[Federal Register Volume 63, Number 209 (Thursday, October 29, 1998)]
[Notices]
[Page 58055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28904]
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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
