693JJ925RQ000382 Draft SOW Final.pdf

National Child Restraint Use Special Study (NCRUSS) II Statement of Work (Draft)

SECTION C - Description, Specifications, Work Statement

C.1 Acronyms

CPST Child Passenger Safety Technician CO Contracting Officer COR(TO) Contracting Officer’s Representative (Task Order) CS Contract Specialist DMP Data Management Plan U.S. DOT U.S. Department of Transportation FMVSS Federal Motor Vehicle Safety Standard ICR Information Collection Request IRB Institutional Review Board LATCH Lower Anchors and Tethers for Children NCRUSS National Child Restraint Use Special Study NCSA National Center for Statistics and Analysis NHTSA National Highway Traffic Safety Administration NOPUS National Occupant Protection Use Survey NSUBS National Survey of the Use of Booster Seats PSU Primary Sampling Unit OCIO Office of the Chief Information Officer OMB Office of Management and Budget PIA Privacy Impact Assessment PII Personally Identifiable Information PTA Privacy Threshold Assessment QA/QC Quality Assurance/Quality Control SOW Statement of Work

C.2 Background

Child restraint systems are any device that meets the FMVSS prescribed by NHTSA, including child safety seats, booster seats used in conjunction with seatbelts, or harnesses that are designed for use in motor vehicles to restrain, seat, or position a child. Child safety seats reduce fatal injury by 71% for infants under 1 year old and by 54% for toddlers 1 to 4 years old (NCSA, 2024). NHTSA conducted the NCRUSS in 2011 to observe the use of car seats and booster seats for child passengers from birth to 8 years old. The 2011 NCRUSS also examined whether the levels of use and/or misuse were related to any specific characteristics of the drivers, their passengers, and/or their vehicles. The data collected by the NCRUSS was used to evaluate the effectiveness of FMVSS No. 225 and FMVSS No. 213. The 2011 NCRUSS sample was a nationally representative sample and data was collected across 24 PSUs located in 17 States (see Greenwell [2015]1 for detailed sampling methodology). PSUs included cities, counties, or groups of adjacent counties, and urban, rural, and suburban environments.

Findings from the 2011 NCRUSS indicated that 94% of children were restrained in car seats or booster seats, 4% were restrained in seat belts, and 2% were unrestrained. However, the NCRUSS estimated overall misuse of car seats and booster seats to be 46%, with misuse estimates of 61% for forward-facing car seats, 49% for rear-facing car seats, 44% for rear-facing convertible car seats, 24% for backless booster seats, and 16% for highback booster seats.

Furthermore, NCRUSS data on lower anchor connectors and tether strap installations (LATCH installations) revealed that rear-facing car seats and forward-facing car seats equipped with lower anchor connectors in seating positions equipped with lower anchors were more likely installed with lower anchor connectors (87% for rear-facing and 48% for forward-facing) than seat belts (22% for rear-facing and 27% for forward-facing). More detailed findings are provided in the Greenwell (2015)1 and Raymond et al. (20172, 20183,4) NCRUSS reports.

Since the 2011 NCRUSS, updated and new literature, research, and standards related to child restraint systems and use of child restraint systems have occurred. NHTSA plans to reconduct the NCRUSS to examine the current state of use of car seats and booster seats for child passengers from birth through 12 years old, and the perceptions of drivers about child restraint systems. The methods originally used in the 2011 NCRUSS (see Barron et al., 20165; Greenwell, 20151), including large-scale survey, interview, and observations, will be evaluated for appropriateness and relevancy, and will be refreshed accordingly. A panel of subject matter experts on child restraint systems will be convened to determine use and misuse of child restraint systems and necessary updates to the NCRUSS methodology and analyses. The panel will also develop categories of misuse (e.g., minor to major issues). The sample size will be expanded to allow for testing of research questions related to subpopulations. Drivers will be interviewed about their knowledge and perceptions of child restraint systems. Interviews will include demographic information on occupants, the driver’s knowledge about the specific child restraint

1 Greenwell, N. K. (2015, May). Results of the national child restraint use special study (Report No. DOT HS 812 142). National Highway Traffic Safety Administration.

https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/812142 2 Raymond, P., Searcy, S., Findley, D., Miller, S., & Redden, C. (2017, October). Additional analysis of the National Child Restraint Use Special Study (Report No. DOT HS 812 462). National Highway Traffic Safety Administration.

https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/812462-additional_analysis_national_child_restraint_use_special_study_ncruss.pdf 3 Raymond, P., Searcy, S., Miller, S., & Redden, C. (2018, March). Additional analysis of National Child Restraint Use Special Study: Characteristics of those not restrained (Report No. DOT HS 812 477). National Highway Traffic Safety Administration. https://rosap.ntl.bts.gov/view/dot/35963 4 Raymond, P., Searcy, S., & Findley, D. (2018, July). Additional analysis of National Child Restraint Use Special Study: Child restraint misuse (Traffic Safety Facts Research Note. Report No. DOT HS 812 527). National Highway Traffic Safety Administration. https://rosap.ntl.bts.gov/view/dot/38686 5 Barron, P., Doyle, C., & Radja, G. (2016, April). 2011 National Child Restraint Usage Special Study user’s coding manual (Report No. DOT HS 812 254). National Highway Traffic Safety Administration.

https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/812254 https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/812142 https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/812462-additional_analysis_national_child_restraint_use_special_study_ncruss.pdf https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/812462-additional_analysis_national_child_restraint_use_special_study_ncruss.pdf https://rosap.ntl.bts.gov/view/dot/35963 https://rosap.ntl.bts.gov/view/dot/38686 https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/812254 system in their vehicle, and the driver’s general knowledge and experience with restraint systems. Interviews will also include questions about potential barriers caregivers and drivers have experienced related to child restraint systems. Observational data on correct and incorrect use of child restraint systems in passenger vehicles will be collected. CPSTs will observe the child restraint systems available and in use in vehicles. Information collected will include the type of restraint that is used, the type of installation, how the child restraint system is installed, and seat belt fit, as necessary.

NHTSA requires contractor support to conduct a large-scale survey that observes and measures the level of child restraint use and misuse in passenger vehicles. The study will also identify current gaps in data related to child restraint use and misuse and collect new data needed to evaluate and update child restraint system use and misuse information. This effort will also require database support (e.g., development and updates to the application used for entry and for quality control of survey data, documentation and training for this application, preparation of the data file and datasets), data analysis, and report preparation of the data collected in the NCRUSS.

C.3 Objective

The primary objective of this task order is to measure the level of child restraint system use and misuse for children riding in passenger vehicles. The project will answer the following questions:

1) What is the overall level of child restraint system use and misuse?

2) What are the rates of use and misuse for the different child restraint system types?

3) What are the observed rates of use and misuse of the specific sub-components, such as

LATCH?

4) What are the specific types and frequencies of misuse, and how can these misuses be categorized?

5) Is the appropriate child safety seat for a child’s age, weight, and height being used?

6) Is use and misuse of child restraint systems associated with any specific characteristics of the drivers, their passengers, and/or their vehicles?

7) What is the association between driver attitudes, knowledge, and awareness of child passenger safety and use and misuse of child restraint systems?

8) Where do drivers obtain information about child restraint system installation (e.g., vehicle manufacturers, safety seat manufacturers, doctor’s offices) and is the source of information related to child restraint system use or misuse?

9) What are the key opportunities for countermeasure development and deployment?

10) What are the differences between the NCRUSS conducted in 2011 and the current

NCRUSS?

C.4 Scope

During this study, the Contractor shall develop and refine survey instruments based on the NCRUSS instrument used in 2011, to further NHTSA’s understanding of use and misuse of child restraint systems. The Contractor shall convene a panel of subject matter experts on child restraint systems to determine definitions for use and misuse and the necessary refinement of the survey methods and instruments. This task also requires the administration of surveys and interviews to, and observations of, drivers with children in child restraint systems.

Furthermore, it requires analyses of the collected survey, interview, and observational data, data management of collected data, a final report describing the background, methods, and results, and a journal article.

C.5 Specific Requirements

The Contractor shall perform the tasks specified below. All deliverables shall be delivered following the Milestones and Deliverables schedule (Section F). For the performance of this contract, the Contractor shall use the methods (e.g., sampling, data collection, data file support, estimation, editing, or other survey procedures) that the Contractor documents in their approved work plan.

The sample of observation sites used shall be expanded from the previous 2011 NCRUSS. The Contractor shall prepare sampling estimates to determine necessary sample size. The Contractor shall convene a panel of experts on child restraint systems use; prepare data collection instruments and materials for data collectors and field supervisors; hire and train data collectors and field supervisors; recruit subjects; collect the survey, interview, and observational data;

quality check and edit the survey, interview, and observational data; create data files of the survey, interview, and observational data; conduct analyses to produce survey, interview, and observational estimates; conduct analyses to test the research questions of this project; and prepare the final report and journal article for the project. The Contractor shall provide detailed descriptions of the sampling methods; recruitment strategies; survey and interview questions;

observational coding methods; data collection software; data collection training; data file development and management; data processing and quality control; final database and data file;

analyses of the collected data; table of estimates; coding manual; and a final report and presentation, in accordance with the Deliverables and Milestones Schedule specified in the task order.

To perform the task, the Contractor shall consider the following:

Target population

All drivers with child passengers (estimated age birth – 12 years) in passenger vehicles on the road during the survey field period in the U.S., including all 50 States and the District of Columbia.

Major estimates Child restraint use and misuse

Previous year conducted 2011

Related projects

The NHTSA 2011 NCRUSS, including the 2015 analyses, 2016 coding manual, and 2017 and 2018 additional analyses of the

NCRUSS.

The NHTSA NOPUS and NSUBS, including the redesign of the NOPUS and NSUBS.

Data collection sites Sites across the United States where large numbers of children travel in passenger vehicles.

Means of data collection

Observation of vehicles entering the collection sites and interviews of drivers recorded on tablets using specially designed software.

The primary purpose of the NCRUSS is to estimate child restraint use in passenger vehicles. In addition, the survey provides detailed information on use and misuse of child restraint systems, demographics of all occupants in a vehicle, and drivers’ attitudes, awareness, and knowledge about use of child restraint systems.

The data are obtained by sending trained data collectors to a probability sample of sites most productive for observing large numbers of children traveling in passenger vehicles such as fast-food restaurants, gas stations, recreation centers, libraries, “big box” stores/chains/retail stores for child products, and day care centers. Data collectors observe use of child restraints systems and restraint types, and obtain information on children’s demographic information, weight, and height, and drivers’ attitudes, awareness, and knowledge about child restraint systems by interviewing the driver. The Contractor shall collect all data on electronic devices (e.g., tablet computers). The Contractor is responsible for providing tablet devices for this survey. Collected data are then downloaded to the Contractor’s central data storage computer, where statistical editing, estimation, and variance estimation procedures are applied to produce estimates and margins of error, and to test whether seasonal changes in rates are significantly different from zero.

The Contractor shall conduct all meeting, sampling, training, recruiting, survey, interview, and observation preparation, data collection, and data analysis activities, and shall prepare a final written report, subject to revision according to the Government’s comments. The Contractor shall make a final presentation to the Government, if requested by the CO.

C.5.1 Kick-Off Meeting

Within four (4) weeks from the task start date, key members of the Contractor’s staff shall participate in a kick-off meeting with the NHTSA COR(TO), CO, and other interested NHTSA staff. The purposes of the kick-off meeting shall be to:

• Review contractual matters, including the terms and conditions of the task;

• Review the SOW, milestones, and deliverables to ensure a common understanding of the objectives;

• Discuss project objectives and the administration of the task; and,

• Address questions from any party.

The Contractor shall be prepared with appropriate briefing materials. PowerPoint slides and other supplementary materials should be submitted to the COR(TO) at least one (1) week prior to the meeting for approval by the COR(TO). Within four (4) days of receipt, the COR(TO) shall provide comments to the Contractor on the briefing materials. The Contractor shall provide revisions to the COR(TO) within two (2) days. At the discretion of the Government, the kick-off meeting shall take place via web conference. The kick-off meeting shall be no more than two (2) hours in duration.

C.5.2 Final Technical Work Plan

The Contractor shall submit a final technical work plan (including the QA/QC plan, sampling methodology, and DMP) two (2) weeks after the kick-off meeting. The technical work plan shall explain the methods used in performing the work of this task for the panel of experts meeting(s), data collection, estimation, editing, other survey procedures, or quality control procedures. The technical work plan shall also include a plan for conducting the Pilot Study. The final technical work plan shall be based on the Contractor’s original and final technical proposals submitted in response to NHTSA’s solicitation, and discussions and agreements reached at the kick-off meeting with the COR(TO) and other NHTSA personnel. All methodologies and analyses used shall be based on statistically sound principles and approved by the COR(TO). The observation sites visited, data items collected, and estimates produced shall be informed by historical NCRUSS content. The COR(TO) will provide historical content as needed. The site visitation schedules shall be determined by the Contractor in a statistically sound manner that reduces the variance of the season-to-season change estimates.

The Contractor shall submit and discuss its QA/QC plan at the kick-off meeting. The QA/QC plan shall be incorporated in the Contractor’s technical work plan. The Contractor shall have a QA/QC program in place throughout the life of the project. To ensure quality while performing work under the task, the Contractor’s QA/QC plan shall, at a minimum:

• Establish a committee or internal team for more serious problems, consisting of the Contractor’s internal management and other representatives from specific relevant groups. The committee shall work to develop solutions for identified problems, disseminating the information to users in a timely manner.

• Perform quality checks, i.e., look for extraneous or otherwise errant data, during all data collection, data editing, and data production.

• Perform unannounced site visits to monitor quality of data collection in the PSUs.

• Identify in the proposal the person responsible for the QA/QC program.

The Contractor shall provide the COR(TO) with the proposed sampling method. The sampling method shall be incorporated in the Contractor’s technical proposal. The proposed sampling method will include descriptions of the estimated sample size, the power analysis used to estimate the sample size, the methodology in identifying PSUs, the sampling sites, data collection schedule, vehicle sampling, and any anticipated and necessary adjustments to sampling (e.g., sampling weights). The Contractor shall provide the COR(TO) with recruitment materials that will be used in recruiting participants.

The Contractor shall include a draft DMP with the final technical work plan. Research projects involving data collection conducted for the U.S. DOT are required to comply with the

Department’s Public Access Plan including development and approval of a DMP. The DMP describes how researchers will handle digital data both during and after a research project. The DMP should be a 2- or 3-page narrative description (no more than 5 pages) covering five key topics: a description of the data; the standards used; access policies; re-use, redistribution, and derivative products policies; and archiving and preservation plans. Once approved by the COR(TO), the DMP will be provided to the National Transportation Library for final approval.

The U.S. DOT’s Public Access Plan and additional information on preparing a DMP, including examples, may be found at https://ntl.bts.gov/ntl/public-access/creating-data-management-plans-extramural-research.

Within four (4) weeks after the kick-off meeting, the COR(TO) will review and approve the technical work plan or provide comments, if necessary. If comments are provided, the Contractor shall provide a revised final technical work plan (including the QA/QC plan and DMP) within one (1) week of receipt of COR(TO) comments. The final work plan shall contain a complete list of project milestones and deliverables. Other than planning, the Contractor shall not perform work on subsequent requirements, prior to COR(TO) approval of the final technical work plan.

The COR(TO) will contact the Contractor with comments or required revisions if additional revisions are necessary for deliverable acceptable within two (2) weeks after receipt. The Contractor shall make revisions if required.

C.5.3 Table Shell of Estimates

The Contractor shall provide the COR(TO) with the table shells of estimates within nine (9) weeks from the Task start date. These table shells of estimates shall describe what estimates the Contractor will compute based on the collected data. The types of estimates to be computed will be determined at the kick-off meeting, and mutually agreed to by the Contractor and the COR(TO). The table shells of estimates shall be submitted in Microsoft Excel format. The COR(TO) will approve the table shells of estimates or request edits within two (2) weeks of receipt. The Contractor shall generate the final table shells of estimates within one (1) week of receiving the COR(TO)’s feedback.

C.5.4 Panel of Subject Matter Experts

The Contractor shall submit a list of child passenger safety subject matter experts to invite to the panel meeting within nine (9) weeks from the Task start date. The panel should include subject matter experts on child restraint systems, child passenger safety, survey methodology, and statistics. The panel shall include at least one (1) certified CPST. The list of proposed stakeholders shall include each subject matter expert’s:

a) Organization

b) Name

c) Phone number and email address

d) Qualifications, including a brief description (2-3 sentences) of why this subject matter expert should be included https://ntl.bts.gov/ntl/public-access/creating-data-management-plans-extramural-research https://ntl.bts.gov/ntl/public-access/creating-data-management-plans-extramural-research

The Contractor shall submit and discuss the plans for the panel of subject matter experts within nine (9) weeks from Task start date. The general plan for the meeting shall include a draft timeline, whether an in-person meeting or videoconferencing will be used (or both), a draft of questions to be asked or a framework for the meeting, a draft letter/email to be sent to invitees, and a draft plan for how information from the meeting will be recorded for use in: (1) evaluating the original 2011 NCRUSS methodology, analyses, and results to determine necessary updates to the study methods, study instruments, and analyses; (2) defining and developing categories of misuse of child restraint systems (e.g., minor to major issues); and (3) providing solutions to measuring and analyzing the categories developed.

Within two (2) weeks of receiving the list and draft plan, the COR(TO) will approve a final list of potential subject matter experts to be contacted, the letter/email to be sent to the invitees, the framework for the meeting, and the plan for collecting information from the meeting. Note that the expert panel meeting shall include no more than 9 external participants.

The Contractor shall include in the plan to review and update the forms listed below with the panel of subject matter experts. These forms can be viewed at https://www.reginfo.gov/public/do/PRAICList?ref_nbr=201008-2127-002. The Contractor shall update the forms to include children 12 years of age and under.

a) The Daily Site Form-Tallies (NHTSA Form 1105) is for collecting information regarding the number of vehicles with children 9 years of age and under that enter the site, as well as the number of children 9 years and under in these vehicles. The purpose of this form is to collection information for non-response bias adjustments.

b) The Interview Form-Vehicle (NHTSA Form 1106) is for collecting the drivers’ knowledge about different restraint systems, whether LATCH is available in the vehicle, and from what sources the drivers obtained information regarding child safety seats.

c) The Interview Form-Children by SP (seating position) (NHTSA Form 1107) is for collecting demographic information (e.g., birth date or age, sex, height, weight) on the vehicle’s occupants who are 12 years of age and under, regardless of the seating position and type of restraint use. In addition, the driver’s relationship to the child will be collected.

d) The Interview Form-Restraints by SP (NHTSA Form 1108) is for collecting information regarding the driver’s general knowledge about and experience with restraints in the vehicle, as well as the driver’s knowledge about one specific CRS in the vehicle. In addition, demographic information about the driver will be collected.

e) The Observation Form-Non-Response (NHTSA Form 1109) is for recording data when a vehicle is approached in order to obtain cooperation of the driver. The field researchers shall observe and collect data on the vehicle and its occupants for use in later adjustments for non-response bias. This data is to be collected whether or not the driver agrees to participate in the study.

f) The Inspection Form-Restraints by SP (NHTSA Form 1110) shall be used by the observer to record their observations about one specific CRS in the vehicle, including the type of restraint that is used, the type of installation (seat belt or LATCH), how the CRS is installed (e.g., if secure, direction, angle), harness use (where applicable), and seat belt fit (for children in boosters or seat belts).

https://www.reginfo.gov/public/do/PRAICList?ref_nbr=201008-2127-002

g) The Inspection Form-Vehicle Restraints (NHTSA Form 1111) shall be used by the observers to record their observations of the location and number of seating positions that are available in the vehicle, the location and number of seating positions that are in use in the vehicle, the type of restraint that is available in each seating position, and the type of restraint that is in use in each seating position.

Within twenty (20) weeks from Task start date, the Contractor shall hold the panel of subject matter experts meeting(s). The Contractor shall provide a report of the findings and actionable updates to the NCRUSS methodology, analyses, and results from the panel meeting(s) to the COR(TO) within twenty-eight (28) weeks from Task start date. The Contractor shall include any additional data collection forms that were revealed in the findings from the panel of subject matter experts in this report. Within two (2) weeks of receiving the report of the findings and actionable updates from the panel meetings, the COR(TO) will review and provide feedback.

The Contractor shall revise the study methods, study instruments, and analyses based on COR(TO) feedback within two (2) weeks.

The Contractor shall provide the COR(TO) with draft electronic copies and screenshots of the refined data collection forms in the data collection software for approval within thirty-four (34) weeks from the task start date. The electronic copies and screenshots shall demonstrate what data will be collected and how the data will be collected. The Contractor shall also indicate what information technology (IT) support will be used. Within two (2) weeks after receiving the electronic copies and draft screen shots from the Contractor, the COR(TO) will approve the electronic copies and draft screenshots or request edits. Within two (2) weeks after receiving COR(TO) feedback, the Contractor shall incorporate the feedback into the data collection materials and training materials.

C.5.5 Prepare Information Collection Support for Regulatory Requirements

Paperwork Reduction Act

OMB implements the Paperwork Reduction Act through regulations governing Federal information collections. The Contactor shall be familiar with OMB’s Questions and Answers When Designing Surveys for Information Collections6 and ensure that all data collection conforms to the OMB regulations, see 5 CFR Part 1320. Federal agencies are required to obtain OMB approval for certain data collections. The initial step in the approval process is to publish a Notice in the Federal Register that notifies the public about the planned information collection and provides sixty (60) days for the public to offer comments. The complete ICR submitted to OMB includes Supporting Statements A and B, as well as all forms and questionnaires that would be used in the Main Data Collection.

6 See website:

https://obamawhitehouse.archives.gov/sites/default/files/omb/inforeg/pmc_survey_guidance_2006.pdf

No later than fifty (50) weeks after award, the Contractor shall submit a draft ICR 60-Day Notice, Supporting Statements A and B, and any forms participants will complete or that will be used for recruitment, including the Informed Consent Form, the interview questions, and survey questions. Information related to the information collection review process can be located here:

https://pra.digital.gov/clearance-process/#issue-a-60-dayrequest- for-comment-in-the-federal-register.

No later than two (2) weeks after receipt, the COR(TO) will either approve the OMB submission, or will contact the contractor for revisions.

No later than two (2) weeks after receiving the COR(TO)’s comments, the Contractor shall address the COR(TO)’s comments and submit the revised OMB ICR package. Revision submission and feedback shall continue until the documents are ready for submission.

No later than sixty (60) weeks after award, the Contractor shall submit a revised OMB ICR package (not including the 30-day notice) to the COR(TO). Note: for the purpose of developing technical and cost proposals, Offerors shall assume that receiving OMB approval of the final, submitted ICR will take at least fourteen (14) months.

Privacy

Federal law and U.S. DOT policy requires that any new information collection be reviewed to assess privacy risk and ensure compliance with privacy requirements when appropriate to protect PII.10 Prior to data collection, a PTA and, possibly, a PIA must be completed by NHTSA’s OCIO and approved by 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 may have to modify an existing PIA if deemed necessary through the PTA process.

No later than fifty (50) weeks after award, the Contractor shall submit the PTA package.

The NHTSA Privacy Officer will review the PTA. Once review is complete, comments will be provided to the Contractor via the COR(TO) within one (1) week of receipt of review.

No later than one (1) week of receipt of comments, the Contractor in conjunction with the COR(TO) shall address the NHTSA Privacy Officer’s comments.

The Contractor shall ensure that all data collected remain strictly confidential and shall not respond to public inquiries regarding the data without the expressed written permission of the CO. All public requests for information under this Task Order shall be forwarded to the COR(TO) immediately.

https://pra.digital.gov/clearance-process/#issue-a-60-dayrequest-%20for-comment-in-the-federal-register https://pra.digital.gov/clearance-process/#issue-a-60-dayrequest-%20for-comment-in-the-federal-register

C.5.6 IRB Approval

The Contractor shall obtain approval for conducting the research from an IRB prior to beginning the recruitment of study participants. The Contractor shall use its 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.

No later than fifty-four (54) weeks after award, the Contractor shall submit a draft IRB package to the COR(TO).

No later than two (2) weeks after receipt, the COR(TO) will provide feedback and the Contractor shall make any revisions necessary to the IRB package until it is accepted. Once the COR(TO) 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(TO) will be available to assist in answering questions from the IRB.

No later than sixty-two (62) weeks after award, the Contractor shall have received IRB approval from the selected IRB (proposed by the Contractor) and submit to the COR(TO) electronic copies of the approved IRB Package, including all materials submitted to the IRB, and the Approval Letter.

C.5.7 Conduct Pilot Study

No later than sixty-six (66) weeks after award, (must occur after IRB approval), the Contractor shall conduct a Pilot Study to test the effectiveness of the different aspects of the design and provide a letter report to the COR(TO) of the results of the Pilot Study and proposed changes to the protocol. The Pilot Study does not have to be the same length of time as the Main Data Collection. The Pilot Study shall include nine (9) or fewer participants.

No later than two (2) weeks of receipt, the COR(TO) will provide feedback on the report and whether changes should be made to the design or other aspects of the Main Data Collection.

C.5.8 Update ICR Materials for Submission to OMB based on Pilot Study

No later than seventy (70) weeks after award, based on the findings of the Pilot Study and the COR(TO)’s feedback, the Contractor shall update the OMB ICR Materials to accommodate any necessary changes (if needed), submitting these materials to the COR(TO).

C.5.9 Draft Final Report

Within seventy-six (76) weeks from the task start date, the Contractor shall prepare a Draft of the Final Report in consultation with the COR(TO). These shall include a complete introduction and method section and outlines for the remaining sections of the report. This report shall be formatted and comply with the publication manual of the American Psychological Association (APA) 7th Edition style manual, in line with the NHTSA Level 3 report template and Style

Guide, and shall be Section 508 compliant (see Section F.5). The report shall include but is not limited to the following topics: data items collected, survey protocols utilized, summary of training materials, summary of data collection activities, summary of quality control procedures, treatment of unknowns, estimates produced, major survey results, and any Contractor recommendations for the improvement of future surveys. The report shall not exceed sixty (60) pages long, single-spaced, (excluding appendices) and shall include the following sections:

• Introduction

• Method

• Results

• Discussion

• Conclusions

• References

• Appendices

Within three (3) weeks after receiving the Draft of the Final Report, the COR(TO) will provide feedback and comments from the Government. Within two (2) weeks of receiving the COR(TO)’s comments, the Contractor shall submit a Revised Draft Final Report after making the necessary edits to address the COR(TO)’s comments.

C.5.10 Data Entry File Development

No later than eighty-four (84) weeks after award, the Contractor shall create data entry software so that data can be entered by field data collectors into the database. The software created will support a web-based application. Ideally, data collected during the study will be placed in its own scheme within the database. Forms will be needed for the following seven (7) survey forms (Note: new forms may be included, and the following seven [7] forms may be revised/updated based on findings from panel of subject matter experts):

a) Observation Forms

1. Daily Site Form-Tallies (site information, as well as counts of vehicle with child passengers and of child passengers)

2. Non-Response (Observations for non-response adjustments)

b) Inspection Forms

1. Restraints (CRS hardware and installation practices observed for one specific

CRS)

2. Vehicle Restraints (SPs and restraints observed to be available and in-use in the vehicle)

c) Interview Forms

1. Vehicle (Drivers general knowledge of restraints and vehicle)

2. Children by SP (Demographic information for children under 12 years of age)

3. Restraints (Drivers’ knowledge about one specific CRS being used; demographic information about the driver)

The Contractor will create a database into which NCRUSS data can be deposited. This data will include:

a) 7 survey forms mentioned above

b) Placard photo(s) of child restraint

c) Any new forms identified/developed by the panel of experts.

The Contractor will monitor the proper operation of the database system.

The Contractor shall use machine-readable, open, non-proprietary formats for data capture, unless the format is not available to capture the data. The file or files must be in a format acceptable and readily available to integrate into NHTSA’s data repository without having additional purchases or software or licensing requirements (for example, *.csv or *.txt).

C.5.11 Develop Dataset Deliverables and Transfer Plan

Within eighty-four (84) weeks of task start date, the Contractor shall prepare a draft of the Dataset Deliverables and Transfer Plan. 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) to NHTSA prior to the end of data collection, the Contractor may propose to transfer the Raw Dataset(s) 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 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.

The COR(TO) will submit feedback on the Dataset Deliverables and Transfer Plan within two

(2) weeks after receipt. The COR(TO) and the Contractor will then work collaboratively with the appropriate offices within NHTSA, including the OCIO (OCIO), to further develop the Dataset Deliverables and Transfer Plan, particularly the details of the transfer of the datasets to NHTSA.

No later than eighty-eight (88) weeks after 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(TO).

C.5.12 Hiring and Training Staff

The Contractor shall be responsible for hiring and training staff. The Contractor shall ensure that each data collection team shall include at least one Spanish-speaking staff member at sites where there is a substantial native Spanish speaking population. The Contractor will be responsible for translating any data collection materials (e.g., interviews and survey forms) into Spanish. Each data collection team shall include a child seat inspector (CPST).

The Contractor shall provide the COR(TO) with electronic copies of the training materials within two (2) weeks from OMB approval. These materials shall reflect the course of instruction given to all data collection personnel. It shall include the quality control efforts during the data collection, data monitoring, and data production. The Contractor shall specify the number of the field staff and their qualifications, including but not limited to, the approach in hiring and strategic planning.

Within eight (8) weeks from OMB approval, the Contractor shall hire and provide training to data collectors and data collection monitors to enable them to properly identify vehicles and people in the population of interest at the specified data collection sites. The training shall enable data collectors to properly identify child restraint types and associated adult restraint use. The training shall also be designed to assist the data collectors with techniques to maximize the response rate of the survey. The Contractor shall inform the COR(TO) of any changes or improvements in the training, including the logistics before, during, and after training.

C.5.13 Data Collection

Within twelve (12) weeks after OMB approval, the Contractor shall begin data collection. The Contractor shall notify the COR(TO) when data collection has begun and when it has concluded.

The Contractor shall also provide a complete list of problems encountered during data collection (to include, but not limited to: how the data collection process flow worked, how the quality control activities performed, etc.), along with the remedial action(s) taken to resolve the issue(s).

The data collection shall conclude within 1 year of the commencement of data collection. The Contractor shall provide a letter report to the COR of the results (the Contractor may use the letter report as a first draft of the Results section of the final report) within six (6) weeks from the end of data collection. The COR(TO) will submit feedback on the letter report within three (3) weeks after receipt.

Data Collection Process

The Contractor shall use tablet devices to collect data on individual drivers, their child passengers, and their vehicles. Any vehicles inadvertently surveyed more than once will be identifiable based on the VIN recorded on the Vehicle Inspection Form, and information from the subsequent interview(s) will only be used for quality control purposes (e.g., checking data supplied, filling in missing demographic data) and will not be entered into the data entry system.

Observations should take approximately fifteen (15) minutes for all forms. One data collector (the interviewer) shall garner cooperation from the participant, and collect data on the interview forms. The second data collector (the CPST) shall collect data on the observation forms. The third data collector (the counter) shall count the number of passenger vehicles with children entering the sites and the number of children riding in these vehicles. The data collectors will review all survey, interview, and observational materials for data entry accuracy and errors. At the conclusion of each observation, the driver will be given a Courtesy Card which contains child passenger safety tips and locations of local child seat check sites, as well as other educational information.

Data Collection Materials and Equipment

The Contractor shall provide data collectors with tablet devices, hand-outs for the participants, large signs with information about the survey, identification badges, the procedures manual, and miscellaneous items needed to obtain and record data such as clip boards, watches, measuring tapes, and digital cameras at each site.

Data Processing/Quality Control

In cases where electronic data collection via tablet devices was not possible, field personnel will code any data collected on-site that was not coded electronically on-site upon return to the office.

There will be one additional week after data collection is completed in order to finish all coding of data and other work needed to complete data collection activities.

The Contractor shall ensure that the data entry software contains automated edit checks, skip patterns, and other features to help ensure that data was entered correctly. The data entry system must include specific rights to users so that data changes may only be completed by field personnel (i.e., PSUs and Zone Centers), and will only be viewable by NHTSA personnel. Case ownership rules will apply such that when a case is “owned” by the PSU, the zone center may not change case data until the case is marked as complete. The data entry software should provide the user the ability to access a case by a case id as well as appropriate filters to locate cases by PSU, date of observation, and/or other fields used to identify a case.

For this project, the data file database will need to be enhanced in order to allow consistency (i.e., edit) checks for the NCRUSS. Cases should be able to be grouped based upon the date of data collection. The Contractor shall conduct regular checks of the data elements to identify outliers, discrepancies between two similar variables, and other inconsistencies via automated logic checks and data runs. These data elements will be flagged, reviewed, and corrected, if necessary.

C.5.14 Revised Final Report

Within forty (40) weeks after the end of data collection, the Contractor shall submit a Revised Draft of the Final Report that is formatted and complies with the 7th Edition of the Publication Manual of the APA , in line with the NHTSA Level 3 report template and Style Guide, and shall be Section 508 compliant (see Section F.5). The report shall not exceed sixty (60) pages long, single-spaced, (excluding references and appendices) and shall include the following sections:

• Introduction

• Method

• Results

• Discussion

• Conclusions

• References

• Appendices

The COR(TO) will provide the Contractor with comments within three (3) weeks of receipt. The Contractor shall submit a Revised Draft Final Report after making necessary edits to address the COR(TO)’s comments within two (2) weeks of receipt.

C.5.15 Submit Table Estimates, Datasets, and Analytical User’s Manual

Within twenty (20) weeks after the end of data collection, the Contractor shall use the collected data to compute estimates based on the table shell of estimates, and deliver them to the COR(TO). The Contractor shall also deliver the datasets, and Analytical User’s Manual to the COR(TO). As noted previously, the Contractor shall use machine-readable, open, non-proprietary formats for data capture, unless the format is not available to capture the data. The file or files must be in a format acceptable and readily available to integrate into 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.).

The datasets shall contain actual observed data sufficient for the Government and public data users to compute all estimates published in the tables of estimates as well as custom estimates.

The datasets shall be accompanied by an Analytical User’s Manual that provides guidance in using the datasets. This Analytical User’s Manual shall describe the structure of the datasets including a description of the files, unique identifiers, file merging instructions, and how to concatenate files. The Analytical User’s Manual shall include the data collection forms and a data dictionary that describes the variables and each of the attribute codes of the datasets. Part of the manual shall also provide instructions and sample analyses programs that show how data users can calculate the published estimates and their associated standard errors.

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

• Raw Dataset(s): this dataset(s) shall correspond to the raw data collected in the study.

The dataset may have minimal post-processing applied including removing any PII.

• Final Reports Analysis Dataset(s): this dataset(s) shall correspond to the dataset(s) used to conduct the descriptive and inferential analyses included in the Final Reports that address the research questions in Section C.3. This dataset(s) shall be de-identified (per the Safe Harbor method, https://www.hhs.gov/hipaa/forprofessionals/privacy/special-topics/de-identification/index.html) and shall be appropriate for public release. In addition to the Final Reports 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 Reports:

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

o Information needed to generate any tables or figures included in the Final Reports (Section C.5.17), 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 Reports 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.

C.5.16 Final Briefing

The Contractor shall prepare and present a final briefing to NHTSA staff. The Contractor shall submit the briefing materials to the COR(TO) in an electronic form within forty-three (43) weeks from end of data collection. Within two (2) weeks after receipt, the COR(TO) will provide comments to the Contractor. This presentation will be due within forty-eight (48) weeks from the end of data collection. The Contractor shall develop and conduct collaboratively with the COR(TO) the final briefing virtually. This virtual briefing shall consist of a 20-30 minute presentation of the studies that includes the background on the project, the methodology for the studies, the results of data analyses for the studies, and a discussion, followed by a question and answer period for the studies.

C.5.17 Final Report for Agency Review

Within fifty (50) weeks after the end of data collection, the Contractor shall submit the Final Report, (incorporating comments from the final briefing and any other comments received) to begin NHTSA’s Agency Review process. The COR(TO) shall be listed as an author if the COR(TO) contributes significantly to the writing and/or design of the project.

The COR(TO) will process the report through NHTSA’s formal review and approval process.

Once the report has gone through the formal NHTSA review process, the COR(TO) will return interim comments to the Contractor. The Contractor shall make final revisions to the report based on the comments received and then submit the finalized report for publication to the COR(TO). The final report shall be completed and finalized for publishing within sixty-two (62) weeks after the end of data collection.

C.5.18 Journal Article

Within sixty-two (62) weeks from end of data collection, the Contractor shall submit one (1) draft journal article to the COR(TO). The Contractor shall ensure the article is ready to be published in a peer-reviewed journal. The COR(TO) and Contractor may collaborate on the manuscript. The COR(TO) shall be listed as an author if the COR(TO) contributes significantly to the writing and/or design of the project.

C.5.19 Biweekly Status Report Meetings

Starting two (2) weeks after the Kick-off Meeting, members of the Contractor’s staff shall conduct a status report meeting once every two (2) weeks with NHTSA’s COR(TO)…