0788 Change Request Memo

“Food and Drug Administration’s Evaluation of the Fresh Empire Campaign on Tobacco”

Overview of the Change Request for OMB Control No. 0910-0788

The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) to update the project schedule and revise the data collection protocol and documents for the fifth follow-up data collection for EFECT. We request that the project schedule be updated to reflect that fifth follow-up data collection period will begin in April 2019 rather than in February 2019.

Contents of change documents

Att #	Document	Edits
	Supporting Statement Part A	Updated to reflect discontinued recruitment methods during this round (i.e., mailed screener) Added Snapchat as a new platform for social media recruitment; Facebook will no longer be used Updated contact information for individuals consulted for questionnaire development Updated references to attachments, and removed references to attachments no longer in use Changed vendor name to the current print vendor Revised itemized cost to federal government to reflect contract costs Removal of mail screener from information collection led to a decrease of 23,685 annual responses and 1,973 burden hours.
	Supporting Statement Part B	Updated to reflect discontinued recruitment methods during this round (i.e., mailed screener) Added Snapchat as a new platform for social media recruitment for the fifth post-test survey; Facebook will no longer be used Updated references to attachments, and removed references to attachments no longer in use Added reference to NEW Attachment 8c (lead letter addressed directly to 18 year-old longitudinal inviting them to participate in the next round of the survey, rather than sending to their parent)
1	Post Campaign Instrument	Items added, edited and deleted from post-campaign instrument; see details in “Summary of Changes to EFECT Instrument for Follow-up 5” Updated expiration date of OMB approval
1a	Fresh Empire Storyboards	Updated storyboards for campaign ads shown in the fifth post-test survey
3	Outcome Web Screener	Revised programming notes Updated to remove discontinued recruitment methods (i.e., in-home recruitment and screening of siblings) Revised item to include Snapchat as a source of recruitment Updated survey length to 40 minutes instead of 30-40 minutes to reflect actual time of post-test survey Some other minor edits to wording Updated expiration date of OMB approval
3a	Social Media Ads	Updated NEW social media ads for use on Instagram and Snapchat
5a	Parental Permission Youth Assent Longitudinal Age 12-17 Household	Clarified instructions for field interviewers Updated expiration date of OMB approval
5b	Informed Consent Longitudinal Age 18 Household	Revised title of document for clarity (not a respondent-facing change) Updated expiration date of OMB approval
5c	Parental Permission Youth Assent Longitudinal Age 12-17 Web	Added information about not receiving incentive if data quality is poor Revised title of document for clarity (not a respondent-facing change) Updated expiration date of OMB approval
5d	Informed Consent Longitudinal Age 18 Web	Added information about not receiving incentive if data quality is poor Updated expiration date of OMB approval
5e	Youth Assent Cross Sectional Age 15 - 17_Social Media Web	Added information about not receiving incentive if data quality is poor Updated expiration date of OMB approval
5f	Youth Assent Cross Sectional Age 13 - 14_Social Media Web	Added information about not receiving incentive if data quality is poor Updated expiration date of OMB approval
5g	Youth Assent Longitudinal Age 13 – 17 Social Media Web	Added information about not receiving incentive if data quality is poor Revised description of document for clarity (not a respondent-facing change) Updated expiration date of OMB approval
5i	Youth Assent Longitudinal Age 15 – 17 Social Media Permission Waived Web	Added information about not receiving incentive if data quality is poor Revised description of document for clarity (not a respondent-facing change) Updated expiration date of OMB approval
6	Study Description	Updated expiration date of OMB approval
8a	Outcome Parent Lead Letter Longitudinal	Minor edits to wording Updated expiration date of OMB approval
8c	Follow-up Age 18 Lead Letter_FU5_NEW	NEW document based on previously-approved Attachment 8a Lead letter is addressed directly to the 18 year-old participant rather than the parent
12	Sorry I Missed You Card	Updated expiration date of OMB approval
13	Unable to Contact Letters	Minor edits to wording Updated expiration date of OMB approval
14a	Questions and Answers Fact Sheet (Household Longitudinal)	Minor edits to wording Updated expiration date of OMB approval
14b	Questions and Answers Fact Sheet (Web Cross Sectional)	Minor edits to wording Updated expiration date of OMB approval
15	Interview Incentive Receipt	Updated expiration date of OMB approval
17	Verification Call Script Age 13 – 17	Updated expiration date of OMB approval
17a	Verification Call Script Age 18	Added expiration date of OMB approval