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U.S. Department of Health and Human Services

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Joint Meeting of the Gastroenterology-Urology Panel and the Radiological Devices Panel of the Medical Devices Advisory Committee - Meeting Announcement

CenterDateTimeLocation
OCSeptember 9, 2013Between approximately 8:00 a.m. and 6:00 p.m.

FDA White Oak Campus
Building 31, The Great Room (Rm 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002 

Agenda

On September 9, 2013, the Office of the Commissioner will convene the joint committee to discuss current evidence on the risks and benefits of computed tomography colonography for screening of asymptomatic patients for colorectal cancer. The joint committee will provide advice that will assist FDA’s consideration of evolving research on this topic and inform the Agency’s continuing regulation of these devices.

Meeting Materials

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 website 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 website after the meeting.  Background material will be available on the Meetings, Conferences, and Workshops page of the FDA website.

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 docket on or after July 11, 2013.
  • Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. on September 9, 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 August 22, 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 August 29, 2013.

Webcast Information

The Office of the Commissioner plans to provide a free of charge, live webcast of the September 9, 2013 meeting of the joint committee.  While the Office of the Commissioner is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible.  The link for the webcast is available at: https://collaboration.fda.gov/gurdac/.

Contact Information

  • Daniel Sigelman, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 32, rm 4254, Silver Spring, MD, 20993-0002, 301-796-4706.
  • e-mail: Daniel.Sigelman@fda.hhs.gov
  • 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 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 Donald Jehn or Denise Royster at least 7 days in advance of the meeting.

Information regarding special accommodations due to a disability, visitor parking and transportation may be accessed at: Public Meetings at the FDA White Oak Campus

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).

Federal Register notice