Document ID: FMCSA-2012-0081-0012
Agency: fmcsa
Document Type: Notice
Title: Qualification of Drivers; Exemption Applications: Implantable Cardioverter Defibrillators
Posted Date: 2015-04-21T04:00Z

[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22259-22261]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-09068]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0081]

Qualification of Drivers; Exemption Applications; Implantable 
Cardioverter Defibrillators

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

ACTION: Notice of application for exemption; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 15 individuals 
for an exemption from the cardiovascular standard [49 CFR 
391.41(b)(4)]. These 15 individuals are requesting an exemption due to 
the presence of implantable cardioverter defibrillators (ICD) as a 
result of their underlying cardiac condition. Of the 15 individuals 
requesting exemptions, three individuals (Craig Bohms, James Dean, and 
Mark Steiner) were previously published in a January 2014 Federal 
Register under the docket listed above. A final decision was not issued 
on these three individuals because the Agency was in the process of 
gathering and analyzing additional data concerning ICDs and commercial 
motor vehicle (CMV) driving. These three individuals are being 
published again with 12 new individuals. If granted, an exemption would 
enable these individuals with ICDs to operate CMVs for up to 2 years in 
interstate commerce.

DATES: Comments must be received on or before May 21, 2015.

ADDRESSES: You may submit comments bearing the Federal Docket 
Management System (FDMS) Docket ID FMCSA-2012-0081 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: Charles A. Horan, III, Director, 
Office of Carrier, Driver and Vehicle Safety, (202) 366-4001, or via 
email at fmcsamedical@dot.gov, or by letter to FMCSA, Room W64-113, 
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.

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-2012-0081'' 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-2012-0081'' 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

[[Page 22260]]

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

Craig Bohms

    Mr. Bohms is a 57-year-old Class A CDL holder in Illinois. Mr. 
Bohms documents that his ICD was implanted in 2013. A March 13, 2015, 
letter from his cardiologist reports Mr. Bohms ``is doing well feeling 
good and has not needed or had any shock therapy from his 
defibrillator. He is stable from a heart rhythm standpoint and may 
drive for his job from that standpoint.''

James Dean

    Mr. Dean is a 55-year-old from Wisconsin. A November 2014 medical 
document received from Mr. Dean indicates that his ICD was implanted in 
August of 2007. An April 2014 routine in-clinic visit document 
indicates no ventricular tachycardia episodes detected and that the 
patient states feeling well with no dizziness or syncope. A March 2014 
document from St. Mary's Hospital indicates Mr. Dean has a rate 
responsive dual chamber ICD.

Daniel Donahue

    Mr. Donahue is a 72-year-old Class A CDL holder in Wisconsin. A 
February 4, 2015 letter from his cardiologist reports that Mr. 
Donahue's ICD was implanted in December 2004. ``[Mr. Donahue ]has never 
required any therapy from his ICD. Since September 2013 to the date of 
this letter, [Mr. Donahue] has only one event of ventricular 
tachycardia which lasted 7 seconds, and did not require any therapy 
from his ICD. His ejection fraction has improved to 42% on his last 
echocardiogram which was done in September 2013.''

Bernard Fritzon

    Mr. Fritzon is a 56-year-old Class A CDL holder in Kansas. A 
February 16, 2015 letter from his cardiologist reports that ``[Mr. 
Fritzon] received an ICD for secondary prevention due to non-ischemic 
cardiomyopathy, and atrial fibrillation. The device was implanted for 
secondary prevention after witnessed ventricular tachycardia during a 
cardiac procedure. Mr. Fritzon's last documented shock from his ICD was 
in April 2014. He has received 3 total inappropriate shocks for atrial 
fibrillation with rapid ventricular response. He is on optimal medical 
therapy for his condition and is stable from a cardiac standpoint.''

Terry Goodhile

    Mr. Goodhile is a 56-year-old from Pennsylvania. A December 2014 
medical form from St. Luke's Occupational Medicine reports that he has 
``hypertrophic cardiomyopathy with ICD.'' The report states that ``he 
is medically stable and is closely monitored by the provider and his 
cardiologist every 3 months.'' Mr. Goodhile reports in a letter that 
his ``ICD was implanted in April 2013 and has never delivered a 
shock.''

Ronald Heinlein

    Mr. Heinlein is a 55-year-old from California. His dual chamber ICD 
was implanted in 2008. A February 6, 2015, letter from his cardiologist 
reports that his device is ``for the purpose of life saving as a back-
up, and that the device has never been used and may never be used.''

David Jensen

    Mr. Jensen is a 52-year-old from California. A February 2, 2015, 
letter from his cardiologist states that his ICD was ``placed in 2011 
and he has had no device firings and no clinical events or arrhythmias. 
He is not prone to syncopal episodes and has never had any in the past. 
He engages in other high risk activities such as parachuting and hang 
gliding.'' His cardiologist reports ``there is no contraindication to 
holding a motor vehicle license for either commercial or non-commercial 
vehicles based on the presence of his ICD.''

Douglas Lopez

    Mr. Lopez is a 32-year-old from New York. His ICD was implanted in 
2011. A February 6, 2015, letter from his cardiologist reports that Mr. 
Lopez's ``device has never fired. His underlying cardiac condition is 
well compensated and stable with therapy.'' Mr. Lopez wrote in a letter 
to the FMCSA that he plays sports, coaches various children's 
athletics, and would be considered an extremely active individual. If 
granted an exemption, Mr. Lopez would like to resume driving a truck in 
interstate commerce.

Leslie Mitchell

    Mr. Mitchell is a 55-year-old Class A CDL holder in Minnesota. He 
has a pacemaker ICD/defibrillator that was implanted in March 2014. In 
July 2014 his cardiologist wrote that ``Mr. Mitchell has had near 
complete recovery of his heart function thanks in part to medication 
and pacemaker therapy. We have seen no evidence concerning heart 
arrhythmias and he does not require defibrillator therapy.'' In August 
2014 his cardiology specialists wrote that ``due to his improved 
cardiac status the tachycardia therapy portion of his biventricular 
Internal Cardiac Defibrillator was disabled (as recommended by his 
physicians). The biventricular pacing (pacemaker) portion of his CRT-D 
device remains functional.''

Michael Politz

    Mr. Politz is a 50-year-old non-CDL holder from Washington State. A 
March 2014 letter from his cardiologist reports that Mr. Politz had a 
defibrillator implanted ``in 2012 for a primary ventricular 
fibrillation. A stress test in Jan 2013 demonstrated ejection fraction 
of 40%, inferior scar but no ischemia. He has had no recurrences of 
hemodynamically significant

[[Page 22261]]

dysrhythmias by monitoring on his implantable defibrillator and no 
syncope, near syncope, or shocks. His cardiologist's letter states that 
he is at a relatively low risk for recurrent episodes as he has been 
revascularized.'' If granted an exemption, Mr. Politz would like to 
resume driving a truck in interstate commerce.

Mark Register

    Mr. Register is a 46-year-old Class B CDL holder in North Carolina. 
An October 2014 affidavit from his cardiologist reports that his ICD 
``was implanted in 2010 for a documented ventricular arrhythmia. Mr. 
Register's ventricular arrhythmia was determined to be a Right 
Ventricular Outflow Tract ventricular tachycardia which was treated by 
ablation in May 2011. His cardiologist is 99.5% confident that the 
source of Mr. Register's original cardiac arrhythmia has been corrected 
and removed. Mr. Register has been clinically stable since that time 
and has experienced no malignant ventricular arrhythmias. His 
defibrillator is medically checked every three months to ensure proper 
function and is ``nothing more than a back-up or ``safety net.'' His 
cardiologist's professional medical opinion is that Mr. Register ``is 
completely and physically capable of operating a commercial motor 
vehicle'' and ``poses no risk in operating a commercial motor 
vehicle.'' His cardiologist cites three recent scholarly articles from 
the Journal of American College of Cardiology and the European Society 
of Cardiology, which conclude that ``patients with defibrillators are 
able to operate motor vehicles just as safely if not more so than the 
general population.''

Charles Rhodes

    Mr. Rhodes is a 59-year-old from Arizona. Mr. Rhodes provided 
medical reports from 2013-2014 from his cardiologists indicating his 
ICD was implanted in February 2013. An October 22, 2014, medical 
history from his cardiologist reports that he follows up regularly in 
the pacemaker clinic every 3 months.

Mark Steiner

    Mr. Steiner is a 65-year-old from Ohio. A January 29, 2015, letter 
from his cardiologist states that his ICD was implanted in 2012 for 
primary prevention. An ICD interrogation conducted on January 29, 2015, 
showed no report of any dysrhythmias or requirement for anti-
tachycardia pacing or defibrillation. His cardiologist states Mr. 
Steiner has had no chest, neck, jaw or arm discomfort, pedal edema, 
near syncope, syncope, or ICD discharge. If granted an exemption, Mr. 
Steiner would like to resume driving a truck in interstate commerce.

Stephen Watts

    Mr. Watts is a 52-year-old Class A CDL holder in Kansas. A December 
2014 letter from his cardiologist reports that his ICD was implanted in 
2013. According to a January 2015 letter from his cardiologists, ``from 
a clinical standpoint he is doing quite well. He has not had any 
shortness of breath, PND or orthopnea. Review of his pacemaker/
defibrillator shows that he has not had any significant dysrhythmias.'' 
A November 2014 letter from his employer states that he has ``driven 
over 1 million accident free miles.'' If granted an exemption, Mr. 
Watts would like to resume driving a truck in interstate commerce.

John Allen Weltz

    Mr. Weltz is a 51-year-old Class A CDL holder in Nebraska. A 
February 2, 2015, letter from his cardiologist reports that Mr. Weltz 
received an ICD on February 28, 2014, and from Mr. Weltz's records, his 
cardiologist does not think he has been shocked. A September 2014 
letter from his cardiologist states, ``He has had no ventricular 
arrhythmias since his ICD was implanted and he is quite stable.'' Mr. 
Weltz reports that for the past 10 years he has been keeping in close 
contact with all of his doctors, keeping all of his medical 
appointments and taking all medication as prescribed.

 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: April 14, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-09068 Filed 4-20-15; 8:45 am]
 BILLING CODE 4910-EX-P