National Panel of Tobacco Consumer Studies

ICR 201802-0910-003

OMB: 0910-0815

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-02-09
Justification for No Material/Nonsubstantive Change
2018-02-08
Justification for No Material/Nonsubstantive Change
2017-07-20
Justification for No Material/Nonsubstantive Change
2017-04-25
Justification for No Material/Nonsubstantive Change
2017-04-21
Justification for No Material/Nonsubstantive Change
2017-01-03
Justification for No Material/Nonsubstantive Change
2016-08-10
Supplementary Document
2016-06-07
Supplementary Document
2016-06-07
Supporting Statement B
2018-02-08
ICR Details
0910-0815 201802-0910-003
Historical Active 201707-0910-013
HHS/FDA CTP
National Panel of Tobacco Consumer Studies
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 02/15/2018
Retrieve Notice of Action (NOA) 02/13/2018
Previous terms continue: When communicating or publishing research outcomes associated with this clearance, CTP will clearly describe the sociodemographic and geographic characteristics of the sample that responded to a given survey, explicitly characterizing potential limitations in generalizability. Consistent with obligations under HHS and OMB’s Information Quality Guidelines, CTP will assess the quality of the information generated by collections conducted under this OMB Control Number for each regulatory or policy purpose under consideration. This first 3 year clearance will cover only the following activities of the panel: Respondent screening, enrollment/replenishment survey, the baseline survey, and the 1st observational study. Future observational studies conducted under this control number will be submitted as revision requests to OMB for formal review.
  Inventory as of this Action Requested Previously Approved
06/30/2019 06/30/2019 06/30/2019
27,935 0 22,793
4,435 0 3,766
0 0 0

The U. S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) proposes to established a high-quality, national panel of about 4,000 tobacco users. The panel will includes individuals who agree to participate in up to 8 experimental or observational studies over a 3-year period to assess consumers’ responses to tobacco marketing, warning statements, product labels, and other communications about tobacco products. CTP proposes the establishment of the panel of consumers because currently existing panels have a number of significant limitations for use in tracking tobacco users.

PL: Pub.L. 111 - 31 201 Name of Law: Tobacco Control Act
  
None

Not associated with rulemaking

  79 FR 62160 10/16/2014
80 FR 32963 06/10/2015
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 27,935 22,793 0 0 5,142 0
Annual Time Burden (Hours) 4,435 3,766 0 0 669 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$5,572,691
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.
02/13/2018


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