[Federal Register Volume 62, Number 225 (Friday, November 21, 1997)]
[Notices]
[Page 62325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30708]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Vaccine 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 regulatory issues.
Date and Time: The meeting will be held on December 11, 1997, 10:30
a.m. to 5:45 p.m., and December 12, 1997, 8 a.m. to 5 p.m.
Location: Holiday Inn Bethesda, 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 12388. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On December 11, 1997, the committee will meet in closed
session to discuss trade secret and/or confidential commercial
information relevant to pending investigational new drug applications
or pending product licensing applications. On December 12, 1997, in
open session, the committee will consider the safety and efficacy of a
new vaccine for the prevention of Rotavirus Diarrhea in children. The
vaccine, RotaShieldTM, is made for infant indication by
Wyeth-Lederle Vaccines and Pediatrics.
Procedure: On December 12, 1997, from 9:30 a.m. to 5 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
December 3, 1997. Oral presentations from the public will be scheduled
between approximately 1:30 p.m. and 2:30 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before December 3, 1997,
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 December 11, 1997, from 10:30
a.m. to 5:45 p.m., and on December 12, 1997, from 8 a.m. to 9:30 a.m.,
the meeting will be closed to permit discussion and review of trade
secret and/or confidential information. These portions of the meeting
will be closed to discuss pending investigational new drug applications
or pending product licensing applications (5 U.S.C. 552b(c)(4)).
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 17, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-30708 Filed 11-20-97; 8:45 am]
BILLING CODE 4160-01-F
