Experimental Study on Warning Statements for Cigarette Graphic Health Warnings

Forms and Documents

Document Name	Status
FDA RIHSC approval letter Amendment 12.12.17.pdf Supplementary Document	2018-01-26
FDA RIHSC approval letter Amendment 6.12.17.pdf Supplementary Document	2018-01-26
FDA RIHSC approval letter 5.4.17.pdf Supplementary Document	2018-01-26
Approval Notice.14146.Full.4-27-17.pdf Supplementary Document	2018-01-26
17-032CTP_IRB Chair Letter 5.17.17.pdf Supplementary Document	2018-01-26
Experimental Study on Warning Statements for Cigarette Graphic Health Warnings 1262017 PTA.pdf Supplementary Document	2018-01-26
SS Part A Experimental Study on Graphic Health Warning Statements.docx Supporting Statement A	2018-01-26
SS Part B Experimental Study on Graphic Health Warning Statements.docx Supporting Statement B	2018-01-26

IC Document Collections

IC ID	Document Title	Status
228331	Adolescent Pretest & Main data collection Other-Study Instrument	New
228330	Adolescent Screener Other-Youht Assent	New
228329	Adult Pretest and Main data collection Other-Adult Consent	New
228327	Adult Screener Other-Invitation E-mail	New

ICR Details

OMB Control No: 0910-0848	ICR Reference No: 201708-0910-011
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Experimental Study on Warning Statements for Cigarette Graphic Health Warnings
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: 01/29/2018
	Date Received in OIRA: 09/19/2017
Terms of Clearance: Approved consistent with the understanding that this study is not intended to generate nationally representative outcomes. Due to the study design, convenience sampling methodology, and methods of analyses-- significant limitations exist with regard to the generalizability of results from this study. Panelists are recruited into the online panel using convenience sampling methods, and thus do not have a known probability of selection into the panel. Recruitment of the study sample from the online panel is also subject to bias resulting from potential differences between survey responders (i.e., panelists who received the invitation and opted to participate in our study) and non-responders (i.e., panelists who were invited but chose not to participate) in characteristics that may be associated with key study outcomes. Because of these limitations, the relationship between treatment and outcomes we find in our study may not generalize to the broader U.S. population. FDA confirms that all such limitations inherent in the study design and methodology will be communicated in all reports, presentations, and policy documents.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2021	36 Months From Approved
Responses	22,444	0	0
Time Burden (Hours)	1,305	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This experimental study will examine consumer reactions to two different versions of textual warning statements that focus on the negative health consequences of cigarette use. The aims of the study are to compare the effect of exposure to the 9 original statements in the Tobacco Control Act to revised versions of the statements. The study is part of the agency’s on-going research efforts to develop and test a new set of cigarette graphic health warnings in fulfilment of its statutory obligation under the Tobacco Control Act. This experimental study, conducted online with a web-based panel, will assess consumers’ beliefs and of the negative health consequences of the use of cigarettes in response to various warning statements. Participants will include adolescents (13-17 years) who either are current smokers or are susceptible non-smokers. In addition, young adults (18-24 years) and older adults (25+ years) who are current smokers will be included. The study will examine if the revised warning statements improve public understanding of the risks associated with smoking as compared to the warning statements listed in the Tobacco Control Act.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 201 Name of Law: Tobacco Control 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:
	82 FR 15359	03/28/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 43764	09/19/2017
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Adolescent Screener
Adolescent Pretest & Main data collection
Adult Screener
Adult Pretest and Main data collection

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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	22,444	0	0	22,444	0	0
Annual Time Burden (Hours)	1,305	0	0	1,305	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $177,632

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 09/19/2017

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