[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]


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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.

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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, 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 http://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.
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    \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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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