Single Source for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Data Coordinating Center (U24 Clinical Trial Required) | RFA DK 23 516

Opportunity Information: Apply for RFA DK 23 516

The funding opportunity titled "Single Source for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Data Coordinating Center (U24 Clinical Trial Required)" (RFA-DK-23-516) is a non-competitive Notice of Funding Opportunity from the National Institutes of Health, specifically the National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK). It is structured as a cooperative agreement (U24), which means NIH program staff are expected to have substantial involvement in the work as it moves forward, rather than acting only as a standard grant funder. The notice is designed to support one award only, with NIH stating its intent to make a single-source award to Johns Hopkins University to continue operating the NASH CRN Data Coordinating Center.

The core purpose is continuity and closeout of major network activities. The Data Coordinating Center is being funded to support the NASH Clinical Research Network as it finishes and reports results from its active clinical treatment trial and also completes the closeout of the network's prospective database known as DB3. In practical terms, this implies the coordinating center will manage and finalize the remaining clinical trial coordination tasks and ensure that the data infrastructure and data products are properly finalized. That typically includes database management, data cleaning and validation, statistical analyses, preparation of final datasets, and support for publications and reporting requirements tied to both the clinical trial and the longitudinal/prospective database.

This NOFO sits within a long-running NIDDK-supported research effort. The NASH CRN has been sponsored by NIDDK since 2002 and has gone through multiple renewals (2009, 2014, and 2019). The network's research has broadly addressed nonalcoholic steatohepatitis (NASH), including its causes and contributing factors, how the disease progresses over time (natural history), the complications that can arise, and therapeutic approaches. By emphasizing continuation of the Data Coordinating Center, NIDDK is signaling that the network is in a mature phase where completing analyses, final reporting, and responsible data closeout are the key priorities, rather than launching a new competitive round for a different coordinating center.

In terms of logistics and funding parameters, the opportunity falls under the Food and Nutrition, Health activity category and is associated with CFDA number 93.847. The award ceiling listed is $1,000,000. The posting indicates an original closing date of 2023-11-08 and a creation date of 2023-09-07. While the metadata includes "Eligible Applicants: Small businesses," the narrative makes clear this is a single-source, non-competitive action intended for Johns Hopkins University, meaning it is not functionally open for broad competition in the way typical grant solicitations are.

Eligibility limitations are explicitly stated for non-U.S. participation. Non-domestic (non-U.S.) entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them in the NIH Grants Policy Statement) are not allowed. In other words, the award is intended to remain entirely within eligible U.S.-based organizational structures without foreign components, consistent with the single-source continuation purpose and NIH policy constraints described in the notice.

Overall, this opportunity is best understood as a targeted, administrative-and-scientific continuity award meant to ensure the NASH CRN can properly finish its remaining clinical trial obligations and responsibly close out, analyze, and disseminate findings from DB3. The emphasis is on completing and reporting ongoing work, preserving data integrity, and delivering final analyses and publications that capture the full value of a network that has been operating for more than two decades under NIDDK sponsorship.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Single Source 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 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 $1,000,000.00 in funding.
• Eligible applicants include: Small businesses.

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