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Allergenic Products Advisory Committee; Notice of Meeting

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Food and Drug Administration, HHS.

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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:​webcast/​Viewer/​?peid=​3074a2c9f7ac478db3303477ac1c146b1d.

November 6, 2013:​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, or, 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​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​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​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).

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Dated: August 29, 2013

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-21555 Filed 9-4-13; 8:45 am]