Qualification of Drivers; Exemption Applications; Narcolepsy, 11863-11865 [2019-05949]
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Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Notices
maintenance, rehabilitation, and
replacement of underground pipe and
cable for the telecom, oil, electricity,
gas, water, and wastewater industries.
Its family of companies includes Ditch
Witch®, Subsite® Electronics, DW/
TXS®, HammerHead®, Radius® HDD,
American Augers®, Trencor® and MTI®
Equipment. CMW designs,
manufactures and sells a range of
products to cover the full life-cycle of
underground pipe and cable, including
horizontal directional drills, walk and
ride trenchers, utility loaders, vacuum
excavators, asset locators, pipe
rehabilitation solutions and after-market
tools.
Some of the equipment designed and
manufactured by CMW utilize small,
commercially available internal
combustion engines to power auxiliary
equipment that is permanently mounted
on a CMV. CMW states that while
auxiliary equipment that is permanently
mounted to CMVs is considered part of
the CMV and subject to the
requirements of 49 CFR 393.65(d), it
‘‘has identified that currently there is
uneven roadside enforcement with
regard to the use of gravity fed fuel
tanks on auxiliary equipment installed
on or used in connection with
commercial motor vehicles.’’
In support of its application, CMW
states:
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Most small commercially available internal
combustion engines used on auxiliary
equipment are equipped from the factory
with gravity fed fuel tanks attached to the
engine . . . The cost of modifying these
small internal combustion engines to remove
the fuel tank from the engine and to reengineer the fuel delivery system to use a
fuel pump to pump fuel from the now
removed fuel tank to the internal combustion
engine requires electrical wiring to be run
from the commercial motor vehicle to operate
the fuel pump. Manufacturers who have gone
to this additional expense, question the
reasoning of removing the fuel tank from
above the engine and placing it beside the
engine and equipping the system with a fuel
pump to transfer fuel from the tank to the
engine. Since the auxiliary equipment only
operates when the CMV is not operating on
the highway there does not seem to be any
legitimate safety reason for this requirement.
A review of previous Federal Register
notices does not describe why this
requirement was added for fuel systems for
auxiliary equipment on commercial motor
vehicles, when this equipment is not
operating while the CMV is operating on the
highway.
The exemption would permit CMW
and all other CMV operators to utilize
auxiliary equipment with gravity fed
fuel systems when the CMV is not
operating on the highway. CMW
believes that granting the temporary
exemption will maintain a level of
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18:57 Mar 27, 2019
Jkt 247001
safety that is equivalent to or greater
than the level of safety achieved without
the exemption because the auxiliary
equipment will not be operating while
the CMV is operating on the highway.
CMW ‘‘believes that because the engine
on the auxiliary equipment will not be
operating while the CMV is traveling on
the highway, so the potential risk of
gravity fed fuel systems leaking on a hot
or operating engine will not be possible,
thereby eliminating the possibility of
fire from the auxiliary equipment.’’
Request for Comments
In accordance with 49 U.S.C. 31315
and 31136(e), FMCSA requests public
comment from all interested persons on
CMW’s application for an exemption
from the requirements of 49 CFR
393.65(d). All comments received before
the close of business on the comment
closing date indicated at the beginning
of this notice will be considered and
will be available for examination in the
docket at the location listed under the
ADDRESSES section of this notice.
Comments received after the comment
closing date will be filed in the public
docket and will be considered to the
extent practicable. In addition to late
comments, FMCSA will also continue to
file, in the public docket, relevant
information that becomes available after
the comment closing date. Interested
persons should continue to examine the
public docket for new material.
Issued on: March 21, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019–05952 Filed 3–27–19; 8:45 am]
11863
an exemption from the hours-of-service
electronic logging device rule. Due to an
error, the name of the first applicant
listed in that publication was twice
misstated. This notice makes it clear
that the name of the first applicant is
Power & Communication Contractors
Association.
DATES: Applicable on December 7, 2018.
FOR FURTHER INFORMATION CONTACT: For
information concerning this notice,
contact Ms. Pearlie Robinson, FMCSA
Driver and Carrier Operations Division;
Office of Carrier, Driver and Vehicle
Safety Standards; Telephone: (202) 366–
4225. Email: MCPSD@dot.gov. If you
have questions on viewing or submitting
material to the docket, contact Docket
Services, telephone (202) 366–9826.
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of December 7,
2018, correct page 63194 as follows: In
the first column, correct the name of the
first applicant listed in the Summary
second sentence to read ‘‘Power &
Communication Contractors
Association.’’ In the third column,
correct the subheading to read, ‘‘Power
& Communication Contractors
Association.’’
Issued on: March 20, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019–05951 Filed 3–27–19; 8:45 am]
BILLING CODE 4910–EX–P
DEPARTMENT OF TRANSPORTATION
BILLING CODE 4910–EX–P
Federal Motor Carrier Safety
Administration
DEPARTMENT OF TRANSPORTATION
[Docket No. FMCSA–2018–0320]
Federal Motor Carrier Safety
Administration
Qualification of Drivers; Exemption
Applications; Narcolepsy
[Dockets No. FMCSA–2017–0243, FMCSA–
2017–0296, FMCSA–2017–0337, FMCSA–
2017–0340, FMCSA–2017–0342, FMCSA–
2017–0356, FMCSA–2017–0361, FMCSA–
2017–0373, FMCSA–2018–0003, FMCSA–
2017–0336]
AGENCY:
Hours of Service (HOS) of Drivers;
Applications for Exemption From the
Electronic Logging Device Rule
Federal Motor Carrier Safety
Administration (FMCSA), DOT.
ACTION: Notice of final disposition:
Denial of applications for exemption;
correction.
AGENCY:
The Federal Motor Carrier
Safety Administration published its
decision in the Federal Register of
December 7, 2018, to deny 10 applicants
SUMMARY:
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Frm 00125
Fmt 4703
Sfmt 4703
Federal Motor Carrier Safety
Administration (FMCSA), DOT.
ACTION: Notice of denial.
FMCSA announces its
decision to deny the application from
one individual 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 either a
clinical diagnosis of epilepsy or any
other condition that is likely to cause a
loss of consciousness or any loss of
ability to control a CMV, or a mental,
nervous, organic, or functional disease
or psychiatric disorder likely to interfere
with his/her ability to drive a
commercial motor vehicle safely.
SUMMARY:
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28MRN1
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Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Notices
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:
FOR FURTHER INFORMATION CONTACT:
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
https://www.regulations.gov. Insert the
docket number, FMCSA–2018–0320, 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.
amozie on DSK9F9SC42PROD with NOTICES
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 November 27, 2018, FMCSA
published a FR notice (83 FR 60953)
announcing receipt of an application
from one individual with a diagnosis of
narcolepsy and requested comments
from the public. This individual
requested an exemption from 49 CFR
391.41(b)(8), which prohibits operation
of a CMV in interstate commerce by
persons with either a clinical diagnosis
of epilepsy or any other condition that
is likely to cause a loss of consciousness
or any loss of ability to control a CMV,
and 49 CFR 391.41(b)(9) a mental,
nervous, organic, or functional disease
or psychiatric disorder likely to interfere
with his/her ability to drive a CMV
safely. The public comment period
closed on December 27, 2018. Four
comments were received in response to
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18:57 Mar 27, 2019
Jkt 247001
this proceeding. Of the four comments
received, two were duplicate comments
received from the applicant, and one
comment was received from a private
citizen. These commenters were in
support of granting an exemption based
on the applicant’s driving history. The
fourth commenter, the American
Academy of Sleep Medicine (AASM)
commented that the Agency should not
grant an exemption for narcolepsy and
outlined nine specific reasons for their
non-support. Details of the AASM’s
comments may be found in the docket
under the comments section.
FMCSA has evaluated the eligibility
of this applicant and concluded that
granting the 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 the regulation 49 CFR
391.41(b)(8) and (b)(9).
In reaching the decision to deny these
exemption requests, the Agency
considered information from the 2009
Evidence Report, ‘‘Narcolepsy (with and
without cataplexy) and Commercial
Motor Vehicle Driver Safety 1,’’ and the
January 2010 Medical Review Board
(MRB) Recommendation 2 that
individuals with narcolepsy be
ineligible for a commercial driver’s
license, even with treatment. A copy of
the Evidence Report is included in the
docket.
III. Basis for Exemption Determination
Under 49 U.S.C. 31136(e) and
31315(b), FMCSA may grant an
exemption from the FMCSRs if the
exemption is likely to 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 each
applicant’s medical information
provided by the applicant, available
medical and scientific data concerning
narcolepsy, and public comments
received. As discussed in the
background section, the Agency
considered information from the 2009
Evidence Report, ‘‘Narcolepsy (with and
without cataplexy) and Commercial
Motor Vehicle Driver Safety,’’ and the
January 2010 recommendation that
individuals with narcolepsy be
ineligible for a commercial driver’s
license, even with treatment.
1 Evidence Report: Narcolepsy (with and without
cataplexy) and Commercial Motor Vehicle Driver
Safety; October 6, 2009.
2 Medical Review Board Meeting; January 6, 2010;
www.mrb.fmcsa.dot.gov/documents/Final_Jan_6_
2010_MRB_Meeting_Summary.pdf.
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Fmt 4703
Sfmt 4703
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. [49 CFR part 391,
APPENDIX A TO PART 391—MEDICAL
ADVISORY CRITERIA, section H.
Epilepsy: § 391.41(b)(8), paragraphs 3, 4,
and 5.] The advisory criteria for 49 CFR
391.41(b)(8), indicates that if an
individual has had a sudden episode of
a non-epileptic seizure or loss of
consciousness of unknown cause that
did not require anti-seizure medication,
the decision whether that person’s
condition is likely to cause the loss of
consciousness or loss of ability to
control a CMV should be made on an
individual basis by the medical
examiner in consultation with the
treating physician.
In those individual cases where a
driver had a seizure or an episode of
loss of consciousness that resulted from
a known medical condition (e.g., drug
reaction, high temperature, acute
infectious disease, dehydration, or acute
metabolic disturbance), certification
should be deferred until the driver has
fully recovered from that condition, has
no existing residual complications, and
is not taking anti-seizure medication.
The advisory criteria for 49 CFR
391.41(b)(9), indicates that a variety of
functional disorders can cause
drowsiness, dizziness, confusion,
weakness or paralysis that may lead to
incoordination, inattention, loss of
functional control and susceptibility to
accidents while driving.
Narcolepsy is a chronic neurological
disorder caused by autoimmune
destruction of hypocretin-producing
neurons inhibiting the brain’s ability to
regulate sleep-wake cycles normally.
Persons with narcolepsy experience
frequent excessive daytime sleepiness,
comparable to how non-narcoleptics
feel after 24 to 48 hours of sleep
deprivation, as well as disturbed
nocturnal sleep, which is often confused
with insomnia. See National Institutes
of Health (NIH) Narcolepsy Fact Sheet at
www.ninds.nih.gov/disorders/
narcolepsy/detail_narcolepsy.htm.
The 2009 Evidence Report,
‘‘Narcolepsy (with and without
cataplexy) and Commercial Motor
Vehicle Driver Safety,’’ addressed
whether or not individuals with
narcolepsy are at an increased risk for
motor vehicle crashes; whether or not
currently recommended treatments for
narcolepsy reduce the risk for motor
vehicle crashes; and the impact of
various medication therapies for
narcolepsy on driver safety.
E:\FR\FM\28MRN1.SGM
28MRN1
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Federal Register / Vol. 84, No. 60 / Thursday, March 28, 2019 / Notices
The evidence report reviewed studies
from the available literature and
evaluated outcomes on measures of
Excessive Daytime Sleepiness (EDS),
cataplexy, event rate, measures of
cognitive and psychomotor function,
and driving performance. The currently
available direct and indirect evidence
support the contention that drivers with
narcolepsy are at an increased risk for
a motor vehicle crash when compared to
otherwise similar individuals who do
not have the disorder. The direct
evidence from three crash studies
conducted of non-CMV drivers showed
that individuals with narcolepsy are at
an increased risk for a crash compared
to individuals who do not have
narcolepsy. The indirect evidence from
studies of driving tests and driving
simulation examined factors associated
with simulated driving outcomes such
as driving performance, tracking error,
fewer correct responses, and more
instances of going out of bounds
compared to healthy controls. While
there are limitations in the quality of the
studies that examined direct crash risk,
both the direct and indirect studies
showed a strong effect size and
statistical significance. The American
Academy of Sleep Medicine (AASM)
and the European Federation of
Neurological Societies recommend
modafinil as the first treatment option
and methylphenidate as the second
treatment option. The AASM also
recommends amphetamine,
methamphetamine, or
dextroamphetamine as alternative
treatments. During literature searches,
no studies that directly examined the
impact of treatment with modafinil,
armodafinil, sodium oxybate (used with
narcolepsy with cataplexy), or antidepressants on crash risk or driving
performance were identified. Therefore,
conclusions regarding treatment with
these medications on crash risk and
driving performance could not be made.
Currently available evidence suggests
that amphetamines and/or
methylphenidate are effective in
improving symptoms of EDS in
individuals with narcolepsy (quality of
studies range from ‘‘moderate to low’’).
However, these improvements do not
result in levels of daytime sleepiness
that can be considered to be normal in
the vast majority of individuals.
Therefore, conclusions regarding to the
impact of treatment with amphetamines,
methylphenidate, or other related
stimulant drugs on cognitive and
psychomotor function among
individuals with narcolepsy could not
be made.
In January 2010, the FMCSA’s MRB
recommended that individuals with
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18:57 Mar 27, 2019
Jkt 247001
narcolepsy be ineligible for a
commercial driver’s license, even with
treatment.
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 these exemptions
would achieve a level of safety
equivalent to, or greater than, the level
of safety maintained without the
exemption. Therefore, the applicant,
Terry L. Curtner (IL), has been denied
an exemption from the physical
qualification standards in 49 CFR
391.41(b)(8) and (b)(9):
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 constitutes final
action by the Agency. The applicant’s
information published today
summarizes the Agency’s recent denials
as required under 49 U.S.C. 31315(b)(4).
Issued on: March 20, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019–05949 Filed 3–27–19; 8:45 am]
BILLING CODE 4910–EX–P
DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials
Safety Administration
[Docket No. PHMSA–2018–0113; Notice No.
2018–23]
Hazardous Materials: Notice of Public
Meetings in 2019 for International
Standards on the Transport of
Dangerous Goods
Pipeline and Hazardous
Materials Safety Administration
(PHMSA), Department of Transportation
(DOT).
ACTION: Notice of 2019 public meetings.
AGENCY:
This notice announces that
PHMSA will host four public meetings
during 2019 in advance of certain
international meetings. For each of these
meetings, PHMSA will solicit public
input on current proposals. The first
meeting will be held in preparation to
the International Civil Aviation
Organization’s (ICAO) Dangerous Goods
Panel (DGP) Working Group 19 meeting
(WG/19) being held April 1–5, 2019, in
Montreal, Canada. The second meeting
will be held in preparation to the 55th
session of the United Nations SubCommittee of Experts on the Transport
of Dangerous Goods (UNSCOE TDG)
being held July 1–5, 2019, in Geneva,
SUMMARY:
PO 00000
Frm 00127
Fmt 4703
Sfmt 4703
11865
Switzerland. The third meeting will be
held in preparation to the 27th meeting
of the ICAO DGP (DGP/27) being held
September 9–20, 2019, in Montreal,
Canada. Finally, the fourth meeting will
be held in preparation to the 56th
session of the UNSCOE TDG being held
December 2–11, 2019, in Geneva,
Switzerland.
Time and Location: Each public
meeting will take place approximately
two weeks preceding the international
meeting at DOT Headquarters, West
Building, 1200 New Jersey Avenue SE,
Washington, DC 20590–0001. Specific
information for each meeting will be
posted when available on the PHMSA
website at https://www.phmsa.dot.gov/
international-program/internationalprogram-overview under ‘‘Upcoming
Events.’’ This information will include
the public meeting date, time,
conference call-in number, and details
for advanced registration.
FOR FURTHER INFORMATION CONTACT:
Steven Webb or Aaron Wiener,
International Program Office of
Hazardous Materials Safety, Department
of Transportation, Washington, DC
20590, (202) 366–8553.
SUPPLEMENTARY INFORMATION:
The purpose of PHMSA’s public
meetings is to allow the public a chance
to give input on the current meeting
proposals.
The 55th and 56th sessions of the
UNSCOE TDG will represent the first
and second meetings scheduled for the
2019–2020 biennium. The UNSCOE
TDG will consider proposals for the
22nd Revised Edition of the United
Nations Recommendations on the
Transport of Dangerous Goods: Model
Regulations (Model Regulations), which
may be implemented into relevant
domestic, regional, and international
regulations starting January 1, 2023.
Copies of working documents, informal
documents, the agenda, and the postmeeting final report may be obtained
from the United Nations Transport
Division’s website at https://
www.unece.org/trans/danger/
danger.html.
The ICAO WG/19 and DGP/27
meetings will represent the second and
third meetings of the 2018–2019
biennium. The ICAO DGP will consider
proposals for the 2021–2022 edition of
the Technical Instructions for the Safe
Transport of Dangerous Goods by Air
(Doc 9284). Copies of working papers,
information papers, the agenda, and the
post-meeting final report may be
obtained from the ICAO DGP website at
https://www.icao.int/safety/Dangerous
Goods/Pages/DGPMeetings.aspx.
E:\FR\FM\28MRN1.SGM
28MRN1
Agencies
[Federal Register Volume 84, Number 60 (Thursday, March 28, 2019)]
[Notices]
[Pages 11863-11865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05949]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2018-0320]
Qualification of Drivers; Exemption Applications; Narcolepsy
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.
ACTION: Notice of denial.
-----------------------------------------------------------------------
SUMMARY: FMCSA announces its decision to deny the application from one
individual 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 either a clinical
diagnosis of epilepsy or any other condition that is likely to cause a
loss of consciousness or any loss of ability to control a CMV, or a
mental, nervous, organic, or functional disease or psychiatric disorder
likely to interfere with his/her ability to drive a commercial motor
vehicle safely.
[[Page 11864]]
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. 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 https://www.regulations.gov.
Insert the docket number, FMCSA-2018-0320, 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 November 27, 2018, FMCSA published a FR notice (83 FR 60953)
announcing receipt of an application from one individual with a
diagnosis of narcolepsy and requested comments from the public. This
individual requested an exemption from 49 CFR 391.41(b)(8), which
prohibits operation of a CMV in interstate commerce by persons with
either a clinical diagnosis of epilepsy or any other condition that is
likely to cause a loss of consciousness or any loss of ability to
control a CMV, and 49 CFR 391.41(b)(9) a mental, nervous, organic, or
functional disease or psychiatric disorder likely to interfere with
his/her ability to drive a CMV safely. The public comment period closed
on December 27, 2018. Four comments were received in response to this
proceeding. Of the four comments received, two were duplicate comments
received from the applicant, and one comment was received from a
private citizen. These commenters were in support of granting an
exemption based on the applicant's driving history. The fourth
commenter, the American Academy of Sleep Medicine (AASM) commented that
the Agency should not grant an exemption for narcolepsy and outlined
nine specific reasons for their non-support. Details of the AASM's
comments may be found in the docket under the comments section.
FMCSA has evaluated the eligibility of this applicant and concluded
that granting the 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 the regulation 49 CFR 391.41(b)(8) and
(b)(9).
In reaching the decision to deny these exemption requests, the
Agency considered information from the 2009 Evidence Report,
``Narcolepsy (with and without cataplexy) and Commercial Motor Vehicle
Driver Safety \1\,'' and the January 2010 Medical Review Board (MRB)
Recommendation \2\ that individuals with narcolepsy be ineligible for a
commercial driver's license, even with treatment. A copy of the
Evidence Report is included in the docket.
---------------------------------------------------------------------------
\1\ Evidence Report: Narcolepsy (with and without cataplexy) and
Commercial Motor Vehicle Driver Safety; October 6, 2009.
\2\ Medical Review Board Meeting; January 6, 2010;
www.mrb.fmcsa.dot.gov/documents/Final_Jan_6_2010_MRB_Meeting_Summary.pdf.
---------------------------------------------------------------------------
III. Basis for Exemption Determination
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs if the exemption is likely to 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 each applicant's medical
information provided by the applicant, available medical and scientific
data concerning narcolepsy, and public comments received. As discussed
in the background section, the Agency considered information from the
2009 Evidence Report, ``Narcolepsy (with and without cataplexy) and
Commercial Motor Vehicle Driver Safety,'' and the January 2010
recommendation that individuals with narcolepsy be ineligible for a
commercial driver's license, even with treatment.
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. [49 CFR part 391,
APPENDIX A TO PART 391--MEDICAL ADVISORY CRITERIA, section H. Epilepsy:
Sec. 391.41(b)(8), paragraphs 3, 4, and 5.] The advisory criteria for
49 CFR 391.41(b)(8), indicates that if an individual has had a sudden
episode of a non-epileptic seizure or loss of consciousness of unknown
cause that did not require anti-seizure medication, the decision
whether that person's condition is likely to cause the loss of
consciousness or loss of ability to control a CMV should be made on an
individual basis by the medical examiner in consultation with the
treating physician.
In those individual cases where a driver had a seizure or an
episode of loss of consciousness that resulted from a known medical
condition (e.g., drug reaction, high temperature, acute infectious
disease, dehydration, or acute metabolic disturbance), certification
should be deferred until the driver has fully recovered from that
condition, has no existing residual complications, and is not taking
anti-seizure medication.
The advisory criteria for 49 CFR 391.41(b)(9), indicates that a
variety of functional disorders can cause drowsiness, dizziness,
confusion, weakness or paralysis that may lead to incoordination,
inattention, loss of functional control and susceptibility to accidents
while driving.
Narcolepsy is a chronic neurological disorder caused by autoimmune
destruction of hypocretin-producing neurons inhibiting the brain's
ability to regulate sleep-wake cycles normally. Persons with narcolepsy
experience frequent excessive daytime sleepiness, comparable to how
non-narcoleptics feel after 24 to 48 hours of sleep deprivation, as
well as disturbed nocturnal sleep, which is often confused with
insomnia. See National Institutes of Health (NIH) Narcolepsy Fact Sheet
at www.ninds.nih.gov/disorders/narcolepsy/detail_narcolepsy.htm.
The 2009 Evidence Report, ``Narcolepsy (with and without cataplexy)
and Commercial Motor Vehicle Driver Safety,'' addressed whether or not
individuals with narcolepsy are at an increased risk for motor vehicle
crashes; whether or not currently recommended treatments for narcolepsy
reduce the risk for motor vehicle crashes; and the impact of various
medication therapies for narcolepsy on driver safety.
[[Page 11865]]
The evidence report reviewed studies from the available literature
and evaluated outcomes on measures of Excessive Daytime Sleepiness
(EDS), cataplexy, event rate, measures of cognitive and psychomotor
function, and driving performance. The currently available direct and
indirect evidence support the contention that drivers with narcolepsy
are at an increased risk for a motor vehicle crash when compared to
otherwise similar individuals who do not have the disorder. The direct
evidence from three crash studies conducted of non-CMV drivers showed
that individuals with narcolepsy are at an increased risk for a crash
compared to individuals who do not have narcolepsy. The indirect
evidence from studies of driving tests and driving simulation examined
factors associated with simulated driving outcomes such as driving
performance, tracking error, fewer correct responses, and more
instances of going out of bounds compared to healthy controls. While
there are limitations in the quality of the studies that examined
direct crash risk, both the direct and indirect studies showed a strong
effect size and statistical significance. The American Academy of Sleep
Medicine (AASM) and the European Federation of Neurological Societies
recommend modafinil as the first treatment option and methylphenidate
as the second treatment option. The AASM also recommends amphetamine,
methamphetamine, or dextroamphetamine as alternative treatments. During
literature searches, no studies that directly examined the impact of
treatment with modafinil, armodafinil, sodium oxybate (used with
narcolepsy with cataplexy), or anti-depressants on crash risk or
driving performance were identified. Therefore, conclusions regarding
treatment with these medications on crash risk and driving performance
could not be made.
Currently available evidence suggests that amphetamines and/or
methylphenidate are effective in improving symptoms of EDS in
individuals with narcolepsy (quality of studies range from ``moderate
to low''). However, these improvements do not result in levels of
daytime sleepiness that can be considered to be normal in the vast
majority of individuals. Therefore, conclusions regarding to the impact
of treatment with amphetamines, methylphenidate, or other related
stimulant drugs on cognitive and psychomotor function among individuals
with narcolepsy could not be made.
In January 2010, the FMCSA's MRB recommended that individuals with
narcolepsy be ineligible for a commercial driver's license, even with
treatment.
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 these exemptions would achieve a level of
safety equivalent to, or greater than, the level of safety maintained
without the exemption. Therefore, the applicant, Terry L. Curtner (IL),
has been denied an exemption from the physical qualification standards
in 49 CFR 391.41(b)(8) and (b)(9):
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 constitutes final action by the
Agency. The applicant's information published today summarizes the
Agency's recent denials as required under 49 U.S.C. 31315(b)(4).
Issued on: March 20, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-05949 Filed 3-27-19; 8:45 am]
BILLING CODE 4910-EX-P