83 FR 47925 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 184 (September 21, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 184 (September 21, 2018)
| Page Range | 47925-47926 | |
| FR Document | 2018-20562 |
[Federal Register Volume 83, Number 184 (Friday, September 21, 2018)] [Notices] [Pages 47925-47926] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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 (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 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
![Federal Register / Vol. 83, No. 184 / Friday, September 21, 2018 / Notices 47925
DEPARTMENT OF HEALTH AND • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
HUMAN SERVICES written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and Rockville, MD 20852.
Food and Drug Administration Drug Administration, 5630 Fishers FOR FURTHER INFORMATION CONTACT: Paul
Lane, Rm. 1061, Rockville, MD 20852. Hart, Center for Tobacco Products, Food
[Docket No. FDA–2018–N–3261] • For written/paper comments and Drug Administration, 10903 New
submitted to the Dockets Management Hampshire Ave., Bldg. 71, Rm. G335,
Modified Risk Tobacco Product Staff, FDA will post your comment, as
Application: Application for Silver Spring, MD 20993–0002, 1–877–
well as any attachments, except for 287–1373, email: AskCTP@fda.hhs.gov.
Copenhagen® Snuff Fine Cut, a Loose information submitted, marked and
Moist Snuff Tobacco Product SUPPLEMENTARY INFORMATION:
identified, as confidential, if submitted
Submitted by U.S. Smokeless Tobacco as detailed in ‘‘Instructions.’’ I. Background
Company LLC Instructions: All submissions received
Section 911 of the Federal Food, Drug,
AGENCY: Food and Drug Administration, must include the Docket No. FDA–
and Cosmetic Act (FD&C Act) (21 U.S.C.
HHS. 2018–N–3261 for ‘‘Application for
387k) addresses the marketing and
Copenhagen® Snuff Fine Cut, a Loose
ACTION: Notice of availability. distribution of MRTPs. MRTPs are
Moist Snuff Tobacco Product Submitted
tobacco products that are sold or
SUMMARY: The Food and Drug by U.S. Smokeless Tobacco Company
LLC.’’ Received comments will be distributed for use to reduce harm or the
Administration (FDA) is announcing the risk of tobacco-related disease
availability for public comment of a placed in the docket and, except for
those submitted as ‘‘Confidential associated with commercially marketed
modified risk tobacco product tobacco products. Section 911(a) of the
application (MRTPA) for Copenhagen® Submissions,’’ publicly viewable at
https://www.regulations.gov or at the FD&C Act prohibits the introduction or
Snuff Fine Cut, a loose moist snuff delivery for introduction into interstate
tobacco product submitted by U.S. Dockets Management Staff between 9
a.m. and 4 p.m., Monday through commerce of any MRTP unless an order
Smokeless Tobacco Co. LLC. issued by FDA pursuant to section
Friday.
DATES: Electronic or written comments • Confidential Submissions—To 911(g) of the FD&C Act is effective with
on the application may be submitted submit a comment with confidential respect to such product.
beginning September 21, 2018. FDA will information that you do not wish to be Section 911(d) of the FD&C Act
establish a closing date for the comment made publicly available, submit your describes the information that must be
period as described in section I. comments only as a written/paper included in a MRTPA, which must be
ADDRESSES: You may submit comments submission. You should submit two filed and evaluated by FDA before an
as follows: copies total. One copy will include the applicant can receive an order from
information you claim to be confidential FDA. FDA is required by section 911(e)
Electronic Submissions of the FD&C Act to make a MRTPA
with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS available to the public (except for
following way: CONFIDENTIAL INFORMATION.’’ The matters in the application that are trade
• Federal eRulemaking Portal: Agency will review this copy, including secrets or otherwise confidential
https://www.regulations.gov. Follow the the claimed confidential information, in commercial information) and to request
instructions for submitting comments. its consideration of comments. The comments by interested persons on the
Comments submitted electronically, second copy, which will have the information contained in the
including attachments, to https:// claimed confidential information application and on the label, labeling,
www.regulations.gov will be posted to redacted/blacked out, will be available and advertising accompanying the
the docket unchanged. Because your for public viewing and posted on application. The determination of
comment will be made public, you are https://www.regulations.gov. Submit whether an order is appropriate under
solely responsible for ensuring that your both copies to the Dockets Management section 911 of the FD&C Act is based on
comment does not include any Staff. If you do not wish your name and the scientific information submitted by
confidential information that you or a contact information to be made publicly the applicant as well as the scientific
third party may not wish to be posted, available, you can provide this evidence and other information that is
such as medical information, your or information on the cover sheet and not made available to the Agency, including
anyone else’s Social Security number, or in the body of your comments and you through public comments.
confidential business information, such must identify this information as Section 911(g) of the FD&C Act
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked describes the demonstrations applicants
that if you include your name, contact as ‘‘confidential’’ will not be disclosed must make to obtain an order from FDA
information, or other information that except in accordance with 21 CFR 10.20 under either section 911(g)(1) or (g)(2).
identifies you in the body of your and other applicable disclosure law. For The applicant, U.S. Smokeless Tobacco
comments, that information will be more information about FDA’s posting Co. LLC, is seeking an order under
posted on https://www.regulations.gov. of comments to public dockets, see 80 section 911(g)(1).
• If you want to submit a comment FR 56469, September 18, 2015, or access An order under section 911(g)(1) of
with confidential information that you the information at: https://www.gpo.gov/ the FD&C Act is for a modified risk
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- tobacco product that significantly
public, submit the comment as a 23389.pdf. reduces harm and the risk of tobacco-
daltland on DSKBBV9HB2PROD with NOTICES
written/paper submission and in the Docket: For access to the docket to related disease to individual tobacco
manner detailed (see ‘‘Written/Paper read the electronic and written/paper users; and benefits the health of the
Submissions’’ and ‘‘Instructions’’). comments received, go to https:// population as a whole. A person seeking
www.regulations.gov and insert the an order under section 911(g)(1) of the
Written/Paper Submissions docket number, found in brackets in the FD&C Act must show that the tobacco
Submit written/paper submissions as heading of this document, into the product, as it is actually used by
follows: ‘‘Search’’ box and follow the prompts consumers, will significantly reduce
VerDate Sep<11>2014 17:30 Sep 20, 2018 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1](https://thefederalregister.org/doc/83_FR_48109/page/1.svg)
![47926 Federal Register / Vol. 83, No. 184 / Friday, September 21, 2018 / Notices
harm and the risk of tobacco-related ucm619683.htm or https:// Electronic Submissions
disease to individual tobacco users and www.regulations.gov. Submit electronic comments in the
will benefit the health of the population Dated: September 17, 2018. following way:
as a whole taking into account both • Federal eRulemaking Portal:
Leslie Kux,
users of tobacco products and persons https://www.regulations.gov. Follow the
who do not currently use tobacco Associate Commissioner for Policy.
[FR Doc. 2018–20562 Filed 9–20–18; 8:45 am]
instructions for submitting comments.
products. Section 911(g)(4) of the FD&C Comments submitted electronically,
Act describes factors that FDA must take BILLING CODE 4164–01–P
including attachments, to https://
into account in evaluating whether a www.regulations.gov will be posted to
tobacco product benefits the health of the docket unchanged. Because your
individuals and the population as a DEPARTMENT OF HEALTH AND
HUMAN SERVICES comment will be made public, you are
whole. solely responsible for ensuring that your
FDA is issuing this notice to inform Food and Drug Administration comment does not include any
the public that a MRTPA for confidential information that you or a
Copenhagen® Snuff Fine Cut submitted third party may not wish to be posted,
by U.S. Smokeless Tobacco Co. LLC has [Docket No. FDA–2018–D–0787]
such as medical information, your or
been filed and is being made available anyone else’s Social Security number, or
Civil Money Penalties Relating to the
for public comment. confidential business information, such
ClinicalTrials.gov Data Bank; Draft
MR0000108: Copenhagen® Snuff Fine Guidance for Food and Drug as a manufacturing process. Please note
Cut Administration Staff, Responsible that if you include your name, contact
Parties, and Submitters of Certain information, or other information that
FDA will post the application identifies you in the body of your
Applications and Submissions to the
documents, including any amendments, comments, that information will be
Food and Drug Administration;
for public comment in batches on a posted on https://www.regulations.gov.
Availability
rolling basis as they are redacted in • If you want to submit a comment
accordance with applicable laws. In this AGENCY: Food and Drug Administration, with confidential information that you
document, FDA is announcing the HHS. do not wish to be made available to the
availability of the first batch of public, submit the comment as a
application documents. FDA intends to ACTION: Notice of availability. written/paper submission and in the
establish a closing date for the comment manner detailed (see ‘‘Written/Paper
period that is both at least 180 days after SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’).
the date of this notice and at least 30 Administration (FDA or Agency) is
days after the final documents from the announcing the availability of a draft Written/Paper Submissions
application are made available for guidance for industry entitled ‘‘Civil Submit written/paper submissions as
public comment. FDA will announce Money Penalties Relating to the follows:
the closing date at least 30 days in ClinicalTrials.gov Data Bank; Draft • Mail/Hand delivery/Courier (for
advance. FDA believes that this Guidance for FDA Staff, Responsible written/paper submissions): Dockets
comment period is appropriate given Parties, and Submitters of Certain Management Staff (HFA–305), Food and
the volume and complexity of the Applications and Submissions to FDA.’’ Drug Administration, 5630 Fishers
application being posted. FDA will The draft guidance provides the current Lane, Rm. 1061, Rockville, MD 20852.
notify the public about the availability thinking of FDA’s Center for Drug • For written/paper comments
of additional application documents Evaluation and Research (CDER), Center submitted to the Dockets Management
and the comment period closing date for Biologics Evaluation and Research Staff, FDA will post your comment, as
via the Agency’s web page for the (CBER), and Center for Devices and well as any attachments, except for
MRTPA (see section II) and by other Radiological Health (CDRH) regarding information submitted, marked and
means of public communication, such civil money penalties that may be identified, as confidential, if submitted
as by email to individuals who have assessed against responsible parties as detailed in ‘‘Instructions.’’
signed up to receive email alerts. To and/or submitters of certain Instructions: All submissions received
receive email alerts, visit FDA’s email applications and submissions to FDA must include the Docket No. FDA–
subscription service management regarding drug products, biological 2018–D–0787 for ‘‘Civil Money
website (http://go.fda.gov/ products, and device products who Penalties Relating to the
subscriptionmanagement), provide an violate applicable Federal Food, Drug, ClinicalTrials.gov Data Bank; Draft
email address, scroll down to the and Cosmetic Act (FD&C Act) Guidance for FDA Staff, Responsible
‘‘Tobacco’’ heading, select ‘‘Modified prohibitions relating to requirements, Parties, and Submitters of Certain
Risk Tobacco Product Application including implementing regulations, Applications and Submissions to FDA.’’
Updates’’, and click ‘‘Submit’’. To submitting registration and/or results Received comments will be placed in
encourage public participation information to the ClinicalTrials.gov the docket and, except for those
consistent with section 911(e) of the data bank, and/or certain certifications submitted as ‘‘Confidential
FD&C Act, FDA is making the redacted to FDA. Submissions,’’ publicly viewable at
MRTPAs that are the subject of this https://www.regulations.gov or at the
DATES: Submit either electronic or
notice available electronically (see Dockets Management Staff between 9
daltland on DSKBBV9HB2PROD with NOTICES
written comments on the draft guidance
section II). a.m. and 4 p.m., Monday through
by November 20, 2018 to ensure that the
Friday.
II. Electronic Access Agency considers your comment on this
• Confidential Submissions—To
draft guidance before it begins work on
Persons with access to the internet submit a comment with confidential
the final version of the guidance.
may obtain the documents at either information that you do not wish to be
https://www.fda.gov/TobaccoProducts/ ADDRESSES: You may submit comments made publicly available, submit your
Labeling/MarketingandAdvertising/ on any guidance at any time as follows: comments only as a written/paper
VerDate Sep<11>2014 17:30 Sep 20, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1](https://thefederalregister.org/doc/83_FR_48109/page/2.svg)
Document Created: 2018-09-21 00:23:13
Document Modified: 2018-09-21 00:23:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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] | |
| FR Citation | 83 FR 47925 |
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