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Federal forms, ICRs, and supporting documents

Information Collection Request

Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products and Tobacco Smoke

ICR 202009-0910-007 · OMB 0910-0880 · Active

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2020-09-17
Supplementary Document
2020-09-17
Justification for No Material/Nonsubstantive Change
2020-08-11
Justification for No Material/Nonsubstantive Change
2020-03-13
Supplementary Document
2020-03-13
Supplementary Document
2020-03-13
Supplementary Document
2019-07-02
Supporting Statement B
2019-07-02
Supporting Statement A
2020-03-13
IC Document Collections
IC ID
Document
Title
Status
236787 Modified
236639 Unchanged
236207 Unchanged
236205 Unchanged
ICR Details
0910-0880 202009-0910-007
Active 202008-0910-017
HHS/FDA CTP
Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products and Tobacco Smoke
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 09/18/2020
Retrieve Notice of Action (NOA) 09/17/2020
  Inventory as of this Action Requested Previously Approved
11/30/2022 11/30/2022 11/30/2022
22,950 0 22,950
2,550 0 2,550
0 0 0
The U.S. Food and Drug Administration’s (FDA’s) Center for Tobacco Products (CTP) is seeking to conduct an experimental/quantitative study consisting of adult and youth (13 to 17 years old) participants to evaluate the best way to convey information about harmful and potentially harmful constituents (HPHCs) in tobacco products and smoke (by brand and by quantity in each brand and subbrand) in a format that is understandable and not misleading to a layperson. The purpose of the research is to gain insight on consumer comprehension of and preferences regarding presentation of information about HPHCs in tobacco products and tobacco smoke, which will inform the Agency’s efforts to implement the mandatory publicly available list of HPHCs required by the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act). Participants will view sample formats and will complete an online survey that will include questions regarding understanding and misleadingness of the HPHC information.
None
None
Not associated with rulemaking
  84 FR 3188 02/11/2019
84 FR 30721 06/27/2019
Yes
4
IC Title Form No. Form Name
Adult - Survey
Youth - Screener
Youth - Survey
Adult - Screener
  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 22,950 22,950 0 0 0 0
Annual Time Burden (Hours) 2,550 2,550 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Updated burden estimates to reflect that more respondents may need to be screened in order to reach the desired sample size and that it may not be possible to close recruitment the exact moment that the total 4,500 completes are obtained.
$208,998
No
    Yes
    No
No
No
No
No
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.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.
09/17/2020