[Federal Register: April 19, 2004 (Volume 69, Number 75)]
[Notices]
[Page 20941-20942]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap04-80]
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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 May
6, 2004, from 1:30 p.m. to 3:30 p.m.
Location: National Institute of Health (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), 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 Laboratory of
DNA Viruses, Division of Viral Products, Office of Vaccines Research
and Review, Center for Biologics and Research (CBER), and in closed
session will discuss the report from the laboratory site visit of March
4, 2004.
Procedure: On May 6, 2004, from 1:30 p.m. to 3 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 April 29,
2004. Oral presentations from the public will be scheduled between
approximately 2 p.m. to 3 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before April 30, 2004, 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 May 6, 2004, from 3 p.m. to 3:30
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 committee will discuss a review of internal
research programs in the Office of Vaccines Research and Review,
Division of Viral Products, CBER.
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).
[[Page 20942]]
Dated: April 9, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-8721 Filed 4-16-04; 8:45 am]
BILLING CODE 4160-01-S