Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD), 20606-20607 [2023-07192]

Agencies

• Federal Motor Carrier Safety Administration
• DEPARTMENT OF TRANSPORTATION

[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, 
[email protected]. 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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