[Federal Register Volume 67, Number 230 (Friday, November 29, 2002)]
[Notices]
[Page 71179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30158]


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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 December 10, 2002, from 
8:30 a.m. to 5 p.m.
    Location: Gaithersburg Holiday Inn, Walker/Whetstone Rooms, Two 
Montgomery Village Ave., Gaithersburg, MD.
    Contact Person: Robert J. Doyle, Center for Devices and 
Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1212, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12526. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application for a device that produces a 
computerized thermal image of the breast of women recommended for 
biopsy.
    Background information, including the agenda and questions for the 
committee, will be available to the public one business day before the 
meeting, on the Internet at http://www.fda.gov/cdrh/panelmtg.html. 
Material will be posted on December 9, 2002.
    Procedure: On December 10, 2002, from 8:30 a.m. to 12:30 p.m., and 
from 1 p.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 by December 3, 2002. On December 10, 2002, oral 
presentations from the public will be scheduled between approximately 
9:15 a.m. and 9:45 a.m., and for an additional 30 minutes near the end 
of the committee deliberations. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before December 3, 2002, 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.
    Closed Committee Deliberations: On December 10, 2002, from 12:30 
p.m. to 1 p.m., the meeting will be closed to the public to permit FDA 
to present to the committee trade secret and/or confidential commercial 
information (5 U.S.C. 552b(c)(4)) regarding pending and future agency 
issues.
    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 301-594-1283, ext. 105, at least 7 days 
in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 21, 2002.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 02-30158 Filed 11-27-02; 8:45 am]
BILLING CODE 4160-01-S