[Federal Register Volume 73, Number 26 (Thursday, February 7, 2008)]
[Notices]
[Pages 7310-7311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2265]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Radiological Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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://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
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 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://www.fda.gov/oc/advisory/default.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).
Dated: January 28, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-2265 Filed 2-6-08; 8:45 am]
BILLING CODE 4160-01-S