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

ICR 201806-0910-012

OMB: 0910-0810

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2018-08-10
Supplementary Document
2018-08-10
Supporting Statement B
2018-08-10
Supporting Statement A
2018-10-18
IC Document Collections
IC ID
Document
Title
Status
ICR Details
0910-0810 201806-0910-012
Historical Active 201802-0910-012
HHS/FDA CTP
Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
Revision of a currently approved collection   No
Regular
Approved with change 10/18/2018
Retrieve Notice of Action (NOA) 08/10/2018
FDA will submit full Supporting Statements A and B for each individual Gen IC submission. The supporting statements must describe the specific purpose of the collection, including the way that the resulting data will be analyzed and used (i.e., identify the activity that the developmental work will inform, and broader purpose of the activity that is being informed by the developmental work being conducted in the particular Gen IC). When incentives are used, FDA will provide a thorough justification. Information gathered will not be used for the purpose of substantially informing influential policy decisions, are intended to inform pretesting of tobacco communication messages and other materials directed at consumers, and are not intended to yield results that are statistically projectable, nationally representative, or precise estimates of population parameters
  Inventory as of this Action Requested Previously Approved
10/31/2021 36 Months From Approved 11/30/2018
157,500 0 83,063
19,741 0 9,430
0 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
  
None

Not associated with rulemaking

  83 FR 6190 02/13/2018
83 FR 39449 08/09/2018
Yes

0

  Total Approved 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 157,500 83,063 0 0 74,437 0
Annual Time Burden (Hours) 19,741 9,430 0 0 10,311 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The burden for this information collection is proposed to increase by 10,311 hours from the current inventory. The burden increase is result of including screeners as a method of collection, an increase in the number of respondents and the categories of respondents.

$525,238
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
08/10/2018


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