[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]
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