Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Availability, 51183-51184 [2014-20394]

Download as PDF Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Notices to aid in the diagnosis of infection or screening for colonization. The scope of this guidance includes nucleic acid-based devices that employ technologies such as polymerase chain reaction, reverse-transcriptase polymerase chain reaction, bead-based liquid arrays, microarrays, resequencing approaches as well as the measurement of individual targets via a common process of sample preparation, target or signal amplification, allele discrimination, and collective interpretation, and are reported out simultaneously. This guidance is not intended to address devices that utilize detection mechanisms other than nucleic acid-based approaches. The document does not apply to devices that are intended to screen donors of blood and blood components, and donors of human cells, tissues, and cellular- and tissue-based products for communicable diseases. The draft of this guidance was issued on November 9, 2012 (77 FR 67379). The comment period closed on February 7, 2013. Two sets of comments were received and reviewed by FDA. The guidance was updated to address comments where appropriate. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on HMMDs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. IV. Paperwork Reduction Act of 1995 This guidance refers to currently 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 parts 801 and 809 have been approved under OMB control number 0910–0485; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073. V. 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. Dated: August 21, 2014. Peter Lurie, Associate Commissioner for Policy and Planning. [FR Doc. 2014–20291 Filed 8–26–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES III. Electronic Access Food and Drug Administration Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Highly Multiplexed Microbiological/ Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1803 to identify the guidance you are requesting. [Docket No. FDA–2014–N–1051] VerDate Mar<15>2010 17:44 Aug 26, 2014 Jkt 232001 Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco products. DATES: Submit either electronic or written comments on the applications by February 23, 2015. Please note, however, that it will be more likely that SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 51183 the Agency is able to consider your comments before referring the applications to the Tobacco Products Scientific Advisory Committee if you submit your comments by November 25, 2014. 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 the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1–877–CTP–1373, AskCTP@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111– 31) (Tobacco Control Act) into law. The Tobacco Control Act grants FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors. Section 911 of the Federal Food, Drug, and Cosmetic Act (the 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 whether an order is appropriate under section 911of the FD&C Act is based on the E:\FR\FM\27AUN1.SGM 27AUN1 mstockstill on DSK4VPTVN1PROD with NOTICES 51184 Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Notices 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, Swedish Match North America Inc., is seeking an order under section 911(g)(1) for each of the 10 products that are the subject of the submitted MRTPAs. 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 tobaccorelated 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 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 MRTPAs submitted by Swedish Match North America Inc. for the following products (identified by FDA Submission Tracking Numbers (STN) (MR0000020—MR0000029)) have been filed and are being made available for public comment for 180 days: • MR0000020: General Loose, smokeless tobacco, loose snus, 1.59 oz (45g), cardboard can (SKU 4852); • MR0000021: General Dry Mint Portion Original Mini, smokeless tobacco, snus portions, 0.21 oz (6g), 20—0.3g portions, plastic can (SKU 4800); • MR0000022: General Portion Original Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4880); • MR0000023: General Classic Blend Portion White Large, smokeless tobacco, snus portions, 0.48 oz (13.5g), 15—0.9g portions, plastic can (SKU 4877); • MR0000024: General Classic Blend Portion White Large, smokeless tobacco, snus portions, 0.38 oz (10.8g), 12—0.9g portions, plastic can (SKU 4878); • MR0000025: General Mint Portion White Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4352); VerDate Mar<15>2010 17:44 Aug 26, 2014 Jkt 232001 • MR0000026: General Nordic Mint Portion White Large, smokeless tobacco, snus portions, 0.48 oz (13.5g), 15—0.9g portions, plastic can (SKU 4876); • MR0000027: General Nordic Mint Portion White Large, smokeless tobacco, snus portions, 0.38 oz (10.8g), 12—0.9g portions, plastic can (SKU 4875); • MR0000028: General Portion White Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4881); and • MR0000029: General Wintergreen Portion White Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4882). FDA believes a 180-day comment period is appropriate because of the volume and complexity of the material being posted in the applications. If you submit comments that apply to some but not all 10 of the products, FDA asks that you identify the applicable product(s) using the STNs listed in this document in your comments. To encourage public participation consistent with section 911(e) of the FD&C Act, FDA is placing the MRTPAs (except for matters in the applications that are trade secrets or otherwise confidential commercial information) that are the subject of this notice on public display at the Division of Dockets Management (see DATES and ADDRESSES) and making them available electronically (see section III). 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. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.accessdata.fda.gov/Static/ widgets/tobacco/SMNA_MRTPA_FDA2014-N-1051.html or http:// www.regulations.gov. Dated: August 22, 2014. Peter Lurie, Associate Commissioner for Policy and Planning. [FR Doc. 2014–20394 Filed 8–26–14; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0007] Outsourcing Facility Fee Rates for Fiscal Year 2015; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Outsourcing Facility Fee Rates for Fiscal Year 2015’’ that appeared in the Federal Register of August 1, 2014 (79 FR 44805). The document announced the rates for fiscal year 2015 for the establishment and reinspection fees related to human drug compounding outsourcing facilities that elect to register under the Federal Food, Drug, and Cosmetic Act. The document was published with the incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Food and Administration, 10990 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993–0002, 301–796–9115. SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, August 1, 2014, in FR Doc. 2014–18111, the following correction is made: 1. On page 44805, in the first column, in the Docket No. heading, ‘‘[Docket No. FDA–2013–N–0007]’’ is corrected to read ‘‘[Docket No. FDA–2014–N–0007]’’. SUMMARY: Dated: August 21, 2014. Peter Lurie, Associate Commissioner for Policy and Planning. [FR Doc. 2014–20331 Filed 8–26–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Small Health Care Provider Quality Improvement Program Health Resources and Services Administration, HHS. ACTION: Notice of Class Deviation From Competition Requirements for Small Health Care Provider Quality Improvement. AGENCY: The Office of Rural Health Policy (ORHP) will award program expansion supplemental awards to the current Small Health Care Provider SUMMARY: E:\FR\FM\27AUN1.SGM 27AUN1

Agencies

[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Pages 51183-51184]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20394]


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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.; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for public comment of modified risk tobacco product 
applications (MRTPAs) submitted by Swedish Match North America Inc. for 
10 tobacco products.

DATES: Submit either electronic or written comments on the applications 
by February 23, 2015. Please note, however, that it will be more likely 
that the Agency is able to consider your comments before referring the 
applications to the Tobacco Products Scientific Advisory Committee if 
you submit your comments by November 25, 2014.

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 the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Center for Tobacco Products, Food and 
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 
1-877-CTP-1373, AskCTP@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control 
Act) into law. The Tobacco Control Act grants FDA authority to regulate 
the manufacture, marketing, and distribution of tobacco products to 
protect public health generally and to reduce tobacco use by minors. 
Section 911 of the Federal Food, Drug, and Cosmetic Act (the 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 whether an order is appropriate under 
section 911of the FD&C Act is based on the

[[Page 51184]]

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, Swedish Match North America Inc., 
is seeking an order under section 911(g)(1) for each of the 10 products 
that are the subject of the submitted MRTPAs.
    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 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 MRTPAs 
submitted by Swedish Match North America Inc. for the following 
products (identified by FDA Submission Tracking Numbers (STN) 
(MR0000020--MR0000029)) have been filed and are being made available 
for public comment for 180 days:
     MR0000020: General Loose, smokeless tobacco, loose snus, 
1.59 oz (45g), cardboard can (SKU 4852);
     MR0000021: General Dry Mint Portion Original Mini, 
smokeless tobacco, snus portions, 0.21 oz (6g), 20--0.3g portions, 
plastic can (SKU 4800);
     MR0000022: General Portion Original Large, smokeless 
tobacco, snus portions, 0.9 oz (24g), 24--1g portions, plastic can (SKU 
4880);
     MR0000023: General Classic Blend Portion White Large, 
smokeless tobacco, snus portions, 0.48 oz (13.5g), 15--0.9g portions, 
plastic can (SKU 4877);
     MR0000024: General Classic Blend Portion White Large, 
smokeless tobacco, snus portions, 0.38 oz (10.8g), 12--0.9g portions, 
plastic can (SKU 4878);
     MR0000025: General Mint Portion White Large, smokeless 
tobacco, snus portions, 0.9 oz (24g), 24--1g portions, plastic can (SKU 
4352);
     MR0000026: General Nordic Mint Portion White Large, 
smokeless tobacco, snus portions, 0.48 oz (13.5g), 15--0.9g portions, 
plastic can (SKU 4876);
     MR0000027: General Nordic Mint Portion White Large, 
smokeless tobacco, snus portions, 0.38 oz (10.8g), 12--0.9g portions, 
plastic can (SKU 4875);
     MR0000028: General Portion White Large, smokeless tobacco, 
snus portions, 0.9 oz (24g), 24--1g portions, plastic can (SKU 4881); 
and
     MR0000029: General Wintergreen Portion White Large, 
smokeless tobacco, snus portions, 0.9 oz (24g), 24--1g portions, 
plastic can (SKU 4882).
    FDA believes a 180-day comment period is appropriate because of the 
volume and complexity of the material being posted in the applications. 
If you submit comments that apply to some but not all 10 of the 
products, FDA asks that you identify the applicable product(s) using 
the STNs listed in this document in your comments. To encourage public 
participation consistent with section 911(e) of the FD&C Act, FDA is 
placing the MRTPAs (except for matters in the applications that are 
trade secrets or otherwise confidential commercial information) that 
are the subject of this notice on public display at the Division of 
Dockets Management (see DATES and ADDRESSES) and making them available 
electronically (see section III).

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.

III. Electronic Access

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

    Dated: August 22, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20394 Filed 8-26-14; 8:45 am]
BILLING CODE 4164-01-P