Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
Extension without change of a currently approved collection
No
Regular
Approved with change
04/18/2025
12/27/2024
Previous terms continue: 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
04/30/2028
36 Months From Approved
04/30/2025
1,768,000
0
661,308
188,534
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
Our estimated burden for the information collection reflects an overall increase of 96,269 hours and a corresponding increase of 1,106,692 responses. We attribute this adjustment to the number of study responses used during the current approval and now estimated for the next 3 years. A greater number of quantitative studies will be conducted over the next 3 years due to the need to develop new creative messages and content. Recent years have seen a dramatic change in media. With the shift to digital media, FDA must adapt to communicate effectively in a digital environment. As digital tobacco use prevention/interventions are still in their infancy, we must better understand the types of digital channels available. To impact public health outcomes, we need to understand how to reach our intended audience. New foundational studies are needed (including those on digital metrics, measurement, and implementation) to support activities and initiatives that will enable the public to receive evidence-based, timely, and clear health communication and education. As a result, we have adjusted our burden estimate and revised the number of respondents to the information 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.
0810 OMB template FINAL.docx
QualitativeandQuantitativeResearchonTobaccoProductsandCommunications342019.pdf