[Federal Register Volume 63, Number 38 (Thursday, February 26, 1998)]
[Notices]
[Pages 9794-9795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4964]
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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 regulatory issues.
Date and Time: The meeting will be held on March 23, 1998, 7:45
a.m. to 6:20 p.m.
Location: Ramada Inn, Embassy Ballroom, 8400 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) Discuss scientific and ethical
considerations of a human challenge model using virulent Salmonella
typhi bacteria; (2) complete recommendations pertaining to the
influenza virus vaccine formulation for 1998 and 1999; and (3) hear
short briefings on research programs in the Laboratories of DNA
Viruses, Hepatitis Viruses, and Bacterial Polysaccharides.
[[Page 9795]]
Procedure: On March 23, 1998, from 7:45 a.m. to 4:50 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
March 16, 1998. Oral presentations from the public will be scheduled
between approximately 8 a.m. to 8:15 a.m. and between approximately
3:30 p.m. to 4:15 p.m. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before March 16, 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 March 23, 1998, from 4:50 p.m.
to 6:20 p.m., the meeting will be closed to review data of a personal
nature where disclosure would constitute a clearly unwarranted invasion
of personal privacy (5 U.S.C. 552b(c)(6)). This portion of the meeting
will be closed to permit discussion of this information.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 20, 1998.
Michael A. Friedman,
Deputy Commissioner of Operations.
[FR Doc. 98-4964 Filed 2-25-98; 8:45 am]
BILLING CODE 4160-01-F