Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising

Forms and Documents

Document Name	Status
Justification Memorandum for 83-C change request 01-30-14.doc Justification for No Material/Nonsubstantive Change	2014-01-30

IC Document Collections

IC ID	Document Title	Status
205296	Phase 2 completes 54% Other-Phase 2	Modified
205295	Phase 1 completes 65% Other-Phase 1	Modified
205294	Pretest (questionnaire) completes 65% Other-Pretest 2	Modified
205293	Pretest (stimuli) completes 65% Other-Pretest	Modified
205292	Screener completes 60% Other-Consent Screen	Modified

ICR Details

OMB Control No: 0910-0737	ICR Reference No: 201402-0910-001
Status: Historical Active	Previous ICR Reference No: 201301-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: 21386
Title: Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/26/2014
	Date Received in OIRA: 02/03/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2016	03/31/2016	03/31/2016
Responses	22,341	0	21,541
Time Burden (Hours)	6,296	0	5,496
Cost Burden (Dollars)	0	0	0

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Abstract: FDA regulations require prescription drug ads to contain accurate information about the benefits and risks of the drug advertised. When this is not the case, corrective advertising is designed to dissipate or correct erroneous beliefs resulting from a false claim. Corrective advertising is one remedy FDA may request in response to false or misleading prescription drug promotion. The current project will examine the influence of corrective messages in the realm of consumer directed prescription drug advertising. The study will investigate how variations in corrective advertising may influence consumers' product beliefs. Specifically, the study will focus on the following variables of interest: (1) exposure to corrective, (2) visual similarity between the original and corrective ads, and (3) time delay between the original and corrective ads. The study findings will inform FDA of relevant consumer issues relating to corrective DTC advertising.

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Authorizing Statute(s): None

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

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Screener completes 60%
Pretest (stimuli) completes 65%
Pretest (questionnaire) completes 65%
Phase 1 completes 65%
Phase 2 completes 54%

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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	22,341	21,541	0	0	800	0
Annual Time Burden (Hours)	6,296	5,496	0	0	800	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $386,286

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 02/03/2014

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