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

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT PART B FINAL 4-30-14.doc Supporting Statement B	2014-06-20
SUPPORTING STATEMENT PART A FINAL 4-30-14.doc Supporting Statement A	2014-06-20

IC Document Collections

IC ID	Document Title	Status
212022	Main Study Other-Questionnaire	New
212021	Pilot Study Other-Questionnaire	New
212020	Main Study Screener Other-Quesionnaire	New
212019	Pilot Study Screener Other-Questionnaire	New

ICR Details

OMB Control No: 0910-0772	ICR Reference No: 201406-0910-012
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/21/2014
	Date Received in OIRA: 06/30/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved
Responses	2,530	0	0
Time Burden (Hours)	246	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): 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
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 71621	11/29/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 30614	05/28/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

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

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new data collection.

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Annual Cost to Federal Government: $178,291

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 06/30/2014

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