[Federal Register Volume 67, Number 34 (Wednesday, February 20, 2002)]
[Notices]
[Pages 7703-7704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4029]


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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

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availability of the draft guidance entitled ``Special Control Guidance 
Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury 
Labeling.'' This draft guidance is neither final nor is it in effect at 
this time. Elsewhere in this issue of the Federal Register, the agency 
is proposing 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 The draft 
guidance document is intended to serve as a special control for these 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.

DATES: Submit written or electronic comments on the draft guidance by 
May 21, 2002. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance entitled ``Special Control Guidance Document on 
Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling'' to 
the Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health (CDRH), Food and Drug Administration, 
1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 301-443-8818. Submit written comments on the draft guidance 
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. 
Comments should be identified with the docket number found in brackets 
in the heading of this document. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the draft guidance.

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

    Elsewhere in this issue of the Federal Register, the agency is 
proposing 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 guidance document contains recommendations concerning the 
content and format of labeling for these devices.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance 
document represents the agency's current thinking on encapsulated 
amalgam, amalgam alloy, and dental mercury labeling. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An alternative approach may be used if such approach 
satisfies the applicable statutes and regulations. This draft guidance 
document is issued as a level 1 guidance consistent with the GGP 
regulations.

III. Electronic Access

    In order to receive the draft guidance entitled ``Special Control 
Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental 
Mercury Labeling '' via your fax machine, call the CDRH Facts-On-Demand 
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. At 
the first voice prompt press 1 to enter the system. At the second voice 
prompt press 1 to order a document. Enter the document

[[Page 7704]]

number (1192) followed by the pound sign (#). Follow the remaining 
voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the Internet. 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 ``Special Control 
Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental 
Mercury Labeling,'' device safety alerts, Federal Register reprints, 
information on premarket submissions (including lists of approved 
applications and manufacturers' addresses), small manufacturers' 
assistance, information on video conferencing and electronic 
submissions, Mammography Matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding this draft 
guidance by May 21, 2002. 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. The draft guidance and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 7, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-4029 Filed 2-19-02; 8:45 am]
BILLING CODE 4160-01-S