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