January 14, 2005
VMAC Meeting on ProHeart 6 ® Scheduled for January 31, 2005
The FDA Veterinary Medicine Advisory Committee (VMAC) will meet on January 31, 2005 , from 8:00 a.m. to 5:30 p.m. , at the DoubleTree Hotel, Plaza Rooms II and III, 1750 Rockville Pike, Rockville , MD. At the January 31, 2005 meeting, VMAC will discuss and make recommendations regarding the voluntary recall of the veterinary drug product PROHEART 6 (sustained release moxidectin) and the Center's risk management strategy.
Information concerning the issues of the voluntary recall of PROHEART 6 (NADA 141-189) manufactured by Fort Dodge Animal Health 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.
The meeting will be open to the public. 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 21, 2005 . Oral presentations from the public will be scheduled between approximately 1:00 p.m. 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 301-827-4515 or address above) before January 21, 2005 . 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.
Additional information about the VMAC Meeting will be included in the January 19, 2005 , Federal Register . As more information becomes available, it will be included on the FDA/Center for Veterinary Medicine Home Page calendar. 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 3014512548.
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 Aleta Sindelar at least 7 days in advance of the meeting.
Issued by:
FDA, Center for Veterinary Medicine,
Office of Management and Communications, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (301) 827-3800 FAX: (301) 827-4065
Internet Web Site: http://www.fda.gov/cvm
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