[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)]
[Notices]
[Pages 73871-73874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30134]


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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0180]


Agency Information Collection Activities; New Information 
Collection Request: 391.41 CMV Driver Medication Form

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 its plan to submit the Information Collection Request (ICR)

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described below to the Office of Management and Budget (OMB) for its 
review and approval and invites public comment on the approval of a new 
ICR titled, 391.41 CMV Driver Medication Form. This ICR is voluntary 
and may be utilized by medical examiners (MEs) responsible for issuing 
Medical Examiner's Certificates (MECs) to commercial motor vehicle 
(CMV) drivers. MEs that choose to use this ICR will do so in an effort 
to communicate with treating healthcare professionals who are 
responsible for prescribing certain medications, so that the ME fully 
understands the reasons the medications have been prescribed. The 
information obtained by the ME when utilizing this ICR will assist the 
ME in determining if the driver is medically qualified under 49 CFR 
391.41 and to ensure that there are no disqualifying medical conditions 
or underlying medical conditions and prescribed medications that could 
adversely affect their safe driving ability or cause incapacitation 
constituting a risk to the public.

DATES: We must receive your comments on or before January 25, 2016.

ADDRESSES: You may submit comments identified by Federal Docket 
Management System (FDMS) Docket Number FMCSA-2015-0180 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, 
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. 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: 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.
    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: Charles A. Horan III, Director, Office 
of Carrier, Driver, and Vehicle, Safety Standards, U.S. Department of 
Transportation, Federal Motor Carrier Safety Administration, West 
Building 6th Floor, 1200 New Jersey Avenue SE., Washington, DC 20590. 
Telephone: 202-366-2362; email [email protected].

SUPPLEMENTARY INFORMATION: 

Background

    The primary mission of the Federal Motor Carrier Safety 
Administration (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 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 in order 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) and 
31502(b)]. The regulations discussing this collection are outlined in 
the Federal Motor Carrier Safety Regulations (FMCSRs) at 49 CFR 390-
399. 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 commercial driver's license/commercial 
learner's permit (CDL/CLP) drivers 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 shall be recorded in 
accordance with the requirements set forth in that section.
    49 CFR 391.41(12) states that a person is physically qualified to 
drive a CMV if that person does not use any drug or substance 
identified in 21 CFR 1308.11 Schedule I, an amphetamine, a narcotic, or 
other habit-forming drug and does not use any non-Schedule I drug or 
substance that is identified in the other Schedules in 21 part 1308 
except when the use is prescribed by a licensed medical practitioner, 
as defined in Sec.  382.107, who is familiar with the driver's medical 
history and has advised the driver that the substance will not 
adversely affect the driver's ability to safely operate a CMV.
    In 2006, FMCSA's Medical Review Board (MRB) deliberated on the 
topic of the use of Schedule II medications. The MRB considered 
information provided in a 2006 FMCSA sponsored Evidence Report and a 
subsequent Medical Expert Panel (MEP) to examine the relationship 
between the licit use of a Schedule II drug and the risk for a motor 
vehicle crash. In 2013, FMCSA tasked the MRB with updating the opinions 
and recommendations of the 2006 Evidence Report and MEP.
    On September 10, 2013, the MRB and Motor Carrier Safety Advisory 
Committee (MCSAC) met jointly to hear presentations on the licit use of 
Schedule II medications and their regulation, and on U.S. Department of 
Transportation drug and alcohol testing protocols. Subsequently, the 
committees engaged in a discussion on the issue as it applies to CMV 
drivers. On September 11, 2013, the MRB discussed the issue in greater 
detail as its task to present a letter report to the Agency relating to 
CMV drivers and Schedule II medication use and to develop a form for 
MEs on the National Registry of Certified Medical Examiners (National 
Registry) to send to treating clinicians of CMV drivers to expound on 
the use of

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these medications by driver applicants. On October 22, 2013, the MRB 
submitted their recommendations to FMCSA. A MEP convened to provide an 
updated opinion on Schedule II Opioids and Stimulants & CMV Crash Risk 
and Driver Performance. The FMCSA revised the task of the MRB 
instructing them to review an updated evidence report and the MEP 
opinion that was furnished subsequent to its deliberations on Schedule 
II Opioids and Stimulants & CMV Crash Risk and Driver Performance: 
Evidence Report and Systematic Review. FMCSA directed the MRB to 
consider this report's findings and confer with the MCSAC on this topic 
during a joint meeting in October 2014. The MRB met in public meetings 
on July 29-30, 2014, and developed Schedule II medication 
recommendations. The MRB presented these recommendations to the MCSAC 
in a joint public meeting on October 27, 2014, where they were 
deliberated by both committees. As a result, FMCSA's MRB and MCSAC 
provided joint recommendations related to the use of Schedule II 
medications by CMV drivers. Because there is moderate evidence to 
support the contention that the licit use of opioids increases the risk 
of motor vehicle crashes and impacts indirect measures of driver 
performance negatively, included was the recommendation that FMCSA 
develop a standardized medication questionnaire to assist the certified 
ME when reviewing prescription medications that have been disclosed 
during the history and physical examination for CMV driver 
certification. The two advisory groups recommended to FMCSA that the 
standardized CMV driver medication questionnaire be voluntary and 
include the following information and questions:
    1. Questionnaire should be titled 391.41 CMV Driver Medication 
Questionnaire.
    2. Questionnaire should request the following information:
    a. Identifying name and date of birth of the CMV driver.
    b. Introductory paragraph stating purpose of the CMV Driver 
Medication Report.
    c. Statements of 391.41(b)(12) (Physical Qualifications of Drivers 
relating to driver use of scheduled substances) and The Driver's Role, 
as found in the Medical Examination Report form found at the end of 49 
CFR 391.43 (Medical Examination; Certificate of Physical Examination).
    d. Name, state of licensure, signature, address and contact 
information of the prescribing healthcare provider, as well as the date 
the form was completed.
    e. Name, signature, date, address and contact information of the 
certified ME.
    3. Report should include the following information:
    a. 1--List all medications and dosages that you have prescribed to 
the above named individual.
    b. 2--List any other medications and dosages that you are aware 
have been prescribed to the above named individual by another treating 
healthcare provider.
    c. 3--What medical conditions are being treated with these 
medications?
    d. 4--It is my medical opinion that, considering the mental and 
physical requirements of operating a CMV and with awareness of a CMV 
driver's role (consistent with The Driver's Role statement on page 2 of 
the form), I believe my patient: (a) has no medication side effects 
from medication(s) that I prescribe that would adversely affect the 
ability to operate a CMV safely; and (2) has no medical condition(s) 
that I am treating with the above medication(s) that would adversely 
affect the ability to operate a CMV safely.
    The public interest in, and 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.
    The purpose for collecting this information is to assist the ME in 
determining if the driver is medically qualified under 49 CFR 391.41 
and to ensure that there are no disqualifying medical conditions that 
could adversely affect their safe driving ability or cause 
incapacitation constituting a risk to the public. 49 CFR 391.41(12) 
states that a person is physically qualified to drive a CMV if that 
person does not use any drug or substance identified in 21 CFR 1308.11 
Schedule I, an amphetamine, a narcotic, or other habit-forming drug and 
does not use any non-Schedule I drug or substance that is identified in 
the other Schedules in 21 part 1308 except when the use is prescribed 
by a licensed medical practitioner, as defined in Sec.  382.107, who is 
familiar with the driver's medical history and has advised the driver 
that the substance will not adversely affect the driver's ability to 
safely operate a CMV.
    The use of this ICR is at the discretion of the ME to facilitate 
communication with treating healthcare professionals who are 
responsible for prescribing certain medications so that the ME fully 
understands the reasons the medications have been prescribed. This 
information will assist the ME in determining whether the underlying 
medical condition and the prescribed medication will impact the 
driver's safe operation of a CMV. Therefore, there is no required 
collection frequency.
    The 391.41 CMV Driver Medication Form will be available as a 
fillable pdf or may be downloaded from the FMCSA Web site. Prescribing 
healthcare providers will also be able to fax or scan and email the 
report to the certified ME. Consistent with the 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 50 percent of the 391.41 CMV Driver 
Medication Forms will be transmitted electronically.
    The information collected from the 391.41 CMV Driver Medication 
Form, will be used by the certified ME that requested the completion of 
the form and will become part of the CMV driver's record maintained 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 examination be 
performed on CMV drivers subject to part 391 who operate in interstate 
commerce. The results of the examination shall be recorded in 
accordance with the requirements set forth in that section. MEs are 
required to maintain records of the CMV driver medical examinations 
they conduct.
    Title: 391.41 CMV Driver Medication Form.
    OMB Control Number: 2126-00XX.
    Type of Request: New collection.
    Respondents: Prescribing healthcare professionals.
    Estimated Number of Respondents: 1,082,200 (total number of 
prescribing healthcare providers in the U.S.)
    Estimated Time per Response: 8 minutes.
    Expiration Date: N/A. This is a new ICR.
    Frequency of Response: Voluntary.
    Estimated Total Annual Burden: 144,293 hours [1,082,200 responses x 
8 minutes to complete response/60 minutes = 144,293].
    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

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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: Nov 6, 2015.
G. Kelly Regal,
Associate Administrator for Office of Research and Information 
Technology.
[FR Doc. 2015-30134 Filed 11-24-15; 8:45 am]
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