Federal Register/Vol. 86, No. 77/Friday, April 23, 2021/Notices
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21814 Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices DEPARTMENT OF JUSTICE Administration; Telephone: (571) 362– compounds, mixtures, or preparations 8201. containing a controlled substance, if he Drug Enforcement Administration SUPPLEMENTARY INFORMATION: finds that such compounds, mixtures, or [Docket No. DEA–372] preparations meet the requirements Posting of Public Comments detailed in 21 U.S.C. 811(g)(3)(B).1 The Exempt Chemical Preparations Under Please note that all comments DEA regulations at 21 CFR 1308.23 and the Controlled Substances Act received are considered part of the 1308.24 further detail the criteria by public record and made available for which the DEA Assistant Administrator AGENCY: Drug Enforcement may exempt a chemical preparation or Administration, Department of Justice. public inspection online at http:// www.regulations.gov and in the DEA’s mixture from certain provisions of the ACTION: Order with opportunity for public docket. Such information CSA. The Assistant Administrator may, comment. includes personal identifying pursuant to 21 CFR 1308.23(f), modify or revoke the criteria by which SUMMARY: The applications for exempt information (such as your name, address, etc.) voluntarily submitted by exemptions are granted and modify the chemical preparations received by the scope of exemptions at any time. Drug Enforcement Administration the commenter. The Freedom of (DEA) between July 1, 2018, and Information Act applies to all comments Exempt Chemical Preparation December 31, 2020, as listed below, received. Applications Submitted Between July 1, were accepted for filing and have been If you want to submit personal 2018, and December 31, 2020 approved or denied as indicated. identifying information (such as your The Assistant Administrator received name, address, etc.) as part of your DATES: Interested persons may file applications between July 1, 2018, and comment, but do not want it to be written comments on this order in December 31, 2020, requesting exempt posted online or made available in the accordance with 21 CFR 1308.23(e). chemical preparation status detailed in public docket, you must include the Electronic comments must be 21 CFR 1308.23. Pursuant to the criteria phrase ‘‘PERSONAL IDENTIFYING submitted, and written comments must stated in 21 U.S.C. 811(g)(3)(B) and in INFORMATION’’ in the first paragraph be postmarked, on or before June 22, 21 CFR 1308.23, the Assistant of your comment. You must also place 2021. Commenters should be aware that Administrator has found that each of the all the personal identifying information the electronic Federal Docket compounds, mixtures, and preparations you do not want posted online or made Management System will not accept described in Chart I below is intended available in the public docket in the first comments after 11:59 p.m. Eastern Time for laboratory, industrial, educational, paragraph of your comment and identify on the last day of the comment period. or special research purposes and not for what information you want redacted. general administration to a human being ADDRESSES: To ensure proper handling If you want to submit confidential or animal and either: (1) Contains no of comments, please reference ‘‘Docket business information as part of your narcotic controlled substance and is No. DEA–372’’ on all correspondence, comment, but do not want it to be packaged in such a form or including any attachments. posted online or made available in the concentration that the packaged Electronic comments: DEA encourages public docket, you must include the quantity does not present any that all comments be submitted through phrase ‘‘CONFIDENTIAL BUSINESS significant potential for abuse; or (2) the Federal eRulemaking Portal, which INFORMATION’’ in the first paragraph contains either a narcotic or non- provides the ability to type short of your comment. You must also narcotic controlled substance and one or comments directly into the comment prominently identify confidential more adulterating or denaturing agents field on the web page or to attach a file business information to be redacted in such a manner, combination, for lengthier comments. Please go to within the comment. quantity, proportion, or concentration http://www.regulations.gov and follow Comments containing personal that the preparation or mixture does not the online instructions at that site for identifying information and confidential present any potential for abuse and, if submitting comments. Upon completion business information identified as the preparation or mixture contains a of your submission you will receive a directed above will generally be made narcotic controlled substance, is Comment Tracking Number for your publicly available in redacted form. If a formulated in such a manner that it comment. Please be aware that comment has so much confidential incorporates methods of denaturing or submitted comments are not business information that it cannot be other means so that the preparation or instantaneously available for public effectively redacted, all or part of that mixture is not liable to be abused or view on Regulations.gov. If you have comment may not be made publicly have ill effects, if abused, and so that received a comment tracking number, available. Comments posted to http:// the narcotic substance cannot in your comment has been successfully www.regulations.gov may include any practice be removed. submitted and there is no need to personal identifying information (such Accordingly, pursuant to 21 U.S.C. resubmit the same comment. as name, address, and phone number) 811(g)(3)(B), 21 CFR 1308.23, and 21 Paper comments: Paper comments included in the text of your electronic CFR 1308.24, the Assistant that duplicate the electronic submission submission that is not identified as Administrator has determined that each are not necessary and are discouraged. directed above as confidential. of the chemical preparations or mixtures Should you wish to mail a comment in An electronic copy of this document generally described in Chart I below and lieu of an electronic comment, it should is available at http:// specifically described in the application be sent via regular or express mail to: www.regulations.gov for easy reference. materials received by DEA is exempt, to Drug Enforcement Administration, the extent described in 21 CFR 1308.24, Attention: DEA Federal Register Legal Authority Representative/DRW, 8701 Morrissette Section 201 of the Controlled 1 This authority has been delegated from the Drive, Springfield, Virginia 22152. Substances Act (CSA) (21 U.S.C. 811) Attorney General to the Administrator of the DEA FOR FURTHER INFORMATION CONTACT: by 28 CFR 0.100, and subsequently redelegated to authorizes the Attorney General, by the Deputy Assistant Administrator pursuant to 28 Terrence L. Boos, Ph.D., Diversion regulation, to exempt from certain CFR 0.104 and Section 7 of the appendix to subpart Control Division, Drug Enforcement provisions of the CSA certain R of part 0. VerDate Sep<11>2014 18:41 Apr 22, 2021 Jkt 253001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 E:\FR\FM\23APN2.SGM 23APN2 khammond on DSKJM1Z7X2PROD with NOTICES2 Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices 21815 from application of sections 302, 303, mixture after the date of application July 1, 2018, and December 31, 2020, 305, 306, 307, 308, 309, 1002, 1003, and requires a new application. The and not otherwise referenced in this 1004 (21 U.S.C. 822–823, 825–829, and requirements set forth in 21 CFR order, may remain under consideration 952–954) of the CSA, and 21 CFR 1308.24(b)–(e) apply to the exempted until DEA receives additional 1301.74, as of the date that was materials. In accordance with 21 CFR information required, pursuant to 21 provided in the approval letters to the 1308.24(g), DEA may prescribe CFR 1308.23(d), as detailed in separate individual requesters. requirements other than those set forth correspondence to individual in 21 CFR 1308.24(b)–(e) on a case-by- requesters. DEA’s order on such Scope of Approval case basis for materials exempted in requests will be communicated to the The exemptions are applicable only to bulk quantities. Accordingly, in order to public in a future Federal Register the precise preparation or mixture limit opportunity for diversion from the publication. described in the application submitted larger bulk quantities, DEA has DEA also notes that these exemptions to DEA in the form(s) listed in this order determined that each of the exempted are limited to exemption from only and only for those above mentioned bulk products listed in this order may those sections of the CSA and the CFR sections of the CSA and the CFR. In only be used in-house by the that are specifically identified in 21 CFR accordance with 21 CFR 1308.24(h), any manufacturer, and may not be 1308.24(a). All other requirements of the change in the quantitative or qualitative distributed for any purpose, or CSA and the CFR apply, including composition of the preparation or transported to other facilities. registration as an importer as required mixture, or change in the trade name or Additional exempt chemical by 21 U.S.C. 957. other designation of the preparation or preparation requests received between BILLING CODE 4410–09–P VerDate Sep<11>2014 18:41 Apr 22, 2021 Jkt 253001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4703 E:\FR\FM\23APN2.SGM 23APN2 khammond on DSKJM1Z7X2PROD with NOTICES2 21816 Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices Chart I Glass or plastic bottle Aalto Scientific, Ltd. Abbott FLQ TDM Base 4/22/2020 or flask: 1-100 mL Glass or plastic bottle Aalto Scientific, Ltd. Abbott FLQ TDM Base 4/22/2020 or flask: 100-500 mL Glass or plastic bottle Aalto Scientific, Ltd.