Limited Competition: NIDDK Program Projects (P01 Clinical Trial Optional) | PAR 23 121

Opportunity Information: Apply for PAR 23 121

The Limited Competition: NIDDK Program Projects (P01 Clinical Trial Optional) opportunity (Funding Opportunity Number PAR-23-121) is a National Institutes of Health (NIH) grant announcement from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) focused on supporting large, team-based research efforts through the Program Project Grant (P01) mechanism. The purpose is to advance biologic and biomedical knowledge by bringing together multiple investigators whose work is connected by a single, clearly defined central theme that fits within NIDDKs mission areas, such as diabetes, endocrinology, digestive diseases, nutrition, obesity, and kidney, urologic, or hematologic diseases. While single-investigator projects can be highly productive, this announcement is aimed at research questions that are complex enough to benefit from a coordinated, multidisciplinary approach where collaboration meaningfully changes what can be achieved.

This announcement specifically invites investigator-initiated renewal applications, meaning Type 2 P01 submissions intended to continue an existing, previously funded P01 program project rather than start a brand-new P01. A key feature of the P01 model is that it is not just a collection of separate projects under one administrative umbrella. Instead, it is expected to operate as an integrated program with several distinct research projects that are scientifically independent in their aims but designed to reinforce one another through shared concepts, methods, study populations, datasets, models, or experimental platforms. The interrelationships among projects should create synergy, producing findings and efficiencies that would be difficult or impossible if each project were funded and run independently as separate R01s.

Another required element of a P01 is the inclusion of one or more shared cores. These cores provide centralized resources, services, or expertise that multiple projects rely on, such as a clinical core, biostatistics and data management, genomics, imaging, metabolomics, animal models, tissue procurement, or other specialized capabilities. The core structure is meant to reduce duplication, standardize approaches across projects, and improve rigor and reproducibility. Leadership expectations are also explicit: project leaders and core leaders should be established investigators with strong records of innovative work and independent funding, and all investigators are expected to actively contribute to program-level goals and share responsibility for overall progress.

The FOA is labeled clinical trial optional, which means applicants may propose clinical trials if they are scientifically appropriate, but clinical trials are not required. This flexibility allows a program project to focus on basic, translational, clinical, or mixed pipelines, as long as the entire program is coherent and the projects and cores clearly align around the unifying theme.

In terms of who can apply, eligibility is broad across U.S.-based organizations and includes state, county, city, township, and special district governments; federally recognized Native American tribal governments; tribal organizations; public housing authorities; independent school districts; public and private institutions of higher education; nonprofits with or without 501(c)(3) status (excluding higher education institutions where applicable); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights a range of institution types often emphasized in federal funding, including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), 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 U.S. territories or possessions. At the same time, non-U.S. (foreign) institutions are not eligible to apply as applicant organizations, and non-U.S. components of U.S. organizations are not eligible. However, foreign components are allowed as defined by the NIH Grants Policy Statement, meaning a U.S. applicant can include certain international elements when justified and compliant with NIH policy.

Key administrative details provided include an original closing date of 2024-02-07, an award ceiling of $6,250,000, and listing under CFDA number 93.847. The opportunity is categorized as discretionary grant funding in the health and food and nutrition-related activity area. More context on how the P01 compares to other collaborative mechanisms supported by NIDDK is referenced through NIDDKs collaborative grants comparison page, which can help applicants decide whether the program project structure is the best fit versus other multi-investigator options.

Overall, this FOA is best understood as support for mature, ongoing, multi-project research programs that have already demonstrated value as an integrated enterprise and are now seeking renewal to continue pursuing a central scientific objective. The strongest renewals typically make a clear case that the collaboration is essential, that shared cores are heavily used and well managed, and that the combined program is producing outcomes that are greater than the sum of its parts.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition: NIDDK Program Projects (P01 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 2023-02-27.
• Applicants must submit their applications by 2024-02-07. (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 $6,250,000.00 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.

Apply for PAR 23 121

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