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Welcome to VMAC Comments by Dr. Stephen F. Sundlof, D.V.M., Ph.D. Director Center for Veterinary Medicine October 13, 2004 Rockville, Maryland

Purpose of Meeting First macrolide under Guidance for Industry #152  Pfizer Animal Health application for use of tulathromycin in cattle, swine CVM reviewed microbial safety information Asking VMAC for input on assessment

Committee Members Arthur L. Craigmill, Ph.D., University of California Sherman (Skip) W. Jack, D.V.M., Ph.D., College of Veterinary Medicine, Mississippi State

Committee Members John J. McGlone, Ph.D., Texas Tech University and Health Sciences Center Lisa Nolan, D.V.M., Ph.D., Iowa State University Mark G. Papich, D.V.M., College of Veterinary Medicine, North Carolina State University

Retiring Committee Members VMAC Chair, John T. Waddell, D.V.M., Sutton Veterinary Clinic, P.C., Sutton, Nebraska Marguerite Pappaioanou, D.V.M.,Ph.D., Office of Global Health, Centers for Disease Control and Prevention Dennis P. Wages, D.V.M., North Carolina State University, College of Veterinary Medicine

Consultants, Future Committee Members Susanne Aref, Ph.D., Department of Statistics, Virginia Polytechnic Institute and State University Gregory Jaffe, Center for Science in the Public Interest

Consultants, Future Committee Members Katrina L. Mealey, D.V.M., Ph.D., Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University Richard A. Sams, Ph.D., Ohio State University, Analytical Toxicology Laboratory, Ohio State University Veterinary Hospital

Supplemental Expertise James E. Leggett, Jr., M.D., Chair of CDER’s Anti-Infective Drugs Advisory Committee, Oregon Health Sciences University

AIDAC Consultants Nathan Thielman, M.D., Duke University Medical Center Christopher Ohl, M.D., Wake Forrest University L. Barth Reller, M.D., D.T.M.&H., Duke University Medical Center

Additional Experts John Powers, M.D. Mike Apley, D.V.M.,

Historic Meeting Drug under review is a macrolide, a Category I drug, thus eligible for VMAC review under Guidance for Industry #152 Qualitative risk assessment of drug Transparent, open public meeting