Limited Competition for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Data Coordinating Center (U24 Clinical Trial Required) | RFA DK 18 506

Opportunity Information: Apply for RFA DK 18 506

This funding opportunity, RFA-DK-18-506, is a limited competition cooperative agreement (U24, clinical trial required) from the National Institutes of Health (NIH), specifically within NIDDK, to continue support for the Data Coordinating Center (DCC) of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN). The main goal is to maintain the central coordinating infrastructure that allows the network to finish ongoing interventional clinical treatment trials and to keep collecting long-term (longitudinal) clinical data and biospecimens from both children and adults affected by nonalcoholic fatty liver disease (NAFLD). NAFLD in this context is broad and includes simple steatosis, steatohepatitis (NASH), and NAFLD-related cirrhosis, with continued follow-up occurring through the NAFLD database study.

The announcement reflects that the NASH CRN is an established, long-running research network sponsored by NIDDK since 2002, with prior renewals in 2009 and 2014. Across its history, the network has focused on understanding causes and contributors to NASH, how the disease progresses over time, what complications arise, and how different therapies perform. By continuing the DCC, NIH is essentially prioritizing continuity: preserving the ability to manage active trials to completion, sustain standardized data collection across sites, and protect the scientific value of long-term patient follow-up and banked specimens. The emphasis on longitudinal biospecimen and data gathering signals that the DCC is expected to support high-quality, consistent collection and curation so that future analyses of disease course, outcomes, and treatment response remain possible and reliable.

Because this is a cooperative agreement, the award mechanism implies substantial involvement from NIH program staff in the conduct and oversight of the project compared with a typical investigator-initiated research grant. The DCC role in a network like NASH CRN generally centers on operational and scientific coordination activities that make multi-site clinical research function smoothly: supporting trial operations, maintaining databases, ensuring data quality control, coordinating statistical design and analysis, managing protocol compliance and reporting, facilitating communications across clinical sites, and enabling the secure handling and tracking of biospecimens and associated clinical metadata. The “clinical trial required” designation indicates that the funded coordinating center is expected to directly support clinical trial activities as part of the network’s portfolio, rather than only observational data management.

Eligibility is narrow, consistent with the “limited competition” framing. The listed eligible applicant type is public and state-controlled institutions of higher education. The notice also clarifies restrictions related to foreign participation: non-U.S. (foreign) institutions are not eligible to apply as the applicant organization, and non-U.S. components of U.S. organizations are not eligible to apply. At the same time, “foreign components,” as defined in the NIH Grants Policy Statement, are allowed, meaning certain parts of the work can involve foreign elements if they meet NIH’s definition and requirements, even though the prime applicant must be eligible and not a foreign institution. Applicants are directed to the full funding announcement for the precise eligibility details and definitions.

Key administrative details include an original closing date of October 31, 2018, a funding activity category aligned with food and nutrition and health, and a CFDA listing of 93.847. The award ceiling is listed as $2,000,000. The opportunity was created on August 24, 2018. Taken together, the FOA is aimed at sustaining the central coordination backbone of an established NIH-sponsored clinical research network so it can complete ongoing trials and preserve the integrity and utility of long-term NAFLD/NASH clinical data and biospecimen resources.

• 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) Data Coordinating Center (U24 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.

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