FDA will submit a mini-supporting statement for each individual Gen IC submission. The mini-supporting statement must describe the specific purpose of the collection, including the way that the resulting data will be 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 justification.
Inventory as of this Action
Requested
Previously Approved
07/31/2021
36 Months From Approved
07/31/2018
11,589
0
24,050
9,293
0
29,059
0
0
0
The Food and Drug Administration (FDA) is requesting approval of a new generic for collecting information through the use of qualitative methods for studies about tobacco products. FDA will employ qualitative research, including individual in-depth interviews (IDIs), small group discussions, and focus groups to explore 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.
US Code:
21 USC 355
Name of Law: Family Smoking Prevention And Tobacco Control Act
US Code:
21 USC 393
Name of Law: FFDCA
FDA has updated the existing burden from 6,184 to an estimated 9,293 hours. This is based on our experience the last three years and forecasting the generics to be submitted during the next approval. Additionally, we have also updated the cost burden estimate and the cost to the Federal government based on current salary figures.
FDA is also noting that the burden figures in ROCIS (24,050 responses and 29,059 hours) are incorrect. An error was made after approval and the updated burden was not entered into ROCIS. The burden should have been updated to 14,800 responses and 6,184 hours.
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.
0796 Generic Clearance_SS B_qualitative Clean.docx
Creative Concept Testing Designed to Prevent Youth ENDS, Cigarette ad Other Tobacco Product