Multi-Site Randomized Controlled Clinical Trial Research Center on Alcohol's Health Effects (U10) | PAR 16 363

Opportunity Information: Apply for PAR 16 363

The opportunity titled "Multi-Site Randomized Controlled Clinical Trial Research Center on Alcohol's Health Effects (U10)" is a National Institutes of Health (NIH) cooperative agreement funding announcement that supports the launch and execution of investigator-initiated, multi-site randomized controlled clinical trials focused on alcohol's health effects. The scientific emphasis is on neurological diseases, with a particular spotlight on stroke, as well as health problems linked to aging. In practical terms, the goal is to fund trials that can answer high-impact clinical questions about how alcohol exposure, reduction, or related interventions affect brain and vascular outcomes and broader aging-related health endpoints, using rigorous randomized trial methods across multiple clinical sites.

A central feature of this FOA is that it is for trial implementation, not trial planning. Applicants are expected to be ready to start the study when the award is made, without needing an additional planning period to finalize major design elements, site readiness, protocols, or operational logistics. Because of that expectation, the FOA strongly points to prior completion of planning activities, especially through an NIAAA-funded U34 clinical trial planning grant. While having an NIAAA U34 is not framed as the only path to eligibility, the announcement makes clear that applicants should already have the groundwork completed to the level normally achieved during a structured planning award, including a well-developed protocol and the operational ability to activate the trial quickly.

The award mechanism is a U10 cooperative agreement, which generally means the project is funded as a partnership between the research team and NIH rather than a fully independent research grant. Under a cooperative agreement, investigators still lead the science and day-to-day trial conduct, but NIH typically has substantial programmatic involvement, often including collaboration on key scientific or operational decisions, adherence to NIH trial policies, and coordinated oversight expectations appropriate for a complex multi-site clinical trial. The activity category is Health, and the listing references CFDA numbers 93.273 and 93.853, indicating it sits within NIH research assistance programs relevant to alcohol research and related health areas.

Eligibility is broad and includes many types of domestic organizations and government entities. Eligible applicants include state, county, city or township 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those nonprofit categories as specified); for-profit organizations other than small businesses; small businesses; and other organizational types listed by the FOA. The announcement also explicitly highlights a range of institution types and community-based entities, such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander 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, reflecting an intent to include diverse institutions and potentially diverse populations in research participation and leadership.

At the same time, the FOA places clear limits on foreign participation. Non-domestic (non-U.S.) entities and non-domestic foreign institutions are not eligible to apply as the primary applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement, meaning a U.S. applicant may include certain foreign collaborations or performance components if they meet NIH definitions and requirements, even though the primary awardee must be a domestic organization.

The administrative details provided indicate the FOA number is PAR 16 363, the opportunity category is discretionary, and the funding instrument type is a cooperative agreement. The original closing date listed is 2016-01-12, and the creation date is 2015-10-05, which situates the announcement historically and may matter for anyone checking whether the FOA is still active versus replaced by a newer iteration. Award ceiling and expected awards are not specified in the provided text, suggesting prospective applicants would have needed to consult the full FOA or NIH program contacts for budget expectations and projected number of awards.

Overall, this opportunity is designed for research teams that already have a fully planned, multi-site randomized controlled trial ready to initiate, and that can use NIH cooperative agreement support to execute a complex clinical trial specifically aimed at clarifying alcohol's effects on stroke and other aging-related health outcomes. The focus on immediate readiness, multi-site infrastructure, and randomized trial rigor signals that NIH was looking for mature, operationally prepared projects capable of producing clinically meaningful evidence rather than exploratory or early-stage planning efforts.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Multi-Site Randomized Controlled Clinical Trial Research Center on Alcohol's Health Effects (U10)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273, 93.853.
• This funding opportunity was created on 2015-10-05.
• Applicants must submit their applications by 2016-01-12. (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 16 363

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