[Federal Register: September 18, 2003 (Volume 68, Number 181)]
[Page 54734]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Veterinary Medicine Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 
    Location: The DoubleTree Hotel, 1750 Rockville Pike, Rockville, MD 
    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 
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 9, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-23781 Filed 9-17-03; 8:45 am]