[Federal Register: February 22, 2002 (Volume 67, Number 36)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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
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 by teleconference on March
6, 2002, from 12:30 p.m. to 4:30 p.m.
Location: Food and Drug Administration, Bldg. 29, conference room
121, 8800 Rockville Pike, Bethesda, MD. This meeting will be held by a
telephone conference call. A speaker telephone will be provided in the
conference room to allow public participation in the meeting.
Contact Person: Jody G. Sachs or Denise H. Royster, Center for
Biologics Evaluation and Research (CBER) (HFM-71), Food and Drug
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: The committee will complete recommendations pertaining to
the influenza virus vaccine formulation for the 2002-2003 season, and
review and discuss the research programs of the following two CBER
Laboratories: Laboratories of Hepatitis Virus and the Laboratory of
Vector-borne Viral Diseases.
Procedure: On March 6, 2002, from 12:30 p.m. to 3:30 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
February 25, 2002. Oral presentations from the public will be scheduled
between approximately 2 p.m. and 2:30 p.m., and between approximately 3
p.m. and 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 February 25, 2002, 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
Closed Committee Deliberations: On March 6, 2002, from 3:30 p.m. to
4:30 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
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Jody G. Sachs or
Denise H. Royster at least 7 days in advance of the meeting.
FDA regrets that it was unable to publish this notice 15 days prior
to the 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 17, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent
[FR Doc. 02-4378 Filed 2-20-02; 1:27 pm]
BILLING CODE 4160-01-S