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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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Name of CommitteeNational Mammography Quality Assurance Advisory Committee
Date and TimeThe meeting was held on the following dates:
Nov 5, 2007 9:00 AM - 5:00 PM
LocationCrown Plaza Rockville, Remington II and III in the Ballroom
3 Research Court
Rockville , MD
Contact InformationNancy Wynne, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3284, or FDA Advisory Committee Information Line, 1-800-741-8138 or 301-443-0572 in the Washington, DC area), code 3014512397. 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 Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
AgendaThe committee will discuss issues related to possible regulation of interventional mammography and receive input from professional organizations. The committee will also receive updates on recently approved alternative standards. 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 http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2007 and scroll down to the appropriate advisory committee link.
ProcedureInterested 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 5, 2007. Oral presentations from the public will be scheduled between approximately 9:30 a.m. and 11:45 a.m. and between approximately 1 p.m. and 2 p.m. 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 September 27, 2007. 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 September 28, 2007.
 Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
ConductFDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ for procedures on public conduct during advisory committee meetings.
Related Documents
Agenda:Agenda for November 5, 2007 MeetingText
Briefing:Briefing Information for November 5, 2007 Meeting Text
Notice of Meeting:Notice of Meeting for November 5, 2007 Text
Other:Waivers for Conflicts of Interest for November 5, 2007 MeetingText
Roster:Roster for November 5, 2007 Meeting: AttendeesText
Transcript:Transcript: for November 5, 2007 MeetingPDF
Transcript:Transcript: for November 5, 2007 MeetingPDF
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
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