Change Request Memo 9.2020

Change Request Memo September 2020.docx

Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products and Tobacco Smoke

Change Request Memo 9.2020

OMB: 0910-0880

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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.




File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorGittleson, Daniel
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File Created2021-01-13

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