60-day FR for the Insulin-Treated Diabetes Mellitus Assessment Form

60-day FR for Insulin-Treated Diabetes Mellitus Assessment Form.pdf

Medical Qualification Requirements

60-day FR for the Insulin-Treated Diabetes Mellitus Assessment Form

OMB: 2126-0006

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Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Notices
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety
Administration
[Docket No. FMCSA–2005–23151]

Agency Information Collection
Activities; Information Collection
Revision Request—Medical
Qualification Requirements, OMB
Control Number 2126–0006
Federal Motor Carrier Safety
Administration (FMCSA), DOT.
ACTION: Notice and request for
comments.
AGENCY:

In accordance with the
Paperwork Reduction Act of 1995,
FMCSA announces that it is considering
submitting the Information Collection
Request (ICR) described below to the
Office of Management and Budget
(OMB) for its review and approval and
invites public comment on a revision to
the Information Collection (IC) titled
Medical Qualification Requirements,
covered by OMB Control Number 2126–
0006, which is currently due to expire
on August 31, 2018. This revision is due
to the Agency’s anticipation of a final
rule to revise its regulations to eliminate
the blanket prohibition against insulindependent diabetic individuals’
operation of commercial motor vehicles
(CMV) in interstate commerce. The final
rule is based on the Agency’s 2015
Notice of Proposed Rulemaking (NPRM)
and subsequent announcement of the
availability of recommendations
provided by FMCSA’s Medical Review
Board (MRB) after an analysis of the
comments received in response to the
NPRM. Based on the MRB’s analysis of
the comments and their
recommendations, FMCSA is
considering replacing the previously
proposed written notification from the
treating clinician (TC) with a form titled
Insulin-Treated Diabetes Mellitus
Assessment Form to be completed by
the TC and provided to the certified
medical examiner (certified ME). This
form could be required for CMV drivers
treated with insulin for diabetes who
wish to drive in interstate commerce.
FMCSA invites public comment on the
proposed IC revision and the form that
it is being considered.
DATES: We must receive your comments
on or before September 25, 2017.
ADDRESSES: You may submit comments
identified by Federal Docket
Management System (FDMS) Docket
Number FMCSA–2005–23151 using any
of the following methods:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the online
instructions for submitting comments.

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SUMMARY:

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• Fax: 1–202–493–2251.
• Mail: Docket Services; 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: U.S.
Department of Transportation, 1200
New Jersey Avenue SE., West Building,
Ground Floor, Room W12–140,
Washington, DC, between 9 a.m. and 5
p.m. e.t., Monday through Friday,
except Federal holidays.
Instructions: All submissions must
include the Agency name and docket
number. For detailed instructions on
submitting comments and additional
information on the exemption process,
see the Public Participation heading
below. Note that all comments received
will be posted without change to http://
www.regulations.gov, including any
personal information provided. Please
see the Privacy Act heading below.
Docket: For access to the docket to
read background documents or
comments received, go to http://
www.regulations.gov, and follow the
online instructions for accessing the
dockets, or go to the street address listed
above.
Privacy Act: Anyone is able to search
the electronic form of all comments
received into any of our dockets by the
name of the individual submitting the
comment (or signing the comment, if
submitted on behalf of an association,
business, labor union, etc.). You may
review DOT’s complete Privacy Act
Statement for the Federal Docket
Management System published in the
Federal Register on January 17, 2008
(73 FR 3316), or you may visit http://
edocket.access.gpo.gov/2008/pdfE8794.pdf.
Public Participation: The Federal
eRulemaking Portal is available 24
hours each day, 365 days each year. You
can obtain electronic submission and
retrieval help and guidelines under the
‘‘help’’ section of the Federal
eRulemaking Portal Web site. If you
want us to notify you that we received
your comments, please include a selfaddressed, stamped envelope or
postcard, or print the acknowledgement
page that appears after submitting
comments online. Comments received
after the comment closing date will be
included in the docket and will be
considered to the extent practicable.
FOR FURTHER INFORMATION CONTACT: Ms.
Christine A. Hydock, Chief, Medical
Programs Division, U.S. Department of
Transportation, Federal Motor Carrier
Safety Administration, West Building
6th Floor, 1200 New Jersey Avenue SE.,
Washington, DC 20590. Telephone:

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202–366–4001; email FMCSAmedical.@
dot.gov.
SUPPLEMENTARY INFORMATION:
Background
The primary mission of FMCSA is to
reduce crashes, injuries, and fatalities
involving large trucks and buses. The
Secretary of Transportation has
delegated to FMCSA its responsibility
under 49 U.S.C. 31136, 31149 and
31502 to prescribe regulations that
ensure that CMVs are operated safely.
As part of this mission, the Agency’s
Medical Programs Division works to
ensure that CMV drivers engaged in
interstate commerce are physically
qualified and able to safely perform
their work.
Information used to determine and
certify driver medical fitness must be
collected for our highways to be safe.
FMCSA is the Federal government
agency authorized to require the
collection of this information and the
authorizing regulations are located at 49
CFR 390–399. FMCSA is required by
statute to establish standards for the
physical qualifications of drivers who
operate CMVs in interstate commerce
for non-excepted industries (49 U.S.C.
31136(a)(3), 31149(c)(1)(A)(i), and
31502(b)). The regulations relevant to
this collection are outlined in the
Federal Motor Carrier Safety
Regulations (FMCSRs) at 49 CFR 390–
399. The FMCSRs at 49 CFR 391.41 set
forth the physical qualification
standards that interstate CMV drivers
who are subject to part 391 must meet,
with the exception of drivers operating
vehicles transporting migrant workers
(who must meet the physical
qualification standards set forth in 49
CFR 398.3). The FMCSRs covering
driver physical qualification records are
found at 49 CFR 391.43, which specify
that a medical examination be
performed on CMV drivers subject to
part 391 who operate in interstate
commerce. The results of the
examination must be recorded in
accordance with the requirements set
forth in that section.
Section 391.41(b)(3) states that a
person is physically qualified to drive a
CMV if that person has no established
medical history or clinical diagnosis of
diabetes mellitus currently requiring
insulin for control. As such, drivers
with insulin-treated diabetes mellitus
(ITDM) are currently prohibited from
driving CMVs in interstate commerce
unless they obtain an exemption from
FMCSA.
On May 4, 2015 (80 FR 25260),
FMCSA published a NPRM proposing to
revise § 391.41(b)(3) to permit drivers
with stable, well controlled ITDM to be

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Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Notices

qualified to operate CMVs in interstate
commerce who meet the proposed new
requirements of §§ 391.45 and 391.46.
The proposal would enable drivers with
ITDM to obtain a Medical Examiner’s
Certificate (MEC), Form MCSA–5876,
from a certified ME at least annually to
operate a CMV in interstate commerce if
the TC provides documentation to the
certified ME that the condition is stable
and well controlled.
To assist in the development of the
final rule, FMCSA requested that the
MRB, under MRB Task 15–1, review
and analyze all comments from medical
professionals, labor and industry, and
trade associations, and identify factors
the Agency should consider when
making decisions about the next steps in
the diabetes rulemaking. In July 2015,
the MRB deliberated on these public
comments for purposes of offering
recommendations to the Agency on this
topic.
In September of 2015, the MRB
provided several detailed
recommendations in a final report of
Task 15–1 to the Agency. In the report,
the MRB recommended that FMCSA
develop a questionnaire for the TC to
send to the certified ME. See
Recommendation II E, ‘‘FMCSA Drivers
With Insulin Treated Diabetes Mellitus
Assessment Form.’’ In September 2016,
the Agency published a Federal
Register notice announcing the
availability of and requesting comments
on the MRB’s Task 15–1
recommendations. The MRB’s final
report for Task 15–1 and the Federal
Register notice are available in the
docket for this rulemaking (in addition
to being available on the Agency’s
public Web site).
The Agency evaluated the MRB’s
recommendations, as well as public
comments, and is considering the use of
an assessment form titled InsulinTreated Diabetes Mellitus Assessment
Form. The Agency may modify the form
and the information that would be
collected in response to any comments
received in response to this notice. The
addition of this requirement will add
33,616 annual burden hours and
$2,823,744 annual salary costs.
However, eliminating the Diabetes
Exemption Program as proposed in the
NPRM will result in 2,219 less annual
burden hours and $68,645 less annual
salary costs. Therefore, the final rule
would provide a net increase of 31,397
in annual burden hours and $2,755,099
in salary costs from the proposed
updated annual burden hours and costs.
The form that is being considered would
include the following information
collected by the TC:

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CMV Driver Information
1. Name
2. DOB
3. Information about the driver’s use of
insulin:
a. Whether the driver is newly
diagnosed or an established insulin
user
b. Date insulin use began
c. Whether or not the driver has been
on a stable insulin regimen for three
months prior
4. Information about the driver’s use of
blood glucose self-monitoring
records
a. Whether or not the driver provided
documentation of ongoing selfmonitoring of blood glucose
measured with an electronic
glucometer for at least the
preceding three months
b. Number of times per day the driver
is testing their blood glucose
c. Whether or not the driver is
compliant with glucose monitoring
based on his/her specific treatment
plan
5. Information about insulin
management and diabetes control
a. Whether or not the driver has
experienced any severe
hypoglycemic episodes within the
preceding three months
b. Whether or not the driver has
experienced any severe
hypoglycemic episodes in the
absence of warning symptoms in
the preceding three months
c. Whether or not the driver has had
his/her HbA1C measured
intermittently over the last 12
months with the most recent
measure within the preceding three
months accompanied by a copy of
the most recent laboratory results.
6. Information about diabetes
complications
a. Whether or not the driver has any
signs of diabetes complications or
target organ damage that impairs
the driver’s ability to safely operate
a CMV
7. Information about progressive eye
diseases
a. Date of last comprehensive dilated
eye examination
b. Whether or not the driver has been
diagnosed with Stage 3 or 4 diabetic
retinopathy
c. Whether or not the driver has been
diagnosed with any other
progressive eye disease(s)
8. Any comments provided by the TC
TC Information
1. Certification that they are the treating
clinician for the driver and that the
driver maintains a stable insulin

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regimen and stable control of his/
her insulin-treated diabetes
mellitus.
2. Date
3. Name
4. Signature
5. Telephone Number
6. Email address
7. Street Address
8. City, State, and Zip Code
The public interest in, and the right
to have, safe highways requires the
assurance that drivers of CMVs can
safely perform the increased physical
and mental demands of their duties.
FMCSA’s medical standards provide
this assurance by requiring drivers to be
examined and medically certified as
physically and mentally qualified to
drive a CMV.
Therefore, the information collected
on this assessment form could assist the
certified ME in determining if the driver
with ITDM that is being examined is
medically qualified under 49 CFR
391.41 to operate a CMV, and to ensure
that there are no medical conditions that
could adversely affect his or her ability
to drive safely or cause incapacitation
constituting a risk to the public.
The use of this form could allow the
certified ME to have communication
with TCs so that the certified ME fully
understands whether the driver with
ITDM that is being examined has stable,
well-controlled diabetes. This
information will assist the ME in
determining whether insulin treatment
or any medical complications of
diabetes will impact a driver’s ability to
safely operate a CMV. Therefore,
FMCSA expects that 100 percent of
drivers who are treated with insulin and
intend to operate a CMV in interstate
commerce will have the form completed
by their TC.
TCs would be able to fax or scan and
email the form to the certified ME.
Consistent with OMB’s commitment to
minimizing respondents’ recordkeeping
and paperwork burdens, and the
increased use of secure electronic
modes of communication, the Agency
anticipates that approximately 25
percent of the Insulin-Treated Diabetes
Mellitus Assessment Forms would be
transmitted electronically.
The information collected from the
Insulin-Treated Diabetes Mellitus
Assessment Form provided to the
certified ME will become part of the
CMV driver’s record maintained for at
least three years by the certified ME.
Therefore, the information will not be
available to the public. The FMCSRs
covering driver physical qualification
records are found at 49 CFR 391.43,
which specify that a medical

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Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Notices
examination be performed on CMV
drivers subject to part 391, subpart E
who operate in interstate commerce.
The results of the examination shall be
recorded in accordance with the
requirements set forth in that section.
Title: Medical Qualification
Requirements.
OMB Control Number: 2126–0006.
Type of Request: Revised collection.
Respondents: Treating Clinicians (i.e.,
healthcare professional who manages
and prescribes insulin for treatment of
a driver’s diabetes mellitus as
authorized by the healthcare
professional’s applicable State licensing
board).
Estimated Number of Respondents:
252,117 treating clinicians.
Estimated Time per Response: 8
minutes.
Expiration Date: 8/31/2018.
Frequency of Response: Required.
Estimated Total Annual Burden:
33,616 hours.
Public Comments Invited: You are
asked to comment on any aspect of this
information collection, including: (1)
Whether the proposed collection is
necessary for the performance of
FMCSA’s functions; (2) the accuracy of
the estimated burden; (3) ways for
FMCSA to enhance the quality,
usefulness, and clarity of the collected
information; and (4) ways that the
burden could be minimized without
reducing the quality of the collected
information. The agency will summarize
or include your comments in the request
for OMB’s clearance of this information
collection.
Issued under the authority of 49 CFR 1.87
on: July 20, 2017.
G. Kelly Regal,
Associate Administrator for Office of
Research and Information Technology and
Chief Information Officer.
[FR Doc. 2017–15835 Filed 7–26–17; 8:45 am]
BILLING CODE 4910–EX–P

DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety
Administration
[Docket No. FMCSA–2017–0019]

Qualification of Drivers; Exemption
Applications; Vision
Federal Motor Carrier Safety
Administration (FMCSA), DOT.
ACTION: Notice of applications for
exemptions; request for comments.

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AGENCY:

FMCSA announces receipt of
applications from 12 individuals for
exemption from the vision requirement
in the Federal Motor Carrier Safety

SUMMARY:

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Regulations (FMCSRs) to operate a
commercial motor vehicle (CMV) in
interstate commerce. If granted, the
exemptions will enable these
individuals to operate CMVs in
interstate commerce without meeting
the vision requirement in one eye.
DATES: Comments must be received on
or before August 28, 2017.
ADDRESSES: You may submit comments
bearing the Federal Docket Management
System (FDMS) Docket No. FMCSA–
2017–0019 using any of the following
methods:
• Federal eRulemaking Portal: Go to
http://www.regulations.gov. Follow the
online 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: West Building
Ground Floor, Room W12–140, 1200
New Jersey Avenue SE., Washington,
DC, between 9 a.m. and 5 p.m., E.T.,
Monday through Friday, except Federal
Holidays.
• Fax: 1–202–493–2251.
Instructions: Each submission must
include the Agency name and the
docket numbers for this notice. Note
that all comments received will be
posted without change to http://
www.regulations.gov, including any
personal information provided. Please
see the Privacy Act heading below for
further information.
Docket: For access to the docket to
read background documents or
comments, go to http://
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., E.T., 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 selfaddressed, 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 http://www.regulations.gov,
as described in the system of records
notice (DOT/ALL–14 FDMS), which can
be reviewed at http://www.dot.gov/
privacy.

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Ms.
Christine A. Hydock, Chief, Medical
Programs Division, (202) 366–4001,
[email protected], FMCSA,
Department of Transportation, 1200
New Jersey Avenue SE., Room W64–
224, Washington, DC 20590–0001.
Office hours are 8:30 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal
holidays. If you have questions
regarding viewing or submitting
material to the docket, contact Docket
Services, telephone (202) 366–9826.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:

I. Background
Under 49 U.S.C. 31136(e) and 31315,
FMCSA may grant an exemption from
the Federal Motor Carrier Safety
Regulations for a two-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.’’ FMCSA can renew
exemptions at the end of each two-year
period.
The 12 individuals listed in this
notice have each requested such an
exemption from the vision requirement
in 49 CFR 391.41(b)(10). Accordingly,
the Agency will evaluate the
qualifications of each applicant to
determine whether granting an
exemption will achieve the required
level of safety mandated by statute.
The physical qualification standard
for drivers regarding vision found in 49
CFR 391.41(b)(10) states that a person is
physically qualified to drive a CMV if
that person:
Has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective
lenses or visual acuity separately corrected to
20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of at least 20/
40 (Snellen) in both eyes with or without
corrective lenses, field of vision of at least
70° in the horizontal Meridian in each eye,
and the ability to recognize the colors of
traffic signals and devices showing standard
red, green, and amber.

In July 1992, the Agency first
published the criteria for the Vision
Waiver Program, which listed the
conditions and reporting standards that
CMV drivers approved for participation
would need to meet (Qualification of
Drivers; Vision Waivers, 57 FR 31458,
July 16, 1992). The current Vision
Exemption Program was established in
1998, following the enactment of
amendments to the statutes governing
exemptions made by § 4007 of the
Transportation Equity Act for the 21st
Century (TEA–21), Public Law 105–178,
112 Stat. 107, 401 (June 9, 1998). Vision
exemptions are considered under the
procedures established in 49 CFR part

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