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) due to changes requested by FDA’s IRB. The FDA IRB will no longer provide IRB oversight for research in which FDA staff are not directly engaged. FDA has updated the following language to clarify that the FDA will not have direct involvement with human subjects to adhere to the new FDA IRB policy.
Track Changed Documents
ExPECTT II Youth Instrument_2nd follow-up |
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Routing for Consent ExPECTT |
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Parent Permission ExPECTT II FU 2-3 |
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Youth Assent under 18 ExPECTT II |
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Youth Consent 18 and up ExPECTT II |
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Study Description ExPECTT II FU 2-3 |
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Lead Letter ExPECTT II 1st and 2nd FU |
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Q&A about ExPECTT II FU 1-3 |
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Telephone Verification Survey ExPECTT II FU 2-3 |
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Notifications ExPECTT |
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Panel Maintenance ExPECTT |
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Survey Invitation Email ExPECTT II FU 2-3 |
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Email Reminder 1 ExPECTT II FU 2-3 |
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Email Reminder 2 ExPECTT II FU 2-3 |
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Email Reminder 3 ExPECTT II FU 2-3 |
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Reminder Letter ExPECTT II FU 1-3 |
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File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Lacorte, Lester (Jao) |
File Modified | 0000-00-00 |
File Created | 2022-04-08 |