0851 Change Request Memo

OMB Change Request Memo.docx

Evaluation of the Food and Drug Administration’s Point-of-Sale Campaign

0851 Change Request Memo

OMB: 0910-0851

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Overview of the Change Request for OMB Control No. 0910-0851

Change Request (83-C)

The Point of Sale Intervention for Tobacco Evaluation (POSITEv) is a longitudinal survey designed to measure the effectiveness of the CTP point-of-sale campaign that is intended to increase motivation to quit among adult smokers aged 25 to 54. Wave 1 data collection for POSITEv is currently underway and was completed between June of 2018 and December of 2018. Wave 2 data collection will be conducted between February of 2019 and June of 2019. Wave 3 data collection will be conducted between September of 2019 and November of 2019. Wave 4 data collection will be conducted between February of 2020 and May of 2020. Waves 2, 3, and 4 data collection will be conducted through online or in-person outcome evaluation questionnaires. In addition, an optional app-based (smartphone required) component of the evaluation passively collects the time, date, and store number when a participant visits convenience stores and asks the participant to complete a brief (7 item) questionnaire every 6 months.

This change request is to revise the consent for app-based data collection, notifications, questions and answers document, and the telephone verification survey. We also request to create two new attachments (14): Web Survey Reminders and (15) Telephone Talking Points

List of New and Revised Study Documents for POSITEv (OMB No. 0910-0851)

OMB Attachment Number

Changes

Attachment 03b POSITEv consent for app-based data collection

  • Revised to clarify information about the app

Attachment 06b Notifications

  • Revised to include new letters appropriate to the follow-up waves.

Attachment 07 Questions and Answers

  • Revised to incorporate questions and responses appropriate to the follow-up waves

Attachment 13 POSITEv Follow-up Telephone Verification Survey


  • Revised to remove content no longer relevant to follow-up verification calls and to add more relevant content

Attachment 14 Web Survey Reminders

  • New document including two thank you/reminder postcards encouraging follow-up wave web survey nonresponders to complete the survey online

Attachment 15 Telephone Talking Points

  • New document used by interviewers to prompt study participants to complete the follow-up interview over the web or schedule an in-person appointment. This document also provides talking points for interviewers to use when attempting to locate a study participant who has moved.



File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorPamela Rao*
File Modified0000-00-00
File Created2021-01-15

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