[Federal Register: February 7, 2008 (Volume 73, Number 26)]
[Page 7310-7311]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Radiological Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Radiological Devices Panel of the Medical 
Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 4, 2008, from 8 
a.m. to 5:30 p.m., and March 5, 2008, from 8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Nancy Wersto, Center for Devices and Radiological 
Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 240-276-3666, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512526. 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.
    Agenda: On March 4 and 5, 2008, the committee intends to discuss 
and make recommendations about computer aided detection and diagnosis 
(CAD) devices for radiological images, e.g., mammograms, chest x-rays, 
and computed tomography (CT) images of the lungs or colon. There will 
be a general discussion focusing on the general methodologies for CAD, 
including how CAD devices are used in clinical decision-making, how the 
devices are tested, and the information needed to properly assess their 
safety and effectiveness. The general discussion will be followed by 
specific discussions related to mammography CAD devices, colon CAD 
devices, and lung CAD devices. These discussions will include how the 
different types of CAD devices are used and the literature published 
regarding these devices, with focus on testing issues related to the 
different devices.
    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/

[[Page 7311]]

dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the 
appropriate advisory committee link.
    Procedure: On March 4, 2008, from 8 a.m. to 5:30 p.m., and on March 
5, 2008, from 8:30 a.m. to 5 p.m., the meeting is open to the public. 
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 February 19, 2008. Oral 
presentations from the public will be scheduled between approximately 
10 a.m. and 10:30 a.m., and between 3:15 p.m. and 3:45 p.m. on March 4, 
2008, and between approximately 9:10 a.m. and 9:40 a.m., and between 
2:15 p.m. and 2:45 p.m. on March 5, 2008. 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 February 11, 2008. 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 February 
12, 2008.
    Closed Presentation of Data: On March 5, 2008, from 8 a.m. to 8:30 
a.m., the meeting will be closed so that the committee may receive an 
update from FDA about devices under evaluation that may be brought 
before the committee in the near future. This portion of the meeting 
will be closed because it involves the discussion and review of trade 
secret and/or confidential information (5 U.S.C. 552b(c)(4)).
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 Shirley Meeks, 
Conference Management Staff, at 240-276-8931, 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm
 for procedures on public conduct during advisory committee 

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

    Dated: January 28, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-2265 Filed 2-6-08; 8:45 am]