FDA will submit full Supporting Statements A and B for each individual Gen IC submission. The supporting statements must describe the specific purpose of the collection, including the way that the resulting data will be analyzed and used (i.e., identify the activity that the developmental work will inform, and broader purpose of the activity that is being informed by the developmental work being conducted in the particular Gen IC). When incentives are used, FDA will provide a thorough justification. Information gathered will not be used for the purpose of substantially informing influential policy decisions, are intended to inform pretesting of tobacco communication messages and other materials directed at consumers, and are not intended to yield results that are statistically projectable, nationally representative, or precise estimates of population parameters
Inventory as of this Action
Requested
Previously Approved
11/30/2018
11/30/2018
11/30/2018
83,063
0
21,600
9,430
0
7,128
0
0
0
The Food and Drug Administration (FDA) is requesting approval of a new generic for collecting information through the use of quantitative methods for studies about tobacco products. FDA will need to employ quantitative research, including surveys and experimental studies to assess knowledge and perceptions about tobacco-related topics with specific target audiences. FDA will only submit an individual generic collection for approval under this generic clearance if the individual collection meets the outlined conditions.
PL:
Pub.L. 111 - 111 31
Name of Law: Family Smoking Prevention and Tobacco Control Act
US Code:
21 USC 372
Name of Law: Federal Food, Drug, and Cosmetic Act
US Code:
21 USC 393(d)(2)(D)
Name of Law: Federal Food, Drug, and Cosmetic Act
US Code:
42 USC 241(a)
Name of Law: Public Health Service Act
US Code:
21 USC 355
Name of Law: Federal Food, Drug, and Cosmetic 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.
0910-0810 change request Feb 18.docx
Gen IC Memo Quantitative data on Tobacco Products and Comminucations Gen IC Memo.doc
The Real Cost Campaign: Online Quantitative Study of Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use