National Panel of Tobacco Consumer Studies

ICR 202004-0910-008

OMB: 0910-0815

Federal Form Document

Forms and Documents
Justification for No Material/Nonsubstantive Change
Supporting Statement B
Supporting Statement A
ICR Details
0910-0815 202004-0910-008
Active 201903-0910-010
National Panel of Tobacco Consumer Studies
No material or nonsubstantive change to a currently approved collection   No
Approved without change 04/29/2020
Retrieve Notice of Action (NOA) 04/28/2020
  Inventory as of this Action Requested Previously Approved
02/28/2023 02/28/2023 02/28/2023
15,602 0 15,602
3,340 0 3,340
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

Not associated with rulemaking

  83 FR 53485 10/23/2018
84 FR 22862 05/20/2019

IC Title Form No. Form Name
Panel Replenishment Baseline and Enrollment Survey
Study B and Study C
Panel Replenishment Household Screening Respondent

  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 15,602 15,602 0 0 0 0
Annual Time Burden (Hours) 3,340 3,340 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
FDA is requesting an extension on the currently approved information collection request for remaining planned studies, panel maintenance and replenishment activities and non-substantive changes to update the estimated burden for an additional year of panel replenishment. The average annual burden hours will increase by 1,699 hours, from 4,435 to 6,134 hours.

Yes Part B of Supporting Statement
Domini Bean 301 796-5733 [email protected]


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.

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