Natural Product, Multi-Site, Clinical Trial, Data Coordinating Center (Collaborative U24 - Clinical Trial Required) | PAR 18 697

Opportunity Information: Apply for PAR 18 697

This opportunity is a National Institutes of Health (NIH) cooperative agreement (U24) focused on supporting the Data Coordinating Center (DCC) for an investigator-initiated, multi-site clinical trial of a natural product. It is specifically tied to late-stage clinical testing, meaning Phase III and beyond, and it is designed to be submitted as a paired application alongside a separate but connected Clinical Coordinating Center (CCC) application. In other words, NIH is not looking for a stand-alone data center proposal; the DCC must be built around, and tailored to, a particular multi-site clinical trial that is being proposed at the same time through the companion clinical trial funding announcement (PAR-18-124). Both the DCC and CCC applications have to be submitted simultaneously to be considered.

The main purpose of the DCC under this FOA is to serve as the operational and analytical backbone of the trial. Applicants are expected to propose a comprehensive, end-to-end coordination plan that covers overall project coordination and administration, centralized data management, and biostatistical support. In practical terms, that typically means building and maintaining the trial data systems, standardizing data collection across sites, ensuring data quality and integrity, overseeing data flow and timelines, supporting randomization and statistical analysis plans, and producing the reports and deliverables needed for trial monitoring and decision-making. Because this is a cooperative agreement, recipients should also expect substantial NIH program involvement during the project period compared to a standard research grant, with NIH staff playing an active role in oversight and coordination.

The scientific scope is anchored in the mission of the National Center for Complementary and Integrative Health (NCCIH). The multi-site trial being supported must be relevant to NCCIH priorities and considered high priority by the Center, so applicants need to ensure the proposed natural product intervention and clinical question fit squarely within NCCIHs strategic vision and research portfolio. The announcement strongly encourages prospective applicants to review NCCIHs mission and research priorities on the NCCIH website and to contact the appropriate NIH scientific or research program contact before submitting, which is often important for confirming fit, clarifying expectations, and avoiding misalignment with NCCIH program goals.

Eligibility is broad across many U.S.-based organization types. Eligible applicants include state, county, and local 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 authorities and Indian housing authorities; nonprofits (including both 501(c)(3) and non-501(c)(3) entities) that are not institutions of higher education; for-profit organizations other than small businesses; and small businesses, among others. The FOA also calls out additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Foreign participation is restricted in a way that is common for NIH opportunities but can be confusing at first glance. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply as the applicant organization. Non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant organization may include certain foreign elements or collaborations when appropriately justified and structured under NIH policy, even though the primary applicant itself must be domestic.

Key administrative details included in the listing are the FOA number PAR-18-697, the funding instrument type (cooperative agreement), the broad activity area (health), and the CFDA number 93.213. The posting indicates an original closing date of November 4, 2019, and it does not specify an award ceiling or expected number of awards in the excerpt provided. The essential takeaway is that this FOA is meant for groups with strong clinical trial coordination, data infrastructure, and biostatistics capability who are partnering tightly with a CCC to run a high-priority, NCCIH-relevant, Phase III or later multi-site natural product clinical trial, with both applications developed as a single, integrated trial package and submitted together.

• 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 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 18 697

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