Agency Information Collection Activities; New Information Collection Request: 391.41 CMV Driver Medication Form |
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G. Kelly Regal
Federal Motor Carrier Safety Administration
November 25, 2015
[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)
[[Page 73872]]
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 charles.horan@dot.gov.
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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