Experimental Study of Graphic Cigarette Warning Labels

ICR 201212-0910-002

OMB: 0910-0668

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement B
2012-12-04
Supporting Statement A
2012-12-04
IC Document Collections
IC ID
Document
Title
Status
194510 Modified
194509 Modified
194508 Modified
ICR Details
0910-0668 201212-0910-002
Historical Inactive 201009-0910-002
HHS/FDA
Experimental Study of Graphic Cigarette Warning Labels
Reinstatement without change of a previously approved collection   No
Regular
Withdrawn 01/25/2013
Retrieve Notice of Action (NOA) 12/05/2012
In accordance with the terms of 5 CFR 1320, this collection has been withdrawn by the agency, pending the resolution of ongoing litigation.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
36 Months From Approved
0 0 0
0 0 0
0 0 0

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.

PL: Pub.L. 111 - 31 3 Name of Law: Tobacco Control Act
  
None

Not associated with rulemaking

  77 FR 18250 03/27/2012
77 FR 72355 12/05/2012
Yes

3
IC Title Form No. Form Name
Pre-test
Screener
Experimental Survey

No
No

$975,331
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
12/05/2012


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