The purpose of this study is to
investigate the impact of limiting the risks presented in
direct-to-consumer (DTC) television ads to those that are serious
and actionable, and including a disclosure to alert consumers that
there are other product risks not disclosed in the ad. We plan to
conduct one online 30-minute pretest with 600 individuals (200 per
medical condition) who self-identify as having been diagnosed with
insomnia, high cholesterol, or depression. Following the pretest,
we plan to conduct 1,500 online (500 per medical condition)
30-minute surveys with adults who self-identify as having been
diagnosed with insomnia, high cholesterol, or depression. In the
pretest and main study, participants will view a DTC ad for their
medical condition that includes either the currently used set of
risks and side effects or an abbreviated set including only serious
and actionable risks and side effects. Additionally, the risk
presentation will either include or not include a disclosure
indicating that not all risks were presented. After viewing the ad,
participants will complete a questionnaire that will include
measures of perceptions, attitudes, and intentions.
Ila Mizrachi 301 796-7726
ila.mizrachi@fda.hhs.gov
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.