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Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD) Publication: Federal Register Agency: Federal Motor Carrier Safety Administration Byline: Larry W. Minor Date: 6 April 2023 Subject: American Government 
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[Federal Register Volume 88, Number 66 (Thursday, April 6, 2023)]
[Notices]
[Pages 20606-20607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07192]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2023-0041]
Qualification of Drivers; Exemption Applications; Implantable
Cardioverter Defibrillator (ICD)
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).
ACTION: Notice of denials.
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SUMMARY: FMCSA announces its decision to deny the applications from
four individuals treated with an Implantable Cardioverter Defibrillator
(ICD) who requested an exemption from the Federal Motor Carrier Safety
Regulations (FMCSRs) prohibiting operation of a commercial motor
vehicle (CMV) in interstate commerce by persons with a current clinical
diagnosis of myocardial infarction, angina pectoris, coronary
insufficiency, thrombosis, or any other cardiovascular disease of a
variety known to be accompanied by syncope (transient loss of
consciousness), dyspnea (shortness of breath), collapse, or congestive
heart failure.
FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room
W64-224, Washington, DC 20590-0001, (202) 366-4001,
fmcsamedical@dot.gov. Office hours are from 8:30 a.m. to 5 p.m. ET
Monday through Friday, except Federal holidays. If you have questions
regarding viewing materials in the docket, contact Dockets Operations,
(202) 366-9826.
SUPPLEMENTARY INFORMATION:
I. Public Participation
A. Viewing Comments
To view comments go to www.regulations.gov. Insert the docket
number (FMCSA-2023-0041) in the keyword box and click ``Search.'' Next,
sort the results by ``Posted (Newer-Older),'' choose the first notice
listed, and click ``Browse Comments.'' If you do not have access to the
internet, you may view the docket online by visiting Dockets Operations
in Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m.
ET Monday through Friday, except Federal holidays. To be sure someone
is there to help you, please call (202) 366-9317 or (202) 366-9826
before visiting Dockets Operations.
B. Privacy Act
In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption requests. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov. As described in the system of records
notice DOT/ALL 14 (Federal Docket Management System), which can be
reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices, the comments are searchable by the name of
the submitter.
II. Background
On February 13, 2023, FMCSA published a notice announcing receipt
of applications from four individuals treated with ICDs and requested
comments from the public (88 FR 9318). The individuals requested an
exemption from 49 CFR 391.41(b)(4) which prohibits operation of a CMV
in interstate commerce by persons with a current clinical diagnosis of
myocardial infarction, angina pectoris, coronary insufficiency,
thrombosis, or any other cardiovascular disease of a variety known to
be accompanied by syncope, dyspnea, collapse, or congestive heart
failure. The public comment period ended on March 15, 2023, and one
comment was received.
FMCSA has evaluated the eligibility of the applicants and concluded
that granting an exemption would not provide a level of safety that
would be equivalent to, or greater than, the level of safety that would
be obtained by complying with Sec. 391.41(b)(4). A summary of each
applicant's medical history related to their ICD exemption request was
discussed in the February 13, 2023, Federal Register notice (88 FR
9318), and will not be repeated here.
[[Page 20607]]
The Agency's decision regarding this exemption application is based
on information from the Cardiovascular Medical Advisory Criteria, an
April 2007 evidence report titled ``Cardiovascular Disease and
Commercial Motor Vehicle Driver Safety,'' \1\ and a December 2014
focused research report titled ``Implantable Cardioverter
Defibrillators and the Impact of a Shock in a Patient When Deployed.''
Copies of these reports are included in the docket.
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\1\ The report is available on the internet at https://rosap.ntl.bts.gov/view/dot/16462.
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FMCSA has published advisory criteria to assist medical examiners
in determining whether drivers with certain medical conditions are
qualified to operate a CMV in interstate commerce.\2\ The advisory
criteria for Sec. 391.41(b)(4) indicates that coronary artery bypass
surgery and pacemaker implantation are remedial procedures and thus,
not medically disqualifying. ICDs are disqualifying due to risk of
syncope.
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\2\ These criteria may be found in 49 CFR part 391, APPENDIX A
TO PART 391--MEDICAL ADVISORY CRITERIA, section D. Cardiovascular:
Sec. 391.41(b)(4), paragraph 4, which is available on the internet
at https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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III. Discussion of Comments
FMCSA received one comment in this proceeding. The comment was from
a cardiovascular specialty nurse. The commenter indicated that a review
of the applicant's ``clinical presentation and health status'' is more
important to consider rather than just the physical presence of an ICD,
suggesting that a decision on whether to grant an exemption should be
made on an individualized basis considering those factors.
As stated in this notice in the section below, FMCSA evaluates each
exemption application on an individualized basis considering all
medical information to include what is provided by the applicant,
available medical and scientific data concerning ICDs, and any relevant
public comments received. Not only does FMCSA consider the physical
presence of an ICD, but also the underlying condition for which the ICD
was implanted that places the individual at high risk for loss of
ability to operate a CMV.
IV. Basis for Exemption Determination
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption.
The Agency's decision regarding these exemption applications is
based on an individualized assessment of the applicants' medical
information, available medical and scientific data concerning ICDs, and
any relevant public comments received.
In the case of persons with ICDs, the underlying condition for
which the ICD was implanted places the individual at high risk for
syncope or other unpredictable events known to result in gradual or
sudden incapacitation. ICDs may discharge, which could result in loss
of ability to safely control a CMV. The December 2014 focused research
report referenced previously upholds the findings of the April 2007
report and indicates that the available scientific data on persons with
ICDs and CMV driving does not support that persons with ICDs who
operate CMVs are able to meet an equal or greater level of safety.
V. Conclusion
The Agency has determined that the available medical and scientific
literature and research provides insufficient data to enable the Agency
to conclude that granting these exemptions would achieve a level of
safety equivalent to, or greater than, the level of safety maintained
without the exemption. Therefore, the following applicants have been
denied an exemption from the physical qualification standards in Sec.
391.41(b)(4):
Kevin Coughlin (MA)
Charles Halepakis (MA)
Antonio Maceroni (MI)
Michael Wilson (FL)
The applicants have, prior to this notice, received a letter of
final disposition regarding their exemption request. The decision
letter fully outlined the basis for the denial and constitute final
action by the Agency. The names of these individuals published today
summarizes the Agency's recent denials as required under 49 U.S.C.
31315(b)(4).
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-07192 Filed 4-5-23; 8:45 am]
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