82 FR 15786 - Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillators
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration Federal Register Volume 82, Issue 60 (March 30, 2017)
Federal Motor Carrier Safety Administration
Federal Register Volume 82, Issue 60 (March 30, 2017)
| Page Range | 15786-15787 | |
| FR Document | 2017-06271 |
[Federal Register Volume 82, Number 60 (Thursday, March 30, 2017)] [Notices] [Pages 15786-15787] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-06271] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2016-0353] Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillators AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of denials of exemption applications. ----------------------------------------------------------------------- SUMMARY: FMCSA announces its decision to deny applications from three individuals seeking exemptions from the Federal cardiovascular standard applicable to interstate truck and bus drivers and discusses the reasons for the denials. The Agency reviewed the medical information of each the individuals who applied for an implantable cardioverter defibrillator (ICD) exemption. Based on a review of the applications and following an opportunity for public comment, FMCSA has concluded that the three individuals in the notice did not demonstrate they could achieve a level of safety that is equivalent to, or greater than, the level of safety that would be obtained by complying with the regulation. DATES: Denial letters were sent to each of the individuals listed in this notice on December 7, 2016. FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief Medical Programs Division, 202-366-4001, U.S. Department of Transportation, FMCSA, 1200 New Jersey Avenue SE., Room W64-224, Washington, DC 20590- 0001. Office hours are from 8:30 a.m. to 5 p.m., e.t., Monday through Friday, except Federal holidays. SUPPLEMENTARY INFORMATION: Background Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the Federal Motor Carrier Safety Regulations for up to five years 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.'' FMCSA can renew exemptions for up to an additional five years at the end of each five-year period.\1\ --------------------------------------------------------------------------- \1\ 49 U.S.C. 81315(b), as amend by section 5206(a) of the FAST ACT, Public Law 114-94, div. A, title V, 129 Stat.1537 (Dec. 4, 2015). --------------------------------------------------------------------------- On October 20, 2016, FMCSA published for public notice and comment FMCSA 2016-0353, listing three individuals seeking exemptions for ICDs. Accordingly, the Agency has evaluated each applicant's request to determine whether granting an exemption will achieve the required level of safety mandated by statute. Evaluation Criteria--Cardiovascular Medical Standard and Advisory Criteria The individuals included in this notice have requested an exemption from the provisions of 49 CFR 391.41(b)(4), which applies to drivers who operate commercial motor vehicles (CMV) in interstate commerce, as defined in 49 CFR 390.5. Section 391.41(b)(4) states that: A person is physically qualified to drive a commercial motor vehicle if-- * * * * * that person has no 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 [a temporary loss of consciousness due to a sudden decline in blood flow to the brain], dyspnea [shortness of breath], collapse, or congestive cardiac failure. The FMCSA provides medical advisory criteria as recommendations for use by medical examiners in determining whether drivers with certain medical conditions and drivers who have undergone certain procedures and/or treatments should be certified to operate CMVs in interstate commerce in accordance with the various physical qualification standards in 49 CFR part 391, subpart E. The advisory criteria are currently set out in Appendix A to 49 CFR part 391. The advisory criteria for section 391.41(b)(4) provide, in part, 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. It is the intent of the Federal Motor Carrier Safety Regulations to render unqualified, a driver who has a current cardiovascular [[Page 15787]] disease which is accompanied by and/or likely to cause symptoms of syncope, dyspnea, collapse, or congestive cardiac failure. However, the subjective decision of whether the nature and severity of an individual's condition will likely cause symptoms of cardiovascular insufficiency is on an individual basis and qualification rests with the medical examiner and the motor carrier. In the case of persons with ICDs, the underlying condition for which the ICD was implanted places the individual at high risk for syncope (a transient loss of consciousness) or other unpredictable events known to result in gradual or sudden incapacitation. ICDs may discharge, which could result in loss of ability to safely control a CMV. See the Evidence Report on ``Cardiovascular Disease and Commercial Motor Vehicle Driver Safety,'' April 2007.\2\ A focused research report entitled ``Implantable Cardioverter Defibrillators and the Impact of a Shock on a Patient When Deployed,'' completed for the FMCSA in December 2014, 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 and upholds the findings of the April 2007 report. Copies of the April 2007 report and the December 2014 report are included in the docket for this notice. --------------------------------------------------------------------------- \2\ Now available at http://ntl.bts.gov/lib/30000/30100/30123/Final_CVD_Evidence_Report_v2.pdf. --------------------------------------------------------------------------- Discussion of Public Comments On October 20, 2016, FMCSA published in a Federal Register Notice the names of three individuals seeking ICD exemption and requested public comment. The public comment period closed on November 21, 2016. One comment was received that was out of scope for this notice. Conclusion FMCSA evaluated the three individual exemption requests on their merits, available data from Evidence Reports and Medical Expert Panel opinions on the impact of ICDs on CMV driving, and the public comments received. The Agency has determined that the available medical literature and data does not support a conclusion that granting these exemptions would achieve a level of safety equivalent to or greater than the level of safety maintained without the exemptions. Each applicant has, prior to this notice, received a letter of final disposition on his/her exemption request. Those decision letters fully outlined the basis for the denial and constitute final Agency action. The list published today summarizes the Agency's recent denials as required under 49 U.S.C. 31315(b)(4). The following three applicants are denied exemptions from the cardiovascular standard: Gary Francher Henry McGuire Matthew Wilson Issued on: March 23, 2017. Larry W. Minor, Associate Administrator for Policy. [FR Doc. 2017-06271 Filed 3-29-17; 8:45 am] BILLING CODE 4910-EX-P
![15786 Federal Register / Vol. 82, No. 60 / Thursday, March 30, 2017 / Notices
and follow the instructions for sending used in aerial firefighting retardant years at the end of each five-year
your comments digitally. drops. period.1
• Mail: Send comments to the Docket [FR Doc. 2017–06269 Filed 3–29–17; 8:45 am] On October 20, 2016, FMCSA
Management Facility; U.S. Department BILLING CODE 4910–13–P
published for public notice and
of Transportation, 1200 New Jersey comment FMCSA 2016–0353, listing
Avenue SE., West Building Ground three individuals seeking exemptions
Floor, Room W12–140, Washington, DC DEPARTMENT OF TRANSPORTATION for ICDs. Accordingly, the Agency has
20590. evaluated each applicant’s request to
• Fax: Fax comments to the Docket Federal Motor Carrier Safety determine whether granting an
Management Facility at 202–493–2251. Administration exemption will achieve the required
• Hand Delivery: Bring comments to level of safety mandated by statute.
the Docket Management Facility in [Docket No. FMCSA–2016–0353] Evaluation Criteria—Cardiovascular
Room W12–140 of the West Building
Medical Standard and Advisory
Ground Floor at 1200 New Jersey Qualification of Drivers; Exemption Criteria
Avenue SE., Washington, DC, between 9 Applications; Implantable Cardioverter
a.m. and 5 p.m., Monday through Defibrillators The individuals included in this
Friday, except Federal holidays. notice have requested an exemption
Privacy: We will post all comments AGENCY: Federal Motor Carrier Safety from the provisions of 49 CFR
we receive, without change, to http:// Administration (FMCSA), DOT. 391.41(b)(4), which applies to drivers
www.regulations.gov, including any ACTION: Notice of denials of exemption who operate commercial motor vehicles
personal information you provide. applications. (CMV) in interstate commerce, as
Using the search function of our docket defined in 49 CFR 390.5. Section
Web site, anyone can find and read the SUMMARY: FMCSA announces its 391.41(b)(4) states that:
comments received into any of our decision to deny applications from three A person is physically qualified to drive a
dockets, including the name of the individuals seeking exemptions from commercial motor vehicle if—
individual sending the comment (or the Federal cardiovascular standard * * * * *
signing the comment for an association, applicable to interstate truck and bus that person has no current clinical diagnosis
business, labor union, etc.). You may drivers and discusses the reasons for the of myocardial infarction, angina pectoris,
review the DOT’s complete Privacy Act denials. The Agency reviewed the coronary insufficiency, thrombosis, or any
Statement in the Federal Register medical information of each the other cardiovascular disease of a variety
known to be accompanied by syncope [a
published on April 11, 2000 (65 FR individuals who applied for an
temporary loss of consciousness due to a
19477–78). implantable cardioverter defibrillator sudden decline in blood flow to the brain],
Docket: To read background (ICD) exemption. Based on a review of dyspnea [shortness of breath], collapse, or
documents or comments received, go to the applications and following an congestive cardiac failure.
http://www.regulations.gov at any time opportunity for public comment, The FMCSA provides medical
or to the Docket Management Facility in FMCSA has concluded that the three advisory criteria as recommendations
Room W12–140 of the West Building individuals in the notice did not for use by medical examiners in
Ground Floor at 1200 New Jersey demonstrate they could achieve a level determining whether drivers with
Avenue SE., Washington, DC, between 9 of safety that is equivalent to, or greater certain medical conditions and drivers
a.m. and 5 p.m., Monday through than, the level of safety that would be who have undergone certain procedures
Friday, except Federal holidays. obtained by complying with the and/or treatments should be certified to
FOR FURTHER INFORMATION CONTACT: regulation. operate CMVs in interstate commerce in
Deana Stedman, ANM–113, Federal DATES: Denial letters were sent to each accordance with the various physical
Aviation Administration, 1601 Lind of the individuals listed in this notice qualification standards in 49 CFR part
Avenue SW., Renton, WA 98057–3356, on December 7, 2016. 391, subpart E. The advisory criteria are
email deana.stedman@faa.gov, phone currently set out in Appendix A to 49
(425) 227–2148. FOR FURTHER INFORMATION CONTACT: Ms.
Christine A. Hydock, Chief Medical CFR part 391. The advisory criteria for
This notice is published pursuant to section 391.41(b)(4) provide, in part,
14 CFR 11.85. Programs Division, 202–366–4001, U.S.
Department of Transportation, FMCSA, that:
Issued in Renton, Washington, on March 1200 New Jersey Avenue SE., Room The term ‘‘has no current clinical diagnosis
24, 2017. of’’ is specifically designed to encompass: ‘‘a
W64–224, Washington, DC 20590–0001.
Victor Wicklund, Office hours are from 8:30 a.m. to 5 clinical diagnosis of’’ (1) a current
Manager, Transport Standards Staff. cardiovascular condition, or (2) a
p.m., e.t., Monday through Friday, cardiovascular condition which has not fully
Petition for Exemption except Federal holidays. stabilized regardless of the time limit. The
SUPPLEMENTARY INFORMATION: term ‘‘known to be accompanied by’’ is
Docket No.: FAA–2017–0133.
designed to include a clinical diagnosis of a
Petitioner: Erickson Aero Tanker, Background cardiovascular disease (1) which is
LLC. accompanied by symptoms of syncope,
Section of 14 CFR Affected: Under 49 U.S.C. 31136(e) and 31315, dyspnea, collapse or congestive cardiac
§ 25.201(b)(1). FMCSA may grant an exemption from
asabaliauskas on DSK3SPTVN1PROD with NOTICES
failure; and/or (2) which is likely to cause
Description of Relief Sought: The the Federal Motor Carrier Safety syncope, dyspnea, collapse, or congestive
petitioner seeks an exemption from the Regulations for up to five years if it cardiac failure.
requirements of 14 CFR 25.201(b)(1) at finds ‘‘such exemption would likely It is the intent of the Federal Motor Carrier
achieve a level of safety that is Safety Regulations to render unqualified, a
Amendment 25–42, with respect to stall
equivalent to or greater than the level driver who has a current cardiovascular
characteristics in the flaps 40/landing
gear up configuration for its DC–9–87 that would be achieved absent such 1 49 U.S.C. 81315(b), as amend by section 5206(a)
(MD–87) airplanes. The exemption, if exemption.’’ FMCSA can renew of the FAST ACT, Public Law 114–94, div. A, title
granted, would allow the airplanes to be exemptions for up to an additional five V, 129 Stat.1537 (Dec. 4, 2015).
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![Federal Register / Vol. 82, No. 60 / Thursday, March 30, 2017 / Notices 15787
disease which is accompanied by and/or summarizes the Agency’s recent denials 61834, September 7, 2016). BTS
likely to cause symptoms of syncope, as required under 49 U.S.C. 31315(b)(4). received permission to collect the data
dyspnea, collapse, or congestive cardiac The following three applicants are under an emergency OMB control
failure. However, the subjective decision of
whether the nature and severity of an
denied exemptions from the number on September 29, 2016.
individual’s condition will likely cause cardiovascular standard: Through this notice, BTS is requesting
symptoms of cardiovascular insufficiency is Gary Francher permission to continue this previously
on an individual basis and qualification rests Henry McGuire approved data collection. This
with the medical examiner and the motor Matthew Wilson information collection is necessary to
carrier. aid BSEE, the oil and gas industry, and
Issued on: March 23, 2017.
In the case of persons with ICDs, the other stakeholders in identifying barrier
Larry W. Minor,
underlying condition for which the ICD failure trends and causes of critical
Associate Administrator for Policy. safety barrier failure events.
was implanted places the individual at
[FR Doc. 2017–06271 Filed 3–29–17; 8:45 am]
high risk for syncope (a transient loss of DATES: Written comments should be
consciousness) or other unpredictable BILLING CODE 4910–EX–P submitted by May 30, 2017.
events known to result in gradual or ADDRESSES: To ensure that your
sudden incapacitation. ICDs may comments are not entered more than
discharge, which could result in loss of DEPARTMENT OF TRANSPORTATION
once into the docket, submit comments
ability to safely control a CMV. See the Bureau of Transportation Statistics by only one of the following methods:
Evidence Report on ‘‘Cardiovascular • Federal eRulemaking Portal: Go to
Disease and Commercial Motor Vehicle [Docket Number DOT–OST–2017–0043] http://www.regulations.gov and follow
Driver Safety,’’ April 2007.2 A focused the instructions for sending your
research report entitled ‘‘Implantable Agency Information Collection
comments electronically. Docket
Cardioverter Defibrillators and the Activity; Notice of Request for
Number: DOT–OST–2017–0043.
Impact of a Shock on a Patient When Approval To Continue To Collect • Mail: Docket Services, U.S.
Deployed,’’ completed for the FMCSA Information: Barrier Failure Reporting Department of Transportation, 1200
in December 2014, indicates that the in Oil and Gas Operations on the Outer New Jersey Avenue SE., West Building,
available scientific data on persons with Continental Shelf Ground Floor, Room W12–140,
ICDs and CMV driving does not support AGENCY: Bureau of Transportation Washington, DC 20590–0001.
that persons with ICDs who operate Statistics (BTS), Office of the Assistant • Hand Delivery: Deliver to mail
CMVs are able to meet an equal or Secretary for Research and Technology address above between 9 a.m. and 5
greater level of safety and upholds the (OST–R), U.S. Department of p.m. EST, Monday through Friday,
findings of the April 2007 report. Copies Transportation. except Federal holidays.
of the April 2007 report and the • Fax: (202) 493–2251.
ACTION: Notice and request for
December 2014 report are included in Identify all transmissions with ‘‘Docket
the docket for this notice. comments.
Number DOT–OST–2017–0043’’ at the
Discussion of Public Comments SUMMARY: In accordance with the beginning of each page of the document.
requirements of the Paperwork Instructions: All comments must
On October 20, 2016, FMCSA include the agency name and docket
Reduction Act of 1995, this notice
published in a Federal Register Notice number for this notice. Paper comments
announces the intention of BTS to
the names of three individuals seeking should be submitted in duplicate. The
request the Office of Management and
ICD exemption and requested public Docket Management Facility is open for
Budget (OMB) to approve continuation
comment. The public comment period examination and copying, at the above
of the following information collection:
closed on November 21, 2016. One address from 9 a.m. to 5 p.m. EST,
Barrier Failure Reporting in Oil and Gas
comment was received that was out of Monday through Friday, except Federal
Operations on the Outer Continental
scope for this notice. holidays. If you wish to receive
Shelf (OCS). In August 2013, the Bureau
Conclusion of Safety and Environmental confirmation of receipt of your written
FMCSA evaluated the three Enforcement (BSEE) and BTS signed an comments, please include a self-
individual exemption requests on their Interagency Agreement (IAA) to develop addressed, stamped postcard with the
merits, available data from Evidence and implement SafeOCS, a voluntary following statement: ‘‘Comments on
Reports and Medical Expert Panel program for confidential reporting of Docket Number DOT–OST–2017–0043.’’
opinions on the impact of ICDs on CMV ‘near misses’ occurring on the OCS. BTS The Docket Clerk will date stamp the
driving, and the public comments has entered into a memorandum of postcard prior to returning it to you via
received. The Agency has determined understanding (MOU) with BSEE to the U.S. mail. Please note that all
that the available medical literature and expand the scope of SafeOCS to include comments received, including any
data does not support a conclusion that an industry-wide repository of personal information, will be posted
granting these exemptions would equipment failure data, analyze and and will be publicly viewable, without
achieve a level of safety equivalent to or aggregate information provided under change, at www.regulations.gov. You
greater than the level of safety this program, and publish reports that may review DOT’s complete Privacy Act
maintained without the exemptions. will provide BSEE, the industry, and all Statement in the Federal Register
OCS stakeholders with essential published on April 11, 2000 (Volume
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Each applicant has, prior to this notice,
received a letter of final disposition on information about failure types and 65, Number 70; pages 19477–78) or you
his/her exemption request. Those modes of critical safety barriers for may review the Privacy Act Statement at
decision letters fully outlined the basis offshore operations related to well www.regulations.gov.
for the denial and constitute final control. The data collection effort that is FOR FURTHER INFORMATION CONTACT:
Agency action. The list published today the subject of this notice addresses the Demetra V. Collia, Bureau of
collection of failure data as referenced Transportation Statistics, Office of the
2 Now available at http://ntl.bts.gov/lib/30000/ in recently issued BSEE regulations (81 Assistant Secretary for Research and
30100/30123/Final_CVD_Evidence_Report_v2.pdf. FR 25887, April 29, 2016) and (81 FR Technology, U.S. Department of
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Document Created: 2017-03-30 01:35:50
Document Modified: 2017-03-30 01:35:50
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of denials of exemption applications. | |
| Dates | Denial letters were sent to each of the individuals listed in this notice on December 7, 2016. | |
| Contact | Ms. Christine A. Hydock, Chief Medical Programs Division, 202-366-4001, U.S. Department of Transportation, FMCSA, 1200 New Jersey Avenue SE., Room W64-224, Washington, DC 20590- 0001. Office hours are from 8:30 a.m. to 5 p.m., e.t., Monday through Friday, except Federal holidays. | |
| FR Citation | 82 FR 15786 |
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