[Federal Register Volume 60, Number 250 (Friday, December 29, 1995)]
[Proposed Rules]
[Page 67345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31460]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. 95N-0176]


Orthopedic Devices: Classification, Reclassification, and 
Codification of Pedicle Screw Spinal Systems; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to March 
4, 1996, the comment period for the proposed rule that published in the 
Federal Register of October 4, 1995 (60 FR 51946). The document 
proposed to classify certain unclassified preamendments pedicle screw 
spinal systems into class II (special controls), and to reclassify 
certain postamendments pedicle screw spinal systems from class III 
(premarket approval) to class II. FDA is taking this action in response 
to several requests for an extension to assure adequate time for 
preparation of comments.

DATES: Written comments by March 4, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Mark N. Melkerson, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2036.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 4, 1995 
(60 FR 51946), FDA published a proposed rule to classify certain 
unclassified preamendments pedicle screw spinal systems into class II 
(special controls), and to reclassify certain postamendments pedicle 
screw spinal systems from class III (premarket approval) to class II. 
FDA is proposing to place certain pedicle screw spinal systems in class 
II because the agency believes that sufficient information exists to 
establish special controls to provide reasonable assurance of its 
safety and effectiveness.
    Interested persons were invited to comment by January 2, 1996. FDA 
received several requests to extend the comment period, including a 
request from a United States District Court Judge presiding over 
product liability actions concerning orthopedic bone screw products. 
The court requested that FDA allow a 60-day extension because court 
orders relating to the disclosure of certain information about pedicle 
screws may make it difficult for parties involved in the litigation to 
submit relevant information to FDA by January 2, 1996.
    Because FDA wants to provide adequate time for the submission of 
all relevant information related to these important public health 
issues, FDA is extending the comment period for 60 days. Accordingly, 
FDA finds under section 520(d) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j(d)) that there is good cause for such an extension.
    Interested persons may, on or before March 4, 1996, submit to 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: December 21, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 95-31460 Filed 12-28-95; 8:45 am]
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