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: 2009 Meeting Materials for the Circulatory Devices Panel Meeting

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 April 16, 2009.
• Oral presentations from the public will be scheduled approximately 30 minutes at the beginning of committee deliberations and approximately 30 minutes near the end of the deliberations. Those desiring to make 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 April 13, 2009.

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 April 14, 2009.

• James Swink
  Center for Devices and Radiological Health (HFZ-450)
  Food and Drug Administration
  9200 Corporate Blvd.
  Rockville, MD 20850
  Phone: 240-276-4050 E-mail: james.swink@fda.hhs.gov

• FDA Advisory Committee Information Line
  1-800-741-8138
  (301-443-0572 in the Washington DC area)
  Code: 3014512541
  Please call the Information Line for up-to-date information on this 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 Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the 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.

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 AnnMarie Williams at (240) 276-8932 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings.

Information about procedures on public conduct during advisory committee meetings: Public Conduct During FDA Advisory Committee Meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).