[Federal Register: January 23, 2004 (Volume 69, Number 15)]
[Page 3373-3374]
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 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. 
    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 AnnMarie Williams, 
Conference Management

[[Page 3374]]

Staff, at 301-594-1283, ext. 113, at least 7 days in advance of the 
    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 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]