[Federal Register Volume 80, Number 147 (Friday, July 31, 2015)]
[Notices]
[Page 45661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18782]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Modified Risk Tobacco Product Applications: Applications for 10 
Products Submitted by Swedish Match North America Inc.; Reopening of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening the period 
for public comment on modified risk tobacco product applications 
(MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco 
products and announcing the availability for public comment of 
amendments to the MRTPAs. The notice of availability for the 
originally-filed applications appeared in the Federal Register of 
August 27, 2014 (79 FR 51183). In that notice, FDA requested comments 
on the 10 originally-filed MRTPAs that are posted on http://www.regulations.gov and FDA's Web site. The comment period on these 
originally-filed applications closed on February 23, 2015. FDA is 
reopening the comment period to seek comment specifically on amendments 
made to the originally-filed MRTPAs submitted by Swedish Match North 
America Inc.

DATES: Submit either electronic or written comments on the amendments 
by August 31, 2015.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. Identify comments with Docket Number FDA-2014-N-
1051.

FOR FURTHER INFORMATION CONTACT: Center for Tobacco Products, Food and 
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 
1-877-287-1373, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of August 27, 2014 (79 FR 51183), FDA 
published a notice of availability of MRTPAs submitted by Swedish Match 
North America Inc. for 10 tobacco products and gave the public 180 days 
to comment on the applications.
    FDA is required by section 911(e) of the Federal Food, Drug, and 
Cosmetic Act (the 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 received and accepted a number of amendments to Swedish 
Match North America Inc.'s 10 originally-filed MRTPAs and is making 
these amendments available (except for matters in the amendments 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 these 
amendments.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
    Persons with access to the Internet may obtain the document at 
either http://www.accessdata.fda.gov/Static/widgets/tobacco/SMNA_MRTPA_FDA-2014-N-1051.html or http://www.regulations.gov.

     Dated: July 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18782 Filed 7-30-15; 8:45 am]
 BILLING CODE 4164-01-P