[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27487-27489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12369]


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

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.; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability for public comment of modified risk tobacco product 
applications (MRTPAs) 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.

DATES: Submit either electronic or written comments on the application 
by December 12, 2017.

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

[[Page 27488]]

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 Division of Dockets Management 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 Division of Dockets Management. 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 Division of Dockets Management, 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 (g)(2). 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 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 may issue an order under section 911(g)(2) of the FD&C Act with 
respect to a tobacco product that does not satisfy the section 
911(g)(1) standard. A person seeking an order under section 911(g)(2) 
of the FD&C Act must show that:
     Such an order would be appropriate to promote the public 
health;
     Any aspect of the label, labeling, and advertising for the 
product that would cause the product to be an MRTP is limited to an 
explicit or implicit representation that the tobacco product or its 
smoke does not contain or is free of a substance or contains a reduced 
level of a substance, or presents a reduced exposure to a substance in 
tobacco smoke;
     Scientific evidence is not available and, using the best 
available scientific methods, cannot be made available without 
conducting long-term epidemiological studies for an application to meet 
the standards for obtaining an order under section 911(g)(1);
     The scientific evidence that is available without 
conducting long-term epidemiological studies demonstrates that a 
measurable and substantial reduction in morbidity or mortality among 
individual tobacco users is reasonably likely in subsequent studies;
     The magnitude of overall reductions in exposure to the 
substance or substances which are the subject of the application is 
substantial, such substance or substances are harmful, and the product 
as actually used exposes consumers to the specified reduced level of 
the substance or substances;
     The product as actually used by consumers will not expose 
them to higher levels of other harmful substances compared to the 
similar types of tobacco products then on the market unless such 
increases are minimal and the reasonably likely overall impact of use 
of the product remains a substantial and measurable reduction in 
overall morbidity and mortality among individual tobacco users;

[[Page 27489]]

     Testing of actual consumer perception shows that, as the 
applicant proposes to label and market the product, consumers will not 
be misled into believing that the product is or has been demonstrated 
to be less harmful or presents or has been demonstrated to present less 
of a risk of disease than one or more other commercially marketed 
tobacco products; and
     Issuance of the exposure modification order is expected to 
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 satisfies the 
requirements in section 911(g)(2).
    FDA is issuing this notice to inform the public that the following 
MRTPAs submitted by Philip Morris Products S.A. have been filed and are 
being made available for public comment:
     MR0000059: IQOS system with Marlboro Heatsticks
     MR0000060: IQOS system with Marlboro Smooth Menthol 
Heatsticks
     MR0000061: IQOS system with Marlboro Fresh Menthol 
Heatsticks
    Due to the large size of these applications, FDA will post the 
application documents 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 is making the applications available for public comment 
for 180 days from the posting of the first batch of application 
documents. In the event that fewer than 30 days remain in the comment 
period when the final batch is posted, FDA will issue a notice in the 
Federal Register extending the comment period to allow for at least 30 
days of public comment from the day the final batch is posted. FDA 
believes that this comment period is appropriate given the volume and 
complexity of the applications being posted. 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 
http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm546281.htm.

    Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12369 Filed 6-14-17; 8:45 am]
 BILLING CODE 4164-01-P