Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required) | PAR 18 662

Opportunity Information: Apply for PAR 18 662

This NIH funding opportunity (PAR-18-662) from the National Center for Complementary and Integrative Health (NCCIH) supports the creation and operation of a Clinical Coordinating Center (CCC) for investigator-initiated, multi-site clinical trials that test mind and body interventions in NCCIH priority research areas. The trials can be designed as efficacy, effectiveness, or pragmatic studies, but the core expectation is that applicants propose a well-justified, multi-site clinical trial and show they can actually run it. The CCC is meant to be the hub that turns the scientific idea into a functioning, high-quality clinical trial across multiple locations, with clear operational control and coordination.

A central feature of this FOA is that the CCC application must present both the scientific rationale for the intervention and condition being studied, and a detailed, end-to-end operational plan for executing the trial. That includes how the study will be organized and governed, how sites will be selected and managed, how the intervention will be standardized and delivered across sites, and how the protocol will be implemented consistently. NCCIH is looking for applications that do not stop at an interesting hypothesis; they want credible, practical plans that anticipate common multi-site trial challenges and show readiness to manage them.

The CCC is expected to lay out comprehensive project management and trial operations. This typically includes a leadership structure (for example, a steering committee and other oversight bodies), clearly defined roles for investigators and sites, timelines, communication plans, training procedures, quality assurance, and monitoring plans to maintain protocol fidelity. Applications are also expected to describe participant recruitment and retention strategies in detail, since enrolling and keeping participants engaged is often the make-or-break factor in multi-site mind and body trials. NCCIH also expects a focus on performance milestones and tracking progress against them, along with plans for scientific conduct (such as adherence to good clinical practice, human subjects protections, and consistent intervention delivery) and a thoughtful approach to dissemination of results so findings can reach clinicians, communities, and researchers.

Funding uses a two-phase, milestone-driven cooperative agreement mechanism (UG3/UH3). In practical terms, the UG3 phase is usually a planning and start-up period where the team completes key preparatory tasks and demonstrates readiness to launch, while the UH3 phase supports full implementation of the clinical trial once predefined milestones are met. Because this is a cooperative agreement rather than a standard grant, NCCIH staff typically have substantial scientific and programmatic involvement, with progress tied to milestone achievement. Applicants should therefore be prepared to operate in a more collaborative, accountability-driven environment than a traditional R01-style award.

A major requirement is that the CCC application cannot stand alone. It must be paired with a separate, companion Data Coordinating Center (DCC) application submitted under PAR-18-116. The DCC is responsible for the data management and data analysis plan for the same clinical project, and NCCIH will only consider applications that are submitted together as a coordinated package. This design signals that NCCIH wants strong separation of responsibilities: the CCC drives clinical execution, while the DCC ensures robust data infrastructure, quality control, and analytic rigor for the shared trial.

Eligibility is broad and includes many U.S.-based organizations and government entities, such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments; tribal organizations (including those other than federally recognized tribal governments); 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 FOA also highlights participation from a wide range of institution types and community-connected organizations, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. At the same time, non-U.S. institutions are not eligible to apply as applicant organizations, and non-U.S. components of U.S. organizations are not eligible; however, foreign components as defined by NIH policy may be allowed, which typically means certain discrete international elements can participate under a U.S. applicant when justified and compliant with NIH rules.

Applicants are encouraged to align proposals with NCCIHs mission, strategic vision, and high-priority research areas, and the FOA explicitly recommends reviewing NCCIH planning materials on the NCCIH website. It also strongly encourages potential applicants to contact the relevant NCCIH scientific/research program contact before submitting, which is often important for confirming fit with NCCIH priorities, understanding expectations for the UG3/UH3 structure, and avoiding misalignment between the proposed trial and what NCCIH is prepared to support.

Key administrative details provided include the activity category (Health) and CFDA number 93.213, with the funding instrument being a cooperative agreement. The opportunity was created on 2018-02-14, and the original listed closing date was 2020-06-29. The award ceiling and expected number of awards are not specified in the provided summary, so applicants would typically need to consult the full FOA and NIH guide notices for budget expectations, limits, and current application cycles.

• 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 2018-02-14.
• Applicants must submit their applications by 2020-06-29. (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 18 662

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