Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL PART B 6-5-2015.docx Supporting Statement B	2015-06-29
SUPPORTING STATEMENT FINAL PART A 6-5-2015.docx Supporting Statement A	2015-06-29

IC Document Collections

IC ID	Document Title	Status
217235	Number of Completes, Main Study Other-Survey	New
217233	Pretest 2 Completes Other-Survey	New
217231	Pretest 1 Completes Other-Survey	New
217228	Number of Main Study Screener Completes (assumes 10% eligible) Other-Survey	New
217227	Pretest 2 Screener Completes (assumes 10% eligible) Other-Survey	New
217221	Pretest 1 Screener Completes (assumes 10% eligible) Other-Survey	New

ICR Details

OMB Control No: 0910-0803	ICR Reference No: 201506-0910-030
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads
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: 09/30/2015
	Date Received in OIRA: 06/29/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved
Responses	8,970	0	0
Time Burden (Hours)	1,954	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this study is to examine effects of variation in exposure frequency to direct-to-consumer (DTC) prescription drug television ads. We plan to conduct up to two pretests with 105 individuals each, with adults who self-identify as having been diagnosed with seasonal allergies. Following the pretests, we plan to conduct the main study with 600 adults who self-identify as having been diagnosed with seasonal allergies. In the pretests and main study, participants will view a DTC ad for seasonal allergies one, two, or four times, depending on the experimental condition. The DTC ad will be embedded in clutter reels and presented as part of 42 minutes of television programming. Combined, the television show and clutter reels will make up a 60-minute television package. After viewing the stimuli, participants will complete a questionnaire that will include measures of perception, memory, judgments about the ad, intentions to use the medication advertised, and possible moderators of effects, such as need for cognition and demographics.

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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:
	79 FR 67172	11/12/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 34672	06/17/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Pretest 1 Screener Completes (assumes 10% eligible)
Pretest 2 Screener Completes (assumes 10% eligible)
Number of Main Study Screener Completes (assumes 10% eligible)
Pretest 1 Completes
Pretest 2 Completes
Number of Completes, 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	8,970	0	0	8,970	0	0
Annual Time Burden (Hours)	1,954	0	0	1,954	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: $1,198,806

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: 06/29/2015

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