Medical Review Board Task Report on Insulin Treated Diabetes Mellitus and Commercial Motor Vehicle Drivers, 62448-62450 [2016-21724]
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ehiers on DSK5VPTVN1PROD with PROPOSALS
62448
Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Proposed Rules
GSAR clause 552.212–4 Alternate I, and
therefore all provisions of clause 552.212–4
Alternate I that apply to ‘‘materials’’ also
apply to order-level materials. The ordering
activity shall follow procedures under the
Federal Travel Regulation and FAR Part 31
when order-level materials include travel.
(3) Order-level materials shall only be
acquired in direct support of an order and
not as the primary basis.
(4) The cumulative value of order-level
materials awarded under an FSS order shall
not exceed 33 percent of the total value of the
order.
(5) All order-level materials shall be placed
under the Order-Level Materials SIN.
(6) Prior to the placement of an order that
includes order-level materials, the ordering
activity shall follow procedures in FAR
8.404(h).
(7) To support the price reasonableness of
order-level materials, the contractor
proposing order-level materials as part of a
solution shall submit a minimum of three
quotes obtained by the contractor for each
order-level material above the micropurchase threshold. One of these three quotes
may include materials furnished by the
contractor under FAR 52.212–4 Alternate I
(i)(1)(ii)(A) If the contractor cannot obtain
three quotes, the contractor shall provide the
rationale for why they cannot obtain three
quotes to support the contracting officer’s
determination in (d)(7) of this section.
(8) The ordering activity contracting officer
must make a determination that prices for all
order-level materials are determined fair and
reasonable. The ordering activity contracting
officer may base their determination on a
comparison of the quotes received in
response to the task or delivery order
solicitation or other relevant pricing
information available.
(9) Prior to an increase in the ceiling price
of order-level materials above the micropurchase threshold, the ordering activity
contracting officer shall—
(i) Conduct an analysis of pricing and other
relevant factors to determine if the action is
in the best interest of the Government and
obtain the approval at the levels described in
FAR 8.405–6(d); or
(ii) Follow the procedures at FAR 8.405–
6 for a change that modifies the general scope
of the order.
(10) In accordance with GSAR clause
552.215–71 Examination of Records by GSA,
GSA has the authority to examine the
contractor’s records for compliance with the
pricing provisions in FAR clause 52.212–4
Alternate I, to include examination of any
books, documents, papers, and records
involving transactions related to the contract
for overbillings, billing errors, and
compliance with the IFF and the Sales
Reporting clauses of the contract.
(11) Order-level materials are exempt from
the following clauses:
(i) 552.216–70 Economic Price
Adjustment—FSS Multiple Award Schedule
Contracts.
(ii) 552.238–71 Submission and
Distribution of Authorized FSS Schedule
Pricelists.
(iii) 552.238–75 Price Reductions.
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(End of Clause)
[FR Doc. 2016–21610 Filed 9–8–16; 8:45 am]
BILLING CODE 6820–61–P
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety
Administration
49 CFR Part 391
[Docket No. FMCSA–2005–23151]
RIN 2126–AA95
Medical Review Board Task Report on
Insulin Treated Diabetes Mellitus and
Commercial Motor Vehicle Drivers
Federal Motor Carrier Safety
Administration (FMCSA), DOT.
ACTION: Notice of availability; request
for comments.
AGENCY:
In May 2015, FMCSA
published a notice of proposed
rulemaking (NPRM) in the Federal
Register to allow drivers with stable,
well-controlled insulin-treated diabetes
mellitus (ITDM) to be qualified to
operate commercial motor vehicles
(CMVs) in interstate commerce. The
comment period closed on July 6, 2015
and the Agency received over 1,250
comments. In that same month, FMCSA
requested the Medical Review Board
(MRB) to provide the Agency with
advice by reviewing and analyzing the
comments and providing
recommendations to FMCSA for its
consideration. The Agency announces
the availability of the MRB’s report and
requests comments on the MRB
recommendations. The Final MRB Task
15–01 Report is posted in the docket at
FMCSA–2005–23151.
DATES: Comments must be received on
or before November 8, 2016.
ADDRESSES: You may submit comments
bearing the Federal Docket Management
System (FDMS) Docket No. FMCSA–
2005–23151 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,
Room W12–140, 1200 New Jersey
Avenue SE., 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., ET, Monday through Friday,
except Federal Holidays.
• Fax: 1–202–493–2251.
SUMMARY:
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Each submission must include
FMCSA and docket number FMCSA–
2005–23151. 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 visit 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., ET,
Monday through Friday, except Federal
holidays. The on-line 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 of records
notice (DOT/ALL–14 FDMS), which can
be reviewed at www.dot.gov/privacy.
FOR FURTHER INFORMATION CONTACT: Ms.
Christine A. Hydock, 1200 New Jersey
Ave. SE., Washington, DC 20590, or by
phone at (202) 366–4001 or by email at
FMCSAMedical@dot.gov. If you have
questions on viewing or submitting
material to the docket, contact Docket
Services, telephone (202) 366–9826.
SUPPLEMENTARY INFORMATION:
I. Public Participation and Request for
Comments
FMCSA encourages you to participate
by submitting comments and related
materials.
Submitting Comments
If you submit a comment, please
include the docket number for this
notice (FMCSA–2005–23151), indicate
the specific section of this document to
which each comment applies, and
provide a reason for each suggestion or
recommendation. 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
https://www.regulations.gov, put the
E:\FR\FM\09SEP1.SGM
09SEP1
Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Proposed Rules
docket number, FMCSA–2005–23151, in
the keyword box, and click ‘‘Search.’’
When the new screen appears, click on
the ‘‘Comment Now!’’ button and type
your comment into the text box on the
following screen. Choose whether you
are submitting your comment as an
individual or on behalf of a third party
and then submit. If you submit your
comments by mail or hand delivery,
submit them in an unbound format, no
larger than 81⁄2 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, selfaddressed postcard or envelope.
FMCSA will consider these
comments, in addition to the comments
submitted in response to the NPRM, in
determining how to proceed with this
rulemaking.
ehiers on DSK5VPTVN1PROD with PROPOSALS
Viewing Comments and Documents
To view comments, as well as any
documents mentioned in this notice as
being available in the docket, go to
https://www.regulations.gov. Insert the
docket number, FMCSA–2005–23151, in
the keyword box, and click ‘‘Search.’’
Next, click the ‘‘Open Docket Folder’’
button and choose the document to
review. If you do not have access to the
Internet, you may view the docket
online by visiting the Docket
Management Facility in Room W12–140
on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., E.T., Monday through
Friday, except Federal holidays.
II. Background
Diabetes mellitus is a disease
manifested by the body’s inability to
maintain normal function of insulin, a
substance that controls glycemic levels
in the blood. Diabetes presents a major
health challenge, particularly those who
drive CMVs in interstate commerce.
Under 49 CFR 391.41(b)(3), a person is
physically qualified to drive a
commercial motor vehicle if that person
has no established medical history or
clinical diagnosis of diabetes mellitus
currently requiring insulin for control.
Since 2003, FMCSA has maintained an
exemption program for individuals that
use insulin to treat their diabetes
mellitus, that allows them to drive in
interstate commerce if their diabetes is
stable and they meet criteria of the
program. 68 FR 52441 (Sept. 3, 2003), as
revised, 70 FR 67777 (Nov. 8, 2005).
In May 2015, FMCSA issued an
NPRM in the Federal Register to allow
drivers with stable, well-controlled
ITDM to be qualified to operate CMVs
in interstate commerce. The NPRM
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15:27 Sep 08, 2016
Jkt 238001
would enable individuals with ITDM to
obtain a Medical Examiner’s Certificate
(MEC) from a Certified Medical
Examiner (CME) at least annually in
order to operate in interstate commerce
as long as evidence is presented by the
treating clinician who prescribes insulin
documenting that the driver’s condition
is stable and well-controlled. The
comment period on the NPRM closed on
July 6, 2015, and the Agency received
more than 1,250 comments.
MRB Tasking
The MRB was established to provide
FMCSA with medical advice and
recommendations on medical standards
and guidelines for the physical
qualifications of operators of CMVs,
medical examiner education, and
medical research. 49 U.S.C. 31149(a)(1).
The MRB, in view of its statutory
creation and advisory function, is
chartered by the Department of
Transportation as an advisory
committee under the provisions of the
Federal Advisory Committee Act. 5
U.S.C. App. See https://
www.facadatabase.gov/committee/
committee.aspx?cid=2084&aid=47. See
also Announcement of Establishment of
the Federal Motor Carrier Safety
Administration Medical Review Board,
70 FR 57642 (Oct. 3, 2005). The
members of the MRB are appointed by
the Secretary to reflect expertise in a
variety of medical specialties relevant to
the driver fitness requirements of
FMCSA. 49 U.S.C. 31149(a)(2).
In an effort to assist in the
development of the final rule, on July
15, 2015, FMCSA requested advice from
the MRB for the Agency to consider.
Specifically, FMCSA asked the members
to review and analyze all comments
from medical professionals and
associations, and identify factors the
Agency should consider when making a
decision about the next steps in the
diabetes rulemaking. A public meeting
to discuss this matter was held by the
MRB on July 21 and 22, 2015. The
Agency received the MRB’s final report
on September 1, 2015. Details of the
meeting, including the original task,
final report and supporting materials
used by the MRB are posted on the
Agency’s public Web site: https://
www.fmcsa.dot.gov/medical-reviewboard-mrb-meeting-topics.
MRB Final Report
The MRB’s final report is available in
the docket for this rulemaking (in
addition to being available on the
Agency’s public Web site). The final
report contains a number of detailed
recommendations for FMCSA to
consider as it develops a final rule. The
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62449
Agency believes that public comment
on the recommendations will assist it in
evaluating the advice it has received
from the MRB. Comments must be
limited to addressing the
recommendations in the MRB final
report. A summary of the report’s major
recommendations is set out below:
The MRB recommended that ITDM
drivers be medically disqualified unless
they meet the following requirements
demonstrating their stable, wellcontrolled ITDM:
1. The driver must provide an FMCSA
Drivers With Insulin Treated Diabetes
Mellitus Assessment Form (set out in the
recommendations) to a medical
examiner that has been completed and
signed by the treating clinician. The
treating clinician must be a Doctor of
Medicine, a Doctor of Osteopathy, a
Nurse Practitioner or a Physician’s
Assistant who prescribed insulin to the
driver and is knowledgeable regarding
the treatment of diabetes.
2. The driver must receive a complete
ophthalmology or optometry exam,
including dilated retinal exam, at least
every 2 years documenting the presence
or absence of retinopathy/macular
edema and the degree of retinopathy
and/or macular edema if present (using
the International Classification of
Diabetic Retinopathy and Diabetic
Macular Edema).
The MRB recommended that medical
examiners be allowed to certify an
ITDM driver as medically qualified for
a time period of no longer than 1 year
only if the driver has not experienced
any of the 8 disqualifying factors below
(which the MRB believes should be
listed in 49 CFR 391.46):
1. Any episode of severe
hypoglycemia within the previous 6
months.
2. Blood sugar less than 60 milligrams
per deciliter (mg/dL) demonstrated in
current glucose logs.
3. Hypoglycemia appearing in the
absence of warning symptoms (i.e.,
hypoglycemic unawareness).
4. An episode of severe hypoglycemia,
blood sugar less than 60 mg/dl, or
hypoglycemic unawareness within the
previous 6 months; the driver should be
medically disqualified and must remain
disqualified for at least 6 months.
5. Uncontrolled diabetes, as
evidenced by Hemoglobin A1c (HbA1c)
level greater than 10 percent. A driver
could be reinstated when HbA1c level is
less than or equal to 10 percent.
6. Stage 3 or 4 diabetic retinopathy; a
driver should be permanently
disqualified.
7. Signs of target organ damage; a
driver should be disqualified until the
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Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Proposed Rules
matter is resolved by treatment, if
possible.
8. Inadequate record of selfmonitoring of blood glucose; a driver
should be disqualified for inadequate
records until the driver can demonstrate
adequate evidence of glucose records
(minimum 1 month).
In addition, the MRB stated that, if a
driver is medically disqualified due to
not meeting the ITDM criteria listed
above, the driver should remain
disqualified for at least 6 months.
Comments Requested
Comments are requested on any and
all of the recommendations provided in
the advisory final report from the
Medical Review Board but only on those
recommendations. To the extent
possible, comments should include
supporting materials, such as, for
example, data analyses, studies, reports,
or journal articles. FMCSA will consider
these comments, in addition to the
comments submitted in response to the
NPRM, in determining how to proceed
with this rulemaking.
Issued on: August 30, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016–21724 Filed 9–8–16; 8:45 am]
BILLING CODE 4910–EX–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
[Docket No. FWS–R2–ES–2016–0099;
4500030113]
RIN 1018–BA74
Endangered and Threatened Wildlife
and Plants; Endangered Species
Status for Guadalupe Fescue
AGENCY:
Information Requested
Fish and Wildlife Service,
Interior.
Proposed rule.
ACTION:
We, the U.S. Fish and
Wildlife Service (Service), propose to
list Festuca ligulata (Guadalupe fescue),
a plant species from the Chihuahuan
Desert of west Texas and Mexico, as an
endangered species under the
Endangered Species Act of 1973, as
amended (Act). If we finalize this rule
as proposed, it would extend the Act’s
protections to this species.
DATES: We will accept comments
received or postmarked on or before
November 8, 2016. Comments submitted
electronically using the Federal
eRulemaking Portal (see ADDRESSES,
ehiers on DSK5VPTVN1PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
15:27 Sep 08, 2016
Jkt 238001
below) must be received by 11:59 p.m.
Eastern time on the closing date. We
must receive requests for public
hearings, in writing, at the address
shown in FOR FURTHER INFORMATION
CONTACT by October 24, 2016
ADDRESSES: You may submit comments
by one of the following methods: (1)
Electronically: Go to the Federal
eRulemaking Portal: https://
www.regulations.gov. In the Search box,
enter FWS–R2–ES–2016–0099, which is
the docket number for this rulemaking.
Then click on the Search button. On the
resulting page, in the Search panel on
the left side of the screen, under the
Document Type heading, click on the
Proposed Rules link to locate this
document. You may submit a comment
by clicking on ‘‘Comment Now!’’
(2) By hard copy: Submit by U.S. mail
or hand-delivery to: Public Comments
Processing, Attn: FWS–R2–ES–2016–
0099, U.S. Fish and Wildlife Service,
MS: BPHC, 5275 Leesburg Pike, Falls
Church, VA 22041–3803.
We request that you send comments
only by the methods described above.
We will post all comments on https://
www.regulations.gov. This generally
means that we will post any personal
information you provide us (see Public
Comments, below, for more
information).
FOR FURTHER INFORMATION CONTACT:
Adam Zerrenner, Field Supervisor, U.S.
Fish and Wildlife Service, Austin
Ecological Services Field Office, 10711
Burnet Rd., Suite 200, Austin, TX
78758; telephone 512–490–0057; or
facsimile 512–490–0974. Persons who
use a telecommunications device for the
deaf (TDD) may call the Federal
Information Relay Service (FIRS) at
800–877–8339.
SUPPLEMENTARY INFORMATION:
Public Comments
We intend that any final action
resulting from this proposed rule will be
based on the best available scientific
and commercial data and will be as
accurate and as effective as possible.
Therefore, we request comments or
information from other concerned
governmental agencies, Native
American tribes, the scientific
community, industry, or any other
interested parties concerning this
proposed rule. We particularly seek
comments concerning:
(1) Guadalupe fescue’s biology, range,
and population trends, including:
(a) Biological or ecological
requirements of the species, including
habitat requirements for soils,
reproduction, and associated species;
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(b) Genetics and taxonomy;
(c) Historical and current range,
including distribution patterns;
(d) Historical and current population
levels, and current and projected trends;
and
(e) Past and ongoing conservation
measures for the species, its habitat, or
both.
(2) Factors that may affect the
continued existence of the species,
which may include habitat modification
or destruction, overutilization, disease,
predation, the inadequacy of existing
regulatory mechanisms, or other natural
or manmade factors.
(3) Biological, commercial trade, or
other relevant data concerning any
threats (or lack thereof) to this species
and existing regulations that may be
addressing those threats.
Please include sufficient information
with your submission (such as scientific
journal articles or other publications) to
allow us to verify any scientific or
commercial information you include.
Please note that submissions merely
stating support for or opposition to the
action under consideration without
providing supporting information,
although noted, will not be considered
in making a determination, as section
4(b)(1)(A) of the Act (16 U.S.C. 1531 et
seq.) directs that determinations as to
whether any species is an endangered or
threatened species must be made
‘‘solely on the basis of the best scientific
and commercial data available.’’
You may submit your comments and
materials concerning this proposed rule
by one of the methods listed above in
ADDRESSES. We request that you send
comments only by the methods
described in ADDRESSES.
If you submit information via https://
www.regulations.gov, your entire
submission—including any personal
identifying information—will be posted
on the Web site. If your submission is
made via a hardcopy that includes
personal identifying information, you
may request at the top of your document
that we withhold this information from
public review. However, we cannot
guarantee that we will be able to do so.
We will post all hardcopy submissions
on https://www.regulations.gov.
Comments and materials we receive,
as well as supporting documentation we
used in preparing this proposed rule,
will be available for public inspection
on https://www.regulations.gov, or by
appointment, during normal business
hours, at the U.S. Fish and Wildlife
Service, Austin Ecological Services
Field Office (see FOR FURTHER
INFORMATION CONTACT).
E:\FR\FM\09SEP1.SGM
09SEP1
Agencies
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Proposed Rules]
[Pages 62448-62450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21724]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
49 CFR Part 391
[Docket No. FMCSA-2005-23151]
RIN 2126-AA95
Medical Review Board Task Report on Insulin Treated Diabetes
Mellitus and Commercial Motor Vehicle Drivers
AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.
ACTION: Notice of availability; request for comments.
-----------------------------------------------------------------------
SUMMARY: In May 2015, FMCSA published a notice of proposed rulemaking
(NPRM) in the Federal Register to allow drivers with stable, well-
controlled insulin-treated diabetes mellitus (ITDM) to be qualified to
operate commercial motor vehicles (CMVs) in interstate commerce. The
comment period closed on July 6, 2015 and the Agency received over
1,250 comments. In that same month, FMCSA requested the Medical Review
Board (MRB) to provide the Agency with advice by reviewing and
analyzing the comments and providing recommendations to FMCSA for its
consideration. The Agency announces the availability of the MRB's
report and requests comments on the MRB recommendations. The Final MRB
Task 15-01 Report is posted in the docket at FMCSA-2005-23151.
DATES: Comments must be received on or before November 8, 2016.
ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2005-23151 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, Room W12-140, 1200 New Jersey Avenue SE., 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., ET, Monday through Friday, except Federal Holidays.
Fax: 1-202-493-2251.
Each submission must include FMCSA and docket number FMCSA-2005-
23151. 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 visit 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., ET, Monday through Friday,
except Federal holidays. The on-line 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 of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.
FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, 1200 New
Jersey Ave. SE., Washington, DC 20590, or by phone at (202) 366-4001 or
by email at FMCSAMedical@dot.gov. If you have questions on viewing or
submitting material to the docket, contact Docket Services, telephone
(202) 366-9826.
SUPPLEMENTARY INFORMATION:
I. Public Participation and Request for Comments
FMCSA encourages you to participate by submitting comments and
related materials.
Submitting Comments
If you submit a comment, please include the docket number for this
notice (FMCSA-2005-23151), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. 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 https://www.regulations.gov,
put the
[[Page 62449]]
docket number, FMCSA-2005-23151, in the keyword box, and click
``Search.'' When the new screen appears, click on the ``Comment Now!''
button and type your comment into the text box on the following screen.
Choose whether you are submitting your comment as an individual or on
behalf of a third party and then submit. 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.
FMCSA will consider these comments, in addition to the comments
submitted in response to the NPRM, in determining how to proceed with
this rulemaking.
Viewing Comments and Documents
To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to https://www.regulations.gov.
Insert the docket number, FMCSA-2005-23151, in the keyword box, and
click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document to review. If you do not have access to the
Internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., E.T., Monday through Friday, except Federal holidays.
II. Background
Diabetes mellitus is a disease manifested by the body's inability
to maintain normal function of insulin, a substance that controls
glycemic levels in the blood. Diabetes presents a major health
challenge, particularly those who drive CMVs in interstate commerce.
Under 49 CFR 391.41(b)(3), a person is physically qualified to drive a
commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control. Since 2003, FMCSA has maintained an exemption
program for individuals that use insulin to treat their diabetes
mellitus, that allows them to drive in interstate commerce if their
diabetes is stable and they meet criteria of the program. 68 FR 52441
(Sept. 3, 2003), as revised, 70 FR 67777 (Nov. 8, 2005).
In May 2015, FMCSA issued an NPRM in the Federal Register to allow
drivers with stable, well-controlled ITDM to be qualified to operate
CMVs in interstate commerce. The NPRM would enable individuals with
ITDM to obtain a Medical Examiner's Certificate (MEC) from a Certified
Medical Examiner (CME) at least annually in order to operate in
interstate commerce as long as evidence is presented by the treating
clinician who prescribes insulin documenting that the driver's
condition is stable and well-controlled. The comment period on the NPRM
closed on July 6, 2015, and the Agency received more than 1,250
comments.
MRB Tasking
The MRB was established to provide FMCSA with medical advice and
recommendations on medical standards and guidelines for the physical
qualifications of operators of CMVs, medical examiner education, and
medical research. 49 U.S.C. 31149(a)(1). The MRB, in view of its
statutory creation and advisory function, is chartered by the
Department of Transportation as an advisory committee under the
provisions of the Federal Advisory Committee Act. 5 U.S.C. App. See
https://www.facadatabase.gov/committee/committee.aspx?cid=2084&aid=47.
See also Announcement of Establishment of the Federal Motor Carrier
Safety Administration Medical Review Board, 70 FR 57642 (Oct. 3, 2005).
The members of the MRB are appointed by the Secretary to reflect
expertise in a variety of medical specialties relevant to the driver
fitness requirements of FMCSA. 49 U.S.C. 31149(a)(2).
In an effort to assist in the development of the final rule, on
July 15, 2015, FMCSA requested advice from the MRB for the Agency to
consider. Specifically, FMCSA asked the members to review and analyze
all comments from medical professionals and associations, and identify
factors the Agency should consider when making a decision about the
next steps in the diabetes rulemaking. A public meeting to discuss this
matter was held by the MRB on July 21 and 22, 2015. The Agency received
the MRB's final report on September 1, 2015. Details of the meeting,
including the original task, final report and supporting materials used
by the MRB are posted on the Agency's public Web site: https://www.fmcsa.dot.gov/medical-review-board-mrb-meeting-topics.
MRB Final Report
The MRB's final report is available in the docket for this
rulemaking (in addition to being available on the Agency's public Web
site). The final report contains a number of detailed recommendations
for FMCSA to consider as it develops a final rule. The Agency believes
that public comment on the recommendations will assist it in evaluating
the advice it has received from the MRB. Comments must be limited to
addressing the recommendations in the MRB final report. A summary of
the report's major recommendations is set out below:
The MRB recommended that ITDM drivers be medically disqualified
unless they meet the following requirements demonstrating their stable,
well-controlled ITDM:
1. The driver must provide an FMCSA Drivers With Insulin Treated
Diabetes Mellitus Assessment Form (set out in the recommendations) to a
medical examiner that has been completed and signed by the treating
clinician. The treating clinician must be a Doctor of Medicine, a
Doctor of Osteopathy, a Nurse Practitioner or a Physician's Assistant
who prescribed insulin to the driver and is knowledgeable regarding the
treatment of diabetes.
2. The driver must receive a complete ophthalmology or optometry
exam, including dilated retinal exam, at least every 2 years
documenting the presence or absence of retinopathy/macular edema and
the degree of retinopathy and/or macular edema if present (using the
International Classification of Diabetic Retinopathy and Diabetic
Macular Edema).
The MRB recommended that medical examiners be allowed to certify an
ITDM driver as medically qualified for a time period of no longer than
1 year only if the driver has not experienced any of the 8
disqualifying factors below (which the MRB believes should be listed in
49 CFR 391.46):
1. Any episode of severe hypoglycemia within the previous 6 months.
2. Blood sugar less than 60 milligrams per deciliter (mg/dL)
demonstrated in current glucose logs.
3. Hypoglycemia appearing in the absence of warning symptoms (i.e.,
hypoglycemic unawareness).
4. An episode of severe hypoglycemia, blood sugar less than 60 mg/
dl, or hypoglycemic unawareness within the previous 6 months; the
driver should be medically disqualified and must remain disqualified
for at least 6 months.
5. Uncontrolled diabetes, as evidenced by Hemoglobin A1c (HbA1c)
level greater than 10 percent. A driver could be reinstated when HbA1c
level is less than or equal to 10 percent.
6. Stage 3 or 4 diabetic retinopathy; a driver should be
permanently disqualified.
7. Signs of target organ damage; a driver should be disqualified
until the
[[Page 62450]]
matter is resolved by treatment, if possible.
8. Inadequate record of self-monitoring of blood glucose; a driver
should be disqualified for inadequate records until the driver can
demonstrate adequate evidence of glucose records (minimum 1 month).
In addition, the MRB stated that, if a driver is medically
disqualified due to not meeting the ITDM criteria listed above, the
driver should remain disqualified for at least 6 months.
Comments Requested
Comments are requested on any and all of the recommendations
provided in the advisory final report from the Medical Review Board but
only on those recommendations. To the extent possible, comments should
include supporting materials, such as, for example, data analyses,
studies, reports, or journal articles. FMCSA will consider these
comments, in addition to the comments submitted in response to the
NPRM, in determining how to proceed with this rulemaking.
Issued on: August 30, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-21724 Filed 9-8-16; 8:45 am]
BILLING CODE 4910-EX-P