[Federal Register Volume 65, Number 39 (Monday, February 28, 2000)]
[Notices]
[Page 10503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4589]


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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 9, 2000, 8 a.m. to 
6 p.m., and on March 10, 2000, 8 a.m. to 3 p.m.
    Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver 
Spring, 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: On March 9, 2000, the committee will discuss the safety and 
efficacy of a combination vaccine from SmithKline Beecham for the 
prevention of Diptheria/Tetanus, Pertussis, Polio, and Hepatitis B. On 
March 10, 2000, the committee will: (1) Complete recommendations 
pertaining to the influenza virus vaccine formulations for the 2000 to 
2001 season, (2) hear a short briefing on the Vaccine Safety Action 
Plan, and (3) be updated on the status of vaccines for the prevention 
of rotavirus disease.
    Procedure: On March 9, 2000, from 9:15 a.m. to 6 p.m., and on March 
10, 2000, from 8 a.m. to 3 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 3, 2000. Oral presentations 
from the public will be scheduled between approximately 9:30 a.m. and 
9:45 a.m. and between approximately 4 p.m. and 4:15 p.m on March 9, 
2000. Oral presentations from the public will be heard on March 10, 
2000, between approximately 10:20 a.m. and 10:30 a.m., between 
approximately 12:30 p.m. and 12:45 p.m., and between approximately 2:45 
p.m. and 3 p.m. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before March 1, 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 March 9, 2000, from 8 a.m. to 
9:15 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)). 
These portions of the meeting will be closed to discuss issues relating 
to pending or proposed investigational new drug applications.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the March 9 and 10, 2000, Vaccines and Related Biological Products 
Advisory Committee meeting. Because the agency believes there is some 
urgency to bring these issues 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: February 16, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-4589 Filed 2-23-00; 3:44 pm]
BILLING CODE 4160-01-F