Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required) | PAR 21 243

Opportunity Information: Apply for PAR 21 243

The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is offering a cooperative agreement funding opportunity for organizations to serve as the Clinical Coordinating Center for investigator-initiated, multi-site clinical trials of mind and body interventions. The focus is on complementary and integrative health approaches that include physical and/or psychological therapeutic inputs, and the trials must align with NCCIH areas of high research priority. The intent is to support fully powered studies that can rigorously test these interventions in real-world or near real-world conditions, including efficacy trials, effectiveness trials, or pragmatic trials, depending on the research question.

A key feature of this opportunity is that the applicant proposing the Clinical Coordinating Center is expected to both develop and implement the entire multi-site clinical trial. In practical terms, the application needs to do more than describe a research idea; it must lay out the scientific rationale for the intervention and indication, and it must provide a detailed operational blueprint for how the study will actually run across multiple sites. NCCIH is looking for a complete plan that covers project management structures, coordination across clinical sites, training and quality assurance, and clear procedures to ensure the trial is conducted consistently and with high scientific integrity. Applications are also expected to include robust participant recruitment and retention strategies, since multi-site trials often succeed or fail based on enrollment and adherence. In addition, the proposal should define performance milestones and explain how progress will be monitored, and it should provide a credible plan for disseminating results so findings can inform science, clinical care, and public health.

Funding is provided through a two-phase, milestone-driven UG3/UH3 cooperative agreement mechanism. This structure typically means there is an initial phase (UG3) intended for finalizing start-up activities and demonstrating readiness to launch, followed by a second phase (UH3) that supports full implementation, contingent on meeting predefined milestones. Because it is a cooperative agreement rather than a standard grant, NCCIH program staff are expected to have substantial involvement during the project, particularly around oversight of milestones, coordination expectations, and trial conduct standards.

An important requirement is that a separate but linked Data Coordinating Center (DCC) application must be submitted at the same time as the Clinical Coordinating Center application. The DCC application is submitted under a companion FOA (referenced as PAR-XX-XXX in the text you provided) and must propose the data management and data analysis plan for the same clinical project. NCCIH will consider the Clinical Coordinating Center and DCC applications together, so applicants need to coordinate the scientific design, operational workflow, and data strategy across the two applications to ensure they are fully aligned (for example, on outcomes, data collection schedules, monitoring, analysis methods, and reporting).

Eligibility is broad and includes many types of U.S.-based organizations, such as state, county, and local governments; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; independent school districts; special district governments; public housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The announcement also explicitly highlights additional eligible applicants 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), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components as defined in NIH policy may be allowed, which generally means certain limited, well-justified international elements could be included when permitted under NIH rules.

From an administrative standpoint, the opportunity is listed as PAR 21-243, categorized as discretionary funding, and uses the cooperative agreement funding instrument. It falls under the health activity category and is associated with CFDA number 93.213. The original closing date shown is March 11, 2024. The announcement encourages applicants to review NCCIHs mission, strategic vision, and research priorities on the NCCIH website and to contact the relevant NCCIH scientific or research program contact before submitting, which is often important for confirming programmatic fit and understanding expectations for trial scope, intervention rationale, and milestone planning.

• 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 2021-06-14.
• Applicants must submit their applications by 2024-03-11. (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 21 243

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