Questions and Answers to 21-71824.docx

Questions and Answers to 21-71824

Please confirm that email proposals are expected. It also states proposals should be on recycled white paper.

This is correct.

Are there existing CDC protocols for all equipment? Actigraphs, electronic equipment?

Not to my knowledge, just data security measures we need to adhere to as specified in the contract. The protocol we will need to follow will be the IRB protocol, which is currently under expedited review.

Will the contractor design the participant training and surveys or just implement?

Thank you for asking for clarification - the training is complete and will be provided by NIOSH through a link for the participants that they will take on their own time at a location convenient to them. The surveys are completed and provided by NIOSH as well and will be uploaded into the electronic devices provided by the contract for implementation.

Is participation fixed at 180 participants or must we over sample to make sure 180 participants complete the study with data.

The sample size is fixed at 180 and accounts for some lost to participation. However, recruitment and participation efforts are intended to be optimized for study retention.

Is CDC providing the NON DISCLSOSURES to the contractor to sign I don't know what is meant by nondisclosures.

Can you share more about the Taxi APP.? We need for our proposal submission requirements.

The company is a taxi company that subscribes to an app specific for taxi drivers. It is app-accessible but also has a physical location where the taxis are inspected. Drivers work on a shift basis, night or day, with hours of service limitations as specified by the city.

Yes, many taxi drivers these days work for an app as well. In San Francisco, the app-based company that the drivers drive for is called 'Flywheel'. I don't know more about the app and you would have to reach out to the company directly.

We need a full month of testing of equipment prior to fielding. Can we propose a revised / viable timeline which captures all the elements of delivery?

I don’t understand what you are asking but you will have to comply to the statement of work.

Does the CDC currently have an IRB agreement for this study? Can you share it. It will help us in our response and design framework.

Yes, it is under review. It has not yet been approved.

Is the timeline correctly noted? Site visit 8/2021 and the work does not begin until following May/2022 (PAGE 12 and 13). September recruiting. Just confirming.

Yes, the timeline is correctly noting - starting work in May was to allow time for approval by OMB, which we have no control over. The study can most certainly begin before May/2022 - we would like it to start as soon as OMB approval is obtained.

Can we have copies of the following:

a. Work and Health Survey. A 30-minute survey that asks about driving a taxi, work environment, health, sleep and fitness habits, health and sleep health, road safety behaviors, and socio-demographic factors.

b. Fatigue Knowledge Survey. A 25-question survey that tests a driver's knowledge about sleep health, fatigue, and driving.

c. Sleep and Activities Diary. A daily diary where participants record their sleep and wake times, rate their fatigue and sleepiness levels several times a day, record their PVT scores several times a day and document their medications use and breaks taken.

These surveys are not yet IRB and OMB approved so we cannot share them.

Task 8: Conduct data collection period 2.

On or before October 31, 2022, the vendor will conduct the second of five 7-day data collection periods. The vendor shall identify, provide, and maintain sufficient validated actigraphs needed to measure sleep metrics to obtain 7 days of estimated fatigue levels for the 180 drivers participating in the study using an actigraph capable of notifying drivers of their estimated fatigue score (ranging 0-100).Three days (72 hours) in advance provide the 180 enrolled drivers with an actigraph to obtain baseline measurements needed to generate a fatigue score.

What is the intervention between deployments?

The intervention between 2nd and 3rd data collection periods (deployments?) is the online training.

How long do you want in between data collection efforts for the same individuals?

At least one week before 1st and 2nd data collection period, an online training following 2nd period within a week, then at least a week following the training for the 3rd data collection period, at least a month following the 3rd data collection period, and at least 3 months following the 4th data collection period.

Please confirm you do want to collect data during the holidays. NOV/DEC.

Yes. Again, the study is most certainly encouraged to begin before May/2022 - this all depends on OMB approval which sets the pace, not us.