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

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This opportunity is NIH Notice of Funding Opportunity PAR 24-123 from the National Center for Complementary and Integrative Health (NCCIH). It supports investigator-initiated, multi-site clinical trials focused on natural products, with the intent to fund larger, later-stage studies (Phase III and beyond).

What kinds of studies does PAR 24-123 support?

It supports rigorous, definitive, multi-site clinical trials that test the effects of well-characterized natural products. The focus is on later-stage (Phase III and beyond) studies that are positioned to produce results that can meaningfully influence practice, guidelines, or future research directions.

What types of interventions are considered "natural products" under this opportunity?

The scope includes products such as botanicals, probiotics, and products marketed as dietary supplements. It also explicitly includes well-defined nutritional regimens where the intervention is standardized to a specific naturally occurring compound (for example, omega-3 fatty acids, anthocyanidins, or polyphenols), as long as there is compelling preliminary evidence supporting a definitive, multi-site trial.

Is this opportunity intended for early-stage or later-stage clinical trials?

This NOFO is intended for larger, later-stage trials (Phase III and beyond), not early exploratory clinical studies.

What is the main purpose of the Clinical Coordinating Center (CCC) in this NOFO?

The application is for a Clinical Coordinating Center (CCC), which is expected to serve as the operational and scientific hub for developing and carrying out the proposed multi-site clinical trial. The CCC is responsible for coordinating trial conduct across sites and demonstrating the team can execute the study as proposed.

What does NCCIH expect CCC applicants to include in the application?

CCC applications are expected to include (1) a clear scientific rationale explaining why the natural product and clinical question justify a Phase III-or-later multi-site trial, and (2) a comprehensive, practical execution plan showing readiness to run the trial across multiple sites. The plan should address project management and coordination, site oversight, recruitment and retention, quality control for trial conduct, and performance milestones. Applicants are also expected to address how results will be communicated and disseminated after study completion.

Does this opportunity require a milestone-driven approach?

Yes. The award uses a two-phase, milestone-driven UG3/UH3 structure. Progression depends on meeting pre-specified performance milestones designed to demonstrate readiness to proceed from start-up to full implementation.

What is the UG3 phase meant to cover?

The UG3 phase is a time-limited start-up period focused on finalizing trial-ready elements and demonstrating readiness to proceed. Examples described in the opportunity include confirming operational capacity, meeting planning benchmarks, ensuring sites and procedures are prepared, and satisfying other pre-specified milestones.

What is the UH3 phase meant to cover?

If UG3 milestones are met, the project transitions to the UH3 phase, which supports full implementation of the multi-site clinical trial.

What does it mean that this is a cooperative agreement?

This opportunity uses a cooperative agreement mechanism, meaning NCCIH will have substantial involvement during the project rather than acting only as a funder. The milestone-driven UG3/UH3 structure is part of how NCCIH manages readiness and risk in the funded trial.

Can a CCC application be submitted by itself?

No. A CCC application under PAR 24-123 cannot stand alone. An accompanying Data Coordinating Center (DCC) application must be submitted at the same time under the separate companion announcement PAR-20-219.

What is the role of the Data Coordinating Center (DCC) and why is it required?

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 both applications must reflect a coordinated, integrated trial effort.

How will NCCIH review the CCC and DCC applications?

NCCIH will consider the CCC and DCC applications together. Applicants should ensure the two applications align on study design, endpoints, data flow, oversight, and reporting, and that responsibilities between clinical operations and data/statistics leadership are clearly divided while remaining tightly coordinated.

What operational elements are highlighted as important for multi-site execution?

The NOFO highlights the need for practical details covering 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.

Is dissemination of results part of the expectations for this trial?

Yes. Applicants are expected to address how results will be communicated and disseminated once the study is completed, reflecting the expectation that later-stage trials should generate findings that can influence practice, guidelines, or future research.

What areas of research should applicants focus on?

The opportunity emphasizes alignment with NCCIHs mission and current research priorities. Applicants are encouraged to consult NCCIH planning and priority materials on the NCCIH website and align the proposed clinical question and trial approach with those priorities.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S.-based organizations, including (as listed) 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.

Are specific institution types explicitly highlighted as eligible?

Yes. The NOFO highlights additional eligible applicant categories often emphasized in federal health research funding, including 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). It also mentions faith-based or community-based organizations and U.S. territories or possessions.

Are foreign organizations eligible to apply?

No. Foreign organizations are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible.

Are any international collaborations allowed at all?

The NOFO notes that foreign components, as defined by NIH policy, may be allowed. This typically means discrete parts of the project may involve non-U.S. collaborators or activities if they meet NIH requirements and are well-justified.

What is the funding mechanism and structure for this opportunity?

This is a discretionary funding opportunity using the cooperative agreement instrument, structured as a two-phase UG3/UH3 award with milestone-based transition from start-up (UG3) to full trial implementation (UH3).

What is the CFDA number and funding category?

The opportunity is in the health funding category and lists CFDA number 93.213.

What is the application due date listed in the opportunity description?

The listed original application due date is July 15, 2026.

What is the overall goal of PAR 24-123?

The overall goal is to support teams that are ready to run definitive, multi-site clinical trials of well-characterized natural product interventions, with a strong emphasis on operational readiness, milestone accountability, and an integrated clinical (CCC) and data/statistics (DCC) coordinating structure.