Competing Revisions to Existing NIH Single Project Research Grants and Cooperative Agreements (Clinical Trial Optional)

The Competing Revisions to Existing NIH Single Project Research Grants and Cooperative Agreements (PA-23-317) program supports the expansion of ongoing NIH-funded projects to address emerging research needs or take advantage of new opportunities. This funding opportunity applies to awards within participating NIH Institutes, Centers, and Offices (ICOs) and is contingent upon eligibility, the scope of the proposed expansion, and alignment with the ICO mission. Applications must respond to Notices of Special Interest (NOSIs) published by the ICOs to be considered. The program enables NIH award recipients to apply for additional funds to enhance their existing projects or programs. Applications may involve clinical trials and must reflect innovative approaches, rigorous scientific merit, and significant potential impact on the field. The proposed project expansion must align with the NIH mission and address current scientific challenges or opportunities. The program uses the same funding mechanism as the parent award. The budget and project period for revisions must fall within the approved period of the parent grant and may extend up to two years unless otherwise stated in the relevant NOSI. Application budgets must be justified based on project needs. The anticipated number of awards depends on NIH appropriations and the merit of submitted applications. Organizations that manage eligible NIH parent awards may apply. This includes U.S. higher education institutions, nonprofits, for-profits, tribal organizations, and foreign entities. The application must be submitted by the recipient organization of the parent award. Individuals must be designated as Program Directors or Principal Investigators (PDs/PIs) on active grants. Foreign organizations and foreign components of U.S. organizations are eligible. All applicants must meet registration requirements, including those for SAM, eRA Commons, and Grants.gov. Applications must adhere to the instructions in the SF424 (R&R) Application Guide, the competitive revision NOSI, and the parent grant terms. They must also include detailed descriptions of the proposed expansion, address any ethical considerations, and meet NIH policy requirements. Applications must follow page limitations, budget guidelines, and specific instructions for including human subjects, clinical trials, or animal research if applicable. Applications will be reviewed for scientific merit, innovation, the significance of the project, investigator qualifications, and the proposed approach. Criteria include the potential impact of the expanded project, the alignment with NIH priorities, and the feasibility of the proposed timeline. Applications involving clinical trials will require detailed justifications for the study design and participant protections. Successful applicants will receive a formal Notice of Award (NoA) that details the terms and conditions of the funding. The expansion must remain within the approved scope of the parent project. Progress reports and financial documentation will be required during and after the project. All awards are subject to NIH terms and policies, including those for data management and sharing.