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
01/21/2021
Requested
Previously Approved
10/31/2021
10/31/2021
157,500
157,500
25,041
19,741
0
0
The Food and Drug Administration (FDA)
is requesting approval of a new 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 5,300 burden hours. The new estimated total is 25,041 hours.
FDA will use these hours to seek OMB approval for remaining studies
prior to seeking an extension of the umbrella information
collection. No other changes are occurring.
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.