Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements

Forms and Documents

Document Name	Status
Justification Memo 0791 for 83-I change request 10-14-15.docx Justification for No Material/Nonsubstantive Change	2015-10-15
SUPPORTING STATEMENT PART B FINAL 3-18-15.doc Supporting Statement B	2015-03-18
SUPPORTING STATEMENT PART A FINAL 3-18-15.doc Supporting Statement A	2015-03-18

IC Document Collections

IC ID	Document Title	Status
215729	Completes, Main Study Other-Provider Survey	Modified
215728	Completes, Pretest Phase 2 Other-Provider Survey	Modified
215727	Completes, Pretests Phase 1 Other-Consumer Survey	Modified
215726	Screener Completes Other-Screener Items	Unchanged

ICR Details

OMB Control No: 0910-0791	ICR Reference No: 201510-0910-007
Status: Historical Active	Previous ICR Reference No: 201503-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements
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: 12/09/2015
	Date Received in OIRA: 10/21/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	05/31/2018	05/31/2018
Responses	11,740	0	11,740
Time Burden (Hours)	2,392	0	2,392
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this study is to examine the impact of price comparison information and additional contextual information on prescription drug product perceptions in direct-to-consumer (DTC) and health care-directed professional advertising for prescription drugs. We plan to conduct one online 30-minute pretest with 400 individuals who self-identify as having been diagnosed with diabetes, and one online 30-minute pretest with physicians who are General Practitioners or Specialists. Following the pretests, we plan to conduct 1,500 online 30-minute surveys with adults who self-identify as having been diagnosed with diabetes, and 1,440 online 30-minute surveys with physicians who are General Practitioners or Specialists. In the pretests and main study, participants will view a DTC ad (consumers) or professional ad (physicians) for diabetic neuropathy with or without a claim that compares the fictitious drug to another treatment for this indication. We are also varying the presence of context (yes, no) that explains the two products may not be comparable in terms of efficacy and safety and that the acquisition costs do not necessarily reflect the actual prices paid. After viewing the fictitious 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(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:
	79 FR 26255	05/07/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 18407	04/06/2015
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
Screener Completes
Completes, Pretests Phase 1
Completes, Pretest Phase 2
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	11,740	11,740	0	0	0	0
Annual Time Burden (Hours)	2,392	2,392	0	0	0	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: This is a new data collection.

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Annual Cost to Federal Government: $876,381

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: 10/21/2015

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