establishing intervention fidelity and data flow processes that can support a large-scale trial.

The CCC award cannot stand alone. NCCIH requires a paired, companion application for a Data Coordinating Center (DCC) using the U24 mechanism under PAR-24-087. The DCC is expected to propose and lead the data management and statistical/data analysis infrastructure for the same clinical project. Both the CCC (UG3/UH3) and DCC (U24) applications must be submitted at the same time for NCCIH to consider the overall program. This effectively makes the application a coordinated package: the CCC focuses on trial leadership and operations across clinical sites, while the DCC focuses on data systems, data quality, and analysis plans. Applicants should plan for tight integration between the two centers, including aligned timelines, shared governance, and clear division of responsibilities.

Because this is a cooperative agreement, NCCIH will have substantial involvement compared with a typical research project grant. The CCC application is expected to include performance milestones and operational plans that can be monitored over time, as well as a dissemination plan describing how results will be communicated to scientific audiences and other stakeholders. NCCIH also encourages applicants to contact the relevant NIH scientific or research staff before submission, which is often important for confirming fit with NCCIH priorities and ensuring the proposed trial design matches the expectations for a multi-site, late-phase study.

Eligibility is broad and includes many types of domestic U.S. organizations and governments, such as state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities listed in the notice. The NOFO also highlights inclusion of several mission-relevant institution types and community-centered organizations, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, among others. However, non-U.S. (foreign) organizations are not eligible to apply as the applicant organization, and non-U.S. components of U.S. organizations are not eligible. At the same time, foreign components may be allowed as defined in NIH policy, meaning certain limited collaborations outside the U.S. can be included if they meet NIH requirements.

Key administrative details from the source include that this is a discretionary NIH funding opportunity using the cooperative agreement instrument, in the health funding category, associated with CFDA 93.213. The original closing date listed is July 16, 2024, and the opportunity was created on December 20, 2023. The NOFO does not specify an award ceiling or expected number of awards in the provided excerpt, so applicants would need to consult the full announcement and related NIH guidance for budget expectations, review criteria, and the detailed requirements for the UG3/UH3 milestones and the companion U24 DCC application.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (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): 93.213.
• This funding opportunity was created on 2023-12-20.
• Applicants must submit their applications by 2024-07-16. (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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