Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1

ICR 200604-0910-005

OMB: 0910-0591

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ICR Details
0910-0591 200604-0910-005
Historical Active
Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
New collection (Request for a new OMB Control Number)   No
Approved with change 05/25/2006
Retrieve Notice of Action (NOA) 04/27/2006
This study is approved consistent with the revised supporting statement and survey instruments of 5/24/06. The study design is appropriate for the purpose of the study identified in the supporting statement. However, in describing the data collected and results of the analysis, FDA will clearly acknowledge that the sample for this study represents a convenience sample and as such the results do not provide nationally representative estimates of consumer attitudes, knowledge, behaviors, etc.
  Inventory as of this Action Requested Previously Approved
05/31/2009 05/31/2009
1 0 0
156 0 0
0 0 0

Current regulations require a brief summary of risk information to accompany prescription drug advertisements (CFR 202.1(e)(3) (iii). In print ads, this is typically accomplished by reprinting the risk-related sections of the prescribing information on an adjacent page of risk information, often using the original medical terminology. This approach has drawbacks when used in direct-to-consumer prescription drug advertising. Consumers may use the brief summary for many purposes, such as to learn about new treatments, to compare with other prescription brands or over-the-counter (OTC)......



  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 1 0 0 1 0 0
Annual Time Burden (Hours) 156 0 0 156 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0



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