Notice2023-14462
Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 10, 2023
Issuing agencies
Transportation DepartmentFederal Motor Carrier Safety Administration
Abstract
FMCSA announces its decision to deny the application from one individual 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.
Full Text
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<title>Federal Register, Volume 88 Issue 130 (Monday, July 10, 2023)</title>
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[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Notices]
[Pages 43643-43644]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14462]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2023-0042]
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 application from one
individual 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,
<a href="/cdn-cgi/l/email-protection#f1979c9282909c94959892909db1959e85df969e87"><span class="__cf_email__" data-cfemail="b6d0dbd5c5d7dbd3d2dfd5d7daf6d2d9c298d1d9c0">[email protected]</span></a>. 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 <a href="http://www.regulations.gov">www.regulations.gov</a>. Insert the docket
number (FMCSA-2023-0042) 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
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.
[[Page 43644]]
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 <a href="http://www.regulations.gov">www.regulations.gov</a>. As described in the system of records
notice DOT/ALL 14 (Federal Docket Management System), which can be
reviewed at <a href="https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices">https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices</a>, the comments are searchable by the name of
the submitter.
II. Background
On May 18, 2023, FMCSA published a Federal Register notice (88 FR
31842) announcing receipt of one application from an individual treated
with an ICD and requested comments from the public. The individual
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 June 20,
2023, and no comments were received.
FMCSA has evaluated the eligibility of the applicant 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 the
applicant's medical history related to their ICD exemption request was
discussed in the May 18, 2023, Federal Register notice (88 FR 31842)
requesting comments and will not be repeated here.
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 <a href="https://rosap.ntl.bts.gov/view/dot/16462">https://rosap.ntl.bts.gov/view/dot/16462</a>.
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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 <a href="https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf">https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf</a>.
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III. Discussion of Comments
FMCSA received no comments in this proceeding.
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 this exemption application 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 this exemption would achieve a level of
safety equivalent to, or greater than, the level of safety maintained
without the exemption. Therefore, Nicholas Steffler (NC) has been
denied an exemption from the physical qualification standards in Sec.
391.41(b)(4).
The applicant has, 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 constitutes final action by
the Agency. The name of this individual published today summarizes the
Agency's recent denial as required under 49 U.S.C. 31315(b)(4).
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-14462 Filed 7-7-23; 8:45 am]
BILLING CODE 4910-EX-P
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