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Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

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Food and Drug Administration, HHS.



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 Committee: Vaccines and Related Biological Products 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 January 30, 2001, 8 a.m. to 6:30 p.m., and on January 31, 2001, 9 a.m. to 6 p.m.

Location: Holiday Inn, Versailles I, II, and III, 8120 Wisconsin Ave., Bethesda, MD.

Contact Person: Nancy T. Cherry or Denise H. Royster, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301 827 0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12391. Please call the Information Line for up-to-date information on this meeting.

Agenda: On January 30, 2001, the committee will discuss the influenza virus vaccine formulation for the 2001-2002 season. On January 31, 2001, the committee will hear a review of LYMErixTM (Lyme disease vaccine, SmithKline Beecham) safety profile including an update of post-marketing safety data.

Procedure: On January 30, 2001, from 8 a.m. to 6:30 p.m., and on January 31, 2001, from 9 a.m. to 6 p.m., the meeting is open to the public. 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 22, 2001. Oral presentations from the public will be scheduled between approximately 2 p.m. and 2:30 p.m. on January 30, 2001. Oral presentation from the public will be heard on January 31, 2001, between approximately 1:45 p.m. and 2:15 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before January 22, 2001, 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.

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

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Dated: December 18, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

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[FR Doc. 00-33019 Filed 12-26-00; 8:45 am]