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Veterinary Medicine Advisory Committee (VMAC)
Fall 2006 Meeting
DoubleTree Hotel, Plaza Rooms II-III
1750 Rockville Pike, Rockville, MD
September 25, 2006
8:30 a.m. to 5:00 p.m

FDA's Veterinary Medicine Advisory Committee (VMAC) will meet on September 25, 2006, from 8:30 a.m. to 5:00 p.m., at the DoubleTree Hotel, Plaza Rooms II-III, 1750 Rockville Pike, Rockville, MD.  At the meeting, VMAC will discuss the microbial food safety of an antimicrobial drug application currently under review for use in food producing animals in accordance with FDA/Center for Veterinary Medicine's Guidance for Industry #152. Microbial food safety is that part of the human food safety evaluation that looks at the impact of the use an antimicrobial drug on the development of resistance among pathogenic, zoonotic bacteria of human health concern (Salmonella, E. coli, Campylobacter, etc.).

Interested persons may present data, information, or views, orally or in writing, on the issues pending before the committee.  Written submissions may be sent to Aleta Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855.  Written comments must submitted by September 13, 2006.  Oral presentations from the public will be scheduled between approximately 1:00 and 2:00 p.m. The time allotted for each presentation may be limited.  Individuals wishing to make oral presentations should notify Aleta Sindelar (telephone number 240-276-9004, e-mail Aleta.Sindelar@FDA.HHS.gov, or address above) before September 13, 2006.

The Maryland State Board of Veterinary Medical Examiners has approved one hour of continuing education credit for this one day meeting.

Up-to-date information on the VMAC meeting is also available on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 301-451-2548.

Hotel reservations, if needed should be made directly with the DoubleTree Hotel at (301) 468-1100 or http://www.rockvillehotel.com/.

CVM Update - VMAC Fall 2006 Meeting Scheduled for September 25th, August 22, 2006

Federal Register Notice - OC 2006178. Veterinary Medicine Advisory Committee; Notice of Meeting. Page 48931 [FR Doc. E6013818]August 22, 2006 | htm | | pdf | | Pre-Pub | Meeting on September 25, 2006

Microbial Food Safety of an Antimicrobial Drug Application

• Background Materials
  • Agenda | html | | doc | | pdf |
  • Registered Speakers | html | | pdf |
  • Framework Document
  • Guidance for Industry 152 - Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern | doc | | pdf |
  • Cefquinome formulations for parenteral injection for the treatment of bovine respiratory disease
  • Members and Consultants | doc | | pdf | 
  • Presentations
  • VMAC 2006 Questions

1.  Do the findings presented in the sponsor’s (qualitative risk) assessment demonstrate that cefquinome is safe with respect to the potential for transfer of antimicrobial resistant organisms to humans?

2.  Are there other issues to consider relative to this class of antimicrobial agents (4^th generation cephalosporins)?

• Other species for which it should/should not be approved?
• Routes of administration that are/are not acceptable?
• Indications that are/are not appropriate? 
• Other relevant issues?

3.  Are the risk management recommendations appropriate, or should they be modified?

• Transcript | html | | doc |

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