[Federal Register Volume 62, Number 240 (Monday, December 15, 1997)]
[Notices]
[Pages 65709-65710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32676]


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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). The meeting will 
be open 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 regulatory issues.
    Date and Time: The meeting will be held on January 12, 1998, 11 
a.m. to 6 p.m., and January 13, 1998, 7:30 a.m. to 5:30 p.m.
    Location: Parklawn Bldg., conference rooms G and H, 5600 Fishers 
Lane, Rockville, MD.
    Contact Person: Jodi H. Nashman, 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: On January 12, 1998, the committee will discuss and make 
recommendations for reclassification petitions for non- and semi-
constrained shoulders and uni- and total patellofemorotibial knees. On 
January 13, 1998, the committee will discuss and make recommendations 
for the reclassification petitions for patellofemoral knees and 
constrained elbows, and for the classification of calcium sulfate pre-
formed pellets (plaster of paris pellets).
    Procedure: 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 5, 
1998. Oral presentations from the public regarding the reclassification 
petitions for non- and semi-constrained shoulders and uni- and total 
patellofemorotibial knees will be scheduled between approximately 11 
a.m. and 12 m. on January 12, 1998. Oral presentations

[[Page 65710]]

from the public regarding the reclassification petitions for 
patellofemoral knees and constrained elbows, as well as for the 
classification of calcium sulfate pre-formed pellets (plaster of paris 
pellets) will be scheduled between approximately 7:30 a.m. and 8:30 
a.m. on January 13, 1998. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before January 5, 1998, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-32676 Filed 12-12-97; 8:45 am]
BILLING CODE 4160-01-F