Federal Register/Vol. 83, No. 170/Friday, August 31, 2018/Rules

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Federal Register/Vol. 83, No. 170/Friday, August 31, 2018/Rules 44474 Federal Register / Vol. 83, No. 170 / Friday, August 31, 2018 / Rules and Regulations readily visible part of the outside of the in their place the words ‘‘floating of isomers in schedule I. This action is floating cabin. cabin’’. based on a finding by the Acting * * * * * ■ 10. Amend § 1304.412 by: Administrator that the placement of N- (c) A floating cabin moored at a ■ a. Adding in alphabetical order ethylpentylone in schedule I of the location approved pursuant to the definitions for ‘‘Existing floating cabin’’ Controlled Substances Act (CSA) is regulations in this subpart shall not be and ‘‘New floating cabin’’; necessary to avoid an imminent hazard relocated and moored at a different ■ b. Removing the definition of to the public safety. As a result of this location without prior approval by TVA, ‘‘Nonnavigable houseboat’’; and order, the regulatory controls and except for movement to a new location ■ c. Adding in alphabetical order administrative, civil, and criminal within the designated harbor limits of definitions for ‘‘Rebuilding’’ and sanctions applicable to schedule I the same commercial dock or marina. ‘‘Tennessee River System’’. controlled substances will be imposed The additions read as follows: on persons who handle (manufacture, § 1304.103 [Removed and Reserved] distribute, reverse distribute, import, ■ 7. Remove and reserve § 1304.103. § 1304.412 Definitions. export, engage in research, conduct ■ 8. Amend § 1304.204 by revising * * * * * instructional activities or chemical paragraphs (a), (b), and (n) to read as Existing floating cabin means a analysis, or possess), or propose to follows: floating cabin that was located or handle N-ethylpentylone. moored on the Tennessee River System DATES: This temporary scheduling order § 1304.204 Docks, piers, and boathouses. on or before December 16, 2016. is effective August 31, 2018, until * * * * * * * * * * August 31, 2020. If this order is (a) Docks, piers, boathouses, and all New floating cabin means a floating extended or made permanent, the DEA other residential water-use facilities cabin that was not located or moored on will publish a document in the Federal shall not exceed a total footprint area of the Tennessee River System on or before Register. greater than 1,000 square feet, unless the December 16, 2016. proposed water-use facility will be FOR FURTHER INFORMATION CONTACT: * * * * * located in an area of preexisting Thomas D. Sonnen, Diversion Control Rebuilding means replacement of all development. For the purpose of this Division, Drug Enforcement or a significant portion of an approved regulation, ‘‘preexisting development’’ Administration; Mailing Address: 8701 obstruction to the same configuration, means either: The water-use facility will Morrissette Drive, Springfield, Virginia total footprint, and dimensions (length, be located in a subdivision recorded 22152; Telephone: (202) 598–2896. width, and height) as the approved before November 1, 1999, and TVA SUPPLEMENTARY INFORMATION: plans, standards, and conditions of the permitted at least one water-use facility Section 26a permit. Legal Authority in the subdivision prior to November 1, 1999; or if there is no subdivision, * * * * * Section 201 of the CSA, 21 U.S.C. 811, where the water-use facility will be Tennessee River System means TVA provides the Attorney General with the located within a quarter-mile radius of reservoirs, the Tennessee River or any of authority to temporarily place a another water-use facility that TVA the Tennessee River’s tributaries. substance in schedule I of the CSA for permitted prior to November 1, 1999. * * * * * two years without regard to the TVA may allow even larger facilities David L. Bowling, requirements of 21 U.S.C. 811(b) if he where an applicant requests and Vice President, Land & River Management. finds that such action is necessary to justifies a waiver or variance, set forth avoid an imminent hazard to the public in §§ 1304.212 and 1304.408 [FR Doc. 2018–18887 Filed 8–30–18; 8:45 am] safety. 21 U.S.C. 811(h)(1). In addition, respectively, but such waivers or BILLING CODE 8120–08–P if proceedings to control a substance variances shall be made in TVA’s permanently are initiated under 21 discretion and on a case-by-case basis. U.S.C. 811(a)(1) while the substance is (b) Docks, boatslips, piers, and fixed DEPARTMENT OF JUSTICE temporarily controlled under section or floating boathouses are allowable. 811(h), the Attorney General may Drug Enforcement Administration These and other water-use facilities extend the temporary scheduling 1 for associated with a lot must be sited up to one year. 21 U.S.C. 811(h)(2). 21 CFR Part 1308 within a 1,000- or 1,800-square-foot Where the necessary findings are rectangular or square area as required by [Docket No. DEA–482] made, a substance may be temporarily § 1304.204(a) at the lakeward end of the scheduled if it is not listed in any other access walkway that extends from the Schedules of Controlled Substances: schedule under section 202 of the CSA, shore to the structure. Access walkways Temporary Placement of N- 21 U.S.C. 812, or if there is no to the water-use structure are not Ethylpentylone in Schedule I exemption or approval in effect for the included in calculating the 1,000- or AGENCY: Drug Enforcement substance under section 505 of the 1,800-square foot area. Administration, Department of Justice. Federal Food, Drug, and Cosmetic Act * * * * * ACTION: Temporary amendment; (FDCA), 21 U.S.C. 355. 21 U.S.C. (n) Except for floating cabins temporary scheduling order. 811(h)(1). The Attorney General has approved in accordance with subpart B delegated scheduling authority under 21 of this part, toilets and sinks are not SUMMARY: The Acting Administrator of U.S.C. 811 to the Administrator of the permitted on water-use facilities. the Drug Enforcement Administration is DEA. 28 CFR 0.100. * * * * * issuing this temporary scheduling order to schedule the synthetic cathinone, 1- 1 Though DEA has used the term ‘‘final order’’ § 1304.406 [Amended] (1,3-benzodioxol-5-yl)-2-(ethylamino)- with respect to temporary scheduling orders in the ■ past, this document adheres to the statutory 9. Amend § 1304.406 in the first pentan-1-one (N-ethylpentylone, language of 21 U.S.C. 811(h), which refers to a sentence by removing the words ephylone) and its optical, positional, ‘‘temporary scheduling order.’’ No substantive ‘‘nonnavigable houseboat’’ and adding and geometric isomers, salts, and salts change is intended. VerDate Sep<11>2014 16:04 Aug 30, 2018 Jkt 244001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\FR\FM\31AUR1.SGM 31AUR1 daltland on DSKBBV9HB2PROD with RULES Federal Register / Vol. 83, No. 170 / Friday, August 31, 2018 / Rules and Regulations 44475 Background A substance meeting the statutory ethylpentylone reported in NFLIS for requirements for temporary scheduling 2013. N-Ethylpentylone was first Section 201(h)(4) of the CSA, 21 may only be placed in schedule I. 21 identified in NFLIS in May 2014. U.S.C. 811(h)(4), requires the U.S.C. 811(h)(1). Substances in schedule STRIDE/STARLiMS registered over 300 Administrator to notify the Secretary of I are those that have a high potential for reports from DEA forensic laboratories the Department of Health and Human abuse, no currently accepted medical from January 2013 to December 2017. Services (HHS) of his intention to use in treatment in the United States, There were no occurrences of N- temporarily place a substance in and a lack of accepted safety for use ethylpentylone reported in STRIDE/ schedule I of the CSA.2 The Acting under medical supervision. 21 U.S.C. STARLiMS for 2013. N-Ethylpentylone Administrator transmitted notice of his 812(b)(1). was first reported to STRIDE/ intent to place N-ethylpentylone in Available data and information for N- STARLiMS in December 2015. schedule I on a temporary basis to the ethylpentylone, summarized below, Additionally, U.S. Customs and Border Acting Assistant Secretary for Health of indicate that this synthetic cathinone Protection (CBP) encounters of N- HHS by letter dated November 22, 2017. has a high potential for abuse, no ethylpentylone have occurred. The Acting Assistant Secretary currently accepted medical use in N-Ethylpentylone, like other synthetic responded to this notice of intent by treatment in the United States, and a cathinones, is a designer drug of the letter dated December 13, 2017, and lack of accepted safety for use under phenethylamine class and it is advised that based on a review by the medical supervision. The DEA’s three- pharmacologically similar to schedule I Food and Drug Administration (FDA), factor analysis and the Assistant synthetic cathinones (e.g., cathinone, there are currently no active Secretary’s December 13, 2017 letter are methcathinone, mephedrone, investigational new drug applications or available in their entirety under the tab methylone, pentylone, and MDPV) and approved new drug applications for N- ‘‘Supporting Documents’’ of the public well-known schedule I and II ethylpentylone. The Acting Assistant docket of this action at sympathomimetic agents (e.g., Secretary also stated that HHS has no www.regulations.gov under FDMS methamphetamine, 3,4- objection to the temporary placement of Docket ID: DEA–2018–0011 (Docket methylenedioxymethamphetamine N-ethylpentylone in schedule I of the Number DEA–482). (MDMA), and cocaine). N- ethylpentylone, similar to these CSA. The DEA has taken into N-Ethylpentylone consideration the Assistant Secretary’s substances, causes stimulant related comments as required by 21 U.S.C. Around 2014, the synthetic cathinone, psychological and somatic effects. 811(h)(4). N-Ethylpentylone is not N-ethylpentylone, emerged in the Consequently, there have been currently listed in any schedule under United States’ illicit drug market after documented reports of emergency room the CSA, and no exemptions or the scheduling of other popular admissions and numerous deaths approvals are in effect for this substance synthetic cathinones (e.g., ethylone, 4- associated with the abuse of N- under section 505 of the FDCA, 21 methyl-N-ethylcathinone (4–MEC), ethylpentylone.
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