NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required) | PAR 21 102

Opportunity Information: Apply for PAR 21 102

The NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required), Funding Opportunity Number PAR-21-102, is a National Institutes of Health (NIH) discretionary grant mechanism designed to support investigator-initiated, hypothesis-driven, multi-center clinical trials that are considered high risk but have a strong potential payoff. The core idea is to fund studies that involve more than one clinical center and that, if successful, could meaningfully shift clinical practice and/or improve public health outcomes. The clinical topic must align with the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which broadly covers diseases and conditions related to diabetes, endocrinology and metabolic disorders, digestive diseases, nutrition, obesity-related issues, and kidney, urologic, and hematologic diseases, among related areas.

This opportunity uses the U01 cooperative agreement format, which matters because it is not a traditional “hands-off” research project grant. Under a cooperative agreement, NIH (here, NIDDK) expects to have substantial scientific and/or programmatic involvement during the conduct of the study. In practice, that typically means awardees should be prepared for ongoing coordination with NIDDK staff, adherence to NIH and NIDDK expectations for oversight and performance milestones, and collaboration around trial governance, monitoring, and reporting. The “Clinical Trial Required” designation makes it clear that the application must propose an actual clinical trial, not simply observational work, infrastructure development, or pre-trial planning.

A major restriction in this FOA is that planning activities are not allowed as part of the U01 application. Applicants are expected to come in with key planning work already completed before submission. That generally implies that essential elements such as protocol development, feasibility considerations, site readiness, recruitment strategies, statistical planning, and operational and regulatory pathways should already be sufficiently mature to move into implementation. For teams that are not yet ready to launch and still need a structured planning period, the FOA points them toward an implementation planning cooperative agreement (U34, referenced as TEMP9971) as the more appropriate first step. Because this readiness line can be easy to misjudge, the FOA strongly encourages early consultation with NIDDK Scientific/Research staff before submitting either a U34 or a U01, so applicants can confirm fit, expectations, and the level of maturity required.

In terms of eligibility, the FOA is broad and includes many common U.S.-based applicant types: state, county, and city governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized tribal governments; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); and small businesses. The announcement also explicitly calls out additional eligible applicants such as 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), faith-based or community-based organizations, regional organizations, eligible federal agencies, Indian/Native American Tribal Governments other than federally recognized entities, and U.S. territories or possessions. At the same time, it draws clear boundaries around foreign involvement: non-domestic (non-U.S.) entities (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 in the NIH Grants Policy Statement are allowed, which typically means certain well-justified elements of the research can be conducted outside the U.S. under a U.S. applicant institution, subject to NIH policy requirements and approvals.

The FOA is categorized under the Health and Food and Nutrition funding activity area and is associated with CFDA number 93.847. The funding instrument is a cooperative agreement (U01). The opportunity was created on December 23, 2020, and the original closing date listed is January 7, 2024. The excerpt does not provide an award ceiling or expected number of awards, so applicants would need to consult the full FOA text and/or discuss budget scope with NIDDK program staff to understand typical budget ranges, project periods, and the institute’s current capacity and priorities for new trials.

Overall, this opportunity is aimed at teams that are ready to run a rigorous, multi-site clinical trial now, not teams that are still working out whether the trial is feasible. NIDDK is signaling that it wants bold but well-justified studies with clear hypotheses and a realistic path to producing practice-changing evidence, and it expects applicants to engage early with NIDDK staff to confirm alignment and readiness before investing heavily in a full U01 submission.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (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 2020-12-23.
• Applicants must submit their applications by 2024-01-07. (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.

Apply for PAR 21 102

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