NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional) | PAR 21 101

Opportunity Information: Apply for PAR 21 101

The NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional), Funding Opportunity Number PAR-21-101, is an NIH cooperative agreement designed to help investigators plan complex, hypothesis-driven, multi-center clinical studies (meaning more than one study site) that fall within the scientific mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The central idea is that NIDDK uses a two-part pathway for certain high-risk multi-center clinical studies, where the first part is a structured planning phase supported by a U34 award. This planning step is meant to reduce avoidable failures later by stress-testing the scientific rationale and operational readiness before a full-scale implementation effort is launched.

The U34 mechanism specifically supports the detailed, practical work required to move a promising multi-site clinical study from concept to an implementation-ready package. In practice, the award is intended to (1) enable early peer review of the study rationale so reviewers can assess whether the question is important, timely, and strong enough to justify the complexity and cost of a multi-center effort; (2) allow thorough assessment of the proposed design and protocol, including whether the endpoints, eligibility criteria, recruitment strategy, and statistical approach are appropriate and feasible; (3) fund the creation and refinement of essential study conduct documents, most notably a Manual of Operations (MOO), which typically lays out standardized procedures across sites for recruitment, consent, intervention delivery, outcome assessment, safety monitoring, data handling, and quality assurance; and (4) support development of other core building blocks needed to run the trial or clinical study consistently across all centers, such as training plans, site workflows, data management processes, and other operational materials that commonly determine whether multi-center studies succeed.

Because this is a cooperative agreement rather than a standard grant, it implies a more active partnership between the awardee and NIDDK during the planning period compared to traditional investigator-initiated mechanisms. The opportunity also highlights that consultation with NIDDK scientific staff before submitting a U34 application is strongly encouraged. That expectation typically reflects the reality that multi-center studies require alignment on feasibility, scope, and institute priorities early on, and that the planning award should be structured around deliverables that clearly position the project for the next stage (a later implementation application, if pursued).

The clinical study proposed under this U34 should be hypothesis-driven, and it must focus on diseases and conditions within NIDDKs mission areas, which broadly include diabetes, endocrinology and metabolic diseases, digestive diseases, nutrition-related disorders within the institutes scope, and kidney and urologic diseases. The announcement labels the initiative as supporting "high-risk" multi-center clinical studies, which generally signals studies that are complex, logistically demanding, novel in approach, or uncertain in feasibility without deliberate upfront planning and standardization.

Eligibility is broad across many U.S.-based organization types, consistent with many NIH opportunities. Eligible applicants include state, county, and city or township 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 other than federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The opportunity explicitly calls out additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions. At the same time, non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, the notice allows "foreign components" as defined in the NIH Grants Policy Statement, meaning a U.S. applicant may include certain eligible international elements when justified and structured according to NIH policy, even though the applicant organization itself must be domestic.

From an administrative standpoint, the opportunity sits under the NIH, uses the cooperative agreement funding instrument, and is categorized under the Food and Nutrition, Health activity area with CFDA number 93.847. The listed award ceiling is $225,000, and the original closing date shown is 2024-02-15. Taken together, those details signal that the U34 is not meant to fund the full conduct of a large multi-center trial, but rather the planning and documentation work that makes a later multi-center study application credible, consistent across sites, and ready for execution.

Overall, this opportunity is best understood as a structured planning runway for investigators who have a strong multi-center clinical study idea but need dedicated time and resources to finalize the protocol, prove feasibility across sites, standardize procedures, and assemble the operational backbone (especially the Manual of Operations and related materials). The goal is to bring the proposed study to a point where both peer reviewers and NIDDK can judge the science, design, and real-world implementability with much higher confidence before moving on to the next phase of funding.

• 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 Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)" 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 2024-02-15. (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 $225,000.00 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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