Limited Competition for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Clinical Centers (U01 Clinical Trial Required) | RFA DK 23 515

Opportunity Information: Apply for RFA DK 23 515

This funding opportunity (RFA DK 23 515) is a National Institutes of Health (NIH) cooperative agreement (U01) designed to keep the existing Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) clinical centers operating while they finish ongoing clinical treatment trials and continue long-term, systematic collection of patient data and biospecimens. The emphasis is on sustaining the clinical site infrastructure that supports active studies and the network's longitudinal NAFLD database work involving both children and adults diagnosed across the spectrum of nonalcoholic fatty liver disease (NAFLD), including simple steatosis, nonalcoholic steatohepatitis (NASH), and NAFLD-related cirrhosis. Because the mechanism is a U01 cooperative agreement and explicitly states "Clinical Trial Required," awardees should expect substantial NIH program involvement and an expectation that funded sites will carry out the clinical trial-related responsibilities and network protocols rather than operating as fully independent investigator-initiated projects.

Programmatically, the NOFO is positioned as a continuation of a long-running, NIDDK-sponsored national research network that began in 2002 and was renewed in 2009 and 2014. The NASH CRN has historically targeted major unanswered questions about NASH and related NAFLD conditions, including causes and contributing factors, disease progression and natural history, complications, and treatment approaches. This continuation notice focuses on enabling the network to complete active trials already underway and to preserve the value of long-term follow-up by continuing to gather standardized clinical information and biospecimens over time. In practice, that typically means maintaining consistent enrollment and retention practices, ensuring high-quality data capture, supporting protocol-driven visits and assessments, and managing biospecimen handling so that samples remain usable for current analyses and future research questions.

The opportunity is described as a limited competition, meaning it is not structured as a wide-open solicitation for entirely new centers or new, unrelated projects, but rather as a mechanism to keep the established network clinical sites supported during a defined period of continued trial completion and longitudinal follow-up. The funding activity category is listed under Food and Nutrition, Health, with CFDA number 93.847, and the sponsoring agency is NIH (with the network historically sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, NIDDK). The original application closing date provided is 2023-11-08, and an award ceiling of $250,000 is listed in the source data.

Eligibility is broad across many domestic organization types, spanning 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 tribal governments; other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses); small businesses; and other categories. The notice also explicitly calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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 other than federally recognized, and U.S. territories or possessions. At the same time, the NOFO draws clear limits around foreign involvement: non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, and foreign components (as defined by NIH policy) are not allowed.

Overall, the core purpose is continuity and completion: keeping NASH CRN clinical centers funded so they can finish active treatment trials and protect the long-term scientific value of the network by continuing standardized, longitudinal NAFLD data and biospecimen collection across pediatric and adult populations. This structure supports consistent multi-site methods, preserves long-term cohorts, and enables ongoing analyses of disease drivers, progression, outcomes, and therapeutic responses in a way that single-site studies usually cannot match.

• 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 Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Clinical 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 2023-09-07.
• Applicants must submit their applications by 2023-11-08. (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 $250,000.00 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.

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