Generic Clearance for the Collection of Quantitative 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
Approved consistent with the understanding that FDA will submit individual collections under this generic clearance to OMB. These submissions will include the actual study instruments along with a memo describing the specific study goal, the study design, any incentives to be used, and the sampling and analysis plans. Each IC request should include a justification for the chosen incentive (unless it is equivalent to or less than the pre-approved "standard" for focus groups ($75) and cognitive interviews ($40)). Further, FDA will send OMB an annual report summarizing the number of hours used, as well as the nature and results of the activities completed under this clearance.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
12/31/2024
12/31/2024
12/31/2024
661,308
0
661,308
91,865
0
91,865
0
0
0
The Food and Drug Administration (FDA) is requesting extension of approval of a 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
The Food and Drug Administration is submitting this non-substantive change request to add a second year of data collection to the individual generic approval âMonthly Monitoring Studyâ (ICR Reference 201907-0910-006). The purpose of the Monthly Monitoring Study is to assess changes in vape use and perceptions. Given the evolving tobacco product landscape resulting from changes in product regulations, e-cigarette brand and flavor availability, and the COVID-19 pandemic which has impacted youth vaping, we would like to extend our data collection for another year to continue to track how these factors impact youthâs use and perceptions around vaping in order to inform future communication and educational initiatives. We estimate the burden to be identical for the second year to the first year. Therefore, we are doubling the previous estimate to cover the second-year burden. The new estimated total is 13,650 hours, an increase by 6,824 hours. There are no other changes to the collection.
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 83-C FDA Tobacco Prevention Broad Quantitative Research 11-18-22.docx
Generic Clearance SS A_0820 2021 Final.pdf
Copy Testing of Tobacco Prevention and Cessation Advertisements Research Study