[Federal Register Volume 63, Number 86 (Tuesday, May 5, 1998)]
[Notices]
[Pages 24812-24813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11806]


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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 may 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 regulatory issues.
    Date and Time: The meeting will be held on May 26 and 27, 1998, 8 
a.m. to 5:45 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Nancy T. Cherry or Denise H. Royster, Center for 
Biologics Evaluation and Research (HFM-21), 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: The committee will: (1) Consider the safety and efficacy of 
a new vaccine from SmithKline for the prevention of Lyme disease; (2) 
consider the safety and efficacy of a live, oral, attenuated vaccine 
for the prevention of cholera; and (3) discuss issues relating to the 
potential inclusion of a boxed warning on the package insert for live 
polio virus vaccine.
    Procedure: On May 26 and 27, 1998, from 9 a.m. to 5:45 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 
May 19, 1998. Oral

[[Page 24813]]

presentations from the public will be scheduled between approximately 9 
a.m. and 9:15 a.m., and between approximately 3:30 p.m. and 3:45 p.m., 
on May 26, 1998, and between approximately 9 a.m. and 9:15 a.m., and 
between approximately 1:30 p.m. and 1:45 p.m., and between 
approximately 3:30 p.m. and 3:45 p.m., on May 27, 1998. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before May 19, 
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 May 26 and 27, 1998, from 8 a.m. 
to 9 a.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 pending 
investigational new drug applications or pending product licensing 
applications.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 28, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-11806 Filed 5-4-98; 8:45 am]
BILLING CODE 4160-01-F