Limited Competition for Continuation of the Integrated Islet Distribution Program (U24 Clinical Trial Not Allowed) | RFA DK 20 509

Opportunity Information: Apply for RFA DK 20 509

The National Institutes of Health (NIH) announced a limited-competition funding opportunity, RFA-DK-20-509, titled "Limited Competition for Continuation of the Integrated Islet Distribution Program (U24 Clinical Trial Not Allowed)." This is a discretionary NIH cooperative agreement (U24) focused on sustaining a key national research infrastructure: the Integrated Islet Distribution Program (IIDP). The purpose of the announcement is not to create a new islet distribution network from scratch, but to renew and continue the existing IIDP so it can keep supplying the diabetes research community with high-quality human islets and related standardized data. Because it is a continuation mechanism, the FOA is structured to invite only one application, and that application must come from the Program Director(s)/Principal Investigator(s) who currently lead the IIDP.

At its core, the IIDP exists to make human pancreatic islets available to qualified biomedical researchers, since human islets are still one of the most critical and hard-to-obtain resources for understanding diabetes in ways that animal models cannot fully capture. The program supports research aimed at clarifying human islet cell biology and accelerating the development of therapies to prevent, treat, or better manage diabetes. By maintaining a reliable pipeline of human islet preparations, the IIDP helps ensure that investigators across institutions can access consistent biological materials needed for experiments, comparisons across studies, and replication of findings.

The work supported under this opportunity centers on coordinating a national distribution system rather than conducting clinical trials, which is why the FOA explicitly states "Clinical Trial Not Allowed." The IIDP model functions by establishing and maintaining partnerships with qualified islet isolation facilities that can procure, isolate, prepare, and ship human islets. Beyond simply moving samples from point A to point B, the program plays a coordinating role that includes quality and standardization functions across the network, helping ensure that distributed preparations meet shared expectations and are accompanied by useful characterization data.

A major operational responsibility described in the FOA is the management of an investigator access process. The IIDP runs an application or eligibility system so that researchers requesting islets meet program requirements and can be approved to receive shipments. Once investigators are eligible, the program also manages communications about islet availability, which is important because supply depends on donor availability and isolation success rates, and demand can fluctuate. In practice, this means the program acts as a clearinghouse that matches available islet preparations with approved scientific needs in a transparent and organized way.

The FOA also emphasizes cost recovery. The IIDP oversees a fee-based cost recovery system in which islet recipients pay fees that help offset program costs. This system is part of how the program remains sustainable while still operating as a shared national resource. Managing this aspect involves setting, collecting, and administering fees and ensuring the process is consistent and workable for the research community while aligning with NIH expectations for stewardship of federal funds.

Another central element is standardized phenotypic and genotypic analysis of islet preparations distributed across the IIDP network. This means the program is not only distributing tissue, but also overseeing consistent characterization so investigators receive materials with comparable baseline information. Standardized data can include measures that describe the preparation and help researchers interpret results, compare experiments across labs, and build datasets that are more interoperable. The FOA frames this standardization as a network-wide responsibility, implying ongoing oversight and coordination rather than one-off testing.

Eligibility is restricted by design. Although the NIH lists certain categories of eligible applicants in general (such as eligible federal agencies and U.S. territories or possessions), this specific FOA is limited competition and invites only the current IIDP leadership to apply. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. At the same time, foreign components, as defined in the NIH Grants Policy Statement, are allowed, meaning the funded U.S.-based program may include certain foreign collaborations or elements if they meet NIH definitions and policy requirements.

Key administrative details included in the source information are that the awarding agency is NIH, the program is categorized under health (CFDA 93.847), the funding instrument is a cooperative agreement (indicating substantial NIH involvement and coordination compared to a standard grant), and the maximum award amount (award ceiling) is listed as $2,000,000. The opportunity was created on September 22, 2020, with an original closing date of February 9, 2021. Overall, the announcement is essentially a renewal pathway meant to preserve continuity of a nationally important resource-sharing program that supports diabetes research by ensuring ongoing access to human islets, coordinated distribution logistics, standardized sample characterization, investigator eligibility management, and a structured cost recovery approach.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition for Continuation of the Integrated Islet Distribution Program (U24 Clinical Trial Not Allowed)" 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 2020-09-22.
• Applicants must submit their applications by 2021-02-09. (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: Others.

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