Change Request Memo

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

2	ExPECTT II Youth Instrument_2nd follow-up	Remove the RIHSC number Updated OMB expiration date
6_E2a	Routing for Consent ExPECTT	Updated OMB expiration date
6_E2b3	Parent Permission ExPECTT II FU 2-3	Remove the RIHSC number Updated OMB expiration date
6_E2c2	Youth Assent under 18 ExPECTT II	Remove the RIHSC number Updated OMB expiration date
6_E2d	Youth Consent 18 and up ExPECTT II	Remove the RIHSC number Updated OMB expiration date
08_E2b	Study Description ExPECTT II FU 2-3	Remove the RIHSC number Updated OMB expiration date
10_E2d	Lead Letter ExPECTT II 1st and 2nd FU	Remove the RIHSC number Updated OMB expiration date
11_E2b	Q&A about ExPECTT II FU 1-3	Remove the RIHSC number Updated OMB expiration date
12_E2b	Telephone Verification Survey ExPECTT II FU 2-3	Remove the RIHSC number Updated OMB expiration date
13_E2a	Notifications ExPECTT	Remove the RIHSC number Updated OMB expiration date
15_E1	Panel Maintenance ExPECTT	Updated OMB expiration date
18_E2d	Survey Invitation Email ExPECTT II FU 2-3	Remove the RIHSC number Updated OMB expiration date
19_E2e	Email Reminder 1 ExPECTT II FU 2-3	Remove the RIHSC number Updated OMB expiration date
20_E2d	Email Reminder 2 ExPECTT II FU 2-3	Remove the RIHSC number Updated OMB expiration date
21_E2d	Email Reminder 3 ExPECTT II FU 2-3	Remove the RIHSC number Updated OMB expiration date
22	Reminder Letter ExPECTT II FU 1-3	Remove the RIHSC number Updated OMB expiration date