Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer Prescription Drug Advertisements

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
SUPPORTING STATEMENT PART B FINAL SPOUSAL INFLUENCE STUDY 6-3-2015.docx	Supporting Statement B	Uploaded 2015-06-03	Repair queued
SUPPORTING STATEMENT PART A FINAL SPOUSAL INFLUENCE STUDY 6-3-2015.docx	Supporting Statement A	Uploaded 2015-06-03	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
216852	Main Study - Number of Completes	Other-Survey	New
216851	Main Study - Number to Complete the Screener	Other-Screening Questions	New
216850	Pretesting - Number of Completes	Other-Survey	New
216849	Pretesting - Number to Complete the Screener	Other-Screening questions	New

ICR Details

OMB Control No:	ICR Reference No: 201506-0910-007
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer Prescription Drug Advertisements
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OIRA Conclusion Action: Withdrawn	Conclusion Date: 12/11/2015
	Date Received in OIRA: 06/09/2015
Terms of Clearance: FDA withdraws this collection for further consideration.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this study is to examine differences between consumers viewing direct-to-consumer (DTC) prescription drug ads with a spouse or partner versus alone, in order to generate insight about the social context in which DTC ads are viewed. We plan to conduct pretesting with 120 adults, including individuals who self-identify as having been diagnosed with asthma and their spouse or partner. Following the pretests, we plan to conduct the main study with 792 adults, again including individuals who self-identify as having been diagnosed with asthma and their spouse or partner. In the pretests and main study, participants will view a DTC prescription drug television ad for asthma characterized by either high benefits and risks or low benefits and risks, depending on experimental condition. In addition, participants will view this ad either alone or with their spouse or partner, depending on experimental condition. After viewing the stimuli, participants will complete a questionnaire that will include measures of perceptions, attitudes, and intentions.

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 68278	11/14/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 30077	05/26/2015
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Pretesting - Number to Complete the Screener
Pretesting - Number of Completes
Main Study - Number to Complete the Screener
Main Study - Number of Completes

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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: $1,163,454

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: 06/09/2015

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