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U.S. Department of Health and Human Services

Animal & Veterinary

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Veterinary Medicine Advisory Committee Meeting on Antimicrobial Scheduled

FDA Veterinarian Newsletter 2006 Volume XXI, No III

The Food and Drug Administration’s (FDA) Veterinary Medicine Advisory Committee (VMAC) is scheduled to meet on September 25, 2006, to discuss the microbial food safety of an antimicrobial drug application currently under review for use in food producing animals.

The panel will review the microbial food safety of cefquinome formulations for parenteral injection to treat bovine respiratory disease in cattle. A review by an external panel of the microbial food safety aspects of an antimicrobial under review for potential approval is in accordance with FDA’s Center for Veterinary Medicine’s (CVM) Guidance for Industry, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern” (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, such as Salmonella, E. coli, and Campylobacter.

The drug sponsor has submitted information to the Agency to address microbial food safety concerns. The Agency has reviewed that information, and now seeks input from the VMAC as to whether the Agency’s assessment of the information and strategies for managing any potential microbial food safety risks are appropriate. The Agency will be posing a series of questions to the VMAC to promote discussion and ultimately gain VMAC recommendations with regard to the Agency’s assessment.

Details

Date: September 25, 2006
Place: DoubleTree Hotel, Plaza Rooms II-III, 1750 Rockville Pike, Rockville, MD.
Time: 8:30 a.m. to 5:00 p.m.

Comments

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 be submitted by September 13, 2006.

Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. The time allotted for each presentation may be limited. Individuals wishing to make oral presentations should notify Aleta Sindelar (by telephone, at 240-276-9004, by e-mail, at aleta.sindelar@fda.hhs.gov, or by mail, at the address above) before September 13, 2006. They should submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. They will be notified of their allotted time prior to the meeting.

Additional information
Information concerning the issues of microbial food safety is available to the VMAC members and the public in advance of the meeting and posted on CVM’s website. Additional information about the VMAC meeting also will be posted on the CVM website.
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.