80_FR_65491 80 FR 65285 - Docket No. FMCSA-2012-0081]

80 FR 65285 - Docket No. FMCSA-2012-0081]

DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration

Federal Register Volume 80, Issue 206 (October 26, 2015)

Page Range65285-65286
FR Document2015-27210

FMCSA announces its decision to deny applications from 14 of 15 individuals seeking exemptions from the Federal cardiovascular standard applicable to interstate truck and bus drivers and the reasons for the denials. The Agency reviewed the medical information of each of the individuals who applied for an implantable cardioverter defibrillator (ICD) exemption. Because the medical information received from the cardiologist concerning one individual indicates the ICD has been disabled due to improvement of his heart function, the exemption is no longer needed to operate commercial motor vehicles (CMVs) in interstate commerce. Based on a review of the applications and following an opportunity for public comment, FMCSA has concluded that the remaining 14 individuals in the notice did not demonstrate 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 206 (Monday, October 26, 2015) 
[Federal Register Volume 80, Number 206 (Monday, October 26, 2015)]
[Notices]
[Pages 65285-65286]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27210]


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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 denials of exemption applications.

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SUMMARY: FMCSA announces its decision to deny applications from 14 of 
15 individuals seeking exemptions from the Federal cardiovascular 
standard applicable to interstate truck and bus drivers and the reasons 
for the denials. The Agency reviewed the medical information of each of 
the individuals who applied for an implantable cardioverter 
defibrillator (ICD) exemption. Because the medical information received 
from the cardiologist concerning one individual indicates the ICD has 
been disabled due to improvement of his heart function, the exemption 
is no longer needed to operate commercial motor vehicles (CMVs) in 
interstate commerce. Based on a review of the applications and 
following an opportunity for public comment, FMCSA has concluded that 
the remaining 14 individuals in the notice did not demonstrate 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: Denial letters were sent to each of the individuals listed in 
this notice on July 24, 2015.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief Medical 
Programs Division, 202-366-4001, U.S. Department of Transportation, 
FMCSA, 1200 New Jersey Avenue SE., Room W64-224, 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.
    On April 21, 2015, FMCSA published for public notice and comment, 
FMCSA 2012-0081 listing 15 individuals seeking exemptions for ICDs. 
Accordingly, the Agency has evaluated each applicant's request to 
determine whether granting an exemption will achieve the required level 
of safety mandated by statute.

Evaluation Criteria--Cardiovascular Medical Standard and Advisory 
Criteria

    The individuals included in this notice have requested an exemption 
from the provisions of 49 CFR 391.41(b)(4), which applies to drivers 
who operate CMVs in interstate commerce, as defined in 49 CFR 390.5. 
Section 391.41(b)(4) states that:

``. . . a person is physically qualified to drive a commercial motor 
vehicle 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 (temporary loss of consciousness due to 
a sudden decline in blood flow to the brain), dyspnea (shortness of 
breath), collapse, or congestive cardiac failure.''

    The FMCSA provides medical advisory criteria as recommendations for 
use by medical examiners in determining whether drivers with certain 
medical conditions, procedures, and/or treatments should be certified 
to operate CMVs in interstate commerce in accordance with the various 
physical qualification standards in 49 CFR part 391, subpart E. 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) provide 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

[[Page 65286]]

syncope, dyspnea, collapse, or congestive cardiac failure.
    It is the intent of the FMCSRs to render unqualified, a driver 
who has a current cardiovascular disease which is accompanied by 
and/or likely to cause symptoms of syncope, dyspnea, collapse, or 
congestive cardiac failure. However, the subjective decision of 
whether the nature and severity of an individual's condition will 
likely cause symptoms of cardiovascular insufficiency is on an 
individual basis and qualification rests with the medical examiner 
and the motor carrier.

    In the case of persons with ICDs, the underlying condition for 
which the ICD was implanted places the individual at high risk for 
syncope (a transient loss of consciousness) or other unpredictable 
events known to result in gradual or sudden incapacitation. ICDs may 
discharge, which could result in loss of ability to safely control a 
CMV. See the Evidence Report on Cardiovascular Disease and Commercial 
Motor vehicle Driver Safety, April 2007.\1\ A focused research report 
on Implantable Cardioverter Defibrillators and the Impact of a Shock on 
a Patient When Deployed completed for the FMCSA December 2014 indicates 
that the available scientific data on persons with ICDs and CMV driving 
does not support that persons with ICDs who operate CMVs are able to 
meet an equal or greater level of safety and upholds the findings of 
the April 2007 report.
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    \1\ Now available at http://ntl.bts.gov/lib/30000/30100/30123/Final_CVD_Evidence_Report_v2.pdf.
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Discussion of Public Comments

    On April 21, 2015, FMCSA published in a Federal Register Notice, 
the names of 15 individuals requesting ICD exemption and requested 
public comment. The public comment period closed on May 21, 2015. A 
total of 29 commenters responded to the notice. The majority of 
commenters were in favor of the applicants continuing to drive CMV's 
with ICD's. Commenters believed that the individuals seeking exemptions 
were responsible drivers who had safe driving histories and were 
compliant with their medical treatment programs. One anonymous 
commenter encouraged the FMCSA not to grant these individuals 
exemptions due to concerns of the risks of the underlying medical 
conditions in combination with operating a commercial motor vehicle.

FMCSA's Response

    FMCSA acknowledges the commenters' reports of medical compliance 
and safe driving histories of the applicants. However, based on the 
available medical literature and data, FMCSA believes that drivers with 
an ICD are at risk for incapacitation if the device discharges in 
response to cardiovascular symptoms. This risk is combined with the 
risks associated with the underlying cardiovascular condition for which 
the ICD has been implanted as a primary or secondary preventive 
measure.
    Mr. Leslie Mitchell no longer has a functioning ICD and may operate 
CMVs in interstate commerce based on the decision of the medical 
examiner. Mr. Mitchell has a pacemaker/ICD but the ICD portion was 
disabled because his cardiologist determined he no longer needs 
tachycardia therapy. Therefore, if a medical examiner determines that 
he meets the cardiovascular standard and all other physical 
qualification standards for operating a commercial motor vehicle in 
interstate commerce, he may be issued a medical certificate.

Conclusion

    FMCSA evaluated the remaining 14 of 15 individual exemption 
requests on their merits, available data from Evidence Reports and 
Medical Expert Panel opinions on ICDs and commercial motor vehicle 
driving, and the public comments received. The Agency has determined 
that the available medical literature and data does not support a 
conclusion that granting these exemptions would achieve a level of 
safety equivalent to or greater than, the level of safety maintained 
without the exemptions. Each applicant has, prior to this notice, 
received a letter of final disposition on his/her exemption request. 
Those decision letters fully outlined 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 14 applicants are denied exemptions from the 
cardiovascular standard concerning ICDs.

Craig Bohms
James Dean
Terry Goodhile
David Allan Jensen
Michael Politz
Charles Rhodes
Mark Steiner
Daniel Donahue
Bernard Fritzson
Ronald Heinlein
Douglas Lopez
Mark Register
Stephen Watts
John Allen Weltz

    Issued on: October 15, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-27210 Filed 10-23-15; 8:45 am]
 BILLING CODE 4910-EX-P

Federal Register / Vol. 80, No. 206 / Monday, October 26, 2015 / Notices 65285 12, 2015. This collection is necessary in Estimated Average Burden per SUPPLEMENTARY INFORMATION: order to determine applicants’ Response: 30 minutes. Estimated Total Annual Burden: 225 Background qualifications for certification as Aviation Medical Examiners (AMEs). hours. Under 49 U.S.C. 31136(e) and 31315, DATES: Written comments should be Issued in Washington, DC, on October 14, FMCSA may grant an exemption from submitted by November 25, 2015. 2015. the Federal Motor Carrier Safety Ronda Thompson, Regulations for a 2-year period if it finds ADDRESSES: Interested persons are ‘‘such exemption would likely achieve a invited to submit written comments on FAA Information Collection Clearance Officer, IT Enterprises Business Services level of safety that is equivalent to or the proposed information collection to greater than the level that would be Division, ASP–110. the Office of Information and Regulatory achieved absent such exemption.’’ Affairs, Office of Management and [FR Doc. 2015–27171 Filed 10–23–15; 8:45 am] FMCSA can renew exemptions at the Budget. Comments should be addressed BILLING CODE 4910–13–P end of each 2-year period. to the attention of the Desk Officer, On April 21, 2015, FMCSA published Department of Transportation/FAA, and for public notice and comment, FMCSA sent via electronic mail to oira_ DEPARTMENT OF TRANSPORTATION 2012–0081 listing 15 individuals submission@omb.eop.gov, or faxed to Federal Motor Carrier Safety seeking exemptions for ICDs. (202) 395–6974, or mailed to the Office Administration Accordingly, the Agency has evaluated of Information and Regulatory Affairs, each applicant’s request to determine Office of Management and Budget, Docket No. FMCSA–2012–0081] whether granting an exemption will Docket Library, Room 10102, 725 17th achieve the required level of safety Street NW., Washington, DC 20503. Qualification of Drivers; Exemption mandated by statute. Public Comments Invited: You are Applications; Implantable Cardioverter asked to comment on any aspect of this Evaluation Criteria—Cardiovascular Defibrillators information collection, including (a) Medical Standard and Advisory Whether the proposed collection of AGENCY: Federal Motor Carrier Safety Criteria information is necessary for FAA’s Administration (FMCSA), DOT. The individuals included in this performance; (b) the accuracy of the ACTION: Notice of denials of exemption notice have requested an exemption estimated burden; (c) ways for FAA to applications. from the provisions of 49 CFR enhance the quality, utility and clarity SUMMARY: FMCSA announces its 391.41(b)(4), which applies to drivers of the information collection; and (d) decision to deny applications from 14 of who operate CMVs in interstate ways that the burden could be 15 individuals seeking exemptions from commerce, as defined in 49 CFR 390.5. minimized without reducing the quality the Federal cardiovascular standard Section 391.41(b)(4) states that: of the collected information. The agency applicable to interstate truck and bus ‘‘. . . a person is physically qualified to drive will summarize and/or include your drivers and the reasons for the denials. a commercial motor vehicle if that person has comments in the request for OMB’s The Agency reviewed the medical no current clinical diagnosis of myocardial clearance of this information collection. information of each of the individuals infarction, angina pectoris, coronary FOR FURTHER INFORMATION CONTACT: insufficiency, thrombosis, or any other who applied for an implantable cardiovascular disease of a variety known to Ronda Thompson at (202) 267–1416, or cardioverter defibrillator (ICD) be accompanied by syncope (temporary loss by email at: Ronda.Thompson@faa.gov. exemption. Because the medical of consciousness due to a sudden decline in SUPPLEMENTARY INFORMATION: information received from the blood flow to the brain), dyspnea (shortness OMB Control Number: 2120–0604. cardiologist concerning one individual of breath), collapse, or congestive cardiac Title: Aviation Medical Examiner indicates the ICD has been disabled due failure.’’ Program. to improvement of his heart function, The FMCSA provides medical Form Numbers: FAA Form 8520–2. the exemption is no longer needed to advisory criteria as recommendations Type of Review: Renewal of an operate commercial motor vehicles for use by medical examiners in information collection. (CMVs) in interstate commerce. Based determining whether drivers with Background: The Federal Register on a review of the applications and certain medical conditions, procedures, Notice with a 60-day comment period following an opportunity for public and/or treatments should be certified to soliciting comments on the following comment, FMCSA has concluded that operate CMVs in interstate commerce in collection of information was published the remaining 14 individuals in the accordance with the various physical on August 12, 2015 (80 FR 48391). 14 notice did not demonstrate they could qualification standards in 49 CFR part CFR part 183 describes the requirements achieve a level of safety that is 391, subpart E. The advisory criteria are for delegating to private physicians the equivalent to, or greater than, the level currently set out as part of the medical authority to conduct physical of safety that would be obtained by examination report published with 49 examinations on persons wishing to complying with the regulation. CFR 391.43. The advisory criteria for apply for their airmen medial certificate. DATES: Denial letters were sent to each section 391.41(b)(4) provide that: This collection of information is for the of the individuals listed in this notice The term ‘‘has no current clinical diagnosis purpose of obtaining essential on July 24, 2015. of’’ is specifically designed to encompass: ‘‘a information concerning the applicants’ FOR FURTHER INFORMATION CONTACT: Ms. clinical diagnosis of’’ (1) a current asabaliauskas on DSK5VPTVN1PROD with NOTICES professional and personal qualifications. Christine A. Hydock, Chief Medical cardiovascular condition, or (2) a The FAA uses the information to screen Programs Division, 202–366–4001, U.S. cardiovascular condition which has not fully and select the designees who serve as stabilized regardless of the time limit. The Department of Transportation, FMCSA, term ‘‘known to be accompanied by’’ is aviation medical examiners. 1200 New Jersey Avenue SE., Room designed to include a clinical diagnosis of a Respondents: Approximately 450 W64–224, Washington, DC 20590–0001. cardiovascular disease (1) which is applicants annually. Office hours are from 8:30 a.m. to 5 p.m. accompanied by symptoms of syncope, Frequency: Information is collected Monday through Friday, except Federal dyspnea, collapse or congestive cardiac on occasion. holidays. failure; and/or (2) which is likely to cause VerDate Sep<11>2014 18:53 Oct 23, 2015 Jkt 238001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 E:\FR\FM\26OCN1.SGM 26OCN1

65286 Federal Register / Vol. 80, No. 206 / Monday, October 26, 2015 / Notices syncope, dyspnea, collapse, or congestive ICD are at risk for incapacitation if the DEPARTMENT OF TRANSPORTATION cardiac failure. device discharges in response to It is the intent of the FMCSRs to render cardiovascular symptoms. This risk is Pipeline and Hazardous Materials unqualified, a driver who has a current combined with the risks associated with Safety Administration cardiovascular disease which is accompanied by and/or likely to cause symptoms of the underlying cardiovascular condition [Docket ID PHMSA–2014–0092] syncope, dyspnea, collapse, or congestive for which the ICD has been implanted cardiac failure. However, the subjective as a primary or secondary preventive Pipeline Safety: National Pipeline decision of whether the nature and severity measure. Mapping System; Extension of of an individual’s condition will likely cause Mr. Leslie Mitchell no longer has a Comment Period and Notice of symptoms of cardiovascular insufficiency is functioning ICD and may operate CMVs Operator Workshop on an individual basis and qualification rests in interstate commerce based on the with the medical examiner and the motor decision of the medical examiner. Mr. AGENCY: Pipeline and Hazardous carrier. Mitchell has a pacemaker/ICD but the Materials Safety Administration In the case of persons with ICDs, the ICD portion was disabled because his (PHMSA), DOT. underlying condition for which the ICD cardiologist determined he no longer ACTION: Notice and request for was implanted places the individual at needs tachycardia therapy. Therefore, if comments; extension of comment high risk for syncope (a transient loss of a medical examiner determines that he period and announcement of a National consciousness) or other unpredictable meets the cardiovascular standard and Pipeline Mapping System Operator events known to result in gradual or all other physical qualification Technical Workshop. sudden incapacitation. ICDs may standards for operating a commercial discharge, which could result in loss of motor vehicle in interstate commerce, SUMMARY: PHMSA is sponsoring a one- ability to safely control a CMV. See the he may be issued a medical certificate. day National Pipeline Mapping System Evidence Report on Cardiovascular (NPMS) operator technical workshop on Conclusion November 18, 2015, at a Washington, Disease and Commercial Motor vehicle Driver Safety, April 2007.1 A focused FMCSA evaluated the remaining 14 of DC area hotel. This notice also research report on Implantable 15 individual exemption requests on announces that the comment period for Cardioverter Defibrillators and the their merits, available data from the 60-day information collection Impact of a Shock on a Patient When Evidence Reports and Medical Expert published on August 27, 2015, (80 FR Deployed completed for the FMCSA Panel opinions on ICDs and commercial 52084) is extended until November 25, December 2014 indicates that the motor vehicle driving, and the public 2015, in order to conduct this workshop available scientific data on persons with comments received. The Agency has that will provide PHMSA with ICDs and CMV driving does not support determined that the available medical important information as it prepares to that persons with ICDs who operate literature and data does not support a improve the NPMS submission process CMVs are able to meet an equal or conclusion that granting these to accept additional data. greater level of safety and upholds the exemptions would achieve a level of DATES: The NPMS operator technical findings of the April 2007 report. safety equivalent to or greater than, the workshop will be held on November 18, level of safety maintained without the 2015, at a Washington, DC-area hotel, Discussion of Public Comments exemptions. Each applicant has, prior to from 8:00 a.m. to 5:00 p.m. The On April 21, 2015, FMCSA published this notice, received a letter of final comment period for the 60-day in a Federal Register Notice, the names disposition on his/her exemption information collection published on of 15 individuals requesting ICD request. Those decision letters fully August 27, 2015 (80 FR 52084) is exemption and requested public outlined the basis for the denial and extended from October 26, 2015 to comment. The public comment period constitute final Agency action. The list November 25, 2015. closed on May 21, 2015. A total of 29 published today summarizes the ADDRESSES: The workshop location, and commenters responded to the notice. Agency’s recent denials as required hotel information will be announced in The majority of commenters were in under 49 U.S.C. 31315(b)(4). PRIMIS at https://primis.phmsa.dot.gov/ favor of the applicants continuing to The following 14 applicants are meetings/MtgHome.mtg?mtg=107 once drive CMV’s with ICD’s. Commenters denied exemptions from the the conference room space has been believed that the individuals seeking cardiovascular standard concerning procured. exemptions were responsible drivers ICDs. FOR FURTHER INFORMATION CONTACT: who had safe driving histories and were Craig Bohms Amy Nelson at 202–493–0591 or by compliant with their medical treatment James Dean Terry Goodhile email at amy.nelson@dot.gov. programs. One anonymous commenter David Allan Jensen SUPPLEMENTARY INFORMATION: The encouraged the FMCSA not to grant these individuals exemptions due to Michael Politz purpose of the workshop is to discuss concerns of the risks of the underlying Charles Rhodes and understand existing and future Mark Steiner NPMS submission technical issues such medical conditions in combination with Daniel Donahue operating a commercial motor vehicle. as (1) the format in which operators are Bernard Fritzson storing the data that is submitted to the FMCSA’s Response Ronald Heinlein NPMS, (2) how pipe segmentation for Douglas Lopez the submissions is determined, (3) how asabaliauskas on DSK5VPTVN1PROD with NOTICES FMCSA acknowledges the Mark Register commenters’ reports of medical data is submitted in a linear referencing Stephen Watts compliance and safe driving histories of John Allen Weltz format, and (4) options Geographic the applicants. However, based on the Information Systems technicians have Issued on: October 15, 2015. when an attribute includes the word available medical literature and data, Larry W. Minor, ‘‘predominant’’ (i.e., submitting actual FMCSA believes that drivers with an Associate Administrator for Policy. data or rolling up data to create a 1 Now available at http://ntl.bts.gov/lib/30000/ [FR Doc. 2015–27210 Filed 10–23–15; 8:45 am] ‘‘predominant’’ value). This workshop 30100/30123/Final_CVD_Evidence_Report_v2.pdf. BILLING CODE 4910–EX–P will not discuss any proposed new data VerDate Sep<11>2014 18:53 Oct 23, 2015 Jkt 238001 PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 E:\FR\FM\26OCN1.SGM 26OCN1


Document Created: 2018-02-27 08:56:05
Document Modified: 2018-02-27 08:56:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of denials of exemption applications.
DatesDenial letters were sent to each of the individuals listed in this notice on July 24, 2015.
ContactMs. Christine A. Hydock, Chief Medical Programs Division, 202-366-4001, U.S. Department of Transportation, FMCSA, 1200 New Jersey Avenue SE., Room W64-224, Washington, DC 20590- 0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through Friday, except Federal holidays.
FR Citation80 FR 65285 
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