Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required) | PAR 24 313

Opportunity Information: Apply for PAR 24 313

This funding opportunity (PAR-24-313) is a National Institutes of Health (NIH) cooperative agreement that supports the creation and operation of a Data Coordinating Center (DCC) for an investigator-initiated, multi-site clinical trial of a natural product. It is designed specifically for Phase III and later clinical trials that align with the mission and high-priority research interests of the National Center for Complementary and Integrative Health (NCCIH), which is the NIH center focused on complementary, integrative, and natural product-related health research. The award uses the U24 mechanism, meaning it is intended to fund a dedicated coordinating infrastructure rather than the clinical trial itself, and it involves substantial NIH programmatic involvement typical of cooperative agreements.

A key feature of this opportunity is that the DCC application cannot stand alone. It must be paired with a corresponding Clinical Coordinating Center (CCC) application for the same multi-site trial, and both applications must be submitted at the same time for NCCIH to consider them. In practice, the CCC generally leads trial execution at clinical sites (operations, recruitment, intervention delivery, clinical oversight), while the DCC provides the cross-site backbone that makes the trial function as a single, consistent study: common data systems, centralized statistical leadership, uniform procedures, and coordinated governance. The NOFO is explicitly structured so the DCC plan is tailored to, and integrated with, the collaborating CCC-led trial application submitted under the companion clinical trial announcement (referenced as TEMP-26943 in the posting). NCCIH strongly encourages prospective applicants to contact the relevant Scientific/Research program contact before submission, which signals that early alignment with NCCIH priorities and expectations is important for competitiveness and responsiveness.

The purpose of the DCC under this NOFO is to propose and deliver a comprehensive, end-to-end coordination plan that covers overall project coordination plus administrative, data management, and biostatistical support for the multi-site trial. That typically means establishing and running trial-wide systems and processes such as: study governance support (committee structures, meeting cadence, documentation), standardized operating procedures across sites, centralized randomization support if needed, case report form development, data capture and data quality systems, data security and access controls, data cleaning and reconciliation workflows, monitoring of data completeness and protocol adherence metrics, statistical analysis planning and execution, interim reporting to oversight bodies when applicable, and preparation of datasets and documentation for sharing and publication. The emphasis is on making sure that all participating sites generate consistent, high-integrity data and that the trial can be managed efficiently across locations, timelines, and participant populations.

Eligibility is broad and includes many types of U.S.-based organizations: 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 tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The NOFO also calls out additional applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations and U.S. territories or possessions. At the same time, it clearly restricts foreign participation at the applicant level: non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components as defined by NIH policy are allowed, which generally means certain well-justified international elements could be included within a U.S.-led application if they meet NIH requirements and are appropriately justified.

From an administrative standpoint, this is listed as a discretionary funding opportunity with a Health funding activity category and CFDA number 93.213. The agency is NIH, with NCCIH as the relevant center. The opportunity was created on October 30, 2024, and the listed original closing date is July 14, 2026. The posting does not provide an award ceiling or expected number of awards in the excerpt provided, which often means applicants need to consult the full announcement and related NIH guidance for budget expectations, project period norms, and any institute-specific limits or recommendations.

Overall, this NOFO is best understood as support for the centralized operational and analytical hub of a large, later-phase natural product clinical trial, where NCCIH wants to see a well-integrated DCC-CCC partnership. The DCC is expected to demonstrate that it can manage complex, multi-site trial data and oversight demands at a high level, while aligning tightly with NCCIH priorities and the specific design and operational realities of the companion CCC trial application.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Natural Product Multi-Site Clinical Trial Data Coordinating Center (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 2024-10-30.
• 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 24 313

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