Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillators

Larry W. Minor
Federal Motor Carrier Safety Administration
November 27, 2015

[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Notices]
[Pages 74200-74202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30156]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0371]


Qualification of Drivers; Exemption Applications; Implantable 
Cardioverter Defibrillators

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

ACTION: Notice of applications for exemptions; request for comments.

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SUMMARY: FMCSA announces receipt of 7 applications for exemptions from 
the cardiovascular standard [49 CFR 391.41(b)(4)]. These 7 individuals 
are requesting an exemption due to the presence of implantable 
cardioverter defibrillators (ICD) as a result of their underlying 
cardiac condition. If granted, the exemptions would enable these 
individuals with ICDs to operate commercial motor vehicles (CMVs) in 
interstate commerce for up to 2 years.

DATES: Comments must be received on or before December 28, 2015.

ADDRESSES: You may submit comments bearing the Federal Docket 
Management System (FDMS) Docket ID FMCSA-2015-0371 using any of the 
following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Docket Management Facility; U.S. Department of 
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor, 
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room 
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 
5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket ID for 
this Notice. Note that DOT posts all comments received without change 
to www.regulations.gov, including any personal information included in 
a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or 
comments, go to www.regulations.gov, at any time 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., Monday through Friday, 
except Federal holidays. The FDMS is available 24 hours each day, 365 
days each year. If you want acknowledgment that we received your 
comments, please include a self-addressed, stamped envelope or postcard 
or print the acknowledgement page that appears after submitting 
comments on-line.
    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 records notice (DOT/ALL-14 FDMS), which can be reviewed at 
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Christine A. Hydock, Chief, Medical 
Programs Division, (202) 366-4001, fmcsamedical@dot.gov, FMCSA, 
Department of Transportation, 1200

[[Page 74201]]

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.

Submitting Comments

    You may submit your comments and material online or by fax, mail, 
or hand delivery, but please use only one of these means. FMCSA 
recommends that you include your name and a mailing address, an email 
address, or a phone number in the body of your document so that FMCSA 
can contact you if there are questions regarding your submission. To 
submit your comment online, go to http://www.regulations.gov and in the 
search box insert the docket number ``FMCSA-2015-0371'' and click the 
search button. When the new screen appears, click on the blue ``Comment 
Now!'' button on the right hand side of the page. On the new page, 
enter information required including the specific section of this 
document to which each comment applies, and provide a reason for each 
suggestion or recommendation. If you submit your comments by mail or 
hand delivery, submit them in an unbound format, no larger than 8\1/2\ 
by 11 inches, suitable for copying and electronic filing. If you submit 
comments by mail and would like to know that they reached the facility, 
please enclose a stamped, self-addressed postcard or envelope. We will 
consider all comments and material received during the comment period 
and may change this proposed rule based on your comments. FMCSA may 
issue a final rule at any time after the close of the comment period.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this 
notice, or to submit your comment online, go to www.regulations.gov and 
in the search box insert the docket number ``FMCSA-2015-0371'' and 
click ``Search.'' Next, click ``Open Docket Folder'' and you will find 
all documents and comments related to the proposed rulemaking.

SUPPLEMENTARY INFORMATION:

Background

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant 
exemptions from certain parts of the Federal Motor Carrier Safety 
Regulations. FMCSA must publish a notice of each exemption request in 
the Federal Register [49 CFR 381.315(a)]. The Agency must provide the 
public an opportunity to inspect the information relevant to the 
application, including any safety analyses that have been conducted. 
The Agency must also provide an opportunity for public comment on the 
request.
    The Agency reviews safety analyses and public comments submitted, 
and determines whether granting the exemption would likely achieve a 
level of safety equivalent to, or greater than, the level that would be 
achieved by the current regulation (49 CFR 381.305). The Agency may 
grant an exemption subject to specified terms and conditions. The 
decision of the Agency must be published in the Federal Register (49 
CFR 381.315(b)) with the reasons for denying or granting the 
application and, if granted, the name of the person or class of persons 
receiving the exemption, and the regulatory provision from which the 
exemption is granted. The notice must also specify the effective period 
and explain the terms and conditions of the exemption. The exemption 
may be renewed (49 CFR 381.300(b)).
    The FMCSA provides medical advisory criteria for use by medical 
examiners in determining whether drivers with certain medical 
conditions should be certified to operate CMVs in interstate commerce. 
The advisory criteria are currently set out as part of the medical 
examination report published with 49 CFR 391.43. The advisory criteria 
for section 391.41(b)(4) indicate that the term ``has no current 
clinical diagnosis of'' is specifically designed to encompass:
    ``a clinical diagnosis of'' (1) a current cardiovascular condition, 
or (2) a cardiovascular condition which has not fully stabilized 
regardless of the time limit. The term ``known to be accompanied by'' 
is designed to include a clinical diagnosis of a cardiovascular disease 
(1) which is accompanied by symptoms of syncope, dyspnea, collapse or 
congestive cardiac failure; and/or (2) which is likely to cause 
syncope, dyspnea, collapse, or congestive cardiac failure.

Summary of Applications

Ellis James Benson

    Mr. Benson is a 53 year old Class A CDL holder in Minnesota. A June 
2, 2015 letter from his cardiologist reports that Mr. Benson's 
defibrillator was implanted on November 12, 2008. His records show that 
his defibrillator delivered therapies on February 27, 2014, and on 
February 28, 2015. In 2008 (his most recent study) showed a left 
ejection fraction of 55-60%.

Jon Carey

    Mr. Carey is a 51 year old route salesman in Colorado. A May 2015 
letter from his cardiologist reports that Mr. Carey's ICD ``was 
implanted in March 2009 after he experienced a ventricular fibrillation 
arrest''. ``Since that incident, his defibrillator has never gone off 
and he's had no progression of coronary disease''. Recent 
echocardiography shows ``improved ventricular function with an EF of 
40-50%''. ``Mr. Carey is active without limitations without angina, 
heart failure, or arrhythmia symptoms''. ``The patient is clear to 
receive a CDL license from my standpoint. I see no issues with him 
driving commercial vehicles.''

Martin Carter

    Mr. Carter is a 47 year old Class A CDL holder in Maine. A March 
11, 2015 letter from his cardiologist reports that Mr. Carter underwent 
ICD implantation on 4/1/2011. ``At the time of the ICD placement, his 
ejection fraction was between 30-35%''. His cardiologists note that 
``since that time, the patient has gotten progressively stronger''. 
``Ejection fraction 10/5/2012 was 37% and 11/26/13 was 44%''. ``The 
patient had a stress test 11/26/2013 which showed no inducible 
myocardial ischemia''. ``In a patient such as this, the ICD would never 
have been considered for implantation''. ``His ICD has never discharged 
and he has been followed regularly''. ``The patient's cardiovascular 
status has recovered to the point that the ICD is no longer medically 
necessary but no cardiologist is willing to remove the device''. ``It 
is my medical opinion that the patient has recovered sufficiently from 
his ischemic cardiomyopathy that he no longer meets the restriction of 
ejection fraction less than 40% limiting his ability to drive. I would 
ask that he be considered for reinstatement of commercial tractor-
trailer license''. ``Prior to the placement of his ICD, Mr. Carter was 
treated medically and surgically and responded well''. ``He had a near 
syncopal episode on 3/2/2010 felt to be secondary to excessive 
medication and dehydration. He has had no recurrences since that 
time.''

Carl Jeglum

    Mr. Jeglum is a 58 year old Class A CDL holder in Washington. An 
October 22, 2015 letter from his cardiologist reports that in ``March 
of 2005, (Mr. Jeglum) had an Internal Cardiac Defibrillator placed.'' 
``Since then his implantable device has been checked frequently and has 
remained stable without further incident.'' ``The device has never been 
discharged or deployed since the time he has had the device in place.'' 
``He has not had any ongoing cardiac symptoms and in my opinion is 
fully capable of performing his usual

[[Page 74202]]

duties as a driver as per the guidelines for the Department of 
Transportation.'' Mr. Jeglum writes, ``I already have a intrastate 
waiver with no problems in the past 10 years.''

William Kastner

    Mr. Kastner is a 61 year old CDL holder in New Jersey. A May 2015 
letter from his cardiologist reports that Mr. Kastner's defibrillator 
``was implanted in 2006 after he experienced a myocardial infarction 
resulting in reduced left ventricular ejection fraction''. His 
cardiologist notes that ``Mr. Kastner has never had an episode of 
syncope, symptomatic palpitations, loss of consciousness, cardiac 
arrest, documented ventricular tachycardia or ventricular 
fibrillation.'' His electrophysiology group has recommended ``that it 
is safe for him to continue to ride his motorcycle, and he has had no 
adverse events or effects from this''. He is followed regularly by his 
electrophysiologist office and has no untoward events with his 
defibrillator. ``He has never had any syncope, palpitations, or 
discharges from his cardiac defibrillator.''

Mark Todd Smith

    Mr. Smith is a 52 year old class A-CDL holder in Georgia. Medical 
documentation from his cardiologist between 2013 and June 2015 reports 
that he was upgraded from a dual chamber ICD to a biventricular ICD for 
ventricular arrhythmias. Mr. Smith had a pulmonary valve replacement in 
2015. A September 2015 report from his cardiologist states ``he has no 
complaints of PND (paroxysmal nocturnal dyspnea), orthopnea, LE (lower 
extremity) edema, syncope, or pre-syncope''. An October 2015 letter 
from his cardiologist reports that his ICD has ``shown normal 
function''. ``He also uses it as a pacemaker.'' ``Since 2014, he has 
not had ICD therapy because he underwent a procedure to correct that 
problem''. ``Considering his cardiac issues, he is safer to drive 
professionally now than he ever has been.''

Andre Williams

    Mr. Williams is a 57 year old CDL holder in Georgia. An August 2015 
letter from his cardiologist reports that Mr. Williams's ICD was 
implanted in February 2013. ``His ICD has been checked every 6 months 
and has not fired/deployed''. ``He has done well with no ICD shocks''.

Request for Comments

    In accordance with 49 U.S.C. 31315 and 31136(e), FMCSA requests 
public comment from all interested persons on the exemption 
applications described in this notice. We will consider all comments 
received before the close of business on the closing date indicated 
earlier in the notice.

    Issued on: November 13, 2015.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2015-30156 Filed 11-25-15; 8:45 am]
 BILLING CODE 4910-EX-P