80 FR 49301 - Qualification of Drivers; Exemption Applications; Narcolepsy

DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration

Federal Register Volume 80, Issue 158 (August 17, 2015)

Page Range		49301-49302
FR Document		2015-20187

FMCSA announces its decision to deny applications from three individuals seeking exemptions from the prohibitions against operating a commercial motor vehicle (CMV) in interstate commerce by persons with: (1) 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 operate a CMV safely, or (2) a mental, nervous, organic, or functional disease or psychiatric disorder likely to interfere with his/her ability to drive a commercial motor vehicle safely. FMCSA has statutory authority to exempt individuals from certain parts of the Federal Motor Carrier Safety Regulations, if the exemptions granted will not compromise safety. The Agency must conclude that granting these exemptions provides a level of safety that will be equivalent to or greater than the level of safety maintained without the exemptions for these CMV drivers. Based on a review of the applications and following an opportunity for public comment, FMCSA has concluded that the individuals did not demonstrate that they could achieve a level of safety that is equivalent to, or greater than, the level of safety that would be obtained by complying with the regulation.

Federal Register, Volume 80 Issue 158 (Monday, August 17, 2015)

[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Pages 49301-49302]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20187]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0373]


Qualification of Drivers; Exemption Applications; Narcolepsy

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of denial of exemption applications.

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SUMMARY: FMCSA announces its decision to deny applications from three 
individuals seeking exemptions from the prohibitions against operating 
a commercial motor vehicle (CMV) in interstate commerce by persons 
with: (1) 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 operate a CMV safely, or (2) a mental, nervous, organic, 
or functional disease or psychiatric disorder likely to interfere with 
his/her ability to drive a commercial motor vehicle safely. FMCSA has 
statutory authority to exempt individuals from certain parts of the 
Federal Motor Carrier Safety Regulations, if the exemptions granted 
will not compromise safety. The Agency must conclude that granting 
these exemptions provides a level of safety that will be equivalent to 
or greater than the level of safety maintained without the exemptions 
for these CMV drivers. Based on a review of the applications and 
following an opportunity for public comment, FMCSA has concluded that 
the individuals did not demonstrate that they could achieve a level of 
safety that is equivalent to, or greater than, the level of safety that 
would be obtained by complying with the regulation.

DATES: This decision is effective July 24, 2015.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan III, Director, Office 
of Carrier, Driver and Vehicle Safety Standards, (202) 366-4001, or via 
email at [email protected], or by letter FMCSA, Room W64-224, 
Department of Transportation, 1200 New Jersey Avenue SE., Washington, 
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday 
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption 
from the Federal Motor Carrier Safety Regulations for a 2-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.'' FMCSA can renew exemptions at the end of each 
2-year period. The three individuals listed in this notice have each 
requested such an exemption from the physical qualification 
requirements in 49 CFR 391.41(b)(8) and (b)(9), which applies to 
drivers of CMVs in interstate commerce. Accordingly, the Agency 
evaluates the qualifications of each applicant to determine whether 
granting an exemption will achieve the required level of safety 
mandated by statute.
    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 often is confused with 
insomnia. See NIH Narcolepsy Fact Sheet at www.ninds.nih.gov/disorders/narcolepsy/detail_narcolepsy.htm.
    The Agency considered the topic of narcolepsy and the potential 
impact on commercial drivers in a 2009 Evidence Report. The Evidence 
Report ``Narcolepsy (with and without cataplexy) and Commercial Motor 
Vehicle Driver Safety'' addressed several key questions.\1\
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    \1\ Evidence Report: Narcolepsy (with and without cataplexy) and 
Commercial Motor Vehicle Driver Safety; October 6, 2009.
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    Key Question 1: Are individuals with narcolepsy (with and without 
cataplexy) at an increased risk for a motor vehicle crash when compared 
to comparable individuals without the disorder?
    Key Question 2: Do currently recommended treatments for narcolepsy 
reduce the risk for a motor vehicle crash?
    Key question 2 was further divided into several questions 
concerning the impact of various medication therapies for narcolepsy on 
driver safety. The complete report is included in the docket FMCSA 
2014-0373.
    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. For key question 1, the currently 
available evidence (both direct and indirect) 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 strength of the evidence was rated as strong. 
The direct evidence (from three crash studies) (study quality rating of 
``Low'') conducted with 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 (studies of driving 
tests and driving simulation, quality rating ``moderate''), examined 
factors associated with simulated driving outcomes, (driving 
performance, tracking error, fewer correct responses and more instances 
of going out of bounds compared to healthy controls). In summary, while 
there are limitations in the quality of the studies that examined 
direct crash risk in the evidence base, all study results showed a 
strong effect size and statistical significance. Indirect evidence of 
crash provides strong support for the direct crash study findings. 
Based upon available information, there is strong evidence that non-
commercial drivers with narcolepsy are at an increased risk of crash.
    Concerning key question 2 and its sub-questions, the American 
Academy of Sleep Medicine (AASM) and the European Federation of 
Neurological Societies recommend modafinil as the first-line of 
treatment and

[[Page 49302]]

methylphenidate as the second-line of treatment. The AASM also 
recommends amphetamine, methamphetamine, or dextroamphetamine as 
alternative second-line treatments. 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 during the literature 
searches. Evidence-based conclusions pertaining to treatment with these 
medications on crash risk and driving performance could not be drawn.
    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. Evidence-based conclusions pertaining to the 
impact of treatment with amphetamines, methylphenidate, or other 
related stimulant drugs on cognitive and psychomotor function among 
individuals with narcolepsy cannot be drawn at this time.
    In January 2010, the FMCSA's Medical Review Board (MRB) recommended 
that individuals with narcolepsy be ineligible for a commercial 
driver's license, even with treatment.\2\
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    \2\ Medical Review Board Meeting; January 6, 2010; http://www.mrb.fmcsa.dot.gov/documents/Final_Jan_6_2010_MRB_Meeting_Summary.pdf.
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Discussion of Public Comments

    The FMCSA published the names of three individuals seeking 
exemption in a Federal Register Notice, on April 17, 2015, and 
requested public comment. The public comment period closed on May 18, 
2015. A total of 17 commenters responded. The majority of commenters 
were in favor of the applicants continuing to drive CMV's with 
Narcolepsy. Fourteen commenters consisting mainly of private citizens 
stated that the individual drivers listed in the notice were 
responsible drivers, were stable and compliant with their medication 
therapy, had safe driving histories, and believed that the individuals 
would continue to be safe drivers while on medication The State of New 
York's medical consultants reviewed the docket and suggested that 
drivers with narcolepsy be allowed to operate commercially only if they 
have been treated medically and have been event-free for at least one 
year. Three commenters did not support exemption for drivers with 
narcolepsy. One anonymous commenter encouraged the FMCSA not to grant 
exemptions to these individuals due to concerns of the high risk of the 
underlying medical condition in combination with operating a large CMV.

FMCSA Response

    To evaluate the effects of these exemption requests on safety, 
FMCSA reviewed and considered the content of each request individually 
and all comments received.
    FMCSA acknowledges comments received attesting that individual 
applicants are responsible drivers currently on a stable therapeutic 
regimen which includes medication therapy. The Agency considered 
available medical and scientific data concerning medication therapy for 
narcolepsy. As discussed in the background section of this notice, 
evidence-based conclusions pertaining to treatment with medications on 
crash risk and driving performance could not be drawn.
    Concerning ATAs comments recommending granting fewer exemptions and 
revising the current medical standards, FMCSA acknowledges ATA's 
concerns. The FMCSA has statutory authority (49 U.S.C. 31136(e) and 
31315), to consider granting exemptions from the Federal Motor Carrier 
Safety Regulations for a 2-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 
FMCSA reviews its medical standards through the use of evidence 
reports, various medical expert panels and the Agency's Medical Review 
Board and proposes evidence-based revisions to the medical standards 
through the rulemaking process which takes a considerable length of 
time.
    The exemption process is the Agency's most viable alternative in 
the short term to consider whether drivers with disqualifying medical 
conditions and who are found to meet an equivalent level of safety, 
should be permitted to operate in interstate commerce.

Conclusion

    FMCSA evaluated the three individual exemption requests on their 
merits and available data from FMCSA's Evidence Reports, the Medical 
Review Board recommendations and public comments received. The Agency 
has determined that the available medical and scientific literature and 
research provides insufficient data to enable the Agency to conclude 
that granting the exemptions would achieve a level of safety equivalent 
to or greater than the level of safety maintained without the 
exemption. Each applicant has, prior to this notice, received a letter 
of final disposition on his/her exemption request. Those decision 
letters outlined fully the basis for the denial and constitute final 
Agency action. The list published today summarizes the Agency's recent 
denials as required under 49 U.S.C. 31315(b)(4).
    The following three applicants are denied exemptions from the 
physical qualification standards in [49 CFR 391.41(b)(8)] and [49 CFR 
391.41(b)(9)]: Thomas Skagen, Charles Larry Peterson, and Stanley 
Jandreau.

    Issued on: August 3, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-20187 Filed 8-14-15; 8:45 am]
 BILLING CODE 4910-EX-P

49302 Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices

methylphenidate as the second-line of for drivers with narcolepsy. One exemptions would achieve a level of
treatment. The AASM also recommends anonymous commenter encouraged the safety equivalent to or greater than the
amphetamine, methamphetamine, or FMCSA not to grant exemptions to these level of safety maintained without the
dextroamphetamine as alternative individuals due to concerns of the high exemption. Each applicant has, prior to
second-line treatments. No studies that risk of the underlying medical condition this notice, received a letter of final
directly examined the impact of in combination with operating a large disposition on his/her exemption
treatment with modafinil, armodafinil, CMV. request. Those decision letters outlined
sodium oxybate (used with narcolepsy FMCSA Response fully the basis for the denial and
with cataplexy), or anti-depressants on constitute final Agency action. The list
crash risk or driving performance were To evaluate the effects of these published today summarizes the
identified during the literature searches. exemption requests on safety, FMCSA Agency’s recent denials as required
Evidence-based conclusions pertaining reviewed and considered the content of under 49 U.S.C. 31315(b)(4).
to treatment with these medications on each request individually and all The following three applicants are
crash risk and driving performance comments received. denied exemptions from the physical
could not be drawn. FMCSA acknowledges comments qualification standards in [49 CFR
Currently available evidence suggests received attesting that individual 391.41(b)(8)] and [49 CFR 391.41(b)(9)]:
that amphetamines and/or applicants are responsible drivers Thomas Skagen, Charles Larry Peterson,
methylphenidate are effective in currently on a stable therapeutic and Stanley Jandreau.
improving symptoms of EDS in regimen which includes medication
therapy. The Agency considered Issued on: August 3, 2015.
individuals with narcolepsy (quality of Larry W. Minor,
studies range from ‘‘moderate to low’’). available medical and scientific data
concerning medication therapy for Associate Administrator for Policy.
However, these improvements do not
result in levels of daytime sleepiness narcolepsy. As discussed in the [FR Doc. 2015–20187 Filed 8–14–15; 8:45 am]
that can be considered to be normal in background section of this notice, BILLING CODE 4910–EX–P

the vast majority of individuals. evidence-based conclusions pertaining
Evidence-based conclusions pertaining to treatment with medications on crash
risk and driving performance could not DEPARTMENT OF TRANSPORTATION
to the impact of treatment with
amphetamines, methylphenidate, or be drawn.
Concerning ATAs comments Federal Motor Carrier Safety
other related stimulant drugs on Administration
cognitive and psychomotor function recommending granting fewer
among individuals with narcolepsy exemptions and revising the current [Docket No. FMCSA–2000–8398; FMCSA–
cannot be drawn at this time. medical standards, FMCSA 2003–14504; FMCSA–2005–20560; FMCSA–
In January 2010, the FMCSA’s acknowledges ATA’s concerns. The 2009–0154; FMCSA–2009–0303; FMCSA–
Medical Review Board (MRB) FMCSA has statutory authority (49 2011–0124]
recommended that individuals with U.S.C. 31136(e) and 31315), to consider
granting exemptions from the Federal Qualification of Drivers; Exemption
narcolepsy be ineligible for a Applications; Vision
commercial driver’s license, even with Motor Carrier Safety Regulations for a 2-
treatment.2 year period if it finds ‘‘such exemption AGENCY: Federal Motor Carrier Safety
would likely achieve a level of safety Administration (FMCSA), DOT.
Discussion of Public Comments that is equivalent to or greater than the ACTION: Notice of renewal of
The FMCSA published the names of level that would be achieved absent exemptions; request for comments.
three individuals seeking exemption in such exemption.’’ The FMCSA reviews
a Federal Register Notice, on April 17, its medical standards through the use of SUMMARY: FMCSA announces its
2015, and requested public comment. evidence reports, various medical expert decision to renew the exemptions from
The public comment period closed on panels and the Agency’s Medical the vision requirement in the Federal
May 18, 2015. A total of 17 commenters Review Board and proposes evidence- Motor Carrier Safety Regulations for 22
responded. The majority of commenters based revisions to the medical standards individuals. FMCSA has statutory
were in favor of the applicants through the rulemaking process which authority to exempt individuals from
continuing to drive CMV’s with takes a considerable length of time. the vision requirement if the
Narcolepsy. Fourteen commenters The exemption process is the exemptions granted will not
consisting mainly of private citizens Agency’s most viable alternative in the compromise safety. The Agency has
stated that the individual drivers listed short term to consider whether drivers concluded that granting these
in the notice were responsible drivers, with disqualifying medical conditions exemption renewals will provide a level
were stable and compliant with their and who are found to meet an of safety that is equivalent to or greater
medication therapy, had safe driving equivalent level of safety, should be than the level of safety maintained
histories, and believed that the permitted to operate in interstate without the exemptions for these
individuals would continue to be safe commerce. commercial motor vehicle (CMV)
drivers while on medication The State Conclusion drivers.
of New York’s medical consultants DATES: This decision is effective
FMCSA evaluated the three
reviewed the docket and suggested that September 22, 2015. Comments must be
individual exemption requests on their
drivers with narcolepsy be allowed to received on or before September 16,
mstockstill on DSK4VPTVN1PROD with NOTICES

merits and available data from FMCSA’s
operate commercially only if they have 2015.
Evidence Reports, the Medical Review
been treated medically and have been
Board recommendations and public ADDRESSES: You may submit comments
event-free for at least one year. Three
comments received. The Agency has bearing the Federal Docket Management
commenters did not support exemption
determined that the available medical System (FDMS) numbers: Docket No.
2 Medical Review Board Meeting; January 6, 2010; and scientific literature and research [Docket No. FMCSA–2000–8398;
http://www.mrb.fmcsa.dot.gov/documents/Final_ provides insufficient data to enable the FMCSA–2003–14504; FMCSA–2005–
Jan_6_2010_MRB_Meeting_Summary.pdf. Agency to conclude that granting the 20560; FMCSA–2009–0154; FMCSA–

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Document Created: 2015-12-15 11:06:30
Document Modified: 2015-12-15 11:06:30

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 denial of exemption applications.
Dates		This decision is effective July 24, 2015.
Contact		Charles A. Horan III, Director, Office of Carrier, Driver and Vehicle Safety Standards, (202) 366-4001, or via email at [email protected], or by letter FMCSA, Room W64-224, Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday through Friday, except Federal holidays.
FR Citation		80 FR 49301

80 FR 49301 - Qualification of Drivers; Exemption Applications; Narcolepsy

DEPARTMENT OF TRANSPORTATIONFederal Motor Carrier Safety Administration

Federal Register Volume 80, Issue 158 (August 17, 2015)

DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration