Medical Waivers for Merchant Mariner Credential Applicants With Anti-Tachycardia Devices or Implantable Cardioverter Defibrillators, 55174-55175 [2012-22006]
Download as PDF
55174
Federal Register / Vol. 77, No. 174 / Friday, September 7, 2012 / Proposed Rules
Dated: August 23, 2012.
W.C. Early,
Acting Regional Administrator, Region III.
Federal holidays. The telephone number
is 202–366–9329.
To avoid duplication, please use only
one of these four methods. See the
‘‘Public Participation’’ portion of the
SUPPLEMENTARY INFORMATION section
below for instructions on submitting
comments.
[FR Doc. 2012–22098 Filed 9–6–12; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HOMELAND
SECURITY
If
you have questions about this notice,
call or email Lieutenant Ashley Holm,
Mariner Credentialing Program Policy
Division (CG–CVC–4), U.S. Coast Guard,
telephone 202–372–1128, email
MMCPolicy@uscg.mil. If you have
questions on viewing material in the
docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone
202–366–9826.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Coast Guard
46 CFR Part 10
[Docket No. USCG–2012–0734]
Medical Waivers for Merchant Mariner
Credential Applicants With AntiTachycardia Devices or Implantable
Cardioverter Defibrillators
Coast Guard, DHS.
Notice of proposed policy
change and request for comments.
AGENCY:
ACTION:
Public Participation
The Coast Guard is seeking
public comment regarding criteria for
granting medical waivers to mariners
who have anti-tachycardia devices or
implantable cardioverter defibrillators
(ICDs). Current Coast Guard guidance
found in Navigation and Vessel
Inspection Circular 04–08, Medical and
Physical Evaluation Guidelines for
Merchant Mariner Credentials (NVIC
04–08), states that anti-tachycardia
devices or ICDs are generally not
waiverable. The Coast Guard is
considering changing that policy. Prior
to issuing a policy change on whether
to grant waivers for anti-tachycardia
devices or ICDs and the criteria for such
waivers, the Coast Guard will accept
comments from the public on whether
the proposed criteria would adequately
address safety concerns regarding
merchant mariners with ICDs.
DATES: Comments and related material
must either be submitted to our online
docket via https://www.regulations.gov
on or before October 9, 2012 or reach
the Docket Management Facility by that
date.
ADDRESSES: You may submit comments
identified by docket number USCG–
2011–0734 using any one of the
following methods:
(1) Federal eRulemaking Portal:
https://www.regulations.gov.
(2) Fax: 202–493–2251.
(3) Mail: Docket Management Facility
(M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue SE., Washington, DC 20590–
0001.
(4) Hand delivery: Same as mail
address above, between 9 a.m. and 5
p.m., Monday through Friday, except
You may submit comments and
related material regarding whether this
proposed policy change should be
incorporated into a final policy on
issuing medical waivers to mariners
with ICDs. All comments received will
be posted, without change, to https://
www.regulations.gov and will include
any personal information you have
provided.
Submitting comments: If you submit a
comment, please include the docket
number for this notice (USCG–2012–
0734) and provide a reason for each
suggestion or recommendation. You
may submit your comments and
material online or by fax, mail or hand
delivery, but please use only one of
these means. We recommend that you
include your name and a mailing
address, an email address, or a
telephone number in the body of your
document so that we can contact you if
we have questions regarding your
submission.
To submit your comment online, go to
https://www.regulations.gov and insert
‘‘USCG–2012–0734’’ in the ‘‘Search’’
box. Click ‘‘Search,’’ find this notice in
the list of Results, and then click on the
corresponding ‘‘Comment Now’’ box. If
you submit your comments by mail or
hand delivery, submit them in an
unbound format, no larger than 81⁄2 by
11 inches, suitable for copying and
electronic filing. If you submit
comments by mail and would like to
know that they reached the Facility,
please enclose a stamped, self-addressed
postcard or envelope. We will consider
all comments and material received
during the comment period.
Viewing the comments: To view
comments, as well as documents
mentioned in this notice as being
available in the docket, go to https://
mstockstill on DSK4VPTVN1PROD with PROPOSALS
SUMMARY:
VerDate Mar<15>2010
16:33 Sep 06, 2012
Jkt 226001
PO 00000
Frm 00016
Fmt 4702
Sfmt 4702
www.regulations.gov and insert ‘‘USCG–
2012–0734’’ in the ‘‘Search’’ box. Click
‘‘Search’’ and use the filters on the left
side of the page to highlight ‘‘Public
Submissions’’ or other document types.
If you do not have access to the Internet,
you may view the docket online by
visiting the Docket Management Facility
in Room W12–140 on the ground floor
of the Department of Transportation
West Building, 1200 New Jersey Avenue
SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through
Friday, except Federal holidays. We
have an agreement with the Department
of Transportation to use the Docket
Management Facility.
Privacy Act: Anyone can search the
electronic form of comments received
into any of our dockets by the name of
the individual submitting the comment
(or signing the comment, if submitted
on behalf of an association, business,
labor union, etc.). You may review a
Privacy Act system of records notice
regarding our public dockets in the
January 17, 2008 issue of the Federal
Register (73 FR 3316).
Background and Purpose
Coast Guard regulations in 46 CFR
10.215 contain the medical standards
that merchant mariners must meet prior
to being issued a merchant mariner
credential (MMC). In cases where the
mariner does not meet the medical
standards in 46 CFR 10.215, the Coast
Guard may issue a waiver when
extenuating circumstances exist that
warrant special consideration. See 46
CFR 10.215(g).
In NVIC 04–08, the Coast Guard states
that anti-tachycardia devices and ICDs
are generally not waiverable. Since the
issuance of NVIC 04–08 on September
15, 2008, a number of mariners have
sought and received waivers for antitachycardia devices or ICDs in
accordance with 46 CFR 10.215(g).
However, because NVIC 04–08 does not
identify waiver criteria associated with
anti-tachycardia devices or ICDs, it has
been difficult for Coast Guard personnel
to consistently evaluate merchant
mariners with anti-tachycardia devices
or ICDs and assess whether an
applicant’s medical condition warrants
granting a medical waiver under 46 CFR
10.215(g). Accordingly, the Coast Guard
is considering whether to change its
policy regarding waivers for antitachycardia devices or ICDs, and under
what criteria a mariner may be eligible
for waiver consideration.
The Coast Guard intends to consider
public input as well as the
recommendations of the Merchant
Mariner Medical Advisory Committee,
established under the authority of 46
E:\FR\FM\07SEP1.SGM
07SEP1
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 174 / Friday, September 7, 2012 / Proposed Rules
U.S.C. 7115, prior to establishing a final
policy on whether waivers should be
granted for anti-tachycardia devices or
ICDs, and if so, under what
circumstances. Because of the
complexity of the issues involved, the
Coast Guard intends to thoroughly
analyze the issues prior to issuing the
final policy.
The Coast Guard specifically requests
public comment on the likelihood of an
ICD inappropriately firing and whether
that shock could potentially
incapacitate a merchant mariner.
Additionally, the Coast Guard seeks
public comment on whether the criteria
listed below are appropriate and
sufficient to evaluate whether a mariner
should be eligible for consideration for
a medical waiver under 46 CFR
10.215(g).
Below is a series of 12 questions we
are considering as the criteria for
granting a medical waiver. A review of
the mariner’s record should lead the
Coast Guard to answer ‘‘no’’ for each
question in order for the mariner to be
eligible for waiver consideration. We
request public comment regarding
whether the 12 questions below
represent an appropriate and sufficient
list of the criteria a mariner should be
required to meet in order to be eligible
for waiver consideration, or whether we
should eliminate or modify any of the
questions, or add other questions to the
list.
(1) Does the mariner have a diagnosis
of a cardiac channelopathy affecting the
electrical conduction of the heart
(including Brugada syndrome, Long QT
syndrome, etc.)?
(2) Does the mariner have a prior
history of ventricular fibrillation or
episodes of sustained ventricular
tachycardia and, if so, did the
arrhythmia episode occur greater than
three years ago?
(3) Was the ICD or anti-tachycardia
device implanted more than three years
ago?
(4) Has the ICD fired or has the
mariner required anti-tachycardia
pacing within the last three years?
(5) Does the mariner’s condition
present any confounding risk factors for
inappropriate shock such as
uncontrolled atrial fibrillation?
(6) Is the mariner’s ejection fraction
greater than 40% with a steady or
improving trend?
(7) Does the mariner have a history of
any symptomatic or clinically
significant heart failure in the past two
years?
(8) Does the mariner’s record contain
any evidence of significant reversible
ischemia on myocardial perfusion
imaging exercise stress testing?
VerDate Mar<15>2010
16:33 Sep 06, 2012
Jkt 226001
(9) Has the mariner’s exercise capacity
been assessed to be greater than or equal
to 10 metabolic equivalents (METs)?
(10) Did the mariner provide a written
opinion of the treating cardiologist or
electrophysiologist that supports a
determination that the mariner is at low
risk for future arrhythmia, adverse
cardiac event or sudden incapacitation
based upon objective testing and
standard evaluation tools?
(11) Does the mariner have any other
medical conditions which may alone, or
in combination with an ICD or antitachycardia device, affect the mariner’s
fitness?
(12) Is the mariner applying for an
original credential, raise-in-grade, or
renewal of an existing credential?
Authority: We issue this request for public
comments under the authority of 5 U.S.C.
552(a).
Dated: August 13, 2012.
P.F. Thomas,
Captain, U.S. Coast Guard, Director of
Inspections and Compliance.
[FR Doc. 2012–22006 Filed 9–6–12; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Part 578
[Docket No. NHTSA–2012–0131; Notice 1]
RIN 2127–AL16
Civil Penalties
National Highway Traffic
Safety Administration (NHTSA), DOT.
ACTION: Notice of Proposed Rulemaking.
AGENCY:
This document proposes to
increase the maximum civil penalty
amounts for violations of motor vehicle
safety requirements for the National
Traffic and Motor Vehicle Safety Act, as
amended, and violations of bumper
standards and consumer information
provisions. Specifically, this proposes
increases in maximum civil penalty
amounts for single violations of motor
vehicle safety requirements, a series of
related violations of school bus and
equipment safety requirements, a series
of related violations of bumper
standards, and a series of related
violations of consumer information
regarding crashworthiness and damage
susceptibility requirements. This action
would be taken pursuant to the Federal
Civil Monetary Penalty Inflation
Adjustment Act of 1990, as amended by
the Debt Collection Improvement Act of
SUMMARY:
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
55175
1996, which requires us to review and,
as warranted, adjust penalties based on
inflation at least every four years.
DATES: Comments on the proposal are
due October 9, 2012.
Proposed effective date: 30 days after
date of publication of the final rule in
the Federal Register.
ADDRESSES: You may submit comments
to the docket number identified in the
heading of this document by any of the
following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov. Follow the
online instructions for submitting
comments.
• Mail: Docket Management Facility:
U.S. Department of Transportation, 1200
New Jersey Avenue SE., West Building
Ground Floor, Room W12–140,
Washington, DC 20590–0001
• Hand Delivery or Courier: 1200
New Jersey Avenue SE., West Building
Ground Floor, Room W12–140, between
9 a.m. and 5 p.m. ET, Monday through
Friday, except Federal holidays.
• Fax: 202–493–2251.
Regardless of how you submit your
comments, please note the docket
number of this document.
Instructions: For detailed instructions
on submitting comments and additional
information on the rulemaking process,
see the Public Participation heading of
the SUPPLEMENTARY INFORMATION section
of this document. Note that all
comments received will be posted
without change to https://
www.regulations.gov, including any
personal information provided. Please
see the ‘‘Privacy Act’’ heading below.
Privacy Act: Please see the Privacy
Act heading under Rulemaking
Analyses.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov or the street
address listed above. Follow the online
instructions for accessing the dockets.
FOR FURTHER INFORMATION CONTACT:
Matthew Weisman, Office of Chief
Counsel, NHTSA, telephone (202) 366–
5834, facsimile (202) 366–3820, 1200
New Jersey Ave, SE., Washington, DC
20590.
SUPPLEMENTARY INFORMATION:
Background
In order to preserve the remedial
impact of civil penalties and to foster
compliance with the law, the Federal
Civil Monetary Penalty Inflation
Adjustment Act of 1990 (28 U.S.C. 2461
Notes, Pub. L. 101–410), as amended by
the Debt Collection Improvement Act of
1996 (Pub. L. 104–134) (referred to
collectively as the ‘‘Adjustment Act’’ or,
E:\FR\FM\07SEP1.SGM
07SEP1
Agencies
[Federal Register Volume 77, Number 174 (Friday, September 7, 2012)]
[Proposed Rules]
[Pages 55174-55175]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22006]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
46 CFR Part 10
[Docket No. USCG-2012-0734]
Medical Waivers for Merchant Mariner Credential Applicants With
Anti-Tachycardia Devices or Implantable Cardioverter Defibrillators
AGENCY: Coast Guard, DHS.
ACTION: Notice of proposed policy change and request for comments.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard is seeking public comment regarding criteria
for granting medical waivers to mariners who have anti-tachycardia
devices or implantable cardioverter defibrillators (ICDs). Current
Coast Guard guidance found in Navigation and Vessel Inspection Circular
04-08, Medical and Physical Evaluation Guidelines for Merchant Mariner
Credentials (NVIC 04-08), states that anti-tachycardia devices or ICDs
are generally not waiverable. The Coast Guard is considering changing
that policy. Prior to issuing a policy change on whether to grant
waivers for anti-tachycardia devices or ICDs and the criteria for such
waivers, the Coast Guard will accept comments from the public on
whether the proposed criteria would adequately address safety concerns
regarding merchant mariners with ICDs.
DATES: Comments and related material must either be submitted to our
online docket via https://www.regulations.gov on or before October 9,
2012 or reach the Docket Management Facility by that date.
ADDRESSES: You may submit comments identified by docket number USCG-
2011-0734 using any one of the following methods:
(1) Federal eRulemaking Portal: https://www.regulations.gov.
(2) Fax: 202-493-2251.
(3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
(4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is 202-366-9329.
To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section below for instructions on submitting comments.
FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice, call or email Lieutenant Ashley Holm, Mariner Credentialing
Program Policy Division (CG-CVC-4), U.S. Coast Guard, telephone 202-
372-1128, email MMCPolicy@uscg.mil. If you have questions on viewing
material in the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone 202-366-9826.
SUPPLEMENTARY INFORMATION:
Public Participation
You may submit comments and related material regarding whether this
proposed policy change should be incorporated into a final policy on
issuing medical waivers to mariners with ICDs. All comments received
will be posted, without change, to https://www.regulations.gov and will
include any personal information you have provided.
Submitting comments: If you submit a comment, please include the
docket number for this notice (USCG-2012-0734) and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail or hand delivery, but please use only
one of these means. We recommend that you include your name and a
mailing address, an email address, or a telephone number in the body of
your document so that we can contact you if we have questions regarding
your submission.
To submit your comment online, go to https://www.regulations.gov and
insert ``USCG-2012-0734'' in the ``Search'' box. Click ``Search,'' find
this notice in the list of Results, and then click on the corresponding
``Comment Now'' box. If you submit your comments by mail or hand
delivery, submit them in an unbound format, no larger than 8\1/2\ by 11
inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the Facility,
please enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period.
Viewing the comments: To view comments, as well as documents
mentioned in this notice as being available in the docket, go to https://www.regulations.gov and insert ``USCG-2012-0734'' in the ``Search''
box. Click ``Search'' and use the filters on the left side of the page
to highlight ``Public Submissions'' or other document types. If you do
not have access to the Internet, you may view the docket online by
visiting the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. We have an agreement
with the Department of Transportation to use the Docket Management
Facility.
Privacy Act: Anyone can search the electronic form of comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review a
Privacy Act system of records notice regarding our public dockets in
the January 17, 2008 issue of the Federal Register (73 FR 3316).
Background and Purpose
Coast Guard regulations in 46 CFR 10.215 contain the medical
standards that merchant mariners must meet prior to being issued a
merchant mariner credential (MMC). In cases where the mariner does not
meet the medical standards in 46 CFR 10.215, the Coast Guard may issue
a waiver when extenuating circumstances exist that warrant special
consideration. See 46 CFR 10.215(g).
In NVIC 04-08, the Coast Guard states that anti-tachycardia devices
and ICDs are generally not waiverable. Since the issuance of NVIC 04-08
on September 15, 2008, a number of mariners have sought and received
waivers for anti-tachycardia devices or ICDs in accordance with 46 CFR
10.215(g). However, because NVIC 04-08 does not identify waiver
criteria associated with anti-tachycardia devices or ICDs, it has been
difficult for Coast Guard personnel to consistently evaluate merchant
mariners with anti-tachycardia devices or ICDs and assess whether an
applicant's medical condition warrants granting a medical waiver under
46 CFR 10.215(g). Accordingly, the Coast Guard is considering whether
to change its policy regarding waivers for anti-tachycardia devices or
ICDs, and under what criteria a mariner may be eligible for waiver
consideration.
The Coast Guard intends to consider public input as well as the
recommendations of the Merchant Mariner Medical Advisory Committee,
established under the authority of 46
[[Page 55175]]
U.S.C. 7115, prior to establishing a final policy on whether waivers
should be granted for anti-tachycardia devices or ICDs, and if so,
under what circumstances. Because of the complexity of the issues
involved, the Coast Guard intends to thoroughly analyze the issues
prior to issuing the final policy.
The Coast Guard specifically requests public comment on the
likelihood of an ICD inappropriately firing and whether that shock
could potentially incapacitate a merchant mariner. Additionally, the
Coast Guard seeks public comment on whether the criteria listed below
are appropriate and sufficient to evaluate whether a mariner should be
eligible for consideration for a medical waiver under 46 CFR 10.215(g).
Below is a series of 12 questions we are considering as the
criteria for granting a medical waiver. A review of the mariner's
record should lead the Coast Guard to answer ``no'' for each question
in order for the mariner to be eligible for waiver consideration. We
request public comment regarding whether the 12 questions below
represent an appropriate and sufficient list of the criteria a mariner
should be required to meet in order to be eligible for waiver
consideration, or whether we should eliminate or modify any of the
questions, or add other questions to the list.
(1) Does the mariner have a diagnosis of a cardiac channelopathy
affecting the electrical conduction of the heart (including Brugada
syndrome, Long QT syndrome, etc.)?
(2) Does the mariner have a prior history of ventricular
fibrillation or episodes of sustained ventricular tachycardia and, if
so, did the arrhythmia episode occur greater than three years ago?
(3) Was the ICD or anti-tachycardia device implanted more than
three years ago?
(4) Has the ICD fired or has the mariner required anti-tachycardia
pacing within the last three years?
(5) Does the mariner's condition present any confounding risk
factors for inappropriate shock such as uncontrolled atrial
fibrillation?
(6) Is the mariner's ejection fraction greater than 40% with a
steady or improving trend?
(7) Does the mariner have a history of any symptomatic or
clinically significant heart failure in the past two years?
(8) Does the mariner's record contain any evidence of significant
reversible ischemia on myocardial perfusion imaging exercise stress
testing?
(9) Has the mariner's exercise capacity been assessed to be greater
than or equal to 10 metabolic equivalents (METs)?
(10) Did the mariner provide a written opinion of the treating
cardiologist or electrophysiologist that supports a determination that
the mariner is at low risk for future arrhythmia, adverse cardiac event
or sudden incapacitation based upon objective testing and standard
evaluation tools?
(11) Does the mariner have any other medical conditions which may
alone, or in combination with an ICD or anti-tachycardia device, affect
the mariner's fitness?
(12) Is the mariner applying for an original credential, raise-in-
grade, or renewal of an existing credential?
Authority: We issue this request for public comments under the
authority of 5 U.S.C. 552(a).
Dated: August 13, 2012.
P.F. Thomas,
Captain, U.S. Coast Guard, Director of Inspections and Compliance.
[FR Doc. 2012-22006 Filed 9-6-12; 8:45 am]
BILLING CODE 9110-04-P