Experimental Evaluation of Variations in Content & Format of the Brief Summery in D-T-C Print Advertisements for Prescription Drugs

Forms and Documents

Document Name	Status
FDA DTC.doc Supplementary Document	2007-10-05
B.doc Supporting Statement B	2007-05-04
SupportingStatement23_022207 (2).doc Supporting Statement A	2007-05-04

IC Document Collections

IC ID	Document Title	Status
180102	Experimental Evaluation of Variations in Content & Format of the Brief Summery in D-T-C Print Advertisements for Prescription Drugs	New

ICR Details

OMB Control No: 0910-0611	ICR Reference No: 200705-0910-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Evaluation of Variations in Content & Format of the Brief Summery in D-T-C Print Advertisements for Prescription Drugs
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 without change	Conclusion Date: 10/05/2007
	Date Received in OIRA: 05/10/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2010	36 Months From Approved
Responses	1,200	0	0
Time Burden (Hours)	437	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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 trypically accomplished by reprinting the risk-related sections of the prescribing information on an adjacent page of risk informaiton, oten using the original medical terminology. THis approach has drawbacks when used in d-t-c prescriiton drug advertising. Two studies (content and format) are the focus of the current OMB proposal.

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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:
	71 FR 23921	04/25/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 11889	03/14/2007
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Experimental Evaluation of Variations in Content & Format of the Brief Summery in D-T-C Print Advertisements for Prescription Drugs

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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	1,200	0	0	1,200	0	0
Annual Time Burden (Hours)	437	0	0	437	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: This is a new collection of information. The prescription drug advertising regulations specify that the information about risks must included each specific side effect and contraindication from the advertised drug's approved labeling. More recent research and feedback suggests that listing all possible risks may not be the best way to communicate. FDA will use this study to examine how consumers interact with the brief summary.

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Annual Cost to Federal Government: $225,000

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? Yes

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)? Uncollected

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: 05/10/2007

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