Notice2021-15739
Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD)
Primary source
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Published
July 23, 2021
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 86 Issue 139 (Friday, July 23, 2021)</title>
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[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39099-39100]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15739]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2021-0036]
Qualification of Drivers; Exemption Applications; Implantable
Cardioverter Defibrillator (ICD)
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).
ACTION: Notice of denial.
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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, (202) 366-4001, <a href="/cdn-cgi/l/email-protection#aec8c3cdddcfc3cbcac7cdcfc2eecac1da80c9c1d8"><span class="__cf_email__" data-cfemail="d9bfb4baaab8b4bcbdb0bab8b599bdb6adf7beb6af">[email protected]</span></a>, FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. 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-2021-0036, 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 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. 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 FDMS), which can be reviewed at
<a href="http://www.transportation.gov/privacy">www.transportation.gov/privacy</a>.
II. Background
On February 9, 2021, FMCSA published a Federal Register notice (86
FR 8830) announcing receipt of an application from one 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 closed on March 11,
2021, and one comment was 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 the ICD exemption request was
discussed in the February 9, 2021, Federal Register notice 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 one comment in this proceeding. The comment was from
a private citizen who did not support granting the exemption. The
individual disagreed that granting an exemption for an ICD would ensure
the safety of the driver and local pedestrians.
FMCSA evaluates each ICD application received to determine whether
an equivalent or greater level of safety can be achieved by the
applicant. While FMCSA has received and carefully evaluated many ICD
exemption application requests, thus far the Agency has been unable to
conclude that granting an exemption to any of the applicants would
achieve a level of safety equivalent to, or greater than, the level of
safety maintained without an exemption.
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
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individualized assessment of the applicant's 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.
IV. 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, the following applicant has been
denied an exemption from the physical qualification standards in Sec.
391.41(b)(4):
Matthew Wackt (WI)
The applicant has, prior to this notice, received a letter of final
disposition regarding his exemption request. The decision letter fully
outlined the basis for the denial and constitute final action by the
Agency. The name of the individual 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. 2021-15739 Filed 7-22-21; 8:45 am]
BILLING CODE 4910-EX-P
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