[Federal Register Volume 78, Number 247 (Tuesday, December 24, 2013)]
[Notices]
[Pages 77774-77776]
[FR Doc No: 2013-30662]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-25854; FMCSA-2013-0107; FMCSA-2013-0108]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to grant requests from seven
individuals for exemptions from the regulatory requirement that
interstate commercial motor vehicle (CMV) drivers have ``no established
medical history or clinical diagnosis of epilepsy or any other
condition which is likely to cause loss of consciousness or any loss of
ability to control a CMV.'' The regulation and the associated advisory
criteria published in the Code of Federal Regulations as the
``Instructions for Performing and Recording Physical Examinations''
have resulted in numerous drivers being prohibited from operating CMVs
in interstate commerce based on the fact that they have had one or more
seizures and are taking anti-seizure medication, rather than an
individual analysis of their circumstances by a qualified medical
examiner. The Agency concluded that granting exemptions for these CMV
drivers will provide a level of safety that is equivalent to or greater
than the level of safety maintained without the exemptions. FMCSA
grants exemptions that will allow these seven individuals to operate
CMVs in interstate commerce for a 2-year period. The exemptions preempt
State laws and regulations and may be renewed.

DATES: The exemptions are effective December 24, 2013. The exemptions
expire on December 24, 2015.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Division Chief,
Physical Qualifications, Office of Medical Programs,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Department of Transportation, 1200 New
Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001. Office
hours are 8:30 a.m. to 5 p.m., e.t., Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION:

A. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's complete Privacy Act Statement in the
Federal Register (73 FR 3316, January 17, 2008). This statement is also
available at http://Docketinfo.dot.gov.

B. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the 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 statute also allows the Agency to renew exemptions at
the end of the 2-year period.
    FMCSA grants seven individuals an exemption from the regulatory
requirement in Sec.  391.41(b)(8), to allow these individuals who take
anti-seizure medication to operate CMVs in interstate commerce for a 2-
year period. The Agency's decision on these exemption applications is
based on an individualized assessment of each applicant's medical
information, including the root cause of the respective seizure(s), the
length of time elapsed since the individual's last seizure, and each
individual's treatment regimen. In addition, the Agency reviewed each
applicant's driving record found in the Commercial Driver's License
Information System (CDLIS) \1\ for commercial driver's license (CDL)
holders, and interstate and intrastate inspections recorded in Motor
Carrier Management Information System (MCMIS).\2\ For non-CDL holders,
the Agency reviewed the driving records from the State licensing
agency. The Agency acknowledges the potential consequences of a driver
experiencing a seizure while operating a CMV. However, the Agency
believes the drivers covered by the exemptions granted here have
demonstrated that they are unlikely to have a seizure and their medical
condition does not pose a risk to public safety.
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    \1\ Commercial Driver License Information System (CDLIS) is an
information system that allows the exchange of commercial driver
licensing information among all the States. CDLIS includes the
databases of fifty-one licensing jurisdictions and the CDLIS Central
Site, all connected by a telecommunications network.
    \2\ Motor Carrier Management Information System (MCMIS) is an
information system that captures data from field offices through
SAFETYNET, CAPRI, and other sources. It is a source for FMCSA
inspection, crash, compliance review, safety audit, and registration
data.
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    In reaching the decision to grant these exemption requests, the
Agency considered both current medical literature and information and
the 2007 recommendations of the Agency's Medical Expert Panel (MEP).
The Agency previously gathered evidence for potential changes to the
regulation at 49 CFR 391.41(b)(8) by conducting a comprehensive review
of scientific literature that was compiled into the ``Evidence Report
on Seizure Disorders and Commercial Vehicle Driving'' (Evidence Report)
[CD-ROM HD TL230.3 .E95 2007]. The Agency then convened a panel of
medical experts in the field of neurology (the MEP) on May 14-15, 2007,
to review 49 CFR 391.41(b)(8) and the advisory criteria regarding
individuals who have experienced a seizure, and the 2007 Evidence
Report. The Evidence Report and the MEP recommendations are published
on-line at http://www.fmcsa.dot.gov/rules-regulations/topics/mep/mep-reports.htm, under Seizure Disorders, and are in the docket for this
notice.

MEP Criteria for Evaluation

    On October 15, 2007, the MEP issued the following recommended
criteria for evaluating whether an individual with epilepsy or a
seizure disorder should be allowed to operate a CMV.\3\ The MEP
recommendations are included in previously published dockets.
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    \3\ Engel, J., Fisher, R.S., Krauss, G.L., Krumholz, A., and
Quigg, M.S., ``Expert Panel Recommendations: Seizure Disorders and
Commercial Motor Vehicle Driver Safety,'' FMCSA, October 15, 2007.
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    Epilepsy diagnosis. If there is an epilepsy diagnosis, the
applicant should be seizure-free for 8 years, on or off medication. If
the individual is taking anti-seizure medication(s), the plan for
medication should be stable for 2 years. Stable means no changes in
medication, dosage, or frequency of medication administration.
Recertification for drivers with an epilepsy diagnosis should be
performed every year.
    Single unprovoked seizure. If there is a single unprovoked seizure
(i.e., there is no known trigger for the seizure), the individual
should be seizure-free for 4 years, on or off medication. If the
individual is taking anti-seizure medication(s), the plan for
medication should be stable for 2 years. Stable means no changes in
medication, dosage, or frequency of medication administration.
Recertification for drivers with a single unprovoked seizure should be
performed every 2 years.
    Single provoked seizure. If there is a single provoked seizure
(i.e., there is a known reason for the seizure), the Agency should
consider specific criteria that fall into the following two categories:
low-risk factors for recurrence and moderate-to-high risk factors for
recurrence.
     Examples of low-risk factors for recurrence include
seizures that were caused by a medication; by non-penetrating head
injury with loss of consciousness less than or equal to 30 minutes; by
a brief loss of consciousness not likely to recur while driving; by
metabolic derangement not likely to recur; and by alcohol or illicit
drug withdrawal.
     Examples of moderate-to-high-risk factors for recurrence
include seizures caused by non-penetrating head injury with loss of
consciousness or amnesia greater than 30 minutes, or penetrating head
injury; intracerebral hemorrhage associated with a stroke or trauma;
infections; intracranial hemorrhage; post-operative complications from
brain surgery with significant brain hemorrhage; brain tumor; or
stroke.
    The MEP report indicates individuals with moderate to high-risk
conditions should not be certified. Drivers with a history of a single
provoked seizure with low risk factors for recurrence should be
recertified every year.

Medical Review Board Recommendations and Agency Decision

    FMCSA presented the MEP's findings and the Evidence Report to the
Medical Review Board (MRB) for consideration. The MRB reviewed and
considered the 2007 ``Seizure Disorders and Commercial Driver Safety''
evidence report and the 2007 MEP recommendations. The MRB recommended
maintaining the current advisory criteria, which provide that ``drivers
with a history of epilepsy/seizures off anti-seizure medication and
seizure-free for 10 years may be qualified to drive a CMV in interstate
commerce. Interstate drivers with a history of a single unprovoked
seizure may be qualified to drive a CMV in interstate commerce if
seizure-free and off anti-seizure medication for a 5 year period or
more'' [Advisory criteria to 49 CFR 391.43(f)].
    The Agency acknowledges the MRB's position on the issue but
believes relevant current medical evidence supports a less conservative
approach. The medical advisory criteria for epilepsy and other seizure
or loss of consciousness episodes was based on the 1988 ``Conference on
Neurological Disorders and Commercial Drivers'' (NITS Accession No.
PB89-158950/AS). A copy of the report can be found in the docket
referenced in this notice.
    The MRB's recommendation treats all drivers who have experienced a
seizure the same, regardless of individual medical conditions and
circumstances. In addition, the recommendation to continue prohibiting
drivers who are taking anti-seizure medication from operating a CMV in
interstate commerce does not consider a driver's actual seizure history
and time since the last seizure. The Agency has decided to use the 2007
MEP recommendations as the basis for evaluating applications for an
exemption from the seizure regulation on an individual, case-by-case
basis.

C. Exemptions

    Following individualized assessments of the exemption applications,
including a review of detailed follow-up information requested from
each applicant, FMCSA is granting exemptions from 49 CFR 391.41(b)(8)
to seven individuals. Under current FMCSA regulations, all of the seven
drivers receiving exemptions from 49 CFR 391.41(b)(8) would have been
considered physically qualified to drive a CMV in interstate commerce
except that they presently take or have recently stopped taking anti-
seizure medication. For these seven drivers, the primary obstacle to
medical qualification was the FMCSA Advisory Criteria for Medical
Examiners, based on the 1988 ``Conference on Neurological Disorders and
Commercial Drivers,'' stating that a driver should be off anti-seizure
medication in order to drive in interstate commerce. In fact, the
Advisory Criteria have little if anything to do with the actual risk of
a seizure and more to do with assumptions about individuals who are
taking anti-seizure medication.
    In addition to evaluating the medical status of each applicant,
FMCSA evaluated the crash and violation data for the seven drivers,
some of whom currently drive a CMV in intrastate commerce. The CDLIS
and MCMIS were searched for crash and violation data on the seven
applicants. For non-CDL holders, the Agency reviewed the driving
records from the State licensing agency.
    These exemptions are contingent on the driver maintaining a stable
treatment regimen and remaining seizure-free during the 2-year
exemption period. The exempted drivers must submit annual reports from
their treating physicians attesting to the stability of treatment and
that the driver has remained seizure-free. The driver must undergo an
annual medical examination by a medical examiner, as defined by 49 CFR
390.5, following the FCMSA's regulations for the physical
qualifications for CMV drivers.
    FMCSA published a notice of receipt of application and requested
public comment during a 30-day public comment period in a Federal
Register notice for each of the applicants. A short summary of the
applicants' qualifications and a discussion of the comments received
follows this section. For applicants who were denied an exemption, a
notice will be published at a later date.

D. Comments

Docket  FMCSA-2006-25854

    On August 9, 2007, FMCSA published a notice of receipt of exemption
applications and requested public comments on nine individuals (72 FR
44916). The comment period ended on September 10, 2007. Five commenters
responded to the Federal Register Notice. A discussion of these
comments and a decision was made on four applicants in (72 FR 3069).
FMCSA has determined that one of these applicants

should be granted an exemption. The Agency will issue a decision on the
other drivers at a later date.

Docket  FMCSA-2013-0107

    On July 12, 2013, FMCSA published a notice of receipt of exemption
applications and requested public comment on nine individuals (78 FR
41988). The comment period ended on August 12, 2013. Seven commenters
responded to the Federal Register notice. All commenters support the
idea of granting an exemption. FMCSA has determined that one of these
applicants should be granted an exemption. The Agency will issue a
decision on the other drivers at a later date.

Docket  FMCSA-2013-0108

    On September 16, 2013, FMCSA published a notice of receipt of
exemption applications and requested public comment on six individuals
(78 FR 56984). The comment period ended on October 16, 2013. One
commenter responded to the Federal Register notice. This commenter
expressed his safety concerns about permitting drivers with a history
of seizure to drive commercially, and stated it does not make sense to
allow these drivers to drive 80,000 lb. trucks up and down our
highways.
    FMCSA Response: The Agency believes that evaluating each
individual's medical history on a case-by-case basis and investigating
the past driving/violation record ensures an acceptable level of safety
for a driver who has not experienced a seizure for an extended period
of time. Drivers, who have been seizure-free, on or off medication for
at least four years, pose a minimal risk to public safety. The Agency
considered the 2007 Evidence Report and the 2007 MEP recommendations to
determine the driver's level of risk for recurrence of seizure. The
Agency believes this data and information addresses this commenter's
concerns.
    FMCSA has determined that five of these applicants should be
granted an exemption. The Agency will issue a decision on the other
driver at a later date.
Stephen Amell, Sr.
    Mr. Amell is a 55 year-old driver in Vermont. He has a history of a
single seizure in 2004 and has remained seizure free since that time.
He takes anti-seizure medication with the dosage and frequency
remaining the same for six years. If granted the exemption, he would
like to drive a CMV. His physician states that he is supportive of Mr.
Amell receiving an exemption.
Erik Fleiner
    Mr. Fleiner is a 25 year-old class A commercial driver's license
holder in Nevada. He has a history of seizures and has remained seizure
free for at least 10 years. He takes anti-seizure medication with the
dosage and frequency remaining the same for 10 years. If granted the
exemption, he would like to continue to drive a CMV. His physician
states that he is supportive of Mr. Fleiner receiving an exemption.
Gary Freeman
    Mr. Freeman is a 48 year-old class A commercial driver's license
holder in Wisconsin. He has a history of seizures and has remained
seizure free for at least 10 years. He takes anti-seizure medication
with the dosage and frequency remaining the same for over seven years.
His physician states that he is supportive of Mr. Freeman receiving an
exemption.
Aaron Gillette
    Mr. Gillette is a 42 year-old driver in South Dakota. He has a
history of epilepsy and has remained seizure free for over eight years.
He takes anti-seizure medication with the dosage and frequency
remaining the same for seven years. His physician states that he is
supportive of Mr. Gillette receiving an exemption.
David Kestner
    Mr. Kestner is a 28 year-old driver in Virginia. He has a history
of epilepsy and has remained seizure free for nine years. He takes
anti-seizure medication with the dosage and frequency remaining the
same for five years. His physician states that he is supportive of Mr.
Kestner receiving an exemption.
Michael Kramer
    Mr. Kramer is a 46 year-old driver in Kansas. He had a seizure due
to a brain tumor which was removed in 2009. He has remained seizure-
free since that time. He does not require anti-seizure medication. His
physician is supportive of Mr. Kramer receiving an exemption.
Chad Smith
    Mr. Smith is a 36 year-old driver in Massachusetts. He has a
history of seizures and has remained seizure free for at least 15
years. He takes anti-seizure medication with the dosage and frequency
remaining the same for six years. His physician states that he is
supportive of Mr. Smith receiving an exemption.

E. Basis For Exemption

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the epilepsy/seizure standard in 49 CFR 391.41(b)(8) if the
exemption is likely to achieve an equivalent or greater level of safety
than would be achieved without the exemption. Without the exemption,
applicants will continue to be restricted to intrastate driving. With
the exemption, applicants can drive in interstate commerce. Thus, the
Agency's analysis focuses on whether an equal or greater level of
safety is likely to be achieved by permitting each of these drivers to
drive in interstate commerce as opposed to restricting the driver to
driving in intrastate commerce.

Conclusion

    The Agency is granting exemptions from the epilepsy standard, 49
CFR 391.41(b)(8), to seven individuals based on a thorough evaluation
of each driver's qualifications, safety experience, and medical
condition. Safety analysis of information relating to these seven
applicants meets the burden of showing that granting the exemptions
would achieve a level of safety that is equivalent to or greater than
the level that would be achieved without the exemption. By granting the
exemptions, the interstate CMV industry will gain seven highly trained
and experienced drivers. In accordance with 49 U.S.C. 31315(b)(1), each
exemption will be valid for 2 years, with annual recertification
required unless revoked earlier by FMCSA. The exemption will be revoked
if the following occurs: (1) the person fails to comply with the terms
and conditions of the exemption; (2) the exemption has resulted in a
lower level of safety than was maintained prior to being granted; or
(3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136 and 31315.
    FMCSA exempts the following seven drivers from the prohibition of
CMV operations by persons with a clinical diagnosis of epilepsy or
seizures for a period of 2 years with annual medical certification
required: Stephen Amell, Sr. (VT); Erik Fleiner (NV); Gary Freeman
(WI); Aaron Gillette (SD); David Kestner (VA); Michael Kramer (KS); and
Chad Smith (MA). If the exemption is still in effect at the end of the
2-year period, the person may apply to FMCSA for a renewal under
procedures in effect at that time.

    Issued on: December 16, 2013.
Anne S. Ferro,
Administrator.
[FR Doc. 2013-30662 Filed 12-23-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 205 (Monday, October 24, 2011)]
[Notices]
[Page 65732]
[FR Doc No: 2011-27397]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0001]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Health and Diet Survey

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Health and Diet Survey'' has been
approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On May 27, 2011, the Agency submitted a
proposed collection of information entitled ``Health and Diet Survey''
to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number. OMB has now approved the information collection and has
assigned OMB control number 0910-0545. The approval expires on
September 30, 2014. A copy of the supporting statement for this
information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: October 18, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-27397 Filed 10-21-11; 8:45 am]
BILLING CODE 4160-01-P