Experimental Study of Graphic Cigarette Warning Labels

Forms and Documents

Document	Type	Status	Availability
Supporting_statement_-_Part_B-120412.doc	Supporting Statement B	Uploaded 2012-12-04	Available
Supporting_statement_-_Part_A_0668-120412.doc	Supporting Statement A	Uploaded 2012-12-04	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
194510	Experimental Survey	Instruction	Modified
194509	Screener	Instruction	Modified
194508	Pre-test	Instruction	Modified

ICR Details

OMB Control No: 0910-0668	ICR Reference No: 201212-0910-002
Status: Historical Inactive	Previous ICR Reference No: 201009-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Study of Graphic Cigarette Warning Labels
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn	Conclusion Date: 01/25/2013
	Date Received in OIRA: 12/05/2012
Terms of Clearance: In accordance with the terms of 5 CFR 1320, this collection has been withdrawn by the agency, pending the resolution of ongoing litigation.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: FDA's Center for Tobacco Products will conduct an experimental study to evaluate the relative efficacy of various graphic images depicting the risks of cigarette smoking for influencing consumers' attitudes, beliefs, perceptions, and intended behaviors related to cigarette smoking. The information collected from the study will inform the Agency's efforts to implement the graphic health warnings required by the Tobacco Control Act. Although graphic warnings were to become effective 15 months after the rule was issued, a panel of the U.S. Court of Appeals of the District of Columbia held, on August 24, 2012 that the rule in its current form violates the First Amendment. FDA expects that the information that FDA proposes to collect will be relevant to FDA's regulation of cigarette warnings no matter the final outcome of the current litigation. The current approval for this information collectino expired October 31, 2012, and FDA seeks to reinstate it and to reflect that there is no change in reporting burden. At this time, the Agency is not collecting any information, awaits OMB review and approval, and believes, therefore, that FDA is not in violation of the PRA.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 3 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:
	77 FR 18250	03/27/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 72355	12/05/2012
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
Pre-test
Screener
Experimental Survey

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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: $975,331

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: 12/05/2012

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