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, 22877-22879 [08-1187]
Download as PDF
<![CDATA[
Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Proposed Rules
1. Highly malignant tumors, such as
medulloblastoma or other primitive
neuroectodermal tumors (PNETs) with
documented metastases, grades III and IV
astrocytomas, glioblastoma multiforme,
ependymoblastoma, diffuse intrinsic brain
stem gliomas, or primary sarcomas.
2. Progressive or recurrent following initial
antineoplastic therapy.
*
*
*
*
*
*
*
13.14 Lungs.
*
*
*
OR
C. Carcinoma of the superior sulcus
(including Pancoast tumors) with multimodal
antineoplastic therapy. Consider under a
disability until at least 18 months from the
date of diagnosis. Thereafter, evaluate any
residual impairment(s) under the criteria for
the affected body system.
*
*
*
*
*
13.23 Cancers of the female genital tract—
carcinoma or sarcoma.
*
*
*
*
*
E. Ovaries, as described in 1 or 2:
1. All tumors except germ cell tumors, with
at least one of the following:
a. Tumor extension beyond the pelvis; for
example, tumor implants on peritoneal,
omental, or bowel surfaces.
b. Metastases to or beyond the regional
lymph nodes.
c. Recurrent following initial
antineoplastic therapy.
*
*
*
*
*
13.24 Prostate gland—carcinoma.
*
*
*
*
*
B. With visceral metastases (metastases to
internal organs).
*
*
*
*
*
13.27 Primary site unknown after
appropriate search for primary—metastatic
carcinoma or sarcoma, except for squamous
cell carcinoma confined to the neck nodes.
*
*
*
*
*
*
*
lymphomas in children under 13.05 in part
A.
*
*
*
*
*
2. Leukemia.
a. Acute leukemia. * * * Recurrent disease
must be documented by peripheral blood,
bone marrow, or cerebrospinal fluid
examination, or by testicular biopsy. * * *
*
*
*
*
*
4. Thyroid tumors. We use the criteria in
113.09 to evaluate anaplastic carcinoma and
carcinoma treated with radioactive iodine.
Medullary carcinoma of the thyroid gland,
which is not treated with radioactive iodine,
is rare in children. We evaluate medullary
carcinoma in children under 13.09C in part
A.
5. Brain tumors. We use the criteria in
113.13 to evaluate malignant brain tumors.
We consider a brain tumor to be malignant
if it is classified as grade II or higher under
the World Health Organization’s
classification of tumors of the central nervous
system (WHO Classification of Tumours of
the Central Nervous System, 2007). We
evaluate any complications of malignant
brain tumors, such as resultant neurological
or psychological impairments, under the
criteria for the affected body system. We
evaluate benign brain tumors under 111.05.
*
*
*
*
*
113.01 Category of Impairments, Malignant
Neoplastic Diseases
*
*
*
*
*
113.13 Brain tumors. (See 113.00K5.)
Highly malignant tumors, such as
medulloblastoma or other primitive
neuroectodermal tumors (PNETs) with
documented metastases, grades III and IV
astrocytomas, glioblastoma multiforme,
ependymoblastoma, diffuse intrinsic brain
stem gliomas, or primary sarcomas.
*
*
*
*
*
[FR Doc. E8–9170 Filed 4–25–08; 8:45 am]
*
BILLING CODE 4191–02–P
Part B
*
*
113.00 MALIGNANT NEOPLASTIC
DISEASES
*
*
*
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
*
Food and Drug Administration
*
rwilkins on PROD1PC63 with PROPOSALS
I. What do these terms in the listings
mean?
1. Metastases: The spread of tumor cells by
blood, lymph, or other body fluid. This term
does not include the spread of tumor cells by
direct extension of the tumor to other tissue
or organs.
2. Persistent: Failure to achieve a complete
remission.
3. Progressive: The malignancy became
more extensive after treatment.
4. Recurrent, relapse: A malignancy that
had been in complete remission or entirely
removed by surgery has returned.
AGENCY:
*
*
*
*
K. How do we evaluate specific malignant
neoplastic diseases?
1. Lymphoma.
a. We provide criteria for evaluating
aggressive lymphomas that have not
responded to antineoplastic therapy in
113.05. Indolent lymphomas are rare in
children. We will evaluate indolent
VerDate Aug<31>2005
17:54 Apr 25, 2008
Jkt 214001
21 CFR Part 872
[Docket No. FDA–2008–N–0163] (formerly
Docket No. 2001N–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
Food and Drug Administration,
HHS.
Proposed rule; reopening of
comment period.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is reopening for
90 days, the comment period for the
PO 00000
Frm 00042
Fmt 4702
Sfmt 4702
22877
proposed rule, published in the Federal
Register of February 20, 2002 (67 FR
7620), on the classification of
encapsulated amalgam alloy and dental
mercury, the reclassification of dental
mercury, and the issuance of special
controls for amalgam alloy. In the
Federal Register of July 17, 2002 (67 FR
46941), the initial comment period was
reopened for 60 days. The agency is
taking this action to provide the public
with an additional opportunity to
comment and to request data and
information that may have become
available since publication of the
proposed rule.
DATES: Submit written or electronic
comments by July 28, 2008.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2008–N–
0163 (formerly Docket No. 2001N–
0067), by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal, as
described previously, in the ADDRESSES
portion of this document under
Electronic Submissions.
Instructions: All submissions received
must include the agency name and
Docket No(s). and Regulatory
Information Number (RIN) (if a RIN
number has been assigned) for this
rulemaking. All comments received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘How to Submit
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
E:\FR\FM\28APP1.SGM
28APP1
22878
Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Proposed Rules
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Michael E. Adjodha, Center for Devices
and Radiological Health (HFZ–480),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3688.
SUPPLEMENTARY INFORMATION:
rwilkins on PROD1PC63 with PROPOSALS
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.’’ In that document,
FDA proposed the following actions: (1)
Issue a separate classification regulation
for encapsulated amalgam alloy and
dental mercury; (2) amend the
classification for amalgam alloy by
adding special controls; and (3)
reclassify dental mercury from class I
(general controls) to class II. FDA
proposed that all three products would
have the same labeling guidance as a
special control. In addition, FDA
proposed that dental mercury would
have a voluntary American National
Standards Institute (ANSI) standard as a
special control; encapsulated amalgam
alloy and dental mercury would have
voluntary ANSI and International
Standards Organization (ISO) standards
as special controls; and the amalgam
alloy products would have a voluntary
ISO standard as a special control. Since
that time, a 2006 joint meeting of the
Dental Products Panel and the
Peripheral and Central Nervous System
Drugs Advisory Committee raised the
need for FDA to further consider
scientific issues that are potentially
relevant to this classification and we
seek additional comments on the
proposed classification.
In an effort to provide an update on
the latest scientific information
concerning dental amalgam, a working
group of the U.S. Department of Health
and Human Services, known as the
Trans-agency Working Group on the
Health Effects of Dental Amalgam,
commissioned a new review of the
scientific literature in 2004 (the 2004
review). The 2004 review, funded by the
National Institutes of Health in
cooperation with FDA, the Centers for
Disease Control and Prevention, and the
Office of the Chief Dental Officer of the
Public Health Service, was completed in
2004 by Life Sciences Research Office,
Inc. (LSRO). LSRO engaged an
independent panel of experts from
VerDate Aug<31>2005
17:54 Apr 25, 2008
Jkt 214001
academia with preeminent
qualifications and experience in the
appropriate scientific disciplines
needed for the 2004 review. The 2004
review was a systematic and
comprehensive evaluation of
approximately 300 peer-reviewed
studies of dental amalgam and mercury
vapor published from 1996 through
2003, intended to determine whether
these studies provided new evidence
related to the health effects of dental
amalgam in humans. The panel
concluded that the studies contained
insufficient evidence to support a
correlation or causal relationship
between exposure to dental amalgam
and kidney or cognitive dysfunction;
neurodegenerative disease (specifically
Alzheimer’s disease and Parkinson’s
disease); autoimmune disease
(including multiple sclerosis); or
adverse pregnancy outcomes (Refs. 1
and 2).
Dental amalgam was the subject of an
advisory committee meeting in 2006. As
announced in the Federal Register of
April 3, 2006 (71 FR 16582), on
September 6 and 7, 2006, FDA held a
joint meeting of the Dental Products
Panel and the Peripheral and Central
Nervous System Drugs Advisory
Committee (the 2006 joint committee).
The 2006 joint meeting was held to
discuss and make recommendations to
FDA on a draft FDA White Paper (2006
draft White Paper) (Ref. 3) regarding the
potential adverse health risks associated
with exposure to mercury in dental
amalgam. The goal of the 2006 draft
White Paper was to provide an
assessment and conclusions regarding
significant new information and health
risks from mercury in dental amalgam
and to build on previous Public Health
Service literature reviews and risk
assessments (1993 and 1997) and
reviews by other Federal agencies since
1997. The 2006 joint committee,
comprised of 24 panelists, heard
presentations from the following groups:
(1) Scientists; (2) regulatory officials
from Canada and Sweden, on the
scientific basis for the regulation of
dental amalgam in their respective
countries; and (3) FDA, on how the
United States has regulated and
evaluated dental amalgam. Numerous
public speakers also presented their
views.
The 2006 joint committee then
deliberated on a series of questions FDA
had posed on its draft review of the
dental amalgam literature and provided
recommendations to the agency related
to those questions (Ref. 4). By majority
vote, the committee concluded that
FDA’s draft White Paper had significant
limitations. Among its criticisms, the
PO 00000
Frm 00043
Fmt 4702
Sfmt 4702
2006 joint committee identified
insufficient explanation about the
following: (1) How the scientific
references were chosen; (2) failure to
identify the significant gaps in the
scientific knowledge, particularly with
respect to exposure limits; and (3) lack
of attention to sensitive subpopulations.
The majority of the 2006 joint
committee voted that it could not find
the conclusions of the draft White Paper
to be ‘‘reasonable.’’
Despite the limitation on the draft
White Paper, the 2006 joint committee
generally agreed that there is no
evidence that dental amalgams cause
health problems. The 2006 joint
committee also agreed that the most
recent well-controlled clinical studies,
including two prospective clinical
studies in children (Refs. 5 and 6),
showed no evidence of neurological
harm from dental amalgams. In
addition, a more recent article
corroborated this evidence (Ref. 7).
Panelists provided individual
recommendations, including
recommendations that FDA consider
requirements related to the use of dental
amalgam in pregnant women and small
children, as well as patient information
to ensure that consumers understand
that these devices contain mercury.
II. Reopening of the Comment Period
FDA believes it is important for
members of the public to have the
opportunity to further comment on
FDA’s proposal. Accordingly, FDA is
asking for comments concerning
whether these devices should be
classified into class II (special controls).
We specifically request comments
supported by empirical data and
scientific evidence concerning this
classification and these special controls.
In addition, if class II (special controls)
is the appropriate classification for these
devices, FDA requests comment on
whether the two types of special
controls proposed by FDA in 2002
(materials and labeling) provide
reasonable assurance of the safety and
effectiveness of these devices and on
whether the proposed special control
guidance document should be revised in
light of the recommendations and with
respect to the discussions by the 2006
joint committee.
• Controls on the Materials. For
example, should the material controls
proposed by FDA address conformance
to recognized consensus standards that
make recommendations for testing,
compressive strength, and identifying
the mercury vapor released by the
device?
• Labeling Controls. For example,
how should labeling controls, if any,
E:\FR\FM\28APP1.SGM
28APP1
Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Proposed Rules
rwilkins on PROD1PC63 with PROPOSALS
address the disclosure of composition,
including mercury content, and
precautions regarding use of the device
in sensitive subpopulations composed
of individuals who respond biologically
at lower levels of exposure to mercury
than the general population? If so,
which subpopulations should be
included (e.g., children under age 6,
pregnant and lactating women,
hypersensitive or immunocompromised
individuals)? Should the labeling
controls require more specific patient
labeling (e.g., informing patients of
identified sensitive subpopulations of
the mercury content, the alternatives to
the device and their relative costs, and
health risks associated with the failure
to obtain dental care)?
For the agency’s future analysis of
benefits and costs of the regulatory
options for dental amalgams, FDA also
requests comments, including available
data, on the following questions:
(1) How many annual procedures use
mercury amalgams? What are the
trends?
(2) What are the differences in cost
between amalgams and alternative
materials (e.g., composite, other metals,
ceramics, etc.)? Are there differences in
replacement lives?
(3) What are reimbursement rates for
dental amalgam and the alternative
materials?
(4) How would labeling describing the
risks of amalgam for certain
subpopulations (e.g., children under age
6, pregnant and lactating women,
hypersensitive or immunocompromised
individuals) affect the demand for, and
use of, mercury amalgam? How would
the risks included in the labeling be
communicated to those subpopulations?
(5) What is the current exposure to
mercury for patients? For professionals?
What would be the reduction in
exposure associated with the
alternatives described previously in this
section of this document?
III. How to Submit 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 to https://www.regulations.gov
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.
Please note that on January 15, 2008,
the FDA Division of Dockets
VerDate Aug<31>2005
17:54 Apr 25, 2008
Jkt 214001
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Governmental-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
IV. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Review and Analysis of the Literature on
the Potential Adverse Health Effects of Dental
Amalgam, LSRO, July 2004.
2. Brownawell, A.M., et al., ‘‘The Potential
Adverse Health Effects of Dental Amalgam,’’
Toxicological Reviews, 24(1):1–10, 2006.
3. Draft FDA Update/Review of Potential
Adverse Health Risks Associated With
Exposure to Mercury in Dental Amalgam,
National Center for Toxicological Research,
FDA, August 2006.
4. Transcripts from the Joint Meeting of
Dental Products Panel and Central Nervous
System Drugs Advisory Committee,
September 6 and 7, 2006.
5. Bellinger, D.C., et al.,
‘‘Neuropsychological and Renal Effects of
Dental Amalgam in Children: A Randomized
Trial,’’ Journal of the American Medical
Association, 295:1775–1783, 2006.
6. DeRouen, T.A., et al., ‘‘Neurobehavioral
Effects of Dental Amalgam in Children: A
Randomized Clinical Trial,’’ Journal of the
American Medical Association, 295:1784–
1792, 2006.
7. Dunn, Julie E., ‘‘Scalp hair and urine
mercury content of children in the Northeast
United States: The New England Children’s
Amalgam Trial,’’ Environmental Research,
Vol. 107, Issue 1, pages 79 to 88, May 2008.
Dated: April 22, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. 08–1187 Filed 4–23–08; 10:15 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
22879
Notice of proposed rulemaking
and withdrawal of notice of proposed
rulemaking.
ACTION:
SUMMARY: This document contains
proposed regulations regarding the use
of designated summonses and related
summonses and the effect on the period
of limitations on assessment when a
case is brought with respect to a
designated or related summons. This
document also withdraws the previous
proposed regulations published in the
Federal Register on July 31, 2003 (68 FR
44905). These proposed regulations
reflect changes to section 6503 of the
Internal Revenue Code of 1986 made by
the Omnibus Budget Reconciliation Act
of 1990 and the Small Business Job
Protection Act of 1996. These
regulations affect corporate taxpayers
that are examined under the
coordinated issue case (CIC) program
and are served with designated or
related summonses. These regulations
also affect third parties that are served
with designated or related summonses
for information pertaining to the
corporate examination.
DATES: Written or electronic comments
and requests for a public hearing must
be received by July 28, 2008.
ADDRESSES: Send submissions to:
CC:PA:LPD:PR (REG–208199–91), room
5203, Internal Revenue Service, P.O.
Box 7604, Ben Franklin Station,
Washington, DC 20044. Alternatively,
submissions may be hand delivered
between the hours of 8 a.m. and 4 p.m.
to: CC:PA:LPD:PR (REG–208199–91),
Courier’s Desk, Internal Revenue
Service, 1111 Constitution Avenue,
NW., Washington, DC. Comments may
also be submitted electronically to the
Federal eRulemaking Portal at https://
www.regulations.gov (IRS REG–208199–
91).
FOR FURTHER INFORMATION CONTACT:
Concerning the proposed regulations,
Elizabeth Rawlins, (202) 622–3630;
concerning submissions of comments,
Richard Hurst, (202) 622–7180 or
Richard.A.Hurst@IRSCounsel.Treas.Gov
(not toll-free numbers).
SUPPLEMENTARY INFORMATION:
26 CFR Part 301
Background
[REG–208199–91]
This document contains proposed
regulations amending the Procedure and
Administration regulations (26 CFR part
301) under section 6503. Section 11311
of the Omnibus Budget Reconciliation
Act of 1990 (Pub. L. 101–508, 104 Stat.
1388) amended section 6503(k) to
suspend the period of limitations on
assessment when a case is brought with
respect to a designated or related
summons. Section 6503(k) was
RIN 1545–BC55
Suspension of Running of Period of
Limitations During a Proceeding to
Enforce or Quash a Designated or
Related Summons
Internal Revenue Service (IRS),
Treasury.
AGENCY:
PO 00000
Frm 00044
Fmt 4702
Sfmt 4702
E:\FR\FM\28APP1.SGM
28APP1
]]>Agencies
[Federal Register Volume 73, Number 82 (Monday, April 28, 2008)]
[Proposed Rules]
[Pages 22877-22879]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-1187]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. FDA-2008-N-0163] (formerly Docket No. 2001N-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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is reopening for 90
days, the comment period for the proposed rule, published in the
Federal Register of February 20, 2002 (67 FR 7620), on the
classification of encapsulated amalgam alloy and dental mercury, the
reclassification of dental mercury, and the issuance of special
controls for amalgam alloy. In the Federal Register of July 17, 2002
(67 FR 46941), the initial comment period was reopened for 60 days. The
agency is taking this action to provide the public with an additional
opportunity to comment and to request data and information that may
have become available since publication of the proposed rule.
DATES: Submit written or electronic comments by July 28, 2008.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0163 (formerly Docket No. 2001N-0067), by any of the following
methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to https://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``How to Submit Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts
[[Page 22878]]
and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Michael E. Adjodha, Center for
Devices and Radiological Health (HFZ-480), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-
3688.
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.'' In
that document, FDA proposed the following actions: (1) Issue a separate
classification regulation for encapsulated amalgam alloy and dental
mercury; (2) amend the classification for amalgam alloy by adding
special controls; and (3) reclassify dental mercury from class I
(general controls) to class II. FDA proposed that all three products
would have the same labeling guidance as a special control. In
addition, FDA proposed that dental mercury would have a voluntary
American National Standards Institute (ANSI) standard as a special
control; encapsulated amalgam alloy and dental mercury would have
voluntary ANSI and International Standards Organization (ISO) standards
as special controls; and the amalgam alloy products would have a
voluntary ISO standard as a special control. Since that time, a 2006
joint meeting of the Dental Products Panel and the Peripheral and
Central Nervous System Drugs Advisory Committee raised the need for FDA
to further consider scientific issues that are potentially relevant to
this classification and we seek additional comments on the proposed
classification.
In an effort to provide an update on the latest scientific
information concerning dental amalgam, a working group of the U.S.
Department of Health and Human Services, known as the Trans-agency
Working Group on the Health Effects of Dental Amalgam, commissioned a
new review of the scientific literature in 2004 (the 2004 review). The
2004 review, funded by the National Institutes of Health in cooperation
with FDA, the Centers for Disease Control and Prevention, and the
Office of the Chief Dental Officer of the Public Health Service, was
completed in 2004 by Life Sciences Research Office, Inc. (LSRO). LSRO
engaged an independent panel of experts from academia with preeminent
qualifications and experience in the appropriate scientific disciplines
needed for the 2004 review. The 2004 review was a systematic and
comprehensive evaluation of approximately 300 peer-reviewed studies of
dental amalgam and mercury vapor published from 1996 through 2003,
intended to determine whether these studies provided new evidence
related to the health effects of dental amalgam in humans. The panel
concluded that the studies contained insufficient evidence to support a
correlation or causal relationship between exposure to dental amalgam
and kidney or cognitive dysfunction; neurodegenerative disease
(specifically Alzheimer's disease and Parkinson's disease); autoimmune
disease (including multiple sclerosis); or adverse pregnancy outcomes
(Refs. 1 and 2).
Dental amalgam was the subject of an advisory committee meeting in
2006. As announced in the Federal Register of April 3, 2006 (71 FR
16582), on September 6 and 7, 2006, FDA held a joint meeting of the
Dental Products Panel and the Peripheral and Central Nervous System
Drugs Advisory Committee (the 2006 joint committee). The 2006 joint
meeting was held to discuss and make recommendations to FDA on a draft
FDA White Paper (2006 draft White Paper) (Ref. 3) regarding the
potential adverse health risks associated with exposure to mercury in
dental amalgam. The goal of the 2006 draft White Paper was to provide
an assessment and conclusions regarding significant new information and
health risks from mercury in dental amalgam and to build on previous
Public Health Service literature reviews and risk assessments (1993 and
1997) and reviews by other Federal agencies since 1997. The 2006 joint
committee, comprised of 24 panelists, heard presentations from the
following groups: (1) Scientists; (2) regulatory officials from Canada
and Sweden, on the scientific basis for the regulation of dental
amalgam in their respective countries; and (3) FDA, on how the United
States has regulated and evaluated dental amalgam. Numerous public
speakers also presented their views.
The 2006 joint committee then deliberated on a series of questions
FDA had posed on its draft review of the dental amalgam literature and
provided recommendations to the agency related to those questions (Ref.
4). By majority vote, the committee concluded that FDA's draft White
Paper had significant limitations. Among its criticisms, the 2006 joint
committee identified insufficient explanation about the following: (1)
How the scientific references were chosen; (2) failure to identify the
significant gaps in the scientific knowledge, particularly with respect
to exposure limits; and (3) lack of attention to sensitive
subpopulations. The majority of the 2006 joint committee voted that it
could not find the conclusions of the draft White Paper to be
``reasonable.''
Despite the limitation on the draft White Paper, the 2006 joint
committee generally agreed that there is no evidence that dental
amalgams cause health problems. The 2006 joint committee also agreed
that the most recent well-controlled clinical studies, including two
prospective clinical studies in children (Refs. 5 and 6), showed no
evidence of neurological harm from dental amalgams. In addition, a more
recent article corroborated this evidence (Ref. 7). Panelists provided
individual recommendations, including recommendations that FDA consider
requirements related to the use of dental amalgam in pregnant women and
small children, as well as patient information to ensure that consumers
understand that these devices contain mercury.
II. Reopening of the Comment Period
FDA believes it is important for members of the public to have the
opportunity to further comment on FDA's proposal. Accordingly, FDA is
asking for comments concerning whether these devices should be
classified into class II (special controls). We specifically request
comments supported by empirical data and scientific evidence concerning
this classification and these special controls. In addition, if class
II (special controls) is the appropriate classification for these
devices, FDA requests comment on whether the two types of special
controls proposed by FDA in 2002 (materials and labeling) provide
reasonable assurance of the safety and effectiveness of these devices
and on whether the proposed special control guidance document should be
revised in light of the recommendations and with respect to the
discussions by the 2006 joint committee.
Controls on the Materials. For example, should the
material controls proposed by FDA address conformance to recognized
consensus standards that make recommendations for testing, compressive
strength, and identifying the mercury vapor released by the device?
Labeling Controls. For example, how should labeling
controls, if any,
[[Page 22879]]
address the disclosure of composition, including mercury content, and
precautions regarding use of the device in sensitive subpopulations
composed of individuals who respond biologically at lower levels of
exposure to mercury than the general population? If so, which
subpopulations should be included (e.g., children under age 6, pregnant
and lactating women, hypersensitive or immunocompromised individuals)?
Should the labeling controls require more specific patient labeling
(e.g., informing patients of identified sensitive subpopulations of the
mercury content, the alternatives to the device and their relative
costs, and health risks associated with the failure to obtain dental
care)?
For the agency's future analysis of benefits and costs of the
regulatory options for dental amalgams, FDA also requests comments,
including available data, on the following questions:
(1) How many annual procedures use mercury amalgams? What are the
trends?
(2) What are the differences in cost between amalgams and
alternative materials (e.g., composite, other metals, ceramics, etc.)?
Are there differences in replacement lives?
(3) What are reimbursement rates for dental amalgam and the
alternative materials?
(4) How would labeling describing the risks of amalgam for certain
subpopulations (e.g., children under age 6, pregnant and lactating
women, hypersensitive or immunocompromised individuals) affect the
demand for, and use of, mercury amalgam? How would the risks included
in the labeling be communicated to those subpopulations?
(5) What is the current exposure to mercury for patients? For
professionals? What would be the reduction in exposure associated with
the alternatives described previously in this section of this document?
III. How to Submit 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 to https://
www.regulations.gov 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Governmental-wide, electronic docket
management system. Electronic comments or submissions will be accepted
by FDA only through FDMS at https://www.regulations.gov.
IV. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Review and Analysis of the Literature on the Potential
Adverse Health Effects of Dental Amalgam, LSRO, July 2004.
2. Brownawell, A.M., et al., ``The Potential Adverse Health
Effects of Dental Amalgam,'' Toxicological Reviews, 24(1):1-10,
2006.
3. Draft FDA Update/Review of Potential Adverse Health Risks
Associated With Exposure to Mercury in Dental Amalgam, National
Center for Toxicological Research, FDA, August 2006.
4. Transcripts from the Joint Meeting of Dental Products Panel
and Central Nervous System Drugs Advisory Committee, September 6 and
7, 2006.
5. Bellinger, D.C., et al., ``Neuropsychological and Renal
Effects of Dental Amalgam in Children: A Randomized Trial,'' Journal
of the American Medical Association, 295:1775-1783, 2006.
6. DeRouen, T.A., et al., ``Neurobehavioral Effects of Dental
Amalgam in Children: A Randomized Clinical Trial,'' Journal of the
American Medical Association, 295:1784-1792, 2006.
7. Dunn, Julie E., ``Scalp hair and urine mercury content of
children in the Northeast United States: The New England Children's
Amalgam Trial,'' Environmental Research, Vol. 107, Issue 1, pages 79
to 88, May 2008.
Dated: April 22, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. 08-1187 Filed 4-23-08; 10:15 am]
BILLING CODE 4160-01-S
