Drug Induced Liver Injury Network (DILIN) Clinical Centers (U01 - Clinical Trial Optional) | RFA DK 22 013

Opportunity Information: Apply for RFA DK 22 013

This funding opportunity (RFA-DK-22-013) supports the continuation of the Drug-Induced Liver Injury Network (DILIN) by funding multiple DILIN Clinical Centers through the NIH cooperative agreement mechanism (U01; clinical trial optional). The central goal is to maintain and expand a coordinated, prospective national effort to find, enroll, and carefully document patients with suspected drug-induced liver injury (DILI), including cases linked to herbal and dietary supplements (HDS). These clinical centers serve as the front line of the network, identifying eligible patients, collecting standardized clinical information, and contributing to the systematic characterization of how DILI presents, progresses, and resolves across a wide range of agents and patient populations.

The opportunity is built around the reality that DILI is one of the hardest liver conditions to diagnose and manage because it can resemble nearly any other liver disease and can be triggered by hundreds of prescription drugs, over-the-counter products, and supplements. Over roughly two decades, DILIN has become a major source of evidence used by clinicians and researchers to understand DILI frequency, risk patterns, clinical features, and outcomes. The network has also helped move the field toward understanding mechanisms of injury (pathogenesis), which is critical for improving diagnosis, developing potential treatments, and ultimately preventing cases. In that sense, the clinical centers are not only expected to enroll participants, but to contribute to a consistent, high-quality evidence base that can support broader scientific advances and public health impact.

DILIN operates as a network, and this announcement specifically funds the Clinical Centers, while a separate companion announcement (RFA-DK-22-508) supports the DILIN Data Coordinating Center. The clinical centers and the data coordinating center are meant to function together: the clinical sites generate well-phenotyped cases and associated data, and the coordinating center supports standardized data management and network-wide operations. Because this is a cooperative agreement, recipients should expect substantial NIH involvement typical of U01 awards, with programmatic collaboration and coordinated expectations across sites rather than fully investigator-driven independence.

Eligibility is broad and includes many U.S.-based organization types commonly allowed under NIH funding: state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized Native American tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits (including both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The announcement also highlights categories such as Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. However, non-U.S. entities are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.

From an administrative perspective, the opportunity is listed as discretionary funding, uses a cooperative agreement funding instrument, and falls under the health-related activity category (CFDA 93.847). The sponsoring agency is the National Institutes of Health. The posting shows an award ceiling of $1,800,000. The opportunity was created on 2022-08-24, and the original closing date was 2022-10-27. In practical terms, applicants were being solicited to serve as DILIN Clinical Centers capable of consistently identifying and enrolling DILI/HDS cases and performing the careful clinical characterization needed to sustain the network’s role as the primary structured U.S. resource for understanding drug- and supplement-related liver injury.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Drug Induced Liver Injury Network (DILIN) Clinical Centers (U01 - Clinical Trial Optional)" 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.)
• Each selected applicant is eligible to receive up to $1,800,000.00 in funding.
• 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 22 013

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