Risk and Benefit Perception Scale Development

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT PART B FINAL 4-14-15.doc Supporting Statement B	2015-04-15
SUPPORTING STATEMENT PART A FINAL 4-15-15.doc Supporting Statement A	2015-04-15

IC Document Collections

IC ID	Document Title	Status
214034	Main Study Other-Questionnaire	New
214033	Pretest Other- Questionnaire	New
214031	Main Study Screener Other-Questionnaire	New
214029	Pretest Screener Other-Email Invitation	New

ICR Details

OMB Control No: 0910-0784	ICR Reference No: 201411-0910-015
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Risk and Benefit Perception Scale Development
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 with change	Conclusion Date: 05/18/2015
	Date Received in OIRA: 11/28/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved
Responses	33,300	0	0
Time Burden (Hours)	6,310	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of this project is to develop and validate risk and benefit perception scales and to explore various methods for measuring perceptions, attitudes, and intentions about prescription drug advertising that can be used for research moving forward. We plan to conduct 1,000 online 30-minute pretests with individuals who self-identify as having been diagnosed with either chronic pain or high blood pressure, 5,000 online 30-minute surveys with adults who self-identify as having been diagnosed with either chronic pain or high blood pressure, and 5,000 online 30-minute surveys with adults from a general population sample who do not have the target medical conditions. In the pretests and self-identified medical condition samples, participants will view an ad that matches their medical condition (chronic pain or hypertension). In the final sample, half of the general population sample will be exposed to the DTC ad for chronic pain, and half will be exposed to the DTC ad for high blood pressure. We are also varying the level of risk (high, low) and benefit (high, low) in the ad. After viewing the fictitious DTC ad, participants will complete a questionnaire that will include measures of perceptions, attitudes, and intentions.

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Authorizing Statute(s): US Code: 21 USC 393(b)(2)(c) Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 42 USC 300u(a)(4) Name of Law: Public Health Service 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 22143	04/21/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 69121	11/20/2014
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
Pretest
Pretest Screener
Main Study
Main Study Screener

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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	33,300	0	0	33,300	0	0
Annual Time Burden (Hours)	6,310	0	0	6,310	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: $1,669,260

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: 11/28/2014

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