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U.S. Department of Health and Human Services

Advisory Committees

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December 11-12, 2013: Allergenic Products Advisory Committee Meeting Announcement

CBERDecember 11-12, 2013On December 11, 2013 from 9:00 a.m. to approximately 3:30 p.m.

On December 12, 2013 from 8:30 a.m. to approximately 2:45 p.m.
FDA White Oak Campus,
10903 New Hampshire Ave.,
Bldg. 31 Conference Center, the
Great Room (rm. 1503A),
Silver Spring, MD 20993-0002

On December 11, 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 December 12, 2013, the committee will meet in open session to discuss and make recommendations  on the safety and efficacy of Grastek, a Timothy Grass Pollen Extract tablet for sublingual use, manufactured by Merck.

Meeting Materials
Materials for this meeting are available at the Blood, Vaccines and Other Biologics Advisory Committee main page.

Public Participation Information
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 December 4, 2013.
  • Oral presentations from the public will be scheduled between approximately 12 noon and 12:30 p.m. on December 11, 2013, and between approximately 11:10 a.m. and 11:40 p.m. on December 12, 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 November 26, 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 November 27, 2013.
  • For those unable to attend in person, the meeting will also be Webcast.  The link for the Webcast is available at:  https://collaboration.fda.gov/apac
  • Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading “Resources for You,” click on “Public Meetings at the FDA White Oak Campus.”  Please note that visitors to the White Oak Campus must enter through Building 1.

Contact Information

  • Donald Jehn or Joanne Lipkind
    1401 Rockville Pike, HFM-71, Rockville, MD 20852
    FAX: 301-827-0294
    e-mail: Donald.Jehn@fda.hhs.gov or email: joanne.lipkind@fda.hhs.gov         
  • FDA Advisory Committee Information Line
    1-800-741-8138 (301-443-0572 in the Washington, DC, area). Please call the Information Line for up-to-date information on this meeting.

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.

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.

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. 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 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). Official FR Notice