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CVM Annual Report Fiscal Year 2008: October 1, 2007-September 30, 2008 A Message from the Director A Message from the Center Leadership Team About CVM Other FDA Centers have joined in the campaign for improved health literacy. The user fees will supplement appropriated funding for new animal drug review. payday loans CVM is an active participant in the Agency's Critical Path Initiative. Here is an overview of Critical Path Initiatives studies initiated in 2008. Nevertheless, CVM set a goal of 100 percent compliance with the regulation. We found no serious violations; thus, no enforcement action was required.

A decade ago we set a goal of 100 percent actual compliance with the rule. His legacy with CVM is a great one, and we thank him for all that he did. HIGHLIGHTS OF FY 2008: ACCOMPLISHMENTS THROUGH THE WORK OF OUR PEOPLE

You will find more details on each accomplishment elsewhere in this report. Extension and Expansion of User Fees to Expedite New Animal Drug Approvals Please feel free to share your comments and to come and meet with us. How do we achieve and maintain a participative/collaborative work culture? The Center for Veterinary Medicine is a consumer protection organization. Drug sponsors must submit tests to establish drug safety and effectiveness. Antimicrobial resistance Implementation of Guidance for Industry # 152. Metabolism studies were started to verify the choice of the marker compounds.

We met or exceeded the goals for the first four years, FY 2004 to FY 2007. Performance and financial reports for FY 2008 will be published separately.

Award Nomination - Dr. Renate Reimschuessel, Service to America Medal finalist Dr. Reimschuessel is a research biologist at CVM's Office of Research. VETSULIN (porcine insulin zinc) is the first approved insulin for cats. AQUAFLOR, as approved for furunculosis, is a Designated drug under MUMS. Department of Agriculture, and the Centers for Disease Control and Prevention. RESEARCH TO SUPPORT ANTIMICROBIAL RESISTANCE SURVEILLANCE AND REGULATION One such Stx2 variant, Stx2dact, is associated with increased disease severity. Molecular Diagnostic Assays for Detecting Genes of Biomedical Importance During the same time period, four new BSE cases were detected in Canada. Nevertheless, the FDA concluded that additional protections were needed.

A CVM staff member, Dr. Dragan Momcilovic, continued to serve as the only U.S. We also continued to provide educational outreach to the regulated industry. The first method being developed is for penicillin G in bovine tissues.

MEDICATED FEED MILL INSPECTIONS VOLUNTARY SELF-INSPECTION PROGRAM We intend to review data for two fiscal years before deciding how to proceed. representative to the working group and is coordinating input from U.S. CVM's approach to this challenge has two aspects, as described below. The Agency released the draft guidance for public comment in September 2008.

The guidance is titled GFI #187 Containing Heritable rDNA Constructs (Draft). CVM's ongoing interactions with the trade components of the U.S.

Department of Agriculture's Foreign Agricultural Service and assists the U.S. Following are highlights of our accomplishments during the past fiscal year.

Removal of Restrictions on African Rodents, Prairie Dogs, and Other Animals Executive Management Results Objective: Initiate the CVM Succession Plan. Program Results Objective: Develop CVM Career/Leadership Development Programs. Geological Survey's Upper Midwest Environmental Science Center (USGS/UMESC). In vivo/in vitro and interspecies comparisons Critical Path research. In developing the drugs, we will use the concept of quality by design. Salmonella diversity studies critical path collaboration studies. Dr. Vaughn and members of the U.S. Delegation to CCRVDF met with the U.S. To do the best job it can, CVM must communicate with its stakeholders.

During the year, CVM completed work on a new database of approved animal drugs. Yoko Adachi Susan J. Bright, D.V.M. Connie R. Mahon Ruby Singh, Ph.D.

EXCELLENCE IN LABORATORY SCIENCE - Shaohua Zhao, D.V.M., M.P.V.M., Ph.D. Kristen L. Anderson, Ph.D. Matthew D. Anderson, Ph.D. Julie V. Bailey, Ph.D. Dennis M. Bensley, Jr., Ph.D. Renee S. Blosser Stephanie C. Bowman, Ph.D. Petra M. Garosi, P.M.P. John K. Harshman, Ph.D. Diane L. Heinz, D.V.M. Rial A. Christensen, Ph.D. Karen B. Ekelman, Ph.D. Devaraya R. Jagannath, Ph.D. Cindy L. Burnsteel, D.V.M. Petra M. Garosi, P.M.P. Robin B. Keyser, Ph.D. Arnel B. Peralta, D.V.M. Sharon L. Ricciardo Herman M. Schoenemann III, Ph.D. Daniel C. Burnette Jean-Michel Campagne, Ph.D. H. Gregg Claycamp, Ph.D.

Elizabeth P. Cormier, Ph.D. Bharati R. Dhruva, Ph.D. Cory D. Evans, Ph.D. Charles P. O'Brien, Ph.D. Michael E. Oehlsen, Ph.D. Rebecca L. Owen, Ph.D. Jason W. Abbott Karen E. Blickenstaff Sharon L. Friedman Althea Glenn William J. Burkholder, D.V.M., Ph.D. Jack Geltman George Graber, Ph.D. Laura C. Alvey Neal Bataller, D.V.M. Catherine P. Beck Sharon A. Benz, Ph.D. Michaela G. Alewynse, Ph.D. Sharon A. Benz, Ph.D. Rial A. Christensen, Ph.D.

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