2024-22575. Agency Information Collection Activities; Proposed Collection; Comment Request; Promotion of Prescription Drugs Within a Talk Show Format  

  • Table 1—Study Experimental Design

    Sponsorship prominence Endorser type and risk prominence
    Patient guest Physician guest
    Higher risk prominence Lower risk prominence Higher risk prominence Lower risk prominence
    None.
    Once.
    Periodic.
    Constant.

    Following the video, respondents will be asked questions pertaining to their recall and comprehension of risks and benefits depicted in the advertisement, perceptions of endorser characteristics, perceptions of drug qualities, and behavioral intentions.

    We estimate the burden of this collection of information as follows: ( print page 80255)

    Table 2—Estimated Annual Reporting Burden 1

    Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response 2 Total hours
    Pretest
    Pretest Screener Completes 400 1 400 0.03 (2 minutes) 12
    Pretest Questionnaire Completes 80 1 80 0.30 (18 minutes) 24
    Main Study
    Main Study Screener Completes 3,200 1 3,200 0.03 (2 minutes) 96
    Main Study Questionnaire Completes 640 1 640 0.30 (18 minutes) 192
    Total 324
    1  There are no capital costs or operating and maintenance costs associated with this collection of information.
    2  Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.

Document Information

Published:
10/02/2024
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2024-22575
Dates:
Either electronic or written comments on the collection of information must be submitted by December 2, 2024.
Pages:
80252-80255 (4 pages)
Docket Numbers:
Docket No. FDA-2024-N-3653
PDF File:
2024-22575.pdf