Reports, Forms, and Record Keeping Requirements |
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Jon Krohmer
National Highway Traffic Safety Administration
24 April 2019
[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 amy.berning@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 (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]
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