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21 FDA Veterinarian 1 (2006)

handle is hein.animal/fdavt0021 and id is 1 raw text is: CVM Issues ADUFA Performance Report for FY 04-05 T he Center for Veterinary Medicine (CVM) confirmed in a recent re- port about its user fee program that the Center exceeded the performance goals set for Fiscal Year (FY) 2004 and, according to the data available at the end of that fiscal year, is exceeding its FY 2005 goals for those FY 2005 sub- missions reviewed and acted on as of September 30, 2005. Until all submis- sions in the FY 2005 receipt cohort (all applications submitted during FY 2005) are completed, only a preliminary per- formance assessment can be provided for that cohort. Through the Animal Drug User Fee Act (ADUFA) of 2003, Congress autho- rized the Food and Drug Administra- tion (FDA) to collect user fees to add resources to CVM's drug review pro- cess. At the same time, FDA agreed to meet certain deadlines for animal drug review. The deadlines require FDA to review and act on submissions within shorter periods of time each new year over the five-year life of the Act. ADUFA also requires FDA to present Congress with annual performance re- ports following the close of a fiscal year. (The Federal fiscal year begins October 1 and ends September 30 of the follow- ing calendar year.) (Continued, next page) CVM Offers Several Lines of Communications for Constituents by Dr. Charlotte Spires, Office of New Animal Drug Evaluation, Dr Marcia Larkins, Ombudsman; Linda Grassie, Director, Communications Staff T he Center for Veterinary Medicine (CVM) of the Food and Drug Admi n- istration (FDA) works to educate animal health stakeholders and consumers, and to develop and disseminate infor- mation as it carries out its consumer protection mission. CVM operates under and enforces applicable provisions of the Federal Food, Drug, and Cosmetic Act and other authorities. The Center is respon- sible for the evaluation, approval, and surveillance of animal drugs, food ad- ditives, feed ingredients, and marketed animal devices. The Center has developed a vari- ety of mechanisms for communicating with its constituencies to foster open and collegial partnerships, respond to stakeholder concerns, and to keep the public abreast of Center activities, so that the Center can better carry out its mission. Here are some of the sources of in- formation available to the public. Website The most comprehensive source for publicly available information about CVM of interest to the animal health community is CVM's website (www. fda.gov/cvm). It contains a variety of educational booklets and other infor- mation for free download. The resources available on IN THI CVM's website include publi- What cations such as: the FDA Vet- I 1 erinarian newsletter (previous Advic( issues as well as this edition); Take CVM Updates, which are like Revie press releases for the trade by F press; CVM Annual Reports; CVM Program Policy and Procedures Manual; a list of FDA Approved Animal Drugs in the Green Book; guidance documents; and other information and publications on issues of interest to vet- erinarians and animal owners, some in Spanish. One of the major revisions to the CVM website this year was to the Adverse Drug Experience Reporting page (www.fda.gov/cvm/adetoc htm). (Continued, page 3) S ISSUE Veterinarians Should Tell Clients About Control and Their Pets ........................... 6 to Dog Owners Whose Pets N SA ID s .................................................... 7 v of Animal Production Drugs D A ........................................................ 8

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