39892 Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Notices 

1The report is available on the internet at https:// 

rosap.ntl.bts.gov/view/dot/16462. 

2These 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-vol5- 

part391-appA.pdf. 

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: 

I. Public Participation 

A. Viewing Comments 

To view comments go to 

www.regulations.gov. Insert the docket 

number, FMCSA–2022–0026, 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. 

Background 

On February 17, 2022, FMCSA 

published a Federal Register notice (87 

FR 9101) announcing receipt of 

applications from two 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 March 21, 2021, and 13 

comments were 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 February 

17, 2022, 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 

§ 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. 

II. Discussion of Comments 

FMCSA received 13 comments in this 

proceeding. All comments received 

were from private citizens and 

employers in support of Kelly Lemus 

and focused on her experience and skill 

as a CMV driver, her stable health, and 

that her ICD has not deployed. No 

adverse comments were received in this 

proceeding. 

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 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. 

III. 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 

applicants have been denied an 

exemption from the physical 

qualification standards in § 391.41(b)(4): 

Michael Bianculli (MA); Kelly Lemus 

(WA) 

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. 2022–14225 Filed 7–1–22; 8:45 am] 

BILLING CODE 4910–EX–P 

DEPARTMENT OF TRANSPORTATION 

Federal Motor Carrier Safety 

Administration 

[Docket No. FMCSA–2022–0083] 

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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Notices 39893 

1The report is available on the internet at https:// 

rosap.ntl.bts.gov/view/dot/16462. 

2These 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-vol5- 

part391-appA.pdf. 

three 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, 

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: 

I. Public Participation 

A. Viewing Comments 

To view comments go to 

www.regulations.gov. Insert the docket 

number, FMCSA–2022–0083, 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. 

Background 

On April 27, 2022, FMCSA published 

a Federal Register notice (87 FR 25079) 

announcing receipt of applications from 

three 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 May 27, 2022, 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 April 27, 

2022, 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 

§ 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. 

II. Discussion of Comments 

FMCSA received 109 comments in 

this proceeding. All of the comments 

were from private citizens. The majority 

of the comments were in support of Mr. 

Abiud Ortuno. The remaining 

comments were not attributed to a 

specific applicant. All of the comments 

were supportive of granting ICD 

exemptions to the applicants. No 

adverse comments were received in this 

proceeding. Several commenters felt 

that FMCSA should rely on the 

authority of a cardiologist’s clearance to 

receive an ICD exemption to drive a 

CMV. In one commenter’s opinion, 

CMV operators and other people in 

general without ICDs suffer cardiac 

arrest in greater numbers than those 

with ICDs, and whether younger or 

older, one cannot predict when this 

could happen. The commenter believes 

that texting and other medical 

conditions were more of a risk to safety 

while driving a CMV than the 

possibility of having a cardiac arrest and 

encouraged FMCSA to grant the 

exemptions due to the shortage of CMV 

drivers. Another commenter stated that 

FMCSA should revise its regulations in 

accordance with current medical 

standards and with 49 U.S.C. 31136(e) 

and 31315. One commenter referred to 

two research studies, one from the 

American College of Cardiology that 

supported statistically low fatality rates 

from road accidents among individuals 

with ICDs than fatality rates of the 

general population, and a second study 

of a subgroup analysis of the AVID trial, 

in which the annual incidence of 

accidents in the ICD population was 

estimated to be 3.4 percent per year, 

significantly lower than the 7.1 percent 

per year accident rate in the general 

driving population in the USA.’’ 

Regarding the comment concerning 

medical clearance by a cardiologist to 

grant ICD exemptions, while FMCSA 

does not rely solely on a cardiologist’s 

medical clearance or opinion to 

determine whether to grant an ICD 

exemption, FMCSA does consider the 

cardiologist’s medical documentation 

and opinions received as a part of the 

applicant’s exemption request in 

evaluating whether to grant an 

exemption. In response to the comments 

that other safety risks are greater than 

the risk of ICD deployment due to a 

cardiac arrest, and that FMCSA should 

update our standards and revise them in 

accordance with 49 U.S.C. 31136(e) and 

31315, FMCSA is concerned about all 

safety risks concerning CMVs. FMCSA 

engages in research, and partners with 

the Agency’s Medical Review Board, 

medical experts, and our stakeholders to 

provide evidence-based rulemaking and 

guidance with the ultimate goal of 

keeping our roadways safe. FMCSA’s 

exemption process is consistent with 

the current requirements of 49 U.S.C. 

31136(e) and 31315 as further discussed 

in the Basis for Exemption 

Determination section that follows in 

the next section. In response to the 


lotter on DSK11XQN23PROD with NOTICES1
39894 Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Notices 

1This final rule was subsequently amended on 

June 10, 2016, in response to a petition for 

reconsideration submitted by the Association of 

American Railroads. See 81 FR 37521. 

comment regarding the two research 

studies, the studies do not appear to 

have a clear relevance to ICDs and CMVrelated crashes. The commenter did not 

include specific citations for the study 

information that was referenced. The 

Antiarrhythmics Versus Implantable 

Defibrillators study appears to evaluate 

the efficacy of cardiac medication 

treatment over treatment with an ICD 

rather than ICD crash risk. 

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 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. 

III. 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 

applicants have been denied an 

exemption from the physical 

qualification standards in § 391.41(b)(4): 

Timothy Broome (SC); Bryce A. Norman 

(CA); Abiud J. Ortuno (FL) 

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. 2022–14226 Filed 7–1–22; 8:45 am] 

BILLING CODE 4910–EX–P 

DEPARTMENT OF TRANSPORTATION 

Federal Railroad Administration 

[Docket No. FRA–2022–0002–N–13] 

Proposed Agency Information 

Collection Activities; Comment 

Request 

AGENCY: Federal Railroad 

Administration (FRA), U.S. Department 

of Transportation (DOT). 

ACTION: Notice of information collection; 

request for comment. 

SUMMARY: Under the Paperwork 

Reduction Act of 1995 (PRA) and its 

implementing regulations, FRA seeks 

approval of the Information Collection 

Request (ICR) abstracted below. Before 

submitting this ICR to the Office of 

Management and Budget (OMB) for 

approval, FRA is soliciting public 

comment on specific aspects of the 

activities identified in the ICR. 

DATES: Interested persons are invited to 

submit comments on or before 

September 6, 2022. 

ADDRESSES: Written comments and 

recommendations for the proposed ICR 

should be submitted on regulations.gov 

to the docket, Docket No. FRA–2022– 

0002. All comments received will be 

posted without change to the docket, 

including any personal information 

provided. Please refer to the assigned 

OMB control number (2130–0017) in 

any correspondence submitted. FRA 

will summarize comments received in 

response to this notice in a subsequent 

notice and include them in its 

information collection submission to 

OMB for approval. 

FOR FURTHER INFORMATION CONTACT: Mr. 

John Purnell, Information Collection 

Clearance Officer, at email: 

john.purnell@dot.gov or telephone: 

(202) 713–0246, or Ms. Hodan Wells, 

Information Collection Clearance 

Officer, at email: hodan.wells@dot.gov 

or telephone: (202) 868–9412. 

SUPPLEMENTARY INFORMATION: The PRA, 

44 U.S.C. 3501–3520, and its 

implementing regulations, 5 CFR part 

1320, require Federal agencies to 

provide 60-days’ notice to the public to 

allow comment on information 

collection activities before seeking OMB 

approval of the activities. See 44 U.S.C. 

3506, 3507; 5 CFR 1320.8 through 

1320.12. Specifically, FRA invites 

interested parties to comment on the 

following ICR regarding: (1) whether the 

information collection activities are 

necessary for FRA to properly execute 

its functions, including whether the 

activities will have practical utility; (2) 

the accuracy of FRA’s estimates of the 

burden of the information collection 

activities, including the validity of the 

methodology and assumptions used to 

determine the estimates; (3) ways for 

FRA to enhance the quality, utility, and 

clarity of the information being 

collected; and (4) ways for FRA to 

minimize the burden of information 

collection activities on the public, 

including the use of automated 

collection techniques or other forms of 

information technology. See 44 U.S.C. 

3506(c)(2)(A); 5 CFR 1320.8(d)(1). 

FRA believes that soliciting public 

comment may reduce the administrative 

and paperwork burdens associated with 

the collection of information that 

Federal regulations mandate. In 

summary, FRA reasons that comments 

received will advance three objectives: 

(1) reduce reporting burdens; (2) 

organize information collection 

requirements in a ‘‘user-friendly’’ format 

to improve the use of such information; 

and (3) accurately assess the resources 

expended to retrieve and produce 

information requested. See 44 U.S.C. 

3501. 

The summary below describes the ICR 

that FRA will submit for OMB clearance 

as the PRA requires: 

Title: U.S. DOT Crossing Inventory. 

OMB Control Number: 2130–0017. 

Abstract: On January 6, 2015, FRA 

published in the Federal Register a final 

rule that requires railroads that operate 

one or more trains through highway-rail 

or pathway crossings to submit 

information to the U.S. DOT National 

Highway-Rail Crossing Inventory about 

the crossings through which they 

operate.1 These amendments, mandated 

by section 204 of the Rail Safety 

Improvement Act of 2008, require 

railroads to submit information about 

previously unreported and new 

highway-rail and pathway crossings to 

the U.S. DOT National Highway-Rail 

Crossing Inventory, and to periodically 

update existing crossing data. 

In this 60-day notice, FRA made 

multiple adjustments which increased 

the previously approved burden hours 

from 8,293 hours to 8,663 hours. For 

instance: 


lotter on DSK11XQN23PROD with NOTICES1