Experimental Study on Warning Statements for Cigarette Graphic Health Warnings

ICR 201708-0910-011

OMB: 0910-0848

Federal Form Document

Forms and Documents
ICR Details
0910-0848 201708-0910-011
Historical Active
Experimental Study on Warning Statements for Cigarette Graphic Health Warnings
New collection (Request for a new OMB Control Number)   No
Approved with change 01/29/2018
Retrieve Notice of Action (NOA) 09/19/2017
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
01/31/2021 36 Months From Approved
22,444 0 0
1,305 0 0
0 0 0

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.

PL: Pub.L. 111 - 31 201 Name of Law: Tobacco Control Act

Not associated with rulemaking

  82 FR 15359 03/28/2017
82 FR 43764 09/19/2017

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

  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
Miscellaneous Actions
This is a new information collection.

Jonna Capezzuto 301 796-3794 [email protected]


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.

© 2021 OMB.report | Privacy Policy