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U.S. Department of Health and Human Services

Animal & Veterinary

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VMAC Meeting to Discuss Cephalosporins and Animal Biotechnology

October 2, 2003

FDA plans to convene its next Veterinary Medicine Advisory Committee (VMAC) meeting on November 3-5, 2003, at the DoubleTree Hotel, 1750 Rockville Pike, Rockville, MD 20852. The meeting will be held from 8:30 a.m. until 5:00 p.m. on November 3 - 4, and 8:30 a.m. until 1:00 p.m. on November 5. The meeting will be open to the public.

On November 3, the Committee will seek recommendations on the potential approval of 4th generation cephalosporins for use as therapeutic antibiotic new animal drugs for veterinary medicine. VMAC is likely to consider both a specific drug product currently under review at FDA’s Center for Veterinary Medicine (CVM) as well as the subject of 4th generation cephalosporins as a whole.

On November 4-5, the Committee will consider two animal biotechnology issues -- cloning and genetic engineering. The Committee will consider a risk assessment on cloning through somatic cell nuclear transfer of animals that addresses both food and animal safety on November 4. VMAC will consider issues relating to the responsibilities of sponsors and investigators involved in genetic engineering research with food animals on November 5. The Committee will review contemplated Center information exchange approaches and assistance for investigators. VMAC will provide feedback on the clarity of the message and the most efficient way to inform this group of investigators.

Background information will be made available to Committee members and the public in advance of the meeting and posted on the CVM Home Page. A limited number of paper copies of the background information will be available at the registration table.

Interested persons may present data, information, or views, orally or in writing, on the issues pending before the Committee. Written submissions may be made to the contact person, Aleta Sindelar, Executive Secretary, VMAC, Center for Veterinary Medicine, HFV-3, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 301-827-4515. Oral presentations from the public will be scheduled between 10:00 a.m. and 12:00 p.m. on November 3-5. The time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify Aleta Sindelar before October 27, 2003, and 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. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public 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 Anna Roy, Conference Management Staff, at 301-827-2947, at least 7 days in advance of the meeting.

When it is available, updated information about the meeting will be included on the CVM Home Page and on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area) code 12546.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855