Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required) | PAR 24 275

Opportunity Information: Apply for PAR 24 275

The National Center for Complementary and Integrative Health (NCCIH) is soliciting applications for a Clinical Coordinating Center (CCC) to lead investigator-initiated, fully powered, multi-site clinical trials focused on complementary and integrative health approaches, particularly mind and body interventions. These trials can be designed as efficacy, effectiveness, or pragmatic studies and must align with NCCIH-designated areas of high research priority. The central expectation is that applicants propose Phase III (and later) multi-site trials with strong scientific justification and a clear path to producing rigorous, generalizable evidence about interventions that include physical and/or psychological therapeutic inputs, as well as multicomponent programs that may combine physical, psychological, and nutritional elements.

A CCC application under this opportunity is meant to function as the operational and scientific backbone of the trial. Applicants are expected to lay out the scientific rationale for the study question and provide a comprehensive plan for executing the trial across multiple sites. This includes the full project management structure, governance, and coordination approach; detailed participant recruitment and retention strategies suitable for multi-site implementation; and clear performance milestones that show how progress will be tracked and evaluated. The CCC is also responsible for ensuring high-quality scientific conduct across sites, including consistent protocol implementation, adherence to regulatory and ethical requirements, and plans for communicating and disseminating findings once the study is complete.

The funding mechanism is a milestone-driven, two-phase cooperative agreement using the UG3/UH3 structure. In practical terms, this means the project begins with a UG3 planning and start-up phase tied to specific, measurable milestones, and only transitions to the UH3 implementation phase if those milestones are successfully met. Because it is a cooperative agreement rather than a standard grant, NCCIH anticipates substantial involvement with awardees during the project, particularly around milestone achievement, trial conduct, and operational decision-making.

A key requirement is that the CCC application must be paired with a separate but coordinated Data Coordinating Center (DCC) application using the U24 mechanism under PAR-24-087. The DCC application is expected to propose the data management and data analysis plan for the same clinical project. Both applications (CCC and the corresponding DCC) must be submitted at the same time, and NCCIH will consider them together. This structure is intended to ensure that the operational leadership of the trial (CCC) and the data/statistical leadership (DCC) are both fully developed and aligned from the outset, with clear division of responsibilities and a shared plan for maintaining data quality, security, and analytic rigor.

Eligible applicants are broad and include many types of U.S.-based organizations and government entities. Examples listed include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); and small businesses. The opportunity also explicitly notes eligibility for organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, foreign organizations are not eligible to apply, and non-domestic components of U.S. organizations are not eligible.

The sponsoring agency is the National Institutes of Health (NIH), with the program housed within NCCIH, and the opportunity is categorized under health (CFDA 93.213). The funding opportunity number is PAR-24-275, and the instrument type is a cooperative agreement. The posting date provided is September 11, 2024, and the closing date listed is July 14, 2026. While an award ceiling and expected number of awards are not specified in the provided source data, the emphasis of the NOFO is less on a preset budget cap and more on proposing an appropriately powered, well-managed, milestone-driven multi-site trial that fits NCCIH priorities and can be executed reliably.

Applicants are encouraged to review NCCIHs strategic vision and priority areas via the NCCIH website and to contact the relevant NCCIH scientific/research program official before submitting. That outreach is positioned as important because the NOFO is tightly tied to NCCIH priority areas, and early communication can help ensure the proposed trial, intervention approach, and design choices match what the institute is aiming to fund, especially given the complexity of a multi-site Phase III trial and the need to coordinate simultaneously with a separate 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 2024-09-11.
• Applicants must submit their applications by 2026-07-14. (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 24 275

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