Document ID: FDA-2011-N-0002-0076
Agency: fda
Document Type: Notice
Title: Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Posted Date: 2011-07-22T04:00Z

[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44016-44017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18506]

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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 September 20, 2011, from 
8 a.m. to approximately 5:15 p.m.
    Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry 
Pkwy., Gaithersburg, MD 20977, 301-977-8900. 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=84f95996804743439bcc5be69d1908051d.
    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 September 20, 2011, the committee will meet in open 
session to hear an overview of the research program in the Laboratory 
of Enteric and Sexually Transmitted Diseases, Division of Bacterial, 
Parasitic and Allergenic Products, Office of Vaccines Research and 
Review, Center for Biologics Evaluation and Research, FDA. 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 September 20, 2011, between approximately 8 a.m. and 
10 a.m., and between approximately 10:45 a.m. and 5:15 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 September 13, 2011. Oral presentations from the public will 
be scheduled between approximately 9:30 a.m. and 10 a.m. and between 
approximately 3:45 p.m. and 4:15 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 September 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

[[Page 44017]]

regarding their request to speak by September 2, 2011.
    Closed Committee Deliberations: On September 20, 2011, between 
approximately 10:15 a.m. and 10:45 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: July 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-18506 Filed 7-21-11; 8:45 am]
BILLING CODE 4160-01-P