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.
table that charts list comparision
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 agencyâs 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 consumersâ 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.
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.
FDA RIHSC approval letter Amendment 12.12.17.pdf
SS Part A Experimental Study on Graphic Health Warning Statements.docx
Adolescent Pretest & Main data collection