Draft SOW - (693JJ922RQ000378) National Roadside Surve.pdf

SECTION C – DESCRIPTION/ SPECIFICATIONS/ WORK STATEMENT

National Roadside Survey

C.1 BACKGROUND

The National Highway Traffic Safety Administration (NHTSA) is an agency of the U.S. Department of Transportation (DOT). NHTSA’s mission is to save lives, prevent injuries and reduce traffic-related health care and other economic costs. The agency develops, promotes and implements effective educational, engineering and enforcement programs with the goal of ending preventable tragedies and reducing economic costs associated with vehicle use and highway travel. This contract addresses the problem of impaired driving.

A major component of addressing the impaired driving crash risk question is determining the incidence of drivers on the road with positive blood alcohol concentrations (BACs) and/or who have measurable amounts of drugs in their system. Previous research (see below) has been conducted on the incidence of impaired drivers on the road. This research project will provide current data on the incidence of alcohol-positive, and drug-positive, drivers through a national roadside survey. The methodology will largely follow from the most recent surveys but will strive for more representative samples of drivers. NHTSA is dedicated to conducting research in an equitable manner, including research topics, and through data collection and analyses. In this study, NHTSA will obtain data from road users other than drivers at our data collection locations. It will also pilot test a methodology for conducting a roadside survey without drivers, focused on other road users as participants.

Five “national roadside surveys” have previously been conducted (1973, 1 1986, 2, 1996,3 2007,4 and 2013-20145) to obtain data on this issue. In these surveys, drivers were randomly selected to

1 Wolfe, A. (1974) 1973 US National Roadside Breath Testing Survey: Procedures and Results. University of Michigan Safety Research Institute.

2 Lund, A.K. and Wolfe, A.C. (1991) Changes in the Incidence of Alcohol-Impaired Driving in the United States, 1973-1986. Journal of Studies on Alcohol, 52.

3 Voas, B.; Wells, J.; Lestina, D.; Williams, A.; and Green, M. (1998) Drinking and Driving in the United States: The 1996 National Roadside Survey. Accident Analysis and Prevention, Vol. 30 (2), pp 267-275.

4 Lacey, J., Kelley-Baker, T., Furr-Holden, D., Voas, R., Moore, C., Brainard, K., Tippetts, A., Romano, E., Torres, P., and Berning, A. (2009a). 2007 National Roadside Survey of Alcohol and Drug Use by Drivers: Methodology (DOT HS 811 237). National Highway Traffic Safety Administration; and Lacey, J., Kelley-Baker, T., Furr-Holden, D., Voas, R., Romano, E., Torres, P., Tippetts, A., Ramirez, A., Brainard, K, and Berning, A. (2009b). 2007 National Roadside Survey of Alcohol and Drug Use by Drivers: Alcohol Results (DOT HS 811 248). National Highway Traffic Safety Administration; and Lacey, J., Kelley-Baker, T., Furr- Holden, D., Voas, R., Romano, E., Ramirez, A., Brainard, K., Moore, C., Torres, P., and Berning, A. (2009c). 2007 National Roadside Survey of Alcohol and Drug Use by Drivers: Drug Results (DOT HS 811 249). National Highway Traffic Safety Administration.

5 Kelley-Baker, T., Lacey, J. H., Berning, A., Ramirez, A., Moore, C., Brainard, K., … Pell, K. (2016). 2013-2014 National Roadside Study of alcohol and drug use by drivers: Methodology (DOT HS 812 294). National Highway Traffic Safety Administration; Ramirez, A, Berning, A., Kelley-Baker, T., Lacey, J. H., Yao, J., Tippetts, A. S., … & Compton, R. (2016). 2013–2014 National Roadside Study of Alcohol and Drug Use by Drivers: Alcohol Results (DOT HS 812 from weekend night (and Friday day starting in the 2007 survey) traffic on representative roadways across the 48 contiguous United States to voluntarily participate. In the first three surveys, once the driver pulled into the research area, they were asked to provide a breath sample and to answer a few questions regarding drinking and driving behavior and the current trip. In the 2007 survey, for the first time, drivers were also asked to provide an oral fluid and a blood sample, and to answer questions on drug use.

As noted in NHTSA’s Research Note on the 2013-2014 survey,6 the surveys reveal a decreasing trend in alcohol use from the first survey in 1973 to the most recent one in 2013– 2014. Figure 1 shows the percentage of weekend nighttime drivers with BAC as measured by breath (BrACs) across three categories: BrAC of .005 to .049 g/210dL;7 BrACs of .050 to .079; and BrACs of .080 and higher. The surveys found a decline in each BrAC category. Further, there was a large decrease in the percentage of drivers who were alcohol positive, from 35.9% in 1973 to 8.3% in 2013–2014. For BrACs of .08 and higher, there was a decrease from 7.5% in 1973 to 1.5% in 2013–2014, revealing an impressive 80% reduction in the percentage of alcohol-impaired drivers on the road on weekend nights. Also of importance is the decrease from 6.1% to 1.6% from 1973 to 2013–2014 for BrACs of .050 to .079 category.

Figure 1. Percentage of Weekend Nighttime Drivers by BrAC Category in the Five National Roadside Surveys

The 2013-2014 survey also found (Figure 2) 12.1% of drivers were positive for the presence of an illegal drug (separate from over-the-counter and prescription medications). It yielded important information on drug prevalence across drug category, time periods, and provided initial trend data compared to the 2007’s survey’s results.

Figure 2 Drug Prevalence by Data Collection Period, Drug Category, and Type of Drug Test in

362). National Highway Traffic Safety Administration; Kelley-Baker, T., Berning, A., Ramirez, A., Lacey, J. H., Carr, K., Waehrer, G., Compton, R. (2017). 2013-2014 National Roadside Study of alcohol and drug use by drivers: Drug results (DOT HS 812 411). Washington, DC: National Highway Traffic Safety Administration.

6 Berning, A., Compton, R., & Wochinger, K. (2015). Results of the 2013–2014 National Roadside Survey of alcohol and drug use by drivers. (Traffic Safety Facts Research Note. DOT HS 812 118). National Highway Traffic Safety Administration.

7 g/210 dL is grams per 210 liters of breath. In 2021, the illegal limit in all States is .08., except for Utah where it is .05.

However, from 1973 to 2004 States had BAC limits ranging from .08 to .15.

the 2013-2014 National Roadside Survey

Drug Category

Oral Fluid Test

Blood Test

Oral Fluid and/or

N % N % N % Weekday Daytime

Any Illegal Drug5 189 10.6% 137 11.3% 221 12.1% Only Medications6 (prescription and over-the-counter) 197 8.4% 128 10.3% 234 10.3%

Weekend Nighttime Any Illegal Drug 783 13.9% 423 14.3% 852 15.2% Only Medications (prescription and over-the-counter) 317 5.9% 216 6.9% 391 7.3%

There is considerable interest in obtaining current data and it is time to conduct another roadside survey, planned for data collection in 2024. This survey is needed to better determine the extent of alcohol-impaired and drugged driving and to develop and allocate appropriate countermeasures. It is also appropriate to increase the equity of the survey throughout our survey methodology and analyses and to also gather information on road users other than drivers.

C.2 OBJECTIVES

The objectives of this contract are to perform alcohol- and drugged driving research. At a minimum, the contract covers the topics below.

• A national roadside survey in 2024 to estimate the prevalence of the following on the nation’s roads. The methodology will be based on sampling drivers but the contractor shall include convenience sampling of other road users who are readily available at data collection locations. The contractor shall determine:

o drivers and other road users at various BACs (blood alcohol concentrations), o drivers and other road users with the presence of various (over-the-counter, prescription, and illegal) drugs, in their system, and o drivers and other road users with alcohol and other drugs in their system.

• A pilot test of a methodology, including a sampling strategy, and protocol for a survey of pedestrians, bicyclists, electric scooter riders, and those with assistive aids.8 This pilot test will not include drivers.

• Optional Task: Conduct additional research with subjects obtained from the base research effort. This research could include obtaining data on attitudes and awareness of traffic safety issues, human subjects testing and/or validation studies with newly developed behavioral test batteries or technology.

8 Such as wheelchairs or mobility scooters.

C.3 GENERAL REQUIREMENTS

For the national roadside survey, the contractor shall obtain data on alcohol and drug use of drivers and other road users through breath samples and oral fluid samples. Each subject will be asked several questions regarding their general road use behavior, alcohol use, drinking and driving behavior, drug use, and drugged driving behavior.

As with the past roadside surveys, roadside survey effort will focus on drivers. New for this survey, NHTSA is interested in obtaining data from other road users also already at the locations, such as pedestrians, bicyclists, electric scooter riders, and others using assistive aids. The survey is voluntary and anonymous. Although there may be some variations, in general the contractor shall plan on using the protocol from the 2013-2014 survey, as described in NHTSA’s methodology report. Data shall be collected from drivers and others in a representative selection of sites across the contiguous United States, beginning in spring 2024. To compare data to past studies, at a minimum, sampling will occur on Friday and Saturday late-nights, and Friday days.

The contractor shall obtain an oral fluid sample from a minimum of 8,000 drivers, with additional samples from the convenience sampling of other road users. The specimens shall be tested for selected over-the counter, prescription, and illegal drugs.

The contractor shall ensure that all aspects of the study, including but not limited to, site selection, coordination with local officials, scheduling and travel, data collector training, sampling methods, data collection, specimen handling, specimen analysis, data analysis, and report(s) preparation are conducted smoothly, efficiently, and on schedule.

For the separate pilot test of methodology and protocol for a survey of pedestrians, bicyclists, electric scooter riders, and those using assistive aids, the contractor shall obtain data on alcohol and drug use through breath samples and oral fluid samples. Whereas in the roadside survey requirement presented above (which will now include convenience sampling only for other road users) at the locations selected for drivers, this pilot test is focused on other road users and will not include drivers. The methodology and protocol shall be based on these subjects. Site and location selection will be based on areas with high transit use by these road users, and questions be focused on transportation via walking, biking, scootering, and use of assistive aids. NHTSA is interested in learning whether a large-scale roadside survey of non-driver road users is feasible for the future. This will provide NHTSA and partners in traffic safety with valuable information as to needed sampling methodology, specific protocol revisions, or issues that need to be considered.

NHTSA may award an optional task to conduct additional research with subjects participating in the surveys, including drivers and other road users. This research could include obtaining data on attitudes and awareness of traffic safety issues, human subjects testing and/or validation studies with newly developed behavioral test batteries or technology. Having a cadre of subjects “on hand” who have just volunteered to participate in research efforts allows NHTSA to include them in additional research NHTSA is conducting. For example, NHTSA may have a behavioral test battery which has only undergone lab development. Our access to subjects who have already demonstrated a wiliness to participate in research, and for which we will also have alcohol and blood tests results, provides an opportunity to consolidate research. NHTSA can also expand our subject pool to include a much wider opportunity for participation. Other potential areas of interest are testing new technology, for example to detect alcohol or drug presence through breath, oral fluid or via skin; examine occupant protection and child safety seat use; or to ask additional survey questions on other traffic safety topics.

C.4 SPECIFIC REQUIREMENTS

C.4.1 Task 1: Attend Kick-Off Meeting Within three weeks of contract award, the Contracting Officer’s Representative (COR) will conduct a kick-off meeting. This meeting will be to brief NHTSA and partners on the objectives of this project, and to present the contractor’s approach for the methodology. The contractor shall assist the COR in developing briefing materials for the meeting based on their proposed approach, and will cover parts of the presentation designated by the COR.

The contractor shall also meet with a smaller set of NHTSA representatives to discuss the project’s objectives, methodology, issues, milestones, and deliverables. The contractor shall allow a half-day day for these meetings. For budgeting purposes, the contractor shall plan on this being a video meeting.

One week before the meeting, the contractor shall provide the COR with meeting materials. The COR will review these and submit needed revisions to the contractor.

C.4.2 Task 2: Examine Methodological Issues

In this task the contractor shall discuss in a letter report the broad methodological approaches of the previous five national roadside surveys, most notably the 2013-2014 survey, and consider which components worked well, and whether any components could be restructured or otherwise improved. NHTSA’s goal is to have a scientifically-sound methodology for this project, which yields the most critical information and reduces error size. The contractor shall balance the need for statistical power and increased knowledge, with practical issues and costs. Discussions between NHTSA and the contractor during this task will guide the contractor’s work when developing the data collection and analysis plan. The contractor shall submit a letter report within 2 months of award. The COR will provide comments to the contractor. After approval, the contractor shall incorporate the decisions into the Data Collection and Analysis Plan in Task 3.

Overall, the methodology must answer the Research Questions below. The contractor is encouraged to propose additional questions:

• What is the prevalence of alcohol-positive drivers on the road?

• What is the distribution of BACs of drivers on the road?

o What percentage of drivers have a BAC of .05, .08, and higher?

• What is the prevalence of selected over-the-counter, prescription, and illegal drugs in the system of drivers on the road?

• What percentage of drivers are both alcohol-positive and drug-positive?

o What percentage of .05 and .08 and higher BAC drivers are also drug-positive?

• What information is available on drivers who decline to participate in the interview and to provide breath and/or oral fluid (e.g., what are the demographics of these drivers, is there information on alcohol or drug use)? This question addresses non-response bias.

• How do the results of the 2013 Roadside Survey compare to those of the 1973, 1986, 1996, 2007, and 2013-2014 surveys?

As NHTSA is using this research to learn about other road users as well, the methodology must answer these research questions:

• What protocol components are needed for obtaining participation from pedestrians, bicyclists, electric scooter riders, and those using assistive aids?

• What is the prevalence of alcohol in these road users?

• What is the distribution of BACs of these road users?

o What percentage of road users have a BAC of .05, .08, and higher?

• What is the prevalence of selected over-the-counter, prescription, and illegal drugs in the systems of these road users? What percentage of these road users are both alcohol-positive and drug-positive?

o What percentage of .05 and .08 and higher BAC drivers are also drug-positive?

• What information is available on road users who decline to participate in the interview and to provide breath and/or oral fluid (e.g., what are the demographics of these drivers, is there information on alcohol or drug use)? This question addresses non-response bias.

• What is the relative additional cost for obtaining information from non-drivers? Once a site and locations are selected and a team is readied for a survey of drivers, how many more team members (and training, etc.) is required for the same team to also obtain information from the other road users?

In addition, looking at the drivers and non-drivers together:

• What is the prevalence of all alcohol-positive road users?

• What is the distribution of BACs of all road users?

o What percentage of all road users have a BAC of .05, .08, and higher?

• What is the prevalence of selected over-the-counter, prescription, and illegal drugs in the system of all road users?

• What percentage of road users are both alcohol-positive and drug-positive?

To address these questions, the contractor shall discuss these methodological topics:

SELECTION AND NUMBER OF SITES

The national roadside survey requires a sample of sites representing the contiguous United States.

Past surveys have been based on Primary Sampling Units (PSUs) following the structure of NHTSA’s National Automotive Sampling System (NASS7).9 PSUs are cities, large counties, or groups of counties from within four regions of the country and three levels of population density;

the NASS relies on data on police crash reports. Each survey has to a large extent followed the sampling plans of previous surveys (and allowed for replacement sites if necessary). Although not all the same sites participate in each survey, the resulting data allows for analyses of trends across time. NHTSA wants to ensure this continuity of sampling for comparability across years; however, NHTSA is interested if there is a strategy with site selection, or with weighting, to increase the reach of sites to achieve equity in data collection across the country.

The 2013-2014 (and 2007) surveys used 60 sites; this was to increase the representativeness of the sample over earlier surveys, which used 24 sites. The larger number of sites allows increased representativeness but presents logistical challenges. For example, key challenges in the most

9 The NASS is a nationally representative probability sample selected from all police-reported crashes. The sample is obtained from approximately 400 police jurisdictions in 60 sites across the United States.

recent surveys were gaining the support of local law enforcement agencies in each of the 60 sites, and travel logistics (e.g., multiple teams available the same weekends, and scheduling around extreme weather times) for those sites. Although NHTSA has previously used 60 sites for this survey, offerors may propose with justification an alternate number that will achieve the overall objectives of the project, and without losing the ability to have trend data.

SAMPLE SIZE

The objective in the 2013-2014 survey was to obtain a bodily fluid sample from at least 8,000 drivers. Researchers obtained 7,881 oral fluid samples. A few subjects who did not provide oral fluid did provide a blood sample – as such the desired sample was reached.

NHTSA is envisioning a sample for this survey as robust as the previous surveys. The contractor shall discuss the statistical power required to achieve analysis goals and address the research questions. An increased sample size could strengthen statistical power, but again an increase in sample size has cost implications. Alternatively, although a reduction in sample size might reduce the statistical power, other methodological improvements in the study’s design might strengthen the overall study. Offerors may propose and justify an appropriate sample size that fits with the best overall methodology.

All previous roadside surveys have had excellent participation rates. NHTSA anticipates reduced rates in this survey due to some people’s concern about participating in research and lingering impact of the COVID public health emergency. The contractor shall detail strategies to optimize participation rates and address the need to protect the data collectors and the public.

As data collection teams are at locations, this survey will also include recruitment of road users other than drivers who are at these locations and are “readily available” to approach and request to participate. These road users will be a convenience sample. NHTSA is not envisioning random sampling of any of these road users but rather “making use of potential subjects as they pass the data collection activity.” That is, as a pedestrian, bicyclist, electronic scooter user, or user of an assistive aid passes the data collection, a data collector shall engage them and inquire if they would be interested in participating. If yes, applicable information would be requested, such as the breath and oral fluid sample. To the extent a data collector is available, these road users would be approached. These subjects would also be eligible for other components of the study.

DATA COLLECTION DAYS/TIME

Prior to 2007, the national roadside surveys collected data from 10:00 pm – 12:00 midnight on Fridays and Saturdays, and 1:00 a.m. – 3:00 a.m. on Saturdays and Sundays (basically late nights on Friday and Saturdays). In 2007, as data on drug use was being collected, data collection was expanded to include a weekday. Due to the logistics of sending a research team to sites, the only cost-effective approach was to add Friday days (rather than any other week day). To increase the representativeness of this approach, two different time frames on Fridays were used, some sites had 9:30 a.m. - 11:30 a.m. data collection, and others had 1:30 p.m. - 3:30 p.m. data collections. While this approach worked well, it would be beneficial to know if other week days are different from Friday days – in that maybe Friday day survey results (in terms of alcohol or drug use) were closer to weekend results than a week day. Again, the question is whether adding an additional day (beyond Friday) of data collection will yield significantly more information to justify the additional costs when the primary objective is to determine the prevalence of drug (and alcohol) use of drivers on the road.

If recommended by the contractor, it shall justify consideration of additional day(s) of data collection. For budgeting purposes, offerors shall bid on the data collection periods used in 2013-2014.

NUMBER AND TYPES OF SURVEY QUESTIONS

Prior to the 2007 survey, participants were only asked a few questions – the survey was very short and the intention was to mainly request a breath sample. As such, this allowed the research team to collect data from a large number of subjects in a relatively short time. In the most recent surveys, additional information on demographics, alcohol use and abuse, interaction with the criminal justice system, and drug use and abuse was obtained. While all the information was worthwhile, it significantly increased the time to complete a survey. The contractor shall consider if any of the questions from the 2013-2014 survey should be omitted.

It may be appropriate to frame the current survey as a survey on “health” vs. “impaired driving,” especially as other Federal agencies and traffic safety partners are interested in the research. The contractor shall expect additional survey questions, such as on current health, and recent illnesses or injuries.

COLLECTION OF ORAL FLUID TO DETECT DRUG PRESENCE

A continuing issue in NHTSA’s impaired driving research involving bodily fluid samples is whether to include only oral fluid samples or also blood samples. The 2007 and 2013-2014 surveys included both types of samples. In some respects, the samples provide similar information, but for some drugs, most notably THC10, they provide different types of information on drug use. A positive oral fluid for the parent compound is likely to be associated with very recent THC use, the timeframe consistent with potential impairing effects; whereas the blood sample would detect the inactive metabolites -consistent with less recent use (e.g., in the days before sample was taken). As with the other methodological issues, using both oral fluid and blood samples provides additional information, but at dramatically increased costs and logistical issues. The costs come not only from the need for blood kits and lab tests, but also the need for a certified phlebotomist at each data collection site, data analysis, and report preparation.

NHTSA is envisioning only oral fluid will be used in this survey, unless new, easy, and efficient blood testing procedures are available, such as testing via dried blood dots for drugs of most interest such as THC and cocaine. For budgeting purposes, offerors should assume drug detection will come via only oral fluid samples.

Within this task, the contractor shall meet with NHTSA representatives to discuss the methodological issues, and how they inform the research questions. The contractor shall plan on at least two (2) 4-hour meetings. For each of these, the contractor shall work with the COR ahead of time on developing materials for discussion.

Given the complexity and importance of the information in this letter report, the contractor shall plan on submitting a thorough and well-justified letter report discussing the methodological issues.

The contractor shall highlight where decisions are needed from NHTSA.

10 delta-9-tetrahydrocannabinol (Δ-9-THC) is a component of cannabis that can cause impairing effects.

C.4.3 Task 3: Prepare Data Collection and Analysis Plan, including Data Collection Protocol

This task builds on the methodological issues and research questions from Task 2 and NHTSA’s decisions on methodology. The purpose of this task is to develop a data collection and data analysis plan detailing how the individual components of data collection and analyses will be conducted. To a large extent the contractor shall follow from the past roadside surveys, and the survey conducted by NHTSA in cooperation with the State of Washington.11 The contractor shall discuss each of these topics and note any potential improvements from past surveys:

• Site sampling and selection,

• Site recruitment including coordination with local officials, including materials for the local media (e.g., handouts to frequently asked questions),

• Data collection scheduling and travel arrangements,

• Data collector training and monitoring,

• Individual site location sampling methods,

• Protocol for data collection,

• Equipment, materials, and supplies for data collection,

• Specimen handling,

• Drug screening and confirmatory analysis plan; and

• Data analysis.

SITE SAMPLING AND SELECTION

The contractor shall detail the procedure for site sampling, discuss weighting of site data, discuss how back-up sites will be selected and managed, and discuss criteria for site selection.

SITE RECRUITMENT INCLUDING COORDINATION WITH LOCAL OFFICIALS, INCLUDING MATERIALS FOR

MEDIA

The contractor shall recruit local enforcement agency(ies) to coordinate with during data collection. A local contact will also be needed to respond to questions from the media or the public. At times, coordination beyond the law enforcement agency may be required, for example the city council, mayor, or prosecutor’s office may also need to approve participation.

Mid-way through the 2013-2014 survey, NHTSA used only data collectors to recruit drivers from the roadway. Unlike in past surveys, law enforcement officers no longer had a patrol vehicle, often with lights on, ahead of the data collection location. NHTSA believes it is crucial to still have law enforcement present, but officers must be unobtrusive to not intimidate or provide a sense of coercion to possible participants or active subjects. In this manner, a security strategy is needed with 1 to 2 security officers in the data collection bay, but out of the visual line of oncoming drivers or other road users. Across surveys, these officers have been present in case there is a security issue, rather than having an active role. In addition, officers often have assisted the site manager with determining if specific locations are appropriate – for example, related to traffic flow, and geographical issues such as blind spots in the travel lane, or when parking lot lights turn

11 Ramirez, A., Berning, A., Carr, K., Scherer, M., Lacey, J. H., Kelley-Baker, T., & Fisher, D. A. (2016). Marijuana, other drugs, and alcohol use by drivers in Washington State (DOT HS 812 299). Washington, DC: National Highway Traffic Safety Administration. Also see Thomas, F. D., Berning, A., Blomberg, R.D., Graham, L.A., Darrah, J.R., and Tippetts, A.S. (xxxxxx, 2021). A how to guide for conducting a statewide roadside survey of alcohol and other drugs (in press). National Highway Traffic Safety Administration.

off at night. Some agencies will want officers to be on-duty; others will want officers to be off-duty. If acceptable to the local agency, retired officers may also be considered.

The contractor shall discuss the procedure for initial recruitment of sites, and coordination prior to and during data collection. Additionally, the contractor shall discuss how substitutions will be handled if a PSU and/or law enforcement agency is selected but cannot, for whatever reason, be used.

Materials for the Local Media – The contractor shall develop materials for the media that can be customized at any site. This includes talking points about project objectives and other frequently asked questions. It will also include a short video of a mock data collection, as used in the Washington survey where NHTSA worked with that State on a statewide roadside survey. The contractor shall work through a local government or policy agency for any distribution of media materials – no member of the research team will engage with media.

DATA COLLECTION SCHEDULING AND TRAVEL ARRANGEMENTS

The contractor shall present its strategy for scheduling all aspects of data collection. This shall include, but not be limited to, pre-meetings with law enforcement and any other local officials, transporting a data collection team to and from each site, and a breakdown of the schedule for data collection (e.g., how far ahead the team would arrive to the site, and then to the specific location).

The contractor’s plan shall allow for sufficient staff coverage for all data collection activities, but also be balanced to avoid excess staff. The contractor shall also discuss how it shall efficiently and cost-effectively manage travel arrangements (e.g., plane reservations, hotel reservations, vehicle rental, shipment of supplies).

DATA COLLECTOR TRAINING AND MONITORING

Each data collection team must include a site manager and enough data collectors to manage the expected volume of participants. All team members must have extensive training on the objectives of the project, how to handle the equipment, the study protocol, and the safety and ethical treatment of subjects. They must participate in enough practice sessions to reach proficiency in all potential situations (e.g., impaired drivers, uncooperative drivers) that may occur in the field.

All team members must be proficient in their role when data collection begins, including at the initial sites. Data collectors are critical to the success of the survey. A key part of the data collectors’ role is to encourage subject participation, work well with the public, and ability to work in various conditions and environments (e.g., outdoors, often in poor weather).

The contractor shall discuss its strategy for recruiting and training data collectors, and for monitoring data collector performance during the study for quality control, and to immediately fix any issues. The contractor’s plan must include a strategy to ensure high professional standards and strive for high subject participation. The contractor shall also note necessary training materials or learning strategies. This roadside survey may be dealing with lingering impact of COVID, including additional public health precautions, and increased hesitancy from potential participants.

The contractor shall present its strategy for addressing these issues.

INDIVIDUAL LOCATION12 SAMPLING METHODS

Once a site has been selected and secured, the contractor must determine appropriate data collection locations – a different location for each time period. Locations are typically un-used parking lots. The contractor shall be mindful of equity issues and ensure all areas within a site are included as potential locations. At a minimum, it is necessary for these locations to be safe for data collection, sufficiently lit, have sufficient traffic flow to achieve the required sample size, and for locations on the same night, be in close proximity so the team can pack up at one location, and get to the next location in time to set-up. The contractor shall discuss its strategy for selecting locations and how substitutions will be handled if necessary (e.g., if a crash in the neighborhood changes traffic flow at the time of data collection).

PROTOCOL FOR DATA COLLECTION

The contractor shall ensure all procedures with subjects are approved by an Institutional Review Board. The contractor shall propose incentive amounts for components of data collection. It is crucial the survey follow a strict protocol, to ensure that similar data is collected from subjects in the same manner. The protocol shall also allow the results of the survey to be compared to earlier surveys.

For Drivers – Vehicle Sampling Plan It is critical that drivers be sampled in an unbiased manner. For studies such as this, the procedure is the traffic control team member be given an indication of when a data collector is ready for a potential subject. At this point, the traffic control person will the pick the nth (e.g., 3rd) vehicle that is approaching and encourage the driver to enter the research bay. The plan shall include motorcyclists, to the extent that any motorcyclist is approaching the location when a data collector is available shall be encouraged to participate.

The contractor shall detail its proposed method for sampling vehicles/drivers from the roadway and encouraging them to participate, and directing them to the research bays – such as use of “Paid Survey Here” signs. There will be some ineligible vehicles (e.g., commercial) and ineligible drivers (e.g., underage, unable to understand the data collector) who must be screened out of the selection process. The contractor shall have a strategy for recording the number of vehicles that pass the location during data collection, the number who enter the research bay, the number of drivers who participate, and the number who decline participation although initially coming into the research bay.

The contractor shall also have a strategy for dealing with drivers trying to enter the survey even though they were not randomly selected, for example with a screening question of “Did you hear about this survey before you were waved in?”

For Other Road Users - Sampling Plan

New for this survey will be data collection of road users other than drivers. NHTSA acknowledges sampling here will not be representative of these road users but rather a convenience sample. This information will provide NHTSA for the first time with information about alcohol- and drug-positive people in transit, other than drivers. As such, the sample shall include pedestrians, bicyclists, electronic scooter riders, and users of mobility aids. Potential subjects are those in transit, 12 The term site is used for the overall site (PSU), chosen for representativeness of the country, such as Miami, Florida and for which there will be 60 sites. Locations are the randomly selected places within each site where data collection will occur. There will be 5 locations within each site. There will be 300 locations total across the country.

rather than people waiting for a ride, socializing, or otherwise in-place. As much as is feasible, the plan shall maximize recruitment of these road users – as with motorcyclists.

Interview Protocol

Throughout the interview, the contractor shall obtain informed consent from participants. At a minimum, the protocol for this survey shall include a brief introduction by a data collector to the subject regarding the voluntary and anonymous nature of the study; a request for a breath test,13 and a request for an oral fluid sample. Each subject may also be asked questions on their transit behavior, drinking and driving (etc.) behavior, alcohol use and abuse, drug use and abuse, and drugged driving (etc.) behavior.

NHTSA anticipates a protocol similar to the one described below, though the contractor is encouraged to propose improvements. The contractor shall accommodate the process for the non-driver (other road user) subjects.

• The research team arrives at the location; quickly unpacks, and sets up equipment (e.g., “Voluntary Survey Ahead” signs).

• Security officer(s) arrives and coordinates with the site manager; position the vehicle and self “out of the way” but able to monitor the whole research area.

• At the start of the data collection period, the traffic control person begins encouraging randomly selected drivers into the research area.

• A member of the team directs the driver into a specific research bay; several bays will be in operation.

• The data collector notes easily observable information about the driver and vehicle and records that data (e.g., type of vehicle, number of passengers, seat belt usage, gender of driver, and likely age of driver. NHTSA is interested in learning more use of occupant protection for each vehicle). Identifying information, such as license plate numbers must not be recorded.

• The data collector approaches the driver and briefly explains the study, explains it is voluntary and anonymous and that driver could stop at any point, and indicates the incentive amount for participating. The data collector obtains consent for continuing, or the driver proceeds back into traffic flow and the driver is counted as non-participating. In the past, the data collector obtained a passive alcohol reading for the driver, and recorded the result.

NHTSA is not planning on using passive alcohol sensors for this study.

• The data collector asks a few questions regarding the subject’s general driving patterns and driving on that trip.

• The data collector asks a few questions regarding the subject’s drinking behavior.

• The data collector requests a breath test from the driver. The devices record but do not display the BAC.

• The data collector requests an oral fluid sample from the driver.14 Drivers who meet

13 The device must provide an accurate BAC reading.

14 Use of a written survey both keeps the drivers “busy” while the oral fluid device is in their mouths, and also allows drivers to respond to potentially sensitive questions in a more confidential manner. The protocol shall allow for others with the subject, including children or pets, to be engaged in an activity or with a small treat, to avoid the criteria answer additional specific questions, such as on drinking behaviors or on use of medications or other drugs.

• In the most recent surveys, the data collector requested a blood sample. NHTSA is not planning on obtaining blood samples from participants.

• The data collector thanks the driver and directs the person safely out of the research area and onto the road.

The contractor shall detail all protocol components for this survey, based upon the overall methodological strategy approved by NHTSA in Task C.4.2.

The contractor shall discuss potential problems (e.g., non-selected drivers attempting to enter the research area, incomplete interviews, non-functioning equipment, disruptive drivers or passengers, bad weather) and how such issues will be minimized.

In the most recent surveys, for a subset of initially declining subjects, the site manager offered drivers an increased incentive. For drivers who then participated, we compared alcohol and drug use to drivers who initially participated versus those who initially declined. This information is extremely helpful to NHTSA when discussing the applicability of results, and shall be included in this survey.

The contractor shall be prepared throughout the entire interview and data collection process to ensure the safety of all research staff and subjects. If a participant is believed to be impaired (by alcohol, another drug, or any other reason), the contractor shall enact an impaired driving protocol and take appropriate measures to provide that person an alternate method home.

The protocol shall maximize collection of as much data as possible, as quickly as possible, and also maintain the safety of the public and research team. The contractor shall discuss measures to balance high participation while being cost-efficient.

EQUIPMENT, MATERIALS, AND SUPPLIES FOR DATA COLLECTION

The contractor shall supply all equipment, materials, and supplies needed for data collection, and data analyses. This includes items such as breath testers, oral fluid collection devices, survey signs, lights, traffic cones, survey forms, data collection devices and accessories, data collector uniforms, retro-reflective vests, and personal safety equipment such as gloves and masks. The contractor shall specify which devices are appropriate, and the quantity of items needed (e.g., one breath tester for each of xx data collectors).

SPECIMEN HANDLING

The contractor shall detail how the oral fluid and/or blood specimens are handled once they are obtained from the subject. For example, the contractor shall discuss safe handling procedures, and maintaining the integrity of the sample. The contractor shall discuss how the specimens will be securely packaged and shipped to a laboratory for testing.

subject feeling rushed on their behalf.

DRUG SCREENING AND CONFIRMATORY ANALYSIS PLAN

One of the key objectives of this roadside survey is to estimate the prevalence of drugged driving.

NHTSA is interested in over-the-counter, prescription, and illegal drugs that impair driving performance. It is not practical to screen for all such drugs within the scope of this project, however, the contractor shall test for drugs which 1) can impair driving performance, and 2) for which there is an indication that some percentage of drivers use this drug.

The table below lists the drugs NHTSA most recently has tested for when examining drug prevalence.15 This should be considered as a close example of what NHTSA will require in this survey. The contractor may propose for deletions or additions with justification. The contractor shall discuss what percentage of tests will likely require confirmatory testing. The contractor shall discuss how quickly specimens will be analyzed, and how quickly the results will be known.

15 Thomas, F. D., Berning, A., Darrah, J., Graham, L., Blomberg, R., Griggs, C., Crandall, M., Schulman, C., Kozar, R., Neavyn, M., Cunningham, K., Ehsani, J., Fell, J., Whitehill, J., Babu, K., Lai, J., and Rayner, M. (2020, October). Drug and alcohol prevalence in seriously and fatally injured road users before and during the COVID-19 public health emergency (Report No. DOT HS 813 018). National Highway Traffic Safety Administration.

Table 1. Selected Drugs and Metabolites for Toxicology Testing

Class/Category Parent Drug or Metabolite (Abbreviation) Alcohol ethyl alcohol

Cannabinoids delta-9-tetrahydrocannabinol (Δ-9-THC), 11-hydroxy-Δ⁹-tetrahydrocannabinol (11-OH-THC), 11-nor-9-carboxy-Δ⁹-tetrahydrocannabinol (11-COOH-THC)#

Stimulants cocaine, benzoylecgonine (BZE)#, cocaethylene; amphetamine;

methamphetamine; 3,4-methylenedioxy-methamphetamine (MDMA); 3,4-methylenedioxyamphetamine (MDA); ephedrine; pseudoephedrine;

phenylpropanolamine; phentermine; methylphenidate

Sedatives Benzodiazepines Barbiturates Muscle Relaxers Sleep Aids diazepam; nordiazepam;* oxazepam;* temazepam;* clonazepam, 7-aminoclonazepam; alprazolam; lorazepam; chlordiazepoxide; midazolam;

bromazepam; butalbital; secobarbital; phenobarbital; carisoprodol;

meprobamate; cyclobenzaprine; zolpidem

Opioids/Narcotic Analgesics

6-monoacetylmorphine (6-AM)^; morphine;* codeine; hydrocodone;

hydromorphone;* oxycodone; oxymorphone;* methadone, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP);# buprenorphine norbuprenorphine;

fentanyl, norfentanyl;# furanylfentanyl; acetylfentanyl; carfentanil;

fluorofentanyl; tramadol

Antidepressants sertraline; fluoxetine; amitriptyline; nortriptyline; imipramine; desipramine;

citalopram; doxepin; venlafaxine; trazadone

Over the Counter dextromethorphan; diphenhydramine; chlorpheniramine; doxylamine Other phencyclidine; ketamine; α-pyrrolidinopentiophenone (alpha-PVP)

# Inactive metabolite *These compounds can be parent drugs or active metabolites of other drugs.

^Heroin can only be definitively detected by the presence of the 6-AM metabolite

DATA ANALYSIS

The contractor shall discuss their plan for analyzing the data collected in this project, to answer the research questions noted in Task C.4.2 and throughout this SOW. At a starting point, the contractor shall conduct the same data runs as those reported in the 2013-2014 study, with similar analyses for the data from non-drivers. NHTSA is interested in increasing the breadth of our analyses, especially across demographic or other variables which can inform discussions of equity within traffic safety research.

The contractor shall discuss how weighting will be applied, and how that will impact raw data – that is, in a practice sense, what does the weighting accomplish?

A key issue with the comparisons of current data to past years’ will be the not-exact comparability of some variables and how those issues will be handled. For example, as survey questions get tweaked, they are no longer the same as in past years. For drug test results, it is likely for a number of the drugs, the toxicology lab will have more sensitive equipment and techniques, thus the detection thresholds will be lower for several substances, which will impact the percentage of subjects “drug positive.”

The contractor shall discuss possible significance testing; and discuss any limitations of the data analyses based on the proposed data collection activities.

The contractor shall submit to the COR a detailed data collection plan and analysis plan within 4 months of contract award. The contractor is encouraged to submit sections of the plan as they are completed, rather than waiting until it completes the entire plan. In this way, NHTSA can begin reviewing and commenting on the plan while the contractor continues work with other sections plan. The COR will provide comments within 2 weeks of receipt.

During this task, the contractor shall plan on two (2) 4-hour planning sessions with NHTSA to determine the best approaches.

C. 4.4 Task 4: Plan Pilot Test of Methodology and Protocol for a Survey of Pedestrians, Bicyclists, Electric Scooter Riders, and those with Assistive Aids

This task shall be concurrent with Task 4.3.

This task is serving NHTSA as a pilot of the feasibility of conducting surveys similar to the roadside survey for non-drivers. Like the approach in Task 3, the contractor shall plan the methodology and protocol for a pilot survey of non-drivers, that is, for pedestrians, bicyclists, electric riders, and those with assistive aids. However, whereas Task 3 includes data collection with these road users as they are available at the sites and locations chosen based on drivers (which may continue in future studies), this task is focused developing the methodology specifically for these other road users – with no drivers involved. As it is a pilot test to determine feasibility versus a full survey to determine representativeness across the country, the contractor shall plan for 4 sites in this task. The sites will be from the pool of sites for Task 3. NHTSA’s desired sample size is 500 completed oral fluid samples.

Within this task, the contractor shall cover the same requirements as in 3, including:

SITE SAMPLING

The purpose of sampling across sites for this pilot is different than for the full-roadside survey. As the contractor considers site selection, it should be based on “how can that site inform our knowledge?” either for the methodology and protocol, or for results from alcohol and drug testing, and other survey questions. Considerations should include large urban areas with high pedestrian and bicyclist traffic (compared to vehicles), areas with a more even mix of vehicle and other road user volume; and suburban areas with core areas with transit other than vehicle. To be feasible for NHTSA, especially given the costs of data collection, the sites and locations will need sufficient volume of activity to justify inclusion.

SITE RECRUITMENT INCLUDING COORDINATION WITH LOCAL OFFICIALS,

INCLUDING MATERIALS FOR MEDIA

The contractor shall discuss strategy for recruiting sites and coordinating with local officials.

Separate materials for the media will be required, including a separate video.

DATA COLLECTION SCHEDULING AND TRAVEL ARRANGEMENTS

The contractor shall discuss data scheduling and travel arrangements. Data collection for sites for this task may be conducted during the same weekends for the driver roadside survey.

DATA COLLECTOR TRAINING AND MONITORING

The contractor shall detail a plan for training data collectors for interviewing non-drivers – this is new for this study and existing training materials to not exist. Training may occur concurrently as for the Task 3 effort.

INDIVIDUAL SITE LOCATION SAMPLING METHODS

The contractor shall discuss criteria for how individual locations within a site will be determined.