Reports, Forms, and Record Keeping Requirements, 33306-33308 [2018-15212]
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33306
Federal Register / Vol. 83, No. 137 / Tuesday, July 17, 2018 / Notices
complete submission, including the
information you claim to be confidential
business information, to the Chief
Counsel, NHTSA, 1200 New Jersey Ave.
SE, W41–326, Washington DC 20590. In
addition, you should submit two copies,
from which you have deleted the
claimed confidential business
information, to Docket Management at
the address given above. When you send
a comment containing information
claimed to be confidential business
information, you should submit a cover
letter setting forth the information
specified in our confidential business
information regulation (49 CFR part
512).
SUPPLEMENTARY INFORMATION:
daltland on DSKBBV9HB2PROD with NOTICES
Background
In the early 2000s, NHTSA convened
a panel of international experts on drugimpaired driving to review
developments in the field of drugs and
human performance and to identify the
specific effects that both high priority
illicit and prescription drugs have on
driving. The experts represented the
fields of psychopharmacology,
behavioral psychology, drug chemistry,
forensic toxicology, medicine, and law
enforcement. That effort resulted in the
publication of a document entitled
Drugs and Human Performance Fact
Sheets (DOT HS 809 725) in June 2004.
Each Fact Sheet covered one of the
selected sixteen drugs that impair
driving. The selected drugs included
over-the-counter medications such as
dextromethorphan and
diphenhydramine; prescription
medications such as carisoprodol,
diazepam, and zolpidem; and abused
and/or illegal drugs such as cocaine,
GHB, ketamine, LSD, marijuana,
methadone, methamphetamine, MDMA,
morphine, PCP, and toluene. Each
individual drug Fact Sheet covered
information regarding drug chemistry,
usage and dosage information,
pharmacology, drug effects, effects on
driving, drug evaluation and
classification, and the panel’s
assessment of driving risks. More
specifically, the Fact Sheets provided
details on the physical description of
the drug, synonyms, and
pharmaceutical or illicit sources;
medical and recreational uses,
recommended and abused doses, typical
routes of administration, and potency
and purity; mechanism of drug action
and major receptor sites; drug
absorption, distribution, metabolism
and elimination data; blood and urine
concentrations; psychological and
physiological effects, and drug
interactions; drug effects on
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17:07 Jul 16, 2018
Jkt 244001
psychomotor performance effects;
driving simulator and epidemiology
studies; and drug recognition evaluation
profiles. Each Fact Sheet concludes with
general statements about the drugs’
ability to impair driving performance. A
list of key references and recommended
reading was also provided for each drug.
Since 2004, new research on these
and other impairing drugs has become
available. As a result, NHTSA plans to
evaluate whether additional drugs that
impair driving should be included in
the Fact Sheets and to add them as
appropriate, as well as to update
information on the effects of the sixteen
aforementioned drugs on driving.
NHTSA will base the revised Fact
Sheets on the state of current scientific
knowledge. The agency intends to
design the revised Fact Sheets to
continue to provide practical guidance
to toxicologists, pharmacologists, law
enforcement officers, attorneys, and the
general public to use in the evaluation
of future cases.
In order to assist on the development
of the new edition of the Fact Sheets,
NHTSA invites comments and
suggestions from the general public on
additional drugs as well as relevant
research studies that have become
available since 2004 that could be
included in the updated fact sheets. To
the extent possible, such comments and
suggestions should be accompanied by
information about the drug, including
the extent of its use, its pharmacology
and pharmodynamics, and how
impairing it is for driving, along with
references.
Authority: 44 U.S.C. Section 3506(c)(2)(A).
Issued in Washington, DC, on July 12,
2018.
Jeff Michael,
Associate Administrator, Research and
Program Development.
[FR Doc. 2018–15209 Filed 7–16–18; 8:45 am]
BILLING CODE 4910–59–P
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
[U.S. DOT Docket No. NHTSA–2018–0060]
Reports, Forms, and Record Keeping
Requirements
National Highway Traffic
Safety Administration (NHTSA), DOT.
ACTION: Request for public comment on
proposed collection of information.
AGENCY:
Before a Federal agency can
collect certain information from the
public, it must receive approval from
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
the Office of Management and Budget
(OMB). Under procedures established
by the Paperwork Reduction Act of
1995, before seeking OMB approval,
Federal agencies must solicit public
comment on proposed collections of
information, including extensions and
reinstatements of previously approved
collections. This document describes
the collection of information for which
NHTSA intends to seek OMB approval.
DATES: Comments must be received on
or before September 17, 2018.
ADDRESSES: You may submit comments
identified by DOT Docket Number
NHTSA–2018–0060 using any of the
following methods:
Electronic submissions: Go to https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Mail: Docket Management Facility,
M–30, U.S. Department of
Transportation, 1200 New Jersey
Avenue SE, West Building Ground
Floor, Room W12–140, Washington, DC
20590.
Hand Delivery: West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue SE, Washington, DC, between 9
a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
Fax: 1–202–493–2251.
Instructions: Each submission must
include the agency name and the docket
number for this Notice. Note that all
comments received will be posted
without change to https://
www.regulations.gov, including any
personal information provided.
FOR FURTHER INFORMATION CONTACT:
Mary Byrd, Contracting Officer’s
Representative, Office of Behavioral
Safety Research (NPD–320), National
Highway Traffic Safety Administration,
1200 New Jersey Avenue SE,
Washington, DC 20590. Ms. Byrd’s
phone number is 202–366–5595, and
her email address is mary.byrd@dot.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995,
before an agency submits a proposed
collection of information to OMB for
approval, it must publish a document in
the Federal Register providing a 60-day
comment period and otherwise consult
with members of the public and affected
agencies concerning each proposed
collection of information. The OMB has
promulgated regulations describing
what must be included in such a
document. Under OMB’s regulations (5
CFR 1320.8(d)), an agency must ask for
public comment on the following:
(i) Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
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17JYN1
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Federal Register / Vol. 83, No. 137 / Tuesday, July 17, 2018 / Notices
(ii) the accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used;
(iii) how to enhance the quality,
utility, and clarity of the information to
be collected; and
(iv) how to minimize the burden of
the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses.
In compliance with these
requirements, NHTSA asks public
comment on the following proposed
collection of information:
Title: Emergency Medical Services
Sleep Health and Fatigue Education
Type of Request: New information
collection.
OMB Clearance Number: None.
Form Number: NHTSA Forms 1460,
1461, 1462, 1463, 1464, 1465, 1466, and
1467.
Requested Expiration Date of
Approval: Three years from date of
approval.
Summary of the Collection of
Information: The National Highway
Traffic Safety Administration (NHTSA)
proposes to collect information from
Emergency Medical Services (EMS)
personnel who operate ambulances on
the roadway for a one-time voluntary
study to evaluate the effectiveness of a
fatigue mitigation intervention that
delivers education and training. Up to
200 EMS agencies across the United
States will be contacted and screened in
order to recruit a total of 30 agencies to
participate in the study. NHTSA
anticipates contacting up to 100 EMS
personnel per participating agency
(3,000 total) to screen and recruit 1,500
eligible participants for the study.
NHTSA expects 1,200 voluntary
participants to complete the sign-up
process, including providing
demographic information and shift
schedules, and to consent to participate
in the 24-week study. Participants will
complete a baseline survey that includes
self-reported fatigue and sleepiness and
will retake the survey halfway through
the study and again at the end of the
study. All participants will complete the
ten ten-minute training modules during
the study period. Once the study is
underway, participants will be asked to
respond to daily text messages about
sleepiness and fatigue for eight weeks of
the 24-week study. Finally, NHTSA will
ask 30 of the 1,200 participants to
provide additional information by
keeping a daily sleep diary for eight
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17:07 Jul 16, 2018
Jkt 244001
weeks and by taking a brief vigilance
task test to measure fatigue at the
beginning and end of each shift over
eight days.
Background: The mission of the
NHTSA is to save lives, prevent injuries
and reduce economic costs due to motor
vehicle crashes. In support of this
mission, NHTSA’s Office of Behavioral
Safety Research studies behaviors and
attitudes in highway safety, focusing on
drivers, passengers, pedestrians, and
motorcyclists, and it uses the results to
develop and refine countermeasures to
deter unsafe behaviors and promote safe
alternatives. An efficient EMS system is
integral to reducing injury and mortality
on and off our Nation’s highways and is
key to ensuring prompt emergency
response to any type of illness or injury.
The Nation’s best preparation for any
incident, large or small, is a
comprehensive EMS system, ready
every day for every emergency.
A 2015 NHTSA study published at
EMSworld.com found that on average
there are 4,500 crashes per year
involving ambulances, and these
crashes result in an average of 33 deaths
per year. As indicated in various media
reports of high profile crashes, fatigue
and sleep deprivation are likely
contributors. Furthermore, a 2012 study
by Patterson, Weaver, Frank, et al.
published in Prehospital Emergency
Care found that the odds of injury,
medical error, and safety-compromising
behaviors among fatigued EMS
personnel are twice that of personnel
who do not report fatigue. A 2015 study
by Patterson, Weaver and Hostler in
Emergency Medical Services: Clinical
Practice and Systems Oversight found
that more than half of EMS personnel
report fatigue, poor sleep, or inadequate
recovery between shifts.
While greater than half of EMS
personnel report work-related fatigue,
there are no guidelines for the
management of fatigue in EMS. In 2013,
the National EMS Advisory Council
(NEMSAC) adopted an advisory that
recommended NHTSA and federal
partners disseminate evidence-based
information to aid the EMS community
in efforts to develop fatigue risk
management programs. In response,
NHTSA kicked off the ‘‘Fatigue in EMS’’
initiative in 2016. The project aims to
address the potential dangers of
drowsiness and fatigue among EMS
workers, including the risk of traffic
crashes, injuries to providers and
patients, and medical errors. After an
extensive review of more than 30,000
published research articles, the project
team released its evidence-based
guidelines for fatigue risk management,
along with companion materials and
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Fmt 4703
Sfmt 4703
33307
expert commentaries in January 2018.
The guidelines, which are described in
a 2018 publication by Patterson,
Higgins, Van Dogen, et al. in Prehospital
Emergency Care, intend to combat the
effects of fatigue through the following
five recommendations:
1. Reliable and/or valid fatigue and
sleepiness survey instruments should be
used to measure and monitor fatigue in
EMS personnel.
2. EMS personnel should work shifts
shorter than 24 hours in duration.
3. EMS workers should have access to
caffeine as a fatigue countermeasure.
4. EMS personnel should have the
opportunity to nap while on duty to
mitigate fatigue.
5. EMS personnel should receive
education and training to mitigate
fatigue and fatigue-related risks.
Description of the Need for the
Information and Proposed Use of the
Information: After developing and
disseminating the evidence-based
guidelines for fatigue risk management,
the second phase of NHTSA’s ‘‘Fatigue
in EMS’’ initiative is to test the impact
of one or more of the recommendations.
NHTSA proposes to use the information
collected to evaluate the effectiveness of
the fifth recommendation, education
and training, on reducing fatigue among
EMS personnel. The overarching goals
of this project are to determine whether
providing education and training to
EMS personnel on the importance of
sleep health and dangers of fatigue
affect diverse indicators of sleep,
fatigue, and safety as well as to enhance
our general understanding of the
relationships between shift work, sleep,
and fatigue in EMS operations. If the
training is demonstrated to be effective
at improving sleep quality and reducing
fatigue, then it will be more widely
distributed to the EMS community
through State offices as well as through
the National Association of State
Emergency Medical Services Officials.
Data Collection Plan: Members of the
research team will coordinate
recruitment and enrollment of EMS
organizations and individual EMS
personnel. Recruitment will be limited
to EMS organizations and affiliated
personnel located in the United States.
The research team will use webinars,
conference calls, and a website to
advertise the research study to those
that may be interested. The team
expects to collect information from as
many as 200 organizations to recruit the
target of 30 moderately-sized EMS
organizations (50 to 300 personnel) who
provide around-the-clock ground-based
services. The team will measure interest
and eligibility using an agency-level
screening form, which is estimated to
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33308
Federal Register / Vol. 83, No. 137 / Tuesday, July 17, 2018 / Notices
take 5 minutes to complete for a total
expected burden of 17 hours. The 30
participating agencies will then recruit
EMS clinicians currently working fulltime or part-time using a recruitment
flyer distributed to employees. The
research team expects to collect
information from as many as 3,000
individuals to identify up to 1,500
eligible participants. The team will
measure eligibility using an individuallevel screening form, which is estimated
to take 5 minutes to complete for a total
expected burden of 250 hours.
The research team will have the 1,500
eligible individuals watch a video
explaining the study and the consent
process and will then ask them to
indicate their consent to participate.
The consenting process is expected to
take 10 minutes for a total expected
burden of 250 hours. The research team
expects 1,200 eligible individuals to
consent and agree to participate. These
individuals will then complete the
registration process including providing
demographic information and shift
schedules, complete a baseline survey
including self-reported fatigue and
sleepiness. Half of the participants will
be asked to complete ten training
sessions of ten minutes each within ten
days. The other half will be asked to
complete the training within ten days of
the mid-point of the study. The
expected burden for the registration
process, baseline survey and training
intervention is 145 minutes per
participant for a total burden of 2,900
hours. Once the study is underway,
participants will be asked to respond to
daily text messages about sleepiness and
fatigue for eight weeks of the 24-week
study. The expected burden of
responding is 5 minutes per response
for a total burden of 5,600. The research
team also will ask participants to
complete follow-up surveys at the study
mid-point and at the end of the study.
The expect burden of responding is 25
minutes per survey for a total burden of
1,000 hours.
A subset of participants (30 of the
1,200) will complete a daily sleep diary
for eight weeks of the 24-week study.
Completing the diary is expected to take
3 minutes per day for a total burden of
84 hours. This subset also will be asked
to take a brief Psychomotor Vigilance
Task test twice per day (at the start and
at the end of shift) for a total of eight
days spread across the study period.
Completing each test is expected to take
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17:07 Jul 16, 2018
Jkt 244001
• HSR 6—Post-acute and Long-term
Care on August 22, 2018;
• HSR 7—Opioid and Pain
Management Special Emphasis on
August 24, 2018;
• MRA 0—Mentored Research on
August 24, 2018;
• HSR 8—Implementation Research
Project on August 23, 2018;
• HS8 A—Randomized Program
Evaluations on August 23, 2018; and
• HSR 9—Learning Health Initiative
on August 23, 2018.
The purpose of the Board is to review
health services research and
development applications involving: the
measurement and evaluation of health
Authority: 44 U.S.C. Section 3506(c)(2)(A). care services; the testing of new
methods of health care delivery and
Issued in Washington, DC, on July 12,
2018.
management; and mentored research.
Applications are reviewed for scientific
Jeff Michael,
and technical merit, mission relevance,
Associate Administrator, Research and
and the protection of human and animal
Program Development.
subjects. Recommendations regarding
[FR Doc. 2018–15212 Filed 7–16–18; 8:45 am]
funding are submitted to the Chief
BILLING CODE 4910–59–P
Research and Development Officer.
Each subcommittee meeting of the
Board will be open to the public the first
DEPARTMENT OF VETERANS
day for approximately one half-hour
AFFAIRS
from 8:00 a.m. to 8:30 a.m. at the start
of the meeting on August 21 (HSR 0, 1,
Health Services Research and
4), August 22 (HSR 1, 4, 6), August 23
Development Service, Scientific Merit
(HSR 2, 3, 5, 8, 9, and HS8A), and
Review Board; Notice of Meetings
August 24 (HSR 2, 5, 7, and MRA 0) to
The Department of Veterans Affairs
cover administrative matters and to
(VA) gives notice under the Federal
discuss the general status of the
Advisory Committee Act that the Health program. Members of the public who
Services Research and Development
wish to attend the open portion of the
Service Scientific Merit Review Board
subcommittee meetings may dial 1 (800)
will conduct in-person and
767–1750, participant code 10443#.
teleconference meetings of its eleven
The remaining portion of each
Health Services Research (HSR)
subcommittee meeting will be closed for
subcommittees on the dates below from the discussion, examination, reference
8:00 a.m. to approximately 4:30 p.m.
to, and oral review of the intramural
(unless otherwise listed) at the FHI 360
research proposals and critiques. During
Conference Center, 1825 Connecticut
the closed portion of each subcommittee
Avenue NW, Washington, DC 20009
meeting, discussion and
(unless otherwise listed):
recommendations will include
• HSR 0—Community Care on August qualifications of the personnel
21, 2018;
conducting the studies (the disclosure of
• HSR 1—Health Care and Clinical
which would constitute a clearly
Management on August 21–22, 2018;
unwarranted invasion of personal
• HSR 2—Behavioral, Social, and
privacy), as well as research information
Cultural Determinants of Health and
(the premature disclosure of which
Care on August 23–24, 2018;
would likely compromise significantly
• HSR 3—Healthcare Informatics on
the implementation of proposed agency
August 23, 2018;
action regarding such research projects).
• HSR 4—Mental and Behavioral
As provided by subsection 10(d) of
Health on August 21–22, 2018;
Public Law 92–463, as amended by
Public Law 94–409, closing the meeting
• HSR 5—Health Care System
is in accordance with 5 U.S.C.
Organization and Delivery on August
552b(c)(6) and (9)(B).
23–24, 2018;
five minutes for a total burden of 40
hours. The purpose of these additional
data collections is to assess the validity
and reliability of the self-reported study
measures.
Estimate of the Total Annual
Reporting and Record Keeping Burden
Resulting from the Collection of
Information: The total estimated burden
for EMS agency recruitment (17 hours),
recruitment of EMS clinicians (250
hours), the consenting process (250
hours), initial data collection and
training (2,900), follow-up data
collection (6,600), and additional data
collection for assessing measurement
error (124) is 10,141 hours.
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E:\FR\FM\17JYN1.SGM
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Agencies
[Federal Register Volume 83, Number 137 (Tuesday, July 17, 2018)]
[Notices]
[Pages 33306-33308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15212]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
[U.S. DOT Docket No. NHTSA-2018-0060]
Reports, Forms, and Record Keeping Requirements
AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.
ACTION: Request for public comment on proposed collection of
information.
-----------------------------------------------------------------------
SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatements of previously approved collections. This
document describes the collection of information for which NHTSA
intends to seek OMB approval.
DATES: Comments must be received on or before September 17, 2018.
ADDRESSES: You may submit comments identified by DOT Docket Number
NHTSA-2018-0060 using any of the following methods:
Electronic submissions: Go to https://www.regulations.gov. Follow
the online instructions for submitting comments.
Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590.
Hand Delivery: West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
Fax: 1-202-493-2251.
Instructions: Each submission must include the agency name and the
docket number for this Notice. Note that all comments received will be
posted without change to https://www.regulations.gov, including any
personal information provided.
FOR FURTHER INFORMATION CONTACT: Mary Byrd, Contracting Officer's
Representative, Office of Behavioral Safety Research (NPD-320),
National Highway Traffic Safety Administration, 1200 New Jersey Avenue
SE, Washington, DC 20590. Ms. Byrd's phone number is 202-366-5595, and
her email address is [email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulations (5 CFR
1320.8(d)), an agency must ask for public comment on the following:
(i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
[[Page 33307]]
(ii) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
(iii) how to enhance the quality, utility, and clarity of the
information to be collected; and
(iv) how to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
In compliance with these requirements, NHTSA asks public comment on
the following proposed collection of information:
Title: Emergency Medical Services Sleep Health and Fatigue
Education
Type of Request: New information collection.
OMB Clearance Number: None.
Form Number: NHTSA Forms 1460, 1461, 1462, 1463, 1464, 1465, 1466,
and 1467.
Requested Expiration Date of Approval: Three years from date of
approval.
Summary of the Collection of Information: The National Highway
Traffic Safety Administration (NHTSA) proposes to collect information
from Emergency Medical Services (EMS) personnel who operate ambulances
on the roadway for a one-time voluntary study to evaluate the
effectiveness of a fatigue mitigation intervention that delivers
education and training. Up to 200 EMS agencies across the United States
will be contacted and screened in order to recruit a total of 30
agencies to participate in the study. NHTSA anticipates contacting up
to 100 EMS personnel per participating agency (3,000 total) to screen
and recruit 1,500 eligible participants for the study. NHTSA expects
1,200 voluntary participants to complete the sign-up process, including
providing demographic information and shift schedules, and to consent
to participate in the 24-week study. Participants will complete a
baseline survey that includes self-reported fatigue and sleepiness and
will retake the survey halfway through the study and again at the end
of the study. All participants will complete the ten ten-minute
training modules during the study period. Once the study is underway,
participants will be asked to respond to daily text messages about
sleepiness and fatigue for eight weeks of the 24-week study. Finally,
NHTSA will ask 30 of the 1,200 participants to provide additional
information by keeping a daily sleep diary for eight weeks and by
taking a brief vigilance task test to measure fatigue at the beginning
and end of each shift over eight days.
Background: The mission of the NHTSA is to save lives, prevent
injuries and reduce economic costs due to motor vehicle crashes. In
support of this mission, NHTSA's Office of Behavioral Safety Research
studies behaviors and attitudes in highway safety, focusing on drivers,
passengers, pedestrians, and motorcyclists, and it uses the results to
develop and refine countermeasures to deter unsafe behaviors and
promote safe alternatives. An efficient EMS system is integral to
reducing injury and mortality on and off our Nation's highways and is
key to ensuring prompt emergency response to any type of illness or
injury. The Nation's best preparation for any incident, large or small,
is a comprehensive EMS system, ready every day for every emergency.
A 2015 NHTSA study published at EMSworld.com found that on average
there are 4,500 crashes per year involving ambulances, and these
crashes result in an average of 33 deaths per year. As indicated in
various media reports of high profile crashes, fatigue and sleep
deprivation are likely contributors. Furthermore, a 2012 study by
Patterson, Weaver, Frank, et al. published in Prehospital Emergency
Care found that the odds of injury, medical error, and safety-
compromising behaviors among fatigued EMS personnel are twice that of
personnel who do not report fatigue. A 2015 study by Patterson, Weaver
and Hostler in Emergency Medical Services: Clinical Practice and
Systems Oversight found that more than half of EMS personnel report
fatigue, poor sleep, or inadequate recovery between shifts.
While greater than half of EMS personnel report work-related
fatigue, there are no guidelines for the management of fatigue in EMS.
In 2013, the National EMS Advisory Council (NEMSAC) adopted an advisory
that recommended NHTSA and federal partners disseminate evidence-based
information to aid the EMS community in efforts to develop fatigue risk
management programs. In response, NHTSA kicked off the ``Fatigue in
EMS'' initiative in 2016. The project aims to address the potential
dangers of drowsiness and fatigue among EMS workers, including the risk
of traffic crashes, injuries to providers and patients, and medical
errors. After an extensive review of more than 30,000 published
research articles, the project team released its evidence-based
guidelines for fatigue risk management, along with companion materials
and expert commentaries in January 2018. The guidelines, which are
described in a 2018 publication by Patterson, Higgins, Van Dogen, et
al. in Prehospital Emergency Care, intend to combat the effects of
fatigue through the following five recommendations:
1. Reliable and/or valid fatigue and sleepiness survey instruments
should be used to measure and monitor fatigue in EMS personnel.
2. EMS personnel should work shifts shorter than 24 hours in
duration.
3. EMS workers should have access to caffeine as a fatigue
countermeasure.
4. EMS personnel should have the opportunity to nap while on duty
to mitigate fatigue.
5. EMS personnel should receive education and training to mitigate
fatigue and fatigue-related risks.
Description of the Need for the Information and Proposed Use of the
Information: After developing and disseminating the evidence-based
guidelines for fatigue risk management, the second phase of NHTSA's
``Fatigue in EMS'' initiative is to test the impact of one or more of
the recommendations. NHTSA proposes to use the information collected to
evaluate the effectiveness of the fifth recommendation, education and
training, on reducing fatigue among EMS personnel. The overarching
goals of this project are to determine whether providing education and
training to EMS personnel on the importance of sleep health and dangers
of fatigue affect diverse indicators of sleep, fatigue, and safety as
well as to enhance our general understanding of the relationships
between shift work, sleep, and fatigue in EMS operations. If the
training is demonstrated to be effective at improving sleep quality and
reducing fatigue, then it will be more widely distributed to the EMS
community through State offices as well as through the National
Association of State Emergency Medical Services Officials.
Data Collection Plan: Members of the research team will coordinate
recruitment and enrollment of EMS organizations and individual EMS
personnel. Recruitment will be limited to EMS organizations and
affiliated personnel located in the United States. The research team
will use webinars, conference calls, and a website to advertise the
research study to those that may be interested. The team expects to
collect information from as many as 200 organizations to recruit the
target of 30 moderately-sized EMS organizations (50 to 300 personnel)
who provide around-the-clock ground-based services. The team will
measure interest and eligibility using an agency-level screening form,
which is estimated to
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take 5 minutes to complete for a total expected burden of 17 hours. The
30 participating agencies will then recruit EMS clinicians currently
working full-time or part-time using a recruitment flyer distributed to
employees. The research team expects to collect information from as
many as 3,000 individuals to identify up to 1,500 eligible
participants. The team will measure eligibility using an individual-
level screening form, which is estimated to take 5 minutes to complete
for a total expected burden of 250 hours.
The research team will have the 1,500 eligible individuals watch a
video explaining the study and the consent process and will then ask
them to indicate their consent to participate. The consenting process
is expected to take 10 minutes for a total expected burden of 250
hours. The research team expects 1,200 eligible individuals to consent
and agree to participate. These individuals will then complete the
registration process including providing demographic information and
shift schedules, complete a baseline survey including self-reported
fatigue and sleepiness. Half of the participants will be asked to
complete ten training sessions of ten minutes each within ten days. The
other half will be asked to complete the training within ten days of
the mid-point of the study. The expected burden for the registration
process, baseline survey and training intervention is 145 minutes per
participant for a total burden of 2,900 hours. Once the study is
underway, participants will be asked to respond to daily text messages
about sleepiness and fatigue for eight weeks of the 24-week study. The
expected burden of responding is 5 minutes per response for a total
burden of 5,600. The research team also will ask participants to
complete follow-up surveys at the study mid-point and at the end of the
study. The expect burden of responding is 25 minutes per survey for a
total burden of 1,000 hours.
A subset of participants (30 of the 1,200) will complete a daily
sleep diary for eight weeks of the 24-week study. Completing the diary
is expected to take 3 minutes per day for a total burden of 84 hours.
This subset also will be asked to take a brief Psychomotor Vigilance
Task test twice per day (at the start and at the end of shift) for a
total of eight days spread across the study period. Completing each
test is expected to take five minutes for a total burden of 40 hours.
The purpose of these additional data collections is to assess the
validity and reliability of the self-reported study measures.
Estimate of the Total Annual Reporting and Record Keeping Burden
Resulting from the Collection of Information: The total estimated
burden for EMS agency recruitment (17 hours), recruitment of EMS
clinicians (250 hours), the consenting process (250 hours), initial
data collection and training (2,900), follow-up data collection
(6,600), and additional data collection for assessing measurement error
(124) is 10,141 hours.
Authority: 44 U.S.C. Section 3506(c)(2)(A).
Issued in Washington, DC, on July 12, 2018.
Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2018-15212 Filed 7-16-18; 8:45 am]
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