[Federal Register: November 29, 2002 (Volume 67, Number 230)]
[Notices]
[Page 71179]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no02-92]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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