Modified Risk Tobacco Product Application: Application for Copenhagen® Snuff Fine Cut, a Loose Moist Snuff Tobacco Product Submitted by U.S. Smokeless Tobacco Company LLC, 47925-47926 [2018-20562]
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Federal Register / Vol. 83, No. 184 / Friday, September 21, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3261]
Modified Risk Tobacco Product
Application: Application for
Copenhagen® Snuff Fine Cut, a Loose
Moist Snuff Tobacco Product
Submitted by U.S. Smokeless Tobacco
Company LLC
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability for public comment of a
modified risk tobacco product
application (MRTPA) for Copenhagen®
Snuff Fine Cut, a loose moist snuff
tobacco product submitted by U.S.
Smokeless Tobacco Co. LLC.
DATES: Electronic or written comments
on the application may be submitted
beginning September 21, 2018. FDA will
establish a closing date for the comment
period as described in section I.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
daltland on DSKBBV9HB2PROD with NOTICES
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:
VerDate Sep<11>2014
17:30 Sep 20, 2018
Jkt 244001
• 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–
2018–N–3261 for ‘‘Application for
Copenhagen® Snuff Fine Cut, a Loose
Moist Snuff Tobacco Product Submitted
by U.S. Smokeless Tobacco Company
LLC.’’ 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.
• 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/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
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
47925
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 20993–0002, 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 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 pursuant to 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 a 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 a 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 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).
The applicant, U.S. Smokeless Tobacco
Co. LLC, is seeking an order under
section 911(g)(1).
An order under section 911(g)(1) of
the FD&C Act is for a modified risk
tobacco product that significantly
reduces harm and the risk of tobaccorelated disease to individual tobacco
users; and benefits the health of the
population as a whole. 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
E:\FR\FM\21SEN1.SGM
21SEN1
47926
Federal Register / Vol. 83, No. 184 / Friday, September 21, 2018 / Notices
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 is issuing this notice to inform
the public that a MRTPA for
Copenhagen® Snuff Fine Cut submitted
by U.S. Smokeless Tobacco Co. LLC has
been filed and is being made available
for public comment.
daltland on DSKBBV9HB2PROD with NOTICES
MR0000108: Copenhagen® Snuff Fine
Cut
FDA will post the application
documents, including any amendments,
for public comment 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 intends to
establish a closing date for the comment
period that is both at least 180 days after
the date of this notice and at least 30
days after the final documents from the
application are made available for
public comment. FDA will announce
the closing date at least 30 days in
advance. FDA believes that this
comment period is appropriate given
the volume and complexity of the
application being posted. FDA will
notify the public about the availability
of additional application documents
and the comment period closing date
via the Agency’s web page for the
MRTPA (see section II) and by other
means of public communication, such
as by email to individuals who have
signed up to receive email alerts. To
receive email alerts, visit FDA’s email
subscription service management
website (https://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 obtain the documents at either
https://www.fda.gov/TobaccoProducts/
Labeling/MarketingandAdvertising/
VerDate Sep<11>2014
17:30 Sep 20, 2018
Jkt 244001
ucm619683.htm or https://
www.regulations.gov.
Electronic Submissions
Dated: September 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20562 Filed 9–20–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–0787]
Civil Money Penalties Relating to the
ClinicalTrials.gov Data Bank; Draft
Guidance for Food and Drug
Administration Staff, Responsible
Parties, and Submitters of Certain
Applications and Submissions to the
Food and Drug Administration;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Civil
Money Penalties Relating to the
ClinicalTrials.gov Data Bank; Draft
Guidance for FDA Staff, Responsible
Parties, and Submitters of Certain
Applications and Submissions to FDA.’’
The draft guidance provides the current
thinking of FDA’s Center for Drug
Evaluation and Research (CDER), Center
for Biologics Evaluation and Research
(CBER), and Center for Devices and
Radiological Health (CDRH) regarding
civil money penalties that may be
assessed against responsible parties
and/or submitters of certain
applications and submissions to FDA
regarding drug products, biological
products, and device products who
violate applicable Federal Food, Drug,
and Cosmetic Act (FD&C Act)
prohibitions relating to requirements,
including implementing regulations,
submitting registration and/or results
information to the ClinicalTrials.gov
data bank, and/or certain certifications
to FDA.
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by November 20, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
PO 00000
Frm 00053
Fmt 4703
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
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–
2018–D–0787 for ‘‘Civil Money
Penalties Relating to the
ClinicalTrials.gov Data Bank; Draft
Guidance for FDA Staff, Responsible
Parties, and Submitters of Certain
Applications and Submissions to FDA.’’
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.
• 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
E:\FR\FM\21SEN1.SGM
21SEN1
]]>Agencies
[Federal Register Volume 83, Number 184 (Friday, September 21, 2018)]
[Notices]
[Pages 47925-47926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20562]
[[Page 47925]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3261]
Modified Risk Tobacco Product Application: Application for
Copenhagen[supreg] Snuff Fine Cut, a Loose Moist Snuff Tobacco Product
Submitted by U.S. Smokeless Tobacco Company LLC
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for public comment of a modified risk tobacco product
application (MRTPA) for Copenhagen[supreg] Snuff Fine Cut, a loose
moist snuff tobacco product submitted by U.S. Smokeless Tobacco Co.
LLC.
DATES: Electronic or written comments on the application may be
submitted beginning September 21, 2018. FDA will establish a closing
date for the comment period as described in section I.
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-2018-N-3261 for ``Application for Copenhagen[supreg] Snuff Fine
Cut, a Loose Moist Snuff Tobacco Product Submitted by U.S. Smokeless
Tobacco Company LLC.'' 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.
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 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 20993-0002, 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 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 pursuant to 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 a 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 a 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
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). The applicant, U.S. Smokeless Tobacco Co. LLC, is
seeking an order under section 911(g)(1).
An order under section 911(g)(1) of the FD&C Act is for a modified
risk tobacco product that significantly reduces harm and the risk of
tobacco-related disease to individual tobacco users; and benefits the
health of the population as a whole. 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
[[Page 47926]]
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 is issuing this notice to inform the public that a MRTPA for
Copenhagen[supreg] Snuff Fine Cut submitted by U.S. Smokeless Tobacco
Co. LLC has been filed and is being made available for public comment.
MR0000108: Copenhagen[supreg] Snuff Fine Cut
FDA will post the application documents, including any amendments,
for public comment 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
intends to establish a closing date for the comment period that is both
at least 180 days after the date of this notice and at least 30 days
after the final documents from the application are made available for
public comment. FDA will announce the closing date at least 30 days in
advance. FDA believes that this comment period is appropriate given the
volume and complexity of the application being posted. FDA will notify
the public about the availability of additional application documents
and the comment period closing date via the Agency's web page for the
MRTPA (see section II) and by other means of public communication, such
as by email to individuals who have signed up to receive email alerts.
To receive email alerts, visit FDA's email subscription service
management website (https://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 obtain the documents at
either https://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm619683.htm or https://www.regulations.gov.
Dated: September 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20562 Filed 9-20-18; 8:45 am]
BILLING CODE 4164-01-P
