Experimental Study of Cigarette Warnings

Forms and Documents

Document Name	Status
Statistical Analysis Plan.pdf Supplementary Document	2018-12-21
Experimental Study of Cigarette Warnings SS Part B - CTP Clean 3.8.19.docx Supporting Statement B	2019-03-08
Experimental Study of Cigarette Warnings SS Part A - CTP Clean 3.8.19.docx Supporting Statement A	2019-03-08
IRB Approval Letters.pdf Supplementary Document	2018-12-21
Experimental Study on Cigarette Graphic Health Warnings 2nd Study Privacy Analysis.pdf Supplementary Document	2018-12-21

IC Document Collections

IC ID	Document Title	Status
234614	Adolescent - Main data collection Other-Youth Assent Session 1	New
234613	Adolescent -Screener for main data collection Other-Screener Survey	New
234612	Adolescent -Pretest Other-Session 1 Survey	New
234611	Adolescent -Screener for pretest Other-Email to Parents of Adolescents	New
234610	Adult - Main data collection Other-Adult Consent Session 1	New
234609	Adult -Screener for main data collection Other-Screener Survey	New
234608	Adult - Pretest Other-Session 1 Survey	New
234607	Adult -Screener for pretest Other-Email to Adults	New

ICR Details

OMB Control No: 0910-0866	ICR Reference No: 201812-0910-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Experimental Study of Cigarette 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: 03/08/2019
	Date Received in OIRA: 12/21/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2022	36 Months From Approved
Responses	91,267	0	0
Time Burden (Hours)	6,562	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: FDA’s Center for Tobacco Products will conduct this experimental study to inform its implementation of section 201 of the Tobacco Control Act to issue a rule directing the use of textual warning statements accompanied by color graphics depicting the negative health consequences of cigarette smoking. The purpose of this experimental study is twofold: (1) it builds upon previous research that informed the selection of textual warning statement and image pairings that are designed to be the most effective in increasing public understanding of the negative health consequences of cigarette smoking; and (2) it eventually will support a proposed rule in fulfilment of the Agency’s statutory obligation under section 201 of the Tobacco Control Act.

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Authorizing Statute(s): None

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:
	83 FR 48625	09/26/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 65685	12/21/2018
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
Adult -Screener for pretest
Adult - Pretest
Adult -Screener for main data collection
Adult - Main data collection
Adolescent -Screener for pretest
Adolescent -Pretest
Adolescent -Screener for main data collection
Adolescent - 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	91,267	0	0	0	91,267	0
Annual Time Burden (Hours)	6,562	0	0	0	6,562	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: New collection

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Annual Cost to Federal Government: $898,363

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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.     Yes

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: 12/21/2018

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