Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD), 5275-5276 [2020-01550]

Download as PDF Federal Register / Vol. 85, No. 19 / Wednesday, January 29, 2020 / Notices to cause the loss of consciousness or any loss of ability to control a CMV. In addition to the regulations, FMCSA has published advisory criteria 1 to assist medical examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce. III. Discussion of Comments Federal Motor Carrier Safety Administration [Docket No. FMCSA–2019–0167] Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD) FMCSA received no comments in this proceeding. Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of denials. IV. Conclusion SUMMARY: AGENCY: Based on its evaluation of the one renewal exemption application, FMCSA announces its decision to exempt the following driver from the epilepsy and seizure disorders prohibition in § 391.41(b)(8). As of October 22, 2019, and in accordance with 49 U.S.C. 31136(e) and 31315(b), Anthony Martens (SD) has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers (84 FR 66454). This driver was included in docket number FMCSA–2015–0118. The exemption is applicable as of October 22, 2019, and will expire on October 22, 2021. In accordance with 49 U.S.C. 31315(b), the exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b). Issued on: January 23, 2020. Larry W. Minor, Associate Administrator for Policy. [FR Doc. 2020–01551 Filed 1–28–20; 8:45 am] BILLING CODE 4910–EX–P lotter on DSKBCFDHB2PROD with NOTICES DEPARTMENT OF TRANSPORTATION 1 These criteria may be found in APPENDIX A TO PART 391—MEDICAL ADVISORY CRITERIA, section H. Epilepsy: § 391.41(b)(8), paragraphs 3, 4, and 5, which is available on the internet at https:// www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/ CFR-2015-title49-vol5-part391-appA.pdf. VerDate Sep<11>2014 17:27 Jan 28, 2020 Jkt 250001 FMCSA announces its decision to deny applications from four 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 (transient loss of consciousness), dyspnea (shortness of breath), collapse, or congestive heart failure. 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., ET, Monday through Friday, except Federal holidays. If you have questions regarding viewing materials in the docket, contact Docket Operations, (202) 366–9826. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Public Participation A. Viewing Documents and Comments To view comments, as well as any documents mentioned in this notice as being available in the docket, go to http://www.regulations.gov/ docket?D=FMCSA-2019-0167 and choose the document to review. If you do not have access to the internet, you may view the docket online by visiting Docket Operations in Room W12–140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays. B. Privacy Act In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 5275 DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL– 14 FDMS), which can be reviewed at www.transportation.dot.gov/privacy. II. Background On October 1, 2019 FMCSA published a Federal Register notice (84 FR 52163) announcing receipt of applications from four individuals treated with ICDs and requesting comments from the public. These four individuals requested an exemption from 49 CFR 391.41(b)(4) that 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 October 31, 2019 and three comments were 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 § 391.41(b)(4). A summary of each applicant’s medical history related to their ICD exemption request was discussed in the October 1, 2019, Federal Register notice and will not be repeated here. The Agency’s decision regarding these exemption applications is based on information from the cardiovascular Medical Advisory Criteria, an April 2007 evidence report titled ‘‘Cardiovascular Disease and Commercial Motor Vehicle Driver Safety,’’ 1 and further supported in a December 2014 focused research report titled ‘‘Implantable Cardioverter Defibrillators and the Impact of a Shock in a Patient When Deployed.’’ Copies of these 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.2 The advisory criteria for § 391.41(b)(4) indicates that coronary artery bypass surgery and pacemaker 1 The April 2007 Evidence report is available on the internet at https://rosap.ntl.bts.gov/view/dot/ 16462. 2 These criteria may be found in 49 CFR part 391, APPENDIX A TO PART 391—MEDICAL ADVISORY CRITERIA, section D. Cardiovascular: § 391.41(b)(4), paragraph 4, which is available on the internet at https://www.gpo.gov/fdsys/pkg/CFR2015-title49-vol5/pdf/CFR-2015-title49-vol5part391-appA.pdf. E:\FR\FM\29JAN1.SGM 29JAN1 5276 Federal Register / Vol. 85, No. 19 / Wednesday, January 29, 2020 / Notices lotter on DSKBCFDHB2PROD with NOTICES 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 three comments in this proceeding. Of the three comments received, two were duplicate comments from an anonymous commenter. The anonymous commenter supports all three individuals being granted an exemption based on the documentation that they have provided, that they have improved cardiac statuses, and that their ICDs have never deployed. The commenter states that individuals with epilepsy and diabetes are able to get approved for exemptions despite their condition and treatment. This commenter states that the Agency should do more research and make exemption decisions on a case-by-case basis. Mr. Christopher Oakland, an applicant, commented in support of FMCSA granting exemptions for 1 year to individuals who provide medical documentation from a qualified healthcare provider, that the individual is stable, the individual has no documented symptoms of syncope, dyspnea, collapse or congestive heart failure as stated in the cardiovascular standard, and the ICD has not administered therapy. Mr. Oakland commented that he submitted a total of three letters and that two of the three letters are from two different electrocardiologists. He further commented that the Federal Register notice posted that he submitted only two letters. In response to the first commenter, FMCSA reviews and considers each request received for an ICD exemption individually to determine whether the applicant is able to meet a level of safety equivalent to, or greater than, the level achieved without an exemption. While the individuals’ underlying cardiac conditions may demonstrate levels of improvement, their medical treatment plans also rely on the ICD device. The device, though it may not have deployed since implantation, may unpredictably deploy at a future date to deliver therapy. Based on the available medical and scientific data concerning ICDs, FMCSA finds that the applicants have an ongoing risk for incapacitation if the device discharges in response to cardiovascular symptoms. This risk for incapacitation does not meet an equal or greater level of safety that would be achieved absent an exemption. Concerning the comments on the need for additional research, FMCSA has processes and procedures in place to consider new research and existing VerDate Sep<11>2014 17:27 Jan 28, 2020 Jkt 250001 research so that the Agency’s determinations are evidence-based. Mr. Oakland contacted the Agency prior to the close of the comment period to confirm that he submitted a total of three letters, one from his cardiologist, and letters from two separate electrophysiologists. Mr. Oakland was informed that the statement in the Federal Register regarding the submission of two letters was an oversight, and confirmed that the content of each of the electrophysiologists’ letters was considered prior to the date that the Federal Register notice was published. IV. Basis for Exemption Determination Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-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 Agency’s decision regarding these exemption applications is based on an individualized assessment of each applicant’s medical information, available medical and scientific data concerning ICDs, and the public comments received. ICDs are electronic devices that treat cardiac arrest, ventricular fibrillation, and ventricular tachycardia, through the delivery of rapid pacing stimuli or shock therapy. ICDs treat but do not prevent arrhythmias. Therefore, the individual remains at risk for syncope or loss of consciousness. The underlying conditions for which the ICD was implanted therefore places these individuals at high risk for syncope or other unpredictable events know to result in gradual or sudden incapacitation. In addition, ICDs may discharge, which could result in loss of ability to safely control a CMV. The December 2014 focused research report referenced previously upholds the findings of the April 2007 report and indicates that the available scientific data on individuals with ICDs and CMV driving does not support that individuals with ICDs who operate CMVs are able to meet an equal or greater level of safety. FMCSA’s individual assessment of the exemption applications and the public comments does not provide any basis for departing from its general views on the risks posed by individual with an underlying cardiovascular condition that requires the implantation of an ICD to control. In the case of persons with ICDs, the underlying condition for which the ICD was implanted places the individual at high risk for syncope or other PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 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. The December 2014 focused research report referenced previously upholds the findings of the April 2007 report and 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. V. Conclusion The Agency has determined that the available medical and scientific literature and research provides insufficient data, even when considered with the individual assessment of each application, 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 four applicants have been denied exemptions from the physical qualification standards in § 391.41(b)(4): Christopher Cloud (GA) Joby Doucet (LA) Robert D. Forbes (NY) Christopher Oakland (RI) 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 constitute 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: January 23, 2020. Larry W. Minor, Associate Administrator for Policy. [FR Doc. 2020–01550 Filed 1–28–20; 8:45 am] BILLING CODE 4910–EX–P DEPARTMENT OF THE TREASURY Renewal Without Change of Information Collection Requirements in Connection With the Imposition of a Special Measure Concerning the Islamic Republic of Iran as a Jurisdiction of Primary Money Laundering Concern Financial Crimes Enforcement Network (‘‘FinCEN’’), Treasury. ACTION: Notice and request for comments. AGENCY: As part of a continuing effort to reduce paperwork and respondent burden, FinCEN invites comment on a renewal, without change, to information SUMMARY: E:\FR\FM\29JAN1.SGM 29JAN1

Agencies

[Federal Register Volume 85, Number 19 (Wednesday, January 29, 2020)]
[Notices]
[Pages 5275-5276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01550]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0167]


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 four 
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 (transient loss of 
consciousness), dyspnea (shortness of breath), 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., 
ET, Monday through Friday, except Federal holidays. If you have 
questions regarding viewing materials in the docket, contact Docket 
Operations, (202) 366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice 
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2019-0167 and choose the document to review. If you do 
not have access to the internet, you may view the docket online by 
visiting Docket Operations in Room W12-140 on the ground floor of the 
DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590, 
between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal 
holidays.

B. 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 
of records notice (DOT/ALL-14 FDMS), which can be reviewed at 
www.transportation.dot.gov/privacy.

II. Background

    On October 1, 2019 FMCSA published a Federal Register notice (84 FR 
52163) announcing receipt of applications from four individuals treated 
with ICDs and requesting comments from the public. These four 
individuals requested an exemption from 49 CFR 391.41(b)(4) that 
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 October 
31, 2019 and three comments were 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 Sec.  391.41(b)(4). A 
summary of each applicant's medical history related to their ICD 
exemption request was discussed in the October 1, 2019, Federal 
Register notice and will not be repeated here.
    The Agency's decision regarding these exemption applications is 
based on information from the cardiovascular Medical Advisory Criteria, 
an April 2007 evidence report titled ``Cardiovascular Disease and 
Commercial Motor Vehicle Driver Safety,'' \1\ and further supported in 
a December 2014 focused research report titled ``Implantable 
Cardioverter Defibrillators and the Impact of a Shock in a Patient When 
Deployed.'' Copies of these reports are included in the docket.
---------------------------------------------------------------------------

    \1\ The April 2007 Evidence report is available on the internet 
at https://rosap.ntl.bts.gov/view/dot/16462.
---------------------------------------------------------------------------

    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.\2\ The advisory 
criteria for Sec.  391.41(b)(4) indicates that coronary artery bypass 
surgery and pacemaker

[[Page 5276]]

implantation are remedial procedures and thus, not medically 
disqualifying. Implantable cardioverter defibrillators are 
disqualifying due to risk of syncope.
---------------------------------------------------------------------------

    \2\ These criteria may be found in 49 CFR part 391, APPENDIX A 
TO PART 391--MEDICAL ADVISORY CRITERIA, section D. Cardiovascular: 
Sec.  391.41(b)(4), paragraph 4, which is available on the internet 
at https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received three comments in this proceeding. Of the three 
comments received, two were duplicate comments from an anonymous 
commenter. The anonymous commenter supports all three individuals being 
granted an exemption based on the documentation that they have 
provided, that they have improved cardiac statuses, and that their ICDs 
have never deployed. The commenter states that individuals with 
epilepsy and diabetes are able to get approved for exemptions despite 
their condition and treatment. This commenter states that the Agency 
should do more research and make exemption decisions on a case-by-case 
basis. Mr. Christopher Oakland, an applicant, commented in support of 
FMCSA granting exemptions for 1 year to individuals who provide medical 
documentation from a qualified healthcare provider, that the individual 
is stable, the individual has no documented symptoms of syncope, 
dyspnea, collapse or congestive heart failure as stated in the 
cardiovascular standard, and the ICD has not administered therapy. Mr. 
Oakland commented that he submitted a total of three letters and that 
two of the three letters are from two different electrocardiologists. 
He further commented that the Federal Register notice posted that he 
submitted only two letters.
    In response to the first commenter, FMCSA reviews and considers 
each request received for an ICD exemption individually to determine 
whether the applicant is able to meet a level of safety equivalent to, 
or greater than, the level achieved without an exemption. While the 
individuals' underlying cardiac conditions may demonstrate levels of 
improvement, their medical treatment plans also rely on the ICD device. 
The device, though it may not have deployed since implantation, may 
unpredictably deploy at a future date to deliver therapy. Based on the 
available medical and scientific data concerning ICDs, FMCSA finds that 
the applicants have an ongoing risk for incapacitation if the device 
discharges in response to cardiovascular symptoms. This risk for 
incapacitation does not meet an equal or greater level of safety that 
would be achieved absent an exemption. Concerning the comments on the 
need for additional research, FMCSA has processes and procedures in 
place to consider new research and existing research so that the 
Agency's determinations are evidence-based.
    Mr. Oakland contacted the Agency prior to the close of the comment 
period to confirm that he submitted a total of three letters, one from 
his cardiologist, and letters from two separate electrophysiologists. 
Mr. Oakland was informed that the statement in the Federal Register 
regarding the submission of two letters was an oversight, and confirmed 
that the content of each of the electrophysiologists' letters was 
considered prior to the date that the Federal Register notice was 
published.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption 
from the FMCSRs for no longer than a 5-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 Agency's decision regarding these exemption applications is 
based on an individualized assessment of each applicant's medical 
information, available medical and scientific data concerning ICDs, and 
the public comments received.
    ICDs are electronic devices that treat cardiac arrest, ventricular 
fibrillation, and ventricular tachycardia, through the delivery of 
rapid pacing stimuli or shock therapy. ICDs treat but do not prevent 
arrhythmias. Therefore, the individual remains at risk for syncope or 
loss of consciousness. The underlying conditions for which the ICD was 
implanted therefore places these individuals at high risk for syncope 
or other unpredictable events know to result in gradual or sudden 
incapacitation. In addition, ICDs may discharge, which could result in 
loss of ability to safely control a CMV. The December 2014 focused 
research report referenced previously upholds the findings of the April 
2007 report and indicates that the available scientific data on 
individuals with ICDs and CMV driving does not support that individuals 
with ICDs who operate CMVs are able to meet an equal or greater level 
of safety. FMCSA's individual assessment of the exemption applications 
and the public comments does not provide any basis for departing from 
its general views on the risks posed by individual with an underlying 
cardiovascular condition that requires the implantation of an ICD to 
control.
    In the case of persons with ICDs, the underlying condition for 
which the ICD was implanted places the individual at high risk for 
syncope 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. The December 2014 focused research 
report referenced previously upholds the findings of the April 2007 
report and 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.

V. Conclusion

    The Agency has determined that the available medical and scientific 
literature and research provides insufficient data, even when 
considered with the individual assessment of each application, 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 four 
applicants have been denied exemptions from the physical qualification 
standards in Sec.  391.41(b)(4):

Christopher Cloud (GA)
Joby Doucet (LA)
Robert D. Forbes (NY)
Christopher Oakland (RI)

    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 constitute 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: January 23, 2020.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-01550 Filed 1-28-20; 8:45 am]
BILLING CODE 4910-EX-P