[Federal Register: January 23, 2004 (Volume 69, Number 15)]
[Notices]
[Page 3373-3374]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ja04-62]
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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 February 3, 2004, from
8:30 a.m. to 5 p.m.
Location: Gaithersburg Marriott, Salons A, B, C, and D, 9751
Washingtonian Blvd., 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 3014512526. 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 computer aided detection
device that identifies nodules in CT (computerized tomography) images
of the lung. Background information, including the agenda and questions
for the committee, will be available to the public 1 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 February 2, 2004.
Procedure: On February 3, 2004, from 9 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 by
January 27, 2004. On February 3, 2004, oral presentations from the
public will be scheduled between approximately 9:20 a.m. and 9:50 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 January 27, 2004, 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 February 3, 2004, from 8:30 a.m.
to 9 a.m., the meeting will be closed to permit discussion and review
of trade secret and/or confidential commercial 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 AnnMarie Williams,
Conference Management
[[Page 3374]]
Staff, at 301-594-1283, ext. 113, at least 7 days in advance of the
meeting.
FDA regrets that it was unable to publish this notice 15 days prior
to the Radiological Devices Panel of the Medical Devices Advisory
Committee meeting. Because the agency believes there is some urgency to
bring this issue to public discussion and qualified members of the
Radiological Devices Panel of the Medical Devices Advisory Committee
were available at this time, the Commissioner of Food and Drugs
concluded that it was in the public interest to hold this meeting even
if there was not sufficient time for the customary 15-day public
notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: January 5, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-1379 Filed 1-22-04; 8:45 am]
BILLING CODE 4160-01-S