[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Notices]
[Page 14414]
From the Federal Register Online via the Government Publishing 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