Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required) | PAR 24 123

Opportunity Information: Apply for PAR 24 123

This funding opportunity (PAR 24-123) from the National Institutes of Health, through the National Center for Complementary and Integrative Health (NCCIH), supports investigator-initiated, multi-site clinical trials focused on natural products. The intent is to fund larger, later-stage studies (Phase III and beyond) that rigorously test the effects of products such as botanicals, probiotics, and items marketed as dietary supplements in areas that NCCIH has identified as high research priorities. The scope also explicitly includes well-defined nutritional regimens where the intervention is standardized to a specific naturally occurring compound, such as omega-3 fatty acids, anthocyanidins, or polyphenols, as long as there is compelling preliminary evidence to justify a definitive, multi-site trial.

A key feature of this NOFO is that it is for a Clinical Coordinating Center (CCC). The CCC is expected to be the operational and scientific hub that develops and carries out the proposed multi-site clinical trial. Applications should lay out a clear scientific rationale for why the natural product and clinical question merit a Phase III-or-later trial, and they must also present a comprehensive plan that shows the team can actually execute the study across multiple sites. That includes practical details on overall project management and coordination, site oversight, recruitment and retention strategies tailored to the study population, quality control for trial conduct, and plans to meet well-defined performance milestones. Applicants are also expected to address how results will be communicated and disseminated once the study is completed, reflecting the expectation that trials at this stage should produce findings that can influence practice, guidelines, or future research directions.

The award uses a cooperative agreement mechanism, meaning NCCIH will have substantial involvement during the project rather than acting only as a funder. Specifically, the mechanism is a two-phase, milestone-driven UG3/UH3 structure. In general terms, the UG3 phase functions as a time-limited start-up period focused on finalizing trial-ready elements and demonstrating readiness to proceed (for example, confirming operational capacity, meeting planning benchmarks, ensuring sites and procedures are prepared, and satisfying other pre-specified milestones). If those milestones are met, the project transitions to the UH3 phase, which supports full implementation of the multi-site clinical trial. This structure is meant to reduce risk and ensure that only trials that are truly ready to launch move into the more resource-intensive implementation phase.

Another non-negotiable requirement is that the CCC application cannot stand alone. An accompanying Data Coordinating Center (DCC) application must be submitted at the same time under a separate companion announcement (PAR-20-219). The DCC application is expected to cover the data management and statistical/data analysis infrastructure for the same clinical project. NCCIH will consider the CCC and DCC applications together, so applicants need to show that the clinical operations leadership and the data/statistics leadership are aligned on study design, endpoints, data flow, oversight, and reporting. Practically, this means the two applications should read as parts of one integrated trial effort, with clear division of responsibilities and strong coordination plans.

Eligibility is broad and includes many types of U.S.-based organizations, such as state, local, and tribal governments (including federally recognized tribes), public and private institutions of higher education, independent school districts, special district governments, public housing authorities/Indian housing authorities, nonprofits with or without 501(c)(3) status, for-profit organizations (other than small businesses), and small businesses, among others. The NOFO also highlights additional eligible applicant categories often emphasized in federal health research funding, including 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 (AANAPISISs), as well as faith-based or community-based organizations and U.S. territories or possessions. Foreign organizations are not eligible to apply, 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 discrete parts of the project may involve non-U.S. collaborators or activities if they meet NIH requirements and are well-justified.

Administratively, this is a discretionary funding opportunity using the cooperative agreement instrument, in the health funding category, with CFDA number 93.213. The listed original application due date is July 15, 2026. Applicants are encouraged to align their proposed clinical question and trial approach with NCCIHs mission and current research priorities by consulting NCCIH planning and priority materials on the NCCIH website. Overall, the opportunity is aimed at teams ready to run definitive, multi-site trials of well-characterized natural product interventions, with a strong emphasis on operational readiness, milestone accountability, and an integrated clinical and data coordinating structure.

• 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 Natural Products (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 2024-02-02.
• Applicants must submit their applications by 2026-07-15. (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 24 123

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