National Cancer Institute Program Project Applications for the Years 2023, 2024, and 2025 (P01 Clinical Trial Optional)

The National Cancer Institute (NCI), a component of the National Institutes of Health (NIH) under the Department of Health and Human Services, invites grant applications for its Program Project Applications for the Years 2023, 2024, and 2025 (P01 Clinical Trial Optional). The funding opportunity is outlined under the Funding Opportunity Announcement (FOA) PAR-23-059, a reissue of PAR-20-077. The NCI aims to support integrated, multi-project cancer research programs led by collaborative teams of independent investigators who work towards a unifying scientific goal. These programs are based on the belief that collaborative efforts accelerate the acquisition of knowledge more effectively than individual projects. The purpose of this FOA is to fund investigator-initiated Program Projects (P01) in any area of cancer research, including but not limited to cancer biology, cancer prevention, cancer diagnosis, cancer treatment, and cancer control. The funding scope encompasses basic, translational, clinical, and population-based studies. Each application must consist of at least three research projects and an Administrative Core. Additionally, applicants may propose Shared Resource Core(s) if they are necessary to enhance productivity and cost-effectiveness. The projects within each application must be interrelated and synergistic, addressing a common central theme or focus. Eligible applicants include higher education institutions (both public and private), non-profit organizations, for-profit organizations, local governments, and state governments. Specific entities include public/state controlled institutions of higher education, private institutions of higher education, nonprofits with and without 501(c)(3) IRS status, small businesses, other for-profit organizations, state and local governments, tribal governments, and certain federal government agencies. Foreign institutions are not eligible to apply, though foreign components of U.S. organizations are allowed. Submission requirements dictate that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide. A letter of intent is requested 30 days prior to the application due date, but it is not mandatory. The application must include components such as an Overall section, an Administrative Core, a minimum of three Research Projects, and optional Shared Resource Core(s). Each component has specific page limitations and content guidelines detailed in the FOA. Applications must be submitted electronically through NIH ASSIST or an institutional system-to-system solution, with all required registrations completed in advance. Applications are evaluated based on scientific and technical merit by appropriate Scientific Review Groups convened by the NCI. Review criteria include significance, investigator qualifications, innovation, approach, and environment. For clinical trials, additional criteria such as study design, data management, and ethical considerations are also assessed. Reviewers also evaluate program integration, the quality and utility of shared resource cores, and the adequacy of the administrative core. The FOA provides for multiple application deadlines, with standard NIH review and award cycles. The next upcoming standard application deadline is September 25, 2025, with subsequent review and award cycles scheduled through 2026. The maximum project period is five years, and budgets are not limited but should reflect the actual needs of the proposed project. Applicants requesting $500,000 or more in direct costs in any year must contact a Scientific/Research Contact at least six weeks prior to submission. Applicants can contact the Referral Officer at the National Cancer Institute via telephone at 240-276-6390 or email at ncirefof@dea.nci.nih.gov for scientific and research-related inquiries. Financial or grants management inquiries can be directed to Crystal Wolfrey at wolfreyc@mail.nih.gov or by phone at 240-276-6277. The FOA is set to expire on May 8, 2026. Recipients are required to adhere to NIH policies, including those related to data management and sharing, human subjects protections, and civil rights compliance.