Change Request Memo 9.2020

U.S Food and Drug Administration

Measuring Consumer Comprehension of Displays of Harmful and

Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke

(OMB Control No. 0910-0880)

The Food and Drug Administration is submitting this nonmaterial/non-substantive change request to incorporate updates to the instruments under this collection. The changes are detailed below.

Track Changed Documents

Appendix	Title	Change
K	Online Survey Questionnaire	Updated language at the end of the survey to no longer refer to smokefree.gov as “our website” as requested.
RIHSC/IRB Protocol		In Section VIII, Sub-Section B, clarified that participants with low socioeconomic status and those without a high school diploma or GED are not mutually exclusive, and these groups may overlap. In Section VIII, Sub-Section F, updated language to match the change described above in Appendix K. In Section XIII, removed reference to FDA analyzing the data because a contractor will be editing that data as part of a separate project. In XVIII, Sub-Section C, provided the requested detail regarding processes for reviewing and reporting participant complaints and potential protocol deviations.