Experimental Evaluation of the Impact of Distraction

Forms and Documents

Document Name	Status
Paragraph for OMB042109.doc Supplementary Document	2009-05-18
Distraction stat info.doc Supporting Statement B	2008-12-02
DTC distraction 071608ss2.doc Supporting Statement A	2008-12-04

IC Document Collections

IC ID	Document Title	Status
187719	Experimental Evaluation of the Impact of Distraction	New
187718	Experimental Evaluation of the Impact of Distraction	New
187717	Experimental Evaluation of the Impact of Distraction	New
187716	Experimental Evaluation of the Impact of Distraction	New

ICR Details

OMB Control No: 0910-0634	ICR Reference No: 200901-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Evaluation of the Impact of Distraction
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/26/2009
	Date Received in OIRA: 01/06/2009
Terms of Clearance: 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
Expiration Date	05/31/2012	36 Months From Approved
Responses	9,600	0	0
Time Burden (Hours)	920	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 300u(a)(4) Name of Law: Public Health Service 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:
	72 FR 47051	08/22/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 79887	12/30/2008
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
Experimental Evaluation of the Impact of Distraction
Experimental Evaluation of the Impact of Distraction
Experimental Evaluation of the Impact of Distraction
Experimental Evaluation of the Impact of Distraction

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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	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $167,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 01/06/2009

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