Experimental Study of Comparative Direct-to-Consumer (DTC) Advertising

ICR 201307-0910-005

OMB: 0910-0707

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2013-07-22
IC Document Collections
IC ID
Document
Title
Status
200469 Modified
200468 Modified
200467 Modified
ICR Details
0910-0707 201307-0910-005
Historical Active 201112-0910-003
HHS/FDA 20116
Experimental Study of Comparative Direct-to-Consumer (DTC) Advertising
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 07/26/2013
Retrieve Notice of Action (NOA) 07/23/2013
  Inventory as of this Action Requested Previously Approved
04/30/2015 04/30/2015 04/30/2015
26,930 0 26,930
3,240 0 3,240
0 0 0

The present study aims to investigate how consumers interpret and react to DTC comparative drug ads. Specifically, the study will explore two types of drug comparisons in DTC ads: (1) drug efficacy comparisons and (2) other evidence-based comparisons, such as dosing, mechanism of action, and indication. The study findings will inform FDA of relevant consumer issues relating to comparative DTC advertising.

US Code: 21 USC 393(b)(2)(c) Name of Law: Federal Food Drug and Cosmetic Act
   US Code: 42 USC 300u(a)(4) Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

Yes

3
IC Title Form No. Form Name
Screener
Pretests
Questionnaires

  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 26,930 26,930 0 0 0 0
Annual Time Burden (Hours) 3,240 3,240 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,482,034
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.
07/23/2013


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