[Federal Register Volume 65, Number 206 (Tuesday, October 24, 2000)]
[Notices]
[Page 63604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27229]



[[Page 63604]]

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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 3, 2000, 8 a.m. 
to 5:30 p.m.
    Location: Holiday Inn, Versailles I and II, 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, 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 3, 2000, the committee will hear an update on 
issues relating to transmissible spongiform encephalopathy and will 
review safety and efficacy data pertaining to a diphtheria/tetanus/
acellular pertussis vaccine manufactured by Aventis Pasteur Ltd.
    Procedure: On November 3, 2000, from 8:30 a.m. to 5:30 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 
October 26, 2000. Oral presentations from the public will be scheduled 
between approximately 1:50 p.m. and 2:20 p.m., and between 
approximately 3:20 p.m. and 3:50 p.m. on November 3, 2000. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
October 26, 2000, 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 3, 2000, from 8 a.m. to 
8:20 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 will be closed to permit discussion of pending 
investigational new drug applications or pending product licensing 
applications.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the November 3, 2000, meeting of the Vaccines and Related Biological 
Products Advisory Committee. Because the agency believes there is some 
urgency to bring this issue to public discussion and qualified members 
of the Vaccines and Related Biological Products Advisory Committee were 
available at this time, the Commissioner of Food and Drugs concluded 
that it was in the public interest to hold this meeting even if there 
was not sufficient time for the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 17, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-27229 Filed 10-23-00; 8:45 am]
BILLING CODE 4160-01-F