[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)]
[Notices]
[Pages 55616-55617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25224]



[[Page 55616]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Modified Risk Tobacco Product Applications: 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.; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is extending the period 
for public comment on modified risk tobacco product applications 
(MRTPAs) submitted by Philip Morris Products S.A. for its IQOS system 
with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol 
Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks.

DATES: FDA is extending the comment period on the MRTPAs made available 
for public comment through the notice of availability that appeared in 
the Federal Register of June 15, 2017 (82 FR 27487).

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: 
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.'' 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. Please note that FDA intends to 
establish a date on which the comment period will close by publishing a 
notice in the Federal Register (see SUPPLEMENTARY INFORMATION).
     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, Document Control Center, 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 of the first batch of documents from 
modified risk tobacco product applications (MRTPAs) submitted by Philip 
Morris Products S.A. and gave the public 180 days to comment on the 
applications. In that notice, FDA announced that it would post the 
remaining MRTPA documents on a rolling basis as they were redacted in 
accordance with applicable laws and that it would extend the comment 
period if fewer than 30 days remained when the last batch of 
application documents was posted. In this notice, FDA is extending the 
period for public comment. Once all documents from the MRTPAs, 
including amendments, are posted, FDA intends to issue a notice in the 
Federal Register announcing when the comment period will close, which 
will be no earlier than 30 days from the date the last batch of 
application documents is posted. As stated in the Federal Register 
notice of June 15, 2017, FDA believes that this comment period is 
appropriate given the volume and complexity of the applications being 
posted.
    FDA is required by section 911(e) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 387k(e)) 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

[[Page 55617]]

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.

II. Electronic Access

    Persons with access to the Internet may access the application 
documents at: http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm546281.htm.

    Dated: November 16, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25224 Filed 11-21-17; 8:45 am]
 BILLING CODE 4164-01-P


