[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38661-38662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18445]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-D-0129 (formerly Docket No. 2001D-0064)]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Dental Amalgam, Mercury, 
and Amalgam Alloy; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Class II Special Controls 
Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.'' This 
guidance document describes a means by which manufacturers of dental 
amalgam, mercury, and amalgam alloy may comply with special controls 
that apply to these class II devices. Elsewhere in this issue of the 
Federal Register, FDA is publishing a final rule to classify dental 
amalgam into class II (special controls), reclassify dental mercury 
from class I (general controls) to class II (special controls), and 
designate a special controls guidance document to support the class II 
classification of these two devices, as well as the current class II 
classification of amalgam alloy.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Class II Special Controls Guidance Document: Dental 
Amalgam, Mercury, and Amalgam Alloy'' to the Division of Small 
Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Michael Adjodha, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 2606, Silver Spring, MD 20993-0002, 301-
796-6276.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 20, 2002 (67 FR 7620), FDA 
issued a proposed rule to issue a separate regulation classifying 
encapsulated dental amalgam into class II (special controls); amending 
the class II classification of amalgam alloy by designating special 
controls; and reclassifying dental mercury from class I (general 
controls) to class II (special controls). Also, in the Federal Register 
of February 20, 2002 (67 FR 7703), FDA announced the availability of 
the draft guidance entitled ``Special Control Guidance Document on 
Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling,'' 
which would serve as a special control for all three devices. The 
comment period on the proposed rule closed on May 21, 2002. FDA 
reopened the comment period in July 2002 (67 FR 46991) and again in 
April 2008 (73 FR 22877) to provide the public with additional 
opportunities to comment and to submit data and information that may 
have become available since publication of the proposed rule. The 
comment period closed on July 28, 2008.
    FDA received more than 1,400 comments on the proposed rule and the 
draft special controls guidance document. Because of the intertwined 
nature of the proposed rule and the draft guidance, and because of the 
significant overlap in comments, FDA considered all comments in 
preparing both the final rule and the special controls guidance 
document. The analysis of comments is contained in the preamble to the 
final rule.

[[Page 38662]]

II. Significance of Special Controls Guidance Document

    The final rule designates the guidance document entitled ``Class II 
Special Controls Guidance Document: Dental Amalgam, Mercury, and 
Amalgam Alloy'' as the special control for mercury, amalgam alloy, and 
dental amalgam. FDA believes that adherence to the recommendations 
described in this guidance document, in addition to the general 
controls under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.), will provide reasonable assurance of the safety and 
effectiveness of dental amalgam, mercury, and amalgam alloy. Following 
the effective date of the final rule, any firm submitting a 510(k) 
premarket notification for dental amalgam, mercury, or amalgam alloy, 
as well as any firm currently marketing the devices, must address the 
issues covered in the special controls guidance. The firm must show 
that its device addresses the issues of safety and effectiveness 
identified in the special controls guidance, either by following the 
recommendations in the guidance or by some other means that provides 
equivalent assurances of safety and effectiveness.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. To receive ``Class II Special Controls Guidance 
Document: Dental Amalgam, Mercury, and Amalgam Alloy'' you may either 
send an e-mail request to [email protected] to receive an electronic 
copy of the document or send a fax request to 301-847-8149 to receive a 
hard copy. Please use the document number (1192) to identify the 
guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at http://www.regulations.gov.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper 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 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18445 Filed 7-29-09; 4:15 pm]
BILLING CODE 4160-01-S