[Federal Register: October 23, 2007 (Volume 72, Number 204)]
[Notices]
[Page 60022-60023]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc07-49]
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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 by teleconference on
November 14, 2007, from 1 p.m. to approximately 4:30 p.m.
Location: National Institutes of Health, Building 29B, Conference
Rooms A/B, Bethesda, MD. This meeting will be held by teleconference.
The public is welcome to attend the meeting at the specified location
where
[[Page 60023]]
a speaker phone will be provided. Public participation in the meeting
is limited to the use of the speaker phone in the conference room.
Important information about transportation and directions to the
National Institutes of Health (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, one
of which must be a government issued photo 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 Dr. 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. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On November 14, 2007, the committee will meet in open
session to hear updates of the research programs in: (1) The Laboratory
of Method Development, Division of Viral Products, Center for Biologics
Evaluation and Research, FDA and (2) the Laboratory of Mycobacterial
Diseases & Cellular Immunology, Division of Bacterial Parasitic &
Allergenic Products, Center for Biologics Evaluation and Research, FDA.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 and scroll down to the appropriate advisory committee
link.
Procedure: On November 14, 2007, from 1 p.m. to approximately 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 on or before November 7, 2007. Oral presentations from the
public will be scheduled between approximately 2:30 p.m. and 3:30 p.m.
Those desiring to make formal oral presentations should notify the
contact person 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 on or before October 30, 2007.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by October 31, 2007.
Closed Committee Deliberations: On November 14, 2007, from
approximately 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
committee will discuss reports of intramural research programs and make
recommendations regarding personnel staffing decisions.
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.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm
for procedures on public conduct during advisory committee
meetings.
Dated: October 17, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20854 Filed 10-22-07; 8:45 am]
BILLING CODE 4160-01-S