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, 27487-27489 [2017-12369]
Download as PDF
<![CDATA[
Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
manufacturing plant; (5) name,
telephone number, and email address of
the contact person; (6) list of products
divided into three categories: Presently
shipped, ready to ship, and available for
shipment in the next 3 years; (7)
identities of agencies that inspected the
plant; (8) date of last inspection, plant
number, and copy of last inspection
notice; and (9) if other than an FDA
inspection, copy of last inspection
report.
We request that this information be
updated every 2 years.
We use the information submitted by
firms to determine their eligibility for
placement on the export lists, which are
published on our Web site. The purpose
of the lists is to help foreign
governments in their determinations of
which U.S. milk product manufacturers
and processors are eligible to export to
their respective countries.
FDA has recently developed an
electronic registry system (Form FDA
3972) that allows milk product
manufacturers and processors to
electronically send a request to FDA to
be included on the export lists.
Manufacturers and processors that
prefer to submit a paper request in a
format of their own choosing will still
have the option to do so. Electronic
Form FDA 3972 collects the same
27487
information as is currently collected via
the existing paper-based process. Draft
screenshots of Form FDA 3972 and
instructions are available at https://
www.fda.gov/Food/
GuidanceRegulation/ImportsExports/
Exporting/ucm496929.htm and is
entitled ‘‘Dairy Listing Module.’’
Description of Respondents:
Respondents to this collection of
information include U.S. milk product
manufacturers/processors subject to
FDA jurisdiction that wish to export to
certain foreign countries that require
inclusion on export lists.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
New requests to be placed on the lists ...................
Biennial update ........................................................
Occasional updates .................................................
2,000
2,000
200
1
1
1
2,000
2,000
200
1 ................................
0.5 (30 minutes) ........
0.5 (30 minutes) ........
2,000
1,000
100
Total ..................................................................
........................
........................
........................
....................................
3,100
pmangrum on DSK3GDR082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate on the number
of manufacturers/processors that have
submitted new written requests,
biennial updates, and occasional
updates over the past 10 years. The
estimate of the number of burden hours
it will take a manufacturer/processor to
gather the information needed to be
placed on the list or update its
information is based on FDA’s
experience with manufacturers/
processors submitting similar requests.
FDA believes that the information to be
submitted will be readily available to
manufacturers/processors. This
collection is also incorporating
information collected to maintain lists
of eligible exporters of dairy products
who wish to export to the EU from OMB
control number 0910–0320, ‘‘Request for
Information from U.S. Processors that
Export to the European Community.’’
FDA estimates that 2,000 firms will
average 60 minutes (1 hour) to submit
new requests for inclusion on the list,
2,000 firms will average 30 minutes (0.5
hour) to update their information every
2 years, and 200 firms will average 30
minutes (0.5 hour) to occasionally
update their information in this system.
We also believe that submission via the
electronic registry system will not affect
the burden estimates. An electronic
registry will enhance the ability of firms
to more efficiently request inclusion on
export lists. FDA calculates, therefore,
that the total burden for this collection
VerDate Sep<11>2014
14:10 Jun 14, 2017
Jkt 241001
is 3,100 hours ((2,000 × 1) plus (2,000
× 0.5) plus (200 × 0.5)).
submitted by Philip Morris Products
S.A.
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DATES:
[FR Doc. 2017–12356 Filed 6–14–17; 8:45 am]
BILLING CODE 4164–01–P
Electronic Submissions
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.
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
SUMMARY:
PO 00000
Frm 00026
Fmt 4703
Submit either electronic or
written comments on the application by
December 12, 2017.
ADDRESSES: You may submit comments
as follows:
Sfmt 4703
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
E:\FR\FM\15JNN1.SGM
15JNN1
27488
Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
pmangrum on DSK3GDR082PROD with NOTICES
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
VerDate Sep<11>2014
14:10 Jun 14, 2017
Jkt 241001
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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: AskCTP@fda.hhs.gov.
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
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
that the tobacco product, as it is actually
used by consumers, will significantly
reduce harm and the risk of tobaccorelated 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;
E:\FR\FM\15JNN1.SGM
15JNN1
pmangrum on DSK3GDR082PROD with NOTICES
Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
• 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 https://
www.fda.gov/TobaccoProducts/
Labeling/MarketingandAdvertising/
ucm546281.htm.
VerDate Sep<11>2014
14:10 Jun 14, 2017
Jkt 241001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0424]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Temporary
Marketing Permit Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension/
reinstatement of an existing collection
of information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
reporting requirements contained in
existing FDA regulations governing
temporary marketing permit
applications.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by August 14, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 14,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 14, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov/. Follow
the instructions for submitting
comments. Comments submitted
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
27489
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–
2011–N–0424 for ‘‘Temporary
Marketing Permit Applications.’’
Received comments, those filed in a
timely manner (see ADDRESSES), 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
E:\FR\FM\15JNN1.SGM
15JNN1
]]>Agencies
[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:
AskCTP@fda.hhs.gov.
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
https://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
