Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3) | PAR 17 174

Opportunity Information: Apply for PAR 17 174

The NIH National Center for Complementary and Integrative Health (NCCIH) funding opportunity titled "Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3)" (PAR-17-174) supports the creation and operation of a Clinical Coordinating Center (CCC) for large, investigator-initiated, multi-site clinical trials. The trials supported under this announcement are intended to be Phase III and beyond and must focus on testing the effects of natural products in areas that NCCIH has identified as high research priorities. In practical terms, this FOA is aimed at later-stage, definitive studies that require strong coordination across multiple clinical sites, standardized procedures, and rigorous trial oversight to produce results that are credible and broadly informative for clinical practice and public health.

A key feature of this opportunity is that it is specifically for the Clinical Coordinating Center function rather than simply funding a single clinical site. Applicants are expected to propose a CCC that will drive the overall design and execution of the multi-site trial, including the scientific rationale and the full operational plan. This includes developing a trial design that can answer the primary research question convincingly, setting up the governance and management structure needed for multi-site execution, and ensuring that the protocol, procedures, and data collection methods are consistent across all participating locations. Because natural product trials can involve complexities such as product standardization, sourcing, quality control, and reproducibility across batches, the CCC role is especially important for ensuring the intervention being tested is well-characterized and implemented consistently across sites.

The CCC is expected to take primary responsibility for the day-to-day and strategic management of the trial. That includes project management, establishing and monitoring performance milestones, and ensuring high-quality scientific conduct across all sites. The CCC should also present concrete plans for participant recruitment and retention, which are often among the biggest risks to successful completion of large clinical trials. In a multi-site setting, recruitment plans typically need to be both centrally coordinated and locally adaptable, so the CCC is expected to define strategies, set targets, monitor enrollment progress, and intervene when sites fall behind. Retention is treated as equally important, since differential dropout across sites can threaten statistical power and bias results, so a strong application would describe realistic retention methods and monitoring approaches.

The award uses a cooperative agreement mechanism, meaning NCCIH will have substantial involvement in the project rather than acting solely as a funder. Cooperative agreements generally imply more active collaboration with NIH program staff on major aspects of trial oversight and milestone evaluation. This FOA uses the UG3/UH3 two-phase, milestone-driven structure. The UG3 phase functions as an initial, time-limited stage focused on finalizing key elements required to launch a complex multi-site trial, such as completing protocol development, operational workflows, recruitment planning, data management readiness, and other startup requirements. Progress in the UG3 phase is assessed against pre-specified milestones. If milestones are met, the project transitions into the UH3 phase, which supports full implementation of the clinical trial, including enrollment, follow-up, and execution of the protocol across the network of sites. This structure is designed to reduce the risk of investing in a full-scale trial before critical feasibility and readiness benchmarks have been achieved.

In addition to executing the trial itself, the CCC is expected to handle dissemination of results. This goes beyond publishing papers and typically includes plans for timely reporting, communication of findings to relevant stakeholders, and sharing outcomes in a way that supports transparency and reuse. For multi-site trials, dissemination planning may also involve data sharing considerations, documentation of protocols and analytic methods, and coordinated messaging to ensure results are communicated accurately and responsibly, especially when the intervention relates to widely used natural products that may already be available to consumers.

From an eligibility standpoint, this is a discretionary federal funding opportunity in the health category (CFDA 93.213) offered by the National Institutes of Health. A wide range of applicant organizations are eligible, including state, county, and local governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); small businesses; independent school districts; special district governments; and eligible tribal entities, including federally recognized Native American tribal governments and other Native American tribal organizations. The FOA also explicitly calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions, reflecting NIH's broad eligibility framework and interest in inclusive participation across institution types.

Foreign eligibility is more restrictive in line with typical NIH rules for certain cooperative agreements. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as the applicant organization. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed. In practice, this means a U.S.-based applicant can include certain international elements in the project if they are justified and meet NIH policy requirements, but the primary applicant organization must be domestic and the project cannot be structured as a non-U.S. applicant or non-U.S. organizational component leading the application.

The opportunity was created on March 10, 2017, and the original closing date listed is March 6, 2018. While the provided record does not specify an award ceiling or expected number of awards, the emphasis of the FOA is clear: NCCIH is seeking well-prepared coordinating centers capable of delivering rigorous, later-phase, multi-site clinical trials of natural products, with strong operational leadership, milestone-based accountability, and a clear plan for producing and disseminating high-quality evidence in NCCIH priority areas.

• 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)" 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 2018-03-06. (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 17 174

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