RFP_693JJ924R000021_Older Novice Driver Naturalistic Driving Study_06.24.2024.pdf

693JJ924R000021

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 81

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

H

G

F

E

D

C

B

A

SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BYCODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 253 (c) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

693JJ924RQ00000306/24/2024

X

693JJ9

National Highway Traffic Safety Adm Office of Acquisition Management 1200 New Jersey Avenue, S.E.

Washington DC 20590

1200 ES 07/24/2024

LARRY BURSEY

larry.bursey.ctr@dot.gov

X

X

X

X

X

X

X

X

X

X

X

X

X

PAGE(S)

26. NAME OF CONTRACTING OFFICER (Type or print)

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

1-2

4-20 21-22 24-27 28-34 35-40

41-50

52-63

64-76

77-81

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____0_________ calendar days (60 calendar days unless a different period is inserted

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 81

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

693JJ924R000021

(A) (B) (C) (D) (E) (F)

00001

TITLE: Older Novice Driver Naturalistic Driving Study

The purpose of this project to conduct a naturalistic driving study with younger (age 15.5-16.5) and older (age 18-20) novice drivers in the first 12 months of independent driving.

The study design and analyses shall be based on materials developed for this study under a prior project.

Older Novice Driver Naturalistic Driving Study

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

REQUEST FOR PROPOSAL (RFP)

Older Novice Driver Naturalistic Driving Study

RFP # 693JJ924R000021

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 SUPPLIES/SERVICES

a. The Contractor shall furnish the necessary qualified personnel, facilities, materials, supplies, equipment and services to perform the effort entitled: “Older Novice Driver Naturalistic Driving Study” to support the National Highway Traffic Safety Administration’s (NHTSA) in accordance with the Statement of Work, Section C, and as itemized in Section F, “Deliveries or Performance.” All support services provided to the Government shall be performed by the Contractor’s employees or personnel otherwise retained by the Contractor to fulfill specific work requirements of the resultant Contract.

b. The Government anticipates award of a Cost-Plus Fixed Fee (CPFF) Contract issued in accordance with FAR 16.306.

B.2 ESTIMATED TOTAL COST AND FEE AMOUNT

Item No.

Item Description Quantity Unit of

Measure Estimated Cost Fixed Fee

Total Estimated Cost and Fixed Fee

Older Novice Driver Naturalistic Driving Study, in accordance with the Statement of Work

60 Months $ $ $

Note: The Contracting Officer (CO) is the only individual who can legally commit or obligate the Government to the expenditure of public funds. No cost chargeable to the proposed Contract can be incurred before receipt of a fully executed Contract or specific written authorization from the Contracting Officer.

(End of Section B)

SECTION C

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 BACKGROUND

The National Highway Traffic Safety Administration (NHTSA) is an operating administration of the U.S. Department of Transportation (DOT). NHTSA’s mission is to save lives, prevent injuries, and reduce economic costs due to road traffic crashes, through education, research, safety standards, and enforcement activity.

In 2021, drivers ages 15 to 20—many of whom were novices—represented 8.4% of drivers involved in fatal crashes but only 5% of all licensed drivers.1 While young novice drivers’ crash rates have declined since States began implementing Graduated Driver Licensing (GDL) programs in the 1990s,2 motor vehicle crashes remain a leading cause of death among young people.3 As a group, novice drivers’ crash rates are highest during the initial months of licensure and decline over time.4 However, individual novices may not follow this pattern of incrementally declining risk.5 For example, when novices were grouped by longitudinal profiles (“trajectories”) of risky driving over the first 20 weeks of independent driving, some novices drove safely throughout this period while others remained at consistently high risk.6

One factor that may influence heterogeneity of risk among novice drivers is the age at which they receive licensure and begin driving independently. Crash rates are generally highest for novice drivers at first licensure and decline with experience.4 However, the declines among older novices appear to be slower than for those licensed at younger ages,7 and some evidence suggests that drivers first licensed at age 18 may have higher crash rates during their first several months of driving than drivers first licensed at ages 16 or 17.8,9

1 National Center for Statistics and Analysis. (2023, August). Young drivers: 2021 data (Traffic Safety Facts. Report No. DOT HS 813 492). National Highway Traffic Safety Administration.

https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/813492 2 McCartt, A. T., & Teoh, E. R. (2015). Tracking progress in teenage driver crash risk in the United States since the advent of graduated driver licensing programs. Journal of Safety Research, 53, 1-9.

3 Webb, C. N. (2018, February). Motor vehicle traffic crashes as a leading cause of death in the United States, 2015 (Traffic Safety Facts Crash Stats. Report No. DOT HS 812 499). National Highway Traffic Safety Administration.

https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/812499 4 E.g., Mayhew, D. R., Simpson, H. M., & Pak, A. (2003). Changes in collision rates among novice drivers during the first months of driving. Accident Analysis & Prevention, 35, 683-691.

5 Mirman, J.H., Curry, A.E., & Mirman, D. (2019). Learning to drive: A reconceptualization. Transportation Research Part F: Traffic Psychology and Behaviour, 62, 316-326.

6 Missikpode, C., Peek-Asa, C., McGehee, D. V., & Wallace, R. (2019). Classifying and predicting risky driving among novice drivers: A group-based trajectory approach. Journal of Safety Research, 68, 215-222.

7 Curry, A. E., Pfeiffer, M. R., Durbin, D. R., & Elliott, M. R. (2015a). Young driver crash rates by licensing age, driving experience, and license phase. Accident Analysis & Prevention, 80, 243-250.

8 Chapman, E. A., Masten, S. V., & Browning, K. K. (2014). Crash and traffic violation rates before and after licensure for novice California drivers subject to different driver licensing requirements. Journal of Safety Research, 50, 125–138.

9 Walshe, E. A., Romer, D., Wyner, A. J., Cheng, S., Elliott, M. R., Zhang, R., Gonzalez, A. K., Oppenheimer, N., & Winston, F. K. (2022). Licensing examination and crash outcomes post-licensure in young drivers. JAMA Network Open, 5(4), e228780.

Furthermore, while an increasing proportion of young people are delaying licensure until age 18 or older,10 few States currently apply the full GDL program to novices ages 18 to 20.11 Licensure delays are more likely among Latino, Black, and lower socioeconomic status (SES) young people,12 raising the possibility of inequities in which novices receive the benefits of GDL.

However, because little is known about the safety and driving habits of newly-licensed drivers 18 and older, questions remain about whether and how to develop GDL provisions for older novices that reduce exposure to risk while still ensuring mobility.

The heterogeneity of risk among novice drivers has also led to a call to “move beyond” population-level interventions towards interventions tailored for novices with higher levels of risk or who have already exhibited unsafe driving behaviors.13 Therefore, it is critical to understand which novice drivers are likely to begin, and to remain, at greatest risk during the first months of independent driving. Conversely, understanding which novices are likely to have persistently low risk—and whether their early independent driving experiences differ in ways that promote learning but preserve safety—can be useful for those developing recommendations and education for newly-licensed drivers. Yet, few demographic or psychological factors have emerged as significant and consistent predictors of whether novices follow high- or low-risk trajectories of unsafe driving after the transition to independent driving.6,14 Similarly, it is unknown whether the amount, type, or patterns of driving in the first months of independent driving differ, or evolve differently over time, for high- and low-risk novice drivers.

To address these questions, a prior NHTSA project (https://rosap.ntl.bts.gov/view/dot/67045) involved designing, and determining the potential challenges for conducting, a hypothetical naturalistic driving study (NDS) with younger (age 15.5 – 16.5) and older (age 18 – 20) novice drivers in the first period of independent driving. Under this project, a research team developed materials related to the design and execution of the hypothetical study, including:

• A literature review of existing research relevant to the research questions and potential methodological approaches for the hypothetical study;

• A study design and data analysis plan;

• Questionnaires to be administered at various timepoints during the hypothetical study;

• Materials required for submission to an Institutional Review Board (IRB);

• A data management plan (DMP);

• Participant consent forms;

10 Tefft, B. C., Williams, A. F., & Grabowski, J. G. (2014). Driver licensing and reasons for delaying licensure among young adults ages 18-20, United States, 2012. Injury Epidemiology, 1, 4.

11 Insurance Institute for Highway Safety. (2022, August). Graduated licensing laws by state.

https://www.iihs.org/topics/teenagers/graduated-licensing-laws-table 12 Vaca, F. E., Li, K., Tewahade, S., Fell, J. C., Haynie, D. L., Simons-Morton, B. G., & Romano, E. (2021a).

Factors contributing to delay in driving licensure among U.S. high school students and young adults. Journal of Adolescent Health, 68(1), 191 – 198.

13 Winston, F.K., Puzino, K., Romer, D. (2016). Precision prevention: Time to move beyond universal interventions.

Injury Prevention, 22, 87-91.

14 Roman, G. D., Poulter, D., Barker, E., McKenna, F. P., & Rowe, R. (2015). Novice drivers’ individual trajectories of driver behavior over the first three years of driving. Accident Analysis & Prevention, 82, 61-69.

https://www.iihs.org/topics/teenagers/graduated-licensing-laws-table

• Information Collection Request (ICR) support materials describing the study for submission to the Office of Management and Budget (OMB) to comply with the Paperwork Reduction Act (PRA);

• A draft Introduction and Methods sections for a Final Report describing the hypothetical study; and

• An assessment of potential challenges to conducting the hypothetical study, along with solutions.

The research team for this prior project found that most existing NDS of novice drivers have not included novices 18 and older. Additionally, although older novices are more likely to be Black, Latino, and lower SES,12 most prior NDS have used convenience samples that overrepresented White and higher SES novice drivers. When designing the study, the research team determined that an alternative approach was necessary to obtain more representative samples of novice drivers. Specifically, the research team devised a recruitment approach in which, along with a partnership with a State driver licensing agency, researchers could increase the likelihood of reaching a diverse group of potential participants. Additionally, the research team suggested a ‘hybrid’ approach to data collection, in which most participants would have NDS data collected via an app on their personal smartphones, while a smaller subgroup would additionally be outfitted with the kinds of in-vehicle data acquisition systems (DAS) traditionally used in NDS.

This approach removes barriers to participation associated with the installation of in-vehicle equipment, permits the recruitment of a larger number of participants, and allows researchers to examine the correspondence between NDS data obtained with smartphones versus in-vehicle equipment.

Note to Offerors: Offerors may review information related to this prior study and details about the study design and analyses in the Final Report at https://rosap.ntl.bts.gov/view/dot/67045.

Additionally, a summary of the study design and analyses is available in Section J, Attachment 6.

NHTSA will provide all the information from this prior study to the Contractor after award.

C.2 PURPOSE

The purpose of this contract is to conduct an NDS to address the following research questions:

1) Do older novices exhibit different trajectories of risky driving in the first 12 months of independent driving than younger novices?

2) Do older novice drivers differ from younger novices in the amount, type, or patterns of driving they do during the first period of independent driving? Do they differ with respect to demographic, psychological, or other individual characteristics associated with risky driving?

3) After beginning to drive independently, do most novice drivers exhibit the pattern of initially high but decreasing rates of risky driving? Or, do some groups of novice drivers follow different trajectories—e.g., consistently high or low rates of risky driving?

4) Do novice drivers who consistently engage in, or consistently refrain from, risky driving during the first period of independent driving differ in the amount, type, or patterns of https://rosap.ntl.bts.gov/view/dot/67045 driving they do during this period? Do they differ with respect to demographic, psychological, or other characteristics associated with risky driving?

5) How accurate is naturalistic driving data about novice drivers’ performance and exposure collected using a smartphone app compared to data collected with an in-vehicle DAS?

C.3 OBJECTIVE

The objective of this contract is to conduct an NDS with younger (age 15.5 – 16.5) and older (age 18 – 20) novice drivers in their first 12 months of independent driving to answer the research questions in Section C.2.

C.4 ACRONYMS

The following is a list of key acronyms used throughout the Statement of Work (SOW). This list may not be exhaustive.

ACOR Alternate Contracting Officer’s Representative CO Contracting Officer COR Contracting Officer’s Representative CS Contract Specialist DAS Data acquisition system(s) DMP Data Management Plan DOT U. S. Department of Transportation GIF Graphic Interchange Format GPO Government Printing Office ICR Information Collection Request IRB Institutional review board JPEG Joint Photographic Expert Group MOU Memorandum of Understanding NDS Naturalistic driving study NHTSA National Highway Traffic Safety Administration OMB Office of Management and Budget PIA Privacy Impact Assessment PII Personally Identifiable Information PTA Privacy Threshold Analysis

C.5 REQUIREMENTS

C.5.1 Kick-Off Meeting

Within one (1) month of award, the Contractor shall attend a Kick-Off Meeting, either virtually using teleconferencing software or at NHTSA Headquarters in Washington, DC, with the COR, CO and/or CS, and any other interested NHTSA personnel. The purpose of this meeting is to discuss the administration of the contract and the goal, objective, and anticipated challenges for the effort. The meeting will serve to identify any potential problems and their solutions to ensure successful completion of the project.

This shall also be a working meeting for the Contractor and NHTSA, allowing up to two

(2) hours for the meeting. The COR will provide the background for the project. The Contractor shall then discuss the firm’s approach for the project, the schedule of project activities, and deliverable requirements and specifications.

Prior to the meeting, the Contractor shall work with the COR to prepare appropriate briefing materials for the Kick-Off meeting. Materials for the Kick-Off Meeting shall be completed and submitted to the COR for review and approval at least one (1) week prior to the Kick-Off Meeting. The COR will send feedback to the Contractor on Kick- Off Meeting materials within three (3) days of receipt.

C.5.2 Submit Updated Study Design & Data Analysis Plan

Within one (1) week of award, the COR will send to the Contractor the materials developed for the study under a prior project (https://rosap.ntl.bts.gov/view/dot/67045).

These materials include:

• A literature review of existing research relevant to the study;

• An assessment of potential challenges to conducting the study;

• Study Design & Data Analysis Plan;

• ICR Package (including Supporting Statement Parts A and B, 60-day Federal

Register Notice, consent forms, and study questionnaires);

• IRB Package;

• Data Management Plan consistent with DOT’s Public Access Plan

(https://www.transportation.gov/mission/open/official-dot-public-access-plan-v11);

• Draft Introduction and Methods section for the Final Report;

In this task, the Contractor shall review the Study Design & Data Analysis Plan and suggest any updates or changes necessary to ensure the study is feasible and will provide data to answer the research questions in Section C.2. For any updates or changes proposed, the Contractor shall provide a justification, with reference to any documentation that supports the change.

Within three (3) months of award, the Contractor shall submit the Updated Study Design & Data Analysis Plan to the COR. The COR will provide feedback to the Contractor within two (2) weeks of receipt. The Contractor shall submit the Final Updated Study Design & Data Analysis Plan within four (4) months of award.

https://www.transportation.gov/mission/open/official-dot-public-access-plan-v11 https://www.transportation.gov/mission/open/official-dot-public-access-plan-v11

C.5.3 Submit Data Acquisition Systems Report

Within five (5) months of award, the Contractor shall submit to the COR the Data Acquisition Systems Report. In this report, the Contractor shall identify two (2) to five

(5) options for naturalistic driving data collection via smartphone app and two (2) to five

(5) options for naturalistic driving data collection via in-vehicle DAS.

Smartphone Apps

For smartphone apps, the Contractor shall only consider options that can be installed both on smartphones with Android or iOS systems. The Contractor shall consider apps that are currently available on the commercial market, freely available, or apps previously developed by the Contractor. The Contractor shall describe the benefits and drawbacks of each smartphone app option, considering factors such as:

• The kinds of data that can be acquired via the app and whether these data are sufficient to answer the research questions in Section C.2;

• The costs associated with using, acquiring, and/or storing data via the app for the study period, including any costs arising from the transfer of NDS data from participants’ smartphones to the Contractor via cellular data;

• Whether the app requires any interaction from participants, excluding initial installation and removal of app at the end of the study;

• Whether additional equipment (e.g., cell phone holder, device placed elsewhere in vehicle) can be used to communicate with the smartphone app and provide additional information about travel mode, participant role (driver vs. passenger), etc., as well as the cost of such additional equipment;

• Any available information on the reliability and/or accuracy of the performance and exposure data generated by the app (e.g., from the developer, described in peer-reviewed journal articles, etc.);

• The nature of the data generated by the app and/or received by the Contractor, including the amount of post-processing required to prepare the data for analysis and any required linkages with other data sets (e.g., OpenStreetMaps);

• The way in which the data collected impacts participants’ privacy;

• The ease with which participants will be able to download and install (and use, if necessary) the app; and

• Any other factors the Contractor believes relevant for understanding the app’s benefits and drawbacks for use in the current study.

In-Vehicle DAS

For in-vehicle DAS, the Contractor may consider DAS that are currently available on the commercial market or previously developed by the Contractor. The Contractor shall describe the benefits and drawbacks of each DAS option, considering factors such as:

• The kinds of data that can be acquired via the DAS and whether these data are sufficient to answer the research questions in Section C.2;

• The costs associated with using and/or acquiring the DAS for the study period;

• The ease with which the Contractor can install and remove the DAS, and the ease with which the DAS can be moved to a new vehicle, if necessary;

• Any burden participants are likely to perceive with having the DAS in their vehicles for the study period;

• The way in which the data collected impacts participants’ privacy;

• Any other factors the Contractor believes relevant for understanding the app’s benefits and drawbacks for use in the current study.

Within two (2) weeks of receipt, the COR will submit feedback on the Data Acquisition Systems Report and will select the smartphone app and in-vehicle DAS to be used in the study.

C.5.4 Develop Dataset Deliverables and Transfer Plan

Within seven (7) months of award, the Contractor shall submit to the COR the Dataset Deliverables and Transfer Plan. This document shall describe the datasets to be delivered to NHTSA, as well as potential approaches for accomplishing the transfer of the datasets to NHTSA.

Dataset Deliverables

In the Dataset Deliverables and Transfer Plan, the Contractor shall describe the datasets resulting from this study that will be delivered to NHTSA.

Datasets delivered to NHTSA should use machine-readable, open, non-proprietary formats when possible. The file or files must be in a format acceptable and readily available to integrate NHTSA’s data repository without having additional purchases or software or licensing requirements (for example, *.csv or *.txt). Each dataset delivered to NHTSA shall also be accompanied by documentation describing the dataset, e.g., a data dictionary or codebook, relevant meta-data, etc.

At a minimum, the Contractor shall deliver the following datasets to NHTSA:

• Raw Dataset: this dataset shall correspond to the raw data collected in the study, from the in-vehicle DAS, the smartphone app, and the questionnaires. The dataset may have minimal post-processing applied, e.g., to remove non-driver trips, to remove instances of equipment failure, to transform sensor-specific data to machine-readable formats, to time synch data from multiple sensors, etc. The raw dataset will likely contain PII, e.g., from video cameras included with the in-vehicle DAS.

• Final Report Analysis Dataset(s): this dataset(s) shall correspond to the dataset(s) used to conduct the descriptive and inferential analyses included in the Final Report (Section C.5.14) that address the research questions in Section C.2. This dataset shall be de-identified (per the Safe Harbor method, https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html) and shall be appropriate for public release. In addition to the Final Report Analysis Datasets and their associated documentation (e.g., data dictionary/codebook, meta-data, the Contractor shall also submit the following materials related to the descriptive and inferential analyses required for the Final Report (Section C.5.14):

o Programming code or syntax from statistical software used to generate the descriptive and inferential statistical analyses included in the Final Report, including sufficient information or comments for a user of that software to reproduce the main analyses.

• Information needed to generate any tables or figures included in the Final Report (Section C.5.14), e.g., the values of means and confidence intervals plotted in a figure; a series of x-y pairs plotted in a figure; this information shall be contained within a text file or spreadsheet. This information is required in case any figures and tables included in the Final Report need to be modified to ensure they are compliant with the requirements of Section 508 of the Rehabilitation Act (https://www.section508.gov/). See Section F.5.

• Additional Analysis Dataset(s): the Contractor shall propose between one (1) and three (3) additional analysis datasets to be created. These datasets shall be de-identified (per the Safe Harbor method). Data in these additional analysis datasets may be aggregated, enriched, transformed, or selected in order to make the data accessible and useful for NHTSA and other researchers to address research questions other than those described in Section C.2. For example, an additional analysis dataset could include all crash and near-crash events, along with a sample of baseline events;

data aggregated to the level of individual trips, with trip-level metrics; or a sample of distracted driving events, along with a sample of baseline events. The additional analysis datasets proposed by the Contractor shall not require extensive manual coding.

Datasets Transfer

In the Dataset Deliverables and Transfer Plan, the Contractor shall also describe potential approaches for transferring the dataset deliverables to NHTSA. Although it is not feasible to transfer the Final Report Analysis Dataset(s) and Additional Analysis Datasets to NHTSA prior to the end of data collection (Section C.5.12), the Contractor may propose to transfer the Raw Dataset to NHTSA in batches during the data collection period.

Potential transfer approaches include, for example, copying the datasets to a NHTSA-specified cloud location or copying data to a NHTSA-owned system that will then be https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html https://www.section508.gov/ physically connected to the NHTSA storage infrastructure. The plan should also describe the nature of the datasets to be transferred and the estimated size of each dataset.

Within two (2) weeks of receipt, the COR will submit feedback on the Dataset Deliverables and Transfer Plan. The COR and the Contractor will then work collaboratively with the appropriate offices within NHTSA, including the Office of the Chief Information Officer OCIO, to further develop the Dataset Deliverables and Transfer Plan, particularly the details of the transfer of the datasets to NHTSA.

Within twenty-six (26) months of award, the Contractor will submit the Final Dataset Deliverables and Transfer Plan. The Contractor shall not proceed with any proposed plan for transferring the datasets to NHTSA without approval from the COR.

C.5.5 Develop Pilot Study Plan

Within eight (8) months of award, the Contractor shall submit to the COR the Pilot Study Plan. This document shall describe the plan for conducting a pilot study with nine

(9) or fewer participants. While preferred, participants do not need to be ages 15.5 – 20 or novice drivers. Data collection during the pilot study should last for one (1) month.

The goals of the pilot study are for the Contractor to familiarize themselves with the way in which the smartphone app and in-vehicle DAS are installed and used, the kinds of data they produce, the way in which the data must be cleaned prior to analysis, and the kinds of analyses that can be performed using the data to answer the research questions in Section C.2. Participants in the pilot study shall also respond to at least one of the study questionnaires, delivered to participants in the same way as will be done in the full study.

The pilot study will also allow the Contractor to estimate the nature and size of the raw dataset that will be transferred to NHTSA at the end of the study.

The Pilot Study Plan shall also describe the way in which the Contractor will recruit pilot participants and the ways in which data from the pilot study will be used by the Contractor to verify the procedures proposed for the full study.

The COR will send feedback to the Contractor within two (2) weeks of receipt of the Pilot Study Plan.

C.5.6 Identify Potential Study Sites

Within eight (8) months of award, the Contractor shall submit to the COR the Potential Study Sites letter report. When developing this report, the Contractor shall draw upon information about potential States for study sites contained within the Final Updated Study Design & Data Analysis Plan, as well as any other information the Contractor believes is relevant to suggesting potential study sites. In the Potential Study Sites report, the Contractor shall suggest five (5) States, in order of preference, for participation as study sites.

When recommending States as potential study sites, the Contractor shall consider factors such as:

• State GDL laws, both current and pending;

• Sociodemographic characteristics of young people or novice drivers in the State, especially the degree to which those characteristics align with what is known about novice drivers ages 15.5 - 20, nationally;

• The degree to which conclusions made from data collected in that State would generalize to other State contexts;

• The volume of novice driver licensing at State licensing agency offices; and

• Any other factors the Contractor believes are relevant for selecting a study site with the highest likelihood of participating and of yielding data that can answer the research questions in Section C.2.

The COR will provide feedback to the Contractor within two (2) weeks of receipt of the Potential Study Sites, including the COR’s approval of the order in which States should be considered as potential study sites.

C.5.7 Submit Updated/Developed Study Materials

The Contractor shall review study materials developed under the prior project and suggest any updates or changes necessary, as well as develop additional materials needed.

The materials to be updated or developed include: ICR package (including Supporting Statement Parts A and B, 60-day Federal Register Notice, consent forms, and study questionnaires); IRB package for the full study; DMP; and Privacy Threshold Assessment (PTA) (Note: the PTA was not developed under the prior project.)

As described in Section C.5.2, the COR will share with the Contractor the versions of these materials developed under the prior project within one (1) week of award (along with other materials, as described in Section C.5.2). The Contractor shall ensure that the ICR and IRB Packages reflect the study as described in the Updated Study Design & Data Analysis Plan, including incorporating information about the data acquisition systems selected for use in the study and potential States for study sites. The Contractor shall also ensure that the DMP is updated and accurately reflects the study design (see https://doi.org/10.21949/1520562 for information on creating DMPs).

Finally, a Privacy Threshold Analysis (PTA) was not developed under the prior project.

The Contractor shall create the PTA as part of this task, using the template provided to the Contractor by the COR. The PTA shall address data to be collected both during the Pilot Study (Section C.5.10) and the full study (Section C.5.12).

Additionally, note that the materials developed under the prior project did not assume that the raw dataset or any datasets containing PII would be transferred to NHTSA at the end of the study (Section C.5.16). Therefore, some materials will require updates that incorporate this aspect of the study, e.g., language in consent forms or details in the https://doi.org/10.21949/1520562

DMP. The Contractor shall ensure that IRB protocols and study consent forms protect participant privacy and are consistent with Federal regulations. The Contractor shall also ensure that the study consent forms permit the transfer of data—including data containing PII—to NHTSA and permit NHTSA and other qualified researchers to use study data in the future to address new research questions.

When updating study materials, the Contractor shall recommend whether obtaining a Certificate of Confidentiality from the U.S. Department of Health and Human Services, National Institutes of Health (https://grants.nih.gov/policy/humansubjects/coc.htm) is necessary to protect participants’ privacy and will aid in recruitment.

Within eleven (11) months of award, the Contractor shall submit the following Updated/Developed Study Materials:

• ICR Package (including Supporting Statement Parts A and B, 60-day Federal Register Notice, consent forms, and study questionnaires);

• IRB Package for the full study;

• DMP; and

• PTA.

The COR will provide feedback to the Contractor within two (2) weeks of receipt. The Contractor shall submit the Final Study Materials within twelve (12) months of award.

More information about obtaining IRB approval, preparing a PTA, and preparing an OMB Information Collection Request (ICR) is described below.

IRB Approval, Privacy Threshold/Impact Assessments, and OMB Clearance

NHTSA requires IRB approval, a Privacy Threshold Assessment (PTA), and PRA clearance through an approved OMB Information Collection Request (ICR) for this project. A Privacy Impact Assessment (PIA) may be required if deemed necessary through the PTA process. The Contractor will be responsible for preparing draft versions of the IRB applications (both for the Pilot Study and the full study), the PTA (which shall describe data collected during both the Pilot Study and the full study), and the ICR package. The Contractor shall also be responsible for submitting the IRB applications (see Sections C.5.8 and C.5.11). The COR will be responsible for submitting the PTA (and if needed, will prepare and submit a PIA) and ICR, with Contractor support.

Data collection for the Pilot Study may not begin until approval has been received from an IRB (see Section C.5.8) and until the COR notifies the Contractor that the PTA and/or PIA have been adjudicated and approved. Data collection for the full study (see Section C.5.12) may not begin until all three approvals (IRB, PTA and/or PIA, and ICR) have been received.

https://grants.nih.gov/policy/humansubjects/coc.htm

IRB Approval

The Contractor shall prepare and implement all activities necessary for the review of data collection methods by an Institutional Review Board (IRB). The Contractor shall use their own IRB or a certified IRB that is registered and covered by an approved assurance of compliance under the Department of Health and Human Services, Office for Human Research Protections. Offerors should include costs for this process in their budgets.

All consent forms required for the Pilot Study and the full study must be approved by NHTSA’s Office of the Chief Counsel prior to submission of the IRB application. A copy of the official IRB approvals shall be submitted to the COR upon receipt of approval from the IRB.

Privacy Threshold and Impact Assessments (PTA and PIA)

Federal law and statutes require that any new information collection be reviewed to ensure that privacy issues are addressed and that appropriate protections are put in place to protect all personally identifiable information (PII). Prior to data collection for the full study, a Privacy Threshold Assessment (PTA) and possibly a Privacy Impact Assessment (PIA) must be completed by NHTSA’s Office of the Chief Information Officer and the Office of the Secretary of Transportation (OST) to ensure that any PII collected for the project is necessary information and to review project protocols for protecting PII to ensure that they are appropriate and sufficient.

The Contractor will prepare the PTA for this project, which shall describe the data to be collected both during the Pilot Study and the full study. Once the COR has submitted the PTA, the Contractor shall work with NHTSA staff and assist the COR in the completion of the PTA, and PIA if needed, and any follow-up on the submission that may be required.

When updating study materials, the Contractor shall recommend whether obtaining a Certificate of Confidentiality from the U.S. Department of Health and Human Services, National Institutes of Health (https://grants.nih.gov/policy/humansubjects/coc.htm) is necessary to protect participants’ privacy and will aid in recruitment.

Paperwork Reduction Act Clearance

The Paperwork Reduction Act (PRA) requires a Federal agency to obtain clearance from the Office of Management and Budget (OMB) when it performs an information collection the Contactor shall be familiar with the PRA15 and ensure that all data collection conforms to the OMB guidelines. OMB clearance shall be required for conducting the full study in this project. The Contractor shall work with NHTSA staff to develop the Federal Register notices and the ICR for OMB approval. The COR will be

15 https://pra.digital.gov/ https://grants.nih.gov/policy/humansubjects/coc.htm responsible for submitting the ICR package for approval. Obtaining approval is a lengthy process.

Offerors should note that this Statement of Work assumes that OMB approval will be obtained thirteen (13) months after the Contractor has submitted the ICR package to the

COR.

C.5.8 Obtain IRB Approval for Pilot Study

The Contractor shall obtain approval for conducting the Pilot Study from an IRB prior to beginning recruitment of participants for the pilot study. The Contractor shall use their own IRB or a certified IRB that is registered and covered by an approved assurance of compliance under the Department of Health and Human Services, Office for Human Research Protections. While the IRB package for the full study was developed under the prior project, the IRB package for the pilot study was not. Therefore, as part of this task, the Contractor shall prepare a Draft IRB Package for the Pilot Study; however, it is anticipated that the IRB package for the Pilot Study will contain much of the same information as the IRB package for the full study.

Within thirteen (13) months of award, the Contractor shall submit to the COR a Draft IRB Package for the Pilot Study. The COR will provide feedback within two (2) weeks of receipt. Once the COR approves the Package, the Contractor is responsible for submitting the materials to the selected IRB and responding to any revisions necessary to obtain IRB approval. The COR will be available to assist in answering questions from the IRB.

Within fifteen (15) months of award, the Contractor shall have received IRB approval from the selected IRB and submit to the COR electronic copies of the approved IRB Package for the Pilot Study.

C.5.9 Finalize Study Site

Upon receipt of the COR’s approval of the Potential Study Sites letter report (Section C.5.6), the Contractor shall work with the COR to begin reaching out to potential States (and specifically, State licensing agencies) to serve as study sites. Before beginning communication with State officials, however, the Contractor shall wait for approval from the COR. The COR shall be available to assist with identifying and contacting State officials and to meet with State officials to discuss the State and State licensing agency’s involvement in the study.

Within twenty (20) months of award, the Contractor shall finalize the State (and State licensing agency) to serve as the site for the full study.

C.5.10 Conduct Pilot Study

Upon receipt of IRB approval, the Contractor shall begin conducting the pilot study as described in the Pilot Study Plan (Section C.5.5) with nine (9) or fewer participants.

Within twenty (20) months of award, the Contractor shall submit to the COR the Pilot Study Results letter report. This report shall describe the results of the pilot study, any challenges encountered during the pilot study, and any changes the Contractor recommends to the full study based on the pilot study results and/or challenges. The report shall also describe the nature and size of the raw data collected during the pilot study, to help develop an estimate of the nature and size of the raw dataset that will be produced by the full study. The COR will provide feedback on the Pilot Study Results letter report within two (2) weeks of receipt.

C.5.11 Obtain IRB Approval for Full Study

Upon receipt of clearance from OMB, the Contractor shall make any changes requested by OMB and/or as a result of findings from the Pilot Study to the Updated Study Design & Data Analysis Plan, the IRB Package, and to any other study materials to which OMB requested a change.

Then, the Contractor shall obtain approval for conducting the full study from an IRB prior to beginning recruitment of participants. The Contractor shall use their own IRB or a certified IRB that is registered and covered by an approved assurance of compliance under the Department of Health and Human Services, Office for Human Research Protections. The Contractor is responsible for submitting the IRB Package for the full study to the selected IRB and responding to any revisions necessary to obtain IRB approval. The COR will be available to assist in answering questions from the IRB.

Additionally, if the Contractor recommended obtaining a Certificate of Confidentiality for the study, with COR approval, the Contractor shall submit the appropriate documentation to the NIH in order to obtain the Certificate of Confidentiality (https://public.era.nih.gov/commonsplus/public/coc/request/init.era).

Within twenty-six (26) months of award, the Contractor shall have received approval from the selected IRB and submit to the COR electronic copies of the approved IRB Package for the full study. Additionally, if approved by the COR, the Contractor shall have received a Certification of Confidentiality from the NIH and submit to the COR electronic copies of the approved Certification of Confidentiality for the study.

C.5.12 Conduct Full Study

Upon receipt of clearance from OMB and approval from the IRB, the Contractor shall conduct the full study. Within forty-four (44) months of award, the Contractor shall complete data collection for the full study.

https://public.era.nih.gov/commonsplus/public/coc/request/init.era

For each month in which data is collected, the Contractor shall include in their Monthly Progress Reports (Section F.4.1) information about recruitment efforts, the status of data collection, including the number of participants recruited that month, the retention of previously recruited participants, the number of participants who completed data collection that month, progress towards recruitment for various groups (e.g., older vs.

younger novices; novices with different sociodemographic characteristics), and any other issues related to data collection (e.g., technical issues, barriers to recruitment, etc.)

C.5.13 Submit Data Analysis Report

Within fifty (50) months of award, the Contractor shall submit the Data Analysis Report. In this letter report, the Contractor shall summarize the results of descriptive and inferential analyses conducted using the data collected in Section C.5.12. The intent of this report is to provide the COR an opportunity to review the study’s results, offer feedback, and suggest any needed changes to ensure that the analyses address the research questions in Section C.2, prior to the Contractor submitting the Final Report.

The COR will provide feedback on the Data Analysis Report within 2 weeks of receipt.

C.5.14 Submit Draft Final Report

Within fifty-three (53) months of award, the Contractor shall submit the Draft Final Report. In preparing the Draft Final Report, the Contractor shall draw upon material developed in the prior project, namely, the Draft Introduction and Methods sections, making changes as necessary to reflect the current study design.

The Draft Final Report shall include the following sections:

• Executive Summary

• Introduction

• Methods

• Results

• Discussion

• References

• Appendices (if any)

The Draft Final Report shall adhere to standards detailed in the Publication Manual of the American Psychological Association (APA), 7th edition. According to the APA manual, “plagiarism is the act of presenting the words, ideas, or images of another as your own”

(p. 254); the manual also notes that plagiarism can be “deliberate or unintentional” (p.

254). The Contractor must ensure that the Draft Final Report is original and free from any form of plagiarism.16 The Contractor must represent and warrant that the research work, 16 See also: APA. (2021). 7th Edition Avoiding Plagiarism Guide. https://apastyle.apa.org/instructional-aids/avoiding-plagiarism.pdf https://apastyle.apa.org/instructional-aids/avoiding-plagiarism.pdf https://apastyle.apa.org/instructional-aids/avoiding-plagiarism.pdf including all written content, analyses, and findings, is original and does not infringe upon the intellectual property rights of any third party.

The Contractor shall ensure that the Draft Final Report is written using the NHTSA report template, which the COR will provide to the Contractor at award.

In the Discussion section, the Contractor shall clearly describe how the results inform the research questions listed in Section C.2. The Contractor shall also include in the Discussion any limitations of the study. Finally, the Contractor shall also include in the Discussion information about the way in which the study’s results can be translated to practice—particularly the implications of the results for State GDL programs and older novice drivers, and for driver education and training.

The COR will provide feedback on the Draft Final Report within three (3) weeks of receipt. Within fifty-five (55) months, the Contractor shall make the required revisions and submit to the COR the Revised Draft Final Report.

C.5.15 Final Briefing Meeting

Within fifty-six (56) months of award, the Contractor shall conduct collaboratively with the COR a Final Briefing Meeting, either virtually using teleconferencing software or in-person at NHTSA Headquarters in Washington, DC. The Final Briefing shall consist of a 30 – 45-minute presentation of the project given by the Contractor that includes the background and motivation for the project, the study’s design and hypotheses, the study’s results, and a discussion of the study’s results, particularly targeted at implications for novice driver safety research and program development. The Contractor’s presentation shall be followed by a question-and-answer period. During the presentation, the Contractor shall present relevant methodological, statistical, and technical information in an accurate way that is also understandable to those without research backgrounds, as both researchers and non-researchers are likely to be in attendance.

The Contractor shall submit Materials (e.g., a PowerPoint presentation) for the Final Briefing Meeting to the COR for review and approval at least one (1) week prior to the Final Briefing Meeting. The COR (TO) will send feedback to the Contractor on Final Briefing Meeting materials within three (3) days of receipt.

C.5.16 Transfer Datasets and Other Materials

Within fifty-eight (58) months of award, the Contractor shall transfer to NHTSA the datasets, data dictionaries/codebooks, meta-data, and any other materials described in the Final Dataset…