[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, [email protected], 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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