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Veterinary Medicine Advisory Committee

Center Date Time Location
CVM January 31, 2005 8 a.m. - 5:30 p.m.

DoubleTree Hotel
Plaza II and III
1750 Rockville Pike
Rockville, MD

Agenda:
The committee will discuss and make recommendations regarding the voluntary recall of the drug product, PROHEART 6 (NADA 141-189), manufactured by Fort Dodge Animal Health. The committee will also discuss the Center for Veterinary Medicine's risk management strategy.

Background material and meeting information will become available no later than one business day before the meeting.

Procedure:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by January 21, 2005. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on January 31, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before January 21, 2005, 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 Aleta Sindelar at least 7 days in advance of the meeting.

Contact Person:
Aleta Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Pl., Rockville MD 20855, 301-827-4515, or e-mail: asindela@cvm.fda.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512548. Please call the Information Line for up-to-date information on this meeting.

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