Document ID: FDA-2011-N-0002-0117
Agency: fda
Document Type: Notice
Title: Allergenic Products Advisory Committee
Posted Date: 2011-09-26T04:00Z

[Federal Register Volume 76, Number 186 (Monday, September 26, 2011)]
[Notices]
[Pages 59406-59407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24597]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Allergenic 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). The meeting will 
be open to the public.
    Name of Committee: Allergenic 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 October 25, 2011, from 
8:30 a.m. to approximately 1:30 p.m.

[[Page 59407]]

    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=ca9ce867368c410999cde1d63208e9ef1d.
    Contact Person: Donald W. Jehn or Joanne Lipkind, 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 October 25, 2011, the committee will meet in open 
session to hear and discuss CBER's review of scientific and medical 
literature concerning the use of non-standardized allergen extracts in 
the diagnosis and treatment of allergic disease. FDA is announcing the 
availability of this report entitled ``CBER's Report of Scientific and 
Medical Literature and Information on Non-Standardized Allergen 
Extracts in the Diagnosis and Treatment of Allergic Disease'' elsewhere 
in this issue of the Federal Register.
    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: 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 
October 18, 2011. Oral presentations from the public will be scheduled 
between approximately 11:30 a.m. and 12:30 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 October 11, 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 October 11, 2011.
    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 
Joanne Lipkind 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: September 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24597 Filed 9-23-11; 8:45 am]
BILLING CODE 4160-01-P