Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing

ICR 201406-0910-012

OMB: 0910-0772

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement B
2014-06-20
Supporting Statement A
2014-06-20
IC Document Collections
ICR Details
0910-0772 201406-0910-012
Historical Active
HHS/FDA CDER
Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 08/21/2014
Retrieve Notice of Action (NOA) 06/30/2014
  Inventory as of this Action Requested Previously Approved
08/31/2017 36 Months From Approved
2,530 0 0
246 0 0
0 0 0

This project is designed to determine how risk communications in direct-to-consumer (DTC) ads are perceived by consumers and to test the effect of distraction in these ads. We plan to conduct 30 in-person 60-minute pretests and 300 in-person 30-minute main interviews with adults who self-identify as needing to lose more than 30 pounds. Participants will be randomly assigned to one of two test conditions (low or high distraction in a DTC TV ad). Participants will watch a fictitious DTC ad, during which we will use eye tracking technology to evaluate their eye movements to measure attention. They will complete a questionnaire that will include measures of recall, perceptions, attitudes, and intentions.

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

Not associated with rulemaking

  78 FR 71621 11/29/2013
79 FR 30614 05/28/2014
Yes

4
IC Title Form No. Form Name
Main Study Screener
Pilot Study Screener
Pilot Study
Main Study

  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 2,530 0 0 2,530 0 0
Annual Time Burden (Hours) 246 0 0 246 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$178,291
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.
06/30/2014


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