Market Claims in Direct-to-Consumer Prescription Drug Print Ads

Forms and Documents

Document	Type	Status	Availability
0824 Justification Memorandum for 83-C change request.pdf	Justification for No Material/Nonsubstantive Change	Uploaded 2017-02-14	Available
Market Claims in DTC Print Ads SS Part A 2016.pdf	Supporting Statement A	Uploaded 2016-07-25	Repair queued
Market Claims in DTC Print Ads SS Part B 2016.pdf	Supporting Statement B	Uploaded 2016-07-25	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
222609	Completes; follow-up study	Other-Survey Recruit and Consent	Unchanged
222608	Completes; pretest 3	Other-Survey Recruit and Consent	Unchanged
222607	Completes; main study	Other-Survey Recruit and Consent	Unchanged
222606	Completes; pretest 2	Other-Survey Recruit and Consent	Unchanged
222605	Completes; pretest 1	Other-Survey Recruit and Consent	Unchanged
222604	Screener completes	Other-Survey Recruit and Consent	Unchanged

ICR Details

OMB Control No: 0910-0824	ICR Reference No: 201702-0910-007
Status: Historical Active	Previous ICR Reference No: 201607-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Market Claims in Direct-to-Consumer Prescription Drug Print Ads
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: 02/16/2017
	Date Received in OIRA: 02/14/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	09/30/2019	09/30/2019
Responses	2,961	0	2,961
Time Burden (Hours)	630	0	630
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this research is to examine the impact of market claims and quantitative efficacy information in direct-to-consumer (DTC) print advertising for prescription drugs. There are two phases to this research: a main study and a follow-up study. In preparation for the main study, we plan to conduct two online 30-minute pretests with 504 adults (252 per pretest) who self-identify as having been diagnosed with diabetes. Following pretests, and to comprise the main study, we plan to conduct 495 online 30-minute surveys with adults who self-identify as having been diagnosed with diabetes. In the pretests and main study, participants will view a DTC ad for diabetic neuropathy with or without two types of marketing claims (#1 Prescribed, New, none). We are also varying the type of quantitative efficacy information about the product (High, Low, none) that provides information about how well the product works. After viewing the fictitious ad, participants will complete a questionnaire that will include measures of perceptions, understanding, attitudes, and intentions. In a follow-up study, we will examine the tradeoff between efficacy and market claim by systematically varying the quantitative efficacy information in the ad. We plan to conduct one online 15-minute pretest for the follow-up study with 108 adults who self-identify as having been diagnosed with diabetes. Following that pretest, and to comprise the follow-up study, we plan to conduct 216 online 15-minute surveys with adults who self-identify as having been diagnosed with diabetes. In the follow-up study, participants will view a series of DTC ads for diabetic neuropathy in sets of two with both a marketing claim and quantitative efficacy information that varies along a continuum of effectiveness in a series of 48 trials. In each comparison, participants will be asked to choose one version of the product ad.

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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:
	80 FR 42823	07/20/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 26807	05/04/2016
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
Screener completes
Completes; pretest 1
Completes; pretest 2
Completes; main study
Completes; pretest 3
Completes; follow-up 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	2,961	2,961	0	0	0	0
Annual Time Burden (Hours)	630	630	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 information collection request to support agency study.

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Annual Cost to Federal Government: $176,581

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 02/14/2017

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