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Federal Register/Vol. 82, No. 13/Monday, January 23, 2017/Proposed Rules 8004 Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Proposed Rules DEPARTMENT OF HEALTH AND comment will be made public, you are www.regulations.gov. Submit both HUMAN SERVICES solely responsible for ensuring that your copies to the Division of Dockets comment does not include any Management. If you do not wish your Food and Drug Administration confidential information that you or a name and contact information to be third party may not wish to be posted, made publicly available, you can 21 CFR Part 1132 such as medical information, your or provide this information on the cover [Docket No. FDA–2016–N–2527] anyone else’s Social Security number, or sheet and not in the body of your confidential business information, such comments and you must identify this Tobacco Product Standard for N- as a manufacturing process. Please note information as ‘‘confidential.’’ Any Nitrosonornicotine Level in Finished that if you include your name, contact information marked as ‘‘confidential’’ Smokeless Tobacco Products information, or other information that will not be disclosed except in identifies you in the body of your accordance with 21 CFR 10.20 and other AGENCY: Food and Drug Administration, comments, that information will be applicable disclosure law. For more HHS. posted on http://www.regulations.gov. information about FDA’s posting of • ACTION: Proposed rule. If you want to submit a comment comments to public dockets, see 80 FR with confidential information that you 56469, September 18, 2015, or access SUMMARY: The Food and Drug do not wish to be made available to the the information at: http://www.fda.gov/ Administration (FDA) is proposing a public, submit the comment as a regulatoryinformation/dockets/ tobacco product standard that would written/paper submission and in the default.htm. establish a limit of N-nitrosonornicotine manner detailed (see ‘‘Written/Paper Docket: For access to the docket to (NNN) in finished smokeless tobacco Submissions’’ and ‘‘Instructions’’). read background documents or the products. FDA is taking this action Written/Paper Submissions electronic and written/paper comments because NNN is a potent carcinogenic received, go to http:// agent found in smokeless tobacco Submit written/paper submissions as www.regulations.gov and insert the products and is a major contributor to follows: docket number, found in brackets in the • Mail/Hand delivery/Courier (for the elevated cancer risks associated with heading of this document, into the written/paper submissions): Division of smokeless tobacco use. Because ‘‘Search’’ box and follow the prompts Dockets Management (HFA–305), Food products with higher NNN levels pose and/or go to the Division of Dockets and Drug Administration, 5630 Fishers higher risks of cancer, FDA finds that Management, 5630 Fishers Lane, Rm. establishing a NNN limit in finished Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments 1061, Rockville, MD 20852. smokeless tobacco products is Submit comments on information submitted to the Division of Dockets appropriate for the protection of the collection issues to the Office of Management, FDA will post your public health. Management and Budget in the comment, as well as any attachments, DATES: Submit either electronic or following ways: except for information submitted, written comments on the proposed rule • Fax to the Office of Information and marked and identified, as confidential, by April 10, 2017. In accordance with Regulatory Affairs, OMB, Attn: FDA if submitted as detailed in 21 CFR 10.40(c), in finalizing this Desk Officer, FAX: 202–395–7285, or ‘‘Instructions.’’ email to [email protected]. rulemaking FDA will review and Instructions: All submissions received All comments should be identified with consider all comments submitted before must include the Docket No. FDA– the title, Tobacco Product Standard: the time for comment on this proposed 2016–N–2527 for ‘‘Tobacco Product NNN Level in Finished Smokeless regulation has expired. If your comment Standard for N-nitrosonornicotine Level Tobacco Products. is submitted after the expiration of the in Finished Smokeless Tobacco comment period, it will not be reviewed Products.’’ Received comments will be FOR FURTHER INFORMATION CONTACT: Beth and considered by FDA unless you placed in the docket and, except for Buckler or Colleen Lee, Office of apply for, and receive, an extension of those submitted as ‘‘Confidential Regulations, Center for Tobacco the comment period pursuant to 21 CFR Submissions,’’ publicly viewable at Products (CTP), Food and Drug 10.40(b)(3). Submit comments on http://www.regulations.gov or at the Administration, Document Control information collection issues under the Division of Dockets Management Center, Bldg. 71, Rm. G335, 10903 New Paperwork Reduction Act of 1995 (the between 9 a.m. and 4 p.m., Monday Hampshire Ave., Silver Spring, MD PRA) by February 22, 2017, (see the through Friday. 20993–0002, 877–287–1373, ‘‘Paperwork Reduction Act of 1995’’ • Confidential Submissions—To [email protected]. section). See section VII of this submit a comment with confidential SUPPLEMENTARY INFORMATION: document for the proposed effective information that you do not wish to be Table of Contents date of a final ruled based on this made publicly available, submit your document. comments only as a written/paper I. Executive Summary submission. You should submit two A. Purpose of the Proposed Rule ADDRESSES: You may submit comments B. Summary of the Major Provisions of the as follows: copies total. One copy will include the Proposed Rule information you claim to be confidential Electronic Submissions C. Legal Authority with a heading or cover note that states D. Costs and Benefits Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS II. Background Information following way: CONFIDENTIAL INFORMATION.’’ The A. Purpose • Federal eRulemaking Portal: http:// Agency will review this copy, including B. Legal Authority www.regulations.gov. Follow the the claimed confidential information, in C. Additional Considerations and Requests instructions for submitting comments. its consideration of comments. The for Comment III. Scope of Proposed Standard Comments submitted electronically, second copy, which will have the A. Smokeless Tobacco Products including attachments, to http:// claimed confidential information B. Current Prevalence and Initiation Rates www.regulations.gov will be posted to redacted/blacked out, will be available IV. Rationale for Developing a Standard for the docket unchanged. Because your for public viewing and posted on http:// NNN VerDate Sep<11>2014 19:31 Jan 19, 2017 Jkt 241001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\23JAP2.SGM 23JAP2 mstockstill on DSK3G9T082PROD with PROPOSALS2 Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Proposed Rules 8005 A. Smokeless Tobacco is Carcinogenic finished smokeless tobacco product that 387g) including authority related to the B. NNN in Smokeless Tobacco Products is is not in compliance with the product reduction of constituents or harmful Carcinogenic standard. However, the proposed rule components in tobacco products under C. NNN in Smokeless Tobacco Products would provide an exception for tobacco section 907(a)(4)(A)(ii) and to the testing D. Basis for the NNN Limit in the Proposed Standard retailers and distributors; we would not of tobacco products under section E. Information on Technical Achievability consider tobacco retailers and 907(a)(4)(B)(ii) through (iv); FDA’s F. Analytical Method distributors to be in violation of part authorities related to the sale and V. Standard is Appropriate for the Protection 1132 as it relates to the sale or distribution of tobacco products under of Public Health distribution of finished smokeless sections 907(a)(4)(B)(v) and 906(d); A. Benefits to the Population as a Whole tobacco products that exceed the FDA’s authority to require tobacco B. The Likelihood That Existing Users of allowed NNN level if they meet certain product manufacturers to establish and Tobacco Products Will Stop Using Such criteria set forth in the rule. maintain records under section 909 of Products C. The Likelihood That Non-Users Will The proposed rule would require that the FD&C Act (21 U.S.C. 387i); FDA’s Start Using Tobacco Products the mean level of NNN in any batch of authorities related to adulterated and D. Conclusion finished smokeless tobacco products not misbranded tobacco products under VI. Description of Proposed Regulation exceed 1.0 microgram per gram (mg/g) of sections 902 and 903 (21 U.S.C. 387b A. General Provisions (Proposed Subpart tobacco (on a dry weight basis) at any and 387c); FDA’s authorities related to A) time through the product’s labeled prohibited acts under section 301 of the B. Product Requirements (Proposed expiration date as determined by FD&C Act (21 U.S.C. 331); and FDA’s Subpart B) specified product testing. The rule rulemaking and inspection authorities C. Labeling and Recordkeeping Requirements (Proposed Subpart C) would require that all finished under sections 701 and 704 of the FD&C VII. Proposed Effective Date smokeless tobacco products have an Act (21 U.S.C. 371 and 374). expiration date and provide that the VIII. Incorporation by Reference D. Costs and Benefits IX. Economic Analysis of Impacts expiration date be no later than the final X. Analysis of Environmental Impact date the manufacturer can demonstrate The costs of the proposed rule, when XI. Paperwork Reduction Act of 1995 that the NNN level in the finished finalized, will be due to affected entities XII. Executive Order 13132 smokeless tobacco product conforms to ensuring that the smokeless tobacco XIII. Executive Order 13175 the limit when the product is stored products comply with the proposed XIV. References under its intended conditions (e.g., product standard. We have estimated I. Executive Summary room temperature or refrigeration). the annualized costs associated with the To ensure that products conform to proposed rule over 20 years to be A.
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