[Federal Register Volume 65, Number 4 (Thursday, January 6, 2000)]
[Notices]
[Pages 783-784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-237]
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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 January 27, 2000, 8 a.m.
to 6:30 p.m., and on January 28, 2000, 8 a.m. to 3 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, 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 January 27, 2000, the committee will: (1) Review the
current understanding of the immune correlates of protection against
invasive Haemophilus influenzae type b disease, and (2) discuss the
potential clinical significance of reduced antibody responses to PRP
(polyribitol phosphate) polysaccharide following administration of
combination vaccines containing Haemophilus influenzae type b conjugate
vaccines. On January 28, 2000, the committee will: (1) Discuss the
influenza virus vaccine formulation for the 2000 to 2001 season, and
(2) be briefed on selected individual research programs in the
Laboratory of Pediatric and Respiratory Viral Diseases.
Procedure: On January 27, 2000, from 9 a.m. to 6:30 p.m., and on
January 28, 2000, from 8 a.m. to 2:25 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 January 19, 2000. Oral
presentations from the public will be scheduled between approximately
9:10 a.m. and 9:25 a.m. and between approximately 4 p.m. and 4:15 p.m.
on January 27, 2000. Oral presentations from the public will be heard
on January 28, 2000, between approximately 8:20 a.m. and 8:30 a.m.,
between approximately 1:30 p.m. and 1:40 p.m., and between
approximately 2:15 p.m. and 2:25 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before January 19, 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 January 27, 2000, 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)).
This portion of the meeting will be closed to permit discussion of
pending investigational new drug applications or pending product
licensing applications. On January 28, 2000, from 2:25 p.m. to 3 p.m.,
the meeting will be closed to permit discussion where disclosure would
constitute a clearly unwarranted invasion of personal privacy (5 U.S.C.
552b(c)(6)). The meeting will be closed to discuss personal information
concerning individuals associated with the research programs.
[[Page 784]]
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: December 23, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-237 Filed 1-5-00; 8:45 am]
BILLING CODE 4160-01-F