[Federal Register Volume 67, Number 137 (Wednesday, July 17, 2002)]
[Proposed Rules]
[Pages 46941-46942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17960]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 01N-0067]


Dental Devices: Classification of Encapsulated Amalgam Alloy and 
Dental Mercury and Reclassification of Dental Mercury; Issuance of 
Special Controls for Amalgam Alloy; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening for 60 
days the comment period for the proposed rule on the classification of 
encapsulated amalgam alloy and dental mercury, the reclassification of 
dental mercury, and the issuance of special controls for amalgam alloy. 
The proposed rule was published in the Federal Register of February 20, 
2002 (67 FR 7620). The agency is taking this action in response to a 
request for an extension. The comment period for this information 
closed on May 21, 2002. Elsewhere in this issue of the Federal 
Register, FDA is reopening for 60 days the comment period on the draft 
guidance entitled ``Special Control Guidance Document on Encapsulated 
Amalgam, Amalgam Alloy, and Dental Mercury Labeling.''

DATES: Submit written or electronic comments on the proposed rule by 
September 16, 2002.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Susan Runner, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-5283.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 20, 2002 (67 FR 7620), FDA 
published a proposed rule entitled ``Dental Devices: Classification of 
Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of 
Dental Mercury; Issuance of Special Controls for Amalgam Alloy.''

[[Page 46942]]

    FDA received an electronic request dated May 20, 2002, requesting 
that the agency extend the comment period on the proposed rule for 60 
days, noting the importance of public health issues involved and 
explaining that there were apparently technical difficulties with the 
submission of electronic comments. FDA has determined that it is 
appropriate to grant this request.

II. Comments

    You may submit to the Dockets Management Branch (see ADDRESSES) 
written or electronic comments on classification, reclassification, and 
special controls for dental amalgam products by September 16, 2002. You 
must submit two copies of any comments. Individuals may submit one 
copy. You must identify comments with the docket number found in 
brackets in the heading of this document. Received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 5, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-17960 Filed 7-16-02; 8:45 am]
BILLING CODE 4160-01-S