Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required) | PAR 24 312

Opportunity Information: Apply for PAR 24 312

The National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH), is soliciting applications for a Clinical Coordinating Center (CCC) to support investigator-initiated, multi-site clinical trials that test natural products in NCCIH areas of high research priority. The focus is on later-stage trials (Phase III and beyond) that are ready for rigorous, real-world evaluation across multiple sites. In this program, "natural products" includes botanicals, probiotics, and products marketed as dietary supplements, as well as well-defined nutritional regimens that standardize a specific naturally occurring compound (for example, omega-3 fatty acids, anthocyanidins, or polyphenols) and are backed by compelling preliminary evidence. The underlying goal is to generate clear, high-quality clinical evidence about whether these interventions improve health outcomes in priority areas NCCIH has identified.

The CCC application is expected to do more than describe a research question. It must lay out the scientific rationale for the proposed intervention and provide a complete, end-to-end operational plan for launching and running a complex, multi-site clinical trial. NCCIH is looking for applications that demonstrate the ability to coordinate study start-up, harmonize procedures across sites, oversee clinical operations, and keep the trial on track. A strong application will typically spell out governance and decision-making structures, site onboarding and training plans, quality management processes, intervention fidelity strategies (so the product or regimen is delivered consistently), safety and regulatory oversight plans, and a realistic approach to meeting enrollment targets across diverse populations and locations.

A major emphasis is on practical execution: applicants are expected to present detailed project management approaches, participant recruitment and retention strategies, and clearly defined performance milestones. NCCIH signals that it wants milestone-driven accountability, meaning applicants should propose measurable, time-bound milestones that show readiness to transition from planning to full implementation. The CCC is also expected to address scientific conduct and integrity, including consistent protocol adherence across sites, management of clinical operations, and plans for communicating and disseminating results to appropriate audiences once the trial is complete. Dissemination is treated as part of the trial lifecycle, not an afterthought, so applicants should plan for how results will be shared with scientific, clinical, and potentially public stakeholders.

This opportunity uses a two-phase, milestone-driven cooperative agreement mechanism: UG3/UH3. In practice, that means the project begins with a UG3 phase that supports planning and start-up activities, and then transitions to the UH3 phase for full trial implementation once predefined milestones are met. Because this is a cooperative agreement rather than a traditional grant, NCCIH staff will have substantial involvement in project oversight and coordination. Applicants should be prepared for an active partnership model in which NIH program staff may participate in monitoring progress, reviewing milestone achievement, and helping guide the overall direction to ensure the trial meets NIH expectations for rigor, feasibility, and impact.

A key structural requirement is that a corresponding Data Coordinating Center (DCC) application must be submitted at the same time under a separate companion announcement (PAR-24-125). The DCC is expected to cover the data management and data analysis infrastructure for the same clinical project, and NCCIH will only consider the CCC application alongside its matched DCC application. In other words, applicants need to form a coordinated CCC-DCC team and submit both applications simultaneously so that the combined proposal demonstrates full coverage of clinical operations plus data systems, statistical planning, and analytic strategy.

Eligibility is broad and includes many organization types such as state, county, and local governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; independent school districts; special district governments; and tribal governments and tribal organizations. The announcement also highlights eligibility for a range of mission-relevant institutions and community-rooted organizations, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, and U.S. territories or possessions. At the same time, the policy on foreign involvement is specific: non-U.S. (non-domestic) entities are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply; however, foreign components as defined by the NIH Grants Policy Statement are allowed, which can enable certain international collaborations without making a foreign organization the applicant.

Administratively, this is a discretionary health funding opportunity issued by NIH under Funding Opportunity Number PAR-24-312, using the cooperative agreement funding instrument. The Assistance Listing (CFDA) number is 93.213. The original closing date listed is July 14, 2026. Applicants are also directed to consult NCCIHs mission, strategic vision, and research priorities to ensure alignment, using NCCIHs planning materials available on its website. The overall message of the NOFO is that NCCIH wants well-justified, operationally mature, multi-site Phase III+ trials of promising natural products, supported by a capable Clinical Coordinating Center working in tandem with a required Data Coordinating Center to deliver credible, actionable clinical evidence.

• 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 2024-10-29.
• 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 24 312

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