83 FR 40637 - Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD)
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration Federal Register Volume 83, Issue 158 (August 15, 2018)
Federal Motor Carrier Safety Administration
Federal Register Volume 83, Issue 158 (August 15, 2018)
| Page Range | 40637-40638 | |
| FR Document | 2018-17588 |
[Federal Register Volume 83, Number 158 (Wednesday, August 15, 2018)] [Notices] [Pages 40637-40638] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17588] ----------------------------------------------------------------------- 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: http://www.regulations.gov. Docket: For access to the docket to read background documents or comments, go to http://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 http://www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at http://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 http://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
![Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices 40637
functions; (2) the accuracy of the comments, go to http:// commerce. [Appendix A to Part 391—
estimated burden; (3) ways for the www.regulations.gov and/or Room Medical Advisory Criteria, section D,
FMCSA to enhance the quality, W12–140 on the ground level of the paragraph 4]. The advisory criteria for
usefulness, and clarity of the collected West Building, 1200 New Jersey Avenue 49 CFR 391.41(b)(4) indicates that
information; and (4) ways that the SE, Washington, DC, between 9 a.m. and coronary artery bypass surgery and
burden could be minimized without 5 p.m., e.t., Monday through Friday, pacemaker implantation are remedial
reducing the quality of the collected except Federal holidays. procedures and thus, not medically
information. Privacy Act: In accordance with 5 disqualifying. Implantable cardioverter
Issued under the authority delegated in 49 U.S.C. 553(c), DOT solicits comments defibrillators are disqualifying due to
CFR 1.87 on August 3, 2018. from the public to better inform its risk of syncope.
G. Kelly Regal, rulemaking process. DOT posts these
comments, without edit, including any III. Discussion of Comments
Associate Administrator for Office of
Research and Information Technology. personal information the commenter FMCSA received one comment in this
[FR Doc. 2018–17568 Filed 8–14–18; 8:45 am]
provides, to http://www.regulations.gov, proceeding from an individual who is in
as described in the system of records favor of any ICD treated individual who
BILLING CODE 4910–EX–P
notice (DOT/ALL–14 FDMS), which can has not had any issues for six months,
be reviewed at http://www.dot.gov/ and who has clearance from their
DEPARTMENT OF TRANSPORTATION privacy. cardiologist, being allowed to drive a
II. Background CMV. FMCSA acknowledges the
Federal Motor Carrier Safety commenters’ responses concerning
Administration On January 31, 2018, FMCSA stable medical histories with ICDs.
published a FR notice (83 FR 4545) Based on the available medical
[Docket No. FMCSA–2017–0326] announcing receipt of applications from literature cited above, FMCSA believes
seven individuals treated with ICDs and that a driver with an ICD is at risk for
Qualification of Drivers; Exemption requested comments from the public.
Applications; Implantable Cardioverter incapacitation if the device discharges.
These seven individuals requested an This risk is combined with the risks
Defibrillator (ICD) exemption from 49 CFR 391.41(b)(4) associated with the underlying
AGENCY: Federal Motor Carrier Safety which prohibits operation of a CMV in cardiovascular condition for which the
Administration (FMCSA), DOT. interstate commerce by persons with a ICD has been implanted as a primary or
ACTION: Notice of denials. current clinical diagnosis of myocardial secondary preventive measure.
infarction, angina pectoris, coronary
SUMMARY: FMCSA announces its insufficiency, thrombosis, or any other IV. Basis for Exemption Determination
decision to deny applications from cardiovascular disease of a variety Under 49 U.S.C. 31136(e) and 31315,
seven individuals treated with known to be accompanied by syncope, FMCSA may grant an exemption if it
Implantable Cardioverter Defibrillators dyspnea, collapse, or congestive heart finds such an exemption would likely
(ICDs) who requested an exemption failure. The public comment period achieve a level of safety that is
from the Federal Motor Carrier Safety closed on May 2, 2018 and one equivalent to, or greater then, the level
Regulations (FMCSRs) prohibiting comment was received. that would be achieved absent such an
operation of a commercial motor vehicle FMCSA has evaluated the eligibility exemption.
(CMV) in interstate commerce by of these applicants and concluded that The Agency’s decision regarding these
persons with a current clinical diagnosis granting these exemptions would not exemption applications is based on an
of myocardial infarction, angina provide a level of safety that would be individualized assessment of each
pectoris, coronary insufficiency, equivalent to or greater than, the level applicant’s medical information
thrombosis, or any other cardiovascular of safety that would be obtained by provided by the applicant, available
disease of a variety known to be complying with the regulation 49 CFR medical and scientific data concerning
accompanied by syncope, dyspnea, 391.41(b)(4). A summary of each ICD’s, and public comments received.
collapse, or congestive heart failure. applicant’s medical history related to In the case of persons with ICDs, the
FOR FURTHER INFORMATION CONTACT: Ms. their ICD exemption request was underlying condition for which the ICD
Christine A. Hydock, Chief, Medical discussed in the March 2, 2018, Federal was implanted places the individual at
Programs Division, (202) 366–4001, Register notice and will not be repeated high risk for syncope (a transient loss of
fmcsamedical@dot.gov, FMCSA, in this notice. consciousness) or other unpredictable
Department of Transportation, 1200 In reaching the decision to deny these events known to result in gradual or
New Jersey Avenue SE, Room W64–224, exemption requests, the Agency sudden incapacitation. ICDs may
Washington, DC 20590–0001. Office considered information from the discharge, which could result in loss of
hours are from 8:30 a.m. to 5 p.m., e.t., Cardiovascular Medical Advisory ability to safely control a CMV. See the
Monday through Friday, except Federal Criteria, the April 2007 Evidence Report April 2007 Evidence Report on
holidays. If you have questions ‘‘Cardiovascular Disease and Cardiovascular Disease and Commercial
regarding viewing or submitting Commercial Motor Vehicle Driver Motor vehicle Driver Safety, April
material to the docket, contact Docket Safety, and a December 2014 focused 2007.1 A focused research report on
Services, telephone (202) 366–9826. research report ‘‘Implantable Implantable Cardioverter Defibrillators
SUPPLEMENTARY INFORMATION: Cardioverter Defibrillators and the and the Impact of a Shock on a Patient
Impact of a Shock in a Patient When When Deployed completed for the
daltland on DSKBBV9HB2PROD with NOTICES
I. Electronic Access Deployed.’’ Copies of the reports are FMCSA December 2014 indicates that
You may see all the comments online included in the docket. the available scientific data on persons
through the Federal Document FMCSA has published advisory with ICDs and CMV driving does not
Management System (FDMS) at: http:// criteria to assist medical examiners in support that persons with ICDs who
www.regulations.gov. determining whether drivers with
Docket: For access to the docket to certain medical conditions are qualified 1 Now available at http://ntl.bts.gov/lib/30000/
read background documents or to operate a CMV in interstate 30100/30123/Final_CVD_Evidence_Report_v2.pdf.
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![40638 Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
operate CMVs are able to meet an equal ACTION:Notice of renewal of personal information provided. Please
or greater level of safety and upholds exemptions; request for comments. see the Privacy Act heading below for
the findings of the April 2007 report. further information.
SUMMARY: FMCSA announces its Docket: For access to the docket to
V. Conclusion decision to renew exemptions for 88 read background documents or
The Agency has determined that the individuals from the vision requirement comments, go to http://
available medical and scientific in the Federal Motor Carrier Safety www.regulations.gov at any time or
literature and research provides Regulations (FMCSRs) for interstate Room W12–140 on the ground level of
insufficient data to enable the Agency to commercial motor vehicle (CMV) the West Building, 1200 New Jersey
conclude that granting these exemptions drivers. The exemptions enable these Avenue, SE, Washington, DC, between 9
would achieve a level of safety individuals to continue to operate CMVs a.m. and 5 p.m., e.t., Monday through
equivalent to, or greater than, the level in interstate commerce without meeting Friday, except Federal holidays. The
of safety maintained without the the vision requirements in one eye. FDMS is available 24 hours each day,
exemption. Therefore, the following DATES: Each group of renewed e.t., 365 days each year. If you want
seven applicants have been denied exemptions were applicable on the acknowledgment that we received your
exemptions from the physical dates stated in the discussions below comments, please include a self-
qualification standards in 49 CFR and will expire on the dates stated in addressed, stamped envelope or
391.41(b)(4): the discussions below. Comments must postcard or print the acknowledgement
Frank D’Ercole (NJ) be received on or before September 14, page that appears after submitting
Myles Goodwin (NH) 2018. comments online.
Cody Hairr (NC) ADDRESSES: You may submit comments Privacy Act: In accordance with 5
Dennis R. Pickett (IN) bearing the Federal Docket Management U.S.C. 553(c), DOT solicits comments
William E. Richardson, Jr. (MI) System (FDMS) Docket No. FMCSA– from the public to better inform its
Terry Stephens ( VA) 1999–6480; FMCSA–2000–7006; rulemaking process. DOT posts these
Jeffrey A. Weiner ( MN) FMCSA–2000–7165; FMCSA–2002– comments, without edit, including any
Each applicant has, prior to this 12294; FMCSA–2004–17195; FMCSA– personal information the commenter
notice, received a letter of final 2005–22194; FMCSA–2006–23773; provides, to http://www.regulations.gov,
disposition regarding his/her exemption FMCSA–2006–24783; FMCSA–2008– as described in the system of records
request. Those decision letters fully 0021; FMCSA–2008–0106; FMCSA– notice (DOT/ALL–14 FDMS), which can
outlined the basis for the denial and 2008–0174; FMCSA–2008–0231; be reviewed at http://www.dot.gov/
constitutes final action by the Agency. FMCSA–2009–0291; FMCSA–2010– privacy.
The list published today summarizes 0082; FMCSA–2010–0114; FMCSA–
the Agency’s recent denials as required 2011–0299; FMCSA–2011–0325; FOR FURTHER INFORMATION CONTACT: Ms.
under 49 U.S.C. 31315(b)(4). FMCSA–2012–0104; FMCSA–2012– Christine A. Hydock, Chief, Medical
0161; FMCSA–2012–0214; FMCSA– Programs Division, 202–366–4001,
Issued on: August 8, 2018.
2013–0166; FMCSA–2013–0168; fmcsamedical@dot.gov, FMCSA,
Larry W. Minor, Department of Transportation, 1200
Associate Administrator for Policy. FMCSA–2014–0002; FMCSA–2014–
0003; FMCSA–2014–0004; FMCSA– New Jersey Avenue, SE, Room W64–
[FR Doc. 2018–17588 Filed 8–14–18; 8:45 am] 224, Washington, DC 20590–0001.
2014–0005; FMCSA–2014–0006;
BILLING CODE 4910–EX–P
FMCSA–2014–0007; FMCSA–2014– Office hours are from 8:30 a.m. to 5
0010; FMCSA–2015–0070; FMCSA– p.m., e.t., Monday through Friday,
2015–0072; FMCSA–2015–0350; except Federal holidays. If you have
DEPARTMENT OF TRANSPORTATION questions regarding viewing or
FMCSA–2015–0351; FMCSA–2016–
0028; FMCSA–2016–0029; FMCSA– submitting material to the docket,
Federal Motor Carrier Safety
2016–0030; FMCSA–2016–0031; contact Docket Services, telephone (202)
Administration
FMCSA–2016–0033 using any of the 366–9826.
[Docket No. FMCSA–1999–6480; FMCSA– SUPPLEMENTARY INFORMATION:
following methods:
2000–7006; FMCSA–2000–7165; FMCSA–
2002–12294; FMCSA–2004–17195; FMCSA–
• Federal eRulemaking Portal: Go to I. Background
2005–22194; FMCSA–2006–23773; FMCSA– http://www.regulations.gov. Follow the
2006–24783; FMCSA–2008–0021; FMCSA– online instructions for submitting Under 49 U.S.C. 31136(e) and 31315,
2008–0106; FMCSA–2008–0174; FMCSA– comments. FMCSA may grant an exemption for five
2008–0231; FMCSA–2009–0291; FMCSA– • Mail: Docket Management Facility; years if it finds ‘‘such exemption would
2010–0082; FMCSA–2010–0114; FMCSA– U.S. Department of Transportation, 1200 likely achieve a level of safety that is
2011–0299; FMCSA–2011–0325; FMCSA– New Jersey Avenue, SE, West Building equivalent to or greater than the level
2012–0104; FMCSA–2012–0161; FMCSA– Ground Floor, Room W12–140, that would be achieved absent such
2012–0214; FMCSA–2013–0166; FMCSA– exemption.’’ The statute also allows the
2013–0168; FMCSA–2014–0002; FMCSA–
Washington, DC 20590–0001.
2014–0003; FMCSA–2014–0004; FMCSA– • Hand Delivery: West Building Agency to renew exemptions at the end
2014–0005; FMCSA–2014–0006; FMCSA– Ground Floor, Room W12–140, 1200 of the five-year period. FMCSA grants
2014–0007; FMCSA–2014–0010; FMCSA– New Jersey Avenue, SE, Washington, exemptions from the FMCSRs for a two-
2015–0070; FMCSA–2015–0072; FMCSA– DC, between 9 a.m. and 5 p.m., e.t., year period to align with the maximum
2015–0350; FMCSA–2015–0351; FMCSA– Monday through Friday, except Federal duration of a driver’s medical
2016–0028; FMCSA–2016–0029; FMCSA– Holidays. certification.
daltland on DSKBBV9HB2PROD with NOTICES
2016–0030; FMCSA–2016–0031; FMCSA– • Fax: 1–202–493–2251. The physical qualification standard
2016–0033] Instructions: Each submission must for drivers regarding vision found in 49
include the Agency name and the CFR 391.41(b)(10) states that a person is
Qualification of Drivers; Exemption
docket number(s) for this notice. Note physically qualified to driver a CMV if
Applications; Vision
that all comments received will be that person has distant visual acuity of
AGENCY:Federal Motor Carrier Safety posted without change to http:// at least 20/40 (Snellen) in each eye
Administration (FMCSA), DOT. www.regulations.gov, including any without corrective lenses or visual
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Document Created: 2018-08-15 01:25:47
Document Modified: 2018-08-15 01:25:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of denials. | |
| 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. | |
| FR Citation | 83 FR 40637 |
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