Document ID: FDA-2011-N-0002-0020
Agency: fda
Document Type: Notice
Title: Allergenic Products Advisory Committee
Posted Date: 2011-03-16T04:00Z

[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Notices]
[Page 14414]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6083]

[[Page 14414]]

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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). At least one 
portion of the meeting will be closed 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 May 12, 2011, from 8 
a.m. to approximately 3:30 p.m.
    Location: Bethesda Doubletree Hotel, 8120 Wisconsin Ave., Bethesda, 
MD 20814, Grand Ballroom.
    Contact Person: Gail Dapolito or Jane Brown, Center for Biologics 
Evaluation and Research (HFM-71), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20853, 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 May 12, 2011, in open session, the committee will 
receive updates and have discussion on the following topics: (1) 
Structure and Activities of the Laboratory of Immunobiochemistry (the 
Laboratory), Division of Bacterial, Parasitic, and Allergenic Products, 
Center for Biologics Evaluation and Research, FDA; (2) enzyme-linked 
immunosorbent assay replacement of radial immunodiffusion assays for 
potency determinations of cat and ragweed pollen allergen extracts by 
the Laboratory; (3) statistical considerations for the design and 
interpretation of phase III clinical trials of allergenic products; (4) 
environmental exposure chambers for phase III studies of allergenic 
products, and (5) International Organization for Standardization (ISO) 
17025 accreditation of the Laboratory.
    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 May 12, 2011, from 8 a.m. to approximately 3 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 May 5, 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 
April 27, 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 April 28, 2011.
    Closed Committee Deliberations: On May 12, 2011, from approximately 
3 p.m. to 3:30 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 a 
report 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 Gail Dapolito 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 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6083 Filed 3-15-11; 8:45 am]
BILLING CODE 4160-01-P