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Schedules of Controlled Substances: for up to One Year

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Schedules of Controlled Substances: for up to One Year 11862 Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Rules and Regulations impact is so minimal. Since this is a AWP CA E4 Palmdale, CA [Amended] Substances Act . This action is based on routine matter that will only affect air Palmdale USAF Plant 42 Airport, CA a finding by the Acting Administrator traffic procedures and air navigation, it (Lat. 34°37′46″ N, long. 118°05′04″ W) that the placement of brorphine in is certified that this rule, when That airspace extending upward from the schedule I of the Controlled Substances promulgated, would not have a surface within 1 mile each side of the 270° Act is necessary to avoid an imminent significant economic impact on a bearing from the airport, extending from the hazard to the public safety. As a result substantial number of small entities 4.3-mile radius to 7.5 miles west of Palmdale of this order, the regulatory controls and under the criteria of the Regulatory USAF Plant 42 Airport. This Class E airspace administrative, civil, and criminal Flexibility Act. area is effective during the specific dates and sanctions applicable to schedule I times established, in advance, by a Notice to Environmental Review Airmen. The effective date and time will controlled substances will be imposed on persons who handle (manufacture, The FAA has determined that this thereafter be continuously published in the Chart Supplement. distribute, reverse distribute, import, action qualifies for categorical exclusion export, engage in research, conduct under the National Environmental Paragraph 6005 Class E Airspace Areas instructional activities or chemical Policy Act in accordance with FAA Extending Upward From 700 Feet or More Above the Surface of the Earth. analysis with, or possess), or propose to Order 1050.1F, ‘‘Environmental handle brorphine. Impacts: Policies and Procedures,’’ * * * * * DATES: This temporary scheduling order paragraph 5–6.5a. This airspace action AWP CA E5 Palmdale, CA [Amended] is effective March 1, 2021, until March is not expected to cause any potentially Palmdale USAF Plant 42 Airport, CA 1, 2023. If this order is extended or significant environmental impacts, and (Lat. 34°37′46″ N, long. 118°05′04″ W) made permanent, DEA will publish a no extraordinary circumstances exist That airspace extending upward from 700 document in the Federal Register. that warrant preparation of an feet above the surface within a 6.8-mile FOR FURTHER INFORMATION CONTACT: environmental assessment. radius of the airport, and within 6.1 miles ° Terrence L. Boos, Drug and Chemical List of Subjects in 14 CFR Part 71 each side of the 080 bearing from the airport, Evaluation Section, Diversion Control extending from the 6.8-mile radius to 12.9 Airspace, Incorporation by reference, miles east of the airport, and within 4 miles Division, Drug Enforcement Navigation (air). north and 8 miles south of the 086° bearing Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia Adoption of the Amendment from the airport, extending from the airport to 14.3 miles east of the airport, and within 22152; Telephone: (571) 362–3249. ° In consideration of the foregoing, the 2 miles each side of the 274 bearing from the SUPPLEMENTARY INFORMATION: Federal Aviation Administration airport, extending from the 6.8-mile radius to amends 14 CFR part 71 as follows: 13.4 miles west of Palmdale USAF Plant 42 Legal Authority Airport. The Controlled Substances Act (CSA) PART 71—DESIGNATION OF CLASS A, Issued in Seattle, Washington, on February provides the Attorney General (as B, C, D, AND E AIRSPACE AREAS; AIR 16, 2021. delegated to the Administrator of Drug TRAFFIC SERVICE ROUTES; AND B.G. Chew, Enforcement Administrator (DEA) REPORTING POINTS Acting Group Manager, Operations Support pursuant to 28 CFR 0.100) with the Group, Western Service Center. ■ 1. The authority citation for 14 CFR authority to temporarily place a part 71 continues to read as follows: [FR Doc. 2021–03904 Filed 2–26–21; 8:45 am] substance in schedule I of the CSA for BILLING CODE 4910–13–P two years without regard to the Authority: 49 U.S.C. 106(f), 106(g), 40103, requirements of 21 U.S.C. 811(b), if he 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, finds that such action is necessary to 1959–1963 Comp., p. 389. DEPARTMENT OF JUSTICE avoid an imminent hazard to the public § 71.1 [Amended] safety. 21 U.S.C. 811(h)(1). In addition, ■ 2. The incorporation by reference in Drug Enforcement Administration if proceedings to control a substance are 14 CFR 71.1 of FAA Order 7400.11E, initiated under 21 U.S.C. 811(a)(1) while 1 Airspace Designations and Reporting 21 CFR Part 1308 the substance is temporarily controlled under section 811(h), the Administrator Points, dated July 21, 2020, and [Docket No. DEA–716] effective September 15, 2020, is may extend the temporary scheduling amended as follows: Schedules of Controlled Substances: for up to one year. 21 U.S.C. 811(h)(2). Temporary Placement of Brorphine in Where the necessary findings are Paragraph 5000 Class D Airspace. Schedule I made, a substance may be temporarily * * * * * scheduled if it is not listed in any other AGENCY: AWP CA D Palmdale, CA [Amended] Drug Enforcement schedule under 21 U.S.C. 812, or if there Administration, Department of Justice. is no exemption or approval in effect for Palmdale USAF Plant 42 Airport, CA (Lat. 34°37′46″ N, long. 118°05′04″ W) ACTION: Temporary amendment; the substance under section 505 of the Federal Food, Drug, and Cosmetic Act, That airspace extending upward from the temporary scheduling order. surface to and including 5,000 feet MSL 21 U.S.C. 355. 21 U.S.C. 811(h)(1); 21 within a 4.3-mile radius of Palmdale USAF SUMMARY: The Acting Administrator of CFR part 1308. the Drug Enforcement Administration is Plant 42 Airport. This Class D airspace area Background is effective during the specific dates and issuing this temporary order to schedule times established, in advance, by a Notice to 1-(1-(1-(4-bromophenyl)ethyl)piperidin- The CSA requires the Administrator Airmen. The effective date and time will 4-yl)-1,3-dihydro-2H-benzo[d]imidazol- to notify the Secretary of the thereafter be continuously published in the 2-one (commonly known as brorphine), Chart Supplement. including its isomers, esters, ethers, 1 Though DEA has used the term ‘‘final order’’ Paragraph 6004 Class E Airspace Areas salts, and salts of isomers, esters, and with respect to temporary scheduling orders in the Designated as an Extension to a Class D or past, this document adheres to the statutory ethers whenever the existence of such language of 21 U.S.C. 811(h), which refers to a Class E Surface Area. isomers, esters, ethers, and salts is ‘‘temporary scheduling order.’’ No substantive * * * * * possible, in schedule I of the Controlled change is intended. VerDate Sep<11>2014 16:15 Feb 26, 2021 Jkt 253001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\01MRR1.SGM 01MRR1 Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Rules and Regulations 11863 Department of Health and Human Available data and information for Factor 4. History and Current Pattern of Services (HHS) of his intention to brorphine summarized below indicate Abuse temporarily place a substance in that it has high potential for abuse, no Brorphine is part of a structural class 2 schedule I. 21 U.S.C. 811(h)(4). The currently accepted medical use in of compounds known as substituted Acting Administrator transmitted such treatment in the United States, and a piperidine benzimidazolones. The notice regarding brorphine to the lack of accepted safety for use under general synthesis of brorphine was first Assistant Secretary for Health of HHS medical supervision. DEA’s August reported in the literature in 2018. (Assistant Secretary) by letter dated 2020 three-factor analysis and the Brorphine is not an approved September 22, 2020. The Assistant Assistant Secretary’s October 27, 2020, pharmaceutical product and is not Secretary responded to this notice by letter are available in their entirety approved for medical use anywhere in letter dated October 27, 2020, and under the tab ‘‘Supporting Documents’’ the world. The Assistant Secretary, by a advised that based on a review by the of the public docket of this action at letter to DEA dated October 27, 2020, Food and Drug Administration (FDA), www.regulations.gov. stated that there are no FDA-approved there are currently no investigational NDAs or INDs for brorphine in the Brorphine new drug applications (INDs) or United States. Hence, DEA notes there approved new drug applications (NDAs) is no legitimate channel for brorphine as for brorphine. The Assistant Secretary The availability of synthetic opioids on the illicit drug market continues to a marketed drug product. The also stated that HHS had no objection to appearance of brorphine on the illicit the temporary placement of brorphine pose an imminent hazard to the public safety. Adverse health effects associated drug market is similar to other designer in schedule I of the CSA. drugs trafficked for their psychoactive DEA has taken into consideration the with the abuse of synthetic opioids and the increased popularity of these effects. Assistant Secretary’s comments as Since 2014, numerous synthetic required by subsection 811(h)(4). substances have posed serious health concerns in recent years. The presence opioids structurally related to fentanyl Brorphine is not currently listed in any and several synthetic opioids from other schedule under the CSA, and no of new synthetic opioids with no approved medical use exacerbates the structural classes have begun to emerge exemptions or approvals are in effect for on the illicit drug market as evidenced brorphine under 21 U.S.C.
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