Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required) | PAR 24 125

Opportunity Information: Apply for PAR 24 125

The Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required) opportunity (PAR-24-125) is a National Institutes of Health (NIH) cooperative agreement designed to fund a dedicated Data Coordinating Center (DCC) that will partner with a separately proposed Clinical Coordinating Center (CCC) for an investigator-initiated, multi-site clinical trial. The trial must be Phase III or later and must be submitted under the related clinical trial NOFO (PAR-20-215). The key point is that NIH is not looking for a stand-alone coordinating center; it is specifically seeking a DCC application that is tightly linked to, and tailored for, a companion CCC application. Both applications must be submitted at the same time for the National Center for Complementary and Integrative Health (NCCIH) to consider the overall clinical trial project.

The purpose of the DCC is to provide the backbone infrastructure that makes a complex, multi-site clinical trial run consistently across locations. Applicants are expected to lay out a comprehensive plan for overall project coordination and administration, rigorous data management, and biostatistical support. In practical terms, this typically includes establishing and maintaining trial-wide systems and processes such as data capture and management workflows, data quality assurance, standardization across sites, statistical analysis planning and execution, and coordination of reporting and oversight activities. Because this is a cooperative agreement (U24), the work is generally carried out in close collaboration with NIH program staff, reflecting substantial NIH involvement compared with a standard research grant.

NCCIH will only support trials that align with its mission and are considered high priority by the Center. Since this initiative is focused on natural products, the expectation is that the broader clinical trial being proposed will address questions relevant to NCCIHs strategic vision and research priorities. Applicants are directed to review NCCIH program priorities on the NCCIH website and are strongly encouraged to contact the appropriate NCCIH scientific or research staff before submitting an application. That pre-submission conversation is positioned as an important step to confirm fit, scope, and expectations for both the clinical trial and the coordinating infrastructure.

A major compliance requirement in this NOFO is the Plan for Enhancing Diverse Perspectives (PEDP). The PEDP is not optional; it is required and will be evaluated during peer review as part of the scientific and technical assessment. Applications that do not include a PEDP will be considered incomplete and will be withdrawn without review. The NOFO encourages applicants to carefully follow the PEDP instructions and consult available NIH guidance materials, signaling that reviewers will expect a thoughtful, concrete plan rather than generic statements.

Eligibility for this opportunity is broad across U.S.-based organizations, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) as well as small businesses; and other entities listed in NIH eligibility categories. The NOFO also highlights additional eligible groups such as Historically Black Colleges and Universities (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 (AANAPISI), along with faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, foreign organizations are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply; however, foreign components (as NIH defines them in the NIH Grants Policy Statement) are allowed, which typically means discrete foreign collaborations may be permitted within an otherwise eligible U.S. applicant structure.

The opportunity is administered under CFDA 93.213 (health) with NIH as the funding agency. The original closing date listed is July 19, 2024, and the NOFO description does not specify an award ceiling or the expected number of awards in the provided summary. Overall, this program is best understood as a companion infrastructure award: it funds the specialized coordinating and analytic capacity needed to execute a high-priority, NCCIH-relevant, Phase III (or later) multi-site natural product clinical trial, and it must be submitted in lockstep with the corresponding CCC application.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 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 2024-02-06.
• Applicants must submit their applications by 2024-07-19. (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 24 125

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