Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising

ICR 201301-0910-002

OMB: 0910-0737

Federal Form Document

Forms and Documents
Supporting Statement B
Supporting Statement A
ICR Details
0910-0737 201301-0910-002
Historical Active
Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising
New collection (Request for a new OMB Control Number)   No
Approved without change 03/25/2013
Retrieve Notice of Action (NOA) 01/08/2013
  Inventory as of this Action Requested Previously Approved
03/31/2016 36 Months From Approved
21,541 0 0
5,496 0 0
0 0 0

FDA regulations require prescription drug ads to contain accurate information about the benefits and risks of the drug advertised. When this is not the case, corrective advertising is designed to dissipate or correct erroneous beliefs resulting from a false claim. Corrective advertising is one remedy FDA may request in response to false or misleading prescription drug promotion. The current project will examine the influence of corrective messages in the realm of consumer directed prescription drug advertising. The study will investigate how variations in corrective advertising may influence consumers' product beliefs. Specifically, the study will focus on the following variables of interest: (1) exposure to corrective, (2) visual similarity between the original and corrective ads, and (3) time delay between the original and corrective ads. The study findings will inform FDA of relevant consumer issues relating to corrective DTC advertising.


Not associated with rulemaking

  77 FR 12307 02/29/2012
77 FR 76046 12/26/2012

IC Title Form No. Form Name
Screener completes
Pretest (stimuli) completes
Pretest (questionnaire) completes
Phase 1 completes
Phase 2 completes

  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 21,541 0 0 21,541 0 0
Annual Time Burden (Hours) 5,496 0 0 5,496 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
This is a new information collection request.

Yes Part B of Supporting Statement
Daniel Gitteson 3017965156 [email protected]


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.

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