Change Request

“Food and Drug Administration’s Evaluation of the Fresh Empire Campaign on Tobacco” (OMB Control Number 0910-0788)

Change Request

August 11, 2017

The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) to revise the data collection protocol and documents for the third follow-up data collection for EFECT.

The Evaluation of the Fresh Empire Campaign on Tobacco (EFECT) is designed to measure awareness of and exposure to the campaign and assess its impact on outcome variables of interest. Baseline data collection (July 2015 - November 2015), first follow-up data collection (April 2016 – June 2016), and second follow-up data collection (January – June 2017) were conducted in 15 campaign-targeted cities and 15 comparison cities through in-person and web-based surveys. This change request is to revise the data collection protocol and documents for the third follow-up data collection for EFECT.

In this change request, we request approval to make the following changes to the protocol and data collection documents:

• Revise the wording in multiple documents to reflect the new round of data collection (third follow-up) and timeframe since last survey.

• Adjust burden hours to account for the number of participants to date. No new burden is anticipated as a result of these changes.

• Offer an additional $5 early bird incentive for longitudinal respondents who originally completed an in-person survey to encourage them to complete the web survey.

• Format the post-campaign instrument in a standard template requested by FDA. This template is designed with the intent of being clear and easily-understood by members of the public who may choose to access these documents on reginfo.gov.

• Edit, add, or delete items in the post-campaign instrument to:

• reflect updated campaign messages and media, such as videos

• maintain a reasonable survey length

• clarify instructions and make edits based on mode (web vs. in-person)

• reflect best practices for item (i.e., question) development

Contents and tracked documents:

Att #	Document	Edits
	Supporting Statement Part A	Updated contact information for individuals consulted for questionnaire development Added detail about offering an additional $5 “early bird” incentive during the third follow-up data collection period Revised annualized burden hour estimate to reflect number of participants to date; no new burden resulted from these changes Revised annualized cost burden estimate to reflect the revised burden hours. Updated timeline for post-test data collection.
	Supporting Statement Part B	Clarified that youth who participated in a previous survey wave will be re-contacted at each follow-up wave up to the age of 18 (no change to study protocol) Revised to include information about the early bird incentive in data collection procedures Updated contact information for individuals consulted for questionnaire development
1	Post Campaign Instrument	Items added, edited and deleted from post-campaign instrument; see details in “Summary of Changes to EFECT Post-Campaign Instrument”
3	Outcome Web Screener	Formatted in a template requested by FDA that is more clear for the public: ASK statements clarify who sees items, and GOTO statements describe skip logic in plain English Reformatted to clarify programming notes Changed language from “confidentiality” to “privacy… to the extent allowed by law” Revised to reflect wave of study and possibility of future contact Added language for pop-up box if respondent doesn’t enter zip code since this is an important eligibility criteria Some other minor edits to wording
5a	Parental Permission Youth Assent Longitudinal Age 12-17 Household	Clarified instructions for interviewers Clarified that incentive will be cash (no change to study protocol) Changed “confidentiality” to “privacy” Revised to reflect wave of the study and possibility of future contact Some other minor edits to wording
5b	Informed Consent Longitudinal Age 18 Household	Clarified instructions for interviewers Clarified that incentive will be cash (no change to study protocol) Changed “confidentiality” to “privacy” Revised to reflect wave of the study and possibility of future contact Some other minor edits to wording
5c	Parental Permission Youth Assent Longitudinal Age 12-17 Web	Revised to reflect wave of the study and possibility of future contact Clarified that incentive will be a gift card (no change to study protocol) Added information about early bird incentive Changed “confidentiality” to “privacy” Some other minor edits to wording
5d	Informed Consent Longitudinal Age 18 Web	Revised to reflect wave of the study and possibility of future contact Clarified that incentive will be a gift card (no change to study protocol) Added information about early bird incentive Changed “confidentiality” to “privacy” Some other minor edits to wording
5e	Youth Assent Cross Sectional Age 15 - 17_Social Media Web	Changed “confidentiality” to “privacy” Revised to reflect wave of the study and possibility of future contact Some other minor edits to wording
5f	Youth Assent Cross Sectional Age 13 - 14_Social Media Web	Changed “confidentiality” to “privacy” Revised to reflect wave of the study and possibility of future contact Some other minor edits to wording
5g	Youth Assent Longitudinal Age 13 – 17 Social Media Web	Clarified that incentive will be a gift card (no change to study protocol) Changed “confidentiality” to “privacy” Revised to reflect wave of the study and possibility of future contact Some other minor edits to wording
5i	Youth Assent Longitudinal Age 15 – 17 Social Media Permission Waived	Changed “confidentiality” to “privacy” Revised to reflect wave of the study and possibility of future contact Some other minor edits to wording
6	Study Description	Changed language to “private to the extent allowed by law” for consistency with other documents
8a	Outcome Parent Lead Letter Follow-up 3	Clarified that incentive will be a gift card (no change to study protocol) Added information about early bird incentive Revised to more clearly explain study procedures and option for online survey Changed language to “private to the extent allowed by law” for consistency with other documents Some other minor edits to wording
13	Unable to Contact Letters	Revised how letters are addressed Revised to more clearly explain study procedures and option for online survey Revised to reflect wave of the study Changed language to “private to the extent allowed by law” for consistency with other documents Some other minor edits to wording
14a	Questions and Answers Fact Sheet (Household)	Removed capitalization from “Privacy” and “Privacy Agreement”
14b	Questions and Answers Fact Sheet (Online)	Removed capitalization from “Privacy” and “Privacy Agreement”
15	Interview Incentive Receipt	Changed “confidentiality” to “privacy”
17	Verification Call Script Age 13 – 17	Retitled this document for use with 13 – 17 year-olds Corrected question order and numbering
17a	Verification Call Script Age 18	NEW document based on previously-approved Attachment 17 that uses language suitable for 18 year-olds by removing references to parental permission