Alcoholic Hepatitis Clinical and Translational Network Late Phase Clinical Trials and Observational Studies (Collaborative U01) | RFA AA 18 002

Opportunity Information: Apply for RFA AA 18 002

The Alcoholic Hepatitis Clinical and Translational Network Late Phase Clinical Trials and Observational Studies (Collaborative U01) opportunity (RFA-AA-18-002) is a National Institutes of Health funding announcement issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Its main purpose is to build on and continue an earlier NIAAA-supported Translational Research in Alcoholic Hepatitis program by speeding up the discovery, testing, and validation of better diagnostic tools and more effective treatments for people with Alcoholic Hepatitis (AH). The larger initiative is organized as a coordinated set of five funding opportunity announcements designed to strengthen and consolidate work into a single, more unified Alcoholic Hepatitis (AH) Clinical and Translational Network.

Within that broader AH Network structure, this specific FOA focuses on the “clinical” side of the network: it invites investigator-initiated, multi-site, collaborative late phase clinical trials and observational studies in patients with AH. “Late phase” generally implies studies that are closer to real-world clinical use, such as larger confirmatory trials, pragmatic effectiveness studies, or well-structured observational research intended to refine clinical decision-making, validate biomarkers, compare clinical strategies, and establish evidence for adoption in practice. The intent is not just to fund standalone projects, but to support studies that fit into a coordinated network environment where clinical research can be aligned with data coordination and translational science, making it easier to generate results that are robust, comparable across sites, and useful for patient care.

Awards are made using the U01 cooperative agreement mechanism, which means the project is expected to be collaborative in a structured way, with substantial NIH scientific and/or programmatic involvement compared to a standard investigator-initiated grant. In practice, a cooperative agreement typically comes with expectations around coordination, shared governance, adherence to network-wide policies (such as common data elements and harmonized protocols where appropriate), participation in steering or oversight activities, and close interaction with the NIH and other network components. The FOA sits within a larger program that includes a Clinical component, a Data Coordinating Center, a Translational component, and a Basic and pre-clinical component, with the overarching idea that clinical trials and observational studies can be strengthened by shared infrastructure and by tight linkages to translational and preclinical insights.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, and 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3), excluding higher education institutions where relevant); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, tribal governments that are not federally recognized, and U.S. territories or possessions. At the same time, it draws a clear boundary on foreign eligibility: non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant may include certain scientifically justified international elements under NIH policy even though a foreign organization cannot be the applicant institution.

Administratively, this is a discretionary grant opportunity in the health area, listed under CFDA 93.273, and offered as a cooperative agreement. The source information indicates an original closing date of 2017-10-23, an expected number of awards of 9, and a creation date of 2017-08-23. The award ceiling is not specified in the provided listing, which typically means applicants would need to consult the full FOA text for budget limits, project period expectations, and any network-specific cost caps or required cost categories.

Taken together, the opportunity is designed for research teams that can run rigorous AH clinical studies while also working as part of a larger coordinated network. The emphasis is on collaboration, shared infrastructure, and studies that can directly move the field toward validated diagnostics and treatments for Alcoholic Hepatitis, rather than isolated projects that do not integrate with broader program goals and network standards.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Alcoholic Hepatitis Clinical and Translational Network Late Phase Clinical Trials and Observational Studies (Collaborative U01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273.
• This funding opportunity was created on 2017-08-23.
• Applicants must submit their applications by 2017-10-23. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 9 candidate(s).
• 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.

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