Study of Clinical Efficacy Information in Professional Labeling and Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs

Forms and Documents

Document Name	Status
Sample Consumer Invite.pdf Supplementary Document	2011-08-12
Supporting Statement B - Study of Clinical Efficacy Information.doc Supporting Statement B	2011-08-12
Supporting Statement A - Study of Clinical Efficacy Information.doc Supporting Statement A	2011-08-12

IC Document Collections

IC ID	Document Title	Status
196992	Questionaire, consumers Other-Consumer Questionnaire	New
196991	Pretest consumers Other-Consumer Pretest Questionnaire	New
196990	screener, consumers Other-Consumer Screener	New
196989	Qestionaire, Physicians Other-Physician Questionnaire	New
196988	Pretest, Physicians Other-Physician Pretest Questionnaire	New
196987	Screener, Physicians Other-Physician Screener	New

ICR Details

OMB Control No: 0910-0692	ICR Reference No: 201103-0910-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Study of Clinical Efficacy Information in Professional Labeling and Direct-to-Consumer (DTC) 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 with change	Conclusion Date: 08/12/2011
	Date Received in OIRA: 03/20/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2014	36 Months From Approved
Responses	15,512	0	0
Time Burden (Hours)	1,099	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: FDA regulations require that an advertisement that makes claims about a prescription drug include a "fair balance" of information about the benefits and risks of the advertised product, in terms of both content and presentation (21 CFR 202.1(e)(5)(ii)). In past research FDA has focused primarily on the risk component of the risk-benefit ratio. In the interest of thoroughly exploring the issue of fair balance, however, the presentation of effectiveness, or benefit, information is equally important.

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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:
	75 FR 34142	06/16/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 75477	12/03/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Pretest, Physicians
Qestionaire, Physicians
Screener, Physicians
screener, consumers
Pretest consumers
Questionaire, consumers

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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	15,512	0	0	15,512	0	0
Annual Time Burden (Hours)	1,099	0	0	1,099	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: New collection

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Annual Cost to Federal Government: $378,100

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

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: 03/20/2011

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