[Federal Register Volume 64, Number 201 (Tuesday, October 19, 1999)]
[Notices]
[Pages 56352-56353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27157]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). Portions 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 4, 1999, 8 a.m. 
to 6

[[Page 56353]]

p.m., and on November 5, 1999, 8 a.m. to 4 p.m.
    Location: Holiday Inn, Versailles Ballrooms 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, 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 November 4, 1999, the committee will discuss: (1) Ways 
to demonstrate attenuation of chimeric strains of Cytomegaloviral 
candidate vaccines to support proceeding into clinical trials, and (2) 
the safety data following a fifth successive dose of DTaP (Tripedia) 
manufactured by Connaught Laboratories, Inc. On November 5, 1999, the 
product license application for Wyeth Lederle Vaccines and Pediatrics' 
Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM197 protein) 
will be discussed for use in infants and young children. The committee 
will be asked to consider the safety and efficacy of this vaccine 
against prevention of invasive disease (bacteremia and meningitis) 
caused by Streptococcus pneumoniae (pneumococcus).
    Procedure: On November 4, 1999, from 9 a.m. to 1:30 p.m., and from 
2 p.m. to 6 p.m., and on November 5, 1999, from 9 a.m. to 4 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 
October 28, 1999. Oral presentations from the public will be scheduled 
between approximately 11:30 a.m. and 11:45 a.m., and between 
approximately 3:30 p.m. and 3:45 p.m. on November 4, 1999. On November 
5, 1999, the oral presentations will be scheduled from approximately 
1:30 p.m. to 1:45 p.m., and from approximately 3:15 p.m. to 3:30 p.m. 
Time allotted for each presentation may be limited. Those desiring to 
make formal oral presentations should notify the contact person before 
October 28, 1999, 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 presentations.
    Closed Committee Deliberations: On November 4, 1999, from 8 a.m. to 
9 a.m., and from approximately 1:30 p.m. to 2 p.m., and on November 5, 
1999, from 8 a.m. to 9 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 
permit discussion of pending investigational new drug applications or 
pending product licensing applications.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 12, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-27157 Filed 10-18-99; 8:45 am]
BILLING CODE 4160-01-F