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

ICR 201602-0910-003

OMB: 0910-0819

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2016-07-14
Supporting Statement A
2016-07-14
Supporting Statement B
2016-02-02
ICR Details
0910-0819 201602-0910-003
Historical Active
HHS/FDA CTP
Experimental Study on Consumer Perceptions of Modified Risk Tobacco Products (MRTP)
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 07/19/2016
Retrieve Notice of Action (NOA) 02/02/2016
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
07/31/2019 36 Months From Approved
33,000 0 0
1,899 0 0
0 0 0

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.

PL: Pub.L. 111 - 31 911(a) Name of Law: FD&C Act
  
None

Not associated with rulemaking

  79 FR 68888 11/19/2014
81 FR 5470 02/02/2016
Yes

5
IC Title Form No. Form Name
Adult Screener
Study 1 (Adults)
Study 2 (Adults)
Adolescent Screener
Study 3 (Adolescent)

  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
Yes
Miscellaneous Actions
No
New Collection

$358,565
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@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.
02/02/2016


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