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U.S. Department of Health and Human Services

Advisory Committees

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January 28, 2014: Allergenic Products Advisory Committee Meeting Announcement- Amendment

CenterDateTimeLocation
CBERJanuary 28, 20148:30 a.m. - 3:30 p.m.FDA White Oak Campus
10903 New Hampshire Ave.
Building 31 Conference Center
Great Room, Rm. 1503A
Great Room, Rm. 1503 B/C
Silver Spring, MD  20993

Amendment
This amendment reflects a change in the conference room designation for the meeting:
The meeting will held at the White Oak Campus Conference Center, 10903 New Hampshire Avenue, Building 31 Conference Center, Great Room, Room 1503 B/C not Room 1503 A as originally stated.


Agenda
On January 28, 2014, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of RAGWITEK, a short ragweed pollen allergen extract tablet for sublingual use, manufactured by Merck, indicated for immunotherapy for diagnosed ragweed pollen induced allergic rhinitis, with or without conjunctivitis.

Meeting Materials
Materials for this meeting will be available on the page titled 2014 Meeting Materials, Allergenic Products Advisory Committee.

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 January 21, 2014.
  • 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 January 13, 2014.   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 January 14, 2014.
  • 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

  • Gail Dapolito, 301-827-1289, Fax 301-827-0294, e-mail: gail.dapolito@fda.hhs.gov or Joanne Lipkind, 301-827-1294, Fax 301-827-0294, e-mail: 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 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).