Agency Information Collection Activities; Information Collection Revision Request--Medical Qualification Requirements, OMB Control Number 2126-0006

G. Kelly Regal
Federal Motor Carrier Safety Administration
27 July 2017

[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Notices]
[Pages 35041-35043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15835]



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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

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: 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 insulin-
dependent 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.
     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/pdfE8-794.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 self-addressed, 
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: 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 Sec.  391.41(b)(3) to permit drivers with stable, well 
controlled ITDM to be

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qualified to operate CMVs in interstate commerce who meet the proposed 
new requirements of Sec. Sec.  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 
Insulin-Treated 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:

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 
self-monitoring 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 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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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