[Federal Register Volume 84, Number 215 (Wednesday, November 6, 2019)]
[Notices]
[Pages 59903-59907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24231]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0101]


Agency Information Collection Activities; Information Collection 
Renewal: 391.41 CMV Driver Medication Form, OMB Control Number: 2126-
0064

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

ACTION: Notice and request for comments.

-----------------------------------------------------------------------

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA 
announces its plan to submit the renewal Information Collection Request 
(ICR) described below to the Office of Management and Budget (OMB) for 
its review and approval and invites public comment. This Information 
Collection (IC) is voluntary and may be utilized by certified Medical 
Examiners (ME) responsible for issuing Medical Examiner's Certificates 
(MEC) to commercial motor vehicle (CMV) drivers. Certified MEs who 
choose to use this IC do so in an effort to communicate with treating 
healthcare professionals, who are responsible for

[[Page 59904]]

prescribing certain medications, so that the certified MEs fully 
understand the reasons the medications have been prescribed. The 
information obtained by this IC assists the certified MEs in 
determining if drivers are physically qualified and if there are 
medical conditions or being treated with certain prescribed medications 
that would adversely affect the drivers' ability to safely operate 
CMVs. FMCSA requests approval to renew an ICR titled, ``391.41 CMV 
Driver Medication Form.'' In response to the Federal Register notice 
published on July 3, 2019, requesting public comment, FMCSA received 
two comments.

DATES: Please send your comments to OMB by December 6, 2019. OMB must 
receive your comments by this date in order to act quickly on the ICR.

ADDRESSES: All comments should reference Federal Docket Management 
System (FDMS) Docket Number FMCSA-2019-0101. Interested persons are 
invited to submit written comments on the proposed IC to the Office of 
Information and Regulatory Affairs at OMB. Comments should be addressed 
to the attention of the Desk Officer, Department of Transportation/
Federal Motor Carrier Safety Administration, and sent via electronic 
mail to [email protected] or faxed to (202) 395-6974. An 
alternative, though slower, method is by U.S mail to the Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
Docket Library, Room 10102, 725 17th Street NW, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Mr. 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]. Office hours are from 9 a.m. to 5 p.m., Monday 
through Friday, except Federal Holidays.

SUPPLEMENTARY INFORMATION: 
    Title: 391.41 CMV Driver Medication Form.
    OMB Control Number: 2126-0064.
    Type of Request: Renewal of a currently approved collection.
    Respondents: Prescribing healthcare professionals.
    Estimated Number of Respondents: Up to 1,223,470 (total number of 
prescribing healthcare professionals in the U.S.).
    Estimated Number of Responses: Up to 1,967,006 (total number of CMV 
drivers who may be asked by a certified ME to have the 391.41 CMV 
Driver Medication Form, MCSA-5895, completed by a prescribing 
healthcare professional).
    Estimated Time per Response: 8 minutes.
    Expiration Date: January 31, 2020.
    Frequency of Response: Voluntary.
    Estimated Total Annual Burden: 262,267 hours.
    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 responsibility under 
49 U.S.C. 31136 and 31502 to prescribe regulations that ensure 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 perform their work 
safely.
    Information used to determine and certify that a driver meets the 
physical qualification standards 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. 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 IC are outlined in the Federal Motor Carrier Safety 
Regulations (FMCSRs) at 49 CFR parts 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 commercial driver's license/commercial learner's permit holders 
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.
    The physical qualification standard regarding the use of drugs and 
substances in 49 CFR 391.41(b)(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; or does not use any non-Schedule 
I drug or substance that is identified in the other Schedules in 21 CFR 
part 1308 except when the use is prescribed by a licensed medical 
practitioner, as defined in 49 CFR 382.107,\1\ 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.
---------------------------------------------------------------------------

    \1\ A licensed medical practitioner means a person who is 
licensed, certified, or registered, in accordance with applicable 
Federal, State, local, or foreign laws and regulations, to prescribe 
controlled substances and other drugs (49 CFR 382.107).
---------------------------------------------------------------------------

    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 by a 
subsequent Medical Expert Panel (MEP) to examine the relationship 
between the licit use of a Schedule II drug and the risk of 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 in light of 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 certified MEs on the National Registry of Certified Medical 
Examiners (National Registry) to send to treating healthcare 
professionals of CMV drivers to expound on the use of these medications 
by driver applicants. On October 22, 2013, the MRB submitted its 
recommendations to FMCSA.
    Thereafter, an MEP convened to provide an updated opinion on its 
prior report titled, ``Schedule II Opioids and Stimulants & CMV Crash 
Risk and Driver Performance.'' FMCSA revised the task of the MRB and 
instructed it to review the updated evidence report and MEP opinions in 
the report titled ``Schedule II Opioids and Stimulants & CMV Crash Risk 
and Driver Performance: Evidence Report and Systematic Review'' that 
was furnished subsequent to the MRB's deliberations. 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

[[Page 59905]]

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 negatively impacts indirect measures of driver performance,\2\ 
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 
committees recommended to FMCSA that the standardized CMV driver 
medication questionnaire be voluntary and include the following 
information and questions:
---------------------------------------------------------------------------

    \2\ Schedule II Opioids and Stimulants & CMV Crash Risk and 
Driver Performance: Evidence Report and Systematic Review, October 
18, 2014, available at https://rosap.ntl.bts.gov/view/dot/199.
---------------------------------------------------------------------------

    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 at the end of 49 CFR 
391.43 (Medical Examination; Certificate of Physical Examination).\3\
---------------------------------------------------------------------------

    \3\ After the recommendations, FMCSA began using a new version 
of the examination form titled Medical Examination Report Form, 
MCSA-5875. This version does not include The Driver's Role 
statement. Therefore, The Driver's Role statement no longer appears 
in 49 CFR 391.43, but still appears on the 391.41 CMV Driver 
Medication Form, MCSA-5895.
---------------------------------------------------------------------------

    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 questions:
    a. Question 1--List all medications and dosages that you have 
prescribed to the above named individual.
    b. Question 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. Question 3--What medical conditions are being treated with these 
medications?
    d. Question 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 physical 
qualification standards provide this assurance by requiring drivers to 
be examined and medically certified as physically qualified to drive. 
Accordingly, FMCSA developed the 391.41 CMV Driver Medication Form, 
MCSA-5895.
    The purpose of this voluntary collection of information is to 
assist the certified ME in determining if the driver is physically 
qualified under 49 CFR 391.41 and if there are disqualifying medical 
conditions or certain prescribed medications that would adversely 
affect the driver's ability to drive safely. Section 391.41(b)(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; or 
does not use any non-Schedule I drug or substance that is identified in 
the other Schedules in 21 CFR part 1308 except when the use is 
prescribed by a licensed medical practitioner, as defined in 49 CFR 
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 the 391.41 CMV Driver Medication Form, MCSA-5895, is at 
the discretion of the certified ME and facilitates communication with 
treating healthcare professionals, who are responsible for prescribing 
certain medications, so that the certified ME fully understands the 
reasons the medications have been prescribed. Because the use of the 
form is voluntary, there is no required collection frequency.
    The 391.41 CMV Driver Medication Form, MCSA-5895, may be downloaded 
from the FMCSA website. Prescribing healthcare professionals can fax or 
scan and email the report 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 believes that approximately 50 percent of the 
391.41 CMV Driver Medication Forms, MCSA-5895, are transmitted 
electronically.
    The information collected from the 391.41 CMV Driver Medication 
Form, MCSA-5895, is used by the certified ME who requested the 
completion of the form and is attached to the Medical Examination 
Report Form, MCSA-5875, which becomes part of the CMV driver's record 
maintained by the certified ME. Therefore, the information is not 
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 must 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.

Discussion of Comments Received

    In response to the Federal Register notice published on July 3, 
2019 (84 FR 31980), requesting public comment concerning: (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 burden could be minimized without 
reducing the quality of the collection information, FMCSA received two 
comments. One was from the Owner-Operator Independent Drivers 
Association (OOIDA), and the other one was from an individual. These 
comments are outlined below, along with FMCSA's responses.

Is the collection necessary for the performance of FMCSA's functions?

OOIDA Comment

    OOIDA stated that if this ICR is renewed the number of 
inconsistencies will continue to grow as certified MEs with no personal 
relationship with the driver attempt to evaluate years of long-term 
medication usage. It also stated that the ICR invites second guessing 
of a primary physician by certified MEs who are empowered by an 
unreliable medical form and that studies do not show a significant 
number of CMV

[[Page 59906]]

operators are crashing due to prescription medication use. OOIDA 
continued that this ICR will only increase problems its members have 
already experienced with certified MEs, which have resulted in higher 
costs and lengthy delays for drivers.

FMCSA Response

    Section 391.41(b)(12)(ii) provides that a certified ME may only 
certify a driver who uses controlled drugs or substances listed on 
Schedules II through V in 21 CFR part 1308 if the prescribing 
healthcare professional provides certain information to the certified 
ME. Interstate CMV drivers are required to use a certified ME listed on 
the National Registry for their physical qualification examination and 
certification. Therefore, in many cases the driver is going to a 
certified ME from whom he or she does not routinely receive healthcare 
and who is not a healthcare professional prescribing medications for 
the driver. The 391.41 CMV Driver Medication Form, MCSA-5895, is an 
optional tool a certified ME can use to communicate with the 
prescribing healthcare professional who has a relationship with the 
driver and understands the driver's medical history. The form provides 
a standardized and efficient way for the certified ME to obtain the 
information needed to make a more informed medical certification 
determination. The decision to certify a driver is discretionary and 
continues to rest with the certifying ME.
    FMCSA believes that use of the form should streamline the 
certification process and minimize the amount of time needed to obtain 
the necessary information from the prescribing healthcare professional. 
In addition, 49 CFR 391.43(g)(4) provides a ``determination pending 
category'' that allows up to 45 days to complete the certification 
examination if the certified ME determines additional information is 
needed. The driver may continue to operate a CMV during this period, as 
long as the driver has an unexpired MEC.

Individual Comment

    This individual stated that the 391.41 CMV Driver Medication Form, 
MCSA-5895, would not be necessary for every examination because not 
every driver is taking a medication that would require the certified ME 
to collect this information. The individual noted that when a driver is 
using a Schedule II drug or any other drug that may have negative side 
effects, the information collected aids the certified ME in determining 
whether or not the driver's prescribing physician has taken the 
driver's role into consideration and standardizes the process.
FMCSA Response
    The individual is correct that the form would not be necessary for 
every examination. The comment supports that the form is useful in the 
certification process.

Ways for FMCSA To Enhance the Quality, Usefulness, and Clarity of the 
Collected Information

Individual Comment

    This individual provided the following suggestions for enhancing 
the quality, usefulness, and clarity of the collected information.
     Add the commercial driver's license number as an 
identifier near the driver's date of birth on the form since this is 
becoming the primary identifier for CMV drivers across Commercial 
Driver Medical Exams (CDMEs) and drug screening for FMCSA.
     Consider making this form mandatory during the CDME 
process for drivers currently taking a Schedule II drug.
     Facilitate use by the prescribing provider by putting the 
CDME information, date it was initiated, and contact information on 
page 1, just under the introduction (before the 49 CFR 391.41 excerpt).
     Change wording for precision in question 2 to ``. . . 
prescribed to the above named individual by any other treating health 
care provider.'', instead of ``. . . by another treating. . . .''
     Add a comments section for the prescribing provider to use 
if having difficulty answering ``yes'' or ``no'' to question 4, or if 
has qualification or clarification, etc.
     Consider adding wording to ``The Driver's Role'' that 
indicates:
    [cir] Duties may also include overhead activity such as reaching, 
or forcefully pushing or pulling (adjusting rear-view mirror, 
tightening/loosening load straps), and squatting (inspection, on the 
road maintenance).
    [cir] FMCSA does not allow drivers to be cleared medically for 
specific jobs or duties; a medically qualified driver must be able to 
do all aspects of ``The Driver's Role.''
FMCSA Response
    Because there is moderate evidence to support the contention that 
the licit use of opioids increases the risk of motor vehicle crashes 
and negatively impacts indirect measures of driver performance, FMCSA's 
MRB and MCSAC recommended 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. As part of their 
recommendations, they suggested what should be included on the form to 
assist the certified ME in making a physical qualification 
determination. FMCSA considered their recommendations and included the 
necessary information on the form.
    FMCSA has considered the suggestions, but does not believe they 
would enhance the usefulness of the form or serve the purpose for which 
the form was intended to be used. Adding the driver's license number to 
the form would provide unnecessary personally identifiable information 
to the prescribing healthcare professional. The certified ME's contact 
information is already clearly set forth on page 2 of the form. The use 
of ``by any other,'' rather than ``another,'' is not likely to create 
confusion. FMCSA declines to add a comments section to question 4 
because unqualified medical opinions are sought. The Driver's Role 
statement adequately covers the activities suggested. Question 4 states 
that the medical opinions are to be consistent with The Driver's Role 
statement, which is sufficient to indicate the entire statement is to 
be considered.
    The Agency also declines to make the use of the form mandatory for 
Schedule II drugs, which would require a regulatory change to 
implement. The form was not intended to address only opioids. Moreover, 
49 CFR 391.41(b)(12) provides that a certified ME may only certify a 
driver who uses controlled drugs or substances listed on Schedules II 
through V in 21 CFR part 1308 if the prescribing healthcare 
professional provides certain information to the certified ME. FMCSA 
has provided the 391.41 CMV Driver Medication Form, MCSA-5895, to be 
used by certified MEs at their discretion and as a resource in making 
medical certification determinations of interstate CMV drivers. The use 
of the form is voluntary. The form is just one way that certified MEs 
may communicate with prescribing healthcare professionals so that the 
certified MEs fully understand the reasons the medications have been 
prescribed. FMCSA encourages certified MEs to use the form as often as 
they find necessary.
    Public Comments Invited: You are asked to comment on any aspect of 
this IC, including: (1) Whether the proposed collection is necessary 
for the FMCSA to perform its functions; (2) the accuracy of

[[Page 59907]]

the estimated burden; (3) ways for the 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.

    Issued under the authority delegated in 49 CFR 1.87 on: October 
31, 2019.
Kelly Regal,
Associate Administrator for Office of Research and Information 
Technology.
[FR Doc. 2019-24231 Filed 11-5-19; 8:45 am]
 BILLING CODE 4910-EX-P