[Federal Register: October 29, 1998 (Volume 63, Number 209)]
[Notices]               
[Page 58055]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc98-89]

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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). At least one 
portion of the meeting will be closed 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 November 19, 1998, 8 
a.m. to 6:30 p.m., and on November 20, 1998, 8 a.m. to 3:30 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Persons: 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 November 19, 1998, the committee will discuss issues 
relating to the use of cell substrates. On November 20, 1998, the 
committee will discuss issues relating to the manufacture and safety of 
live attenuated influenza virus vaccines.
    Procedure: On November 19, 1998, from 8 a.m. to 1:30 p.m., and on 
November 20, 1998, from 8 a.m. to 3:30 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 persons by November 12, 1998. 
Oral presentations from the public will be scheduled between 
approximately 8:15 a.m. and 8:30 a.m. on November 19, 1998, and between 
approximately 8:15 a.m. and 8:30 a.m., and between approximately 10:20 
a.m. and 10:50 a.m. on November 20, 1998. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before November 12, 
1998, 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.
    Closed Committee Deliberations: On November 19, 1998, from 1:30 
p.m. to 6:30 p.m., the meeting will be closed to permit discussion and 
review of trade secret and/or confidential information (5 U.S.C. 
552b(c)(4)). These portions of the meeting will be closed to discuss 
issues relating to pending or proposed investigational new drug 
applications.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 22, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-28904 Filed 10-28-98; 8:45 am]
BILLING CODE 4160-01-F