Change Request Memo September 2020

U.S Food and Drug Administration

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 next 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.

Track Changed Documents

Attachment 2. ExPECTT II Youth Instrument_3rd FU_8_2020	Updated to reflect changes in new advertising Updated to reflect changes in terminology for tobacco products
Attachment 6_E2b3. Parent Permission ExPECTT II FU 3-4	Updated to reflect changes to online only data collection due to coronavirus
Attachment 6_E2c2. Youth Assent under 18 ExPECTT II	Updated to reflect changes to online only data collection due to coronavirus
Attachment 6_E2d. Youth Consent 18 and up ExPECTT II	New file for 18+ study participants
Attachment 08_E2b. Study Description ExPECTT II	Updated to reflect changes to online only data collection due to coronavirus
Attachment 08_E2c. Study Description Young Adult ExPECTT II	New file for 18+ study participants
Attachment 10_E2d: Lead Letter ExPECTT II 3rd and 4th FU	Updated to reflect changes to online only data collection due to coronavirus
Attachment 10_E2e. Lead Letter_Young Adult_ExPECTT II 3rd and 4th Follow-up	New file for 18+ study participants
Attachment 11_E2b. Q&As about ExPECTT II	Updated to reflect changes to online only data collection due to coronavirus
Attachment 11_E2c. Q&As_Young Adult_ExPECTT II	New file for 18+ study participants
Attachment 13_E2a Notifications ExPECTT	Updated to reflect changes to online only data collection due to coronavirus
Attachment 13_E2b. Notifications_Young Adult_ExPECTT II 3rd Follow-up	New file for 18+ study participants
Attachment 15_E1 Panel Maintenance ExPECTT	Updated to reflect changes to online only data collection due to coronavirus
Attachment 15_E2a. Panel Maintenance Letter_Young Adult_ExPECTT II 3rd Follow-up	New file for 18+ study participants
Attachment 18_E2d. Survey Invitation Email ExPECTT II	Updated to reflect changes to online only data collection due to coronavirus
Attachment 18_E2e. Survey Invitation Email_Young Adult_ExPECTT II 3rd Follow-up	New file for 18+ study participants
Attachment 19_E2e. Email Reminder 1 ExPECTT II FU 3-4	Updated to reflect changes to online only data collection due to coronavirus
Attachment 19_E2f. Email_reminder1_Young Adult_ExPECTT II FU 3-4	New file for 18+ study participants
Attachment 20_E2d. Email Reminder 2 ExPECTT II FU 3-4	Updated to reflect changes to online only data collection due to coronavirus
Attachment 20_E2e. Email_reminder2 _Young Adult_ExPECTT II FU 3-4	New file for 18+ study participants
Attachment 21_E2d. Email Reminder 3 ExPECTT II FU 3-4	Updated to reflect changes to online only data collection due to coronavirus
Attachment 21_E2e. Email_reminder3 _Young Adult_ExPECTT II FU 3-4	New file for 18+ study participants
Attachment 22_E2a. Reminder Letter ExPECTT II FU 3-4	Updated to reflect changes to online only data collection due to coronavirus
Attachment 22_E2b. Reminder Letter_Young Adult_ExPECTT II 3rd Follow-up	New file for 18+ study participants
Attachment 23_E2a. Email_reminder4 ExPECTT II FU 3-4	Updated to reflect changes to online only data collection due to coronavirus
Attachment 23_E2b. Email_reminder4 _Young Adult_ExPECTT II FU 3-4	New file for 18+ study participants
Attachment 24_E2a. Reminder Letter ExPECTT II FU 3-4	Updated to reflect changes to online only data collection due to coronavirus
Attachment 24_E2b. Reminder Letter_Young Adult_ExPECTT II FU 3-4	New file for 18+ study participants
Attachment 25 – Calling Talking Points	New document
Part A ExPECTT.FU3	Updated to reflect changes to online only data collection due to coronavirus Updated incentive amounts Added burden for the fourth wave of data collection.
Part B ExPECTT.FU3	Updated to reflect changes to online only data collection due to coronavirus Updated incentive amounts