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Qualification of Drivers; Exemption Applications; Narcolepsy Publication: Federal Register Agency: Federal Motor Carrier Safety Administration Byline: Larry W. Minor Date: 28 April 2022 Subject: American Government  , Driver Licensing
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[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25337-25338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09016]
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DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2021-0182]
Qualification of Drivers; Exemption Applications; Narcolepsy
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).
ACTION: Notice of denial.
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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.
FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, (202) 366-4001, fmcsamedical@dot.gov, FMCSA,
DOT, 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 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-2021-0182, 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 request. 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 December 16, 2021, FMCSA published a Federal Register notice (86
FR 71537) announcing receipt of an application from one individual with
a diagnosis of narcolepsy and requested comments from the public. The
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. The public comment period closed on January 18, 2022,
and one comment was received.
FMCSA has evaluated the eligibility of the applicant 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)(8). A summary of the
applicant's medical history related to the narcolepsy exemption request
was discussed in the December 16, 2021, Federal Register notice and
will not be repeated here.
The Agency considered information from the 2009 Evidence Report,
``Narcolepsy (with and without cataplexy) and Commercial Motor Vehicle
Driver Safety,'' and the January 2010 Medical Review Board (MRB)
recommendation 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.
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
individuals without narcolepsy 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 Narcolepsy
Fact Sheet at https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Narcolepsy-Fact-Sheet.
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
[[Page 25338]]
narcolepsy reduce the risk for motor vehicle crashes; and the impact of
various medication therapies for narcolepsy on driver safety.
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 supports 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.
Discussion of Comments
FMCSA received one comment in this proceeding from a private
citizen who did not support granting an exemption in the interest of
public safety and the applicant's well-being. The commenter cites that
the applicant's medical provider states that the applicant's current
treatment has proven effective and that treatment continues without
explicit determination by the medical provider that the current regimen
has sufficiently remedied the applicant's medical condition such that
it would not interfere with the ability to drive a CMV in the future.
FMCSA acknowledges the commenter's concern. When evaluating a medical
exemption application request, FMCSA considers the applicant's relevant
medical information, however the Agency does not make a decision to
grant or deny a medical exemption solely on the basis of an applicant's
medical documentation.
III. 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 this exemption application is based
on an individualized assessment of the applicant's medical information,
available medical and scientific data concerning narcolepsy, and any
relevant public comments received.
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 this exemption would achieve a level of
safety equivalent to, or greater than, the level of safety maintained
without the exemption. Therefore, the following applicant has been
denied an exemption from the physical qualification standards in Sec.
391.41(b)(8):
Sheila Bennett (TN)
The applicant has, 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 name of the individual published in this notice
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. 2022-09016 Filed 4-27-22; 8:45 am]
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