Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements

ICR 201501-0910-003

OMB: 0910-0785

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement B
2015-01-13
Supporting Statement A
2015-01-13
ICR Details
0910-0785 201501-0910-003
Historical Active
HHS/FDA CDER
Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 05/18/2015
Retrieve Notice of Action (NOA) 01/15/2015
  Inventory as of this Action Requested Previously Approved
05/31/2018 36 Months From Approved
23,145 0 0
1,681 0 0
0 0 0

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.

US Code: 42 USC 300u(a)(4) Name of Law: PHS Act
   US Code: 21 USC 393(b)(2)(c) Name of Law: FD&C Act
  
None

Not associated with rulemaking

  79 FR 9217 02/18/2014
80 FR 1637 01/13/2015
Yes

4
IC Title Form No. Form Name
Main Study Screener
Pilot Study Screener
Pilot Study
Main Study

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 23,145 0 0 23,145 0 0
Annual Time Burden (Hours) 1,681 0 0 1,681 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$608,730
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
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.
01/15/2015


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