Experimental Study: Disease Information in Branded Promotional Material

Forms and Documents

Document Name	Status
Supporting Statement Part B.docx Supporting Statement B	2012-11-06
APPENDIX 1 - 60 Day Federal Register Notice.doc Supplementary Document	2012-06-20
APPENDIX 3 - Regulation.doc Supplementary Document	2012-06-20
Supporting Statement Part A.doc Supporting Statement A	2012-11-06

IC Document Collections

IC ID	Document Title	Status
202841	Number of Completes - Study Other-Appendix 2	New
202840	Number of Completes - Pretests Other-Appendix 2	New
202839	Number of Completes - Screener Other-Appendix 4	New

ICR Details

OMB Control No: 0910-0724	ICR Reference No: 201206-0910-009
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Study: Disease Information in Branded Promotional Material
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: 11/26/2012
	Date Received in OIRA: 06/22/2012
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved. However, the agency must submit a final version of the instrument (as it will be fielded) prior to beginning the study.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2015	36 Months From Approved
Responses	14,338	0	0
Time Burden (Hours)	1,873	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This project will investigate the effects of adding disease information to branded prescription drug promotional materials on consumer perceptions and understanding. Part of FDA's public health mission is to ensure the safe use of prescription drugs; therefore it is important to communicate the risks and benefits of prescription drugs to consumers in a way that is clear, useful and non-misleading. The results from this project will be used by FDA to inform its understanding of DTC advertising, inform regulatory policy, and may also help to identify areas for further research.

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Authorizing Statute(s): US Code: 42 USC 300u(a)(4) Name of Law: Section 1701(a)(4) - Public Health Service Act
   US Code: 21 USC 393(d)(2)(c)) Name of Law: Federal Food, Drug, and Cosmetic Act (the 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
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 50737	08/16/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 37051	06/20/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Number of Completes - Screener
Number of Completes - Pretests
Number of Completes - Study

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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	14,338	0	0	0	14,338	0
Annual Time Burden (Hours)	1,873	0	0	0	1,873	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: $1,500,000

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? 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: 06/22/2012

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