Limited Competition for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Clinical Centers (U01 Clinical Trial Required) | RFA DK 18 505

Opportunity Information: Apply for RFA DK 18 505

The funding opportunity titled "Limited Competition for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Clinical Centers (U01 Clinical Trial Required)" (RFA-DK-18-505) is a National Institutes of Health (NIH) announcement designed to keep the existing NASH Clinical Research Network clinical sites operating as they finish ongoing clinical treatment trials and continue long-term, systematic data and biospecimen collection. The core goal is continuity: maintaining established clinical infrastructure and patient cohorts so the network can complete active interventional studies and keep building a longitudinal database of both pediatric and adult patients with the full spectrum of nonalcoholic fatty liver disease (NAFLD), including simple steatosis, nonalcoholic steatohepatitis (NASH), and NAFLD-related cirrhosis. This ongoing, structured follow-up work is framed in the opportunity as the NAFLD database study, emphasizing long-term observation and specimen/data capture in addition to the completion of treatment trials.

This FOA is issued as a cooperative agreement (U01), which means NIH will have substantial involvement in the project’s direction and oversight compared to a standard research grant. The "clinical trial required" designation signals that funded sites are expected to be actively involved in clinical trial activities as part of the network, not merely observational research. In practice, this type of award supports the kind of coordinated, multi-site clinical research that benefits from shared protocols, harmonized data standards, central oversight, and consistency in biospecimen handling and clinical assessments across institutions.

The scientific focus of the NASH CRN, as described in the announcement, spans the major unanswered questions that drive NAFLD and NASH research: understanding etiology and contributing factors, mapping natural history and complications over time, and evaluating therapies. The FOA situates this continuation within a long-running NIH-sponsored effort. The NASH CRN has been supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) since 2002, with renewals in 2009 and 2014, underscoring that this is an established national research network with existing cohorts, procedures, and trial experience. The limited-competition nature of the opportunity further reinforces that the intent is not to create a brand-new network from scratch, but to sustain the already participating clinical centers so they can complete ongoing commitments and preserve the value of long-term follow-up.

Eligibility is restricted. The primary eligible applicant category listed is public and state-controlled institutions of higher education. The announcement also makes clear that non-U.S. entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, foreign components, as defined by NIH Grants Policy, are allowed, meaning certain types of collaboration or elements of work occurring outside the U.S. may be permissible under NIH’s definitions and rules even though foreign institutions cannot serve as the applicant organization. Because these distinctions can be technical and fact-specific, the FOA explicitly directs applicants to consult the full eligibility language in the funding opportunity for the controlling requirements.

Administratively, the opportunity is categorized as discretionary funding and falls under the NIH assistance listing (CFDA) number 93.847, with an activity category tagged to food and nutrition and health. The announcement was created on August 24, 2018, with an original closing date of October 31, 2018. The listed award ceiling is $2,000,000. The number of expected awards is not specified in the provided source text, which is consistent with some NIH postings where final award counts depend on appropriations, program priorities, and application volume/quality.

Overall, this FOA is best understood as a continuation mechanism for an established, multi-center NIDDK-backed clinical research network. It prioritizes finishing active NASH/NAFLD treatment trials already underway and preserving the long-term scientific value of the network by continuing standardized, longitudinal collection of clinical data and biospecimens from children and adults across the NAFLD disease spectrum.

• 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 2018-08-24.
• Applicants must submit their applications by 2018-10-31. (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 $2,000,000.00 in funding.
• Eligible applicants include: Public and State controlled institutions of higher education.

Apply for RFA DK 18 505

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