Change Request Memo

Food and Drug Administration’s Research and Evaluation Survey for the Public Education Campaign on Tobacco among LGBT (RESPECT) (0910-0808)

Change Request

Feb 27, 2018

The Food and Drug Administration is submitting this nonmaterial/non-substantive change request to add a Follow-up 4 to our data collection schedule and refine the data collection documents for Follow-up 4. Follow-Up 4 is scheduled for May through July 2018. During this follow-up data collection effort, we will continue to re-contact participants and recruit new respondents to offset attrition. OMB previously concurred with the submission of this change request.

We request the following changes to the Supporting Statements for Follow up 4 (see details in table below):

• Update the project time schedule and annualized burden hours, cost burden estimate, and cost to the federal government in Part A, and sample size and number of waves in Part B.

• Update procedures in Part A to add data quality checks, and procedures in Part B for the collection of information to re-contact respondents as needed.

• Other minor editing changes in Parts A and B.

We also request the following changes to the following data collection documents (see details in table below):

• Attachment 2: Survey Instrument

• Update wording and instructions to participants to reflect current round of data collection.

• Update video content, screenshots and questions related to current ads.

• Attachment 3: New Participant Screener Instrument

• Revise the locations from the full, official DMA names to the simpler names of the cities.

• Attachments 6a and 6b: New Participant Survey Informed Consent

• Replace the word “confidentiality” with the word “privacy.”

• Add language to indicate that invitations for future surveys are dependent on data quality.

• Attachment 8: Script for Recruiting Intercept Participants

• Update the pre-screening questions in situations where minors are present at the venue.

• Update frequently asked questions about use of contact information.

• Attachment 11: Email to Respondents

• Edit subject lines and update email addresses.

• Add emails that will be sent to respondents who need to be re-invited to the survey or who need to receive an additional incentive.

• Attachment 15: FAQs for Social Media Respondents

• Create new document to include scripted responses to anticipated comments from potential respondents regarding study advertisements used to recruit participants on social media.

Contents of the Change Request Package

Att #	Documents (with tracked changes)	Edits
0	Supporting Statement Part A	Updated annual burden hours, annualized cost burden estimate, annualized cost to the federal government to include estimates for Follow-Up 4. Updated project time schedule to include Follow-Up 4. Updated procedures to add data quality checks; respondents who do not pass these checks will not be invited to participate in future study waves. Changed survey host from Voxco to Qualtrics. Changed “bar” to “venue” to include other recruiting locations.
0	Supporting Statement Part B	Added procedures to contact respondents who need to be re-invited to the survey or who need to receive an additional incentive due to data processing errors. Update sample size numbers and total number of waves. Changed “bar” to “venue” to include other recruiting locations.
2	Follow Up Instrument	Updated wording to ensure respondents can hear audio components of survey. Updated videos and questions related to videos. Updated digital content screenshots. Added instructions on how to finalize survey.
2a	Rational for Item Changes to Follow up Instrument
3	New Participant Screener	Revise the locations from the full, official DMA names to the simpler names of the cities
6a	New Participant Survey Informed Consent	Replaced the word “confidentiality” with the word “privacy.” Added language to indicate that invitations for future surveys is dependent on data quality.
6b	Returning Participant Survey Informed Consent	Replace the word “confidentiality” with the word “privacy.” Added language to indicate that invitations for future surveys is dependent on data quality.
8	Script for Recruiting Intercept Participants	Updated pre-screening question in situations where minors are present. Updated frequently asked questions to provide more specific information about how contact information will be used.
11	Emails to respondents	Added emails that will be sent to respondents who need to be re-invited to the survey or who need to receive an additional incentive. Edited “Digital Gift Card Offer Email” to account for changes to the incentive vendor’s email format. Changed the subject line of the “Follow Up Survey Longitudinal Recruitment E-mail Added email address to “Digital Gift Card Offer Email” and “Thank You Email.”
15	FAQs for Social Media Respondents	New document to include scripted responses to anticipated comments from potential respondents regarding study advertisements to recruit participants via social media.