Change Request Memo

0910-0753 RuSTEC Change Request Memo FU4.docx

Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign

Change Request Memo

OMB: 0910-0753

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Evaluation of the Public Education Campaign on Teen Tobacco (OMB Control No. 0910-0753)


Change Request (83-C)

July 13, 2018


The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) to incorporate edits to the study documents for the fourth follow up round of data collection for the evaluation of the Rural Smokeless Education Campaign (RuSTEC). OMB has previously concurred with the submission of this change request.


This study evaluates The Real Cost Smokeless. The campaign is intended to prevent tobacco use among youth ages 12-17 who are experimenting with or are at risk for using smokeless tobacco. RuSTEC is a longitudinal control/intervention study in rural areas.


RuSTEC Follow up 4

Follow up 4 is planned for September 2018. The following revisions will be made to the data collection documents for RuSTEC for Follow up 4:


  • Revise the wording in the survey instrument to reflect new campaign creative

  • Make minor text edits to reflect 4th follow-up and to add clarity

  • Add Attachment 02a_R: Section F Media Questions


List of Revised Study Documents for RuSTEC Study Follow up 4 (OMB No. 0910-0753)

OMB Attachment #

Change

Rationale

Part A ExPECTT RuSTEC (RS FU4)

Minor edits

Updates to reflect FU4 data collection

02_R. Youth Follow up 4 Instrument

Revise programming / administrative text throughout

Edit for clarity and FU4 data collection

Remove items that are not needed or useful

Items removed either because the campaign does not cover the topic, they are ceilinged, do not reflect current use patterns, or are not useful

Delete media items and add placeholders

Media items will be covered in detail in attachment 2a_R

02a_R. Section F Media Questions

New Document

New document to show media items used in the survey

06_R1. Parent Permission

Minor text edits

Edit text for clarity and new round of data collection

06_R2. Youth Assent

Minor text edits

Edit text for clarity and new round of data collection

10_R. Lead Letter

Minor text edit

Edit for clarity and new round of data collection

11_R. Questions and Answers

Minor text edits

Edit for clarity and new round of data collection

12_R. Field Interviewer Verification

Minor text edits

Edit for clarity and new round of data collection

14_R. Notifications

Minor text edits

Edit for clarity and new round of data collection

15_R. Panel Maintenance Letter

Minor text edits

Edit for clarity and new round of data collection

16_R. Panel_Maint_Update_Form

Text edits

Edit for clarity and add privacy information to include cellphone number

19_R. Email_reminder1

Minor text edits

Edit for clarity and new round of data collection

20_R. Email_reminder2

Minor text edits

Edit for clarity and new round of data collection

21_R. Email_reminder3

Minor text edits

Edit for clarity and new round of data collection

22_R. Panel Maintenance Email

Minor text edits

Edit for clarity and new round of data collection

Add privacy information

Clarify privacy text to include cellphone use

24_R. Consent Forms

Minor text edits

Edit for clarity and new round of data collection

25_R. Lead Letter 18

Minor text edit

Add CTP RIHSC information and add young adults

26_R. Questions and Answers about the Evaluation – 18

Minor text edits

Edit for clarity, add “young adults,” and new round of data collection

27_R. Field Interviewer Verification – 18

Minor text edits

Edit for clarity and new round of data collection

28_R. Survey invitation email – 18

Minor text edit

Edit to add young adults for 18+ population

29_R. Email reminder 1 – 18

Minor text edits

Edit for clarity, add “young adults,” and new round of data collection

30_R. Email reminder 2 – 18

Minor text edits

Edit for clarity, add “young adults,” and new round of data collection

31_R. Email reminder 3 – 18

Minor text edits

Edit for clarity and new round of data collection

32_R. Panel Maintenance Letter - 18

Minor text edits

Edit for clarity, add “young adults,” and new round of data collection

33_R. Panel Maintenance Update Form – 18

Minor text edits and update privacy information

Add privacy information to include use of cellphones

34_R. Reminder Letter – 18

Minor text edits and remove early bird text

Edit for clarity, add “young adult,” new round of data, and to remove early bird text because this reminder letter is sent after early bird is over

35_R. Panel Maintenance Email – 18

Minor text edits

Edit for clarity, young adults, and new round of data collection

Update privacy text

Update privacy text to include cellphone use

36_R. Post_Card_Reminder_Notice

Minor text edit

Add CTP RIHSC number

37_R. Text Message for non-responders

Minor text edit

Edit for clarity and new round of data collection


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