Communicating Composite Scores in Direct-to-Consumer (DTC) Prescription Drug Advertising

Forms and Documents

Document Name	Status
Supporting statement Part B Composite Scores.docx Supporting Statement B	2013-05-14
Supporting statement Part A Composite Scores.docx Supporting Statement A	2013-05-14

IC Document Collections

IC ID	Document Title	Status
206931	Study Phase 2 Main Study Other-Pretest	New
206930	Study Phase 2 Pretest Other-Pretest	New
206929	Study Phase 2 Informed Consent Other-Informed Consent	New
206928	Study Phase 1 Main Study Other-Pretest	New
206927	Study Phase 1 Pretest Other-Pretest	New
206926	Study Phase 1 Informed Consent Other-Informed Consent	New

ICR Details

OMB Control No: 0910-0743	ICR Reference No: 201305-0910-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: 19459
Title: Communicating Composite Scores in Direct-to-Consumer (DTC) Prescription Drug Advertising
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: 07/26/2013
	Date Received in OIRA: 05/16/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2016	36 Months From Approved
Responses	8,004	0	0
Time Burden (Hours)	1,321	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The main goal of the current research is to evaluate how consumers interpret and respond to DTC prescription drug advertising that includes benefit information based on composite scores. Specifically, this research will explore: 1. Whether consumers are aware of how efficacy is measured for specific drugs; 2. How well consumers comprehend the concept of composite scores; 3. Whether exposure to DTC advertisements with composite scores influences consumers' perceptions of a drug's efficacy and risk; and 4. Different methods for presenting composite scores in DTC ads to maximize consumer comprehension and informed decision-making.

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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 21 U.S.C. 393(d)(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:
	77 FR 51027	08/23/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 28224	05/14/2013
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
Study Phase 1 Informed Consent
Study Phase 1 Pretest
Study Phase 1 Main Study
Study Phase 2 Informed Consent
Study Phase 2 Pretest
Study Phase 2 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	8,004	0	0	8,004	0	0
Annual Time Burden (Hours)	1,321	0	0	1,321	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: $356,082

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: 05/16/2013

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