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

ICR 201802-0910-012

OMB: 0910-0810

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2018-02-15
Supporting Statement A
2018-02-15
Supplementary Document
2015-05-27
Supporting Statement B
2015-10-23
ICR Details
0910-0810 201802-0910-012
Historical Active 201411-0910-008
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
Approved without change 02/20/2018
Retrieve Notice of Action (NOA) 02/15/2018
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
11/30/2018 11/30/2018 11/30/2018
83,063 0 21,600
9,430 0 7,128
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

  79 FR 41696 07/17/2014
79 FR 70873 11/28/2014
Yes

  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 83,063 21,600 0 0 61,463 0
Annual Time Burden (Hours) 9,430 7,128 0 0 2,302 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$525,238
Yes Part B of Supporting Statement
    Yes
    Yes
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.
02/15/2018


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