Liver Cirrhosis Network: Clinical Research Centers (U01 Clinical Trial Required) | RFA DK 20 003

Opportunity Information: Apply for RFA DK 20 003

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH), issued this discretionary funding opportunity to build a Liver Cirrhosis Network focused on adult cirrhosis. The aim is to strengthen and accelerate clinical and translational research by funding multiple Clinical Research Centers that can work together under a coordinated structure. This opportunity uses the U01 cooperative agreement mechanism, meaning funded sites would not operate in isolation; instead, they would conduct NIH-supported research with substantial scientific involvement from NIDDK, typically including close collaboration on study design, milestones, operations, and network-wide priorities. The announcement is explicitly marked "Clinical Trial Required," signaling that applicants are expected to be prepared to conduct clinical trials as part of their network activities rather than limiting work to observational studies only.

The network model described here is split across two linked funding announcements. This specific FOA (RFA-DK-20-003) solicits applications for the Clinical Centers, while a companion FOA (RFA-DK-20-004) solicits a single Scientific Data Coordination Center. In practice, this structure is designed to pair clinical sites that recruit, enroll, and follow participants with a centralized team responsible for data coordination and harmonization, data quality and monitoring systems, statistical support, and cross-site operational consistency. Together, the Clinical Centers and the Data Coordination Center are intended to create shared infrastructure that makes multi-site adult cirrhosis studies more feasible, more efficient, and more comparable across institutions.

From an administrative standpoint, the opportunity is categorized under health-related federal assistance (CFDA 93.847) and uses the cooperative agreement instrument rather than a standard grant, which typically indicates a more hands-on NIH role in governance and execution. The issuing agency is NIH/NIDDK. The original closing date listed for applications was December 1, 2020, and the posting date (creation date) was August 14, 2020. The award ceiling and the number of expected awards are not specified in the provided source text, so applicants would normally need to consult the full FOA to confirm budget limits, project period expectations, and how many centers NIDDK planned to support.

Eligibility is broad and includes many common U.S.-based applicant types: 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/Indian housing authorities; nonprofits with and without 501(c)(3) status (when not an institution of higher education); for-profit organizations (other than small businesses); and small businesses. The announcement also emphasizes inclusion of a range of mission-driven and community-connected institutions and organizations, 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), eligible federal agencies, and faith-based or community-based organizations, as well as regional organizations and U.S. territories or possessions.

At the same time, it places clear restrictions on non-U.S. applicants. Non-domestic (non-U.S.) entities and non-domestic foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" are allowed as defined in the NIH Grants Policy Statement, which usually means a U.S. applicant can include certain well-justified international elements (for example, specific collaborations, resources, or activities performed abroad) while remaining U.S.-led and compliant with NIH policy. This distinction matters because it preserves the ability to incorporate international expertise or unique resources without opening the competition to foreign institutions as primary applicants.

Overall, the opportunity is best understood as an NIH-led effort to create a coordinated, multi-center clinical research platform dedicated to adult liver cirrhosis, with an expectation of running clinical trials and producing clinically meaningful evidence. Successful applicants would likely need strong clinical hepatology capabilities, trial-ready infrastructure, a track record of enrolling and retaining participants, and the ability to collaborate effectively across a formal network that shares protocols, data standards, and governance with NIDDK and the companion Data Coordination Center.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Liver Cirrhosis Network: Clinical Research Centers (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2020-08-14.
• Applicants must submit their applications by 2020-12-01. (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 RFA DK 20 003

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