[Federal Register Volume 62, Number 250 (Wednesday, December 31, 1997)]
[Notices]
[Page 68295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-34058]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committee Meeting; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Orthopaedic and 
Rehabilitation Devices Panel of the Medical Devices Advisory Committee. 
This meeting was announced in the Federal Register of December 15, 
1997. The amendment is being made to reflect a change in the agenda and 
procedure which will change the order of reclassification petitions 
being presented to the committee and will also change the order of the 
open public hearings associated with each petition. There are no other 
changes. This amendment will be announced at the beginning of the open 
portion of the meeting.

FOR FURTHER INFORMATION CONTACT: 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 (301-443-5072 in the 
Washington, DC area), code 12521. Please call the Information Line for 
up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 15, 1997 
(62 FR 65709), FDA announced that a meeting of the Orthopaedic and 
Rehabilitation Devices Panel of the Medical Devices Advisory Committee 
would be held on January 12 and 13, 1998. On page 65709, beginning in 
the 3d column, the Agenda and Procedure portions are amended to read as 
follows:
    Agenda: On January 12, 1998, the committee will discuss and make 
recommendations for reclassification petitions for non- and semi-
constrained shoulders and constrained elbows. On January 13, 1998, the 
committee will discuss and make recommendations for reclassification 
petitions for patellofemoral knees and uni- and total 
patellofemorotibial knees, and for 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 reclassification 
petitions for non- and semi-constrained shoulders and constrained 
elbows will be scheduled between approximately 11 a.m. and 12 m. on 
January 12, 1998. Oral presentations from the public regarding 
reclassification petitions for patellofemoral knees and uni- and total 
patellofemorotibial knees, as well as for 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 by 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 24, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-34058 Filed 12-24-97; 10:56 am]
BILLING CODE 4160-01-F