[Federal Register: December 27, 2000 (Volume 65, Number 249)]
[Notices]               
[Page 81877]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de00-99]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Vaccines and Related Biological Products Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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).

    Dated: December 18, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-33019 Filed 12-26-00; 8:45 am]
BILLING CODE 4160-01-F