83 FR 54362 - Modified Risk Tobacco Product Applications for Snus Products Submitted by Swedish Match North America Inc.; Reopening of the Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 209 (October 29, 2018)

Page Range		54362-54363
FR Document		2018-23524

The Food and Drug Administration (FDA or the Agency) is reopening the period for public comment on modified risk tobacco product applications (MRTPAs) for specific General Snus products submitted by Swedish Match North America Inc. and announcing the availability for public comment of a recently received amendment to the MRTPAs. The original notice of availability for the applications appeared in the Federal Register of August 27, 2014. In that notice, FDA requested comments on the originally filed MRTPAs that are posted on https://www.regulations.gov and FDA's website. In the Federal Register of July 31, 2015, FDA issued a notice to reopen and extended the comment period for comments on amendments to the MRTPAs. That comment period closed on August 31, 2015. FDA is now reopening the comment period to seek comment specifically on a recent amendment to the MRTPAs.

Federal Register, Volume 83 Issue 209 (Monday, October 29, 2018)

[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54362-54363]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23524]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1051]


Modified Risk Tobacco Product Applications for Snus Products 
Submitted by Swedish Match North America Inc.; Reopening of the Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the period for public comment on modified risk tobacco 
product applications (MRTPAs) for specific General Snus products 
submitted by Swedish Match North America Inc. and announcing the 
availability for public comment of a recently received amendment to the 
MRTPAs. The original notice of availability for the applications 
appeared in the Federal Register of August 27, 2014. In that notice, 
FDA requested comments on the originally filed MRTPAs that are posted 
on https://www.regulations.gov and FDA's website. In the Federal 
Register of July 31, 2015, FDA issued a notice to reopen and extended 
the comment period for comments on amendments to the MRTPAs. That 
comment period closed on August 31, 2015. FDA is now reopening the 
comment period to seek comment specifically on a recent amendment to 
the MRTPAs.

DATES: Electronic or written comments on the application may be 
submitted beginning October 29, 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-2014-N-1051 for ``Modified Risk Tobacco Product Applications for 
Snus Products Submitted by Swedish Match North America Inc.'' 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: 
AskCTP@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 27, 2014 (79 FR 51183), FDA 
published a notice of availability for MRTPAs submitted by Swedish 
Match North America Inc. and gave the public 180 days to comment on the 
applications. FDA subsequently published a notice in the Federal 
Register of July 31, 2015 (80 FR 45661), to reopen and extend the 
comment period to allow for comment on amendments to the applications. 
The comment period closed on August 31, 2015. On December 14, 2016, FDA

[[Page 54363]]

issued a letter to Swedish Match North America Inc. that denied the 
MRTPAs, in part, and outlined deficiencies in the remaining portions of 
the MRTPAs that the applicant could address by submitting an amendment 
to the applications. FDA recently received an amendment to Swedish 
Match North America Inc.'s MRTPAs and is making the amendment available 
(except for matters in the amendment that are trade secrets or 
otherwise confidential commercial information) for public comment. FDA 
is reopening the period for public comment so that the public has the 
opportunity to review and comment on the amendment.
    FDA is required by section 911(e) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 387k(e)) 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 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.
    FDA has posted the application amendment for public comment, which 
has been redacted in accordance with applicable laws. FDA intends to 
establish a closing date for the comment period that is at least 30 
days after the final documents from the application are made available 
for public comment and will announce the closing date at least 30 days 
in advance. FDA will notify the public about the availability of 
additional application documents, if any, and the closing date for the 
comment period 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. FDA does not 
intend to issue additional notices in the Federal Register regarding 
amendments or the comment period for these MRTPAs. 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/ucm533454.htm or https://www.regulations.gov.

    Dated: October 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23524 Filed 10-26-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices 54363

issued a letter to Swedish Match North MRTPAs that are the subject of this reporting system, entitled the RWHAP
America Inc. that denied the MRTPAs, notice available electronically (see Services Report or the Ryan White
in part, and outlined deficiencies in the section II). Services Report (RSR), is designed to
remaining portions of the MRTPAs that collect information from grant
II. Electronic Access
the applicant could address by recipients, as well as their
submitting an amendment to the Persons with access to the internet subrecipients, funded under Parts A, B,
applications. FDA recently received an may obtain the documents at either C, and D of the RWHAP statute. The
amendment to Swedish Match North https://www.fda.gov/TobaccoProducts/ RWHAP, authorized under Title XXVI
America Inc.’s MRTPAs and is making Labeling/MarketingandAdvertising/ of the Public Health Service Act, as
the amendment available (except for ucm533454.htm or https:// amended by the Ryan White HIV/AIDS
matters in the amendment that are trade www.regulations.gov. Treatment Extension Act of 2009, is
secrets or otherwise confidential Dated: October 23, 2018. administered by HRSA HIV/AIDS
commercial information) for public Leslie Kux, Bureau (HAB). The HRSA RWHAP
comment. FDA is reopening the period funds and coordinates with cities,
Associate Commissioner for Policy.
for public comment so that the public states, and local clinics/community-
[FR Doc. 2018–23524 Filed 10–26–18; 8:45 am]
has the opportunity to review and based organizations to deliver efficient
comment on the amendment. BILLING CODE 4164–01–P and effective HIV care, treatment, and
FDA is required by section 911(e) of support to low-income people living
the Federal Food, Drug, and Cosmetic with HIV (PLWH).
Act (FD&C Act) (21 U.S.C. 387k(e)) to DEPARTMENT OF HEALTH AND Need and Proposed Use of the
make an MRTPA available to the public HUMAN SERVICES Information: The RWHAP statute
(except for matters in the application requires HRSA to monitor the
Health Resources and Services
that are trade secrets or otherwise administration of grant funds, allocation
Administration
confidential commercial information) of funding, service utilization, and
and to request comments by interested Agency Information Collection client demographic and HIV health
persons on the information contained in Activities: Submission to OMB for outcome data (e.g., viral suppression).
the application and on the label, Review and Approval; Public Comment The RSR collects data on the
labeling, and advertising accompanying Request; Ryan White HIV/AIDS characteristics of RWHAP-funded
the application. The determination of Program Client-Level Data Reporting recipients, subrecipients, and the
whether an order is appropriate under System, OMB No. 0906–xxxx–NEW patients or clients served. The RSR
section 911 of the FD&C Act is based on system consists of two online data
the scientific information submitted by AGENCY: Health Resources and Services forms: the Recipient Report and the
the applicant as well as the scientific Administration (HRSA), Department of Service Provider Report; and the Client
evidence and other information that is Health and Human Services. Report, which is a data file containing
made available to the Agency, including ACTION: Notice. the client-level data elements. Data are
through public comments. submitted annually. The RWHAP
FDA has posted the application SUMMARY: In compliance with the statute specifies the importance of
amendment for public comment, which Paperwork Reduction Act of 1995, recipient accountability and linking
has been redacted in accordance with HRSA has submitted an Information performance to budget. The RSR is used
applicable laws. FDA intends to Collection Request (ICR) to the Office of to ensure recipient compliance with the
establish a closing date for the comment Management and Budget (OMB) for statute, including evaluating the
period that is at least 30 days after the review and approval. Comments effectiveness of programs, monitoring
final documents from the application submitted during the first public review recipient and subrecipient performance,
are made available for public comment of this ICR will be provided to OMB. and informing annual reports to
and will announce the closing date at OMB will accept further comments from Congress. Information collected through
least 30 days in advance. FDA will the public during the review and the RSR is critical for HRSA, state/local
notify the public about the availability approval period. grant recipients, and individual service
of additional application documents, if DATES: Comments on this ICR should be providers to understand existing HIV-
any, and the closing date for the received no later than November 28, related service delivery systems and the
comment period via the Agency’s web 2018. clients served. Information in the RSR is
page for the MRTPA (see section II) and used to assess trends in service
by other means of public ADDRESSES: Submit your comments,
utilization and HIV health outcomes for
communication, such as by email to including the ICR Title, to the desk
clients served. Data from the RSR is
individuals who have signed up to officer for HRSA, either by email to
analyzed to identify disparities and gaps
receive email alerts. FDA does not OIRA_submission@omb.eop.gov or by within the service delivery systems. The
intend to issue additional notices in the fax to (202) 395–5806. 60-day notice published on November
Federal Register regarding amendments FOR FURTHER INFORMATION CONTACT: To 27, 2017 (Vol. 82, No. 226).
or the comment period for these request a copy of the clearance requests This new ICR is being developed to
MRTPAs. To receive email alerts, visit submitted to OMB for review, email Lisa replace the existing ICR (OMB control
FDA’s email subscription service Wright-Solomon, the HRSA Information number 0915–0323), for which HRSA
management website (http://go.fda.gov/ Collection Clearance Officer at has collected RSR data since 2009. As
subscriptionmanagement), provide an paperwork@hrsa.gov or call (301) 443– more recipients fully fund services
amozie on DSK3GDR082PROD with NOTICES1

email address, scroll down to the 1984. using other RWHAP-related funding
‘‘Tobacco’’ heading, select ‘‘Modified SUPPLEMENTARY INFORMATION: streams, such as pharmacy rebate
Risk Tobacco Product Application Information Collection Request Title: dollars, HRSA HAB receives less
Updates’’, and click ‘‘Submit’’. To Client-Level Data Reporting System. information on RWHAP eligible clients,
encourage public participation OMB No. 0906–xxxx–NEW. which reduces HRSA HAB’s ability to
consistent with section 911(e) of the Abstract: The Ryan White HIV/AIDS measure the investment and impact of
FD&C Act, FDA is making the redacted Program’s (RWHAP) client-level data all RWHAP-related expenditures at state

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Document Created: 2018-10-27 01:09:23
Document Modified: 2018-10-27 01:09:23

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; reopening of the comment period.
Dates		Electronic or written comments on the application may be submitted beginning October 29, 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 54362

83 FR 54362 - Modified Risk Tobacco Product Applications for Snus Products Submitted by Swedish Match North America Inc.; Reopening of the Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 209 (October 29, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration