Continuation of the Human Pancreas Analysis Program (HPAP) for Type 1 Diabetes (HPAP-T1D) (U01 Clinical Trial Not Allowed) | RFA DK 20 016

Opportunity Information: Apply for RFA DK 20 016

The grant opportunity titled "Continuation of the Human Pancreas Analysis Program (HPAP) for Type 1 Diabetes (HPAP-T1D)" is an NIH cooperative agreement (U01) designed to keep the existing Human Pancreas Analysis Program running and advancing its original mission. The focus is squarely on building and sustaining a high-value national research resource: well-collected, deeply characterized human pancreatic tissues from people with type 1 diabetes, people at risk for developing type 1 diabetes, and appropriately matched control donors. The program is positioned as a key part of the Human Islet Research Network (HIRN), a broader NIH-supported initiative launched in 2014 to accelerate translational research aimed at understanding why and how human beta cells are lost in type 1 diabetes, and to support strategies that could protect beta cells or restore functional beta cell mass.

At the core of this FOA is the expectation that a single, highly capable team will be supported to deliver end-to-end capabilities that span human tissue acquisition through data dissemination. That means the awardee needs demonstrated strength in the practical and scientific realities of working with human pancreas material: identifying appropriate donors or cases, coordinating and conducting tissue collection, handling biospecimen processing and preservation, and then applying multimodal analytical approaches to characterize the tissues in depth. "Multimodal" in this context points to integrating multiple layers of biological readouts (for example, histology and imaging, molecular profiling, cellular and immune characterization, and other complementary assays) so that the resulting dataset is more useful than any single method alone. The team is also expected to have robust informatics and data stewardship capacity, because the FOA emphasizes not just generating data but organizing it in ways that the wider community can search, interpret, and reuse.

The FOA lays out two main program tasks. First, the awardee will identify, collect, and intensively characterize primary pancreatic tissues from three key groups: individuals with established type 1 diabetes, individuals at risk of developing type 1 diabetes, and age-matched controls. The age-matching requirement is important because it helps reduce confounding when comparing disease and non-disease samples; age can affect pancreatic biology, immune features, and baseline tissue characteristics. Second, the awardee will analyze, organize, and broadly share the resulting datasets through the existing PANC DB open-access database resource. In other words, this is not a closed or purely internal project; it is explicitly structured as a community-facing resource effort where data sharing and database maintenance are central deliverables rather than optional add-ons.

Mechanistically, this is a cooperative agreement (U01), which generally means NIH anticipates substantial programmatic involvement beyond what is typical for a standard research grant. Applicants should typically expect ongoing coordination with NIH staff and alignment with network goals, common standards, and resource-sharing expectations. The FOA is also clearly marked "Clinical Trial Not Allowed," signaling that the proposed work should not be structured as a clinical trial as defined by NIH. The emphasis is on biospecimen-based research, profiling, and data/resource generation rather than interventional studies in human participants designed to evaluate clinical outcomes.

Eligibility is broad across many U.S.-based organization types, reflecting the resource-building nature of the program and the range of institutions that might have the necessary tissue, pathology, and data infrastructure. Eligible applicants include state, county, and local governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; independent school districts; special district governments; public housing authorities/Indian housing authorities; and federally recognized Native American tribal governments and certain tribal organizations. The FOA also explicitly notes inclusion of mission-driven and capacity-building institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies.

At the same time, the opportunity draws clear boundaries around foreign participation. Non-domestic (non-U.S.) entities and non-U.S. foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, which typically means a U.S. applicant organization may include certain specific foreign collaborations or elements if they meet NIH policy requirements and are justified, even though the applicant organization itself must be domestic.

From the administrative details provided, the opportunity number is RFA-DK-20-016, issued by the National Institutes of Health, and it falls under the broader health-related assistance listing (CFDA 93.847). The funding instrument is discretionary and categorized under food and nutrition/health. The original closing date listed is November 10, 2020, and the FOA indicates an intention to support one team (it states the FOA will support "one team of investigators"), reinforcing that this is meant to be a centralized, coordinated effort rather than a multi-award program. The award ceiling is not specified in the provided text, so budget limits would need to be confirmed from the full FOA documentation.

Overall, the opportunity is best understood as continued support for a mature, high-impact research infrastructure that supplies the type 1 diabetes community with rare, well-annotated human pancreatic tissue resources and integrated datasets. Success is likely to depend on the applicant demonstrating reliable access to appropriate tissues, rigorous and standardized processing and characterization workflows, strong cross-disciplinary expertise (pancreas biology, immunology, pathology, -omics, imaging, and biobanking), and a proven ability to curate, manage, and share complex data through PANC DB in a way that is genuinely usable by outside researchers and consistent with open-access expectations.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Continuation of the Human Pancreas Analysis Program (HPAP) for Type 1 Diabetes (HPAP-T1D) (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 2020-07-02.
• Applicants must submit their applications by 2020-11-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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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