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Federal Register/Vol. 84, No. 159/Friday, August 16, 2019 42754 Federal Register / Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules DEPARTMENT OF HEALTH AND Electronic Submissions information you claim to be confidential HUMAN SERVICES Submit electronic comments in the with a heading or cover note that states following way: ‘‘THIS DOCUMENT CONTAINS Food and Drug Administration • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The https://www.regulations.gov. Follow the Agency will review this copy, including 21 CFR Part 1141 instructions for submitting comments. the claimed confidential information, in Comments submitted electronically, its consideration of comments. The [Docket No. FDA–2019–N–3065] including attachments, to https:// second copy, which will have the www.regulations.gov will be posted to claimed confidential information RIN 0910–AI39 the docket unchanged. Because your redacted/blacked out, will be available comment will be made public, you are for public viewing and posted on Tobacco Products; Required Warnings solely responsible for ensuring that your https://www.regulations.gov. Submit for Cigarette Packages and comment does not include any both copies to the Dockets Management Advertisements confidential information that you or a Staff. If you do not wish your name and third party may not wish to be posted, contact information to be made publicly AGENCY: Food and Drug Administration, such as medical information, your or available, you can provide this HHS. anyone else’s Social Security number, or information on the cover sheet and not in the body of your comments and you ACTION: Proposed rule. confidential business information, such as a manufacturing process. Please note must identify this information as SUMMARY: The Food and Drug that if you include your name, contact ‘‘confidential.’’ Any information marked Administration (FDA, the Agency, or information, or other information that as ‘‘confidential’’ will not be disclosed we) is issuing a proposed rule to identifies you in the body of your except in accordance with 21 CFR 10.20 establish new required cigarette health comments, that information will be and other applicable disclosure law. For warnings for cigarette packages and posted on https://www.regulations.gov. more information about FDA’s posting advertisements. The proposed rule • If you want to submit a comment of comments to public dockets, see 80 would implement a provision of the with confidential information that you FR 56469, September 18, 2015, or access Family Smoking Prevention and do not wish to be made available to the the information at: http://www.gpo.gov/ Tobacco Control Act (Tobacco Control public submit the comment as a written/ fdsys/pkg/FR-2015-9-18/pdf/2015- Act) that requires FDA to issue paper submission and in the manner 23389.pdf. regulations requiring color graphics detailed (see ‘‘Written/Paper Docket: For access to the docket to depicting the negative health Submissions’’ and ‘‘Instructions.’’) read background documents or the consequences of smoking to accompany electronic and written/paper comments Written/Paper Submissions new textual warning statements. The received, go to https:// Tobacco Control Act amends the Submit written/paper submissions as www.regulations.gov and insert the Federal Cigarette Labeling and follows: docket number, found in brackets in the Advertising Act (FCLAA) of 1965 to • Mail/Hand Delivery/Courier (for heading of this document, into the require each cigarette package and written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts advertisement to bear one of the new Management Staff (HFA–305), Food and and/or go to the Dockets Management required warnings. This proposed rule, Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, once finalized, would specify the color Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. graphics that must accompany the new • For written/paper comments Submit comments on information textual warning statements. FDA is submitted to the Dockets Management collection issues under the Paperwork proposing to take this action to promote Staff, FDA will post your comment, as Reduction Act of 1995 to the Office of greater public understanding of the well as any attachments, except for Management and Budget (OMB) in the negative health consequences of information submitted, marked and following ways: cigarette smoking. identified, as confidential, if submitted • Fax to the Office of Information and as detailed in ‘‘Instructions.’’ DATES: Regulatory Affairs, OMB, Attn: FDA Submit either electronic or Instructions: All submissions received written comments on the proposed rule Desk Officer, FAX: 202–395–7285, or must include the Docket No. FDA– email to [email protected]. by October 15, 2019. Submit comments 2019–N–3065 for ‘‘Tobacco Products; on information collection issues under All comments should be identified with Required Warnings for Cigarette the title, ‘‘Tobacco Products; Required the Paperwork Reduction Act of 1995 by Packages and Advertisements.’’ September 16, 2019. Warnings for Cigarette Packages and Received comments, those filed in a Advertisements.’’ ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be as follows. Please note that late, placed in the docket and, except for FOR FURTHER INFORMATION CONTACT: untimely filed comments will not be those submitted as ‘‘Confidential Courtney Smith or Daniel Gittleson, considered. Electronic comments must Submissions,’’ publicly viewable at Office of Regulations, Center for be submitted on or before October 15, https://www.regulations.gov or at the Tobacco Products, Food and Drug 2019. The https://www.regulations.gov Dockets Management Staff between 9 Administration, Document Control electronic filing system will accept a.m. and 4 p.m., Monday through Center, Bldg. 71, Rm. G335, 10903 New comments until 11:59 p.m. Eastern Time Friday. Hampshire Ave., Silver Spring, MD at the end of October 15, 2019. • Confidential Submissions—To 20993–0002, 877–287–1373, email: Comments received by mail/hand submit a comment with confidential [email protected]. delivery/courier (for written/paper information that you do not wish to be With regard to the information submissions) will be considered timely made publicly available, submit your collection: Amber Sanford, Office of if they are postmarked or the delivery comments only as a written/paper Operations, Food and Drug service acceptance receipt is on or submission. You should submit two Administration, Three White Flint before that date. copies total. One copy will include the North 10A–12M, 11601 Landsdown St., VerDate Sep<11>2014 19:40 Aug 15, 2019 Jkt 247001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP3.SGM 16AUP3 khammond on DSKBBV9HB2PROD with PROPOSALS3 Federal Register / Vol. 84, No. 159 / Friday, August 16, 2019 / Proposed Rules 42755 North Bethesda, MD 20852, PRAStaff@ for cigarette packages and cigarette health warnings, once fda.hhs.gov. advertisements. These new cigarette finalized, would appear prominently on SUPPLEMENTARY INFORMATION: health warnings would consist of cigarette packages and in cigarette textual warning statements advertisements, occupying the top 50 Table of Contents accompanied by color graphics percent of the area of the front and rear I. Executive Summary depicting the negative health panels of cigarette packages and at least A. Purpose of the Proposed Rule consequences of cigarette smoking. The 20 percent of the area at the top of B. Summary of the Major Provisions of the new cigarette health warnings, once cigarette advertisements. Proposed Rule finalized, would appear prominently on In addition, as required under the C. Legal Authority cigarette packages and in cigarette FCLAA, the proposed rule would D. Costs, Benefits, and Informational establish marketing requirements that Effects advertisements, occupying the top 50 Table of Abbreviations/Commonly Used percent of the area of the front and rear would include the random display and Acronyms in This Document panels of cigarette packages and at least distribution of the required warnings for II. Background 20 percent of the area at the top of cigarette packages and quarterly A. Need for the Regulation cigarette advertisements. rotations of the required warnings for B. History of the Rulemaking Cigarette smoking remains the leading cigarette advertisements. A tobacco C. Incorporation by Reference cause of preventable disease and death product manufacturer, distributor, or III. Legal Authority in the United States and is responsible retailer would be required to submit a IV. Cigarette Use in the United States and the for more than 480,000 deaths per year. plan for the random and equal display Resulting Health Consequences Smoking causes more deaths each year and distribution of the required A. Smoking Prevalence and Initiation in the United States than human immunodeficiency virus, warnings on packages and the quarterly B. Negative Health Consequences of illegal drug use, alcohol use, motor rotation in advertisements for approval Smoking vehicle injuries, and firearm-related by FDA. In addition, the proposed rule V. Data Concerning Cigarette Health incidents combined. In developing this would require each tobacco product Warnings proposed rule, FDA determined that the manufacturer required to randomly and A. The Current 1984 Surgeon General’s public holds misperceptions about the equally display and distribute warnings Warnings Are Inadequate health risks caused by smoking and that on packaging
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