
[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Pages 2871-2872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0073]


Request for Information on Psychosocial Predictors of Uptake of 
Tobacco and Other Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information.

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SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco 
Products (CTP), is opening a docket to obtain data and information 
related to psychosocial predictors of uptake and continued use of 
tobacco products, including specific categories of tobacco products and 
specific individual tobacco products, as well as other products from 
which predictors may be adapted for or extrapolated to tobacco 
products. FDA is seeking data and information in the form of reports 
and manuscripts that are unpublished or not available through indexed 
bibliographic databases. The purpose of this request for information 
(RFI) is to gather additional information that could help identify and 
evaluate predictors of consumer initiation, uptake, and use of tobacco 
products. FDA has already searched the publicly available scientific 
literature and is now seeking to supplement that with information that 
is not included in the published scientific literature.

DATES: Submit either electronic or written comments or information by 
March 4, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food

[[Page 2872]]

and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0073 for ``Request for Information on Psychosocial 
Predictors of Uptake of Tobacco and Other Products.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Shireen Ahmad, Office of Science, 
Center for Tobacco Products, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, rm. 4462, Silver Spring, MD 20993-0002, 1-
877-287-1373, email: CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control 
Act) into law. The Tobacco Control Act grants FDA authority to regulate 
the manufacture, marketing, and distribution of tobacco products to 
protect public health generally and to reduce tobacco use by minors. 
FDA is conducting a systematic review and meta-analysis of the 
scientific literature in an effort to identify the best psychosocial 
predictors that longitudinally predict initiation of tobacco product 
use, uptake of specific types of tobacco products, and uptake of 
specific individual tobacco products. This information may be used by 
FDA in future rulemaking and review of industry submissions.

II. Request for Information

    FDA seeks information related to psychosocial predictors of uptake 
of tobacco and other products. FDA has searched the publicly available 
scientific literature and is now looking to supplement that search with 
information from other sources, specifically unpublished data or other 
information. For the purpose of this RFI, FDA considers ``psychosocial 
predictors'' to include constructs that can be measured at the level of 
the individual, such as beliefs, attitudes, perceptions, intentions, 
willingness/openness, curiosity, or other measures that have been used 
in longitudinal research and demonstrated to be associated with product 
uptake or initiation. In addition to studies reporting on tobacco 
products, FDA also would accept information on uptake and use of other 
products from which predictors may be adapted for or extrapolated to 
tobacco products. If such information is submitted, it should include 
an explanation of why the predictor and product could be extrapolated 
to tobacco products.
    For this RFI, FDA is requesting unpublished data (summarized); 
unpublished or prepublication copies of manuscripts, conference 
presentations, and/or posters; dissertations and/or theses; and white 
papers or other unpublished reports. FDA is requesting both data that 
show associations as well as data that fail to show an association 
(i.e., null findings). Specifically, FDA is requesting unpublished data 
from studies on human subjects (including youth, young adults, and 
older adults) that include:
     A longitudinal design (observational or experimental) in 
which there is at least one month between assessments and data are 
reported for at least two time points;
     At least one psychosocial predictor; and
     A quantifiable (continuous or categorical) outcome measure 
of actual product use (not intentions to use) related to initiation or 
uptake.
    Outcomes may include:
     Initiation;
     Continued use;
     Progression to more frequent use;
     Choice of a specific product; or
     Other similar outcomes.
    Data may come from studies outside of the United States; however, 
we prefer that reports be submitted in English.
    For this RFI, FDA is seeking only quantitative scientific data 
presented in report or manuscript format, and not data from qualitative 
studies (e.g., interviews, focus groups), anecdotes, or testimonials. 
FDA is requesting data and information from all interested parties, 
including, but not limited to, academic and government researchers, 
industry, and any other sources.
    When submitting information, please include details about how the 
data were collected, including the sample composition, year(s) of data 
collection, and a detailed summary of the methods and measures used. 
For data summaries, please include both point estimates and measures of 
variance, as well as effect sizes (if available).
    Please also note that when submitting information and data to the 
docket, certain compressed file formats (e.g., zip files) are not 
allowed. Acceptable file formats include: .doc, .docx, .pdf, .ppt, 
.pptx, .rtf, .txt, .xls, .xlsx, .xlsm, .xlsb, and .wpd.

    Dated: January 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00836 Filed 1-15-16; 8:45 am]
 BILLING CODE 4164-01-P


