Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required) | PAR 18 696

Opportunity Information: Apply for PAR 18 696

This NIH opportunity (PAR-18-696) from the National Center for Complementary and Integrative Health (NCCIH) supports the creation of a Clinical Coordinating Center to plan and run investigator-initiated, multi-site clinical trials of natural products. The focus is on late-stage testing (Phase III and beyond) in NCCIH-designated areas of high research priority, meaning the trials are expected to be rigorous, sufficiently powered, and positioned to provide results that can meaningfully influence clinical practice, guidelines, or future research directions. Rather than funding a single-site study or an early feasibility pilot, the intent here is to enable large, multi-center clinical trials with strong coordination, standardized implementation across sites, and clear pathways to publish and share findings.

A defining feature of the FOA is that it funds the Clinical Coordinating Center (CCC) as the operational and scientific hub of the trial. Applicants are expected to lay out the scientific rationale and the full operational blueprint for executing the study across multiple sites. That includes the trial design and justification, the coordination strategy for participating clinical sites, and the concrete plans for managing day-to-day trial execution. The CCC is also expected to take primary responsibility for project management; participant recruitment and retention strategies; defining, tracking, and meeting performance milestones; ensuring high-quality scientific conduct (including protocol adherence and consistent implementation across sites); and disseminating results to the scientific community and other relevant audiences. In practice, this means the CCC application needs to show not only that the research question is important, but that the team has the operational capability to enroll participants, keep sites aligned, maintain quality oversight, and deliver interpretable outcomes on schedule.

The award uses a cooperative agreement mechanism, which signals substantial NIH programmatic involvement compared with a typical research grant. The funding mechanism is the two-phase, milestone-driven UG3/UH3 structure. The UG3 phase is generally used for planning, start-up, and readiness activities tied to predefined milestones (for example, finalizing protocols and manuals, establishing site readiness, regulatory approvals, contracting, recruitment infrastructure, and other launch-critical tasks). The UH3 phase supports the full implementation of the clinical trial after UG3 milestones are met. Because progression is milestone-dependent, applicants need to propose clear, measurable milestones and a credible timeline demonstrating that the trial can successfully transition from planning to execution.

A central requirement of this FOA is that the CCC application cannot stand alone. Applicants must submit an accompanying Data Coordinating Center (DCC) application at the same time under a separate companion announcement, PAR-18-123. The DCC is expected to cover the data side of the trial, including data management and data analysis planning. NCCIH will consider the CCC and DCC applications together, so the two applications should be aligned in trial design assumptions, operational workflows, timelines, and governance. In effect, the opportunity is structured as a coordinated pair of cooperative agreements: one for clinical operations and one for data operations, with both needed to form a complete multi-site clinical trial infrastructure.

Eligibility is broad and includes many U.S.-based public and private organizations, such as state, county, and local governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; special district governments; federally recognized Native American tribal governments; tribal organizations (including those other than federally recognized tribal 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. The FOA also explicitly highlights additional eligible applicant categories often emphasized by NIH, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, 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, non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible. However, foreign components as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant may include certain international elements if they meet NIH definitions and requirements, even though the applicant organization itself must be domestic.

From an administrative standpoint, the opportunity is categorized as discretionary funding and uses a cooperative agreement funding instrument within the health activity category (CFDA 93.213). The posting indicates an original closing date of November 4, 2019, and the public summary does not specify an award ceiling or expected number of awards. Overall, the FOA is best understood as a way for NCCIH to support well-justified, multi-site, late-phase natural product trials by funding the central coordinating infrastructure (the CCC) while requiring a parallel, integrated data coordinating structure (the DCC), with both awards governed by a milestone-based UG3/UH3 approach to reduce risk and promote successful execution.

• 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 2018-03-05.
• Applicants must submit their applications by 2019-11-04. (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 18 696

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