Table of Contents

Updates/Press Releases
Federal Register Notices
Guidance Documents
Risk Assessments
Additional Information
Hyper-Links

CVM Updates/FDA Press Releases

• CVM Update - FDA Revokes Order Prohibiting Extralabel Use of Cephalosporin, November 25, 2008

• CVM Update - FDA Extends Cephalosporin Comment Period and Delays Final Rule, August 15, 2008

• CVM Update - FDA Issues Order Prohibiting Extralabel Use of Cephalosporin Antimicrobial Drugs in Food-Producing Animals, July 2, 2008

• CVM Update - Update on FDA’s Draft Risk Assessment of Streptogramin Antimicrobial Drugs, November 2, 2005
  

• FDA News - FDA Announces Final Decision About Veterinary Medicine, July 28, 2005
  

• CVM Update - Virginiamycin Risk Assessment Available for Review and Comment, November 24, 2004
  

• CVM Update - Initial Decision on Proposed Withdrawal of Baytril Poultry NADA, March 18, 2004
  

• FDA Press Release - FDA Issues Guidance on Evaluating the Safety of Antimicrobial New Animal Drugs to Help Prevent Creating New Resistant Bacteria, October 23, 2003
  

• CVM Update - FDA Proposes Removing Obsolete Antimicrobial Regulations, August 8, 2003
  

• CVM Update - Reminder -- Extra-Label Use Of Fluoroquinolones Prohibited, September 19, 2002
  

• CVM Update - FDA Announces Public Meeting and Availability of Draft Guidance on Antimicrobial Resistance, September 11, 2002

Federal Register Notices

• Enrofloxacin for Poultry; Final Decision on Withdrawal of New Animal Drug Application Following Formal Evidentiary Public Hearing; Availability. Docket No. 2000N-1571, OC 2005193.  Page  44105 [FR Doc. 05-15224]  August 1, 2005 | htm | | pdf | | Pre-Pub |

• Animal Drugs, Feeds, and Related Products; Enrofloxacin for Poultry; Withdrawal of Approval of New Animal Drug Application. Docket No. 2000N-1571, OC 2005194. Final Rule. Pages  44048-44049 [FR Doc. 05-15223]  August 1, 2005 | htm | | pdf | Effective on September 12, 2005

• Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Extension of Comment Period. FR Notice: Docket No. 2004N-0479, CVM 2004122.   Pages  913-914 [FR Doc. 05-00111]   January 5, 2005 | htm | | pdf | Comments due February 23, 2005

• Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Steptogramins in Animals; Availability.  Docket No. 2004N-0479, CVM 2003132.  Pages  68384-68385 [FR Doc. 04-25979]  November 24, 2004 | htm | | pdf  | Comments by January 24, 2005

• Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern; Availability. Docket No. 1998D-1146, CVM 200381. Page 61221 [FR Doc. 03-27113] October 27, 2003 | htm | | pdf |

Guidance Documents

• 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 |

• 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 |
  

  • Docket No. 1998D-1146, CVM 200381. Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern; Availability. Page 61221 [FR Doc. 03-27113] October 27, 2003 | htm | | pdf |
    

  • FDA Press Release - FDA Issues Guidance on Evaluating the Safety of Antimicrobial New Animal Drugs to Help Prevent Creating New Resistant Bacteria, October 23, 2003
    

  • GFI #152 Questions and Answers
    

  • Food and Drug Administration’s New Guidance For Industry on Antimicrobial Drugs for Food Animals, GFI #152, Released October 23, 2003 (PowerPoint Presentation)

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

Risk Assessments

• Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals, November 23, 2004 (pdf) (Draft Virginiamycin Risk Assessment)

  • CVM Update - Update on FDA’s Draft Risk Assessment of Streptogramin Antimicrobial Drugs, November 2, 2005
    

  • CVM Update - Virginiamycin Risk Assessment Available for Review and Comment, November 24, 2004

• 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
  

  • 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

• 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 |

Additional Information

• Final Decision of the Commissioner, Docket Number 2000N-1571 - Withdrawal of Approval the New Animal Drug Application for Enrofloxacin in Poultry

• Public Health Action Plan to Combat Antimicrobial Resistance, Annual Reports, Centers for Disease Control and Prevention

  • Federal Register Notice: | doc | | pdf |

• Animation of Antimicrobial Resistance - Released August 2004

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

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

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

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

• 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)

• 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

Hyper-links

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

• Public Health Action Plan to Combat Antimicrobial Resistance, Annual Reports, Centers for Disease Control and Prevention

  • Federal Register Notice: | doc | | pdf |

• NARMS 

• Antimicrobial Resistance Public Meetings

• Framework Document 

• VMAC Testimony

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