[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,
[email protected].
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