83 FR 58682 - Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD)

DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration

Federal Register Volume 83, Issue 224 (November 20, 2018)

Page Range		58682-58683
FR Document		2018-25281

FMCSA announces its decision to deny applications from four individuals treated with Implantable Cardioverter Defibrillators (ICDs) 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, dyspnea, collapse, or congestive heart failure.

Federal Register, Volume 83 Issue 224 (Tuesday, November 20, 2018)

[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Notices]
[Pages 58682-58683]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-25281]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0242]

Qualification of Drivers; Exemption Applications; Implantable
Cardioverter Defibrillator (ICD)

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of denials.

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SUMMARY: FMCSA announces its decision to deny applications from four
individuals treated with Implantable Cardioverter Defibrillators (ICDs)
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, dyspnea, collapse, or
congestive heart failure.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, (202) 366-4001, fmcsamedical@dot.gov, FMCSA,
Department of Transportation, 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 or submitting material to the docket,
contact Docket Services, telephone (202) 366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2018-0242, in the keyword box, and
click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document to review. If you do not have access to the
internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9
a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

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 www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

On August 15, 2018, FMCSA published a Federal Register notice (83
FR 40649) announcing receipt of applications from four individuals
treated with ICDs and requested comments from the public. These four
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 closed on September
14, 2018, and no comments were received.
FMCSA has evaluated the eligibility of these applicants and
concluded that granting these exemptions 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 the regulation 49 CFR
391.41(b)(4). A summary of each applicant's medical history related to
their ICD exemption request was discussed in the August 15, 2018,
Federal Register notice and will not be repeated in this notice.
In reaching the decision to deny these exemption requests, the
Agency considered information from the Cardiovascular Medical Advisory
Criteria, the April 2007 Evidence Report ``Cardiovascular Disease and
Commercial Motor Vehicle Driver Safety, a December 2014 focused

[[Page 58683]]

research report ``Implantable Cardioverter Defibrillators and the
Impact of a Shock in a Patient When Deployed.'' Copies of the reports
are included in the docket.
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. [Appendix A to Part
391--Medical Advisory Criteria, section D, paragraph 4]. The advisory
criteria for 49 CFR 391.41(b)(4) indicates that coronary artery bypass
surgery and pacemaker implantation are remedial procedures and thus,
not medically disqualifying. Implantable cardioverter defibrillators
are disqualifying due to risk of syncope.

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, FMCSA may grant an exemption if
it finds such an exemption would likely achieve a level of safety that
is equivalent to, or greater then, the level that would be achieved
absent such an exemption.
The Agency's decision regarding these exemption applications is
based on an individualized assessment of each applicant's medical
information provided by the applicant, available medical and scientific
data concerning ICD's, and 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 (a transient loss of consciousness) 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. See the April 2007 Evidence Report on Cardiovascular Disease and
Commercial Motor vehicle Driver Safety, April 2007.\1\ A focused
research report on Implantable Cardioverter Defibrillators and the
Impact of a Shock on a Patient When Deployed completed for the FMCSA
December 2014 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 and
upholds the findings of the April 2007 report.
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\1\ Now available at http://ntl.bts.gov/lib/30000/30100/30123/Final_CVD_Evidence_Report_v2.pdf.
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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 four applicants have
been denied exemptions from the physical qualification standards in 49
CFR 391.41(b)(4):

David Christiansen (IL)
Christopher G. Harville (SC)
Terry W. Meredith (TN)
Grady C. Stone (GA)

Each applicant has, prior to this notice, received a letter of
final disposition regarding his/her exemption request. Those decision
letters fully outlined the basis for the denial and constitutes final
action by the Agency. The list published today summarizes the Agency's
recent denials as required under 49 U.S.C. 31315(b)(4).

Issued on: November 9, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-25281 Filed 11-19-18; 8:45 am]
BILLING CODE 4910-EX-P

Federal Register / Vol. 83, No. 224 / Tuesday, November 20, 2018 / Notices 58683

research report ‘‘Implantable V. Conclusion dates stated in the discussions below
Cardioverter Defibrillators and the The Agency has determined that the and will expire on the dates stated in
Impact of a Shock in a Patient When available medical and scientific the discussions below. Comments must
Deployed.’’ Copies of the reports are literature and research provides be received on or before December 20,
included in the docket. insufficient data to enable the Agency to 2018.
FMCSA has published advisory conclude that granting these exemptions ADDRESSES: You may submit comments
criteria to assist medical examiners in would achieve a level of safety identified by the Federal Docket
determining whether drivers with equivalent to, or greater than, the level Management System (FDMS) Docket No.
certain medical conditions are qualified of safety maintained without the FMCSA–2014–0213; FMCSA–2015–
to operate a CMV in interstate exemption. Therefore, the following 0323 using any of the following
commerce. [Appendix A to Part 391— four applicants have been denied methods:
exemptions from the physical • Federal eRulemaking Portal: Go to
Medical Advisory Criteria, section D,
qualification standards in 49 CFR http://www.regulations.gov. Follow the
paragraph 4]. The advisory criteria for
391.41(b)(4): online instructions for submitting
49 CFR 391.41(b)(4) indicates that
David Christiansen (IL) comments.
coronary artery bypass surgery and • Mail: Docket Management Facility;
pacemaker implantation are remedial Christopher G. Harville (SC)
Terry W. Meredith (TN) U.S. Department of Transportation, 1200
procedures and thus, not medically New Jersey Avenue SE, West Building
disqualifying. Implantable cardioverter Grady C. Stone (GA)
Each applicant has, prior to this Ground Floor, Room W12–140,
defibrillators are disqualifying due to Washington, DC 20590–0001.
notice, received a letter of final
risk of syncope.
disposition regarding his/her exemption • Hand Delivery: West Building
III. Discussion of Comments request. Those decision letters fully Ground Floor, Room W12–140, 1200
outlined the basis for the denial and New Jersey Avenue SE, Washington,
FMCSA received no comments in this constitutes final action by the Agency. DC, between 9 a.m. and 5 p.m., ET,
proceeding. The list published today summarizes Monday through Friday, except Federal
the Agency’s recent denials as required Holidays.
IV. Basis for Exemption Determination • Fax: 1–202–493–2251.
under 49 U.S.C. 31315(b)(4). To avoid duplication, please use only
Under 49 U.S.C. 31136(e) and 31315, Issued on: November 9, 2018. one of these four methods. See the
FMCSA may grant an exemption if it Larry W. Minor, ‘‘Public Participation’’ portion of the
finds such an exemption would likely SUPPLEMENTARY INFORMATION section for
Associate Administrator for Policy.
achieve a level of safety that is instructions on submitting comments.
[FR Doc. 2018–25281 Filed 11–19–18; 8:45 am]
equivalent to, or greater then, the level
BILLING CODE 4910–EX–P FOR FURTHER INFORMATION CONTACT: Ms.
that would be achieved absent such an
Christine A. Hydock, Chief, Medical
exemption.
Programs Division, 202–366–4001,
The Agency’s decision regarding these DEPARTMENT OF TRANSPORTATION fmcsamedical@dot.gov, FMCSA,
exemption applications is based on an Department of Transportation, 1200
individualized assessment of each Federal Motor Carrier Safety New Jersey Avenue SE, Room W64–224,
applicant’s medical information Administration Washington, DC 20590–0001. Office
provided by the applicant, available [Docket No. FMCSA–2014–0213; FMCSA– hours are from 8:30 a.m. to 5 p.m., ET,
medical and scientific data concerning 2015–0323] Monday through Friday, except Federal
ICD’s, and public comments received. holidays. If you have questions
In the case of persons with ICDs, the Qualification of Drivers; Exemption regarding viewing or submitting
underlying condition for which the ICD Applications; Epilepsy and Seizure material to the docket, contact Docket
was implanted places the individual at Disorders Services, telephone (202) 366–9826.
high risk for syncope (a transient loss of AGENCY: Federal Motor Carrier Safety SUPPLEMENTARY INFORMATION:
consciousness) or other unpredictable Administration (FMCSA), DOT. I. Public Participation
events known to result in gradual or ACTION: Notice of renewal of
sudden incapacitation. ICDs may A. Submitting Comments
exemptions; request for comments.
discharge, which could result in loss of If you submit a comment, please
ability to safely control a CMV. See the SUMMARY: FMCSA announces its include the docket number for this
April 2007 Evidence Report on decision to renew exemptions for 12 notice (Docket Nos. FMCSA–2015–0323;
Cardiovascular Disease and Commercial individuals from the requirement in the FMCSA–2014–0213), indicate the
Motor vehicle Driver Safety, April Federal Motor Carrier Safety specific section of this document to
2007.1 A focused research report on Regulations (FMCSRs) that interstate which each comment applies, and
Implantable Cardioverter Defibrillators commercial motor vehicle (CMV) provide a reason for each suggestion or
and the Impact of a Shock on a Patient drivers have ‘‘no established medical recommendation. You may submit your
When Deployed completed for the history or clinical diagnosis of epilepsy comments and material online or by fax,
FMCSA December 2014 indicates that or any other condition which is likely mail, or hand delivery, but please use
the available scientific data on persons to cause loss of consciousness or any only one of these means. FMCSA
with ICDs and CMV driving does not loss of ability to control a CMV.’’ The recommends that you include your
support that persons with ICDs who exemptions enable these individuals name and a mailing address, an email
operate CMVs are able to meet an equal who have had one or more seizures and address, or a phone number in the body
or greater level of safety and upholds are taking anti-seizure medication to of your document so that FMCSA can
the findings of the April 2007 report. continue to operate CMVs in interstate contact you if there are questions
commerce. regarding your submission.
1 Now available at http://ntl.bts.gov/lib/30000/ DATES: Each group of renewed To submit your comment online, go to
30100/30123/Final_CVD_Evidence_Report_v2.pdf. exemptions were applicable on the http://www.regulations.gov, put the

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Document Created: 2018-11-20 07:59:55
Document Modified: 2018-11-20 07:59:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of denials.
Contact		Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001, [email protected], FMCSA, Department of Transportation, 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 or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.
FR Citation		83 FR 58682

83 FR 58682 - Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD)

DEPARTMENT OF TRANSPORTATIONFederal Motor Carrier Safety Administration

Federal Register Volume 83, Issue 224 (November 20, 2018)

DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration