PROJECT SUMMARY/ABSTRACT Application Title: Workshops of the National Academies' Roundtable on Science and Welfare in Laboratory Animal Use (ILAR Roundtable) Funding Opportunity Title: FDA Scientific Conference Grant Program (R13); PAR-19-306. This request is for funding from the Office of the FDA Commissioner (OC/OCS/OCET). The Institute for Laboratory Animal Research (ILAR) of the National Academies of Sciences, Engineering, and Medicine established the Roundtable on Science and Welfare in Laboratory Animal Use in the Fall of 2013. The purpose of the Roundtable is to foster communication and problem solving among the many different constituencies with strong interests in the use and welfare of laboratory animals in research and testing, including, government agencies, pharmaceutical and consumer product corporations, vendors, animal advocacy groups, professional societies, and academic institutions , including scientists and veterinarians. The workshops will be open to the public and webcasted, and there will be no fee charged to attend or view the workshop via the web. This application requests funds from the U.S. Food and Drug Administration to provide partial support toward convening up to two workshops a year, beginning in 2020 for a period of five years under the auspices of the Roundtable. Each workshop will focus on a critical issue related to the science and welfare of laboratory animal use, such as Micro-Physiological Systems for Efficacy and Safety Studies: A Workshop on Advances in Organs-On-Chip Technologies for Animals; The 4th R: Rehoming and Retirement of Non-Human Primates Used in Research; the Ethics and Use of Genetic Modifications in Xenotransplantation; and Laboratory Animal Use and the One Health Paradigm. The workshops present opportunities for 1) outreach to and dialogue with all communities who share an interest in the use of laboratory animals in research; 2) sharing of cutting-edge scientific information; and 3) increased understanding of the topics and identification of possible follow-on activities to improve the quality of biomedical research and laboratory animal welfare. Animal-based research is a fundamental component of the preclinical research and development and proof-of-concept studies of drugs, biologics and medical devices. Ensuring the highest quality of these studies while maintaining appropriate care and use of the animals used depends on building trust and maintaining and information sharing among the research, scientific and veterinary medical communities. As such, the purpose of Roundtable and its workshops is consistent with the mission of the FDA: "…protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation”.

PROJECT SHORT NARRATIVE The purpose of the ILAR Roundtable is to foster communication and problem solving among the many different constituencies with strong interests in the use and welfare of laboratory animals in research and testing, including, government agencies, pharmaceutical and consumer product corporations, vendors, animal advocacy groups, professional societies, and academic institutions , including scientists and veterinarians. The objectives of all workshops organized by the ILAR Roundtable are to: 1 ) provide a forum in which to stimulate open dialogue, exchange information and foster communication ; 2) promote collaboration among a wide range of entities interested in the development of cutting edge laboratory animal research topics; and 3) facilitate discussion on more effective, efficient and humane use of animals and use of animal alternatives in biomedical research.