82 FR 60206 - Modified Risk Tobacco Product Applications: Applications for Six Camel Snus Smokeless Tobacco Products Submitted by R.J. Reynolds Tobacco Company; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 242 (December 19, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) for six Camel Snus smokeless tobacco products submitted by R.J. Reynolds Tobacco Co.

[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60206-60207]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27246]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4678]


Modified Risk Tobacco Product Applications: Applications for Six 
Camel Snus Smokeless Tobacco Products Submitted by R.J. Reynolds 
Tobacco Company; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability for public comment of modified risk tobacco product 
applications (MRTPAs) for six Camel Snus smokeless tobacco products 
submitted by R.J. Reynolds Tobacco Co.

DATES: Electronic or written comments on the applications may be 
submitted until June 18, 2018; however, FDA may modify the comment 
period by providing notice 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-2017-N-4678 for ``Modified Risk Tobacco Product Applications: 
Applications for Six Camel Snus Smokeless Tobacco Products Submitted by 
R.J. Reynolds Tobacco Company.'' 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.thefederalregister.org/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 modified 
risk tobacco products (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 under 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 an 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 an 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(g) 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 (2). The applicant, R.J. Reynolds Tobacco Co., is seeking 
orders under section 911(g)(1) for each of the 6 products that are the 
subject of the submitted MRTPAs. A

[[Page 60207]]

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 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 the MRTPAs for 
the following products submitted by R.J. Reynolds Tobacco Co. have been 
filed and are being made available for public comment:
 MR0000068: Camel Snus Frost
 MR0000069: Camel Snus Frost Large
 MR0000070: Camel Snus Mellow
 MR0000071: Camel Snus Mint
 MR0000072: Camel Snus Robust
 MR0000073: Camel Snus Winterchill
    In this document, FDA is announcing the availability of the 
applications for public comment. FDA will make any amendments submitted 
by the applicant available for public comment on a rolling basis. The 
applications will be available for public comment for 180 days from the 
date this notice is published; however, in the event that fewer than 30 
days remain in the 180-day comment period when an amendment is posted, 
FDA will extend or reopen the comment period to allow for at least 30 
days of public comment on the amendment. FDA believes that this comment 
period is appropriate given the volume and complexity of the 
applications being posted. FDA will notify the public about the 
availability of amendments to these applications and changes to related 
comment periods via the Agency's website and other means of public 
communication. 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: 
https://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/UCM564399.htm.

    Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27246 Filed 12-18-17; 8:45 am]
 BILLING CODE 4164-01-P