1. U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

2. Welcome to VMAC: Microbial Food Safety of Cefquinome Comments by Dr. Stephen F. Sundlof, D.V.M., Ph.D. Director Center for Veterinary Medicine September 25, 2006 Rockville, Maryland

3. Committee Members Arthur L. Craigmill, Ph.D., University of California –veterinary toxicology Corrie Brown, D.V.M., Ph.D., University of Georgia –pathology

4. Committee Members John R. Glisson, D.V.M., MAM, Ph.D.,University of Georgia –avian medicine Sam Groseclose, D.V.M., MPH, Centers for Disease Control and Prevention –public health/epidemiology

5. Committee Members Sherman W. (Skip) Jack, D.V.M., Ph.D., Mississippi State –minor use/minor species veterinary medicine Gregory Jaffe, Center for Science in the Public Interest –consumer representative

6. Committee Members John J. McGlone, Ph.D., Texas Tech University and Health Sciences Center –animal science Mark G. Papich, D.V.M., Ph.D., North Carolina State University –pharmacology

7. Committee Members M. Gatz Riddell, Jr., D.V.M. American Association of Bovine Practitioners –food animal medicine Richard A. Sams, Ph.D., The Ohio State University –chemistry

8. Consultants James E. Leggett, Jr., M.D., Oregon Health Sciences University –infectious diseases L. Barth Reller, M.D., D.T.M.&H., Duke University Medical Center –infectious diseases

9. Purpose of Meeting VMAC input on microbial food safety of antimicrobial for food animal –concept in Guidance for Industry –second VMAC review of antimicrobial animal drug –2004 review of tulathromycin

10. Reason for Review 4 th generation cephalosporin –important to human medicine –3 rd generation considered “critically important” to human health Review appropriate under Guidance

11. Thank you for Coming Valuable assistance from VMAC members, consultants