[Federal Register Volume 90, Number 238 (Monday, December 15, 2025)]
[Notices]
[Pages 58079-58087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-22762]
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DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
[Docket No. NHTSA-2025-0259]
Agency Information Collection Activities; Notice and Request for
Comment; Advanced Drunk Driving Prevention Technology Telltale
Development
AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Notice and request for comments on a request for approval of a
new collection of information.
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SUMMARY: NHTSA invites public comments about our intention to request
approval from the Office of Management and Budget (OMB) for a new
information collection. Before a Federal agency can collect certain
information from the public, it must receive approval from 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
reinstatement of previously approved collections. This document
describes a collection of information for which NHTSA intends to seek
OMB approval on the development and evaluation of an advanced drunk
driving prevention technology telltale.
DATES: Comments must be submitted on or before February 13, 2026.
ADDRESSES: You may submit comments identified by the Docket No. NHTSA-
2025-0259 through any of the following methods:
Electronic submissions: Go to the Federal eRulemaking
Portal at http://www.regulations.gov. Follow the online instructions
for submitting comments.
Fax: (202) 493-2251.
Mail or Hand Delivery: Docket Management, U.S. Department
of Transportation, 1200 New Jersey Avenue SE, West Building, Room W12-
140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except on Federal holidays. To
[[Page 58080]]
be sure someone is there to help you, please call (202) 366-9322 before
coming.
Instructions: All submissions must include the agency name and
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. Please see the Privacy Act heading
below.
Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit https://www.transportation.gov/privacy.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. Follow the online instructions for accessing the
dockets via internet.
FOR FURTHER INFORMATION CONTACT: For additional information or access
to background documents, contact Eric Traube, Office of Vehicle Safety
Research, Human Factors/Engineering Integration Division NSR-310, West
Building, U.S. Department of Transportation, 1200 New Jersey Avenue SE,
Washington, DC 20590; 202-366-5673; [email protected]. Please
identify the relevant collection of information by referring to its OMB
Control Number.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), before an agency submits a proposed
collection of information to OMB for approval, it must first 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 regulation (at 5 CFR 1320.8(d)), an agency must
ask for public comment on the following: (a) 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; (b) 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; (c) how to enhance
the quality, utility, and clarity of the information to be collected;
and (d) 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 for public comments on the following proposed collection of
information for which the agency is seeking approval from OMB.
Title: Advanced Drunk Driving Prevention Technology Telltale
Development.
OMB Control Number: New.
Form Number(s): There are multiple forms for this new information
collection including:
NHTSA Form 2092: Online Survey--Study 1A
NHTSA Form 2086: Eligibility Questionnaire--Study 1B
NHTSA Form 2087: Eligibility Questionnaire--Study 2
NHTSA Form 2081: Appointment Confirmation-Sober--Study 1B
NHTSA Form 2080: Appointment Confirmation-Alcohol Dosed--Study
1B
NHTSA Form 2082: Appointment Confirmation--Study 2
NHTSA Form 2090: Informed Consent Document-Sober--Study 1B
NHTSA Form 2089: Informed Consent Document-Alcohol Dosed--
Study 1B
NHTSA Form 2091: Informed Consent Document--Study 2
NHTSA Form 2083: Combined Driving Questionnaire--Study 1B &
Study 2
NHTSA Form 2096: Telltale Questions--Study 1B
NHTSA Form 2095: Telltale Acceptance Questionnaire--Study 1B
NHTSA Form 2094: Post-Drive Ratings--Study 2
NHTSA Form 2093: Post-Drive Questionnaire--Study 2
NHTSA Form 2097: Wellness Questionnaire--Study 2
NHTSA Form 2084: Debriefing Statement--Study1B
NHTSA Form 2085: Debriefing Statement--Study 2
NHTSA Form 2088: End of Visit Release Agreement--Study 1B &
Study 2
Type of Request: New.
Type of Review Requested: Regular.
Requested Expiration Date of Approval: 3 years from date of
approval.
Summary of the Collection of Information: The National Highway
Traffic Safety Administration (NHTSA) is seeking approval to collect
information from the public as part of a multiyear effort to understand
how best to alert drivers that a drunk driving detection system has (1)
detected the presence of alcohol in their vehicle that corresponds to a
driver that is near or above the legal limit or (2) detected that the
driver's behavioral state is likely to be classified as under the
influence of alcohol or ``drunk.'' The overall objective of this
research is to advance the state of knowledge regarding driver alcohol
impairment detection telltales through developing and evaluating
telltale alternatives and is not immediately intended to inform
regulations or policy. The research will be conducted in three parts,
referred to as Study 1A, Study 1B, and Study 2. All study procedures
are approved by the University of Iowa Institutional Review Board
(IRB).
Study 1 will focus on the evaluation of candidate telltales
developed under this project. In Study 1A, respondents will complete an
online survey to gain initial information about telltale comprehension
and preferences. Participants will be randomly assigned to one of the
candidate telltales and to one of two question display orders for
overall ratings. Study 1B will involve sober and alcohol-impaired
evaluation of the candidate telltales in a research setting.
Participants will be screened and assigned to the sober or alcohol-
dosed visit type based on eligibility. All participants will provide
informed consent, undergo intake and eligibility confirmation
procedures, complete a questionnaire to obtain demographic and driving
behavior information, view the candidate telltales while seated at a
miniSim driving simulator, complete comprehension questions related to
the telltales, complete questions related to telltale efficacy and
acceptance, and be debriefed on study procedures. Alcohol-dosed
participants will receive alcohol to a BrAC level of approximately .08
g/210L for their telltale comprehension, wait at DSRI until their BrAC
is at or below .03 g/210L, and complete an agreement that they will not
drive, bike, or walk home after the visit.
Study 2 will be a repeated-measures simulator study to assess the
impact of the final candidate telltale on pre-drive and mid-drive
decision making. All participants will receive alcohol to a BrAC level
of approximately .08 g/210L. Participants will provide informed
consent, undergo intake and eligibility confirmation procedures,
complete a questionnaire to obtain demographic and driving behavior
information, complete training on a miniSim driving simulator and
complete a
[[Page 58081]]
familiarization drive and a wellness questionnaire to screen for
simulator sickness, complete a sober baseline drive, undergo alcohol
dosing procedures, complete three telltale evaluation drives with post-
drive ratings and a small alcohol booster drink between drives,
complete a post-drive questionnaire, be debriefed on study procedures,
wait at DSRI until their BrAC is at or below .03 g/210L, and complete
an agreement that they will not drive, bike, or walk home after the
visit. Participants will be randomly assigned to one of six possible
telltale evaluation drive orders for the three telltale conditions (no
telltale, telltale pre-drive, telltale mid-drive). The simulator will
collect vehicle data (e.g., brake inputs, steering wheel angle) and
data about the surrounding environment (e.g., distance to surrounding
vehicles and lane markings). Data will be analyzed to understand how
human drivers respond to a drunk driving detection telltale under
different conditions.
Description of the Need for the Information and Proposed Use of the
Information: NHTSA's mission is to save lives, prevent injuries, and
reduce the economic costs of road traffic crashes through education,
research, safety standards, and enforcement activity. As vehicle
technologies advance, they have the potential to dramatically reduce
the loss of life each day in roadway crashes. Alternatively, the
systems may not reach this potential or could potentially decrease
safety when drivers do not understand how to safely interact with the
systems or do not understand the capabilities and limitations. This new
information collection request is for a multipart study to understand
how best to alert drivers that a drunk driving detection system has (1)
detected the presence of alcohol in their vehicle that corresponds to a
driver that is near or above the federal limit of .08 g/dL BAC or (2)
detected that the driver's behavioral state is likely to be classified
as under the influence of alcohol or ``drunk.'' This research supports
NHTSA's mission of safety.
The following components will be used to obtain the necessary
information to achieve this purpose.
(1) Online Survey--Study 1A (NHTSA Form 2092): This survey is
necessary for evaluating initial driver comprehension of candidate
telltales. Results from this survey will be used to improve the
candidate telltales for Study 1B by modifying, eliminating, or creating
new candidates.
(2) Eligibility Questionnaire--Study 1B (NHTSA Form 2086): This
questionnaire is necessary for determining respondent suitability for
the study based on driving experience and history and ability to adhere
to study requirements. To be considered for the alcohol-dosed visit,
suitability is also based on general health and alcohol use.
(3) Eligibility Questionnaire--Study 2 (NHTSA Form 2087): This
questionnaire is necessary for determining respondent suitability for
the study based on driving experience and history, ability to adhere to
study requirements, general health, alcohol use, and ability to safely
drive the miniSim without concerns.
(4) Appointment Confirmation-Sober--Study 1B (NHTSA Form 2081):
This form contains the reminder email and information provided to the
participant and is necessary for reminding participants of their study
visit and communicating necessary information for the visit. No data is
collected or analyzed from this form. The email is sent one time to the
participant 48 hours prior to the scheduled visit. The respondent does
not have to respond to any specific questions but is asked to contact
the research team if there has been a change in health or if they are
currently experiencing any symptoms of illness or are feeling unwell.
To confirm the visit, the participant will click on a link that takes
them to an information page that contains reminders and instructions
for the visit.
(5) Appointment Confirmation-Alcohol Dosed--Study 1B (NHTSA Form
2080): This form contains the reminder email and information provided
to the participant and is necessary for reminding participants of their
study visit and communicating necessary information for the visit. No
data is collected or analyzed from this form. The email is sent one
time to the participant 48 hours prior to the scheduled visit. The
respondent does not have to respond to any specific questions but is
asked to contact the research team if there has been a change in health
or if they are currently experiencing any symptoms of illness or are
feeling unwell. To confirm the visit, the participant will click on a
link that takes them to an information page that contains reminders and
instructions for the visit.
(6) Appointment Confirmation--Study 2 (NHTSA Form 2082): This form
contains the reminder email and information provided to the participant
and is necessary for reminding participants of their study visit and
communicating necessary information for the visit. No data is collected
or analyzed from this form. The email is sent one time to the
participant 48 hours prior to the scheduled visit. The respondent does
not have to respond to any specific questions but is asked to contact
the research team if there has been a change in health or if they are
currently experiencing any symptoms of illness or feeling unwell. To
confirm the visit, the participant will click on a link that takes them
to an information page that contains reminders and instructions for the
visit.
(7) Informed Consent Document-Sober--Study 1B (NHTSA Form 2090):
This form is necessary for obtaining documented informed consent from
the participant to participate in the study. The form describes all
study procedures, data storage and use, and potential risks from the
study.
(8) Intake & Eligibility Confirmation-Sober--Study 1B: This process
includes completion of the research participant substitute W-9 for
payment, review of the driver's license to confirm it is valid by
checking the expiration date and confirming age (for eligibility) and
sex (for balancing sample) as listed on the license, administration of
a breath alcohol concentration (BrAC) reading to ensure sobriety, and
obtaining a urine sample for drug testing. While there is a preferred
order to these procedures, the block is fluid to permit for variability
in participant ability to provide a urine sample at the designated
time. These procedures are necessary to pay the participant and ensure
they meet eligibility requirements before continuing with Study 1B
sober visit procedures.
(9) Combined Driving Questionnaire--Study 1B & Study 2 (NHTSA Form
2083): This form is necessary for obtaining demographic information
(e.g., age, sex, race/ethnicity, household income, employment status,
education, driving experience and comfort, licensure, history of
crashes) and gathering opinions and driving behaviors related to
alcohol and driving. Prior experience with alcohol and driving could
influence telltale comprehension and acceptance. This form is
administered at both the sober and alcohol-dosed visits of Study 1B as
well as the Study 2 visit.
(10) Telltale Evaluation at the Simulator--Study 1B: This block of
procedures in Study 1B, both visit types, includes preparing the
miniSim and seating the participant at the simulator, training on the
evaluation protocol, and administration of the protocol. Participants
are shown twelve telltales one at a time and answer comprehension
questions between telltale displays. NHTSA Form 2096 includes all
telltales and questions to be
[[Page 58082]]
asked as part of this process. Participants will not be driving the
miniSim but will be shown each of the telltales in context on the
simulator's instrument cluster.
(11) Telltale Acceptance Questionnaire--Study 1B (NHTSA Form 2095):
This form is necessary to assess acceptance of the telltales and is
administered after the Telltale Evaluation at the Simulator.
(12) Debriefing Statement--Study 1B (NHTSA Form 2084): This form is
necessary to ensure participants are given full information about the
study and to instruct participants not to share specific details with
others. A researcher will verbally communicate all information
contained in the form and provide a copy to the participant.
(13) Informed Consent Document-Alcohol Dosed--Study 1B (NHTSA Form
2089): This form is necessary for obtaining documented informed consent
from the participant to participate in the study. The form describes
all study procedures, data storage and use, and potential risks from
the study.
(14) Intake & Eligibility Confirmation-Alcohol Dosed--Study 1B &
Study 2: This process includes procedures necessary for eligibility
confirmation and baseline readings as well as standard intake
procedures. Intake procedures include completion of the research
participant substitute W-9 for payment and review of the driver's
license to confirm it is valid by checking the expiration date and
confirming age (for eligibility) and sex as listed on the license (for
balancing sample and required pregnancy testing due to alcohol dosing),
and obtaining measurements of weight and height (for alcohol dosing
calculations). Eligibility procedures include asking a series of ``yes/
no'' questions to confirm nothing has changed in eligibility status
from the online eligibility questionnaire, administration of a breath
alcohol concentration (BrAC) reading to ensure sobriety (and to serve
as baseline) and obtaining a urine sample for drug and pregnancy
testing. Baseline vitals of blood pressure, heart rate, respiratory
rate, pulse oximetry, and temperature are taken. While there is a
preferred order to these procedures, the block is fluid to permit for
variability in participant ability to provide a urine sample at the
designated time.
(15) Alcohol Dosing Procedures--Study 1B & Study 2: This block of
procedures is necessary for the administration of alcohol. Participants
will be dosed to achieve an approximate BrAC level of .08. The
participant will undergo multiple BrAC measurements as part of this
process.
(16) End of Visit Procedures-Alcohol Dosed--Study 1B & Study 2:
This block of procedures comes at the end of the alcohol-dosed visits,
after debriefing is complete. Procedures in this block are to ensure
participant well-being and safety and have been approved by University
of Iowa Risk Management. Procedures include a period of monitoring the
participant while waiting for them to sober to a level at or below a
.03, administering BrAC measurements, discharge vitals, and
administration of NHTSA Form 2088 (the End of Visit Release Agreement).
This agreement is necessary to ensure there is documentation that the
participant understood they could not drive, bike, or walk home.
(17) Informed Consent Document--Study 2 (NHTSA Form 2091): This
form is necessary for obtaining documented informed consent from the
participant to participate in the study. The form describes all study
procedures, data storage and use, and potential risks from the study.
(18) Sober Baseline Driving Procedures--Study 2: This block of
procedures is necessary to prepare participants for their study drives.
Participants will receive protocol training of approximately 5 minutes
on the miniSim driving simulator and on the incentive structure to be
used in the telltale evaluation drives, complete a familiarization
drive of approximately 10 minutes, and complete a sober baseline drive
of approximately 15 minutes. The familiarization drive allows
participants a chance to become comfortable with driving the miniSim
and will prepare them for the drives they will complete later in the
visit. It also serves to screen for simulator sickness. The sober
baseline drive is necessary for gathering information for the purpose
of assessing how drivers interact with the telltale and the impact of
these interactions on safety.
(19) Wellness Questionnaire--Study 2 (NHTSA Form 2097): This form
is necessary for evaluating simulator sickness symptoms to determine
participant ability to complete the telltale evaluation study drives in
the miniSim driving simulator. This questionnaire will be administered
after the familiarization drive and after the final study drive.
(20) Telltale Evaluation Drives--Study 2: These study evaluation
drives are necessary to assess the impact of the final candidate
telltale on pre-drive and mid-drive decision making. Each of the three
study drives, one for each telltale condition (no telltale, pre-drive
telltale, mid-drive telltale), will last approximately 15 minutes. The
drive will take place in a simulated nighttime environment to mimic the
lighting conditions when most alcohol-related crashes occur. Financial
incentives will be used to mimic the motivational tradeoffs of an
impaired driving situation.
(21) Post-Drive Ratings--Study 2 (NHTSA Form 2094): After each of
the telltale evaluation drives, participants will provide a BrAC
measurement and will be asked to complete ratings of their impairment
and asked about their decision-making process during the drive. This
data is necessary to assess telltale efficacy and consequences. At the
same time as these ratings, participants will be given a small booster
drink to create uncertainty in their BrAC level. The drink will contain
orange juice (or pre-approved substitute) with a 5 ml alcohol float.
The drink is only given after the first and second evaluation drives;
no booster drink will be given after the final evaluation.
(22) Post-Drive Questionnaire--Study 2 (NHTSA Form 2093): This form
is necessary to assess telltale efficacy, comprehension, and
acceptance. It will be administered after the final telltale evaluation
drive.
(23) Debriefing Statement--Study 2 (NHTSA Form 2085): This form is
necessary to ensure participants are given full information about the
study and to instruct participants not to share specific details with
others. A researcher will verbally communicate all information
contained in the form and provide a copy to the participant.
Affected Public: Individuals 18 and older from Eastern Iowa and the
surrounding areas who have volunteered to take part in driving studies
or who have opted in to receive research-related emails from the
University of Iowa mass email system. For Study 1A, respondents must be
18 or older and drive a vehicle for personal use, professional use, or
both. The design for Study 1B includes 30 sober drivers ages 18 to 20,
30 sober drivers 21 and older, and 30 alcohol-dosed drivers 21 and
older for an overall sample of 90. The 21 and older groups are further
divided into the following age ranges: 21 to 24, 25 to 40, 41 to 54, 55
to 64, and 65 and older. The design for Study 2 includes 30 alcohol-
dosed drivers 21 and older in the same five age ranges as Study 1B.
Respondents must meet specific eligibility criteria to be included in
this information collection. Businesses are ineligible for the sample
and will not be contacted.
Estimated Number of Respondents: For Study 1A, we estimate 550
respondents. This number is based on the proposed recruitment pool and
a
[[Page 58083]]
response rate of approximately 1%. The target number of respondents for
Study 1B is 90 participants divided across the two dosing conditions
and age groups as described in the ``Affected Public'' section above.
The target number of respondents for Study 2 is 30 participants divided
across the age groups described in the ``Affected Public'' section
above. Recent impairment studies at DSRI have shown that only about 15%
to 20% of potentially eligible participants enroll, and only about 45%
to 50% of respondents to the eligibility questionnaires are potentially
eligible (due to self-termination of the questionnaire or not meeting
criteria). These statistics were used to estimate response rates for
the two online eligibility questionnaires: 600 respondents for Study 1B
and 200 respondents for Study 2. Additionally, recent impairment study
attrition rates ranged from 5% to 15%. These statistics were used to
estimate the maximum number of respondents requested in this new
information collection request: 65 respondents for the sober visit of
Study 1B, 35 respondents for the alcohol-dosed visit of Study 1B, and
35 respondents for Study 2.
Given respondents for Study 1B and Study 2 are a subset of the
respondents to the two online eligibility questionnaires, they are not
counted again for the total number. The total number of estimated
respondents is thus 1,350 across Study 1A, Study 1B, and Study 2 as
shown in Table 1.
Table 1--Estimated Number of Total Respondents
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Estimated
Component respondents
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Study 1A................................................ 550
Study 1B................................................ 600
Study 2................................................. 200
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Total................................................. 1,350
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Frequency: This study will be conducted one time during the three-
year period for which NHTSA is requesting approval.
Estimated Number of Responses: We estimate 2,695 total responses,
or 898 annual responses. The estimated number of responses reflects the
number of respondents anticipated at each component of this information
collection request. Estimates for the sober visit of Study 1B assume
attrition occurs only at the point of eligibility confirmation. Given
the nature of alcohol dosing and adverse events, it is challenging to
determine when a participant might withdraw or be withdrawn for the
alcohol-dosed visit of Study 1B and for Study 2. Additionally, all
participants must complete the debriefing and end of visit procedures
if they are dosed with alcohol even if they do not complete all aspects
of the study protocol. As a result, these estimates assume no attrition
throughout the visit to allow for the highest burden calculation. Table
2 shows the information collection component, the estimated number of
respondents, the frequency of response, and the total number of
responses.
Table 2--Estimated Number of Responses
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Total number
NHTSA form No. Information collection component Respondents Frequency of responses
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Study 1A
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Online Survey--Study 1A........... 550 1 550
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Recruitment and Scheduling for Study 1B & Study 2
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Eligibility Questionnaire--Study 600 1 600
1B.
Eligibility Questionnaire--Study 2 200 1 200
Appointment Reminder Confirmation 65 1 65
Process-Sober--Study 1B.
Appointment Reminder Confirmation 35 1 35
Process-Alcohol Dosed--Study 1B.
Appointment Reminder Confirmation 35 1 35
Process--Study 2.
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Study 1B Sober Visit
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Informed Consent-Sober--Study 1B.. 65 1 65
Intake & Eligibility Confirmation. 65 1 65
Combined Driving Questionnaire.... 60 1 60
Telltale Evaluation at Simulator 60 1 60
(includes form Telltale
Questions--Study 1B).
Telltale Acceptance Questionnaire-- 60 1 60
Study 1B.
Debriefing Statement--Study 1B.... 60 1 60
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Study 1B Alcohol-Dosed Visit
----------------------------------------------------------------------------------------------------------------
Informed Consent-Alcohol Dosed-- 35 1 35
Study 1B.
Intake & Eligibility Confirmation. 35 1 35
Combined Driving Questionnaire.... 35 1 35
Alcohol Dosing Procedures......... 35 1 35
Telltale Evaluation at Simulator 35 1 35
(includes form Telltale
Questions--Study 1B).
Telltale Acceptance Questionnaire-- 35 1 35
Study 1B.
Debriefing Statement--Study 1B.... 35 1 35
End of Visit Procedures (includes 35 1 35
form End of Visit Release
Agreement).
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Study 2
----------------------------------------------------------------------------------------------------------------
Informed Consent--Study 2......... 35 1 35
Intake & Eligibility Confirmation. 35 1 35
Combined Driving Questionnaire.... 35 1 35
Sober Baseline Driving Procedures. 35 1 35
Wellness Questionnaire--Study 2... 35 2 70
Alcohol Dosing Procedures......... 35 1 35
[[Page 58084]]
Telltale Evaluation Drives........ 35 3 105
Post-Drive Ratings--Study 2....... 35 3 105
Post-Drive Questionnaire.......... 35 1 35
Debriefing Statement--Study 2..... 35 1 35
End of Visit Procedures (includes 35 1 35
form End of Visit Release
Agreement).
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: The total estimated burden for
this information collection is 647 hours. The annual burden is 218
hours. Study 1A contributes approximately 46 total hours, Recruitment
and Scheduling for Study 1B & Study 2 contribute approximately 144
total hours, Study 1B sober visits contribute approximately 78 total
hours, Study 1B alcohol-dosed visits contribute approximately 168 total
hours, and Study 2 contributes approximately 212 total hours.
For the sober visit, we assume attrition occurs only at the point
of eligibility confirmation. Given the nature of alcohol dosing and
adverse events, it is challenging to determine when a participant might
withdraw or be withdrawn. Alcohol can also exacerbate simulator
sickness symptoms. Additionally, all participants must complete
Debriefing and End of Visit Procedures if they are dosed with alcohol
even if they do not complete all other procedures. As a result,
respondent numbers at an alcohol-dosed visit assume no attrition
throughout the visit to allow for the highest burden calculation.
The individual form and procedure burden contributions are outlined
in the below text and tables (Table 3-Table 9).
Online Survey--Study 1A (NHTSA Form 2092): We estimate 550
individuals will initiate a response to the survey. Respondents will
take approximately 5 minutes to complete the survey one time.
Eligibility Questionnaire--Study 1B (NHTSA Form 2086): We
estimate 600 respondents will initiate a response to the online
eligibility questionnaire one time, with 300 respondents completing the
questionnaire. Accounting for respondents that are only interested in
the sober visit (5 minutes), respondents that initiate but do not
complete the questionnaire (5 minutes) and respondents that complete
the entire questionnaire (15 minutes), this results in an average of
approximately 10 minutes for 600 respondents, with a single response
each.
Eligibility Questionnaire--Study 2 (NHTSA Form 2087): We
estimate 200 respondents will initiate a response to the online
eligibility questionnaire one time, with 100 respondents completing the
questionnaire. Accounting for respondents that initiate but do not
complete the questionnaire (5 minutes) and for respondents that
complete the entire questionnaire (15 minutes), this results in an
average of approximately 10 minutes for 200 respondents with a single
response each.
Appointment Confirmation-Sober--Study 1B (NHTSA Form
2081): We expect to schedule 65 participants for the sober visit of
Study 1B. The 65 responses will take approximately 5 minutes to read
the information one time and to respond if necessary.
Appointment Confirmation-Alcohol Dosed--Study 1B (NHTSA
Form 2080): We expect to schedule 35 participants for the alcohol-dosed
visit of Study 1B. The 35 responses will take approximately 5 minutes
to read the information one time and to respond if necessary.
Appointment Confirmation--Study 2 (NHTSA Form 2082): We
expect to schedule 35 participants for Study 2. The 35 responses will
take approximately 5 minutes to read the information one time and to
respond if necessary.
Informed Consent Document-Sober--Study 1B (NHTSA Form
2090): We expect 65 participants to complete this form prior to their
participation in the sober visit of Study 1B. Participants will take
approximately 20 minutes to complete the form one time.
Intake & Eligibility Confirmation-Sober--Study 1B--We
expect 65 participants to complete this block of procedures one time
with a duration of 15 minutes. However, only 60 participants are
expected to proceed to subsequent Study 1B sober visit procedures.
Combined Driving Questionnaire--Study 1B & Study 2 (NHTSA
Form 2083): This form is administered at both the sober and alcohol-
dosed visits of Study 1B as well as the Study 2 visit. We expect to
collect data from 130 participants across these three visit types: 60
participants for the Study 1B sober visit, 35 participants for the
Study 1B alcohol-dosed visit, and 35 participants for the Study 2
visit. The 130 participants will take approximately 5 minutes to
complete the form one time.
Telltale Evaluation at the Simulator--Study 1B:
Preparation of the miniSim and protocol training are expected to take
10 minutes and administration of the evaluation protocol (including
administration of NHTSA Form 2096) is expected to take 15 minutes. This
gives a duration of 25 minutes one time for the 60 participants in the
sober visit and the 35 participants in alcohol-dosed visit (95
participants total).
Telltale Acceptance Questionnaire--Study 1B (NHTSA Form
2095): We expect 60 participants in the sober visit and 35 participants
in the alcohol-dosed visit (95 participants total) to complete this
form. Participants will take approximately 5 minutes to complete the
form one time.
Debriefing Statement--Study 1B (NHTSA Form 2084): We
expect 60 participants in the sober visit and 35 participants in the
alcohol-dosed visit (95 participants total) to complete this form.
Participants will take approximately 5 minutes to complete the form one
time.
Informed Consent Document-Alcohol Dosed--Study 1B (NHTSA
Form 2089): We expect 35 participants to complete this form prior to
their participation in the alcohol-dosed visit of Study 1B.
Participants will take approximately 20 minutes to complete the form
one time.
Intake & Eligibility Confirmation--Study 1B Alcohol Dosed
& Study 2: We expect 35 participants from Study 1B and 35 participants
from Study 2 (70 participants total) to complete this block of
procedures one time with a duration of 25 minutes.
Alcohol Dosing Procedures--Study 1B Alcohol Dosed & Study
2: Participants receive three drinks, 10-minutes apart, over a 30-
minute period, then rest for approximately 30 minutes. We expect 35
participants from Study 1B and 35 participants from Study 2 (70
participants total) to complete this 60-minute block of procedures one
time.
[[Page 58085]]
End of Visit Procedures--Study 1B Alcohol Dosed & Study 2:
This block of procedures includes a period of monitoring the
participant for roughly 115 to 120 minutes while they sober to .03 BrAC
or less and a period of discharge procedures that take a combined 20
minutes (includes administration of the End of Visit Release Agreement,
NHTSA Form 2088). This results in a total burden of 140 minutes for
Study 1B Alcohol Dosed and 135 minutes for Study 2. We expect 35
participants in Study 1B Alcohol Dosed and 35 participants in Study 2
to complete these procedures and the End of Visit Release Agreement
form one time.
Informed Consent Document--Study 2 (NHTSA Form 2091): We
expect 35 participants to complete this form prior to their
participation in Study 2. Participants will take approximately 20
minutes to complete the form one time.
Sober Baseline Driving Procedures--Study 2: These
procedures include approximately 5 minutes of protocol training on the
miniSim driving simulator and incentive structure, a familiarization
drive of approximately 10 minutes, and a sober baseline drive of
approximately 15 minutes. We expect 35 participants to complete this
approximately 30-minute block of procedures complete one time.
Wellness Questionnaire--Study 2 (NHTSA Form 2097): We
expect 35 participants to take approximately 5 minutes to complete this
form twice for a total burden of 10 minutes.
Telltale Evaluation Drives--Study 2: We expect 35
participants to complete these three drives one time each. Participants
will take approximately 15 minutes to complete each of the three drives
for a total burden of 45 minutes.
Post-Drive Ratings--Study 2 (NHTSA Form 2094): This group
of procedures (BrAC measurement, ratings, booster drink) will take
approximately 5 minutes and occur 3 times for a total burden of 15
minutes. We expect 35 participants to complete this process one time.
Post-Drive Questionnaire--Study 2 (NHTSA Form 2093): We
expect it will take 35 participants approximately 10 minutes to
complete this form one time.
Debriefing Statement--Study 2 (NHTSA Form 2085): We expect
it will take 35 participants approximately 5 minutes to complete this
form one time.
Table 3--Burden Estimates: Study 1A
----------------------------------------------------------------------------------------------------------------
Estimated
Total/annual burden per Frequency of Total/annual
NHTSA form No. Information collection number of response response opportunity
respondents (minutes) (count) burden hours
----------------------------------------------------------------------------------------------------------------
2092.................... Online Survey--Study 550/183 5 1 46/15
1A.
----------------------------------------------------------------------------------------------------------------
Table 4--Burden Estimates: Recruitment and Scheduling for Study 1B & Study 2
----------------------------------------------------------------------------------------------------------------
Estimated
Total/annual burden per Frequency of Total/annual
NHTSA form No. Information collection number of response response opportunity
respondents (minutes) (count) burden hours
----------------------------------------------------------------------------------------------------------------
2086.................... Eligibility 600/200 10 1 100/33
Questionnaire--Study
1B.
2087.................... Eligibility 200/67 10 1 33/11
Questionnaire--Study
2.
2081.................... Appointment Reminder 65/22 5 1 5/2
Confirmation Process--
Sober--Study 1B.
2080.................... Appointment Reminder 35/12 5 1 3/1
Confirmation Process--
Alcohol Dosed--Study
1B.
2082.................... Appointment Reminder 35/12 5 1 3/1
Confirmation Process--
Study 2.
----------------------------------------------------------------------------------------------------------------
Table 5--Burden Estimates: Study 1B Sober Visit
----------------------------------------------------------------------------------------------------------------
Estimated
Total/annual burden per Frequency of Total/annual
NHTSA form No. Information collection number of response response opportunity
respondents (minutes) (count) burden hours
----------------------------------------------------------------------------------------------------------------
2090.................... Informed Consent-- 65/22 20 1 22/7
Sober--Study 1B.
Intake & Eligibility 65/22 15 1 16/6
Confirmation.
2083.................... Combined Driving 60/20 5 1 5/2
Questionnaire.
2096.................... Telltale Evaluation at 60/20 25 1 25/8
Simulator (includes
form Telltale
Questions--Study 1B).
2095.................... Telltale Acceptance 60/20 5 1 5/2
Questionnaire--Study
1B.
2084.................... Debriefing Statement-- 60/20 5 1 5/2
Study 1B.
----------------------------------------------------------------------------------------------------------------
Table 6--Burden Estimates: Study 1B Alcohol-Dosed Visit
----------------------------------------------------------------------------------------------------------------
Estimated
Total/annual burden per Frequency of Total/annual
NHTSA form No. Information collection number of response response opportunity
respondents (minutes) (count) burden hours
----------------------------------------------------------------------------------------------------------------
2089.................... Informed Consent-- 35/12 20 1 12/4
Alcohol Dosed--Study
1B.
Intake & Eligibility 35/12 25 1 15/5
Confirmation.
2083.................... Combined Driving 35/12 5 1 3/1
Questionnaire.
Alcohol Dosing 35/12 60 1 35/12
Procedures.
[[Page 58086]]
2096.................... Telltale Evaluation at 35/12 25 1 15/5
Simulator (includes
form Telltale
Questions--Study 1B).
2095.................... Telltale Acceptance 35/12 5 1 3/1
Questionnaire--Study
1B.
2084.................... Debriefing Statement-- 35/12 5 1 3/1
Study 1B.
2088.................... End of Visit 35/12 140 1 82/28
Procedures (includes
form End of Visit
Release Agreement).
----------------------------------------------------------------------------------------------------------------
Table 7--Burden Estimates: Study 2
----------------------------------------------------------------------------------------------------------------
Estimated
Total/annual burden per Frequency of Total/annual
NHTSA form No. Information collection number of response response opportunity
respondents (minutes) (count) burden hours
----------------------------------------------------------------------------------------------------------------
2091.................... Informed Consent-- 35/12 20 1 12/4
Study 2.
Intake & Eligibility 35/12 25 1 15/5
Confirmation.
2083.................... Combined Driving 35/12 5 1 3/1
Questionnaire.
Sober Baseline Driving 35/12 30 1 18/6
Procedures.
2097.................... Wellness 35/12 5 2 6/2
Questionnaire--Study
2.
Alcohol Dosing 35/12 60 1 35/12
Procedures.
Telltale Evaluation 35/12 15 3 26/9
Drives.
2094.................... Post-Drive Ratings-- 35/12 5 3 9/3
Study 2.
2093.................... Post-Drive 35/12 10 1 6/2
Questionnaire.
2085.................... Debriefing Statement-- 35/12 5 1 3/1
Study 2.
2088.................... End of Visit 35/12 135 1 79/27
Procedures (includes
form End of Visit
Release Agreement).
----------------------------------------------------------------------------------------------------------------
Table 8--Overall Burden Estimates by Stage
------------------------------------------------------------------------
Total/annual
opportunity
burden (hours)
------------------------------------------------------------------------
Study 1A.............................................. 46/15
Recruitment & Scheduling for Study 1B & Study 2....... 144/48
Study 1B--Sober Visit................................. 78/27
Study 1B--Alcohol-Dosed Visit......................... 168/57
Study 2............................................... 212/72
------------------------------------------------------------------------
Table 9--Overall Burden Estimates by Information Collection
(Alphabetical)
------------------------------------------------------------------------
Total/annual
opportunity
burden (hours)
------------------------------------------------------------------------
Alcohol Dosing Procedures for Study 1B Alcohol Dosed & 70/23
Study 2..............................................
End of Visit Procedures (includes Form 2088 End of 82/28
Visit Release Agreement) for Study 1B Alcohol Dosed..
End of Visit Procedures (includes Form 2088 End of 79/27
Visit Release Agreement) for Study 2.................
Form 2080 Appointment Reminder Confirmation Process-- 3/1
Alcohol Dosed--Study 1B..............................
Form 2081 Appointment Reminder Confirmation Process-- 5/2
Sober--Study 1B......................................
Form 2082 Appointment Reminder Confirmation Process-- 3/1
Study 2..............................................
Form 2083 Combined Driving Questionnaire--Study 1B 11/4
(both Alcohol Dosed & Sober) & Study 2...............
Form 2084 Debriefing Statement--Study 1B (both Alcohol 8/3
Dosed & Sober).......................................
Form 2085 Debriefing Statement--Study 2............... 3/1
Form 2086 Eligibility Questionnaire--Study 1B (both 100/33
Alcohol Dosed & Sober)...............................
Form 2087 Eligibility Questionnaire--Study 2.......... 33/11
Form 2089 Informed Consent--Alcohol Dosed--Study 1B... 12/4
Form 2090 Informed Consent--Sober--Study 1B........... 22/7
Form 2091 Informed Consent--Study 2................... 12/4
Form 2092 Online Survey--Study 1A..................... 46/15
Form 2093 Post-Drive Questionnaire--Study 2........... 6/2
Form 2094 Post-Drive Ratings--Study 2................. 9/3
Form 2095 Telltale Acceptance Questionnaire--Study 1B 8/3
(both Alcohol Dosed & Sober).........................
Form 2097 Wellness Questionnaire--Study 2............. 6/2
Intake and Eligibility Confirmation for Study 1B Sober 16/6
Intake and Eligibility Confirmation for Study 1B 29/10
Alcohol Dosed & Study 2..............................
[[Page 58087]]
Sober Baseline Driving Procedures for Study 2......... 18/6
Telltale Evaluation at Simulator (includes Form 2096 40/13
Telltale Questions--Study 1B) for Study 1B (both
Alcohol Dosed & Sober)...............................
Telltale Evaluation Drives for Study 2................ 26/9
-----------------
Burden of Entire ICR (Total/Annual)............... 647/218
------------------------------------------------------------------------
Estimated Total Annual Burden Cost: Respondents will not incur any
reporting or recordkeeping costs from the information collection.
Respondents will incur a one-time cost for local travel to and from
DSRI. Using the current IRS standard mileage rate of $0.70 per mile,
each respondent is expected to incur no more than $42.00 ($0.70 x 60
miles) in transportation costs. However, we estimate that the total
transportation costs will be higher for alcohol-dosed respondents, who
will not be permitted to walk, bike, or drive when leaving DSRI.
Previous impairment studies conducted at DSRI have shown that $70
compensation for transportation expenses was sufficient to limit
attrition and offset costs of third-party transportation. Therefore,
estimated burden costs associated with Study 1B sober respondents are
$2,730 ($42.00 x 65 respondents) and total costs associated with Study
1B and Study 2 alcohol-dosed respondents to be $4,900 ($70 x 70
respondents). The total costs for this information collection request
are estimated to be $7,630 ($2,730 + $4,900). The annualized cost is
thus $2,543 ($7,630 / 3, rounded).
Public Comments Invited: You are asked to comment on any aspects of
this information collection, including (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Department, including whether the information will
have practical utility; (b) the accuracy of the Department's estimate
of the burden of the proposed information collection; (c) ways to
enhance the quality, utility and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including the use of automated collection
techniques or other forms of information technology.
Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter
35, as amended; 49 CFR 1.49; and DOT Order 1351.29A.
Cem Hatipoglu,
Associate Administrator, Vehicle Safety Research.
[FR Doc. 2025-22762 Filed 12-12-25; 8:45 am]
BILLING CODE 4910-59-P