[Federal Register Volume 67, Number 137 (Wednesday, July 17, 2002)]
[Notices]
[Pages 46991-46992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17961]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0064]


Draft Special Control Guidance Document on Encapsulated 
Amalgam,Amalgam Alloy, and Dental Mercury Labeling; Availability; 
Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (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days the comment period on the draft guidance entitled ``Special 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.'' Elsewhere in this issue of the Federal 
Register, the agency is announcing the extension of the comment period 
on a proposed rule to classify encapsulated amalgam into class II, to 
amend the classification regulation for amalgam alloy to provide for 
special controls, and to reclassify dental mercury into class II. The 
draft guidance document is intended to serve as a special control for 
these devices. The agency is taking this action in response to a 
request for an extension.

DATES: Submit written or electronic comments on the guidance 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, 
9200Corporate Blvd., Rockville, MD 20850, 301-827-5283.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 20, 2002 
(67 FR 7703), FDA published a notice announcing the availability of a 
draft guidance entitled ``Special Control Guidance Document on 
Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling.'' In 
the same issue of the Federal Register (67 FR 7620), the agency 
published a proposed rule to classify encapsulated amalgam into class 
II, to amend the classification regulation for amalgam alloy to provide 
for special controls, and to reclassify dental mercury into class II. 
The draft guidance document is intended to serve as a special control 
for these devices.
    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, and elsewhere in this issue of the 
Federal Register FDA is announcing the reopening of the comment period 
on the proposed rule. FDA believes that it is also appropriate to 
reopen the comment period on the guidance document.
    You may submit to the Dockets Management Branch (see ADDRESSES)

[[Page 46992]]

written or electronic comments on the draft guidance entitled ``Special 
Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and 
Dental Mercury Labeling'' 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. 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. 02-17961 Filed 7-16-02; 8:45 am]
BILLING CODE 4160-01-S