August 22, 2006
VMAC Fall 2006 Meeting Scheduled for September 25th
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: 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 (Salmonella, E. coli, Campylobacter, etc.).
The antimicrobial drug sponsor, Intervet, 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. This will be accomplished by posing a series of questions to the VMAC, to promote discussion and ultimately gain VMAC recommendations with regard to the Agency’s assessment.
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. 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.
FDA welcomes public attendance at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Ms. Sindelar at least seven days in advance of the meeting.
Information concerning the issues of microbial food safety will be made available to the VMAC members and the public in advance of the meeting and posted on the Center for Veterinary Medicine’s VMAC webpage http://www.fda.gov/cvm/VMAC/vmacmeet.htm. A limited number of paper copies of the background information will be available at the registration table the day of the meeting.
Additional information about the VMAC meeting also will be posted on the FDA/Center for Veterinary Medicine Home Page. 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.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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