View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0880
ICR Reference No:
202009-0910-007
Status:
Historical Active
Previous ICR Reference No:
202008-0910-017
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CTP
Title:
Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products and Tobacco Smoke
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
09/18/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/17/2020
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2022
11/30/2022
11/30/2022
Responses
22,950
0
22,950
Time Burden (Hours)
2,550
0
2,550
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
None
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
84 FR 3188
02/11/2019
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 30721
06/27/2019
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Adult - Screener
Adult - Survey
Youth - Screener
Youth - Survey
ICR Summary of Burden
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
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
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.
Annual Cost to Federal Government:
$208,998
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
09/17/2020
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