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Proposed Aggregate Production Quotas for 2021

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Proposed Aggregate Production Quotas for 2021 Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Notices 54407 operate), normal operating levels (hours DEPARTMENT OF JUSTICE www.regulations.gov and follow the per week/weeks per year), time for online instructions at that site for downtime, maintenance, repair, and Drug Enforcement Administration submitting comments. Upon completion cleanup, and a typical or representative [Docket No. DEA–688P] of your submission, you will receive a product mix); and Comment Tracking Number for your comment. Please be aware that (c) the quantity and value of your Proposed Aggregate Production submitted comments are not firm’s(s’) exports to the United States of Quotas for Schedule I and II Controlled Substances and Assessment of instantaneously available for public Subject Merchandise and, if known, an Annual Needs for the List I Chemicals view on Regulations.gov. If you have estimate of the percentage of total Ephedrine, Pseudoephedrine, and received a Comment Tracking Number, exports to the United States of Subject Phenylpropanolamine for 2021 your comment has been successfully Merchandise from the Subject Country submitted, and there is no need to accounted for by your firm’s(s’) exports. AGENCY: Drug Enforcement resubmit the same comment. Paper (12) Identify significant changes, if Administration, Department of Justice. comments that duplicate electronic any, in the supply and demand ACTION: Notice with request for submissions are not necessary and are conditions or business cycle for the comments. discouraged. Should you wish to mail a paper comment in lieu of an electronic Domestic Like Product that have SUMMARY: The Drug Enforcement comment, it should be sent via regular occurred in the United States or in the Administration (DEA) proposes to or express mail to: Drug Enforcement market for the Subject Merchandise in establish the 2021 aggregate production Administration, Attention: DEA Federal the Subject Country since the Order quotas for controlled substances in Register Representative/DPW, 8701 Date, and significant changes, if any, schedules I and II of the Controlled Morrissette Drive, Springfield, Virginia that are likely to occur within a Substances Act (CSA) and assessment of 22152. reasonably foreseeable time. Supply annual needs for the list I chemicals conditions to consider include ephedrine, pseudoephedrine, and FOR FURTHER INFORMATION CONTACT: technology; production methods; phenylpropanolamine. Scott A. Brinks, Diversion Control development efforts; ability to increase DATES: Interested persons may file Division, Drug Enforcement production (including the shift of written comments on this notice in Administration; Mailing Address: 8701 production facilities used for other accordance with 21 CFR 1303.11(c) and Morrissette Drive, Springfield, Virginia products and the use, cost, or 1315.11(d). Electronic comments must 22152, Telephone: (571) 362–3261. availability of major inputs into be submitted, and written comments SUPPLEMENTARY INFORMATION: production); and factors related to the must be postmarked, on or before Posting of Public Comments ability to shift supply among different October 1, 2020. Commenters should be national markets (including barriers to aware that the electronic Federal Docket Please note that all comments importation in foreign markets or Management System will not accept received in response to this docket are changes in market demand abroad). comments after 11:59 p.m. Eastern Time considered part of the public record. Demand conditions to consider include on the last day of the comment period. They will, unless reasonable cause is end uses and applications; the existence Based on comments received in given, be made available by the Drug and availability of substitute products; response to this notice, the Enforcement Administration (DEA) for and the level of competition among the Administrator may hold a public public inspection online at http:// Domestic Like Product produced in the hearing on one or more issues raised. In www.regulations.gov. Such information United States, Subject Merchandise the event the Administrator decides in includes personal identifying produced in the Subject Country, and his sole discretion to hold such a information (such as your name, such merchandise from other countries. hearing, the Administrator will publish address, etc.) voluntarily submitted by a notice of any such hearing in the the commenter. (13) (OPTIONAL) A statement of Federal Register. After consideration of The Freedom of Information Act whether you agree with the above any comments or objections, or after a (FOIA) applies to all comments definitions of the Domestic Like Product hearing, if one is held, the received. If you want to submit personal and Domestic Industry; if you disagree Administrator will publish in the identifying information (such as your with either or both of these definitions, Federal Register a final order name, address, etc.) as part of your please explain why and provide establishing the 2021 aggregate comment, but do not want it to be made alternative definitions. production quotas for schedule I and II publicly available, you must include the Authority: This proceeding is being controlled substances, and an phrase ‘‘PERSONAL IDENTIFYING conducted under authority of Title VII of the assessment of annual needs for the list INFORMATION’’ in the first paragraph Tariff Act of 1930; this notice is published I chemicals ephedrine, of your comment. You must also place pursuant to § 207.61 of the Commission’s pseudoephedrine, and all the personal identifying information rules. phenylpropanolamine. you do not want made publicly By order of the Commission. ADDRESSES: To ensure proper handling available in the first paragraph of your Issued: August 21, 2020. of comments, please reference ‘‘Docket comment and identify what information you want redacted. Lisa Barton, No. DEA–688P’’ on all correspondence, including any attachments. DEA If you want to submit confidential Secretary to the Commission. encourages that all comments be business information as part of your [FR Doc. 2020–18774 Filed 8–31–20; 8:45 am] submitted electronically through the comment, but do not want it to be made BILLING CODE 7020–02–P Federal eRulemaking Portal, which publicly available, you must include the provides the ability to type short phrase ‘‘CONFIDENTIAL BUSINESS comments directly into the comment INFORMATION’’ in the first paragraph field on the web page or attach a file for of your comment. You must also lengthier comments. Please go to http:// prominently identify confidential VerDate Sep<11>2014 19:00 Aug 31, 2020 Jkt 250001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1 jbell on DSKJLSW7X2PROD with NOTICES 54408 Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Notices business information to be redacted aggregate production quotas for 2021 by in the United States, lawful export within the comment. considering the following seven factors: requirements, and the establishment Comments containing personal (1) Total net disposal of the class by and maintenance of reserve stocks, as identifying information or confidential all manufacturers during the current the Administrator finds relevant, business information identified and and 2 preceding years; including changes in the currently located as directed above will generally (2) Trends in the national rate of net accepted medical use in treatment with be made available in redacted form. If a disposal of the class; the chemicals or the substances which comment contains so much confidential (3) Total actual (or estimated) are manufactured from them, the business information or personal inventories of the class and of all economic and physical availability of identifying information that it cannot be substances manufactured from the class, raw materials for use in manufacturing effectively redacted, all or part of that and trends in inventory accumulation; and for inventory purposes, yield and comment may not be made publicly (4) Projected demand for such class as stability problems, potential disruptions available. Comments posted to http:// indicated by procurement quotas to production (including possible labor www.regulations.gov may include any requested pursuant to § 1303.12; strikes), and recent unforeseen personal identifying information (such (5) The extent of any diversion of the emergencies such as floods and fires. 21 as name, address, and phone number) controlled substance in the class; CFR 1315.11(b). included in the text of your electronic (6) Relevant information obtained As may be noted, the five assessment submission that is not identified as from the Department of Health and of annual needs factors considered are directed above as confidential. Human Services (HHS), including from similar, but not identical, to five of the An electronic copy of this document the Food and Drug Administration seven factors considered in determining is available at http:// (FDA), the Centers for Disease Control the aggregate production quotas. In www.regulations.gov for easy reference. and Prevention (CDC), and the Centers determining the proposed 2021 for Medicare and Medicaid Services Legal Authority assessment of annual needs, DEA used (CMS), and relevant information the calculation methodology previously Section 306 of the CSA (21 U.S.C. obtained from the states; and described in the 2010 and 2011 826) requires the Attorney General to (7) Other factors affecting medical, assessment of annual needs (74
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