Change Request Memo Feb 2020

“Creative Concept Testing Designed to Prevent Youth ENDS, Cigarette and Other Tobacco Product Use”

(OMB Control Number 0910-0796)

Change Request

The Food and Drug Administration is submitting this nonmaterial/non-substantive change request to account for changes for a previously approved individual generic request.

On December 20, 2019, the President signed a bill raising the minimum federal tobacco buying age from 18 to 21. Prior to this, communication campaigns (including this gen IC) were aimed mostly for 12-17 or older adults. As this change has occurred, we would like to conduct research with those who are 18-21 to determine how this will affect the Center for Tobacco’s communication strategies. There are no changes in burden as we will just include those who are 18-21 in the current size of recruitment.

Tracked Documents

1. Justification Memo

2. Consent (New Document)

3. Youth Assent

4. Parental Permission

Clean Documents

1. Justification Memo

2. Consent (New Document)

3. Youth Assent

4. Parental Permission