Change Request Memo

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 4^th 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