Experimental Evaluation of the Impact of Distraction

ICR 200901-0910-001

OMB: 0910-0634

Federal Form Document

Forms and Documents
Supplementary Document
Supporting Statement B
Supporting Statement A
ICR Details
0910-0634 200901-0910-001
Historical Active
Experimental Evaluation of the Impact of Distraction
New collection (Request for a new OMB Control Number)   No
Approved with change 05/26/2009
Retrieve Notice of Action (NOA) 01/06/2009
This ICR is approved consistent with amended supporting statement. Specifically, FDA acknowledges that there is a tradeoff between the specificity and control of the research setting, and consequently the utility of the findings, and the generalizability of the findings to the field as a whole. While this study has internal validity, therefore, FDA acknowledges that it has limited external validity. Thus, FDA agrees that this study will not be used to directly inform policy but, rather, that this study represents the first step in FDA's process of investigating this issue scientifically. The study is one piece of the puzzle that will help FDA fulfill its mission to protect public health from false and misleading DTC prescription drug advertisements.
  Inventory as of this Action Requested Previously Approved
05/31/2012 36 Months From Approved
9,600 0 0
920 0 0
0 0 0

FDA regulations require that advertisements that make claims about a prescription drug include a "fair balance" of information about the benefits and risks of advertised products, in terms of both content and presentation. Ads can present information in ways that can optimize or skew the relative balance of risks and benefits. Both healthcare providers and consumers have expressed concerns to FDA about the effectiveness of its regulation of manufacturers' Direct-to-Consumer (DTC) prescription drug advertising, especially as it relates to assuring balanced communication of risks compared with benefits.

US Code: 42 USC 300u(a)(4) Name of Law: Public Health Service Act

Not associated with rulemaking

  72 FR 47051 08/22/2007
73 FR 79887 12/30/2008

  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 9,600 0 0 9,600 0 0
Annual Time Burden (Hours) 920 0 0 920 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
The purpose of the proposed study is to gather empirical evidence to address concerns that the use of competing, compelling visual information about potential drug benefits in DTC advertsing interfers with viewers' processing and comprehension of risk information about drugs.

Yes Part B of Supporting Statement
Eliazabeth Berbakos 3018271482


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:
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    (ii) Use of information;
    (iii) Burden estimate;
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    (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.

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