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Notice of Special Interest (NOSI): Collaborative and Innovative Research to Advance Regulatory Science: Partnership of FDA Centers of Excellence in Regulatory Science and Innovation (CERSI) and NIH Clinical and Translational Science Award (CTSA) Programs

National Institutes of Health

The National Institutes of Health (NIH)’s National Center for Advancing Translational Sciences (NCATS) and the Food and Drug Administration (FDA)’s Office of the Chief Scientist (OCS) intend to collaborate and foster partnership between the NIH’s Clinical and Translational Science Award (CTSA) Program and the FDA’s Centers of Excellence in Regulatory Science and Innovation (CERSI) Program to advance regulatory science by leveraging the resources and expertise from both programs.

Regulatory science is the science of developing tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products, which include medical devices, drugs, biologics, combination products, veterinary medicine, food, cosmetics, dietary supplements, and tobacco products. In addition to the product areas that FDA regulates, FDA also aims to target cross-cutting areas that have the potential to transform how FDA-regulated products are developed, evaluated, and utilized, such as digital health, artificial intelligence, data science, alternative methods, One Health, patient-centered outcomes, and behavior change/ social science. The FDA hosts the CERSI Program to foster robust and innovative approaches to advance regulatory science. The goal for the CERSIs to advance regulatory science individually and synergistically, under the CERSI Program led by the OCS’ Office of Regulatory Science and Innovation (ORSI) , through collaborative interactions with FDA scientific experts and funding offices.

Translational Science is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process. The NIH supports the CTSA Program to develop innovative solutions that will improve the efficiency, quality, and impact of the process for turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and the public. The CTSA Program is a national, collaborative consortium led by the NCATS’ Division of Clinical Innovation .

This Notice of Special Interest (NOSI) related to the CTSA Program Collaborative and Innovative Acceleration (CCIA) Award ( PAR-22-167 : UG3/UH3 Clinical Trial Optional) Initiative describes the NIH and FDA research priorities for regulatory science. The respective shared goals of regulatory science and translational science provide opportunities to tackle high-impact concepts across all stages of the translational science spectrum . The CCIA Notice of Funding Opportunity (NOFO) PAR-22-167 supports synergistic activities that accelerate the translational research process through collaboration and innovation. This NOFO invites applications to develop, demonstrate and disseminate innovative solutions to transform the field of translational science by addressing the inefficiencies that are common across diseases and bringing more interventions to all people more quickly through collaborative science among the CTSA Program hubs, NIH Institutes, Centers, Offices (ICOs), and/or external stakeholders.

This NOSI applies to due dates on or after February 15, 2024 and subsequent receipt dates through October 17, 2024. (Feb 15, 2024; June 18, 2024; Oct 17, 2024)

For eligibility information of this NOSI, please see the NOFO PAR-22-167 .

NOT-TR-24-006