Limited Competition: Competitive Supplement to the Coordinating Center for Type 1 Diabetes TrialNet (U01 Clinical Trial Required) | RFA DK 19 506

Opportunity Information: Apply for RFA DK 19 506

This grant opportunity, titled "Limited Competition: Competitive Supplement to the Coordinating Center for Type 1 Diabetes TrialNet (U01 Clinical Trial Required)" (RFA-DK-19-506), is an NIH discretionary funding announcement that offers a competitive supplement under a cooperative agreement mechanism (U01). It focuses on accelerating intervention research for type 1 diabetes (T1D), a lifelong autoimmune disease that commonly begins in childhood or early adulthood and creates significant daily health and quality-of-life burdens. The scientific rationale behind the opportunity is that recent advances in clinical trial methods and in the understanding of T1D disease mechanisms have opened realistic pathways to delay the onset of T1D or slow its progression, especially if interventions are tested earlier in the disease course.

The purpose of the supplement is to provide additional resources to support the design and execution of new intervention studies conducted through the Type 1 Diabetes TrialNet network (TrialNet). The targeted study populations include people at early, pre-clinical stages of T1D (before full clinical diagnosis, when risk markers are present) as well as individuals with new-onset T1D (recently diagnosed). In practical terms, the supplement is meant to strengthen TrialNet's ability to move promising prevention or early-treatment strategies into well-run, network-based clinical trials that can generate reliable evidence about whether an intervention can delay diagnosis, preserve insulin-producing beta cell function, or otherwise alter the trajectory of disease.

This is a limited competition announcement. Eligibility is essentially restricted to the Program Director/Principal Investigator of the TrialNet Coordinating Center (TNCC) that is already funded and actively supporting TrialNet research operations. The TNCC is described as the hub that provides scientific and operational leadership across the network, including study design and trial monitoring; clinical and laboratory testing capabilities needed to run multi-site trials; and the core infrastructure for data collection, processing, biostatistical analysis, and administrative operations. Because the TNCC serves as the coordinating backbone for TrialNet, the supplement is structured to flow through that center rather than being open to a broad pool of independent applicants.

The announcement lists eligible applicants as public and state-controlled institutions of higher education, reflecting the typical institutional home of a coordinating center of this type. At the same time, the opportunity explicitly limits foreign participation at the applicant level: non-U.S. (non-domestic) entities and non-domestic components of U.S. organizations are not eligible to apply. However, "foreign components" are allowed as defined under the NIH Grants Policy Statement, meaning certain collaborations or performance of specific project elements abroad may be permissible if they meet NIH policy definitions and are justified, even though the applicant organization itself must be domestic.

Key administrative details provided in the source data include the NIH as the funding agency, a creation date of November 14, 2019, and an original application closing date of February 19, 2020. The activity aligns with NIH program areas in health and related categories, and it is associated with CFDA number 93.847. While the excerpt does not specify an award ceiling or the number of expected awards, the limited-competition nature and the fact that it targets the existing TrialNet Coordinating Center indicate that it is intended to add capacity to an established national infrastructure rather than create multiple new independent projects.

Overall, the opportunity is best understood as targeted, operationally focused funding meant to help TrialNet launch and conduct additional high-priority T1D intervention trials in early disease stages, leveraging the coordinating center's centralized expertise in protocol development, regulatory and safety oversight, laboratory and clinical harmonization, and robust data and statistical operations that are essential for network-wide clinical trials.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition: Competitive Supplement to the Coordinating Center for Type 1 Diabetes TrialNet (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 2019-11-14.
• Applicants must submit their applications by 2020-02-19. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Public and State controlled institutions of higher education.

Apply for RFA DK 19 506

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