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

ICR 201402-0910-001

OMB: 0910-0737

Federal Form Document

Forms and Documents
Justification for No Material/Nonsubstantive Change
ICR Details
0910-0737 201402-0910-001
Historical Active 201301-0910-002
HHS/FDA 21386
Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising
No material or nonsubstantive change to a currently approved collection   No
Approved without change 02/26/2014
Retrieve Notice of Action (NOA) 02/03/2014
  Inventory as of this Action Requested Previously Approved
03/31/2016 03/31/2016 03/31/2016
22,341 0 21,541
6,296 0 5,496
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


  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 22,341 21,541 0 0 800 0
Annual Time Burden (Hours) 6,296 5,496 0 0 800 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

Yes Part B of Supporting Statement
ILa Mizrachi 301 796-7726 [email protected]


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