Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
No material or nonsubstantive change to a currently approved collection
No
Regular
Approved without change
11/25/2022
11/22/2022
Previous terms continue: Terms of Clearance: 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. Feedback collected under this generic clearance will not yield data that can be generalized to the overall population. Findings will be used to only to inform experimental research, public education, or communication activities.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
07/31/2024
07/31/2024
07/31/2024
28,174
0
28,174
14,934
0
14,934
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
Our estimated burden for the information collection reflects an overall increase of 5,641 hours and a corresponding increase of 16,585 responses The burden is now estimated to be 14,934 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.
Creative Concept Testing Designed to Prevent Youth and Young Adult Cigarette Smoking (Wave 7)