Agency Information Collection Activities; Information Collection Renewal: 391.41 CMV Driver Medication Form, OMB Control Number: 2126-0064 |
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Kelly Regal
Federal Motor Carrier Safety Administration
6 November 2019
[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]
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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.
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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 oira_submission@omb.eop.gov 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:
charles.horan@dot.gov. 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.
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\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).
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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:
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\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.
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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\
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\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.
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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]
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