Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0785 Justification Memo for 83-I change request.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2015-10-15	Available
SUPPORTING STATEMENT PART B FINAL 1-7-15.docx	Supporting Statement B	Uploaded 2015-01-13	Available
SUPPORTING STATEMENT PART A FINAL 1-7-15.docx	Supporting Statement A	Uploaded 2015-01-13	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
214502	Main Study	Other-Questionnaire	Modified
214501	Pilot Study	Other-Questionnaire	Modified
214500	Main Study Screener	Other-Questionnaire	Modified
214499	Pilot Study Screener	Other-Questionnaire	Modified

ICR Details

OMB Control No: 0910-0785	ICR Reference No: 201510-0910-006
Status: Historical Active	Previous ICR Reference No: 201501-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television 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: 12/09/2015
	Date Received in OIRA: 10/21/2015
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	05/31/2018	05/31/2018
Responses	23,145	0	23,145
Time Burden (Hours)	1,681	0	1,681
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this study is to investigate the impact of limiting the risks presented in direct-to-consumer (DTC) television ads to those that are serious and actionable, and including a disclosure to alert consumers that there are other product risks not disclosed in the ad. We plan to conduct one online 30-minute pretest with 600 individuals (200 per medical condition) who self-identify as having been diagnosed with insomnia, high cholesterol, or depression. Following the pretest, we plan to conduct 1,500 online (500 per medical condition) 30-minute surveys with adults who self-identify as having been diagnosed with insomnia, high cholesterol, or depression. In the pretest and main study, participants will view a DTC ad for their medical condition that includes either the currently used set of risks and side effects or an abbreviated set including only serious and actionable risks and side effects. Additionally, the risk presentation will either include or not include a disclosure indicating that not all risks were presented. After viewing the ad, participants will complete a questionnaire that will include measures of perceptions, attitudes, and intentions.

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Authorizing Statute(s): US Code: 21 USC 393(b)(2)(c) Name of Law: FD&C Act
   US Code: 42 USC 300u(a)(4) Name of Law: PHS 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:
	79 FR 9217	02/18/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 1637	01/13/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
Main Study Screener
Pilot Study Screener
Pilot Study
Main Study

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ICR Summary of Burden

table that charts list 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	23,145	23,145	0	0	0	0
Annual Time Burden (Hours)	1,681	1,681	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: This is a new data collection.

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Annual Cost to Federal Government: $608,730

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: 10/21/2015

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