Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications

ICR 202308-0910-006

OMB: 0910-0810

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2023-08-04
Justification for No Material/Nonsubstantive Change
2023-08-04
Justification for No Material/Nonsubstantive Change
2022-11-18
Justification for No Material/Nonsubstantive Change
2021-12-14
Supporting Statement A
2021-09-16
Supporting Statement B
2021-08-19
Supplementary Document
2021-08-11
Supplementary Document
2021-08-11
IC Document Collections
IC ID
Document
Title
Status
260606 Unchanged
260306 Unchanged
258723 Unchanged
257913 Unchanged
257860 Unchanged
256409 Unchanged
255329 Unchanged
255038 Unchanged
253273 Unchanged
252955 Unchanged
252375 Unchanged
251913 Unchanged
ICR Details
0910-0810 202308-0910-006
Received in OIRA 202211-0910-008
HHS/FDA CTP
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 08/08/2023
  Requested Previously Approved
12/31/2024 12/31/2024
661,308 661,308
91,865 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.
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
  
None
Not associated with rulemaking
  86 FR 12952 03/05/2021
86 FR 51897 09/17/2021
Yes
  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 661,308 661,308 0 0 0 0
Annual Time Burden (Hours) 91,865 91,865 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
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 “Monthly Monitoring Study” (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 youth’s 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.
$525,239
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
No
Jonna Capezzuto 301 796-3794 [email protected]
  No
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.
08/08/2023
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