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

ICR 201607-0910-007

OMB: 0910-0824

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-07-25
Supporting Statement B
2016-07-25
ICR Details
0910-0824 201607-0910-007
Historical Active
HHS/FDA CDER
Market Claims in Direct-to-Consumer Prescription Drug Print Ads
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 09/21/2016
Retrieve Notice of Action (NOA) 07/25/2016
  Inventory as of this Action Requested Previously Approved
09/30/2019 36 Months From Approved
2,961 0 0
630 0 0
0 0 0

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.

None
None

Not associated with rulemaking

  80 FR 42823 07/20/2015
81 FR 26807 05/04/2016
Yes

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

  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 0 0 2,961 0 0
Annual Time Burden (Hours) 630 0 0 630 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new information collection request to support agency study.

$176,581
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
07/25/2016


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