82 FR 60206 - Modified Risk Tobacco Product Applications: Applications for Six Camel Snus Smokeless Tobacco Products Submitted by R.J. Reynolds Tobacco Company; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 242 (December 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 242 (December 19, 2017)
| Page Range | 60206-60207 | |
| FR Document | 2017-27246 |
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)] [Notices] [Pages 60206-60207] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27246] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4678] Modified Risk Tobacco Product Applications: Applications for Six Camel Snus Smokeless Tobacco Products Submitted by R.J. Reynolds Tobacco Company; 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 six Camel Snus smokeless tobacco products submitted by R.J. Reynolds Tobacco Co. DATES: Electronic or written comments on the applications may be submitted until June 18, 2018; however, FDA may modify the comment period by providing notice 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-2017-N-4678 for ``Modified Risk Tobacco Product Applications: Applications for Six Camel Snus Smokeless Tobacco Products Submitted by R.J. Reynolds Tobacco Company.'' 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 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 (2). The applicant, R.J. Reynolds Tobacco Co., is seeking orders under section 911(g)(1) for each of the 6 products that are the subject of the submitted MRTPAs. A [[Page 60207]] 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 is issuing this notice to inform the public that the MRTPAs for the following products submitted by R.J. Reynolds Tobacco Co. have been filed and are being made available for public comment: MR0000068: Camel Snus Frost MR0000069: Camel Snus Frost Large MR0000070: Camel Snus Mellow MR0000071: Camel Snus Mint MR0000072: Camel Snus Robust MR0000073: Camel Snus Winterchill In this document, FDA is announcing the availability of the applications for public comment. FDA will make any amendments submitted by the applicant available for public comment on a rolling basis. The applications will be available for public comment for 180 days from the date this notice is published; however, in the event that fewer than 30 days remain in the 180-day comment period when an amendment is posted, FDA will extend or reopen the comment period to allow for at least 30 days of public comment on the amendment. FDA believes that this comment period is appropriate given the volume and complexity of the applications being posted. FDA will notify the public about the availability of amendments to these applications and changes to related comment periods via the Agency's website and other means of public communication. 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/UCM564399.htm. Dated: December 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27246 Filed 12-18-17; 8:45 am] BILLING CODE 4164-01-P
![60206 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
default.htm or https:// public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
www.regulations.gov. written/paper submission and in the 23389.pdf.
Dated: December 14, 2017. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Leslie Kux,
Submissions’’ and ‘‘Instructions’’). read the electronic and written/paper
comments received, go to https://
Associate Commissioner for Policy. Written/Paper Submissions
www.regulations.gov and insert the
[FR Doc. 2017–27275 Filed 12–18–17; 8:45 am] Submit written/paper submissions as docket number, found in brackets in the
BILLING CODE 4164–01–P follows: heading of this document, into the
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets and/or go to the Dockets Management
DEPARTMENT OF HEALTH AND Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061,
HUMAN SERVICES Drug Administration, 5630 Fishers Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul
Food and Drug Administration • For written/paper comments
submitted to the Dockets Management Hart, Center for Tobacco Products, Food
[Docket No. FDA–2017–N–4678] and Drug Administration, 10903 New
Staff, FDA will post your comment, as
Modified Risk Tobacco Product well as any attachments, except for Hampshire Ave., Bldg. 71, Rm. G335,
Applications: Applications for Six information submitted, marked and Silver Spring, MD 20993–0002, 1–877–
Camel Snus Smokeless Tobacco identified, as confidential, if submitted 287–1373, email: AskCTP@fda.hhs.gov.
Products Submitted by R.J. Reynolds as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION:
Tobacco Company; Availability Instructions: All submissions received I. Background
must include the Docket No. FDA–
AGENCY: Food and Drug Administration, 2017–N–4678 for ‘‘Modified Risk Section 911 of the Federal Food, Drug,
HHS. Tobacco Product Applications: and Cosmetic Act (FD&C Act) (21 U.S.C.
ACTION: Notice. Applications for Six Camel Snus 387k) addresses the marketing and
Smokeless Tobacco Products Submitted distribution of modified risk tobacco
SUMMARY: The Food and Drug by R.J. Reynolds Tobacco Company.’’ products (MRTPs). MRTPs are tobacco
Administration (FDA or Agency) is Received comments will be placed in products that are sold or distributed for
announcing the availability for public the docket and, except for those use to reduce harm or the risk of
comment of modified risk tobacco submitted as ‘‘Confidential tobacco-related disease associated with
product applications (MRTPAs) for six Submissions,’’ publicly viewable at commercially marketed tobacco
Camel Snus smokeless tobacco products https://www.regulations.gov or at the products. Section 911(a) of the FD&C
submitted by R.J. Reynolds Tobacco Co. Dockets Management Staff between 9 Act prohibits the introduction or
DATES: Electronic or written comments a.m. and 4 p.m., Monday through delivery for introduction into interstate
on the applications may be submitted Friday. commerce of any MRTP unless an order
until June 18, 2018; however, FDA may • Confidential Submissions—To issued by FDA under section 911(g) of
modify the comment period by submit a comment with confidential the FD&C Act is effective with respect
providing notice as described in section information that you do not wish to be to such product.
I. made publicly available, submit your Section 911(d) of the FD&C Act
ADDRESSES: You may submit comments comments only as a written/paper describes the information that must be
as follows: submission. You should submit two included in an MRTPA, which must be
copies total. One copy will include the filed and evaluated by FDA before an
Electronic Submissions information you claim to be confidential applicant can receive an order from
Submit electronic comments in the with a heading or cover note that states FDA. FDA is required by section 911(e)
following way: ‘‘THIS DOCUMENT CONTAINS of the FD&C Act to make an MRTPA
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The available to the public (except for
https://www.regulations.gov. Follow the Agency will review this copy, including matters in the application that are trade
instructions for submitting comments. the claimed confidential information, in secrets or otherwise confidential
Comments submitted electronically, its consideration of comments. The commercial information) and to request
including attachments, to https:// second copy, which will have the comments by interested persons on the
www.regulations.gov will be posted to claimed confidential information information contained in the
the docket unchanged. Because your redacted/blacked out, will be available application and on the label, labeling,
comment will be made public, you are for public viewing and posted on and advertising accompanying the
solely responsible for ensuring that your https://www.regulations.gov. Submit application. The determination of
comment does not include any both copies to the Dockets Management whether an order is appropriate under
confidential information that you or a Staff. If you do not wish your name and section 911(g) of the FD&C Act is based
third party may not wish to be posted, contact information to be made publicly on the scientific information submitted
such as medical information, your or available, you can provide this by the applicant as well as the scientific
anyone else’s Social Security number, or information on the cover sheet and not evidence and other information that is
confidential business information, such in the body of your comments and you made available to the Agency, including
as a manufacturing process. Please note must identify this information as through public comments.
that if you include your name, contact ‘‘confidential.’’ Any information marked Section 911(g) of the FD&C Act
sradovich on DSK3GMQ082PROD with NOTICES
information, or other information that as ‘‘confidential’’ will not be disclosed describes the demonstrations applicants
identifies you in the body of your except in accordance with 21 CFR 10.20 must make to obtain an order from FDA
comments, that information will be and other applicable disclosure law. For under either section 911(g)(1) or (2). The
posted on https://www.regulations.gov. more information about FDA’s posting applicant, R.J. Reynolds Tobacco Co., is
• If you want to submit a comment of comments to public dockets, see 80 seeking orders under section 911(g)(1)
with confidential information that you FR 56469, September 18, 2015, or access for each of the 6 products that are the
do not wish to be made available to the the information at: https://www.gpo.gov/ subject of the submitted MRTPAs. A
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![Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices 60207
person seeking an order under section Dated: December 13, 2017. solely responsible for ensuring that your
911(g)(1) of the FD&C Act must show Leslie Kux, comment does not include any
that the tobacco product, as it is actually Associate Commissioner for Policy. confidential information that you or a
used by consumers, will significantly [FR Doc. 2017–27246 Filed 12–18–17; 8:45 am] third party may not wish to be posted,
reduce harm and the risk of tobacco- BILLING CODE 4164–01–P such as medical information, your or
related disease to individual tobacco anyone else’s Social Security number, or
users and will benefit the health of the confidential business information, such
population as a whole taking into DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
account both users of tobacco products HUMAN SERVICES that if you include your name, contact
and persons who do not currently use information, or other information that
Food and Drug Administration identifies you in the body of your
tobacco products. Section 911(g)(4) of
the FD&C Act describes factors that FDA [Docket No. FDA–2011–N–0672] comments, that information will be
posted on https://www.regulations.gov.
must take into account in evaluating • If you want to submit a comment
whether a tobacco product benefits the Agency Information Collection
Activities; Proposed Collection; with confidential information that you
health of individuals and the population do not wish to be made available to the
as a whole. Comment Request; Prominent and
Conspicuous Mark of Manufacturers public, submit the comment as a
FDA is issuing this notice to inform on Single-Use Devices written/paper submission and in the
the public that the MRTPAs for the manner detailed (see ‘‘Written/Paper
following products submitted by R.J. AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’).
Reynolds Tobacco Co. have been filed HHS.
ACTION: Notice. Written/Paper Submissions
and are being made available for public
comment: Submit written/paper submissions as
SUMMARY: The Food and Drug follows:
• MR0000068: Camel Snus Frost Administration (FDA or Agency) is • Mail/Hand delivery/Courier (for
• MR0000069: Camel Snus Frost Large announcing an opportunity for public written/paper submissions): Dockets
comment on the proposed collection of Management Staff (HFA–305), Food and
• MR0000070: Camel Snus Mellow certain information by the Agency. Drug Administration, 5630 Fishers
• MR0000071: Camel Snus Mint Under the Paperwork Reduction Act of Lane, Rm. 1061, Rockville, MD 20852.
• MR0000072: Camel Snus Robust 1995 (PRA), Federal Agencies are • For written/paper comments
required to publish notice in the submitted to the Dockets Management
• MR0000073: Camel Snus Winterchill Federal Register concerning each Staff, FDA will post your comment, as
In this document, FDA is announcing proposed collection of information, well as any attachments, except for
the availability of the applications for including each proposed extension of an information submitted, marked and
public comment. FDA will make any existing collection of information, and identified, as confidential, if submitted
amendments submitted by the applicant to allow 60 days for public comment in as detailed in ‘‘Instructions.’’
available for public comment on a response to the notice. This notice Instructions: All submissions received
rolling basis. The applications will be solicits comments on reprocessed, must include the Docket No. FDA–
available for public comment for 180 single-use device labeling. 2011–N–0672 for ‘‘Agency Information
days from the date this notice is DATES: Submit either electronic or Collection Activities; Proposed
published; however, in the event that written comments on the collection of Collection; Comment Request;
fewer than 30 days remain in the 180- information by February 20, 2018. Prominent and Conspicuous Mark of
day comment period when an ADDRESSES: You may submit comments Manufacturers on Single-Use Devices.’’
amendment is posted, FDA will extend as follows. Please note that late, Received comments, those filed in a
or reopen the comment period to allow untimely filed comments will not be timely manner (see ADDRESSES), will be
for at least 30 days of public comment considered. Electronic comments must placed in the docket and, except for
on the amendment. FDA believes that be submitted on or before February 20, those submitted as ‘‘Confidential
this comment period is appropriate 2018. The https://www.regulations.gov Submissions,’’ publicly viewable at
given the volume and complexity of the electronic filing system will accept https://www.regulations.gov or at the
applications being posted. FDA will comments until midnight Eastern Time Dockets Management Staff between 9
notify the public about the availability at the end of February 20, 2018. a.m. and 4 p.m., Monday through
of amendments to these applications Comments received by mail/hand Friday.
delivery/courier (for written/paper • Confidential Submissions—To
and changes to related comment periods
submissions) will be considered timely submit a comment with confidential
via the Agency’s website and other
if they are postmarked or the delivery information that you do not wish to be
means of public communication. To
service acceptance receipt is on or made publicly available, submit your
encourage public participation
before that date. comments only as a written/paper
consistent with section 911(e) of the
submission. You should submit two
FD&C Act, FDA is making the redacted Electronic Submissions copies total. One copy will include the
MRTPAs that are the subject of this information you claim to be confidential
Submit electronic comments in the
notice available electronically (see with a heading or cover note that states
following way:
section II). • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
sradovich on DSK3GMQ082PROD with NOTICES
II. Electronic Access https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
instructions for submitting comments. Agency will review this copy, including
Persons with access to the internet Comments submitted electronically, the claimed confidential information, in
may obtain the documents at: https:// including attachments, to https:// its consideration of comments. The
www.fda.gov/TobaccoProducts/ www.regulations.gov will be posted to second copy, which will have the
Labeling/MarketingandAdvertising/ the docket unchanged. Because your claimed confidential information
UCM564399.htm. comment will be made public, you are redacted/blacked out, will be available
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Document Created: 2017-12-19 01:31:27
Document Modified: 2017-12-19 01:31:27
| 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. | |
| Dates | Electronic or written comments on the applications may be submitted until June 18, 2018; however, FDA may modify the comment period by providing notice 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 | 82 FR 60206 |
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