Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 Clinical Trial Required) | PAR 21 242

Opportunity Information: Apply for PAR 21 242

This grant opportunity (PAR 21-242) is a National Institutes of Health (NIH) cooperative agreement using the U24 mechanism to support a Data Coordinating Center (DCC) for an investigator-initiated, multi-site clinical trial focused on mind and body interventions that align with the mission and priorities of the National Center for Complementary and Integrative Health (NCCIH). The core idea is that NCCIH is not looking for a stand-alone coordinating center in the abstract; it is specifically soliciting a DCC application that is paired with, and tailored to, a particular multi-site Phase III (and beyond) clinical trial application being submitted at the same time under the corresponding Clinical Coordinating Center (CCC) funding pathway (referenced as TEMP-12554). In practice, this means NCCIH will only consider the DCC if it is part of a matched set of applications: one application proposing the actual clinical trial operations (the CCC) and a second application proposing the coordinating and analytic backbone (the DCC), submitted simultaneously and designed to work together as a single integrated trial enterprise.

The purpose of the DCC is to lay out a full, trial-specific plan for overall coordination and for the technical infrastructure that makes a complex, multi-site trial credible and executable. NCCIH expects the DCC to cover project coordination and administration across participating sites, robust data management systems and workflows, and biostatistical leadership appropriate for a late-phase, multi-site clinical trial. While the FOA language stays high-level, the intent is clear: the DCC should be able to manage trial-wide data standards, quality control, database build and maintenance, data cleaning, audit trails, secure handling of sensitive information, and consistent procedures across sites. On the statistics side, the DCC is expected to support the trial with the design and analytic approach (including randomization schemes as appropriate), interim and final analyses as applicable, monitoring of data quality and performance metrics, and the kinds of reporting and documentation needed for a rigorous multi-site effort. Because this is a cooperative agreement, the award is structured for substantial NIH programmatic involvement compared with a standard research project grant, meaning applicants should anticipate active coordination expectations and ongoing interaction with NCCIH as the trial progresses.

Only trials that NCCIH deems both relevant to its mission and high program priority are intended to fall under this announcement. NCCIH emphasizes that applicants should consult the NCCIH website for its strategic vision and research priorities and, importantly, reach out to the appropriate NCCIH Scientific/Research contact before submission. That pre-submission contact is effectively a signal that fit and priority matter a lot here; applicants are being steered to confirm that the proposed mind and body intervention trial is within scope and competitive before investing in the paired CCC/DCC application package.

Eligibility is broad across U.S.-based organizations and governmental entities, reflecting NIH norms for clinical trial infrastructure. Eligible applicants 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; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other categories. The FOA also highlights additional eligible institution types such as 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, it draws firm boundaries around foreign participation: non-U.S. entities (foreign institutions) cannot apply as applicants, and non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components as defined under the NIH Grants Policy Statement are allowed, which typically means a U.S. applicant organization can include certain foreign activities or collaborations if they meet NIH policy requirements and are well-justified, even though the applicant organization itself must be domestic.

Administrative details from the opportunity listing include that this is a discretionary funding opportunity; the funding instrument is a cooperative agreement; the activity category is health; and the CFDA number is 93.213. The opportunity was created on 2021-06-14, and the listed original closing date is 2024-03-11. Award ceiling and expected awards are not specified in the provided listing, which often means applicants need to consult the full FOA text and NCCIH guidance for budget expectations and the likely scale of support. Overall, the announcement is best read as NCCIH building a structured, two-part submission pathway for high-priority, late-phase, multi-site mind and body intervention trials: one application to run the trial and another, tightly linked application to ensure the data, coordination, and statistics are strong enough to support definitive, practice-informing conclusions.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 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 21 242

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