[Federal Register Volume 66, Number 123 (Tuesday, June 26, 2001)]
[Notices]
[Page 33966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15912]



[[Page 33966]]

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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 July 26, 2001, 8:30 a.m. 
to 5:30 p.m., and on July 27, 2001, 8:30 a.m. to 3:30 p.m.
    Location: Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., 
Gaithersburg, 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, 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 July 26, 2001, the committee will hear presentations on 
the available safety and efficacy data for Aviron, Inc.'s cold adapted, 
live attenuated, trivalent influenza virus vaccine 
(FluMistTM). On July 27, 2001, the committee will discuss 
the available data and the proposed indications for 
FluMistTM.
    Procedure: On July 26, 2001, from 10:15 a.m. to 5:30 p.m., and on 
July 27, 2001, from 8:30 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 person by July 8, 2001. On July 
27, 2001, oral presentations will be held between approximately 9 a.m. 
and 10:15 a.m. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before July 8, 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 July 26, 2001, from 8:30 a.m. to 
10:15 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)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 19, 2001.
Bonnie Malkin,
Special Assistant to the Senior Associate Commissioner.
[FR Doc. 01-15912 Filed 6-25-01; 8:45 am]
BILLING CODE 4160-01-S