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.
0910-0810 change request Jan 21.docx
Monthly Monitoring Study (CTP)