[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Notices]
[Pages 17233-17234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08263]


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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket No. NHTSA-2019-0019]


Reports, Forms, and Record Keeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Request for public comment on a 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 the 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 one collection of information for 
which NHTSA intends to seek OMB approval.

DATES: Comments must be received on or before June 24, 2019.

ADDRESSES: You may submit comments identified by DOT Docket ID Number 
NHTSA--NHTSA-2019-0019 using any of the following methods:
    Electronic submissions: Go to http://www.regulations.gov. Follow 
the on-line 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: Amy Berning, Research Psychologist, 
NHTSA-NPD-130, 1200 New Jersey Avenue SE, W44-237, Washington, DC 
20590. Ms. Berning's phone number is 202-366-5587, 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 (at 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;
    (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 
submissions of responses.
    In compliance with these requirements, NHTSA asks public comment on 
the following proposed collection of information:
    Title: Prevalence of Alcohol and Other Drug Use Among Motor Vehicle 
Crash Victims Admitted to Select Trauma Centers.
    OMB Control Number: None.
    Form No.: None.
    Type of Information Collection Request: Approval of a New 
Information Collection.
    Type of Review Requested: Regular.
    The research study will involve the use of information, including 
blood samples, that was originally collected in the course of clinical 
treatment. Generally, under 5 U.S.C. 1320.3(h)(5), information does not 
include ``[f]acts or

[[Page 17234]]

opinions obtained initially or in follow-on requests, from individuals 
(including individuals in control groups) under treatment or clinical 
examination in connection with research on or prophylaxis to prevent a 
clinical disorder, direct treatment of that disorder, or the 
interpretation of biological analyses of body fluids, tissues, or other 
specimens, or the identification or classification of such specimens.'' 
However, as provided in 5 U.S.C. 1320.3(h), OMB may determine that any 
specific item constitutes ``information.'' NHTSA has consulted with OMB 
on a proposed research study and OMB has determined that, for the 
purpose of NHTSA's research study, the collection of the blood samples 
and de-identified information, including patient demographics, cause of 
injury, and injury severity, is a collection of information for which 
NHTSA must seek clearance from OMB.
    Respondents: Participants will include approximately 7,500 people 
seriously injured in a motor vehicle crash (MVC) arriving at one of the 
selected trauma centers or morgues immediately after the crash injury 
was incurred. As such, participants will include seriously-injured and 
fatally-injured drivers and other crash-involved road users (e.g., 
passengers, pedestrians, bicyclists, scooter riders).
    Estimated Time per Participant: The trauma centers and medical 
examiners at the selected study sites universally draw patients' blood 
for clinical treatment or autopsy purposes. The trauma centers and 
medical examiners also collect other information such as patient 
demographics, cause of injury, injury severity, and drugs administered 
during treatment as part of their normal operating procedures. The only 
blood that will be used in this study will be de-identified blood 
samples that were collected, but not used, during their routine 
clinical procedures. The study will also use other de-identified 
information that was collected as part of their routine clinical 
documentation procedures. Again, this information would be collected 
even in the absence of NHTSA's research study. As such, NHTSA does not 
estimate any burden on the participants.
    Total Estimated Annual Burden Hours: 0.00 hours per year.
    Frequency of Collection: The collection is part of a one-time 
study. The trauma centers will provide de-identified information on a 
patient every time an individual presents to the trauma center as an 
MVC victim. When available, blood samples from MVC victims that were 
already collected as part of routine clinical procedures will be de-
identified and provided for toxicological analyses. Similarly, the 
medical examiners will provide de-identified information on the 
fatally-injured MVC victims in the morgue and will provide a blood 
sample, when available, after all clinical procedures are complete.
    Abstract: The National Highway Traffic Safety Administration 
(NHTSA) seeks to examine the prevalence of legal and illegal drugs in 
the systems of seriously- or fatally-injured drivers and other crash-
involved road users presenting directly to the selected trauma centers 
or medical examiners. The contracted trauma centers and medical 
examiners will provide the study with de-identified blood samples, when 
available, that were already collected during their routine clinical 
treatment activities. The study will then conduct independent drug 
toxicology testing to determine the prevalence of alcohol and other 
drugs in the systems of the participants. The trauma centers and 
medical examiners will also provide the study with other de-identified 
participant classification information such as patient demographics, 
cause of injury, and injury severity. The trauma centers and medical 
examiners will provide this already-collected and de-identified 
information to the study in accordance with all applicable Federal, 
State, and local regulations governing the sharing of such information 
and as approved by the study Institutional Review Board.
    Description of the Need for the Information and Proposed Use of the 
Information: NHTSA's mission is to save lives, prevent injuries and 
reduce traffic-related health care and other economic costs. The agency 
develops, promotes and implements educational, and enforcement programs 
with the goal of ending preventable tragedies and reducing economic 
costs associated with vehicle use and highway travel. There is a dearth 
of information on drug prevalence for seriously-injured MVC victims 
with only a couple studies exploring the issue in the United States 
(e.g., Walsh, et al., 2004 \1\) and Canada (e.g., Brubacher et al., 
2016 \2\). This study seeks to help fill a gap in the state of 
knowledge concerning drug prevalence among MVC victims who are 
seriously- or fatally-injured, and present directly to a trauma center 
or morgue. While the sample is not nationally representative and will 
not be used for national estimates, the results of this research will 
produce information on a large sample of MVC victims, and will assist 
NHTSA in better understanding the prevalence of different drugs among 
the seriously- and-fatally-injured at the participating trauma centers 
and morgues.
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    \1\ Walsh, J. M., Flegel, R., Cangianelli, L. A., Atkins, R., 
Soderstrom, C.A., & Kerns, T. J. (2004). Epidemiology of alcohol and 
other drug use among motor vehicle crash victims admitted to a 
trauma center. Traffic Injury Prevention, 5(3), 254-60.
    \2\ Brubacher, J., Chan, H., Martz, W., Schreiber, W., Abridge, 
M., Eppler, J., Lund, A., Macdonald, S., Drummer, O., Purssell, R., 
Andolfatto, G., Mann, R., & Brant, R. (2016). Prevalence of alcohol 
and drug use in injured British Columbia drivers. BMJ Open, 6(3), 
e009278.

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    Authority: 44 U.S.C. Section 3506(c)(2)(A).

    Issued in Washington, DC on April 19, 2019.
Jon Krohmer,
Associate Administrator, Acting, Research and Program Development.
[FR Doc. 2019-08263 Filed 4-23-19; 8:45 am]
BILLING CODE 4910-59-P


