Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer (DTC) Print Advertisements

Forms and Documents

Document Name	Status
OMB Control No 0910-0703_83C.doc Justification for No Material/Nonsubstantive Change	2012-11-05

IC Document Collections

IC ID	Document Title	Status
198470	Number to Complete the Survey Other-questionnaire	Modified
198468	Number to Complete the Screener Other-Screener	Modified

ICR Details

OMB Control No: 0910-0703	ICR Reference No: 201211-0910-002
Status: Historical Active	Previous ICR Reference No: 201107-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer (DTC) Print Advertisements
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/09/2012
	Date Received in OIRA: 11/06/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2015	02/28/2015	02/28/2015
Responses	80,868	0	80,868
Time Burden (Hours)	6,221	0	6,221
Cost Burden (Dollars)	0	0	0

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Abstract: Section 502(n) of the Federal Food, Drug, and Cosmetic Act specifies that ads for prescription drugs and biological products must provide a true statement of information "in brief summary" about the advertised product's "side effects, contraindications, and effectiveness." The prescription drug advertising regulations (21 CFR ? 202.1(e)(3)(iii); Appendix B) specify that the information about risks must include each specific side effect and contraindication from the advertised drug's FDA-approved labeling, including the Warnings, Precautions, Adverse Reactions, and other relevant sections. Some of the current approaches to fulfilling the brief summary requirement, while adequate from a regulatory perspective, result in ads that may be difficult to read and understand when used in consumer-directed promotion. In recent years, FDA has become concerned about the adequacy of the brief summary in DTC print advertisements for prescription drugs. Because the regulations do not specify how to address each risk, sponsors can use discretion in fulfilling the brief summary requirement under ? 202.1(e)(3)(iii). Frequently, sponsors print in small type, verbatim, the risk-related sections of the approved product labeling (also called the package insert, professional labeling, prescribing information, and direction circular).

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Authorizing Statute(s): US Code: 21 USC 202(e)(3)(iii) Name of Law: FD&C Act
   US Code: 21 USC 502(n) Name of Law: FD&C 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

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Number to Complete the Screener
Number to Complete the Survey

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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	80,868	80,868	0	0	0	0
Annual Time Burden (Hours)	6,221	6,221	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $296,509

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: 11/06/2012

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