51342 Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Rules and Regulations 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. VerDate Sep<11>2014 15:44 Aug 19, 2020 Jkt 250001 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 E:\FR\FM\20AUR1.SGM 20AUR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Rules and Regulations 51343 Isotonitazene reported in the scientific literature in on the other side, and as a blue tablet The availability of synthetic opioids 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 opioid 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 fentanyl 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 heroin 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-benzimidazole-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.