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: 

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 

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 

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 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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Federal Register / Vol. 83, No. 137 / Tuesday, July 17, 2018 / Notices 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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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 

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 

DEPARTMENT OF VETERANS 

AFFAIRS 

Health Services Research and 

Development Service, Scientific Merit 

Review Board; Notice of Meetings 

The Department of Veterans Affairs 

(VA) gives notice under the Federal 

Advisory Committee Act that the Health 

Services Research and Development 

Service Scientific Merit Review Board 

will conduct in-person and 

teleconference meetings of its eleven 

Health Services Research (HSR) 

subcommittees on the dates below from 

8:00 a.m. to approximately 4:30 p.m. 

(unless otherwise listed) at the FHI 360 

Conference Center, 1825 Connecticut 

Avenue NW, Washington, DC 20009 

(unless otherwise listed): 

• HSR 0—Community Care on August 

21, 2018; 

• HSR 1—Health Care and Clinical 

Management on August 21–22, 2018; 

• HSR 2—Behavioral, Social, and 

Cultural Determinants of Health and 

Care on August 23–24, 2018; 

• HSR 3—Healthcare Informatics on 

August 23, 2018; 

• HSR 4—Mental and Behavioral 

Health on August 21–22, 2018; 

• HSR 5—Health Care System 

Organization and Delivery on August 

23–24, 2018; 

• 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 

care services; the testing of new 

methods of health care delivery and 

management; and mentored research. 

Applications are reviewed for scientific 

and technical merit, mission relevance, 

and the protection of human and animal 

subjects. Recommendations regarding 

funding are submitted to the Chief 

Research and Development Officer. 

Each subcommittee meeting of the 

Board will be open to the public the first 

day for approximately one half-hour 

from 8:00 a.m. to 8:30 a.m. at the start 

of the meeting on August 21 (HSR 0, 1, 

4), August 22 (HSR 1, 4, 6), August 23 

(HSR 2, 3, 5, 8, 9, and HS8A), and 

August 24 (HSR 2, 5, 7, and MRA 0) to 

cover administrative matters and to 

discuss the general status of the 

program. Members of the public who 

wish to attend the open portion of the 

subcommittee meetings may dial 1 (800) 

767–1750, participant code 10443#. 

The remaining portion of each 

subcommittee meeting will be closed for 

the discussion, examination, reference 

to, and oral review of the intramural 

research proposals and critiques. During 

the closed portion of each subcommittee 

meeting, discussion and 

recommendations will include 

qualifications of the personnel 

conducting the studies (the disclosure of 

which would constitute a clearly 

unwarranted invasion of personal 

privacy), as well as research information 

(the premature disclosure of which 

would likely compromise significantly 

the implementation of proposed agency 

action regarding such research projects). 

As provided by subsection 10(d) of 

Public Law 92–463, as amended by 

Public Law 94–409, closing the meeting 

is in accordance with 5 U.S.C. 

552b(c)(6) and (9)(B). 


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