[Federal Register Volume 60, Number 172 (Wednesday, September 6, 1995)]
[Proposed Rules]
[Page 46251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22104]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 895 and 898

[Docket No. 94N-0078]


Medical Devices; Proposed Performance Standards for Electrode 
Lead Wires and Proposed Banning of Unprotected Electrode Lead Wires; 
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 October 
20, 1995, the comment period on a proposed rule that published in the 
Federal Register of June 21, 1995 (60 FR 32406). The document proposed 
to establish a performance standard for electrode lead wires, and to 
make unprotected electrode lead wires a banned device upon the 
effective date of the standard. FDA is taking this action in response 
to two requests for an extension of the comment period.

DATES: Written comments by October 20, 1995.

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

FOR FURTHER INFORMATION CONTACT: Marquita B. Steadman, Center for 
Devices and Radiological Health (HFZ-84), Food and Drug Administration, 
2094 Gaither Rd., Rockville, MD 20850, 301-594-4765, ext. 145.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 21, 1995 (60 
FR 32406), FDA issued a proposed rule to establish a performance 
standard for electrode lead wires, and to make unprotected electrode 
lead wires a banned device upon the effective date of the standard.
     FDA has received two requests from trade associations for a 90-day 
extension of the comment period. The reasons given for the requests are 
that the proposed rule has raised potential implications beyond those 
previously anticipated, and additional time is needed for the 
consideration of these issues and the preparation of meaningful 
comments.
     The agency agrees in part with the requests, however, it believes 
that due to the public health significance of this issue, an extension 
for the entire length of time requested is not appropriate. The agency 
is extending the comment period for 45 days, to October 20, 1995.
    Interested persons may, on or before October 20, 1995, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposed rule. 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: August 30, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 95-22104 Filed 8-31-95; 4:29 pm]
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