Limited Competition for the Continuation of the Drug Induced Liver Injury Network Data Coordinating Center (DILIN) (U01 - Clinical Trial Not Allowed) | RFA DK 22 508

Opportunity Information: Apply for RFA DK 22 508

This NIH funding opportunity (RFA-DK-22-508) supports a limited competition to continue the Data Coordinating Center (DCC) for the Drug-Induced Liver Injury Network (DILIN) under a U01 cooperative agreement mechanism, with clinical trials not allowed. The purpose is to keep the national DILIN infrastructure operating and to sustain the centralized functions that allow multiple clinical sites to work as one coordinated network. In practice, the DCC serves as the operational hub that keeps enrollment, data flow, case assessment, quality control, and network-wide analyses consistent over time, which is essential for a condition like drug-induced liver injury (DILI) where cases are relatively uncommon, clinically diverse, and often difficult to diagnose with confidence.

A major emphasis of this continuation is the DCC's role in providing managerial, logistical, and analytic leadership for the network. That includes coordinating communications across participating clinical centers, maintaining standardized protocols and procedures, supporting data capture and management systems, ensuring data quality and harmonization, organizing network governance and meetings, and leading or supporting statistical and epidemiologic analyses that translate collected case data into publishable findings and actionable knowledge. Because DILIN is designed as a structured, systematic, prospective effort, the DCC is central to preserving continuity across years of case accrual and follow-up, allowing trends, outcomes, and risk patterns to be evaluated with rigor.

The announcement also highlights a specific collaborative expansion: the DCC is expected to build an active collaboration with the National Center for Natural Products Research (NCNPR) at the University of Mississippi. The intent of that collaboration is to improve the ability to identify specific hepatotoxic ingredients in herbal and dietary supplements (HDS) that have been implicated in liver toxicity. This is a notable need in the field because HDS-related liver injury can be especially hard to untangle due to complex mixtures of ingredients, variable product quality, labeling limitations, and the potential for adulterants or contaminants. By linking DILIN's clinical characterization and case adjudication strengths with specialized natural products expertise, the network aims to move beyond describing HDS-associated cases toward pinpointing which components may be responsible.

This funding opportunity is paired with a companion announcement (RFA-DK-22-013) that supports continuation of DILIN Clinical Centers (also U01, but clinical trial optional). Together, the two RFAs are structured to maintain both the on-the-ground clinical case identification and evaluation capabilities (Clinical Centers) and the central coordinating backbone (DCC). The overall program context emphasizes that DILI is one of the most challenging liver diseases to diagnose and manage, in part because it can mimic nearly any liver disorder and can be caused by a very wide range of agents, including prescription drugs, over-the-counter products, nutritional supplements, and herbal preparations.

The scientific and public health rationale is built around DILIN's track record and unique role. Over nearly two decades, DILIN has become a leading source of systematically collected, prospectively evaluated information on DILI and HDS-induced liver injury in the United States, with influence internationally through publications and shared methods. The network has advanced understanding of how these injuries present clinically, what outcomes patients experience, and which patterns are associated with worse prognosis, while also creating early inroads into disease mechanisms. By continuing the DCC, NIH is essentially preserving the infrastructure required to keep generating high-quality, comparable data and to support deeper analyses that can inform diagnosis, management, and ultimately prevention.

Eligibility is intentionally restricted. This is a limited competition, meaning only the current recipient(s) funded under the prior award (RFA-DK-17-510) are eligible to apply. The opportunity lists eligible applicant types such as public and state-controlled institutions of higher education, but the key practical constraint is that only the incumbent awardee(s) may submit. Foreign institutions are not eligible, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed, reinforcing that the work and infrastructure are expected to remain domestic.

Administratively, the sponsoring agency is the National Institutes of Health, the instrument is a cooperative agreement (U01), and the activity category is health (CFDA 93.847). The original closing date is listed as October 27, 2022, and the opportunity was created on August 24, 2022. While an award ceiling is not specified in the provided text, the structure and long-running nature of DILIN indicate this is intended to support a substantial coordinating operation rather than a small, short-term research project. Overall, the announcement is best understood as a continuation and enhancement of a national research network’s central coordinating capacity, with an added push to strengthen ingredient-level investigation of HDS-related liver injury through a targeted external collaboration.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of the Drug Induced Liver Injury Network Data Coordinating Center (DILIN) (U01 - Clinical Trial Not Allowed)" 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 2022-08-24.
• Applicants must submit their applications by 2022-10-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Public and State controlled institutions of higher education.

Apply for RFA DK 22 508

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