[Federal Register Volume 90, Number 85 (Monday, May 5, 2025)]
[Notices]
[Pages 19072-19073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07770]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2024-0004]
Qualification of Drivers; Exemption Applications; Implantable
Cardioverter Defibrillator (ICD)
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).
ACTION: Notice of final disposition.
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SUMMARY: FMCSA announces its decision to deny the applications of two
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-2024-0004) 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.
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,
including any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice DOT/
ALL-14 FDMS (Federal Docket Management System), which can be reviewed
at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices. The comments are posted without edit and are
searchable by the name of the submitter.
II. Legal Basis
FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant
exemptions from Federal Motor Carrier Safety Regulations (FMCSRs).
FMCSA must publish a notice of each exemption request in the Federal
Register (49 CFR 381.315(a)). The Agency must provide the public an
opportunity to inspect the information relevant to the application,
including the applicant's safety analysis. The Agency must provide an
opportunity for public comment on the request.
The Agency reviews the application, safety analyses, and public
comments submitted and determines whether granting the exemption would
likely achieve a level of safety equivalent to, or greater than, the
level that would be achieved absent such exemption, pursuant to the
standard set forth in 49 U.S.C. 31315(b)(1). The Agency must publish
its decision in the Federal Register (49 CFR 381.315(b)). If granted,
the notice will identify the regulatory provision from which the
applicant will be exempt the effective period, and all terms and
conditions of the exemption (49 CFR 381.315(c)(1)). If the exemption is
denied, the notice will explain the reason for the denial (49 CFR
381.315(c)(2)). The exemption may be renewed (49 CFR 381.300(b)). FMCSA
grants medical exemptions from the FMCSRs for a 2-year period to align
with the maximum duration of a driver's medical certification.
III. Background
The physical qualification standard for drivers regarding
cardiovascular diseases and loss of consciousness provides that a
person is physically qualified to drive a CMV if that person has ``no
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 cardiac failure'' (49 CFR 391.41(b)(4)). To assist in
applying this standard, FMCSA publishes guidance for medical examiners
(ME) in the form of medical advisory criteria in appendix A to 49 CFR
part 391.\1\ The advisory criteria for Sec. 391.41(b)(4) indicates
that ICDs are installed to address an ongoing underlying cardiovascular
condition and that syncope or collapse is likely to occur as a result
of both the underlying cardiovascular condition as well as when the
ICDs discharge. Therefore, ICDs are medically disqualifying. In April
2007, FMCSA published an evidence report titled, ``Cardiovascular
Disease and Commercial Motor Vehicle Driver Safety,'' presenting
findings regarding cardiovascular disease and CMV driver safety.\2\ In
December 2014, FMCSA published a research report titled, ``Implantable
Cardioverter Defibrillators and the Impact of a Shock in a Patient When
Deployed,'' that provided evidence regarding the potential impact of
ICD deployment and how it may interfere with the safe operation of a
CMV.\3\
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\1\ 49 CFR part 391, app.A.II.C, available at https://www.ecfr.gov/current/title-49/subtitle-B/chapter-III/subchapter-B/part-391/appendix-Appendix%20A%20to%20Part%20391.
\2\ ``Evidence Report: Cardiovascular Disease'' (Apr. 27, 2007),
available at https://doi.org/10.21949/1502991.
\3\ ``Implantable Cardio Defibrillators and the Impact of a
Shock to the Patient when Deployed Research White Paper'' (Dec. 17,
2014), available at https://www.fmcsa.dot.gov/sites/fmcsa.dot.gov/files/2021-06/Cardio%20Defibrillators%20White%20Paper_Final_508C.pdf.
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The Agency considers the medical advisory criteria, the April 2007
evidence report, the December 2014 research report, the application,
and each individual's medical information in deciding whether to grant
the exemption.
On January 15, 2025, FMCSA published a notice announcing receipt of
applications from two individuals requesting an exemption from 49 CFR
391.41(b)(4) and requested comments from the public (90 FR 3997). The
public comment period ended on February 14, 2025, and no comments were
received.
IV. Discussion of Comments
FMCSA received no comments in this proceeding.
[[Page 19073]]
V. Basis for Exemption Determination
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 the conclusion that persons with
ICDs are able to meet an equivalent or greater level of safety in
operating a CMV as persons without those devices.
VI. 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 likely 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):
Micos Mims (AL) and Paul Siefker (OH).
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 constitutes 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. 2025-07770 Filed 5-2-25; 8:45 am]
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