[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Notices]
[Pages 54658-54659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21555]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Allergenic Products Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
[[Page 54659]]
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 November 5, 2013, from 9
a.m. to approximately 3:30 p.m. and on November 6, 2013, from 8:30 a.m.
to approximately 2:45 p.m.
Location: FDA, 5630 Fishers Lane, Conference Room 1066, Rockville,
MD 20857. For those unable to attend in person, the meeting will also
be webcast. The webcast will be available at the following links:
November 5, 2013: http://fda.yorkcast.com/webcast/Viewer/?peid=3074a2c9f7ac478db3303477ac1c146b1d.
November 6, 2013: http://fda.yorkcast.com/webcast/Viewer/?peid=2f114f7579ef42e8b4ca4523b0b26eb51d.
Contact Person: Donald Jehn or Joanne Lipkind, Food and Drug
Administration, 1401 Rockville Pike (HFM-71), Rockville, MD 20852, 301-
827-0314, [email protected] or [email protected], FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area). 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
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.
Agenda: On November 5, 2013, the committee will meet in open
session to discuss and make recommendations on the safety and efficacy
of Oralair, a Sweet Vernal Grass, Perennial Ryegrass, Timothy Grass,
Orchard Grass, and Kentucky Bluegrass Mixed Pollens Allergen Extract
tablet for sublingual use, manufactured by Stallergenes. On November 6,
2013, the committee will meet in open session to discuss and make
recommendations on the safety and efficacy of Grastek, a Timothy Grass
Pollen Allergen Extract tablet for sublingual use, manufactured by
Merck.
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 meeting
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 29, 2013. Oral presentations from the public will be scheduled
between approximately 12 noon and 12:30 p.m. on November 5, 2013, and
between approximately 11:10 a.m. and 11:40 a.m. on November 6, 2013.
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 21, 2013. 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 22,
2013.
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 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: August 29, 2013
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21555 Filed 9-4-13; 8:45 am]
BILLING CODE 4160-01-P