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

The U.S. Department of Health and Human Services, through the National Institutes of Health and specifically the National Cancer Institute, has released a funding opportunity announcement titled National Cancer Institute Program Project Applications for the Years 2023, 2024, and 2025 (P01 Clinical Trial Optional). This program is designed to support integrated, multi-project cancer research programs. The reissue, known as PAR-23-059, replaces the earlier PAR-20-077 for due dates starting May 25, 2023. The program allows both clinical trial and non-clinical trial applications. It reflects the NIH’s emphasis on advancing cancer research through multidisciplinary collaboration and integration across basic, translational, clinical, and population-based science. The purpose of this initiative is to promote investigator-initiated Program Project (P01) applications in diverse areas of cancer research. Projects may include research in cancer biology, prevention, diagnosis, treatment, or control. Each application must include a minimum of three research projects that share a unifying central theme and one Administrative Core. Shared Resource Cores may also be proposed if they enhance productivity and efficiency. The program’s intent is to provide opportunities for collaborations that are greater in scientific value than individual projects conducted in isolation. Applicants are expected to demonstrate synergy and integration across all proposed components. Funding for this program is structured as grants, and applicants are allowed to submit new, renewal, resubmission, or revision applications. Application budgets are not capped, but they must be justified and aligned with the proposed research needs. The maximum project period is five years. The number of awards will depend on the availability of NIH appropriations and the submission of meritorious applications. NIH policies, including those outlined in the NIH Grants Policy Statement, govern all awards. Cost-sharing is not required under this funding opportunity. Eligibility is broad. Institutions of higher education, both public/state-controlled and private, may apply. Nonprofit organizations with or without 501(c)(3) IRS status are eligible. For-profit organizations, including small businesses, are eligible, as are state, county, city, township, and special district governments. Tribal governments, both federally recognized and other, may apply, as can eligible federal agencies and U.S. territories. While foreign institutions may not serve as primary applicants, foreign components of U.S. organizations are allowed under certain conditions. All applicant organizations must complete required registrations including SAM.gov, Grants.gov, eRA Commons, and related systems prior to application submission. Applications follow the NIH multi-project (M) format and must adhere to the SF424 (R&R) Application Guide with specified deviations for this FOA. Letters of intent are encouraged but not required and should be submitted 30 days before the application due date. Application deadlines follow the NIH standard submission cycles with upcoming due dates of May 25, 2025; September 25, 2025; and January 25, 2026. AIDS-related applications have distinct deadlines, the next being September 7, 2025. All submissions must be received by 5:00 PM local time of the applicant organization. The FOA will remain active until its expiration on May 8, 2026. Review criteria emphasize the significance, investigators, innovation, approach, and environment of the proposed projects, as well as integration across components. Applications are subject to NIH peer review, followed by consideration from the appropriate advisory council. Funding decisions will depend on scientific merit, availability of funds, and alignment with program priorities. Award notifications will be issued through a Notice of Award, and funded applicants must comply with NIH requirements related to human subjects, data management and sharing, and safety monitoring for clinical trials. For scientific or peer review inquiries, applicants should contact the Referral Officer at the National Cancer Institute at ncirefof@dea.nci.nih.gov or by phone at 240-276-6390. For financial or grants management inquiries, the designated contact is Crystal Wolfrey at wolfreyc@mail.nih.gov or 240-276-6277. Technical assistance is available through the eRA Service Desk and Grants.gov support. This program represents a major opportunity for collaborative cancer research initiatives that can leverage multidisciplinary expertise to make impactful contributions to the field.

Submit early to allow corrections; applicants over $500k in direct costs must contact NIH in advance; letters of intent recommended.