83 FR 2291 - Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD)

DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration

Federal Register Volume 83, Issue 10 (January 16, 2018)

Page Range		2291-2292
FR Document		2018-00560

FMCSA announces its decision to deny applications from two 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 10 (Tuesday, January 16, 2018)

[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Pages 2291-2292]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00560]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2017-0116]


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 two 
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, [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.

SUPPLEMENTARY INFORMATION: 

I. Electronic Access

    You may see all the comments online through the Federal Document 
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or 
comments, go to http://www.regulations.gov and/or Room W12-140 on the 
ground level of the West Building, 1200 New Jersey Avenue SE, 
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday, 
except Federal holidays.
    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 http://www.regulations.gov, as described in 
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed 
at http://www.dot.gov/privacy.

II. Background

    On May 4, 2017, FMCSA published a FR notice (82 FR 20961) 
announcing receipt of applications from two individuals treated with 
ICDs and requested comments from the public. These two 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 June 5, 
2017, and two 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 May 4, 2017, 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 
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 two comments in this proceeding. Each of the 
comments was favorable towards the applicants continuing to drive CMV's 
with ICD's citing their ICDs have not deployed and their medical and 
physical conditions are stable. FMCSA acknowledges the commenters' 
responses concerning stable medical histories with ICDs. Based on the 
available medical literature cited above, however, FMCSA believes that 
a driver with an ICD is at risk for incapacitation if the device 
discharges. This risk is combined with the risks associated with the 
underlying cardiovascular condition for which the

[[Page 2292]]

ICD has been implanted as a primary or secondary preventive measure.

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 ICDs, 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 two applicants have 
been denied exemptions from the physical qualification standards in 49 
CFR 391.41(b)(4):

Justin D. Dale (IA)
Raymond M. Loffredo (PA)

    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: January 5, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-00560 Filed 1-12-18; 8:45 am]
 BILLING CODE 4910-EX-P

2292 Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices

ICD has been implanted as a primary or the Agency’s recent denials as required comments, go to http://
secondary preventive measure. under 49 U.S.C. 31315(b)(4). www.regulations.gov at any time or
Issued on: January 5, 2018. Room W12–140 on the ground level of
IV. Basis for Exemption Determination
Larry W. Minor,
the West Building, 1200 New Jersey
Under 49 U.S.C.31136(e) and 31315, Avenue SE, Washington, DC, between 9
Associate Administrator for Policy.
FMCSA may grant an exemption if it a.m. and 5 p.m., ET, Monday through
finds such an exemption would likely [FR Doc. 2018–00560 Filed 1–12–18; 8:45 am]
Friday, except Federal holidays. The
achieve a level of safety that is BILLING CODE 4910–EX–P FDMS is available 24 hours each day,
equivalent to, or greater then, the level 365 days each year. If you want
that would be achieved absent such an acknowledgment that we received your
exemption. DEPARTMENT OF TRANSPORTATION
comments, please include a self-
The Agency’s decision regarding these Federal Motor Carrier Safety addressed, stamped envelope or
exemption applications is based on an Administration postcard or print the acknowledgement
individualized assessment of each page that appears after submitting
applicant’s medical information [Docket No. FMCSA–2017–0027] comments online.
provided by the applicant, available Privacy Act: In accordance with 5
medical and scientific data concerning Qualification of Drivers; Exemption U.S.C. 553(c), DOT solicits comments
ICDs, and public comments received. Applications; Vision from the public to better inform its
In the case of persons with ICDs, the AGENCY: Federal Motor Carrier Safety rulemaking process. DOT posts these
underlying condition for which the ICD Administration (FMCSA), DOT. comments, without edit, including any
was implanted places the individual at ACTION: Notice of applications for personal information the commenter
high risk for syncope (a transient loss of exemption; request for comments. provides, to http://www.regulations.gov,
consciousness) or other unpredictable as described in the system of records
events known to result in gradual or SUMMARY: FMCSA announces receipt of notice (DOT/ALL–14 FDMS), which can
sudden incapacitation. ICDs may applications from 14 individuals for an be reviewed at http://www.dot.gov/
discharge, which could result in loss of exemption from the vision requirement privacy.
ability to safely control a CMV. See the in the Federal Motor Carrier Safety FOR FURTHER INFORMATION CONTACT: Ms.
April 2007 Evidence Report on Regulations (FMCSRs) to operate a Christine A. Hydock, Chief, Medical
Cardiovascular Disease and Commercial commercial motor vehicle (CMV) in Programs Division, (202) 366–4001,
Motor vehicle Driver Safety, April interstate commerce. If granted, the fmcsamedical@dot.gov, FMCSA,
2007.1 A focused research report on exemptions will enable these Department of Transportation, 1200
Implantable Cardioverter Defibrillators individuals to operate CMVs in New Jersey Avenue SE, Room W64–224,
and the Impact of a Shock on a Patient interstate commerce without meeting Washington, DC 20590–0001. Office
When Deployed completed for the the vision requirement in one eye. hours are 8:30 a.m. to 5 p.m., ET,
FMCSA December 2014 indicates that DATES: Comments must be received on Monday through Friday, except Federal
the available scientific data on persons or before February 15, 2018. holidays. If you have questions
with ICDs and CMV driving does not regarding viewing or submitting
ADDRESSES: You may submit comments
support that persons with ICDs who material to the docket, contact Docket
bearing the Federal Docket Management
operate CMVs are able to meet an equal Services, telephone (202) 366–9826.
System (FDMS) Docket No. FMCSA–
or greater level of safety and upholds
2017–0027 using any of the following SUPPLEMENTARY INFORMATION:
the findings of the April 2007 report.
methods:
V. Conclusion • Federal eRulemaking Portal: Go to I. Background
http://www.regulations.gov. Follow the Under 49 U.S.C. 31136(e) and 31315,
The Agency has determined that the
online instructions for submitting FMCSA may grant an exemption from
available medical and scientific
comments. the FMCSRs for a five-year period if it
literature and research provides
• Mail: Docket Management Facility; finds ‘‘such exemption would likely
insufficient data to enable the Agency to
U.S. Department of Transportation, 1200 achieve a level of safety that is
conclude that granting these exemptions
New Jersey Avenue SE, West Building equivalent to or greater than the level
would achieve a level of safety
Ground Floor, Room W12–140, that would be achieved absent such
equivalent to, or greater than, the level
Washington, DC 20590–0001. exemption.’’ The statute also allows the
of safety maintained without the
• Hand Delivery: West Building Agency to renew exemptions at the end
exemption. Therefore, the following two
Ground Floor, Room W12–140, 1200 of the five-year period. FMCSA grants
applicants have been denied
New Jersey Avenue SE, Washington, exemptions from the FMCSRs for a two-
exemptions from the physical
DC, between 9 a.m. and 5 p.m., ET, year period to align with the maximum
qualification standards in 49 CFR
Monday through Friday, except Federal duration of a driver’s medical
391.41(b)(4):
Holidays. certification.
Justin D. Dale (IA) • Fax: 1–202–493–2251. The 14 individuals listed in this
Raymond M. Loffredo (PA) Instructions: Each submission must notice have requested an exemption
Each applicant has, prior to this include the Agency name and the from the vision requirement in 49 CFR
notice, received a letter of final docket number(s) for this notice. Note 391.41(b)(10). Accordingly, the Agency
disposition regarding his/her exemption that all comments received will be will evaluate the qualifications of each
daltland on DSKBBV9HB2PROD with NOTICES

request. Those decision letters fully posted without change to http:// applicant to determine whether granting
outlined the basis for the denial and www.regulations.gov, including any an exemption will achieve the required
constitutes final action by the Agency. personal information provided. Please level of safety mandated by statute.
The list published today summarizes see the Privacy Act heading below for The physical qualification standard
further information. for drivers regarding vision found in 49
1 Now available at http://ntl.bts.gov/lib/30000/ Docket: For access to the docket to CFR 391.41(b)(10) states that a person is
30100/30123/Final_CVD_Evidence_Report_v2.pdf. read background documents or physically qualified to drive a CMV if

VerDate Sep<11>2014 22:48 Jan 12, 2018 Jkt 244001 PO 00000 Frm 00162 Fmt 4703 Sfmt 4703 E:\FR\FM\16JAN1.SGM 16JAN1

Document Created: 2018-01-13 02:02:26
Document Modified: 2018-01-13 02:02:26

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 2291

83 FR 2291 - Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD)

DEPARTMENT OF TRANSPORTATIONFederal Motor Carrier Safety Administration

Federal Register Volume 83, Issue 10 (January 16, 2018)

DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration