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U.S. Department of Health and Human Services

Advisory Committees

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March 24, 2010: Veterinary Medicine Advisory Committee Meeting Announcement


 

CenterDateTimeLocation
CVMMarch 24, 20108:30 a.m. to 5 p.m.Rockville Hilton
1750 Rockville Pike
Rockville, MD 20852
301-468-1100

Agenda

The committee will discuss and make recommendations regarding modifications, if any, to the current risk minimization and restricted distribution program for Pfizer's PROHEART® 6 (NADA 141-189), the subsequent safety data collected under the Center for Veterinary Medicine's risk minimization and restricted distribution program, and the agency's role in continued product postmarketing surveillance.

Meeting Materials

Links to meeting materials will be added as they become available. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting.

Public Participation Information

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 on or before March 17, 2010. 
  • Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person 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 on or before March 9, 2010. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 10, 2010. 
  • 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. 
  • FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Contact Information

  • Aleta Sindelar
    Center for Veterinary Medicine (HFV-3)
    Food and Drug Administration
    7519 Standish Pl.
    Rockville, MD 20855
    240-276-9004
    FAX 240-276-9020
    e-mail: aleta.sindelar@fda.hhs.gov 
  • 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. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. 

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).