[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Pages 54658-54659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21555]



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.


    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 
    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 
    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, 
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
    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]