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Vaccines and Related Biological Products Advisory Committee

Agenda:
On December 14, 2005 the committee will hear presentations and make recommendations on the safety and efficacy of a rotavirus vaccine manufactured by Merck.

On December 15, 2005, the committee will hear presentations and make recommendations on the safety and efficacy of ZOSTAVAX (zoster vaccine live (Oka/Merck)) manufactured by Merck.

Background material and meeting information will become available no later than one business day before each meeting day (Simply select the appropriate committee link).

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 December 7, 2005. Oral presentations from the public will be scheduled between approximately 1:15 p.m. and 1:45 p.m. on December 14, 2005 and from approximately 1:30 p.m. and 2:00 p.m. on December 15, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before December 7, 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 Christine Walsh or Denise Royster at least 7 days in advance of the meeting.

Contact Person:
Christine Walsh or Denise Royster, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD. 20852, 301-827-0314.

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512391.