Study of How Consumers Use Flavors to Make Inferences About Electronic Nicotine Delivery System (ENDS) Product Qualities and Intentions to Use (Phase 2)

Forms and Documents

Document Name	Status
IRB Approval Determination Memo.pdf Supplementary Document	2022-02-15
Supporting Statement Part B Flavors Phase 2 Study 2022.docx Supporting Statement B	2022-02-14
Supporting Statement Part A - Flavors Phase 2 Study 2022.docx Supporting Statement A	2022-02-14

IC Document Collections

IC ID	Document Title	Status
251528	Main Study - Young Adults (aged 18-24) Other-Survey	New
251527	Main Study - Youth (aged 13-17) Other-Survey	New
251526	Young Adults (aged 18-24) Other-Consent Form	New
251525	Youth (aged 13-17) Other-Youth Assent Form	New
251524	Young Adults (aged 18-24) Other-Flavors Recruitment Email	New
251523	Youth (aged 13-17)/Parent Panelists of Youth (aged 13-17) Other-Flavors Recruitment Email	New

ICR Details

OMB Control No:	ICR Reference No: 202201-0910-007
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Study of How Consumers Use Flavors to Make Inferences About Electronic Nicotine Delivery System (ENDS) Product Qualities and Intentions to Use (Phase 2)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 02/22/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	262,500	0
Time Burden (Hours)	6,712	0
Cost Burden (Dollars)	0	0

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Abstract: Electronic nicotine delivery systems (ENDS), including but not limited to e-cigarettes, e-pens, e-cigars, e-hookah, vape pens, personal vaporizers, and electronic pipes, have been regulated by the U.S. Food and Drug Administration since 2016 and more research that could inform marketing regulations would be useful. Flavors are an important characteristic of ENDS. ENDS use a liquid (“e-liquid” or “e-juice”) that can come in a diverse range of flavors, including tobacco flavor, menthol, mint, fruit flavors, dessert flavors (e.g., crème brulee, funnel cake), spices (e.g., cinnamon, vanilla), alcohol (e.g., strawberry daiquiri, bourbon, Irish crème), candy (e.g., gummi bears, cotton candy), and other flavors. Both youth and adult ENDS users commonly report that flavors are a main reason why they use ENDS. The objectives of the proposed project are to examine how different features used to advertise ENDS flavors are associated with (a) product appeal and (b) intentions to use the product among youth (aged 13-17 years) and young adults (aged 18-24 years). The proposed project will accomplish these objectives by obtaining product perceptions and use intentions in response to different advertising tactics, such as using flavor-related images or adding flavor descriptors or modifiers to flavor names. In an online survey experiment, youth and young adult study participants will view different ENDS ads with and without key features (flavor-related images; flavor descriptors, such as “cool” and “fresh”; flavor name modifiers, such as cherry crush). This project employs a mixed experimental design in which participants will view ENDS ads with key features and modifiers present or absent. This approach will provide evidence as to how specific advertising features used to convey ENDS flavors affect product perceptions and intentions to use ENDS.

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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:
	86 FR 12468	03/03/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 9067	02/17/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Main Study - Young Adults (aged 18-24)
Main Study - Youth (aged 13-17)
Young Adults (aged 18-24)
Young Adults (aged 18-24)
Youth (aged 13-17)
Youth (aged 13-17)/Parent Panelists of Youth (aged 13-17)

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ICR Summary of Burden

	Total Request	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	262,500	0	0	262,500	0	0
Annual Time Burden (Hours)	6,712	0	0	6,712	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new data collection.

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Annual Cost to Federal Government: $319,393

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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.     No

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: 02/22/2022

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