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

ICR 202108-0910-004

OMB: 0910-0810

Federal Form Document

Forms and Documents
Document
Name
Status
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
ICR Details
0910-0810 202108-0910-004
Received in OIRA 202101-0910-013
HHS/FDA CTP
Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
Extension without change of a currently approved collection   No
Regular 09/20/2021
  Requested Previously Approved
36 Months From Approved 10/31/2021
619,308 157,500
85,041 25,041
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

0

  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 619,308 157,500 0 0 461,808 0
Annual Time Burden (Hours) 85,041 25,041 0 0 60,000 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The burden for this information collection is proposed to increase by 60,000 hours from the current inventory. The burden increase is result of an increase in the number of new quantitative studies that are anticipated underneath this information collection during the next three years.

$525,239
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
No
Rachel Showalter 202 693-2146 Showalter.Rachel@dol.gov

  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.
09/20/2021


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