Experimental Study on Consumer Perceptions of Modified Risk Tobacco Products (MRTP)

Forms and Documents

Document Name	Status
IRB Approval letter.pdf Supplementary Document	2016-07-14
MRTP_OMB Supporting Statement Part A_ July2016.docx Supporting Statement A	2016-07-14
OMB Supporting Statement Part B.doc Supporting Statement B	2016-02-02

IC Document Collections

IC ID	Document Title	Status
219940	Study 3 (Adolescent) Other-Study Stimuli	New
219939	Adolescent Screener Other-Study Materials	New
219938	Study 2 (Adults) Other-Formative Work - Focus Group Study Final Reports	New
219937	Study 1 (Adults) Other-Study Stimuli	New
219936	Adult Screener Other-Study Materials	New

ICR Details

OMB Control No: 0910-0819	ICR Reference No: 201602-0910-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Experimental Study on Consumer Perceptions of Modified Risk Tobacco Products (MRTP)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/19/2016
	Date Received in OIRA: 02/02/2016
Terms of Clearance: Approved consistent with the understanding that as the study will use convenience samples rather than probability samples-- the agency does not intend to generate nationally representative results or precise estimates of population parameters from the experimental study. These limitations regarding the non-generalizability of the study's outcomes will be communicated in all forthcoming publications, reports, and presentations.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2019	36 Months From Approved
Responses	33,000	0	0
Time Burden (Hours)	1,899	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This experimental study, comprised of three sub-studies, will examine consumer reactions to tobacco products claiming to reduce risk or the exposure to a harmful substance to the user. The study is part of the agency’s on-going efforts to better understand the impact of the marketing of “modified risk tobacco products” (MRTP) on consumer perceptions, understanding, and intended behaviors. This experimental study, conducted online with an internet survey panel, will assess consumers’ reactions to hypothetical MRTPs, including their understanding of the product, their attitudes and beliefs about it, and their interest in trying and using the product. The study will include participants from a range of age groups (adolescent, young adults, and adults) and a diversity of tobacco use histories (current, former, never users; adolescents susceptible to use). The study will examine the impact of potential claims about conventional cigarettes and smokeless tobacco products.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 911(a) Name of Law: FD&C Act
  

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:
	79 FR 68888	11/19/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 5470	02/02/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Adult Screener
Study 1 (Adults)
Study 2 (Adults)
Adolescent Screener
Study 3 (Adolescent)

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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	33,000	0	0	33,000	0	0
Annual Time Burden (Hours)	1,899	0	0	1,899	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: New Collection

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Annual Cost to Federal Government: $358,565

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 02/02/2016

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