[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 <a href="/cdn-cgi/l/email-protection#2f424e5d56014d565d4b6f4b405b01484059"><span class="__cf_email__" data-cfemail="bbd6dac9c295d9c2c9dffbdfd4cf95dcd4cd">[email protected]</span></a>.

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

[[Page 33308]]

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


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