Generic Clearance for the
Collection of Quantitative Data on Tobacco Products and
Communications
Extension without change of a currently approved collection
No
Regular
12/27/2024
Requested
Previously Approved
36 Months From Approved
12/31/2024
1,768,000
661,308
188,534
91,865
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.
US Code:
21
USC 355 Name of Law: Federal Food, Drug, and Cosmetic Act
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
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