[Federal Register: December 26, 2001 (Volume 66, Number 247)]
[Page 66423-66424]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Orthopaedic and Rehabilitation 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: Orthopaedic and Rehabilitation 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 January 10, 2002, from 
9:30 a.m. to 5 p.m.
    Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact: Hany W. Demian, Center for Devices and Radiological Health 
(HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-2036, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12521. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on premarket approval application (PMA) for a spinal fusion cage with a 

[[Page 66424]]

factor soaked in a collagen sponge intended for use to treat lumbar 
degenerative disc disease. Background information, including the agenda 
and questions for the committee, will be available to the public on 
January 9, 2002, on the Internet at http://www.fda.gov/cdrh/
    Procedure: On January 10, 2002, from 9:30 a.m. to 1 p.m., and from 
2 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 January 4, 2002. Oral presentations from the 
public will be scheduled between approximately 9:30 a.m. and 10 a.m. on 
January 10, 2002. Near the end of the committee deliberations for the 
PMA, a 30-minute open public session will be conducted for interested 
persons to address issues specific to the submission before the 
committee. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before January 4, 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 Presentation of Data: On January 10, 2002, from 1 p.m. to 2 
p.m., the meeting will be closed to the public to permit the committee 
to discuss and review trade secret and/or confidential commercial 
information presented by a sponsor (5 U.S.C. 552b(c)(4)).
    FDA regrets that it was unable to publish this notice 15 days prior 
to the January 10, 2002, Orthopaedic and Rehabilitation 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 Orthopaedic and Rehabilitation 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: December 18, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-31578 Filed 12-21-01; 8:45 am]