[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]
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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). 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