[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Page 13646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5727]
[[Page 13646]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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 April 6, 2011, between
approximately 9 a.m. and 4 p.m. and on April 7, 2011, between
approximately 8:30 a.m. and 3:30 p.m.
Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
Contact Person: Donald W. Jehn 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), and follow the prompts to the desired
center or product area. 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 the morning of April 6, 2011, the committee will meet in
open session to hear updates of the research programs in the Laboratory
of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and
Allergenic Products, Office of Vaccines Research and Review, Center for
Biologics Evaluation and Research, FDA. In the afternoon of April 6,
2011, the committee will meet in open session and will be briefed on
the use of immunological markers for demonstration of effectiveness of
meningococcal serogroups A, C, Y, and W-135 conjugate vaccines
administered to children less than 2 years of age. On April 7, 2011,
the committee will meet in open session to review and discuss
approaches to licensure of meningococcal serogroup B vaccines.
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://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: On April 6, 2011, from approximately 9 a.m to 10:50 a.m.
and from approximately 12:30 p.m to 4 p.m., the meeting is open to the
public. On April 7, 2011, the entire 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 March 30, 2011. Oral
presentations from the public will be scheduled between approximately
10:20 a.m. and 10:50 a.m. and between approximately 2:30 p.m. and 3
p.m. on April 6, 2011, and between approximately 1:30 p.m. and 2 p.m.
on April 7, 2011. Those individuals interested in making 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 March 22, 2011. 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 March 23,
2011.
Closed Committee Deliberations: On April 6, 2011, between
approximately 10:50 a.m. and 11:30 a.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 the report of the 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 Donald W. Jehn 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://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: March 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5727 Filed 3-11-11; 8:45 am]
BILLING CODE 4160-01-P