Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3) | PAR 17 175

Opportunity Information: Apply for PAR 17 175

The National Institutes of Health, through the National Center for Complementary and Integrative Health (NCCIH), offered this funding opportunity (PAR-17-175) to support investigator-initiated, multi-site clinical trials focused on mind and body interventions in NCCIH-designated areas of high research priority. The core idea is to fund a Clinical Coordinating Center (CCC) that can take primary responsibility for designing, organizing, and running a rigorous multi-site trial, whether that trial is framed as an efficacy study, an effectiveness study, or a more pragmatic trial intended to reflect real-world conditions. In other words, the award is aimed less at a single research site and more at the central operational hub that can coordinate multiple sites to deliver a high-quality, consistent clinical trial.

A key expectation in this announcement is that applicants do more than propose an interesting research question. The CCC application is supposed to lay out the scientific rationale for the intervention and the target condition, and then match that rationale with a complete operational blueprint for how the study will actually happen across sites. That includes a clear plan for project management and governance, trial start-up activities, harmonized study procedures, quality control, and day-to-day coordination among participating sites. The FOA emphasizes practical, concrete planning: how participant recruitment will be achieved across diverse locations, how retention will be maintained over time, and how protocol adherence and data integrity will be monitored so that results are credible and interpretable.

The opportunity also highlights the importance of milestones and accountability. Funding is structured as a two-phase, milestone-driven cooperative agreement using the UG3/UH3 mechanism. The UG3 phase is generally understood as a start-up and planning period where the team finalizes the protocol and operational systems and demonstrates readiness through predefined performance benchmarks. If those milestones are met, the project transitions into the UH3 phase, which supports full implementation of the clinical trial. Because this is a cooperative agreement rather than a standard grant, NIH involvement is typically more active than in an R-series award, with NIH and the awardee working together to ensure that the trial is feasible, well-managed, and on track to meet its recruitment, retention, and quality targets.

Applications under this FOA are expected to address the full scientific conduct of the trial, including how outcomes will be measured consistently across sites, how safety and participant protections will be handled, and how the study will maintain high standards for data management and monitoring. Just as importantly, the CCC is expected to plan for dissemination of results, meaning applicants should explain how findings will be shared with scientific audiences and, where appropriate, with clinicians, patients, and other stakeholders. The emphasis on dissemination signals that NCCIH is looking for trials that can produce actionable evidence, not just exploratory observations.

Eligibility is broad and includes many types of U.S.-based organizations and governments. Eligible applicants listed include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The FOA also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, tribal governments that are not federally recognized, and U.S. territories or possessions. At the same time, it draws a firm line on foreign eligibility: non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which generally means certain international elements can participate when justified, even though the applicant organization itself must be eligible and domestic.

From the administrative details provided, this was a discretionary funding opportunity using a cooperative agreement funding instrument, categorized under health, with CFDA number 93.213. The sponsoring agency is NIH. The record lists an original closing date of February 14, 2018, and a creation date of March 10, 2017. No award ceiling or expected number of awards is specified in the provided data, which typically means applicants would need to consult the full FOA text or NIH notices for budget expectations, scope constraints, and any institute-specific funding plans.

In practical terms, a strong application to this FOA would read like a combined scientific justification and operations manual for a multi-site mind and body intervention trial. It would explain why the trial matters, what exactly will be tested, how the trial will be executed across multiple locations with consistent methods, how enrollment goals will be achieved and maintained, how success will be measured through milestones, and how the results will be responsibly reported and shared. The overall intent is to generate high-quality clinical evidence about mind and body interventions by funding a coordinating center capable of delivering a complex, multi-site study from start-up through final dissemination.

• 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)" 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 2017-03-10.
• Applicants must submit their applications by 2018-02-14. (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 17 175

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