12294 Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Proposed Rules on ‘‘Postmarket Safety Reporting for DEPARTMENT OF HEALTH AND including attachments, to https:// Combination Products.’’ It does not HUMAN SERVICES www.regulations.gov will be posted to establish any rights for any person and the docket unchanged. Because your is not binding on FDA or the public. Food and Drug Administration comment will be made public, you are You can use an alternative approach if solely responsible for ensuring that your it satisfies the requirements of the 21 CFR Parts 1100, 1140, and 1143 comment does not include any applicable statutes and regulations. This [Docket No. FDA–2017–N–6565] confidential information that you or a guidance is not subject to Executive third party may not wish to be posted, RIN 0910–AH60 Order 12866. such as medical information, your or anyone else’s Social Security number, or IV. Paperwork Reduction Act of 1995 Regulation of Flavors in Tobacco confidential business information, such Products as a manufacturing process. Please note This guidance refers to previously AGENCY: Food and Drug Administration, that if you include your name, contact approved collections of information HHS. information, or other information that found in FDA regulations. These identifies you in the body of your ACTION: Advance notice of proposed collections of information are subject to comments, that information will be rulemaking. review by the Office of Management and posted on https://www.regulations.gov. • Budget (OMB) under the Paperwork SUMMARY: The Food and Drug If you want to submit a comment Reduction Act of 1995 (44 U.S.C. 3501– Administration (FDA) is issuing this with confidential information that you 3520). The collections of information in advance notice of proposed rulemaking do not wish to be made available to the 21 CFR 314.80(c) and (e), as well as for (ANPRM) to obtain information related public, submit the comment as a 21 CFR 314.81(b) are approved under to the role that flavors play in tobacco written/paper submission and in the OMB control numbers 0910–0001, products. Specifically, this ANPRM is manner detailed (see ‘‘Written/Paper 0910–0230, and 0910–0291. The seeking comments, data, research Submissions’’ and ‘‘Instructions’’). information collection provisions for 21 results, or other information about, Written/Paper Submissions among other things, how flavors attract CFR 600.80 and 600.81 are approved Submit written/paper submissions as youth to initiate tobacco product use under OMB control number 0910–0308. follows: Those for 21 CFR 606.170 are approved and about whether and how certain • Mail/Hand delivery/Courier (for under OMB control number 0910–0116. flavors may help adult cigarette smokers written/paper submissions): Dockets Those for 21 CFR 606.171 are approved reduce cigarette use and switch to Management Staff (HFA–305), Food and under OMB control number 0910–0458. potentially less harmful products. FDA Drug Administration, 5630 Fishers The information collection provisions is seeking this information to inform Lane, Rm. 1061, Rockville, MD 20852. for 21 CFR 803.50, 803.53, and 803.56 regulatory actions FDA might take with • For written/paper comments respect to tobacco products with flavors, are approved under OMB control submitted to the Dockets Management under the Federal Food, Drug, and numbers 0910–0291 and 0910–0437. Staff, FDA will post your comment, as Cosmetic Act (FD&C Act), as amended The information collection provisions well as any attachments, except for by the Family Smoking Prevention and information submitted, marked and for 21 CFR 806.10 and 806.20 are Tobacco Control Act (Tobacco Control approved under OMB control number identified, as confidential, if submitted Act). Potential regulatory actions as detailed in ‘‘Instructions.’’ 0910–0359. The information collection include, but are not limited to, tobacco provisions for 21 CFR 4.102, 4.103, and Instructions: All submissions received product standards and restrictions on must include the Docket No. FDA– 4.105 are approved under OMB control sale and distribution of tobacco 2017–N–6565 for ‘‘Regulation of Flavors number 0910–0834. products with flavors. in Tobacco Products.’’ Received V. Electronic Access DATES: Submit either electronic or comments, those filed in a timely written comments by June 19, 2018. manner (see ADDRESSES), will be placed Persons with access to the internet ADDRESSES: You may submit comments in the docket and, except for those may obtain the draft guidance at either as follows. Please note that late, submitted as ‘‘Confidential https://www.fda.gov/Combination untimely filed comments will not be Submissions,’’ publicly viewable at Products/GuidanceRegulatory considered. Electronic comments must https://www.regulations.gov or at the Information/ucm109110.htm or https:// be submitted on or before June 19, 2018. Dockets Management Staff between 9 www.regulations.gov. The https://www.regulations.gov a.m. and 4 p.m., Monday through Dated: March 15, 2018. electronic filing system will accept Friday. comments until midnight Eastern Time • Confidential Submissions—To Leslie Kux, at the end of June 19, 2018. Comments submit a comment with confidential Associate Commissioner for Policy. received by mail/hand delivery/courier information that you do not wish to be [FR Doc. 2018–05687 Filed 3–20–18; 8:45 am] (for written/paper submissions) will be made publicly available, submit your BILLING CODE 4164–01–P considered timely if they are comments only as a written/paper postmarked or the delivery service submission. You should submit two acceptance receipt is on or before that copies total. One copy will include the date. information you claim to be confidential with a heading or cover note that states Electronic Submissions ‘‘THIS DOCUMENT CONTAINS Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The following way: Agency will review this copy, including • Federal eRulemaking Portal: the claimed confidential information, in https://www.regulations.gov. Follow the its consideration of comments. The instructions for submitting comments. second copy, which will have the Comments submitted electronically, claimed confidential information VerDate Sep<11>2014 17:00 Mar 20, 2018 Jkt 244001 PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 E:\FR\FM\21MRP1.SGM 21MRP1 sradovich on DSK3GMQ082PROD with PROPOSALS Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Proposed Rules 12295 redacted/blacked out, will be available accessories of deemed tobacco products, surrounding the role of flavors in for public viewing and posted on to be subject to FDA’s tobacco product tobacco products, including the role https://www.regulations.gov. Submit authority (the deeming rule). The flavors play in youth and young adult both copies to the Dockets Management products now subject to FDA’s tobacco use, as well as the existence of Staff. If you do not wish your name and product authority include electronic preliminary data that some adults may contact information to be made publicly nicotine delivery systems (ENDS), use flavored noncombusted tobacco available, you can provide this cigars, waterpipes, pipe tobacco, products to transition away from information on the cover sheet and not nicotine gels, dissolvables that were not combusted tobacco use. See 81 FR in the body of your comments and you already subject to chapter IX of the 28973 at 29014 and 29055. must identify this information as FD&C Act, and other products that meet C. The Role of Flavors in Tobacco ‘‘confidential.’’ Any information marked the statutory definition of ‘‘tobacco Products Use as ‘‘confidential’’ will not be disclosed product’’ (other than accessories) that except in accordance with 21 CFR 10.20 may be developed in the future. Adolescence (under 18, also referred and other applicable disclosure law. For to as youth) and young adulthood (age more information about FDA’s posting B. Flavors and Tobacco Product 18 through 24) represent a time of of comments to public dockets, see 80 Standards heightened vulnerability to both the FR 56469, September 18, 2015, or access Section 907 of the FD&C Act (21 initiation of tobacco product use and the the information at: https://www.gpo.gov/ U.S.C. 387g) gives FDA the authority to development of nicotine dependence fdsys/pkg/FR-2015-09-18/pdf/2015- establish tobacco product standards. To (Ref. 1). Furthermore, flavors in tobacco 23389.pdf. establish a tobacco product standard, products increase the appeal of those Docket: For access to the docket to FDA must find that the standard is tobacco products to youth, and promote read background documents or the appropriate for the protection of the youth initiation (Ref. 2). Thus, the electronic and written/paper comments public health, taking into consideration availability of tobacco products with received, go to https:// scientific evidence concerning the risks flavors at these developmental stages www.regulations.gov and insert the and benefits to the population as a attracts youth to initiate use of tobacco docket number, found in brackets in the whole, including users and nonusers of products and may result in lifelong use heading of this document, into the tobacco products; the increased or (Ref. 2). Researchers examining the ‘‘Search’’ box and follow the prompts decreased likelihood that existing users impact of the Special Rule for Cigarettes and/or go to the Dockets Management of tobacco products will stop using such have concluded that, while the Staff, 5630 Fishers Lane, Rm. 1061, products; and the increased or prohibition of characterizing flavors in Rockville, MD 20852. decreased likelihood that those who do cigarettes has reduced adolescent FOR FURTHER INFORMATION CONTACT: not use tobacco products will start using tobacco product use, the continued Laura Rich or Katherine Collins, Center such products (section 907(a)(3)(A) and availability of menthol cigarettes and for Tobacco Products, Food and Drug (B) of the FD&C Act).