[Federal Register Volume 83, Number 184 (Friday, September 21, 2018)]
[Notices]
[Pages 47925-47926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20562]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3261]


Modified Risk Tobacco Product Application: Application for 
Copenhagen[supreg] Snuff Fine Cut, a Loose Moist Snuff Tobacco Product 
Submitted by U.S. Smokeless Tobacco Company LLC

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for public comment of a modified risk tobacco product 
application (MRTPA) for Copenhagen[supreg] Snuff Fine Cut, a loose 
moist snuff tobacco product submitted by U.S. Smokeless Tobacco Co. 
LLC.

DATES: Electronic or written comments on the application may be 
submitted beginning September 21, 2018. FDA will establish a closing 
date for the comment period as described in section I.

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.
     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-3261 for ``Application for Copenhagen[supreg] Snuff Fine 
Cut, a Loose Moist Snuff Tobacco Product Submitted by U.S. Smokeless 
Tobacco Company LLC.'' 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 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.

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

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 387k) addresses the marketing and distribution of MRTPs. 
MRTPs are tobacco products that are sold or distributed for use to 
reduce harm or the risk of tobacco-related disease associated with 
commercially marketed tobacco products. Section 911(a) of the FD&C Act 
prohibits the introduction or delivery for introduction into interstate 
commerce of any MRTP unless an order issued by FDA pursuant to section 
911(g) of the FD&C Act is effective with respect to such product.
    Section 911(d) of the FD&C Act describes the information that must 
be included in a MRTPA, which must be filed and evaluated by FDA before 
an applicant can receive an order from FDA. FDA is required by section 
911(e) of the FD&C Act to make a MRTPA available to the public (except 
for matters in the application that are trade secrets or otherwise 
confidential commercial information) and to request comments by 
interested persons on the information contained in the application and 
on the label, labeling, and advertising accompanying the application. 
The determination of whether an order is appropriate under section 911 
of the FD&C Act is based on the scientific information submitted by the 
applicant as well as the scientific evidence and other information that 
is made available to the Agency, including through public comments.
    Section 911(g) of the FD&C Act describes the demonstrations 
applicants must make to obtain an order from FDA under either section 
911(g)(1) or (g)(2). The applicant, U.S. Smokeless Tobacco Co. LLC, is 
seeking an order under section 911(g)(1).
    An order under section 911(g)(1) of the FD&C Act is for a modified 
risk tobacco product that significantly reduces harm and the risk of 
tobacco-related disease to individual tobacco users; and benefits the 
health of the population as a whole. A person seeking an order under 
section 911(g)(1) of the FD&C Act must show that the tobacco product, 
as it is actually used by consumers, will significantly reduce

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harm and the risk of tobacco-related disease to individual tobacco 
users and will benefit the health of the population as a whole taking 
into account both users of tobacco products and persons who do not 
currently use tobacco products. Section 911(g)(4) of the FD&C Act 
describes factors that FDA must take into account in evaluating whether 
a tobacco product benefits the health of individuals and the population 
as a whole.
    FDA is issuing this notice to inform the public that a MRTPA for 
Copenhagen[supreg] Snuff Fine Cut submitted by U.S. Smokeless Tobacco 
Co. LLC has been filed and is being made available for public comment.
MR0000108: Copenhagen[supreg] Snuff Fine Cut
    FDA will post the application documents, including any amendments, 
for public comment in batches on a rolling basis as they are redacted 
in accordance with applicable laws. In this document, FDA is announcing 
the availability of the first batch of application documents. FDA 
intends to establish a closing date for the comment period that is both 
at least 180 days after the date of this notice and at least 30 days 
after the final documents from the application are made available for 
public comment. FDA will announce the closing date at least 30 days in 
advance. FDA believes that this comment period is appropriate given the 
volume and complexity of the application being posted. FDA will notify 
the public about the availability of additional application documents 
and the comment period closing date via the Agency's web page for the 
MRTPA (see section II) and by other means of public communication, such 
as by email to individuals who have signed up to receive email alerts. 
To receive email alerts, visit FDA's email subscription service 
management website (http://go.fda.gov/subscriptionmanagement), provide 
an email address, scroll down to the ``Tobacco'' heading, select 
``Modified Risk Tobacco Product Application Updates'', and click 
``Submit''. To encourage public participation consistent with section 
911(e) of the FD&C Act, FDA is making the redacted MRTPAs that are the 
subject of this notice available electronically (see section II).

II. Electronic Access

    Persons with access to the internet may obtain the documents at 
either https://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm619683.htm or https://www.regulations.gov.

    Dated: September 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20562 Filed 9-20-18; 8:45 am]
 BILLING CODE 4164-01-P


