[Federal Register Volume 64, Number 8 (Wednesday, January 13, 1999)]
[Notices]
[Pages 2227-2228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-740]
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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 January 29, 1999, 8:30
a.m. to 6:30 p.m.
Location: Holiday Inn, Versailles Ballrooms III and IV, 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: The committee will: (1) Discuss the influenza virus vaccine
formulation for 1999 and 2000, and (2) hear an update on the status of
influenza A H5N1 viruses.
Procedure: On January 29, 1999, from 8:30 a.m. to 5:30 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 person by
January 22, 1999. Oral
[[Page 2228]]
presentations from the public will be scheduled between approximately
8:45 a.m. and 9:15 a.m., and between 3:30 p.m. and 4 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,
1999, 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 January 29, 1999, from 5:30 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)). This portion 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: January 7, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-740 Filed 1-12-99; 8:45 am]
BILLING CODE 4160-01-F
