[Federal Register: August 4, 2009 (Volume 74, Number 148)]
[Notices]
[Page 38661-38662]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au09-65]
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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 dsmica@fda.hhs.gov 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