[Federal Register Volume 66, Number 34 (Tuesday, February 20, 2001)]
[Notices]
[Pages 10894-10895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4142]


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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 March 7, 2001, from 8 
a.m. to 6:30 p.m., March 8, 2001, from 8 a.m. to 6:30 p.m., and 
March 9, 2001, from 8 a.m. to 12:30 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact: 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, or FDA 
Advisory

[[Page 10895]]

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 March 7, 2001, the committee will review safety and 
immunogenicity data for a combination vaccine, DTaP--Hepatitis B-
IPV, manufactured by SmithKline Beecham Biologicals. On March 8, 
2001, the committee will discuss approaches to develop new 
pneumococcal conjugate vaccines for U.S. licensure. On March 9, 
2001, the committee will complete recommendations pertaining to the 
influenza virus vaccine formulations for the 2001 to 2002 season and 
be briefed on research programs in the Laboratory of Retroviruses 
and the Laboratory of Immunoregulation.
    Procedure: On March 7, 2001, from 9:15 a.m. to 6:30 p.m., the 
meeting is open to the public. On March 8, 2001, from 10 a.m. to 
6:30 p.m., the meeting is open to the public. On March 9, 2001, from 
8 a.m. to 11 a.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 February 28, 2001. Oral 
presentations from the public will be scheduled between 
approximately 1:30 p.m. and 2 p.m. on March 7, 2001. On March 8, 
2001, oral presentations will be held between approximately 2 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 February 28, 2001, 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 7, 2001, from 8 a.m. to 
9 a.m. and on March 8, 2001, from 8 a.m. to 10 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)). This portion of 
the meeting will be closed to permit discussion of pending 
investigational new drug applications or pending product licensing 
applications. On March 9, 2001, from 11 a.m. to 12:30 p.m., the 
meeting will be closed to permit discussion where disclosure would 
constitute a clearly unwarranted invasion of personal privacy (5 
U.S.C. 552b(c)(6)). The meeting will be closed to discuss personal 
information concerning individuals associated with the research 
programs.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 14, 2001.
Bonnie H. Malkin,
Special Assistant to the Senior Associate Commissioner.
[FR Doc. 01-4142 Filed 2-16-01; 8:45 am]
BILLING CODE 4160-01-F