Food and Drug Administration, HHS.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of the Committee: Veterinary Medicine Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on November 3 and 4, 2003, from 8:30 a.m. to 5 p.m.; and on November 5, 2003, from 8:30 a.m. to 1 p.m.
Location: The DoubleTree Hotel, 1750 Rockville Pike, Rockville, MD 20852.
Contact Person: Aleta Sindelar, Center for Veterinary Medicine (CVM) (HFV-3), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4515, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12546. Please call the Information Line for up-to-date information on this meeting.
Agenda: On November 3, 2003, the committee will seek recommendations on the potential approval of fourth generation cephalosporins for use as therapeutic antibiotic new animal drugs for veterinary medicine. The committee is likely to consider both a specific drug product currently under review as well as the subject of fourth generation cephalosporins as a whole. On November 3 and 4, 2003, the committee will consider two animal biotechnology issues: cloning and genetic engineering. On November 4, 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 5, the committee will consider issues relating to the responsibilities of sponsors and investigators involved in genetic engineering research with food animals. The committee will review contemplated center information exchange approaches and assistance for investigators. The committee 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 CVM's home page at http://www.fda.gov/cvm. A limited number of paper copies of the background information will be available at the registration table.
Procedure: 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 by October 24, 2003. Oral presentations from the public will be scheduled between approximately 10 a.m. and 12 noon on November 3, 4, and 5, 2003. The time allotted for each presentation may be limited. Those desiring to make formal oral presentation should notify the contact person 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, 301-827-2947, at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).Start Signature
Dated: September 9, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-23781 Filed 9-17-03; 8:45 am]
BILLING CODE 4160-01-S