[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11754-11755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05346]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0529]


Draft Concept Paper: Illicit Trade in Tobacco Products After 
Implementation of a Food and Drug Administration Product Standard; 
Availability; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft concept paper entitled ``Illicit Trade in 
Tobacco Products after Implementation of an FDA Product Standard.'' FDA 
seeks public comment on the draft concept paper regarding the potential 
for illicit trade markets to develop in response to a tobacco product 
standard. This draft concept paper is offered to stimulate dialogue 
around the subject of possible illicit trade in connection with tobacco 
product standards.

DATES: Although you can comment at any time, to ensure that the Agency 
considers your comment on this draft concept paper, submit either 
electronic or written comments by June 14, 2018.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

[[Page 11755]]

     For written/paper comments submitted to the Dockets 
Management Staff, 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-2018-N-0529 for ``Illicit Trade in Tobacco Products after 
Implementation of an FDA Product Standard.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this draft concept 
paper to the Center for Tobacco Products, Food and Drug Administration, 
Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request or include a fax number 
to which the draft concept paper may be sent. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the draft 
concept paper.

FOR FURTHER INFORMATION CONTACT: Christopher Griffiths, Center for 
Tobacco Products, Food and Drug Administration, Document Control 
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 
20993-0002, 1-877-287-1373, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft concept paper 
entitled ``Illicit Trade in Tobacco Products after Implementation of an 
FDA Product Standard.'' On June 22, 2009, the Family Smoking Prevention 
and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control Act) was 
enacted. The Tobacco Control Act grants FDA authority to implement a 
wide variety of product standards impacting different characteristics 
of existing and future tobacco products. This draft concept paper 
describes aspects of the tobacco product market and consumer behavior 
that may be relevant to the development of illicit trade markets if FDA 
implements a tobacco product standard. FDA faces a complex task when 
assessing the potential for an illicit trade market to develop in 
response to a tobacco product standard. While it remains difficult to 
measure existing illicit trade markets and use existing data to 
reliably predict future illicit markets, it may be possible to isolate 
some of the key factors that may encourage or discourage illicit trade 
in tobacco products. This draft concept paper assists that effort by 
breaking down the potential mechanics of an illicit trade market into 
various components, and examining the factors that could support or 
hinder the establishment of a persistent illicit trade market in the 
face of an FDA tobacco product standard. This paper first discusses the 
legal authority and general approach to establishing tobacco product 
standards, and then discusses the different components of illicit trade 
markets, followed by relevant research in consumer behavior and 
potentially applicable economic research.
    FDA is providing notice and an opportunity to comment on this draft 
concept paper. Please provide evidence or other information supporting 
your comments.

II. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the draft concept paper at either https://www.regulations.gov or https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: March 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05346 Filed 3-15-18; 8:45 am]
 BILLING CODE 4164-01-P