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published on March 10, 2020 (85 FR Legal Authority consideration the Assistant Secretary’s 13741), is adopted as final without The Controlled Substances Act (CSA) comments as required by 21 U.S.C. change. provides the Attorney General with the 811(h)(4). Isotonitazene is not currently listed in any schedule under the CSA, Timothy J. Shea, authority to temporarily place a and no exemptions or approvals are in Acting Administrator. substance in schedule I of the CSA for effect for isotonitazene under section [FR Doc. 2020–17357 Filed 8–19–20; 8:45 am] two years without regard to the requirements of 21 U.S.C. 811(b), if he 505 of the FDCA, 21 U.S.C. 355. DEA BILLING CODE 4410–09–P finds that such action is necessary to has found that the control of avoid an imminent hazard to the public isotonitazene in schedule I on a DEPARTMENT OF JUSTICE safety. 21 U.S.C. 811(h)(1). In addition, temporary basis is necessary to avoid an if proceedings to control a substance imminent hazard to the public safety. Drug Enforcement Administration permanently are initiated under 21 As required by 21 U.S.C. 811(h)(1)(A), U.S.C. 811(a)(1) while the substance is DEA published a notice of intent to 21 CFR Part 1308 temporarily controlled under section temporarily schedule isotonitazene in 811(h), the Attorney General may the Federal Register on June 18, 2020. 1 [Docket No. DEA–631] extend the temporary scheduling for 85 FR 38619. That notice of intent up to one year. 21 U.S.C. 811(h)(2). discussed findings from DEA’s three- Schedules of Controlled Substances: Where the necessary findings are factor analysis dated May 2020, which Temporary Placement of Isotonitazene made, a substance may be temporarily DEA made available on in Schedule I scheduled if it is not listed in any other www.regulations.gov schedule under section 202 of the CSA, contemporaneously with the AGENCY: Drug Enforcement 21 U.S.C. 812, or if there is no Administration, Department of Justice. publication of the notice of intent. This exemption or approval in effect for the temporary scheduling order discusses ACTION: Temporary amendment; substance under section 505 of the updated findings on isotonitazane for Federal Food, Drug, and Cosmetic Act temporary scheduling order. one of the three factors (Factor 5) in (FDCA), 21 U.S.C. 355. 21 U.S.C. DEA’s July 2020 analysis related to law SUMMARY: The Acting Administrator of 811(h)(1); 21 CFR part 1308. The enforcement seizures, overdoses, and the Drug Enforcement Administration is Attorney General has delegated regulatory status. issuing this temporary order to schedule scheduling authority under 21 U.S.C. N,N-diethyl-2-(2-(4 isopropoxybenzyl)- 811 to the Administrator of DEA To find that placing a substance 5-nitro-1H-benzimidazol-1-yl)ethan-1- (Administrator). 28 CFR 0.100. temporarily in schedule I of the CSA is amine (commonly known as necessary to avoid an imminent hazard isotonitazene), including its isomers, Background to the public safety, the Administrator is esters, ethers, salts, and salts of isomers, 21 U.S.C. 811(h)(4) requires the required to consider three of the eight esters, and ethers whenever the Administrator to notify the Secretary of factors set forth in 21 U.S.C. 811(c): The existence of such isomers, esters, ethers, the Department of Health and Human substance’s history and current pattern and salts is possible, in schedule I. This Services (HHS) of his intention to of abuse; the scope, duration, and action is based on a finding by the temporarily place a substance in significance of abuse; and what, if any, Acting Administrator that the placement schedule I of the CSA.2 The Acting risk there is to the public health. 21 of isotonitazene in schedule I of the Administrator transmitted notice of his U.S.C. 811(h)(3). Consideration of these Controlled Substances Act is necessary intent to place isotonitazene in schedule factors includes actual abuse, diversion to avoid an imminent hazard to the I on a temporary basis to the Assistant from legitimate channels, and public safety. As a result of this order, Secretary for Health of HHS (Assistant clandestine importation, manufacture, the regulatory controls and Secretary) by letter dated March 2, 2020. or distribution. 21 U.S.C. 811(h)(3). The Assistant Secretary responded to administrative, civil, and criminal A substance meeting the statutory sanctions applicable to schedule I this notice by letter dated March 31, requirements for temporary scheduling controlled substances will be imposed 2020, and advised that based on a may only be placed in schedule I. 21 on persons who handle (manufacture, review by the Food and Drug U.S.C. 811(h)(1). Substances in schedule distribute, reverse distribute, import, Administration (FDA), there are I are those that have a high potential for export, engage in research, conduct currently no investigational new drug abuse, no currently accepted medical instructional activities or chemical applications (INDs) or approved new use in treatment in the United States, analysis with, or possess), or propose to drug applications (NDAs) for and a lack of accepted safety for use handle isotonitazene. isotonitazene. The Assistant Secretary also stated that HHS had no objection to under medical supervision. 21 U.S.C. DATES: This temporary scheduling order 812(b)(1). is effective August 20, 2020, until the temporary placement of August 20, 2022. If this order is isotonitazene in schedule I of the CSA. Available data and information for extended or made permanent, DEA will The Drug Enforcement isotonitazene summarized below publish a document in the Federal Administration (DEA) has taken into indicate that it has high potential for Register. abuse, no currently accepted medical 1 Though the Drug Enforcement Administration use in treatment in the United States, FOR FURTHER INFORMATION CONTACT: (DEA) has used the term ‘‘final order’’ with respect and a lack of accepted safety for use Scott A. Brinks, Regulatory Drafting and to temporary scheduling orders in the past, this document adheres to the statutory language of 21 under medical supervision. DEA’s May Policy Support Section, Diversion U.S.C. 811(h), which refers to a ‘‘temporary and July 2020 three-factor analyses and Control Division, Drug Enforcement scheduling order.’’ No substantive change is the Assistant Secretary’s March 31, Administration; Mailing Address: 8701 intended. 2020, letter are available in their Morrissette Drive, Springfield, Virginia 2 The Secretary of HHS has delegated to the entirety under the tab ‘‘Supporting 22152; Telephone: (571) 362–3261. Assistant Secretary for Health of HHS the authority to make domestic drug scheduling Documents’’ of the public docket of this SUPPLEMENTARY INFORMATION: recommendations. 58 FR 35460, July 1, 1993. action at www.regulations.gov.

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Isotonitazene reported in the scientific literature in on the other side, and as a blue tablet The availability of synthetic 1957. Isotonitazene is not an approved in Dilaudid counterfeit pills. in the illicit drug market continues to pharmaceutical product and is not Identification of isotonitazene in pose an imminent hazard to the public approved for medical use anywhere in counterfeit pills is deeply concerning safety. Adverse health effects associated the world. As discussed in the because the identity, purity, and with the abuse of synthetic opioids and background section, the Assistant quantity of isotonitazene in this the continued evolution and increased Secretary stated in a March 31, 2020, formulation are uncertain, thus popularity of these substances have letter to DEA that there are no INDs or presenting additional safety concerns FDA-approved NDAs for isotonitazene for unsuspecting users. been a serious concern in recent years. in the United States. Hence, DEA notes In the United States, isotonitazene has As the United States continues to there is no legitimate channel for been identified as a single substance or experience an unprecedented epidemic isotonitazene as a marketed drug in combination with other substances. of misuse and abuse, the product. In April 2019, the United States presence of new synthetic opioids with Since 2014, numerous synthetic Customs and Border Protection (CBP) no approved medical use exacerbates opioids structurally related to seized 1.6 grams of isotonitazene in the epidemic. The trafficking and abuse and several opioids from other California. In addition, Wisconsin State of new synthetic opioids are deadly new structural classes have begun to emerge Crime Laboratories identified trends. in the illicit drug market, as evidenced isotonitazene mixed with and The identification of isotonitazene, by the identification of these drugs in bromazolam, a nonscheduled chemically known as N,N-diethyl-2-(2- forensic drug exhibits and toxicology benzodiazepine, in seized powder. (4 isopropoxybenzyl)-5-nitro-1H- samples. Beginning in April 2019, Further, isotonitazene was identified in benzimidazol-1-yl)ethan-1-amine (other isotonitazene emerged on the illicit a substance obtained from the scene of name: N,N-diethyl-2-[[4-(1- synthetic drug market in the United a death investigation in Iowa. Evidence methylethoxy)phenyl]methyl]-5-nitro- States, as evidenced by its identification suggests that individuals are using 1H--1-ethanamine), in the in drug seizures and in biological isotonitazene as a replacement to heroin illicit drug market has been reported in samples collected and submitted to or other opioids, either knowingly or Canada, Estonia, Germany, Latvia, National Medical Services (NMS) unknowingly. Sweden, and the United States (see Laboratory 3 in August 2019. In August Factor 5. Scope, Duration, and Factor 4 below). Data obtained from 2019, isotonitazene was first reported in Significance of Abuse preclinical pharmacology studies shows a drug case in Belgium and in that isotonitazene has a pharmacological toxicology casework in Canada (a Isotonitazene, similar to profile similar to that of the potent toxicological sample was collected in (schedule I), has been described as a synthetic opioid etonitazene, a schedule March 2019). In the United States, the potent synthetic opioid and evidence I controlled substance. Because of the Center for Forensic Science Research suggests it is being abused for its pharmacological similarities of and Education (under the novel opioidergic effects (see Factor 6). The isotonitazene to etonitazene, the use of psychoactive substances discovery abuse of isotonitazene, similar to other isotonitazene presents a high risk of program) first reported isotonitazene in synthetic opioids, has resulted in abuse and may negatively affect users November 2019. adverse health effects. Isotonitazene has and communities. The abuse of According to a report by the European been positively identified in 18 death isotonitazene has been associated with Monitoring Center for Drugs and Drug investigations between August 2019 and at least 19 fatalities in the United States addiction and Europol,4 between April January 2020. These reports were from (see Factor 5 below). The positive 2019 and January 2020, four member- four states—Illinois (9), Indiana (7), identification of this substance in states (Estonia, Latvia, Germany, and Minnesota (1), and Wisconsin (1). Most overdose and post-mortem cases is a Sweden) have reported 24 isotonitazene (n = 12) of the decedents were male. The serious concern for public safety. Thus, cases involving 109.6 grams of powder ages ranged from 24 to 66 years old with isotonitazene poses an imminent hazard (22 cases) and 4.5 grams of liquid (two an average age of 41. Other substances to public safety. cases). Isotonitazene has been identified in postmortem blood Available data and information for encountered by United States law specimens obtained from these isotonitazene, as summarized below, enforcement primarily in powder form. decedents include etizolam (6); indicates that this substance has a high In March 2020, Canada law enforcement flualprazolam, a nonscheduled potential for abuse, no currently also encountered isotonitazene in a benzodiazepine (7); fentanyl (6); heroin accepted medical use in treatment in the tablet form, as a white triangular tablet (3); , a schedule IV narcotic (2); United States, and a lack of accepted with ‘M’ logo on one side and ‘8’ logo and U–47700, a schedule I synthetic safety for use under medical opioid (1). The average concentration of supervision. DEA’s three-factor analysis 3 NMS Labs, in collaboration with the Center for isotonitazene in these biological is available in its entirety under Forensic Science Research and Education at the samples (blood) was 2.2 ± 2.1 ‘‘Supporting and Related Material’’ of Fredric Rieders Family Foundation and the nanogram/milliliter (ng/ml) (range 0.4 to Organized Crime Drug Enforcement Task Force at the public docket for this action at the U.S. Department of Justice, has received funding 9.5 ng/ml). Isotonitazene was detected www.regulations.gov under Docket from the Centers for Disease Control and Prevention as the only opioid in 50 percent (n = 9) Number DEA–631. to develop systems for the early identification and of the specimens for these decedents. notification of novel psychoactive substances in the DEA 5 is aware of another postmortem Factor 4. History and Current Pattern of drug supply within the United States. Abuse 4 European Monitoring Centre for Drugs and Drug case that occurred in January 2020 in Addiction and Europol (2020), EMCDDA initial Pennsylvania where isotonitazene was The chemical syntheses of report on the new psychoactive substance N,N- identified in a biological sample. In isotonitazene (a benzimidazole diethyl-2-[[4-(1-methylethoxy)phenyl]methyl]-5- total, isotonitazene has been positively derivative) and other benzimidazole nitro-1H-benzimidazole-1-ethanamine (isotonitazene). In accordance with Article 5b of identified in 19 postmortem cases. derivatives (including schedule I Regulation (EC) No 1920/2006 (as amended), substances such as synthetic opioids Publications Office of the European Union, 5 Email communication from DEA Philadelphia etonitazene and ) were first Luxembourg. Field Division on March 4, 2020.

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Recent communication from Minnesota Survey on Drug Use and Health regulatory protein, in a live cell-based Department of Health 6 reports the (NSDUH),9 as of 2018, an estimated 10.3 receptor assay. , an opioid positive identification of isotonitazene million people aged 12 years or older receptor antagonist, blocked in two overdose cases. had misused opioids in the past year, isotonitazene’s activation of the mu- Law enforcement data indicate that including 9.9 million prescription pain . Substances that act as isotonitazene has appeared in the reliever misusers and 808,000 heroin an agonist at the mu-opioid receptors United States’ illicit drug market. users. In 2018, an estimated 2.0 million have a high potential for addiction and According to the National Forensic people had an opioid use disorder can induce dose-dependent respiratory Laboratory Information System which included 1.7 million people with depression. (NFLIS) 7 database, which collects drug a prescription pain reliever use disorder identification results from drug cases and 0.5 million people with heroin use As with any mu-opioid receptor submitted to and analyzed by Federal, disorder. This population abusing agonist, the potential health and safety State, and local forensic laboratories, opioids is likely to be at risk of abusing risks for users are high. The public there have been 48 encounters of isotonitazene. Individuals who initiate health risks attendant to the abuse of isotonitazene in the United States (i.e., use a drug for the first time) use of heroin and other mu-opioid receptor (queried May 14, 2020). These 48 isotonitazene are likely to be at risk of agonists are well established and have encounters occurred in 2019 and 2020 developing substance use disorders, resulted in large numbers of drug in five states: California (1), Iowa (5), overdoses, and death similar to that of treatment admissions, emergency Ohio (4), Tennessee (13), and Wisconsin other opioid (e.g., fentanyl, department visits, and fatal overdoses. (25). One of these encounters consisted , etc.). Law enforcement and According to the Centers for Disease of 1.6 grams of isotonitazene seized by toxicology reports demonstrate that Control and Prevention (CDC), opioids, the CBP in California in April 2019. isotonitazene is being illicitly mainly synthetic opioids other than As of May 2020, Ohio and Wisconsin distributed and abused. , are predominantly enacted emergency legislation to control responsible for drug overdose deaths in Factor 6. What, If Any, Risk There Is isotonitazene as a schedule I controlled recent years. A CDC report shows that to the Public Health substance. Internationally, isotonitazene from 2013 to 2018,10 opioid-related is controlled under Estonia, Latvia, The increase in opioid overdose overdose deaths in the United States Poland, and Sweden drug control deaths in the United States has been increased from 25,052 to 46,802. Of the legislation. In the United Kingdom, exacerbated recently by the availability drug overdose death data for 2018, isotonitazene is controlled under the of potent synthetic opioids in the illicit opioids were involved in about 69.5 Psychoactive Substances Act 2016. drug market. Data obtained from pre- percent of all drug-involved overdose Further, isotonitazene is controlled clinical studies demonstrate that deaths. under the Norwegian Medicines Act and isotonitazene exhibits a Lithuania medicine legislation.8 pharmacological profile similar to that In the United States, isotonitazene has The population likely to abuse of etonitazene and other mu-opioid been co-identified with other substances isotonitazene appears to be the same as receptor agonists. In an in vivo (in mice) in 18 postmortem cases, and DEA is those abusing prescription opioid study, isotonitazene was 500 times more aware of an additional death in January analgesics, heroin, tramadol, fentanyl, potent than morphine as an in 2020, involving isotonitazene. These and other synthetic opioid substances. a tail-flick assay. The tail-flick assay is deaths associated with isotonitazene This is evidenced by the types of other useful in evaluating antinociceptive occurred in five states: Illinois (9), drugs co-identified in isotonitazene fatal effect. Data from in vitro studies showed Indiana (7), Minnesota (1), Pennsylvania overdose cases. Because abusers of that isotonitazene activated the mu- (1), and Wisconsin (1). Information isotonitazene are likely to obtain it opioid receptor and acted as a mu- gathered from case histories and through unregulated sources, the opioid receptor agonist. Isotonitazene, autopsy findings shows that identity, purity, and quantity are similar to and fentanyl, isotonitazene use is similar to that of uncertain and inconsistent, thus posing activated the mu-opioid receptor and classic opioid agonists. Evidence significant adverse health risks to the acted as an agonist via interaction at the obtained from reported cases of death end user. The misuse and abuse of mu-opioid receptor with b-arrestin-2, a scenarios suggests that isotonitazene, opioids have been demonstrated and are similar to heroin, can be used well characterized. According to the 9 The National Survey on Drug Use and Health intravenously.11 most recent data from the National (NSDUH), formerly known as the National Household Survey on Drug Abuse (NHSDA), is The introduction of potent synthetic conducted annually by HHS’ Substance Abuse and opioids such as isotonitazene into the 6 Email communication from Minnesota Mental Health Services Administration (SAMHSA). illicit market exacerbates problematic Department of Health: Biomonitoring and Emerging It is the primary source of estimates of the Contaminants Unit; received May 26, 2020. prevalence and incidence of nonmedical use of opioid use for those seeking these 7 NFLIS represents an important resource in pharmaceutical drugs, illicit drugs, alcohol, and powerful opioids. As documented by a monitoring illicit drug trafficking, including the tobacco use in the United States. The survey is published toxicology report, poly- diversion of legally manufactured pharmaceuticals based on a nationally representative sample of the into illegal markets. NFLIS-Drug is a comprehensive civilian, non-institutionalized population twelve substance abuse remains common in information system that includes data from forensic years of age and older. The survey excludes fatalities associated with the abuse of laboratories that handle the nation’s drug analysis homeless people who do not use shelters, active isotonitazene.12 cases. NFLIS-Drug participation rate, defined as the military personnel, and residents of institutional percentage of the national drug caseload group quarters such as jails and hospitals. The represented by laboratories that have joined NFLIS, NSDUH provides yearly national and state level 10 CDC National Center for Health Statistics is currently 98.5 percent. NFLIS includes drug estimates of drug abuse, and includes prevalence (NCHS), National Vital Statistics System, Mortality. chemistry results from completed analyses only. estimates by lifetime (i.e., ever used), past year, and NCHS Data Brief, Number 356, January 2020. While NFLIS data is not direct evidence of abuse, past month abuse or dependence. The 2018 NSDUH 11 Krotulski AJ, Papsun DM, Kacinko SL, and it can lead to an inference that a drug has been annual report is available at https:// Logan BK (2020). Isotonitazene Quantitation and diverted and abused. See 76 FR 77330, 77332, Dec. www.samhsa.gov/data/sites/default/files/cbhsq- Metabolite Discovery in Authentic Forensic 12, 2011. NFLIS data was queried on May 14, 2020. reports/NSDUHNationalFindingsReport2018/ Casework. Journal of Analytical Toxicology. [Epub 8 The Medicines Act, LOVDATA, https:// NSDUHNationalFindingsReport2018.pdf (last ahead of print]. lovdata.no/dokument/NL/lov/1992-12-04-132, 1992. accessed June 18, 2020). 12 Id.

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Finding of Necessity of Schedule I accordance with 21 U.S.C. 811(a) are 21 U.S.C. 821, 823, 871(b), and in Placement To Avoid Imminent Hazard subject to formal rulemaking procedures accordance with 21 CFR 1301.71– to Public Safety done ‘‘on the record after opportunity 1301.93, as of August 20, 2020. Non- In accordance with 21 U.S.C. for a hearing’’ conducted pursuant to practitioners handling isotonitazene 811(h)(3), based on the available data the provisions of 5 U.S.C. 556 and 557. must also comply with the employee and information summarized above, the 21 U.S.C. 811. The regular scheduling screening requirements of 21 CFR uncontrolled manufacture, distribution, process of formal rulemaking affords 1301.90–1301.93. 4. Labeling and Packaging. All labels, reverse distribution, importation, interested parties with appropriate process and the government with any labeling, and packaging for commercial exportation, conduct of research and additional relevant information needed containers of isotonitazene must be in chemical analysis, possession, and to make a determination. Final compliance with 21 U.S.C. 825, 958(e), abuse of isotonitazene pose an decisions that conclude the regular and be in accordance with 21 CFR part imminent hazard to the public safety. scheduling process of formal 1302. Current DEA registrants shall have DEA is not aware of any currently rulemaking are subject to judicial 30 calendar days from August 20, 2020, accepted medical uses for isotonitazene review. 21 U.S.C. 877. Temporary to comply with all labeling and in the United States. A substance scheduling orders are not subject to packaging requirements. meeting the statutory requirements for judicial review. 21 U.S.C. 811(h)(6). 5. Inventory. Every DEA registrant temporary scheduling, found in 21 who possesses any quantity of U.S.C. 811(h)(1), may only be placed in Requirements for Handling isotonitazene on the effective date of schedule I. Substances in schedule I are Upon the effective date of this this order must take an inventory of all those that have a high potential for temporary order, isotonitazene will be stocks of these substances on hand, abuse, no currently accepted medical subject to the regulatory controls and pursuant to 21 U.S.C. 827 and 958, and use in treatment in the United States, administrative, civil, and criminal in accordance with 21 CFR 1304.03, and a lack of accepted safety for use sanctions applicable to the manufacture, 1304.04, and 1304.11. Current DEA under medical supervision. Available distribution, reverse distribution, registrants shall have 30 calendar days data and information for isotonitazene importation, exportation, engagement in from the effective date of this order to indicate that this substance has a high research, and conduct of instructional be in compliance with all inventory potential for abuse, no currently activities or chemical analysis with, and requirements. After the initial accepted medical use in treatment in the possession of schedule I controlled inventory, every DEA registrant must United States, and a lack of accepted substances, including the following: take an inventory of all controlled safety for use under medical 1. Registration. Any person who substances (including isotonitazene) on supervision. As required by 21 U.S.C. handles (manufactures, distributes, hand on a biennial basis, pursuant to 21 811(h)(4), by a letter dated March 2, reverse distributes, imports, exports, U.S.C. 827 and 958, and in accordance 2020, the Acting Administrator notified engages in research, or conducts with 21 CFR 1304.03, 1304.04, and the Assistant Secretary for Health of instructional activities or chemical 1304.11. DEA’s intention to temporarily place analysis with, or possesses), or who 6. Records. All DEA registrants must isotonitazene in schedule I. DEA desires to handle, isotonitazene must be maintain records with respect to subsequently published a Notice of registered with DEA to conduct such isotonitazene pursuant to 21 U.S.C. 827 Intent in the Federal Register on June activities pursuant to 21 U.S.C. 822, and 958, and in accordance with 21 CFR 18, 2020. 85 FR 38619. 823, 957, and 958, and in accordance parts 1304, 1312, 1317, and § 1307.11. with 21 CFR parts 1301 and 1312, as of Conclusion Current DEA registrants authorized to August 20, 2020. Any person who handle isotonitazene shall have 30 In accordance with the provisions of currently handles isotonitazene, and is calendar days from the effective date of 21 U.S.C. 811(h), the Acting not registered with DEA, must submit this order to be in compliance with all Administrator considered available data an application for registration and may recordkeeping requirements. and information, and herein sets forth not continue to handle isotonitazene as 7. Reports. All DEA registrants who the grounds for his determination that it of August 20, 2020, unless DEA has manufacture or distribute isotonitazene is necessary to temporarily schedule approved that application for must submit reports pursuant to 21 N,N-diethyl-2-(2-(4 isopropoxybenzyl)- registration pursuant to 21 U.S.C. 822, U.S.C. 827 and in accordance with 21 5-nitro-1H-benzimidazol-1-yl)ethan-1- 823, 957, and 958, and in accordance CFR parts 1304 and 1312 as of August amine (commonly known as: with 21 CFR parts 1301 and 1312. Retail 20, 2020. Isotonitazene) in schedule I of the CSA sales of schedule I controlled substances 8. Order Forms. All DEA registrants to avoid an imminent hazard to the to the general public are not allowed who distribute isotonitazene must public safety. under the CSA. Possession of any comply with order form requirements Because the Acting Administrator quantity of these substances in a manner pursuant to 21 U.S.C. 828 and in hereby finds it necessary to temporarily not authorized by the CSA on or after accordance with 21 CFR part 1305 as of place isotonitazene in schedule I to August 20, 2020, is unlawful and those August 20, 2020. avoid an imminent hazard to the public in possession of any quantity of these 9. Importation and Exportation. All safety, this temporary order scheduling substances may be subject to importation and exportation of this substance is effective on the date of prosecution pursuant to the CSA. isotonitazene must be in compliance publication in the Federal Register, and 2. Disposal of stocks. Any person who with 21 U.S.C. 952, 953, 957, 958, and will be in effect for a period of two does not desire or is not able to obtain in accordance with 21 CFR part 1312 as years, with a possible extension of one a schedule I registration to handle of August 20, 2020. additional year, pending completion of isotonitazene must surrender all 10. Quota. Only DEA registered the regular (permanent) scheduling currently held quantities of manufacturers may manufacture process. 21 U.S.C. 811(h)(1) and (2). isotonitazene. isotonitazene in accordance with a The CSA sets forth specific criteria for 3. Security. Isotonitazene is subject to quota assigned pursuant to 21 U.S.C. scheduling a drug or other substance. schedule I security requirements and 826 and in accordance with 21 CFR part Regular scheduling actions in must be handled and stored pursuant to 1303 as of August 20, 2020.

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11. Liability. Any activity involving subject to the notice-and-comment This action will not have substantial isotonitazene not authorized by, or in requirements of section 553 of the APA, direct effects on the States, on the violation of the CSA, occurring as of DEA notes that in accordance with 21 relationship between the national August 20, 2020, is unlawful, and may U.S.C. 811(h)(4), the Acting government and the States, or on the subject the person to administrative, Administrator took into consideration distribution of power and civil, and/or criminal sanctions. comments submitted by the Assistant responsibilities among the various Secretary in response to the notice that Regulatory Matters levels of government. Therefore, in DEA transmitted to the Assistant accordance with E.O. 13132 21 U.S.C. 811(h) provides for a Secretary pursuant to such subsection. (Federalism), it is determined that this temporary scheduling action where Further, DEA believes that this action does not have sufficient such action is necessary to avoid an temporary scheduling action is not a federalism implications to warrant the imminent hazard to the public safety. ‘‘rule’’ as defined by 5 U.S.C. 601(2), preparation of a Federalism Assessment. As provided in this subsection, the and, accordingly, is not subject to the Attorney General may, by order, requirements of the Regulatory List of Subjects in 21 CFR Part 1308 schedule a substance in schedule I on a Flexibility Act. The requirements for the Administrative practice and temporary basis. Such an order may not preparation of an initial regulatory procedure, Drug traffic control, be issued before the expiration of 30 flexibility analysis in 5 U.S.C. 603(a) are Reporting and recordkeeping days from: (1) The publication of a not applicable where, as here, DEA is requirements. notice in the Federal Register of the not required by section 553 of the APA For the reasons set out above, DEA intention to issue such order and the or any other law to publish a general amends 21 CFR part 1308 as follows: grounds upon which such order is to be notice of proposed rulemaking. issued, and (2) the date that notice of In accordance with the principles of PART 1308—SCHEDULES OF the proposed temporary scheduling Executive Orders (E.O.) 12866 and CONTROLLED SUBSTANCES order is transmitted to the Assistant 13563, this action is not a significant Secretary of HHS. 21 U.S.C. 811(h)(1). regulatory action. E.O. 12866 directs ■ 1. The authority citation for part 1308 Inasmuch as 21 U.S.C. 811(h) directs agencies to assess all costs and benefits continues to read as follows: that temporary scheduling actions be of available regulatory alternatives and, Authority: 21 U.S.C. 811, 812, 871(b), issued by order and sets forth the if regulation is necessary, to select 956(b), unless otherwise noted. procedures by which such orders are to regulatory approaches that maximize ■ be issued, including the requirement of net benefits (including potential 2. In § 1308.11, add paragraph (h)(48) a publication in the Federal Register of economic, environmental, public health, to read as follows: a Notice of Intent, the notice-and- and safety effects; distributive impacts; § 1308.11 Schedule I comment requirements of section 553 of and equity). E.O. 13563 is supplemental * * * * * the Administrative Procedure Act to and reaffirms the principles, (h) * * * (APA), 5 U.S.C. 553, do not apply to this structures, and definitions governing temporary scheduling order. The APA regulatory review as established in E.O. (48) N,N-diethyl-2-(2-(4 expressly differentiates between an isopropoxybenzyl)-5-nitro-1H- 12866. E.O. 12866 classifies a benzimidazol-1-yl)ethan-1-amine, order and a rule, as it defines an ‘‘order’’ ‘‘significant regulatory action,’’ its isomers, esters, ethers, salts to mean a ‘‘final disposition, whether requiring review by the Office of and salts of isomers, esters and affirmative, negative, injunctive, or Management and Budget (OMB), as any ethers (Other names: declaratory in form, of an agency in a regulatory action that is likely to result isotonitazene; N,N-diethyl-2-[[4- matter other than rule making.’’ 5 U.S.C. in a rule that may: (1) Have an annual (1-methylethoxy)phenyl]methyl]- 551(6) (emphasis added). The specific effect on the economy of $100 million 5-nitro-1H-benzimidazole-1- language chosen by Congress indicates or more or adversely affect in a material ethanamine) 9614 an intention for DEA to proceed through way the economy; a sector of the * * * * * the issuance of an order instead of economy; productivity; competition; proceeding by rulemaking. Given that jobs; the environment; public health or Timothy J. Shea, Congress specifically requires the safety; or State, local, or tribal Acting Administrator. Attorney General to follow rulemaking governments or communities; (2) create [FR Doc. 2020–17951 Filed 8–19–20; 8:45 am] procedures for other kinds of scheduling a serious inconsistency or otherwise BILLING CODE 4410–09–P actions, see 21 U.S.C. 811(a), it is interfere with an action taken or noteworthy that, in 21 U.S.C. 811(h), planned by another agency; (3) Congress authorized the issuance of materially alter the budgetary impact of DEPARTMENT OF THE TREASURY temporary scheduling actions by order entitlements, grants, user fees, or loan rather than by rule. programs, or the rights and obligations Internal Revenue Service In the alternative, even assuming that of recipients thereof; or (4) raise novel this action might be subject to section legal or policy issues arising out of legal 26 CFR Part 1 553 of the APA, the Acting mandates, the President’s priorities, or [TD 9614] Administrator finds that there is good the principles set forth in the E.O. cause to forgo the notice-and-comment Because this is not a rulemaking action, RIN 1545–AM97 requirements of section 553, as any this is not a significant regulatory action further delays in the process for as defined in Section 3(f) of E.O. 12866. Certain Outbound Property Transfers issuance of temporary scheduling orders In addition, because this action is not by Domestic Corporations; Certain would be impracticable and contrary to considered an E.O. 12866 ‘‘significant Stock Distributions by Domestic the public interest in view of the regulatory action,’’ it does not meet the Corporations; Correcting Amendment manifest urgency to avoid an imminent definition of an E.O. 13771 regulatory AGENCY: Internal Revenue Service (IRS), hazard to the public safety. action. Therefore, the repeal and cost Treasury. Although DEA believes this offset requirements of E.O. 13771 have ACTION: Correcting amendments. temporary scheduling order is not not been triggered.

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