80 FR 22259 - Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillators
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration Federal Register Volume 80, Issue 76 (April 21, 2015)
Federal Motor Carrier Safety Administration
Federal Register Volume 80, Issue 76 (April 21, 2015)
| Page Range | 22259-22261 | |
| FR Document | 2015-09068 |
[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)] [Notices] [Pages 22259-22261] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09068] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2012-0081] Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillators AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of application for exemption; request for comments. ----------------------------------------------------------------------- SUMMARY: FMCSA announces receipt of applications from 15 individuals for an exemption from the cardiovascular standard [49 CFR 391.41(b)(4)]. These 15 individuals are requesting an exemption due to the presence of implantable cardioverter defibrillators (ICD) as a result of their underlying cardiac condition. Of the 15 individuals requesting exemptions, three individuals (Craig Bohms, James Dean, and Mark Steiner) were previously published in a January 2014 Federal Register under the docket listed above. A final decision was not issued on these three individuals because the Agency was in the process of gathering and analyzing additional data concerning ICDs and commercial motor vehicle (CMV) driving. These three individuals are being published again with 12 new individuals. If granted, an exemption would enable these individuals with ICDs to operate CMVs for up to 2 years in interstate commerce. DATES: Comments must be received on or before May 21, 2015. ADDRESSES: You may submit comments bearing the Federal Docket Management System (FDMS) Docket ID FMCSA-2012-0081 using any of the following methods:Federal eRulemaking Portal: Go to www.regulations.gov. Follow the on-line instructions for submitting comments. Mail: Docket Management Facility; U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001. Hand Delivery or Courier: West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. Fax: 1-202-493-2251. Each submission must include the Agency name and the docket ID for this Notice. Note that DOT posts all comments received without change to www.regulations.gov, including any personal information included in a comment. Please see the Privacy Act heading below. Docket: For access to the docket to read background documents or comments, go to www.regulations.gov, at any time or Room W12-140 on the ground level of the West Building, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The FDMS is available 24 hours each day, 365 days each year. If you want acknowledgment that we received your comments, please include a self-addressed, stamped envelope or postcard or print the acknowledgement page that appears after submitting comments on-line. 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 records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy. FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director, Office of Carrier, Driver and Vehicle Safety, (202) 366-4001, or via email at [email protected], or by letter to FMCSA, Room W64-113, Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday through Friday, except Federal holidays. Submitting Comments You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission. To submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number ``FMCSA-2012-0081'' and click the search button. When the new screen appears, click on the blue ``Comment Now!'' button on the right hand side of the page. On the new page, enter information required including the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change this proposed rule based on your comments. FMCSA may issue a final rule at any time after the close of the comment period. Viewing Comments and Documents To view comments, as well as any documents mentioned in this notice, or to submit your comment online, go to www.regulations.gov and in the search box insert the docket number ``FMCSA-2012-0081'' and click ``Search.'' Next, click ``Open Docket Folder'' and you will find all documents and comments related to the proposed rulemaking. SUPPLEMENTARY INFORMATION: Background FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain parts of the Federal Motor Carrier Safety Regulations. FMCSA must publish a notice of each exemption request in the Federal Register [49 CFR 381.315(a)]. The Agency must provide the public an opportunity to inspect the [[Page 22260]] information relevant to the application, including any safety analyses that have been conducted. The Agency must also provide an opportunity for public comment on the request. The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The Agency may grant an exemption subject to specified terms and conditions. The decision of the Agency must be published in the Federal Register (49 CFR 381.315(b)) with the reasons for denying or granting the application and, if granted, the name of the person or class of persons receiving the exemption, and the regulatory provision from which the exemption is granted. The notice must also specify the effective period and explain the terms and conditions of the exemption. The exemption may be renewed (49 CFR 381.300(b)). The FMCSA provides medical advisory criteria for use by medical examiners in determining whether drivers with certain medical conditions should be certified to operate CMVs in interstate commerce. The advisory criteria are currently set out as part of the medical examination report published with 49 CFR 391.43. The advisory criteria for section 391.41(b)(4) indicate that the term ``has no current clinical diagnosis of'' is specifically designed to encompass: ``A clinical diagnosis of'' (1) a current cardiovascular condition, or (2) a cardiovascular condition which has not fully stabilized regardless of the time limit. The term ``known to be accompanied by'' is designed to include a clinical diagnosis of a cardiovascular disease (1) which is accompanied by symptoms of syncope, dyspnea, collapse or congestive cardiac failure; and/or (2) which is likely to cause syncope, dyspnea, collapse, or congestive cardiac failure. Summary of Applications Craig Bohms Mr. Bohms is a 57-year-old Class A CDL holder in Illinois. Mr. Bohms documents that his ICD was implanted in 2013. A March 13, 2015, letter from his cardiologist reports Mr. Bohms ``is doing well feeling good and has not needed or had any shock therapy from his defibrillator. He is stable from a heart rhythm standpoint and may drive for his job from that standpoint.'' James Dean Mr. Dean is a 55-year-old from Wisconsin. A November 2014 medical document received from Mr. Dean indicates that his ICD was implanted in August of 2007. An April 2014 routine in-clinic visit document indicates no ventricular tachycardia episodes detected and that the patient states feeling well with no dizziness or syncope. A March 2014 document from St. Mary's Hospital indicates Mr. Dean has a rate responsive dual chamber ICD. Daniel Donahue Mr. Donahue is a 72-year-old Class A CDL holder in Wisconsin. A February 4, 2015 letter from his cardiologist reports that Mr. Donahue's ICD was implanted in December 2004. ``[Mr. Donahue ]has never required any therapy from his ICD. Since September 2013 to the date of this letter, [Mr. Donahue] has only one event of ventricular tachycardia which lasted 7 seconds, and did not require any therapy from his ICD. His ejection fraction has improved to 42% on his last echocardiogram which was done in September 2013.'' Bernard Fritzon Mr. Fritzon is a 56-year-old Class A CDL holder in Kansas. A February 16, 2015 letter from his cardiologist reports that ``[Mr. Fritzon] received an ICD for secondary prevention due to non-ischemic cardiomyopathy, and atrial fibrillation. The device was implanted for secondary prevention after witnessed ventricular tachycardia during a cardiac procedure. Mr. Fritzon's last documented shock from his ICD was in April 2014. He has received 3 total inappropriate shocks for atrial fibrillation with rapid ventricular response. He is on optimal medical therapy for his condition and is stable from a cardiac standpoint.'' Terry Goodhile Mr. Goodhile is a 56-year-old from Pennsylvania. A December 2014 medical form from St. Luke's Occupational Medicine reports that he has ``hypertrophic cardiomyopathy with ICD.'' The report states that ``he is medically stable and is closely monitored by the provider and his cardiologist every 3 months.'' Mr. Goodhile reports in a letter that his ``ICD was implanted in April 2013 and has never delivered a shock.'' Ronald Heinlein Mr. Heinlein is a 55-year-old from California. His dual chamber ICD was implanted in 2008. A February 6, 2015, letter from his cardiologist reports that his device is ``for the purpose of life saving as a back- up, and that the device has never been used and may never be used.'' David Jensen Mr. Jensen is a 52-year-old from California. A February 2, 2015, letter from his cardiologist states that his ICD was ``placed in 2011 and he has had no device firings and no clinical events or arrhythmias. He is not prone to syncopal episodes and has never had any in the past. He engages in other high risk activities such as parachuting and hang gliding.'' His cardiologist reports ``there is no contraindication to holding a motor vehicle license for either commercial or non-commercial vehicles based on the presence of his ICD.'' Douglas Lopez Mr. Lopez is a 32-year-old from New York. His ICD was implanted in 2011. A February 6, 2015, letter from his cardiologist reports that Mr. Lopez's ``device has never fired. His underlying cardiac condition is well compensated and stable with therapy.'' Mr. Lopez wrote in a letter to the FMCSA that he plays sports, coaches various children's athletics, and would be considered an extremely active individual. If granted an exemption, Mr. Lopez would like to resume driving a truck in interstate commerce. Leslie Mitchell Mr. Mitchell is a 55-year-old Class A CDL holder in Minnesota. He has a pacemaker ICD/defibrillator that was implanted in March 2014. In July 2014 his cardiologist wrote that ``Mr. Mitchell has had near complete recovery of his heart function thanks in part to medication and pacemaker therapy. We have seen no evidence concerning heart arrhythmias and he does not require defibrillator therapy.'' In August 2014 his cardiology specialists wrote that ``due to his improved cardiac status the tachycardia therapy portion of his biventricular Internal Cardiac Defibrillator was disabled (as recommended by his physicians). The biventricular pacing (pacemaker) portion of his CRT-D device remains functional.'' Michael Politz Mr. Politz is a 50-year-old non-CDL holder from Washington State. A March 2014 letter from his cardiologist reports that Mr. Politz had a defibrillator implanted ``in 2012 for a primary ventricular fibrillation. A stress test in Jan 2013 demonstrated ejection fraction of 40%, inferior scar but no ischemia. He has had no recurrences of hemodynamically significant [[Page 22261]] dysrhythmias by monitoring on his implantable defibrillator and no syncope, near syncope, or shocks. His cardiologist's letter states that he is at a relatively low risk for recurrent episodes as he has been revascularized.'' If granted an exemption, Mr. Politz would like to resume driving a truck in interstate commerce. Mark Register Mr. Register is a 46-year-old Class B CDL holder in North Carolina. An October 2014 affidavit from his cardiologist reports that his ICD ``was implanted in 2010 for a documented ventricular arrhythmia. Mr. Register's ventricular arrhythmia was determined to be a Right Ventricular Outflow Tract ventricular tachycardia which was treated by ablation in May 2011. His cardiologist is 99.5% confident that the source of Mr. Register's original cardiac arrhythmia has been corrected and removed. Mr. Register has been clinically stable since that time and has experienced no malignant ventricular arrhythmias. His defibrillator is medically checked every three months to ensure proper function and is ``nothing more than a back-up or ``safety net.'' His cardiologist's professional medical opinion is that Mr. Register ``is completely and physically capable of operating a commercial motor vehicle'' and ``poses no risk in operating a commercial motor vehicle.'' His cardiologist cites three recent scholarly articles from the Journal of American College of Cardiology and the European Society of Cardiology, which conclude that ``patients with defibrillators are able to operate motor vehicles just as safely if not more so than the general population.'' Charles Rhodes Mr. Rhodes is a 59-year-old from Arizona. Mr. Rhodes provided medical reports from 2013-2014 from his cardiologists indicating his ICD was implanted in February 2013. An October 22, 2014, medical history from his cardiologist reports that he follows up regularly in the pacemaker clinic every 3 months. Mark Steiner Mr. Steiner is a 65-year-old from Ohio. A January 29, 2015, letter from his cardiologist states that his ICD was implanted in 2012 for primary prevention. An ICD interrogation conducted on January 29, 2015, showed no report of any dysrhythmias or requirement for anti- tachycardia pacing or defibrillation. His cardiologist states Mr. Steiner has had no chest, neck, jaw or arm discomfort, pedal edema, near syncope, syncope, or ICD discharge. If granted an exemption, Mr. Steiner would like to resume driving a truck in interstate commerce. Stephen Watts Mr. Watts is a 52-year-old Class A CDL holder in Kansas. A December 2014 letter from his cardiologist reports that his ICD was implanted in 2013. According to a January 2015 letter from his cardiologists, ``from a clinical standpoint he is doing quite well. He has not had any shortness of breath, PND or orthopnea. Review of his pacemaker/ defibrillator shows that he has not had any significant dysrhythmias.'' A November 2014 letter from his employer states that he has ``driven over 1 million accident free miles.'' If granted an exemption, Mr. Watts would like to resume driving a truck in interstate commerce. John Allen Weltz Mr. Weltz is a 51-year-old Class A CDL holder in Nebraska. A February 2, 2015, letter from his cardiologist reports that Mr. Weltz received an ICD on February 28, 2014, and from Mr. Weltz's records, his cardiologist does not think he has been shocked. A September 2014 letter from his cardiologist states, ``He has had no ventricular arrhythmias since his ICD was implanted and he is quite stable.'' Mr. Weltz reports that for the past 10 years he has been keeping in close contact with all of his doctors, keeping all of his medical appointments and taking all medication as prescribed. Request for Comments In accordance with 49 U.S.C. 31315 and 31136(e), FMCSA requests public comment from all interested persons on the exemption applications described in this notice. We will consider all comments received before the close of business on the closing date indicated earlier in the notice. Issued on: April 14, 2015. Larry W. Minor, Associate Administrator for Policy. [FR Doc. 2015-09068 Filed 4-20-15; 8:45 am] BILLING CODE 4910-EX-P
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formal scoping record. To ensure that three individuals because the Agency Carrier, Driver and Vehicle Safety, (202)
the full range of issues related to this was in the process of gathering and 366–4001, or via email at
proposed action is addressed, and all analyzing additional data concerning fmcsamedical@dot.gov, or by letter to
the significant issues identified, ICDs and commercial motor vehicle FMCSA, Room W64–113, Department of
comments and suggestions are invited (CMV) driving. These three individuals Transportation, 1200 New Jersey
from interested parties during the are being published again with 12 new Avenue SE., Washington, DC 20590–
scoping period. Comments concerning individuals. If granted, an exemption 0001. Office hours are from 8:30 a.m. to
this proposal will be accepted at the would enable these individuals with 5 p.m., Monday through Friday, except
public meeting or can be sent by mail ICDs to operate CMVs for up to 2 years Federal holidays.
to Bill Elliott, Plans Engineer, in interstate commerce. Submitting Comments
Washington State Department of DATES: Comments must be received on
Transportation, 5720 Capitol Blvd. SE or before May 21, 2015. You may submit your comments and
Bldg 7, Tumwater, Washington 98501, material online or by fax, mail, or hand
ADDRESSES: You may submit comments
or ELLIOTB@wsdot.wa.gov. delivery, but please use only one of
bearing the Federal Docket Management these means. FMCSA recommends that
If significant environmental impacts System (FDMS) Docket ID FMCSA–
are discovered during the you include your name and a mailing
2012–0081 using any of the following address, an email address, or a phone
environmental analysis which cannot be methods:
mitigated to a non-significant level an number in the body of your document
• Federal eRulemaking Portal: Go to so that FMCSA can contact you if there
environmental impact statement (EIS) www.regulations.gov. Follow the on-line
will be prepared for the project. If this are questions regarding your
instructions for submitting comments. submission. To submit your comment
happens, no additional scoping • Mail: Docket Management Facility;
meetings will be held. However, another online, go to http://www.regulations.gov
U.S. Department of Transportation, 1200 and in the search box insert the docket
Notice of Intent to prepare an EIS will New Jersey Avenue SE., West Building
published in the Federal and SEPA number ‘‘FMCSA–2012–0081’’ and click
Ground Floor, Room W12–140, the search button. When the new screen
registers, announcing a future deadline Washington, DC 20590–0001. appears, click on the blue ‘‘Comment
for submitting written comments on the • Hand Delivery or Courier: West Now!’’ button on the right hand side of
EIS’s scope of the alternatives and Building Ground Floor, Room W12–140,
impacts to be considered. See Question the page. On the new page, enter
1200 New Jersey Avenue SE., information required including the
13 in the Council on Environmental Washington, DC, between 9 a.m. and 5 specific section of this document to
Quality’s Forty Most Asked Questions p.m., Monday through Friday, except which each comment applies, and
46 FR 18026 (March 23, 1981). Federal Holidays. provide a reason for each suggestion or
Daniel M. Mathis, • Fax: 1–202–493–2251. recommendation. If you submit your
Each submission must include the comments by mail or hand delivery,
Division Administrator, Olympia,
Washington. Agency name and the docket ID for this submit them in an unbound format, no
Notice. Note that DOT posts all larger than 81⁄2 by 11 inches, suitable for
[FR Doc. 2015–09096 Filed 4–20–15; 8:45 am]
comments received without change to copying and electronic filing. If you
BILLING CODE 4910–22–P
www.regulations.gov, including any submit comments by mail and would
personal information included in a like to know that they reached the
DEPARTMENT OF TRANSPORTATION comment. Please see the Privacy Act facility, please enclose a stamped, self-
heading below. addressed postcard or envelope. We will
Federal Motor Carrier Safety Docket: For access to the docket to consider all comments and material
Administration read background documents or received during the comment period
comments, go to www.regulations.gov, and may change this proposed rule
[Docket No. FMCSA–2012–0081] at any time or Room W12–140 on the based on your comments. FMCSA may
ground level of the West Building, 1200 issue a final rule at any time after the
Qualification of Drivers; Exemption New Jersey Avenue SE., Washington,
Applications; Implantable Cardioverter close of the comment period.
DC, between 9 a.m. and 5 p.m., Monday
Defibrillators through Friday, except Federal holidays. Viewing Comments and Documents
AGENCY: Federal Motor Carrier Safety The FDMS is available 24 hours each To view comments, as well as any
Administration (FMCSA), DOT. day, 365 days each year. If you want documents mentioned in this notice, or
ACTION: Notice of application for
acknowledgment that we received your to submit your comment online, go to
exemption; request for comments. comments, please include a self- www.regulations.gov and in the search
addressed, stamped envelope or box insert the docket number ‘‘FMCSA–
SUMMARY: FMCSA announces receipt of postcard or print the acknowledgement 2012–0081’’ and click ‘‘Search.’’ Next,
applications from 15 individuals for an page that appears after submitting click ‘‘Open Docket Folder’’ and you
exemption from the cardiovascular comments on-line. will find all documents and comments
standard [49 CFR 391.41(b)(4)]. These Privacy Act: In accordance with 5 related to the proposed rulemaking.
15 individuals are requesting an U.S.C. 553(c), DOT solicits comments SUPPLEMENTARY INFORMATION:
exemption due to the presence of from the public to better inform its
implantable cardioverter defibrillators rulemaking process. DOT posts these Background
(ICD) as a result of their underlying comments, without edit, including any FMCSA has authority under 49 U.S.C.
tkelley on DSK3SPTVN1PROD with NOTICES
cardiac condition. Of the 15 individuals personal information the commenter 31136(e) and 31315 to grant exemptions
requesting exemptions, three provides, to www.regulations.gov, as from certain parts of the Federal Motor
individuals (Craig Bohms, James Dean, described in the system records notice Carrier Safety Regulations. FMCSA must
and Mark Steiner) were previously (DOT/ALL–14 FDMS), which can be publish a notice of each exemption
published in a January 2014 Federal reviewed at www.dot.gov/privacy. request in the Federal Register [49 CFR
Register under the docket listed above. FOR FURTHER INFORMATION CONTACT: 381.315(a)]. The Agency must provide
A final decision was not issued on these Charles A. Horan, III, Director, Office of the public an opportunity to inspect the
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information relevant to the application, James Dean saving as a back-up, and that the device
including any safety analyses that have Mr. Dean is a 55-year-old from has never been used and may never be
been conducted. The Agency must also Wisconsin. A November 2014 medical used.’’
provide an opportunity for public document received from Mr. Dean David Jensen
comment on the request. indicates that his ICD was implanted in
Mr. Jensen is a 52-year-old from
The Agency reviews safety analyses August of 2007. An April 2014 routine
California. A February 2, 2015, letter
and public comments submitted, and in-clinic visit document indicates no
from his cardiologist states that his ICD
determines whether granting the ventricular tachycardia episodes
was ‘‘placed in 2011 and he has had no
exemption would likely achieve a level detected and that the patient states
feeling well with no dizziness or device firings and no clinical events or
of safety equivalent to, or greater than, arrhythmias. He is not prone to
the level that would be achieved by the syncope. A March 2014 document from
St. Mary’s Hospital indicates Mr. Dean syncopal episodes and has never had
current regulation (49 CFR 381.305). any in the past. He engages in other high
The Agency may grant an exemption has a rate responsive dual chamber ICD.
risk activities such as parachuting and
subject to specified terms and Daniel Donahue hang gliding.’’ His cardiologist reports
conditions. The decision of the Agency ‘‘there is no contraindication to holding
Mr. Donahue is a 72-year-old Class A
must be published in the Federal CDL holder in Wisconsin. A February 4, a motor vehicle license for either
Register (49 CFR 381.315(b)) with the 2015 letter from his cardiologist reports commercial or non-commercial vehicles
reasons for denying or granting the that Mr. Donahue’s ICD was implanted based on the presence of his ICD.’’
application and, if granted, the name of in December 2004. ‘‘[Mr. Donahue ]has
the person or class of persons receiving Douglas Lopez
never required any therapy from his
the exemption, and the regulatory ICD. Since September 2013 to the date Mr. Lopez is a 32-year-old from New
provision from which the exemption is of this letter, [Mr. Donahue] has only York. His ICD was implanted in 2011.
granted. The notice must also specify one event of ventricular tachycardia A February 6, 2015, letter from his
the effective period and explain the which lasted 7 seconds, and did not cardiologist reports that Mr. Lopez’s
terms and conditions of the exemption. require any therapy from his ICD. His ‘‘device has never fired. His underlying
The exemption may be renewed (49 CFR ejection fraction has improved to 42% cardiac condition is well compensated
381.300(b)). on his last echocardiogram which was and stable with therapy.’’ Mr. Lopez
The FMCSA provides medical done in September 2013.’’ wrote in a letter to the FMCSA that he
advisory criteria for use by medical plays sports, coaches various children’s
Bernard Fritzon athletics, and would be considered an
examiners in determining whether
drivers with certain medical conditions Mr. Fritzon is a 56-year-old Class A extremely active individual. If granted
should be certified to operate CMVs in CDL holder in Kansas. A February 16, an exemption, Mr. Lopez would like to
interstate commerce. The advisory 2015 letter from his cardiologist reports resume driving a truck in interstate
that ‘‘[Mr. Fritzon] received an ICD for commerce.
criteria are currently set out as part of
the medical examination report secondary prevention due to non- Leslie Mitchell
published with 49 CFR 391.43. The ischemic cardiomyopathy, and atrial
fibrillation. The device was implanted Mr. Mitchell is a 55-year-old Class A
advisory criteria for section 391.41(b)(4) CDL holder in Minnesota. He has a
for secondary prevention after
indicate that the term ‘‘has no current pacemaker ICD/defibrillator that was
witnessed ventricular tachycardia
clinical diagnosis of’’ is specifically implanted in March 2014. In July 2014
during a cardiac procedure. Mr.
designed to encompass: ‘‘A clinical his cardiologist wrote that ‘‘Mr. Mitchell
Fritzon’s last documented shock from
diagnosis of’’ (1) a current has had near complete recovery of his
his ICD was in April 2014. He has
cardiovascular condition, or (2) a heart function thanks in part to
received 3 total inappropriate shocks for
cardiovascular condition which has not medication and pacemaker therapy. We
atrial fibrillation with rapid ventricular
fully stabilized regardless of the time have seen no evidence concerning heart
response. He is on optimal medical
limit. The term ‘‘known to be therapy for his condition and is stable arrhythmias and he does not require
accompanied by’’ is designed to include from a cardiac standpoint.’’ defibrillator therapy.’’ In August 2014
a clinical diagnosis of a cardiovascular his cardiology specialists wrote that
disease (1) which is accompanied by Terry Goodhile ‘‘due to his improved cardiac status the
symptoms of syncope, dyspnea, collapse Mr. Goodhile is a 56-year-old from tachycardia therapy portion of his
or congestive cardiac failure; and/or (2) Pennsylvania. A December 2014 biventricular Internal Cardiac
which is likely to cause syncope, medical form from St. Luke’s Defibrillator was disabled (as
dyspnea, collapse, or congestive cardiac Occupational Medicine reports that he recommended by his physicians). The
failure. has ‘‘hypertrophic cardiomyopathy with biventricular pacing (pacemaker)
Summary of Applications ICD.’’ The report states that ‘‘he is portion of his CRT–D device remains
medically stable and is closely functional.’’
Craig Bohms monitored by the provider and his
Michael Politz
cardiologist every 3 months.’’ Mr.
Mr. Bohms is a 57-year-old Class A Goodhile reports in a letter that his ‘‘ICD Mr. Politz is a 50-year-old non-CDL
CDL holder in Illinois. Mr. Bohms was implanted in April 2013 and has holder from Washington State. A March
documents that his ICD was implanted never delivered a shock.’’ 2014 letter from his cardiologist reports
tkelley on DSK3SPTVN1PROD with NOTICES
in 2013. A March 13, 2015, letter from that Mr. Politz had a defibrillator
his cardiologist reports Mr. Bohms ‘‘is Ronald Heinlein implanted ‘‘in 2012 for a primary
doing well feeling good and has not Mr. Heinlein is a 55-year-old from ventricular fibrillation. A stress test in
needed or had any shock therapy from California. His dual chamber ICD was Jan 2013 demonstrated ejection fraction
his defibrillator. He is stable from a implanted in 2008. A February 6, 2015, of 40%, inferior scar but no ischemia.
heart rhythm standpoint and may drive letter from his cardiologist reports that He has had no recurrences of
for his job from that standpoint.’’ his device is ‘‘for the purpose of life hemodynamically significant
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dysrhythmias by monitoring on his syncope, syncope, or ICD discharge. If SUMMARY: In compliance with the
implantable defibrillator and no granted an exemption, Mr. Steiner Paperwork Reduction Act of 1995 (44
syncope, near syncope, or shocks. His would like to resume driving a truck in U.S.C. 3501 et seq.), this notice
cardiologist’s letter states that he is at a interstate commerce. announces that the Information
relatively low risk for recurrent episodes Collection Request (ICR) abstracted
Stephen Watts
as he has been revascularized.’’ If below has been forwarded to the Office
granted an exemption, Mr. Politz would Mr. Watts is a 52-year-old Class A of Management and Budget (OMB) for
like to resume driving a truck in CDL holder in Kansas. A December 2014 review and comment. The ICR describes
interstate commerce. letter from his cardiologist reports that the nature of the information collections
his ICD was implanted in 2013. and their expected burden. The Federal
Mark Register According to a January 2015 letter from Register Notice with a 60-day comment
Mr. Register is a 46-year-old Class B his cardiologists, ‘‘from a clinical period was published on December 19,
CDL holder in North Carolina. An standpoint he is doing quite well. He 2014 (79 FR 75859). No comments were
October 2014 affidavit from his has not had any shortness of breath, received.
cardiologist reports that his ICD ‘‘was PND or orthopnea. Review of his This document describes a collection
implanted in 2010 for a documented pacemaker/defibrillator shows that he of information on nine Federal motor
ventricular arrhythmia. Mr. Register’s has not had any significant vehicle safety standards (FMVSSs) and
ventricular arrhythmia was determined dysrhythmias.’’ A November 2014 letter one regulation, for which NHTSA
to be a Right Ventricular Outflow Tract from his employer states that he has intends to seek OMB approval. The
ventricular tachycardia which was ‘‘driven over 1 million accident free information collection pertains to
treated by ablation in May 2011. His miles.’’ If granted an exemption, Mr. requirements that specify certain safety
cardiologist is 99.5% confident that the Watts would like to resume driving a precautions regarding items of motor
source of Mr. Register’s original cardiac truck in interstate commerce. vehicle equipment must appear in the
arrhythmia has been corrected and vehicle owner’s manual.
John Allen Weltz
removed. Mr. Register has been
Mr. Weltz is a 51-year-old Class A DATES: Comments must be submitted on
clinically stable since that time and has
CDL holder in Nebraska. A February 2, or before May 21, 2015.
experienced no malignant ventricular
arrhythmias. His defibrillator is 2015, letter from his cardiologist reports FOR FURTHER INFORMATION CONTACT: Lou
medically checked every three months that Mr. Weltz received an ICD on Molino, the National Highway Traffic
to ensure proper function and is February 28, 2014, and from Mr. Weltz’s Safety Administration, Office of
‘‘nothing more than a back-up or ‘‘safety records, his cardiologist does not think Rulemaking (NVS–112), (202) 366–1740,
net.’’ His cardiologist’s professional he has been shocked. A September 2014 1200 New Jersey Avenue, W43–311,
medical opinion is that Mr. Register ‘‘is letter from his cardiologist states, ‘‘He Washington, DC 20590.
completely and physically capable of has had no ventricular arrhythmias SUPPLEMENTARY INFORMATION:
operating a commercial motor vehicle’’ since his ICD was implanted and he is National Highway Traffic Safety
and ‘‘poses no risk in operating a quite stable.’’ Mr. Weltz reports that for Administration
commercial motor vehicle.’’ His the past 10 years he has been keeping Title: Consolidated Vehicle Owner’s
cardiologist cites three recent scholarly in close contact with all of his doctors, Manual Requirements for Motor
articles from the Journal of American keeping all of his medical appointments Vehicles and Motor Vehicle Equipment.
College of Cardiology and the European and taking all medication as prescribed. OMB Number: 2127–0541.
Society of Cardiology, which conclude Type of Request: Extension of a
Request for Comments
that ‘‘patients with defibrillators are currently approved collection.
In accordance with 49 U.S.C. 31315 Abstract: In order to ensure that
able to operate motor vehicles just as
and 31136(e), FMCSA requests public manufacturers are complying with the
safely if not more so than the general
comment from all interested persons on FMVSS and regulations, NHTSA
population.’’
the exemption applications described in requires a number of information
Charles Rhodes this notice. We will consider all collections in FMVSS Nos. 108, 110,
Mr. Rhodes is a 59-year-old from comments received before the close of 138, 202a, 205, 208, 210, 213, and 226
Arizona. Mr. Rhodes provided medical business on the closing date indicated and Part 575 Sections 103 and 105.
reports from 2013–2014 from his earlier in the notice. FMVSS No. 108, ‘‘Lamps, reflective
cardiologists indicating his ICD was Issued on: April 14, 2015. devices, and associated equipment.’’
implanted in February 2013. An October Larry W. Minor, This standard requires that certain
22, 2014, medical history from his Associate Administrator for Policy. lamps and reflective devices with
cardiologist reports that he follows up [FR Doc. 2015–09068 Filed 4–20–15; 8:45 am]
certain performance levels be installed
regularly in the pacemaker clinic every on motor vehicles to assure that the
BILLING CODE 4910–EX–P
3 months. roadway is properly illuminated, that
vehicles can be readily seen, and the
Mark Steiner signals can be transmitted to other
DEPARTMENT OF TRANSPORTATION
Mr. Steiner is a 65-year-old from drivers sharing the road, during day,
Ohio. A January 29, 2015, letter from his National Highway Traffic Safety night and inclement weather. Since the
cardiologist states that his ICD was Administration specific manner in which headlamp aim
implanted in 2012 for primary is to be performed is not regulated (only
tkelley on DSK3SPTVN1PROD with NOTICES
prevention. An ICD interrogation Reports, Forms and Recordkeeping the performance of the device is),
conducted on January 29, 2015, showed Requirements; Agency Information aiming devices manufactured or
no report of any dysrhythmias or Collection Activity Under OMB Review installed by different vehicle and
requirement for anti-tachycardia pacing AGENCY: National Highway Traffic headlamp manufacturers may work in
or defibrillation. His cardiologist states Safety Administration (NHTSA), DOT. significantly different ways. As a
Mr. Steiner has had no chest, neck, jaw consequence, to assure that headlamps
ACTION: Notice.
or arm discomfort, pedal edema, near can be correctly aimed, instructions for
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Document Created: 2015-12-16 08:33:29
Document Modified: 2015-12-16 08:33:29
| 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 application for exemption; request for comments. | |
| Dates | Comments must be received on or before May 21, 2015. | |
| Contact | Charles A. Horan, III, Director, Office of Carrier, Driver and Vehicle Safety, (202) 366-4001, or via email at [email protected], or by letter to FMCSA, Room W64-113, Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday through Friday, except Federal holidays. | |
| FR Citation | 80 FR 22259 |
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