Continuation of The Collaborative Islet Transplantation Registry (U01 Clinical Trial Not Allowed) | RFA DK 21 013

Opportunity Information: Apply for RFA DK 21 013

The funding opportunity titled "Continuation of The Collaborative Islet Transplantation Registry (U01 Clinical Trial Not Allowed)" (RFA-DK-21-013) is a National Institutes of Health (NIH) cooperative agreement aimed at continuing and strengthening the Collaborative Islet Transplantation Registry (CITR). The registry has been operating since 2001 and serves as a centralized resource for compiling, curating, and analyzing clinical data related to islet transplantation. Its core purpose is to capture and evaluate real-world clinical activity and outcomes, primarily across North America, while also incorporating data from selected sites in other countries when permissible. The emphasis is not on running a clinical trial, but on maintaining a high-quality registry infrastructure and generating analyses and reports that can inform the broader research and clinical community.

A central component of this program is the ongoing collection of data for both allotransplantation and autotransplantation. In practice, that means the registry tracks outcomes for islet transplants involving donor islets (allo-) as well as cases where a patient receives their own islets back (auto-), such as after pancreatectomy. By collecting standardized data across participating centers, CITR supports comparisons over time and across sites, allowing researchers and clinicians to better understand what factors influence success, safety, and longer-term outcomes. The overall intent is to help identify risk factors and determine key safety and efficacy drivers of islet transplantation as a therapy, especially for patients with type 1 diabetes and for patients undergoing pancreatectomy who may benefit from autotransplantation.

The FOA expects the awardee to operate the registry as a robust, sophisticated data platform. That includes developing and maintaining databases that are usable by the wider research community, enabling data-driven publications and scientific presentations. Beyond simply storing data, the registry is expected to support meaningful analysis of outcomes and trends, which helps translate raw clinical information into evidence that can guide practice and future research. A notable deliverable is an annual public report that summarizes transplantation outcomes and highlights trends over time, providing transparency and a consistent snapshot of how the field is evolving. In addition, the registry is responsible for organizing an annual CITR meeting for contributing sites, which supports coordination, standardization, and shared learning among the centers that provide data.

From an administrative standpoint, this is a discretionary funding opportunity using the cooperative agreement mechanism (U01), which typically indicates substantial NIH involvement in program oversight and collaboration compared with a standard research grant. The activity category is listed under food and nutrition and health, with CFDA number 93.847. The original closing date for applications was 2021-10-20, and the opportunity was created on 2021-07-14. The listed award ceiling is $500,000. The number of expected awards is not specified in the provided source text.

Eligibility is broad and includes many common U.S.-based applicant types such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations (including those other than federally recognized governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also explicitly calls out additional eligible applicant categories including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions.

At the same time, the FOA places clear limits on non-U.S. participation. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement, meaning a U.S.-based applicant may include certain eligible foreign components in the project structure if they meet NIH definitions and requirements, even though a foreign organization cannot be the applicant institution.

Overall, the opportunity is designed to keep CITR operating as the field’s central registry for islet transplantation outcomes, ensuring ongoing data capture, high-quality data systems, regular public reporting, and annual convening of participating sites. The longer-term value is in enabling the research community to use a comprehensive dataset to evaluate safety and effectiveness, spot trends and emerging issues, and refine best practices for islet transplantation in type 1 diabetes and in the setting of pancreatectomy.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Continuation of The Collaborative Islet Transplantation Registry (U01 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 2021-07-14.
• Applicants must submit their applications by 2021-10-20. (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 $500,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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