Quantitative Information in Direct-to-Consumer Television Advertisements Survey

ICR 201804-0910-011

OMB: 0910-0821

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2018-04-09
Justification for No Material/Nonsubstantive Change
2018-04-09
Supporting Statement B
2016-03-31
Supporting Statement A
2016-03-31
ICR Details
0910-0821 201804-0910-011
Historical Active 201709-0910-007
HHS/FDA CDER
Quantitative Information in Direct-to-Consumer Television Advertisements Survey
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 05/15/2018
Retrieve Notice of Action (NOA) 05/04/2018
  Inventory as of this Action Requested Previously Approved
08/31/2019 08/31/2019 08/31/2019
7,239 0 4,826
1,119 0 746
0 0 0

This project is designed to test consumers’ understanding of quantitative information about prescription drugs in direct-to-consumer (DTC) television ads. We plan to conduct two 20-minute surveys with adults 60 years or older. In Study 1, 900 participants will be randomly assigned to one of nine test conditions. The conditions will vary by the type of quantitative efficacy information (none, simple, or complex) and the type of quantitative risk information (none, general, or specific) in a DTC television ad for a fictitious prescription drug to treat cataracts. In Study 2, 900 participants will be randomly assigned to one of six test conditions. The conditions will vary by the type of quantitative efficacy information (none, simple) and the type of efficacy images in the ad (none, accurate improvement, overstated improvement) in the same DTC ad as in Study 1. Participants will watch the DTC television ad and then will complete a questionnaire that will include measures of recall, perceptions, attitudes, and intentions.

US Code: 21 USC 393(b)(2)(c) Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  80 FR 61433 10/13/2015
81 FR 14855 03/18/2016
Yes

  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 7,239 4,826 0 0 2,413 0
Annual Time Burden (Hours) 1,119 746 0 0 373 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Reconduct Study 2 with a slightly revised questionnaire.

$321,746
Yes Part B of Supporting Statement
    No
    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.
05/04/2018


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