Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Availability
Federal Register, Volume 79 Issue 166 (Wednesday, August 27, 2014)
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.
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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:
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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
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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).
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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.
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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
