[Federal Register: October 31, 2006 (Volume 71, Number 210)]
[Notices]
[Page 63773-63774]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc06-63]
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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 via teleconference on
November 16, 2006 from 1 p.m. to 5 p.m.
Location: NIH campus, Food and Drug Administration Bldg. 29B,
Conference Room C, 8800 Rockville Pike, Bethesda, MD. This meeting will
be held by teleconference. The public is welcome to attend the meeting
at the above location. A speakerphone will be provided at the specified
location for public participation in this meeting. Important
information about transportation and directions to the NIH campus,
parking, and security procedures is available on the internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitor/index.htm.
Visitors must show two forms of
identification such as a Federal employee badge, driver's license,
passport, green card, etc. If you are planning to drive to and park on
the NIH campus, you must enter at the South Drive entrance of the
campus which is located on Wisconsin Ave. (the medical center metro
entrance), and allow extra time for vehicle inspection. Detailed
information about security procedures is located at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitorsecurity.htm.
Due to the limited available parking,
visitors are encouraged to use public transportation.
Contact Person: Christine Walsh or Denise 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 3014512391. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The committee will hear an overview on the operations of
the Laboratory of Bacterial Toxins, Division of Bacterial, Parasitic,
and Allergenic Products; and the Laboratory of Vector Borne Virus
Diseases, the Laboratory of Hepatitis Viruses, and the Laboratory of
[[Page 63774]]
Respiratory Viral Diseases, Division of Viral Products, Office of
Vaccines Research and Review, CBER, and in closed session will discuss
the reports from the laboratory site visits of December 6, 2005,
January 11, 2006, and June 29, 2006.
Procedure: On November 16, 2006, from 1 p.m. to 3:55 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
November 9, 2006. Oral presentations from the public will be scheduled
between approximately 2:55 p.m. to 3:55 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before November 9, 2006
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 November 16, 2006 from 3:55 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 committee will discuss a review of
internal research programs in the Office of Vaccines Research and
Review, Division of Viral Products and Division of Bacterial Parasitic
and Allergenic Products, Center for Biologics Evaluation and Research.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
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 Christine Walsh or
Denise Royster at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 26, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-18314 Filed 10-30-06; 8:45 am]
BILLING CODE 4160-01-S