NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required) | PAR 24 103

Opportunity Information: Apply for PAR 24 103

The NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required), funding opportunity number PAR-24-103, is a National Institutes of Health (NIH) discretionary grant mechanism designed to support investigator-initiated, high-risk, multi-center clinical trials. The core idea is to fund ambitious, hypothesis-driven studies that involve more than one clinical center and are positioned to meaningfully influence clinical practice and/or public health. To be a good fit, the proposed trial needs to focus on diseases and conditions within the mission area of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which broadly covers topics such as diabetes, endocrinology and metabolic diseases, digestive diseases, nutrition-related disorders, kidney/urologic/hematologic diseases, and related complications.

This is a cooperative agreement (U01), which means it is not a typical investigator-only grant where the funding agency stays hands-off. Under a U01, NIH (and here, NIDDK specifically) expects to have substantial programmatic involvement during the life of the project. In practice, applicants should anticipate ongoing coordination with NIDDK staff around key elements such as study conduct, milestone tracking, and other areas where the institute has an active stewardship role. Because the FOA is explicitly labeled "Clinical Trial Required," the application is expected to propose an actual clinical trial rather than observational work alone, and the trial must be multi-center (more than one clinical center).

A major structural requirement in this FOA is that all planning activities must be completed before submitting the U01 application. In other words, applicants should not propose to use U01 funds to do early-stage trial planning, feasibility work, or other preparatory steps that belong in a separate planning phase. If a team needs time and resources to finalize the protocol, assemble the network, lock down operational details, or otherwise complete implementation planning, NIDDK points applicants to a separate mechanism first: an implementation planning cooperative agreement (U34, referenced as TEMP9971). This creates a clear two-step pathway for complex trials: use a U34 when you still need structured planning support, and apply to this U01 only when the project is ready to move directly into trial execution.

The FOA strongly encourages consultation with NIDDK scientific/research staff before submitting either a U34 or a U01. That pre-application conversation is important because it can help confirm whether the topic aligns with NIDDK priorities, whether the proposed design meets the FOA expectations for a high-risk multi-center trial, and whether the project is truly ready for a U01 submission (especially given the rule that planning activities are not allowed under this announcement). This kind of consultation can also help applicants think through cooperative agreement expectations, including how NIDDK may interact with the project once it is underway.

Eligibility is broad and includes many common applicant types such as state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education where applicable); for-profit organizations (other than small businesses); small businesses; Native American tribal governments (federally recognized); public housing authorities/Indian housing authorities; and other Native American tribal organizations (other than federally recognized tribal governments). The FOA also explicitly calls out additional eligible applicant categories 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 agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. At the same time, the FOA makes clear that non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S.-based applicant may include certain foreign elements in the project when permissible under NIH policy, even though a foreign organization cannot be the direct applicant.

From an administrative standpoint, the opportunity is listed under CFDA number 93.847 and sits within the broad activity category of Food and Nutrition, Health. The original closing date shown is 2026-11-05, and the posting record indicates a creation date of 2024-01-04. The award ceiling and expected number of awards are not specified in the provided source details, so applicants typically would need to consult the full FOA text and NIH budgeting guidance to understand practical budget expectations, limits (if any), and how NIDDK anticipates supporting projects of different sizes and complexity.

Overall, this FOA is aimed at teams that are ready to run a rigorous, multi-center clinical trial that is inherently higher risk but potentially high impact, with a clear hypothesis and a realistic path to shifting clinical care or public health outcomes in an NIDDK-relevant disease area. The key practical takeaway is readiness: applicants should come in with planning already completed, a multi-site structure in place, and a trial concept mature enough for immediate implementation under a cooperative agreement framework with active NIDDK involvement.

• 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 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 24 103

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