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

ICR 201112-0910-003

OMB: 0910-0707

Federal Form Document

IC Document Collections
ICR Details
0910-0707 201112-0910-003
Historical Active
HHS/FDA
Experimental Study of Comparative Direct-to-Consumer (DTC) Advertising
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 04/09/2012
Retrieve Notice of Action (NOA) 12/14/2011
  Inventory as of this Action Requested Previously Approved
04/30/2015 36 Months From Approved
26,930 0 0
3,240 0 0
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

  76 FR 38663 07/01/2011
76 FR 76978 12/09/2011
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 0 0 26,930 0 0
Annual Time Burden (Hours) 3,240 0 0 3,240 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$1,482,034
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Johnny Vilela 301 796-3792 juanmanuel.vilela@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.
12/14/2011


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