Examination of Online Direct-to-Consumer Prescription Drug Promotion

Forms and Documents

Document Name	Status
0910-0714 83c memo 12-6-12.doc Justification for No Material/Nonsubstantive Change	2012-12-06

IC Document Collections

IC ID	Document Title	Status
200956	Study 3 Other-survey	Modified
200955	Study 2 Other-survey	Modified
200954	Study 1 Other-survey	Modified
200953	Pretests Other-survey	Modified
200952	Screener (Part of Survey Instruments)	Modified

ICR Details

OMB Control No: 0910-0714	ICR Reference No: 201212-0910-003
Status: Historical Active	Previous ICR Reference No: 201201-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Examination of Online Direct-to-Consumer Prescription Drug Promotion
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: 12/12/2012
	Date Received in OIRA: 12/07/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2015	07/31/2015	07/31/2015
Responses	26,200	0	26,200
Time Burden (Hours)	4,883	0	4,883
Cost Burden (Dollars)	0	0	0

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Abstract: FDA regulations require that prescription drug advertisements include a "fair balance" of information about the benefits and risks of advertised products, both in terms of the content and presentation of the information (21 CFR 202.1(e)(5). All prescription drug promotion that makes claims about a product must, therefore, also include risk information in a "balanced" manner. Currently, there are a number of questions surrounding how to achieve "fair balance" in online direct-to-consumer (DTC) promotion. This project is designed to test different ways of presenting prescription drug risk and benefit information on branded drug websites. This research is relevant to current policy questions and debate and will complement qualitative research we plan to conduct on issues surrounding social media ("Examination of Online Direct-to-Consumer Prescription Drug Promotion"; OMB Control No. 0910-0677). The series of studies described in this notice will provide data that, along with other input and considerations, will inform the development of future guidance.

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Authorizing Statute(s): US Code: 21 USC 360 Name of Law: Federal Food, Drug, and Cosmetic 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: 5

IC Title	Form No.	Form Name
Screener (Part of Survey Instruments)
Pretests
Study 1
Study 2
Study 3

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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	26,200	26,200	0	0	0	0
Annual Time Burden (Hours)	4,883	4,883	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: $2,019,620

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: 12/07/2012

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