Pretesting of Tobacco Communications

Forms and Documents

Document	Type	Status	Availability
Tobacco Pretesting Part B SS final 1_17_13.doc	Supporting Statement B	Uploaded 2013-01-18	Available
SS for Pretesting of TB Comm Part A final.doc	Supporting Statement A	Uploaded 2013-01-18	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
211627	Online Quantitative Study of Youth Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use among General Market Youth (Wave 2)	Other-Questionnaire	New
210807	Focus Group Study of Youth Reactions to Creative Advertising Concepts Designed to Reduce Tobacco Use among General Market Youth	Other-Youth Assent	New
210333	Focus Groups with Rural Youth to Test Strategic Concepts Designed to Prevent Youth Smokeless Tobacco Use	Other-Parental Consent Form	New
209915	Youth Reactions to Creative Advertising Concepts Designed to Reduce Tobacco Use among Multicultural Youth	Other-Brand Test Stimuli	New
208858	Online Quantitative Study of Youth Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use	Other-Stimuli	New
208132	Online Qualitative Study of Youth Reactions to Strategic Concepts Designed to Prevent Youth Tobacco Use	Other-Stimuli	New
207764	Focus Group Study of Youth Reactions to Creative Advertising Concepts Designed to Reduce Tobacco Use	Other-Discussion Guide Experimenter Group	New
206333	Interviews with Tobacco Retailers to Inform Retailer Education	Other-Appendix B2 Manager Recruitment Materials	New

ICR Details

OMB Control No: 0910-0674	ICR Reference No: 201301-0910-006
Status: Historical Active	Previous ICR Reference No: 201009-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: 18544
Title: Pretesting of Tobacco Communications
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/28/2013
	Date Received in OIRA: 01/28/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2016	36 Months From Approved	03/31/2013
Responses	16,448	0	16,448
Time Burden (Hours)	2,860	0	2,860
Cost Burden (Dollars)	0	0	0

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Abstract: In order to conduct educational and public information programs relating to tobacco use, as authorized by section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(D)), and to develop stronger health warnings on tobacco packaging as authorized by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), it is beneficial for the Food and Drug Administration (FDA) to conduct research and studies relating to the control and prevention of disease as authorized by section 301 of the Public Health Service Act (42 U.S.C 241(a)). In this generic collection of information, FDA will use formative pretests to assess the likely effectiveness of tobacco communications with specific target audiences. The information collected will serve two major purposes: (1) It will provide the critical knowledge needed about target audiences and the decisionmaking process when choosing to use, not use, or quit using tobacco products, including adolescents (ages 13 to 17) where communications will aim to discourage tobacco use before it starts. (2) It will allow FDA to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences. Pretesting messages with a sample of the target audience will allow FDA to refine messages while they are still in the developmental stage.

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Authorizing Statute(s): US Code: 21 USC 393 Name of Law: FFDCA
  

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:
	77 FR 49819	08/17/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 5462	01/25/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Focus Groups with Rural Youth to Test Strategic Concepts Designed to Prevent Youth Smokeless Tobacco Use
Focus Group Study of Youth Reactions to Creative Advertising Concepts Designed to Reduce Tobacco Use
Online Qualitative Study of Youth Reactions to Strategic Concepts Designed to Prevent Youth Tobacco Use
Focus Group Study of Youth Reactions to Creative Advertising Concepts Designed to Reduce Tobacco Use among General Market Youth
Interviews with Tobacco Retailers to Inform Retailer Education
Online Quantitative Study of Youth Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use
Online Quantitative Study of Youth Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use among General Market Youth (Wave 2)
Youth Reactions to Creative Advertising Concepts Designed to Reduce Tobacco Use among Multicultural Youth

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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	16,448	16,448	0	0	0	0
Annual Time Burden (Hours)	2,860	2,860	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: $225,239

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: 01/28/2013

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