Center for Veterinary Medicine
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Table of Contents

NARMS red bullet
Public Meetings red bullet
CVM Updates red bullet
Framework Document red bullet
VMAC Testimony red bullet

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Antimicrobial Resistance

Latest Information:

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Animation of Antimicrobial Resistance - Released August 2004

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Guidance for Industry #144 - Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals with Respect to Antimicrobial Resistance - VICH GL27, Final Guidance, April 27, 2004 | doc | | pdf |

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Guidance for Industry 152 - Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern, October 23, 2003 | doc | | pdf |

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Enrofloxacin for Poultry: Withdrawal of Approval of Bayer Corporation’s New Animal Drug Application (NADA) 140-828 (Baytril), Docket No. 00N-1571

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Guidance for Industry #144- Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals with Respect to Antimicrobial Resistance, VICH GL27, Draft Guidance - June 12, 2003 | doc | | pdf |

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CVM and Judicious Use of Antimicrobials

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FDA Task Force on Antimicrobial Resistance: Key Recommendations and Report, December 2000

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Effect of the Use of Antimicrobials in Food-Producing Animals on Pathogen Load: Systematic Review of the Published Literature, October 2000

| PathRpt.doc | | PathTables.xls (Tables 1,2,3 and 4) |
| PathFigure.doc |

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Guidance for Industry #121: Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims, March 6, 2001 | doc | | pdf |

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An Approach for Establishing Thresholds in Association with the Use of Antimicrobial Drugs in Food-Producing Animals, December 19, 2000 | doc | | pdf |

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Important Notice: Working @RISK model of the analysis described in the report of "The human health impact of fluoroquinolone resistance Campylobacter associated with the consumption of chicken." Please note that despite the *.xls extension, this file will not be functional and will not have numeric values printed in all the cells unless the user opens it with @RISK 4.0. If the user does not have this software available, opening the file in Excel will allow the user to see input data values and the functions that were used to generate intermediary and final outputs of the model. The output cells, however, will contain "#NAME?" because the @RISK 4.0 functions will be unknown to Excel.

@Risk Model - Analysis of the human health effect of fluoroquinolone resistant Campylobacter in domestically reared and consumed broilers

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Risk Assessment on the Human Health Impact of Fluoroquinolone Resistant Campylobacter Associated with the Consumption of Chicken, dated October 18, 2000,
Revised January 5, 2001

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Antibiotic Resistance in Livestock, USDA/HHS Response to the House and Senate Reports: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Appropriations Bill, 2000, September 14, 2000 (pdf)

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Public Health Action Plan to Combat Antimicrobial Resistance, Centers for Disease Control and Prevention, January 2000

  • Federal Register Notice: | doc | | pdf |

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Human-Use Antibiotics in Livestock Production;
HHS Response to House Report 106-157 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Appropriations Bill, 2000, April 28, 2000

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Risk Assessment of the Public Health Impact of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Request for Comments and for Scientific Data and Information. | pdf | | txt |



Web page updated by mdt, September 20, 2004, 2:00 PM ET

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FDA Logo links to FDA home page HHS Logo links to Department of Health and Human Services website U.S. Food and Drug Administration Center for Veterinary Medicine FDAMA Antimicrobial Resistance Biotechnology Aquaculture Food Safety BSE Guidance Documents Green Book Freedom of Information link to the FDAMA page link to the Antimicrobial Resistance page link to the Biotechnology page link to the Aquaculture page link to the Food Safety page libk to the BSE page link to the Guidance Documents page link to the Green Book page link to the Freedom of Information page