Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required) | PAR 20 215

Opportunity Information: Apply for PAR 20 215

This grant opportunity (PAR 20-215) is a National Institutes of Health (NIH) cooperative agreement aimed at supporting investigator-initiated, multi-site clinical trials of natural products, specifically Phase III and later studies. It is issued through the National Center for Complementary and Integrative Health (NCCIH) and focuses on testing the effects of natural products in NCCIH-designated areas of high research priority. The emphasis is not simply on running a clinical study at one location, but on building and operating a coordinated, multi-site trial effort that can generate rigorous, generalizable evidence about a natural product intervention.

A central requirement of the announcement is the establishment of a Clinical Coordinating Center (CCC). In practical terms, the CCC functions as the operational and scientific hub of the entire trial. Applicants are expected to lay out a clear scientific rationale for the study design and provide a full, end-to-end operational plan showing how the multi-site trial will be developed and executed. The CCC is expected to take the lead on project management across sites, coordinate timelines and deliverables, and ensure that the trial runs consistently and efficiently. This includes building robust participant recruitment and retention strategies suitable for a large, multi-site setting, defining performance milestones that can be tracked over time, and overseeing the scientific conduct of the trial so it meets the standards expected for late-phase clinical research. Another major expectation is dissemination of results, meaning the CCC should have credible plans for how findings will be communicated to scientific audiences and other stakeholders once the study is completed.

The funding mechanism is a two-phase, milestone-driven UG3/UH3 cooperative agreement. This structure is designed to fund projects in stages, with clear go/no-go decision points tied to progress. The UG3 phase generally supports planning and early execution activities needed to demonstrate readiness to move into the main trial phase, while the UH3 phase supports the full implementation of the clinical trial once predetermined milestones have been met. Because this is a cooperative agreement rather than a standard research grant, NIH/NCCIH is expected to have substantial involvement during the project, typically through collaborative oversight, milestone monitoring, and coordination consistent with NIH cooperative agreement practices.

The opportunity is categorized as discretionary funding, with a health-related activity category (CFDA 93.213). While the source text does not specify an award ceiling or the expected number of awards, it clearly indicates the scope is substantial enough to justify a dedicated coordinating center and multi-site Phase III-plus clinical trial infrastructure.

Eligibility is broad and includes many U.S.-based organization types: state, county, and city/township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicant categories 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, eligible federal agencies, regional organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions.

At the same time, there are important limits related to foreign participation. 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 are allowed as defined by the NIH Grants Policy Statement, meaning a U.S.-based applicant may be able to include certain foreign collaborations or elements if they meet NIH’s definition and requirements for foreign components.

Key administrative details in the provided source include the funding opportunity title, the opportunity number PAR 20-215, and that the original closing date listed was 2023-09-07, with a creation date of 2020-05-20. Overall, this FOA is geared toward teams prepared to run large, late-phase, multi-site clinical trials of natural products, with the Clinical Coordinating Center serving as the backbone for trial design, execution, oversight, and final dissemination of results under a milestone-based cooperative agreement 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 2020-05-20.
• Applicants must submit their applications by 2023-09-07. (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 20 215

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