[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Pages 55397-55398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22766]



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.


    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 November 16, 2011, from 
8 a.m. to approximately 5:30 p.m.
    Location: Hilton Washington DC/Silver Spring, 8727 Colesville Rd., 
Silver Spring, MD 20910, 301-589-5200. For those unable to attend in 
person, the meeting will also be Web cast. The link for the Web cast is 
available at http://fda.yorkcast.com/webcast/Viewer/?peid=75dcd91903204870aff160cb9d5528151d.
    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 November 16, 2011, the committee will meet in open 
session to hear an overview of the research program in the Laboratory 
of Method Development, Division of Viral Products, Office of Vaccines 
Research and Review, Center for Biologics Evaluation and Research, FDA. 
The committee will also hear an update on the evaluation of Gullian-
Barre Syndrome after Influenza Vaccine among Medicare population, 2010-
2011. The committee will then discuss and make recommendations on the 
safety and immunogenicity (surrogate endpoint) of Pneumococcal 13-
valent conjugate vaccine (Diphtheria CRM197 Protein) in adults aged 50 
years and older using an accelerated approval regulatory pathway.
    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 November 16, 2011, from 8 a.m. to approximately 9:30 
a.m. and from 10:15 a.m. to approximately 5:30 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 9, 2011. Oral presentations from the public will be scheduled 
between approximately 3:30 p.m. and

[[Page 55398]]

4:30 p.m. 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 November 1, 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 November 
2, 2011.
    Closed Committee Deliberations: On November 16, 2011, between 
approximately 9:45 a.m. and 10:15 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 program in 
the Laboratory of Method Development 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 
    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: August 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22766 Filed 9-6-11; 8:45 am]