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

Forms and Documents

Document Name	Status
Change Request Memo September 2020.docx Justification for No Material/Nonsubstantive Change	2020-09-17
HPHC2 FDA IRB Protocol_CLEAN_9.11.20.docx Supplementary Document	2020-09-17
Change Request Memo.docx Justification for No Material/Nonsubstantive Change	2020-08-11
Change Request Memo 3.20.docx Justification for No Material/Nonsubstantive Change	2020-03-13
Appendix L Online Survey Formats_CLEAN_3.20.docx Supplementary Document	2020-03-13
FDA CTP RTI HPHCs PTA 3.11.2020.pdf Supplementary Document	2020-03-13
RIHSC approval letter.pdf Supplementary Document	2019-07-02
NEW_Supporting Statement_Part B_2019.doc Supporting Statement B	2019-07-02
Updated_Supporting Statement_Part A_CLEAN_3.20.docx Supporting Statement A	2020-03-13

IC Document Collections

IC ID	Document Title	Status
236787	Adult - Survey Other-Online Survey Adult Consent Form	Modified
236639	Adult - Screener Other-Adult Invitation Email	Unchanged
236207	Youth - Survey Other-Online Survey Parental Permission Form	Unchanged
236205	Youth - Screener Other-Parent-Youth Invitation Email	Unchanged

ICR Details

OMB Control No: 0910-0880	ICR Reference No: 202009-0910-007
Status: 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
	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

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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.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Adult - Survey
Youth - Screener
Youth - Survey
Adult - Screener

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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.

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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

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Common Form ICR:  No

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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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