[Federal Register Volume 64, Number 165 (Thursday, August 26, 1999)]
[Notices]
[Page 46688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22102]
[[Page 46688]]
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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 September 14, 1999, 1
p.m. to 5 p.m., and on September 15, 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 September 14, 1999, the committee will: (1) Hear reports
on recent workshops on Thimerosal in Vaccines and Cell Substrates for
Vaccine Development and be updated on recent developments concerning
the rotavirus vaccine manufactured by Wyeth Laboratories, Inc., and (2)
be briefed on selected individual research programs in the Laboratory
of Parasitic Biology and the Laboratory of Biophysics. On September 15,
1999, the committee will discuss the use of immunologic surrogates for
demonstration of protective efficacy of meningococcal conjugate
vaccines.
Procedure: On September 14, 1999, from 1 p.m. to 3:10 p.m., and on
September 15, 1999, from 8 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 September 7, 1999.
Oral presentations from the public will be scheduled between
approximately 2:10 p.m. and 2:50 p.m. on September 14, 1999, and
between approximately 12:10 p.m. and 12:30 p.m. on September 15, 1999.
Time allotted for each presentation may be limited. Those desiring to
make formal oral presentations should notify the contact person before
September 7, 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 presentation.
Closed Committee Deliberations: On September 14, 1999, from 3:10
p.m. to 4 p.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. Also, on September 14, 1999, from 4
p.m. to 5 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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 13, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-22102 Filed 8-25-99; 8:45 am]
BILLING CODE 4160-01-F
