Change Request Memo for OMB

U.S Food and Drug Administration

Change Request (83-C)

Evaluation of the FDA's General Market Youth Tobacco Prevention Campaigns

(OMB Control No. 0910-0753)

The Food and Drug Administration is submitting this nonmaterial/non-substantive change request to update materials related to the Public Education on Teen Tobacco (ExPECTT) for the final (follow-up 5) wave of data collection. Some of our study participants have now aged up and require consent rather than parental consent and assent. Additionally, due to the COVID-19 pandemic, in person data collection has been suspended. The communication materials have been changed to reflect that in person data collection will not occur. FDA has added burden for the fifth follow-up. This resulted in an increase of 2,090 responses and 1,568 hours. The new estimated burden for this collection is 10,462 hours.

The study materials listed below have been updated to reflect changes for follow-up 5:

Tracked Changes Document		Modification
Attachment 2. ExPECTT II Youth Instrument_5th FU_3_17_2022		Updated to reflect changes in new advertising Updated to reflect changes in terminology for tobacco products
Attachment 06b. Parent Guardian Permission ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 06c. Youth Assent under 18 ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 06d. Youth Consent 18 and up ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 10. Lead Letter ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to inform participants that this is the final wave of data collection Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 10b. Lead Letter_Young Adult_ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to inform participants that this is the final wave of data collection Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 11. Q&As about ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 11b. Q&As_Young Adult_ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 13. Notifications ExPECTT II 5th FU		Updated to reflect addition of reminder text messages Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 13b. Notifications_Young Adult_ExPECTT II 5th FU		Updated to reflect addition of reminder text messages Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 15. Panel Maintenance Letter ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to inform participants that this is the final wave of data collection
Attachment 15b. Panel Maintenance Letter_Young Adult_ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to inform participants that this is the final wave of data collection
Attachment 18. Survey Invitation Email ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 18b. Survey Invitation Email_Young Adult_ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 19. Email_reminder1_ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 19b. Email_reminder1_Young Adult_ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 20. Email_reminder2 ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 20b. Email_reminder2 _Young Adult_ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 21. Email_reminder3 ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 21b. Email_reminder3 _Young Adult_ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 22. Reminder Letter ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 22b. Reminder Letter_Young Adult_ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 23. Email_reminder4 ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 23b. Email_reminder4 _Young Adult_ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 24. Reminder Letter ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
Attachment 24b. Reminder Letter_Young Adult_ExPECTT II 5th FU		Updated to reflect changes to online only data collection due to coronavirus Updated to reflect new delivery of incentive payment (mail instead of email)
1.Part A ExPECTT_FU5 3_4_2022		Updated for fifth wave of data collection
2. Part B ExPECTT_FU5_3_4_2022		Updated for fifth wave of data collection

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