83 FR 33306 - Reports, Forms, and Record Keeping Requirements
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration Federal Register Volume 83, Issue 137 (July 17, 2018)
National Highway Traffic Safety Administration
Federal Register Volume 83, Issue 137 (July 17, 2018)
| Page Range | 33306-33308 | |
| FR Document | 2018-15212 |
[Federal Register Volume 83, Number 137 (Tuesday, July 17, 2018)] [Notices] [Pages 33306-33308] From the Federal Register Online [www.thefederalregister.org] [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 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 [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 [[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
![33306 Federal Register / Vol. 83, No. 137 / Tuesday, July 17, 2018 / Notices
complete submission, including the psychomotor performance effects; the Office of Management and Budget
information you claim to be confidential driving simulator and epidemiology (OMB). Under procedures established
business information, to the Chief studies; and drug recognition evaluation by the Paperwork Reduction Act of
Counsel, NHTSA, 1200 New Jersey Ave. profiles. Each Fact Sheet concludes with 1995, before seeking OMB approval,
SE, W41–326, Washington DC 20590. In general statements about the drugs’ Federal agencies must solicit public
addition, you should submit two copies, ability to impair driving performance. A comment on proposed collections of
from which you have deleted the list of key references and recommended information, including extensions and
claimed confidential business reading was also provided for each drug. reinstatements of previously approved
information, to Docket Management at Since 2004, new research on these collections. This document describes
the address given above. When you send and other impairing drugs has become the collection of information for which
a comment containing information available. As a result, NHTSA plans to NHTSA intends to seek OMB approval.
claimed to be confidential business evaluate whether additional drugs that DATES: Comments must be received on
information, you should submit a cover impair driving should be included in or before September 17, 2018.
letter setting forth the information the Fact Sheets and to add them as ADDRESSES: You may submit comments
specified in our confidential business appropriate, as well as to update identified by DOT Docket Number
information regulation (49 CFR part information on the effects of the sixteen NHTSA–2018–0060 using any of the
512). aforementioned drugs on driving. following methods:
SUPPLEMENTARY INFORMATION: NHTSA will base the revised Fact Electronic submissions: Go to http://
Sheets on the state of current scientific www.regulations.gov. Follow the online
Background knowledge. The agency intends to instructions for submitting comments.
In the early 2000s, NHTSA convened design the revised Fact Sheets to Mail: Docket Management Facility,
a panel of international experts on drug- continue to provide practical guidance M–30, U.S. Department of
impaired driving to review to toxicologists, pharmacologists, law Transportation, 1200 New Jersey
developments in the field of drugs and enforcement officers, attorneys, and the Avenue SE, West Building Ground
human performance and to identify the general public to use in the evaluation Floor, Room W12–140, Washington, DC
specific effects that both high priority of future cases. 20590.
illicit and prescription drugs have on In order to assist on the development Hand Delivery: West Building Ground
driving. The experts represented the of the new edition of the Fact Sheets, Floor, Room W12–140, 1200 New Jersey
fields of psychopharmacology, NHTSA invites comments and Avenue SE, Washington, DC, between 9
behavioral psychology, drug chemistry, suggestions from the general public on a.m. and 5 p.m., Monday through
forensic toxicology, medicine, and law additional drugs as well as relevant Friday, except Federal holidays.
enforcement. That effort resulted in the research studies that have become Fax: 1–202–493–2251.
publication of a document entitled available since 2004 that could be Instructions: Each submission must
Drugs and Human Performance Fact included in the updated fact sheets. To include the agency name and the docket
Sheets (DOT HS 809 725) in June 2004. the extent possible, such comments and number for this Notice. Note that all
Each Fact Sheet covered one of the suggestions should be accompanied by comments received will be posted
selected sixteen drugs that impair information about the drug, including without change to http://
driving. The selected drugs included the extent of its use, its pharmacology www.regulations.gov, including any
over-the-counter medications such as and pharmodynamics, and how personal information provided.
dextromethorphan and impairing it is for driving, along with FOR FURTHER INFORMATION CONTACT:
diphenhydramine; prescription references. Mary Byrd, Contracting Officer’s
medications such as carisoprodol, Authority: 44 U.S.C. Section 3506(c)(2)(A). Representative, Office of Behavioral
diazepam, and zolpidem; and abused Safety Research (NPD–320), National
Issued in Washington, DC, on July 12,
and/or illegal drugs such as cocaine, 2018. Highway Traffic Safety Administration,
GHB, ketamine, LSD, marijuana, 1200 New Jersey Avenue SE,
Jeff Michael,
methadone, methamphetamine, MDMA, Washington, DC 20590. Ms. Byrd’s
Associate Administrator, Research and
morphine, PCP, and toluene. Each phone number is 202–366–5595, and
Program Development.
individual drug Fact Sheet covered her email address is mary.byrd@dot.gov.
[FR Doc. 2018–15209 Filed 7–16–18; 8:45 am]
information regarding drug chemistry, SUPPLEMENTARY INFORMATION: Under the
BILLING CODE 4910–59–P
usage and dosage information, Paperwork Reduction Act of 1995,
pharmacology, drug effects, effects on before an agency submits a proposed
driving, drug evaluation and DEPARTMENT OF TRANSPORTATION collection of information to OMB for
classification, and the panel’s approval, it must publish a document in
assessment of driving risks. More National Highway Traffic Safety the Federal Register providing a 60-day
specifically, the Fact Sheets provided Administration comment period and otherwise consult
details on the physical description of with members of the public and affected
the drug, synonyms, and [U.S. DOT Docket No. NHTSA–2018–0060] agencies concerning each proposed
pharmaceutical or illicit sources; collection of information. The OMB has
Reports, Forms, and Record Keeping
medical and recreational uses, promulgated regulations describing
Requirements
recommended and abused doses, typical what must be included in such a
routes of administration, and potency AGENCY: National Highway Traffic document. Under OMB’s regulations (5
daltland on DSKBBV9HB2PROD with NOTICES
and purity; mechanism of drug action Safety Administration (NHTSA), DOT. CFR 1320.8(d)), an agency must ask for
and major receptor sites; drug ACTION: Request for public comment on public comment on the following:
absorption, distribution, metabolism proposed collection of information. (i) Whether the proposed collection of
and elimination data; blood and urine information is necessary for the proper
concentrations; psychological and SUMMARY: Before a Federal agency can performance of the functions of the
physiological effects, and drug collect certain information from the agency, including whether the
interactions; drug effects on public, it must receive approval from information will have practical utility;
VerDate Sep<11>2014 17:07 Jul 16, 2018 Jkt 244001 PO 00000 Frm 00115 Fmt 4703 Sfmt 4703 E:\FR\FM\17JYN1.SGM 17JYN1](https://thefederalregister.org/doc/83_FR_33443/page/1.svg)
![33308 Federal Register / Vol. 83, No. 137 / Tuesday, July 17, 2018 / Notices
take 5 minutes to complete for a total five minutes for a total burden of 40 • HSR 6—Post-acute and Long-term
expected burden of 17 hours. The 30 hours. The purpose of these additional Care on August 22, 2018;
participating agencies will then recruit data collections is to assess the validity • HSR 7—Opioid and Pain
EMS clinicians currently working full- and reliability of the self-reported study Management Special Emphasis on
time or part-time using a recruitment measures. August 24, 2018;
flyer distributed to employees. The Estimate of the Total Annual • MRA 0—Mentored Research on
research team expects to collect Reporting and Record Keeping Burden August 24, 2018;
information from as many as 3,000 Resulting from the Collection of • HSR 8—Implementation Research
individuals to identify up to 1,500 Information: The total estimated burden Project on August 23, 2018;
eligible participants. The team will for EMS agency recruitment (17 hours), • HS8 A—Randomized Program
measure eligibility using an individual- recruitment of EMS clinicians (250 Evaluations on August 23, 2018; and
level screening form, which is estimated hours), the consenting process (250
to take 5 minutes to complete for a total • HSR 9—Learning Health Initiative
hours), initial data collection and
expected burden of 250 hours. on August 23, 2018.
training (2,900), follow-up data
The research team will have the 1,500 collection (6,600), and additional data The purpose of the Board is to review
eligible individuals watch a video collection for assessing measurement health services research and
explaining the study and the consent error (124) is 10,141 hours. development applications involving: the
process and will then ask them to measurement and evaluation of health
Authority: 44 U.S.C. Section 3506(c)(2)(A). care services; the testing of new
indicate their consent to participate.
The consenting process is expected to Issued in Washington, DC, on July 12, methods of health care delivery and
take 10 minutes for a total expected 2018. management; and mentored research.
burden of 250 hours. The research team Jeff Michael, Applications are reviewed for scientific
expects 1,200 eligible individuals to Associate Administrator, Research and and technical merit, mission relevance,
consent and agree to participate. These Program Development. and the protection of human and animal
individuals will then complete the [FR Doc. 2018–15212 Filed 7–16–18; 8:45 am] subjects. Recommendations regarding
registration process including providing BILLING CODE 4910–59–P funding are submitted to the Chief
demographic information and shift Research and Development Officer.
schedules, complete a baseline survey Each subcommittee meeting of the
including self-reported fatigue and DEPARTMENT OF VETERANS Board will be open to the public the first
sleepiness. Half of the participants will AFFAIRS day for approximately one half-hour
be asked to complete ten training from 8:00 a.m. to 8:30 a.m. at the start
sessions of ten minutes each within ten Health Services Research and of the meeting on August 21 (HSR 0, 1,
days. The other half will be asked to Development Service, Scientific Merit 4), August 22 (HSR 1, 4, 6), August 23
complete the training within ten days of Review Board; Notice of Meetings (HSR 2, 3, 5, 8, 9, and HS8A), and
the mid-point of the study. The August 24 (HSR 2, 5, 7, and MRA 0) to
expected burden for the registration The Department of Veterans Affairs cover administrative matters and to
process, baseline survey and training (VA) gives notice under the Federal discuss the general status of the
intervention is 145 minutes per Advisory Committee Act that the Health program. Members of the public who
participant for a total burden of 2,900 Services Research and Development wish to attend the open portion of the
hours. Once the study is underway, Service Scientific Merit Review Board subcommittee meetings may dial 1 (800)
participants will be asked to respond to will conduct in-person and 767–1750, participant code 10443#.
daily text messages about sleepiness and teleconference meetings of its eleven The remaining portion of each
fatigue for eight weeks of the 24-week Health Services Research (HSR) subcommittee meeting will be closed for
study. The expected burden of subcommittees on the dates below from the discussion, examination, reference
responding is 5 minutes per response 8:00 a.m. to approximately 4:30 p.m. to, and oral review of the intramural
for a total burden of 5,600. The research (unless otherwise listed) at the FHI 360 research proposals and critiques. During
team also will ask participants to Conference Center, 1825 Connecticut the closed portion of each subcommittee
complete follow-up surveys at the study Avenue NW, Washington, DC 20009 meeting, discussion and
mid-point and at the end of the study. (unless otherwise listed): recommendations will include
The expect burden of responding is 25 • HSR 0—Community Care on August qualifications of the personnel
minutes per survey for a total burden of 21, 2018; conducting the studies (the disclosure of
1,000 hours. • HSR 1—Health Care and Clinical which would constitute a clearly
A subset of participants (30 of the Management on August 21–22, 2018; unwarranted invasion of personal
1,200) will complete a daily sleep diary • HSR 2—Behavioral, Social, and privacy), as well as research information
for eight weeks of the 24-week study. Cultural Determinants of Health and (the premature disclosure of which
Completing the diary is expected to take Care on August 23–24, 2018; would likely compromise significantly
3 minutes per day for a total burden of • HSR 3—Healthcare Informatics on the implementation of proposed agency
84 hours. This subset also will be asked August 23, 2018; action regarding such research projects).
to take a brief Psychomotor Vigilance • HSR 4—Mental and Behavioral As provided by subsection 10(d) of
Task test twice per day (at the start and Health on August 21–22, 2018; Public Law 92–463, as amended by
daltland on DSKBBV9HB2PROD with NOTICES
at the end of shift) for a total of eight • HSR 5—Health Care System Public Law 94–409, closing the meeting
days spread across the study period. Organization and Delivery on August is in accordance with 5 U.S.C.
Completing each test is expected to take 23–24, 2018; 552b(c)(6) and (9)(B).
VerDate Sep<11>2014 17:07 Jul 16, 2018 Jkt 244001 PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 E:\FR\FM\17JYN1.SGM 17JYN1](https://thefederalregister.org/doc/83_FR_33443/page/3.svg)
Document Created: 2018-07-17 01:39:40
Document Modified: 2018-07-17 01:39:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Request for public comment on proposed collection of information. | |
| Dates | Comments must be received on or before September 17, 2018. | |
| 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 | |
| FR Citation | 83 FR 33306 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR