Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Reopening of Comment Period, 45661 [2015-18782]

Download as PDF Federal Register / Vol. 80, No. 147 / Friday, July 31, 2015 / Notices IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032. V. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. VI. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/cvm or https:// www.regulations.gov. Dated: July 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–18796 Filed 7–30–15; 8:45 am] BILLING CODE 4164–01–P 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. Notice; reopening of the comment period. ACTION: 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 asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:44 Jul 30, 2015 Jkt 235001 Register of August 27, 2014 (79 FR 51183). In that notice, FDA requested comments on the 10 originally-filed MRTPAs that are posted on https:// 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 https:// 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, 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 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 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 45661 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 https://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 https:// www.regulations.gov. Persons with access to the Internet may obtain the document at either https://www.accessdata.fda.gov/Static/ widgets/tobacco/SMNA_MRTPA_FDA2014-N-1051.html or https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: David Anderson, University of Oregon, Eugene: Based on an assessment conducted by the University of Oregon, Eugene (UOE), the Respondent’s admission, and analysis conducted by ORI, ORI and UOE found that Mr. David Anderson, Graduate Student, UOE, engaged in research misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grants R01 MH087214, R01 MH077105, and TA MH020002. ORI found that Respondent engaged in research misconduct by falsifying and/or fabricating data in the following four (4) publications: • Journal of Neuroscience 31(3):1128–38, 2011 (hereafter referred to as ‘‘Paper 1’’). Journal of Experimental Psychology: Human Perception and Performance SUMMARY: E:\FR\FM\31JYN1.SGM 31JYN1

Agencies

[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]


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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: 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 https://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 https://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, 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 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 https://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 https://www.regulations.gov.
    Persons with access to the Internet may obtain the document at 
either https://www.accessdata.fda.gov/Static/widgets/tobacco/SMNA_MRTPA_FDA-2014-N-1051.html or https://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

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