[Federal Register: July 26, 2001 (Volume 66, Number 144)]
[Notices]               
[Page 39048-39049]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy01-63]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

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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: 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 August 8, 2001, from 
9:30 a.m.

[[Page 39049]]

to 4:30 p.m., and August 9, 2001, from 9:30 a.m. to 4 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 and make recommendations on the 
reclassification of metal on metal total hip arthroplasty devices. 
Also, the committee will discuss, make recommendations, and vote on 
premarket approval application (PMA) for a metacarpophalangeal finger 
joint prosthesis.
    Background information for each day's topic, 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://www.fda.gov/
cdrh/panelmtg.html. Material for the August 8 meeting will be posted on 
August 7, 2001; material for the August 9 meeting will be posted on 
August 8, 2001.
    Procedure: On August 8, 2001, from 9:30 a.m. to 3:30 p.m., and on 
August 9, 2001, from 9:30 a.m. to 4 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 August 1, 2001. Oral 
presentations from the public will be scheduled between approximately 
9:30 a.m. and 10 a.m. on August 8, 2001, and between approximately 9:30 
a.m. and 10 a.m. on August 9, 2001. On both days, near the end of the 
committee deliberations for the reclassification petition and 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 August 1, 2001, 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 August 8, 2001, from 3:30 p.m. 
to 4:30 p.m., the meeting will be closed to the public to permit FDA to 
present to the committee trade secret and/or confidential information 
(5 U.S.C. 552b(c)(4)) regarding present and future FDA issues.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 20, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-18750 Filed 7-24-01; 3:30 pm]
BILLING CODE 4160-01-S