Continuation of the Clinical Centers for the Drug Induced Liver Injury Network DILIN (U01) | Apply Online

Opportunity Summary:

The grant opportunity titled "Continuation of the Clinical Centers for the Drug Induced Liver Injury Network DILIN (U01)" (Funding Opportunity Number RFA-DK-13-003) is a National Institutes of Health (NIH) funding announcement designed to support the ongoing work of the Drug Induced Liver Injury Network, commonly referred to as DILIN. The main goal is to encourage applications from qualified investigators at clinical centers who can continue building and maintaining a coordinated, multi-site research network focused on drug-induced liver injury. The announcement emphasizes that drug-induced liver injury remains one of the most difficult liver disease problems to deal with in real-world clinical medicine because it is often hard to recognize, can be mistaken for many other liver conditions, and can arise from a wide range of exposures including prescription medications, over-the-counter products, nutritional supplements, and herbal remedies.

Structurally, the DILIN effort described here is organized as a cooperative agreement (U01), which generally means the NIH expects substantial involvement in the conduct of the program, not just passive funding of independent projects. The network is expected to consist of up to five clinical center sites plus a single data coordinating center. In practical terms, this kind of setup is meant to create a consistent, standardized approach across sites for identifying and evaluating suspected cases, collecting clinical information, tracking outcomes, and ensuring that data are managed and analyzed in a unified way. By keeping the number of clinical sites relatively small and pairing them with a central coordinating hub, the program aims to maintain high-quality, harmonized clinical data while still capturing enough cases to study a condition that can be relatively uncommon at any one location but significant nationally.

The scientific and clinical rationale highlighted in the announcement centers on the complexity and variability of drug-induced liver injury. The FOA notes that hundreds of agents have been implicated, spanning conventional drugs as well as supplements and herbal products. Importantly, the clinical presentation can look like almost any type of liver disease, which is a major reason it is so challenging: patients may present with different patterns of liver test abnormalities, different symptom profiles, and differing timelines, and the condition can overlap with or mimic viral hepatitis, autoimmune liver disease, biliary disorders, metabolic conditions, and other hepatic injuries. A sustained network like DILIN is therefore positioned to improve how these cases are recognized, categorized, and understood, and to support more reliable methods for diagnosis and management through systematic case collection and expert evaluation across sites.

From an administrative standpoint, this opportunity falls under the NIH assistance listing associated with the National Institute of Diabetes and Digestive and Kidney Diseases (CFDA 93.847, Diabetes, Digestive, and Kidney Diseases Extramural Research). It is categorized as discretionary funding and uses the cooperative agreement mechanism rather than a standard research project grant. The FOA indicates there is no cost-sharing or matching requirement, which means applicants are not required to contribute a defined share of project costs from non-federal sources as a condition of the award.

Key dates show that the opportunity was posted on December 20, 2012, with an original and current closing date of February 27, 2013, and an archive date of March 30, 2013. The estimated total funding amount listed is $2,330,000, and the award ceiling is $250,000. These figures indicate a program with multiple awards planned, consistent with a network model involving several clinical centers and a coordinating center, though the ceiling suggests a limit on the amount per award or per budget period as specified in the full announcement.

Eligibility is broad across many types of U.S.-based organizations, reflecting NIH norms for institutional eligibility. Eligible applicants include state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status, with certain conditions), for-profit organizations other than small businesses, and small businesses. The FOA also explicitly includes a range of mission- or population-focused institutions and organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American Native American Pacific Islander serving institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies. At the same time, the announcement clearly excludes non-U.S. entities: foreign institutions may not apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed, reinforcing that this network is intended to be domestically operated.

For applicants and others seeking the complete requirements, expectations, and application instructions, the FOA provides a full announcement link hosted on the NIH grants site. The provided contact route is through the NIH Office of Extramural Research (OER) webmaster for access or linking issues, indicating that detailed scientific and administrative questions would typically be handled through the contacts listed within the full FOA document itself. Overall, this funding opportunity is best understood as a continuation support mechanism for a focused, collaborative clinical research infrastructure aimed at improving the identification, characterization, and understanding of drug-induced liver injury through a coordinated national network of clinical centers and centralized data management.

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