Document ID: FDA-2017-D-3001-0235
Agency: fda
Document Type: Notice
Title: Modified Risk Tobacco Product Applications for IQOS System With Marlboro Heatsticks, IQOS System With Marlboro Smooth Menthol
Heatsticks, and IQOS System With Marlboro Fresh Menthol Heatsticks
Submitted by Philip Morris Products S.A.
Posted Date: 2018-12-26T05:00Z

[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Notices]
[Pages 66282-66283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27807]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-3001]

Modified Risk Tobacco Product Applications for IQOS System With 
Marlboro Heatsticks, IQOS System With Marlboro Smooth Menthol 
Heatsticks, and IQOS System With Marlboro Fresh Menthol Heatsticks 
Submitted by Philip Morris Products S.A.; Closing of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; closing of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a closing 
date for the period for public comment on modified risk tobacco product 
applications (MRTPAs) submitted by Philip Morris Products S.A. for its 
IQOS system products. FDA recently received amendments to these MRTPAs 
and has made them available for public comment.

DATES: Submit either electronic or written comments by February 11, 
2019 to ensure FDA considers your comment before completing its review 
of the applications.

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-D-3001 for ``Modified Risk Tobacco Product Applications for 
IQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth 
Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol 
Heatsticks submitted by Philip Morris Products

[[Page 66283]]

S.A.'' Received comments, those filed in a timely manner (see DATES), 
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.

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, 1-877-CTP-1373, 
AskCTP@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 15, 2017 (82 FR 27487), FDA 
published a notice of availability for MRTPAs submitted by Philip 
Morris Products S.A. for its IQOS products and gave the public 180 days 
to comment on the applications. FDA issued a subsequent notice in the 
Federal Register of November 22, 2017 (82 FR 55616), extending the 
period for public comment and announcing its intent to issue a notice 
in a future edition of the Federal Register announcing when the comment 
period will close. FDA recently received amendments to the MRTPAs and 
has made them available for public comment. In this notice, FDA is 
announcing that the period for public comment on these MRTPAs, 
including amendments, will close on February 11, 2019.
    FDA is required by section 911(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 387k) (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.
    In the event FDA receives additional amendments or otherwise needs 
to modify the comment period closing date, FDA will notify the public 
via the Agency's web page for the MRTPAs (see section II) and by other 
means of public communication, such as by email to individuals who have 
signed up to receive email alerts. FDA does not intend to issue 
additional notices in the Federal Register regarding amendments or the 
comment period for these MRTPAs. 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 access the application 
documents at: https://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm546281.htm.

    Dated: December 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27807 Filed 12-21-18; 8:45 am]
 BILLING CODE 4164-01-P