Reports, Forms, and Record Keeping Requirements |
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Jeff Michael
National Highway Traffic Safety Administration
17 July 2018
[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]
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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.
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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 http://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 http://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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(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]
BILLING CODE 4910-59-P