Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD), 16546-16547 [2022-06120]

Download as PDF 16546 Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Notices DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA–2021–0159] Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillator (ICD) Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT). ACTION: Notice of denials. AGENCY: FMCSA announces its decision to deny the applications from five individuals treated with an ICD 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. SUMMARY: Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366–4001, fmcsamedical@dot.gov, FMCSA, DOT, 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 Dockets Operations, (202) 366–9826. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Public Participation jspears on DSK121TN23PROD with NOTICES1 A. Viewing Comments To view comments go to www.regulations.gov. Insert the docket number, FMCSA–2021–0159, in the keyword box, and click ‘‘Search.’’ Next, sort the results by ‘‘Posted (NewerOlder),’’ choose the first notice listed, and click ‘‘Browse Comments.’’ If you do not have access to the internet, you may view the docket online by visiting Dockets Operations in Room W12–140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590–0001, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366–9317 or (202) 366– 9826 before visiting Dockets Operations. VerDate Sep<11>2014 20:07 Mar 22, 2022 Jkt 256001 B. Privacy Act In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption request. 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.dot.gov/privacy. II. Background On November 12, 2021, FMCSA published a Federal Register notice (86 FR 62868) announcing receipt of applications from five individuals treated with ICDs and requested comments from the public. The 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 December 13, 2021, and one comment was received. FMCSA has evaluated the eligibility of the applicants and concluded that granting an exemption 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 November 12, 2021, Federal Register notice and will not be repeated here. The Agency’s decision regarding this exemption application 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 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 1 The 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: PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 § 391.41(b)(4) indicates that coronary artery bypass surgery and pacemaker implantation are remedial procedures and thus, not medically disqualifying. ICDs are disqualifying due to risk of syncope. III. Discussion of Comments FMCSA received one comment in this proceeding. The commenter supported granting exemptions to the applicants stipulating a 6-month cardiology review and a 6-month medical certification period as safety assurances. FMCSA acknowledges that while a more frequent cardiology review and physical qualification period may be feasible for some of the applicants, others may find a more frequent medical review period burdensome and costly. In addition, there continues to be a risk for arrhythmias, and inherent complications such as inappropriate discharges, and ICD malfunction which could pose a risk to the individual and the public while driving a CMV. 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 the applicants’ medical information, available medical and scientific data concerning ICDs, and any relevant 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 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 § 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\23MRN1.SGM 23MRN1 Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Notices 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 applicants have been denied an exemption from the physical qualification standards in § 391.41(b)(4): Rosie A. Byrd (TX) Thomas Jacobs (NY) Lee Latin (NC) Wayne Pimpare (ME) Bradley Plunket (IL) The applicants have, prior to this notice, received a letter of final disposition regarding their exemption request. The decision letter fully outlined the basis for the denial and constitute final action by the Agency. The names of these individuals published today summarizes the Agency’s recent denials as required under 49 U.S.C. 31315(b)(4). [FR Doc. 2022–06120 Filed 3–22–22; 8:45 am] BILLING CODE 4910–EX–P DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [FMCSA Docket No. FMCSA–2021–0026] Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT). ACTION: Notice of final disposition. AGENCY: FMCSA announces its decision to exempt 32 individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have ‘‘no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.’’ The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to operate CMVs in interstate commerce. DATES: The exemptions were applicable on March 15, 2022. The exemptions expire on March 15, 2024. FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366–4001, fmcsamedical@dot.gov, FMCSA, DOT, jspears on DSK121TN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 20:07 Mar 22, 2022 Jkt 256001 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 or submitting material to the docket, contact Dockets Operations, (202) 366– 9826. SUPPLEMENTARY INFORMATION: or any other condition which is likely 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 (MEs) in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce. I. Public Participation III. Discussion of Comments FMCSA received four comments in this proceeding. Of the four comments received, three were in support of Callon Hegman’s seizure exemption application and one was in support of Shaen Smith’s seizure exemption application. A. Viewing Comments Larry W. Minor, Associate Administrator for Policy. 16547 To view comments go to www.regulations.gov. Insert the docket number, FMCSA–2021–0026, in the keyword box, and click ‘‘Search.’’ Next, sort the results by ‘‘Posted (NewerOlder),’’ choose the first notice listed, and click ‘‘Browse Comments.’’ If you do not have access to the internet, you may view the docket online by visiting Dockets Operations in Room W12–140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590–0001, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366–9317 or (202) 366– 9826 before visiting Dockets Operations. B. Privacy Act In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption request. 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.dot.gov/privacy. II. Background On February 3, 2022, FMCSA published a notice announcing receipt of applications from 32 individuals requesting an exemption from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) and requested comments from the public (87 FR 6231). The public comment period ended on March 7, 2022, and four comments were received. FMCSA has evaluated the eligibility of these applicants and determined that granting exemptions to these individuals would achieve a level of safety equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(8). The physical qualification standard for drivers regarding epilepsy found in § 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 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 statute also allows the Agency to renew exemptions at the end of the 5-year period. FMCSA grants medical exemptions from the FMCSRs for a 2year period to align with the maximum duration of a driver’s medical certification. The Agency’s decision regarding these exemption applications is based on the 2007 recommendations of the Agency’s Medical Expert Panel. The Agency conducted an individualized assessment of each applicant’s medical information, including the root cause of the respective seizure(s) and medical information about the applicant’s seizure history, the length of time that has elapsed since the individual’s last seizure, the stability of each individual’s treatment regimen and the duration of time on or off of anti-seizure medication. In addition, the Agency reviewed the treating clinician’s medical opinion related to the ability of the driver to safely operate a CMV with a history of seizure and each applicant’s driving record found in the commercial driver’s license Information System for commercial driver’s license (CDL) holders, and interstate and intrastate inspections recorded in the Motor Carrier Management Information System. For non-CDL holders, the Agency reviewed the driving records 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. E:\FR\FM\23MRN1.SGM 23MRN1

Agencies

[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Pages 16546-16547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06120]



[[Page 16546]]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2021-0159]


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

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

ACTION: Notice of denials.

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

SUMMARY: FMCSA announces its decision to deny the applications from 
five individuals treated with an ICD 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, 
DOT, 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 Dockets Operations, (202) 366-
9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket 
number, FMCSA-2021-0159, in the keyword box, and click ``Search.'' 
Next, sort the results by ``Posted (Newer-Older),'' choose the first 
notice listed, and click ``Browse Comments.'' If you do not have access 
to the internet, you may view the docket online by visiting Dockets 
Operations in Room W12-140 on the ground floor of the DOT West 
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 
9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays. 
To be sure someone is there to help you, please call (202) 366-9317 or 
(202) 366-9826 before visiting Dockets Operations.

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments 
from the public on the exemption request. 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.dot.gov/privacy.

II. Background

    On November 12, 2021, FMCSA published a Federal Register notice (86 
FR 62868) announcing receipt of applications from five individuals 
treated with ICDs and requested comments from the public. The 
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 December 
13, 2021, and one comment was received.
    FMCSA has evaluated the eligibility of the applicants and concluded 
that granting an exemption 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 November 12, 2021, Federal Register notice and will 
not be repeated here.
    The Agency's decision regarding this exemption application 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 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 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 implantation are remedial procedures and thus, 
not medically disqualifying. ICDs 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 one comment in this proceeding. The commenter 
supported granting exemptions to the applicants stipulating a 6-month 
cardiology review and a 6-month medical certification period as safety 
assurances.
    FMCSA acknowledges that while a more frequent cardiology review and 
physical qualification period may be feasible for some of the 
applicants, others may find a more frequent medical review period 
burdensome and costly. In addition, there continues to be a risk for 
arrhythmias, and inherent complications such as inappropriate 
discharges, and ICD malfunction which could pose a risk to the 
individual and the public while driving a CMV.

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 the applicants' medical 
information, available medical and scientific data concerning ICDs, and 
any relevant 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 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

[[Page 16547]]

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 applicants have been denied an exemption from the 
physical qualification standards in Sec.  391.41(b)(4):

Rosie A. Byrd (TX)
Thomas Jacobs (NY)
Lee Latin (NC)
Wayne Pimpare (ME)
Bradley Plunket (IL)

    The applicants have, prior to this notice, received a letter of 
final disposition regarding their exemption request. The decision 
letter fully outlined the basis for the denial and constitute final 
action by the Agency. The names of these individuals published today 
summarizes the Agency's recent denials as required under 49 U.S.C. 
31315(b)(4).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2022-06120 Filed 3-22-22; 8:45 am]
BILLING CODE 4910-EX-P