Animal & Veterinary
VMAC Meeting Scheduled for January 2002
November 21, 2001
The FDA Veterinary Medicine Advisory Committee (VMAC) will meet on January 22, 23, and 24, 2002, from 8:30 a.m. to 5 p.m., at the DoubleTree Hotel, Plaza Rooms I, II, and III, 1750 Rockville Pike, Rockville, MD. This FDA public advisory committee meeting will be open to the public. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At the January meeting, VMAC will seek recommendations on the issues of import tolerances under the provisions of the Animal Drug Availability Act of 1996 (ADAA), and on the antimicrobial drug effects on pathogen load in food-producing animals as pathogen load relates to the pre-approval process of new animal drug applications (NADAs). Information concerning the discussion of import tolerances can be found in an August 13, 2001 CVM UPDATE and in a Federal Register notice of August 10, 2001.
Information concerning the issues of pathogen load will be made publicly available to the VMAC members and the public in advance of the meeting and posted on the Center for Veterinary Medicine's Home Page. A limited number of paper copies of the background information will be available at the meeting.
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 Aleta Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855. Written comments must submitted by January 4, 2002. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 4:15 p.m. on January 22, and 8:45 a.m. and 11:00 a.m. on January 24, 2002. The time allotted for each presentation may be limited. Individuals wishing to make oral presentations should notify Aleta Sindelar (telephone number 301-827-4515 or address above) before January 4, 2002. 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. Their entire statements should be submitted for the record.
Additional information about the VMAC meeting will be included 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 12546.