Document ID: FMCSA-2016-0175-0001
Agency: fmcsa
Document Type: Notice
Title: Qualification of Drivers; Exemption Applications: Implantable Cardioverter Defibrillators
Posted Date: 2016-08-08T04:00Z

[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52512-52514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18737]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0175]

Qualification of Drivers; Exemption Applications; Implantable 
Cardioverter Defibrillators

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

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

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SUMMARY: FMCSA announces receipt of applications from eleven 
individuals for exemptions from the rules prohibiting operation of a 
commercial motor vehicle (CMV) by persons with a current clinical 
diagnosis of myocardial infarction, angina pectoris, coronary 
insufficiency, thrombosis, or any other cardiovascular disease of a 
variety known to be accompanied by syncope, dyspnea, collapse, or 
congestive heart failure. If granted, the exemptions would enable these 
individuals to operate CMVs for up to two years in interstate commerce.

DATES: Comments must be received on or before September 7, 2016.

ADDRESSES: You may submit comments bearing the Federal Docket 
Management System (FDMS) Docket ID FMCSA-2016-0175 using any of the 
following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov. 
Follow the online 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.
    Instructions: Each submission must include the Agency name and the 
docket ID for this Notice. Note that all comments received will be 
posted without change to http://www.regulations.gov, including any 
personal information provided. Please see the Privacy Act heading below 
for further information.
    Docket: For access to the docket to read background documents or 
comments, go to http://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 online.
    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 http://www.regulations.gov, as described in 
the system records notice (DOT/ALL-14 FDMS), which can be reviewed at 
http://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 New Jersey Avenue SE., Room W64-113, 
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., 
e.t., Monday through Friday, except Federal holidays.

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption 
from the Federal Motor Carrier Safety Regulations (FMCSRs) for a two-
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 two-year period. The eleven 
individuals listed in this notice have requested an exemption from 49 
CFR 391.41(b)(4), which applies to drivers who operates CMVs in 
interstate commerce. Accordingly, the Agency will evaluate the 
qualifications of each applicant to determine whether granting the 
exemption will achieve the required level of safety mandated by 
statute.
    The physical qualification standard found in 49 CFR 391.41(b)(4) 
states that a person is physically qualified to drive a CMV if that 
person

    Has no current clinical diagnosis of myocardial infarction, 
angina pectoris, coronary insufficiency, thrombosis, or any other 
cardiovascular disease of a variety known to be accompanied by 
syncope, dyspnea, collapse, or congestive cardiac failure.

    In addition to the regulations, FMCSA has published advisory 
criteria \1\ to

[[Page 52513]]

assist medical examiners in determining whether drivers with certain 
medical conditions are qualified to operate a CMV in interstate 
commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL ADVISORY 
CRITERIA, section D. Cardiovascular: Sec.  391.41(b)(4), paragraph 4.] 
The advisory criteria states that ICDs are disqualifying due to risk of 
syncope.
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    \1\ See http://www.ecfr.gov/cgi-bin/text-idx?SID=e47b48a9ea42dd67d999246e23d97970&mc=true&node=pt49.5.391&rgn=div5#ap49.5.391_171.a and https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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Qualifications of Applicants

Charles R. Allen
    Mr. Allen is a 47 year old commercial motor vehicle driver in 
Michigan. A report that he provided from July 2015 from the Veterans 
Administration Ann Arbor Healthcare System provider indicates, ``he has 
well compensated class-I-II congestive heart failure with and ICD. He 
has a normal ejection fraction of 50-55%''.
William Blake
    Mr. Blake is a 57 year old Class A CDL holder in New Hampshire. His 
ICD was implanted in June 2015 and has never deployed. A January 5, 
2016 cardiologist report indicates; ``No symptoms referable to ICD or 
underlying rhythm changes. I believe the risk of recurrent ventricular 
tachy-arrhythmias or syncope is very low, however, given the history of 
these abnormalities and the family history of arrhythmias I would favor 
continued ICD implantation''.
Roosevelt Tyrone Brown
    Mr. Brown is a 54 year old Class A CDL holder in South Carolina. A 
March 17, 2016 letter from his cardiologist states that Mr. Brown's ICD 
was implanted October 15, 2013, and that recent echocardiography 
demonstrated an ejection fraction in the 25-30 percent range and a 
calculated ejection fraction of 24% from nuclear stress testing. A 
March 10, 2016 report from his electrophysiologist indicates that Mr. 
Brown has reported one shock from his device. Overall he feels well and 
denies chest pain, shortness of breath, or dyspnea on exertion.
Kevin Coulter
    Mr. Coulter is a 60 year old Class A CDL holder in California. A 
June 2016 letter from his cardiologist states that his ICD was 
implanted in February 2015. No shock has deployed since implantation. 
He has been asymptomatic. He has an ejection fraction of 40-45%, most 
recently measured in April 2015.
John Dudar
    Mr. Dudar is a 55 year old Class A CDL holder in Connecticut. An 
undated cardiologist report indicates that the ICD has been in place 
since 2003. ``He has experienced several shocks from his device and 
around that time was upgraded to biventricular ICD. At least back to 
2009 he has not received any ICD discharges. His device is stable and 
at this point he really has no significant heart failure symptoms. His 
last ejection fraction was estimated at 25% in August 2013. His cardiac 
issues appear stable. He has had no recent ventricular arrhythmias and 
he has a normally functioning Biv-ICD''.
Timothy Godwin
    Mr. Godwin is a 51 year old Class A CDL holder in North Carolina. A 
March 30 2016 report from his cardiac electrophysiologist indicates 
knowledge of the driver and his condition since 2014 and that (Mr. 
Godwin) has not required any therapies before or after ICD implant, nor 
has he lost consciousness at any time. ``I consider him to be safer 
than most other commercial drives who have undiagnosed or untreated 
cardiovascular problems. I feel that rather than the presence or 
absence of an ICD in a patient what is most important is the underlying 
cardiac condition and risk for loss of consciousness. Treated, Mr. 
Godwin is at average risk''.
James Goslee
    Mr. Goslee is a 52 year old driver in Maryland. A May 2016 letter 
from his cardiologist states that his ICD was implanted in June 2104. 
His ICD has never delivered therapy. He follows up regularly in the 
office and is free of cardiac complaints. An April 2016 study shows an 
ejection fraction of 65-70% and an exercise tolerance at 10 minutes of 
Bruce protocol. The current status of underlying heart condition is low 
intermediate cardiovascular risk profile.
Richard Hacker
    Mr. Hacker is 62 year old Class A CDL holder in Maryland. Medical 
documents from June 2016 from his cardiologist state that his ICD was 
implanted in 2007. The device check in June 2016 indicated no events 
for 10.5 years. Mr. Hacker's ejection fraction is 53%. His medical 
documentation indicates that he has no symptoms.
Kathryn Kosse
    Ms. Kosse is a 63 year old Class D holder in Arizona. A May 2016 
letter from her cardiologist states that her defibrillator was 
implanted in October 2014. ``Her ICD has never deployed and her 
symptoms have completely resolved. Her left ventricular ejection 
fraction is normal. Ms. Kosse appears to be in stable cardiovascular 
health''.
Joseph Skrzyniarz
    Mr. Skrzyniarz is a 56 year old Class A CDL holder in Michigan. He 
possesses a one-year Michigan waiver dated October 22, 2015 for 
intrastate driving. A September 15, 2015 cardiologist-
electrophysiologist report indicates that his ICD has been implanted 
since February 2015. He has not received any ICD shocks from his device 
at this time. ``He had two episodes of asymptomatic non-sustained 
ventricular tachycardia. His condition is stable over the past year and 
unchanged. He has not had any ICD shocks or dangerous arrhythmias. He 
has been asymptomatic and is safe to operate a commercial vehicle in 
accordance to his job description which was provided. I have no 
reservations at this time''. A September 17 cardiologist report 
provides that, ``To date the device has not been activated and his 
underlying cardiac condition has been deemed stable.''
Wylanne Deon Stafford
    Mr. Stafford is a 48 year old driver in Illinois. An April 26, 2016 
report from his cardiologist indicates that Mr. Stafford's ICD was 
implanted in 2011 and has never fired. His cardiologist indicates that 
since ICD placement, his ejection fraction has normalized to 55% and he 
is asymptomatic and stable.

II. Request for Comments

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

III. 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-2016-0175'' and 
click the search button. When the new screen appears, click on the blue 
``Comment

[[Page 52514]]

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 materials received during the 
comment period. FMCSA may issue a final determination any time after 
the close of the comment period.

IV. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this 
preamble, go to http://www.regulations.gov and in the search box insert 
the docket number FMCSA-2016-0175 and click ``Search.'' Next, click 
``Open Docket Folder'' and you will find all documents and comments 
related to this notice.

    Issued on: July 29, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-18737 Filed 8-5-16; 8:45 am]
 BILLING CODE 4910-EX-P