NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Not Allowed) | PAR 24 102

Opportunity Information: Apply for PAR 24 102

The NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01, Clinical Trial Not Allowed) is a National Institutes of Health funding opportunity (PAR-24-102) designed to support investigator-initiated, hypothesis-driven, multi-center observational research. The program is aimed at studies that are considered high-risk in terms of complexity, coordination, or scientific uncertainty, but that have the potential to generate valuable insights into diseases and conditions that fall within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). A key feature is that projects must involve more than one clinical center and must be observational in nature; applications proposing clinical trials are not allowed under this announcement.

The focus is on well-developed study concepts that are ready to move directly into implementation. This means that planning work needs to be completed before submitting a U01 application. The FOA explicitly does not permit applicants to use U01 funds for planning activities, feasibility work, or early organizational development that would normally occur before a multi-center study can realistically launch. For teams that still need a structured planning phase, NIDDK points applicants to a separate mechanism: an implementation planning cooperative agreement (U34, referenced as TEMP9971). In practice, this sets a clear expectation that U01 submissions should reflect a study that is already organized enough to begin execution, with protocols, operational strategies, and cross-site coordination plans largely matured.

Because this is a cooperative agreement (U01) rather than a standard grant, awardees should expect substantial scientific and programmatic involvement from NIH staff compared to traditional investigator-driven mechanisms. While the FOA summary does not spell out the details of that involvement, the cooperative agreement structure generally signals a more active partnership with the funding institute around study conduct, governance, milestones, and problem-solving as the project unfolds. Consistent with that approach, NIDDK strongly encourages applicants to consult with NIDDK scientific or research staff well before submission, whether pursuing the U34 planning route or applying directly to the U01. This pre-submission conversation is meant to help applicants confirm fit with NIDDK priorities, ensure the proposed design meets the observational and multi-center requirements, and avoid avoidable misalignment with the FOA.

Eligibility is broad across public, private, and nonprofit sectors. Eligible applicants include state, county, and local 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; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant types 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), eligible federal government agencies, faith-based or community-based organizations, regional organizations, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions. Native American tribal governments that are federally recognized are also included in the general eligibility listing.

At the same time, the FOA draws firm lines around foreign participation. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement, which typically means a U.S. applicant institution may include certain eligible foreign activities or collaborations as part of the overall project when appropriately justified, even though the primary applicant must be domestic.

Administratively, this opportunity is categorized as discretionary funding and uses the cooperative agreement instrument type. The activity category is listed under food and nutrition and health, and the associated CFDA number is 93.847. The opportunity was created on January 4, 2024, and the listed original closing date is November 5, 2026. The summary provided does not specify an award ceiling or the expected number of awards, which suggests applicants should rely on the full FOA text or direct communication with NIDDK staff to understand budget expectations, typical award sizes, and program capacity for new awards.

Overall, the opportunity is best suited for research teams that already have a strong, testable hypothesis; a clear observational design; a multi-center network ready to operate; and the operational groundwork in place to start the study without needing a funded planning phase. The strongest submissions will typically demonstrate tight coordination across clinical sites, credible governance and data harmonization plans, and a compelling justification for why the scientific question requires a multi-center observational approach and why it aligns with NIDDK mission priorities.

• 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 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 2024-01-04.
• Applicants must submit their applications by 2026-11-05. (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 24 102

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