Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD), 40637-40638 [2018-17588]

Download as PDF Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices functions; (2) the accuracy of the estimated burden; (3) ways for the FMCSA to enhance the quality, usefulness, and clarity of the collected information; and (4) ways that the burden could be minimized without reducing the quality of the collected information. Issued under the authority delegated in 49 CFR 1.87 on August 3, 2018. G. Kelly Regal, Associate Administrator for Office of Research and Information Technology. [FR Doc. 2018–17568 Filed 8–14–18; 8:45 am] BILLING CODE 4910–EX–P DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA–2017–0326] Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD) Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of denials. AGENCY: FMCSA announces its decision to deny applications from seven individuals treated with Implantable Cardioverter Defibrillators (ICDs) who requested an exemption from the Federal Motor Carrier Safety Regulations (FMCSRs) prohibiting operation of a commercial motor vehicle (CMV) in interstate commerce 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. FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366–4001, fmcsamedical@dot.gov, FMCSA, Department of Transportation, 1200 New Jersey Avenue SE, Room W64–224, Washington, DC 20590–0001. Office hours are from 8:30 a.m. to 5 p.m., e.t., Monday through Friday, except Federal holidays. If you have questions regarding viewing or submitting material to the docket, contact Docket Services, telephone (202) 366–9826. SUPPLEMENTARY INFORMATION: daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: I. Electronic Access You may see all the comments online through the Federal Document Management System (FDMS) at: https:// www.regulations.gov. Docket: For access to the docket to read background documents or VerDate Sep<11>2014 18:28 Aug 14, 2018 Jkt 244001 comments, go to https:// 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: 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 https://www.regulations.gov, as described in the system of records notice (DOT/ALL–14 FDMS), which can be reviewed at https://www.dot.gov/ privacy. II. Background On January 31, 2018, FMCSA published a FR notice (83 FR 4545) announcing receipt of applications from seven individuals treated with ICDs and requested comments from the public. These seven individuals requested an exemption from 49 CFR 391.41(b)(4) which prohibits operation of a CMV in interstate commerce 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. The public comment period closed on May 2, 2018 and one comment was received. FMCSA has evaluated the eligibility of these applicants and concluded that granting these exemptions would not provide a level of safety that would be equivalent to or greater than, the level of safety that would be obtained by complying with the regulation 49 CFR 391.41(b)(4). A summary of each applicant’s medical history related to their ICD exemption request was discussed in the March 2, 2018, Federal Register notice and will not be repeated in this notice. In reaching the decision to deny these exemption requests, the Agency considered information from the Cardiovascular Medical Advisory Criteria, the April 2007 Evidence Report ‘‘Cardiovascular Disease and Commercial Motor Vehicle Driver Safety, and a December 2014 focused research report ‘‘Implantable Cardioverter Defibrillators and the Impact of a Shock in a Patient When Deployed.’’ Copies of the reports are included in the docket. FMCSA has published advisory criteria to assist medical examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate PO 00000 Frm 00139 Fmt 4703 Sfmt 4703 40637 commerce. [Appendix A to Part 391— Medical Advisory Criteria, section D, paragraph 4]. The advisory criteria for 49 CFR 391.41(b)(4) indicates that coronary artery bypass surgery and pacemaker implantation are remedial procedures and thus, not medically disqualifying. Implantable cardioverter defibrillators are disqualifying due to risk of syncope. III. Discussion of Comments FMCSA received one comment in this proceeding from an individual who is in favor of any ICD treated individual who has not had any issues for six months, and who has clearance from their cardiologist, being allowed to drive a CMV. FMCSA acknowledges the commenters’ responses concerning stable medical histories with ICDs. Based on the available medical literature cited above, FMCSA believes that a driver with an ICD is at risk for incapacitation if the device discharges. 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. IV. Basis for Exemption Determination Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption if it finds such an exemption would likely achieve a level of safety that is equivalent to, or greater then, the level that would be achieved absent such an exemption. The Agency’s decision regarding these exemption applications is based on an individualized assessment of each applicant’s medical information provided by the applicant, available medical and scientific data concerning ICD’s, and public comments received. 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 April 2007 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 1 Now available at https://ntl.bts.gov/lib/30000/ 30100/30123/Final_CVD_Evidence_Report_v2.pdf. E:\FR\FM\15AUN1.SGM 15AUN1 40638 Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices operate CMVs are able to meet an equal or greater level of safety and upholds the findings of the April 2007 report. V. Conclusion The Agency has determined that the available medical and scientific literature and research provides insufficient data to enable the Agency to conclude that granting these exemptions would achieve a level of safety equivalent to, or greater than, the level of safety maintained without the exemption. Therefore, the following seven applicants have been denied exemptions from the physical qualification standards in 49 CFR 391.41(b)(4): Frank D’Ercole (NJ) Myles Goodwin (NH) Cody Hairr (NC) Dennis R. Pickett (IN) William E. Richardson, Jr. (MI) Terry Stephens ( VA) Jeffrey A. Weiner ( MN) Each applicant has, prior to this notice, received a letter of final disposition regarding his/her exemption request. Those decision letters fully outlined the basis for the denial and constitutes final action by the Agency. The list published today summarizes the Agency’s recent denials as required under 49 U.S.C. 31315(b)(4). Issued on: August 8, 2018. Larry W. Minor, Associate Administrator for Policy. [FR Doc. 2018–17588 Filed 8–14–18; 8:45 am] BILLING CODE 4910–EX–P DEPARTMENT OF TRANSPORTATION daltland on DSKBBV9HB2PROD with NOTICES Federal Motor Carrier Safety Administration [Docket No. FMCSA–1999–6480; FMCSA– 2000–7006; FMCSA–2000–7165; FMCSA– 2002–12294; FMCSA–2004–17195; FMCSA– 2005–22194; FMCSA–2006–23773; FMCSA– 2006–24783; FMCSA–2008–0021; FMCSA– 2008–0106; FMCSA–2008–0174; FMCSA– 2008–0231; FMCSA–2009–0291; FMCSA– 2010–0082; FMCSA–2010–0114; FMCSA– 2011–0299; FMCSA–2011–0325; FMCSA– 2012–0104; FMCSA–2012–0161; FMCSA– 2012–0214; FMCSA–2013–0166; FMCSA– 2013–0168; FMCSA–2014–0002; FMCSA– 2014–0003; FMCSA–2014–0004; FMCSA– 2014–0005; FMCSA–2014–0006; FMCSA– 2014–0007; FMCSA–2014–0010; FMCSA– 2015–0070; FMCSA–2015–0072; FMCSA– 2015–0350; FMCSA–2015–0351; FMCSA– 2016–0028; FMCSA–2016–0029; FMCSA– 2016–0030; FMCSA–2016–0031; FMCSA– 2016–0033] Qualification of Drivers; Exemption Applications; Vision Federal Motor Carrier Safety Administration (FMCSA), DOT. AGENCY: VerDate Sep<11>2014 18:28 Aug 14, 2018 Jkt 244001 Notice of renewal of exemptions; request for comments. ACTION: FMCSA announces its decision to renew exemptions for 88 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these individuals to continue to operate CMVs in interstate commerce without meeting the vision requirements in one eye. DATES: Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates stated in the discussions below. Comments must be received on or before September 14, 2018. ADDRESSES: You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA– 1999–6480; FMCSA–2000–7006; FMCSA–2000–7165; FMCSA–2002– 12294; FMCSA–2004–17195; FMCSA– 2005–22194; FMCSA–2006–23773; FMCSA–2006–24783; FMCSA–2008– 0021; FMCSA–2008–0106; FMCSA– 2008–0174; FMCSA–2008–0231; FMCSA–2009–0291; FMCSA–2010– 0082; FMCSA–2010–0114; FMCSA– 2011–0299; FMCSA–2011–0325; FMCSA–2012–0104; FMCSA–2012– 0161; FMCSA–2012–0214; FMCSA– 2013–0166; FMCSA–2013–0168; FMCSA–2014–0002; FMCSA–2014– 0003; FMCSA–2014–0004; FMCSA– 2014–0005; FMCSA–2014–0006; FMCSA–2014–0007; FMCSA–2014– 0010; FMCSA–2015–0070; FMCSA– 2015–0072; FMCSA–2015–0350; FMCSA–2015–0351; FMCSA–2016– 0028; FMCSA–2016–0029; FMCSA– 2016–0030; FMCSA–2016–0031; FMCSA–2016–0033 using any of the following methods: • Federal eRulemaking Portal: Go to https://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: West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE, Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal Holidays. • Fax: 1–202–493–2251. Instructions: Each submission must include the Agency name and the docket number(s) for this notice. Note that all comments received will be posted without change to https:// www.regulations.gov, including any SUMMARY: PO 00000 Frm 00140 Fmt 4703 Sfmt 4703 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 https:// 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., e.t., Monday through Friday, except Federal holidays. The FDMS is available 24 hours each day, e.t., 365 days each year. If you want acknowledgment that we received your comments, please include a selfaddressed, 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 https://www.regulations.gov, as described in the system of records notice (DOT/ALL–14 FDMS), which can be reviewed at https://www.dot.gov/ privacy. Ms. Christine A. Hydock, Chief, Medical Programs Division, 202–366–4001, fmcsamedical@dot.gov, FMCSA, Department of Transportation, 1200 New Jersey Avenue, SE, Room W64– 224, Washington, DC 20590–0001. Office hours are from 8:30 a.m. to 5 p.m., e.t., Monday through Friday, except Federal holidays. If you have questions regarding viewing or submitting material to the docket, contact Docket Services, telephone (202) 366–9826. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Background Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for five years 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 five-year period. FMCSA grants exemptions from the FMCSRs for a twoyear period to align with the maximum duration of a driver’s medical certification. The physical qualification standard for drivers regarding vision found in 49 CFR 391.41(b)(10) states that a person is physically qualified to driver a CMV if that person has distant visual acuity of at least 20/40 (Snellen) in each eye without corrective lenses or visual E:\FR\FM\15AUN1.SGM 15AUN1

Agencies

[Federal Register Volume 83, Number 158 (Wednesday, August 15, 2018)]
[Notices]
[Pages 40637-40638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17588]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2017-0326]


Qualification of Drivers; Exemption Applications; Implantable 
Cardioverter Defibrillator (ICD)

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

ACTION: Notice of denials.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces its decision to deny applications from seven 
individuals treated with Implantable Cardioverter Defibrillators (ICDs) 
who requested an exemption from the Federal Motor Carrier Safety 
Regulations (FMCSRs) prohibiting operation of a commercial motor 
vehicle (CMV) in interstate commerce 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.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief, 
Medical Programs Division, (202) 366-4001, [email protected], FMCSA, 
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224, 
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., 
e.t., Monday through Friday, except Federal holidays. If you have 
questions regarding viewing or submitting material to the docket, 
contact Docket Services, telephone (202) 366-9826.

SUPPLEMENTARY INFORMATION: 

I. Electronic Access

    You may see all the comments online through the Federal Document 
Management System (FDMS) at: https://www.regulations.gov.
    Docket: For access to the docket to read background documents or 
comments, go to https://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: 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 https://www.regulations.gov, as described in 
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed 
at https://www.dot.gov/privacy.

II. Background

    On January 31, 2018, FMCSA published a FR notice (83 FR 4545) 
announcing receipt of applications from seven individuals treated with 
ICDs and requested comments from the public. These seven individuals 
requested an exemption from 49 CFR 391.41(b)(4) which prohibits 
operation of a CMV in interstate commerce 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. The public comment period closed on May 2, 
2018 and one comment was received.
    FMCSA has evaluated the eligibility of these applicants and 
concluded that granting these exemptions would not provide a level of 
safety that would be equivalent to or greater than, the level of safety 
that would be obtained by complying with the regulation 49 CFR 
391.41(b)(4). A summary of each applicant's medical history related to 
their ICD exemption request was discussed in the March 2, 2018, Federal 
Register notice and will not be repeated in this notice.
    In reaching the decision to deny these exemption requests, the 
Agency considered information from the Cardiovascular Medical Advisory 
Criteria, the April 2007 Evidence Report ``Cardiovascular Disease and 
Commercial Motor Vehicle Driver Safety, and a December 2014 focused 
research report ``Implantable Cardioverter Defibrillators and the 
Impact of a Shock in a Patient When Deployed.'' Copies of the reports 
are included in the docket.
    FMCSA has published advisory criteria to assist medical examiners 
in determining whether drivers with certain medical conditions are 
qualified to operate a CMV in interstate commerce. [Appendix A to Part 
391--Medical Advisory Criteria, section D, paragraph 4]. The advisory 
criteria for 49 CFR 391.41(b)(4) indicates that coronary artery bypass 
surgery and pacemaker implantation are remedial procedures and thus, 
not medically disqualifying. Implantable cardioverter defibrillators 
are disqualifying due to risk of syncope.

III. Discussion of Comments

    FMCSA received one comment in this proceeding from an individual 
who is in favor of any ICD treated individual who has not had any 
issues for six months, and who has clearance from their cardiologist, 
being allowed to drive a CMV. FMCSA acknowledges the commenters' 
responses concerning stable medical histories with ICDs. Based on the 
available medical literature cited above, FMCSA believes that a driver 
with an ICD is at risk for incapacitation if the device discharges. 
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.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption if 
it finds such an exemption would likely achieve a level of safety that 
is equivalent to, or greater then, the level that would be achieved 
absent such an exemption.
    The Agency's decision regarding these exemption applications is 
based on an individualized assessment of each applicant's medical 
information provided by the applicant, available medical and scientific 
data concerning ICD's, and public comments received.
    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 April 2007 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

[[Page 40638]]

operate CMVs are able to meet an equal or greater level of safety and 
upholds the findings of the April 2007 report.
---------------------------------------------------------------------------

    \1\ Now available at https://ntl.bts.gov/lib/30000/30100/30123/Final_CVD_Evidence_Report_v2.pdf.
---------------------------------------------------------------------------

V. Conclusion

    The Agency has determined that the available medical and scientific 
literature and research provides insufficient data to enable the Agency 
to conclude that granting these exemptions would achieve a level of 
safety equivalent to, or greater than, the level of safety maintained 
without the exemption. Therefore, the following seven applicants have 
been denied exemptions from the physical qualification standards in 49 
CFR 391.41(b)(4):

Frank D'Ercole (NJ)
Myles Goodwin (NH)
Cody Hairr (NC)
Dennis R. Pickett (IN)
William E. Richardson, Jr. (MI)
Terry Stephens ( VA)
Jeffrey A. Weiner ( MN)

    Each applicant has, prior to this notice, received a letter of 
final disposition regarding his/her exemption request. Those decision 
letters fully outlined the basis for the denial and constitutes final 
action by the Agency. The list published today summarizes the Agency's 
recent denials as required under 49 U.S.C. 31315(b)(4).

    Issued on: August 8, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-17588 Filed 8-14-18; 8:45 am]
 BILLING CODE 4910-EX-P
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