Federal Register / Vol. 85, No. 118 / Thursday, June 18, 2020 / Proposed Rules 36819 DEPARTMENT OF JUSTICE Legal Authority necessary to avoid an imminent hazard Section 201 of the CSA, 21 U.S.C. 811, to the public safety, the Administrator is Drug Enforcement Administration provides the Attorney General with the required to consider three of the eight authority to temporarily place a factors set forth in 21 U.S.C. 811(c): The 21 CFR Part 1308 substance in schedule I of the CSA for substance’s history and current pattern two years without regard to the of abuse; the scope, duration and [Docket No. DEA–631] requirements of 21 U.S.C. 811(b), if he significance of abuse; and what, if any, finds that such action is necessary to risk there is to the public health. 21 Schedules of Controlled Substances: avoid an imminent hazard to the public U.S.C. 811(h)(3). Consideration of these Temporary Placement of Isotonitazene safety. 21 U.S.C. 811(h)(1). In addition, factors includes actual abuse, diversion in Schedule I if proceedings to control a substance are from legitimate channels, and initiated under 21 U.S.C. 811(a)(1) while clandestine importation, manufacture, AGENCY: Drug Enforcement the substance is temporarily controlled or distribution. 21 U.S.C. 811(h)(3). Administration, Department of Justice. under section 811(h), the Attorney A substance meeting the statutory ACTION: Proposed amendment; notice of General may extend the temporary requirements for temporary scheduling intent. scheduling for up to one year. 21 U.S.C. may only be placed in schedule I. 21 811(h)(2). U.S.C. 811(h)(1). Substances in schedule SUMMARY: The Acting Administrator of Where the necessary findings are I are those that have a high potential for the Drug Enforcement Administration is made, a substance may be temporarily abuse, no currently accepted medical issuing this notice of intent to publish scheduled if it is not listed in any other use in treatment in the United States, a temporary order to schedule N,N- schedule under section 202 of the CSA, and a lack of accepted safety for use diethyl-2-(2-(4 isopropoxybenzyl)-5- 21 U.S.C. 812, or if there is no under medical supervision. 21 U.S.C. nitro-1H-benzimidazol-1-yl)ethan-1- exemption or approval in effect for the 812(b)(1). amine (commonly known as substance under section 505 of the Isotonitazene isotonitazene), including its isomers, Federal Food, Drug, and Cosmetic Act esters, ethers, salts, and salts of isomers, The availability of synthetic opioids (FDCA), 21 U.S.C. 355. 21 U.S.C. in the illicit drug market continues to esters, and ethers whenever the 811(h)(1); 21 CFR part 1308. The existence of such isomers, esters, ethers, pose an imminent hazard to the public Attorney General has delegated safety. Adverse health effects associated and salts is possible, in schedule I of the scheduling authority under 21 U.S.C. Controlled Substances Act. When it is with the abuse of synthetic opioids and 811 to the Administrator of DEA the continued evolution and increased issued, the temporary scheduling order (Administrator). 28 CFR 0.100. will impose the regulatory controls and popularity of these substances have been a serious concern in recent years. administrative, civil, and criminal Background As the United States continues to sanctions applicable to schedule I Section 201(h)(4) of the CSA, 21 experience an unprecedented epidemic controlled substances on persons who U.S.C. 811(h)(4), requires the of opioid misuse and abuse, the handle (manufacture, distribute, reverse Administrator to notify the Secretary of presence of new synthetic opioids with distribute, import, export, engage in the Department of Health and Human no approved medical use exacerbates research, conduct instructional Services (HHS) of his intention to the epidemic. The trafficking and abuse activities or chemical analysis, or temporarily place a substance in of new synthetic opioids are deadly new possess), or propose to handle 2 schedule I of the CSA. The Acting trends. isotonitazene. Administrator transmitted notice of his The identification of isotonitazene in intent to place isotonitazene in schedule DATES: June 18, 2020. the illicit drug market has been reported I on a temporary basis to the Assistant in Canada, Estonia, Germany, Latvia, FOR FURTHER INFORMATION CONTACT: Secretary for Health of HHS (Assistant Sweden, and the United States (see Scott A. Brinks, Regulatory Drafting and Secretary) by letter dated March 2, 2020. Factor 4 below). Data obtained from Policy Support Section, Diversion The Assistant Secretary responded to preclinical pharmacology studies show Control Division, Drug Enforcement this notice by letter dated March 31, that isotonitazene has the Administration; Mailing Address: 8701 2020, and advised that based on a pharmacological profile similar to that Morrissette Drive, Springfield, Virginia review by the Food and Drug of the potent synthetic opioid 22152; Telephone: (571) 362–3261. Administration (FDA), there are etonitazene, a schedule I controlled SUPPLEMENTARY INFORMATION: This currently no investigational new drug substance. Because of the document is issued pursuant to the applications (INDs) or approved new pharmacological similarities of temporary scheduling provisions of 21 drug applications (NDAs) for isotonitazene to etonitazene, the use of U.S.C. 811(h). The Drug Enforcement isotonitazene. The Assistant Secretary isotonitazene presents a high risk of Administration (DEA) intends to issue a also stated that HHS had no objection to abuse and may negatively affect users temporary scheduling order (in the form the temporary placement of and communities. The abuse of of a temporary amendment) to add isotonitazene in schedule I of the CSA. isotonitazene has been associated with isotonitazene to schedule I under the Isotonitazene is not currently listed in at least 19 fatalities in the United States Controlled Substances Act (CSA).1 The any schedule under the CSA, and no (see Factor 5 below). The positive temporary scheduling order will be exemptions or approvals are in effect for identification of this substance in post- published in the Federal Register on or isotonitazene under section 505 of the mortem cases is a serious concern for after July 20, 2020. FDCA, 21 U.S.C. 355. public safety. Thus, isotonitazene poses To find that placing a substance an imminent hazard to public safety. 1 Though DEA has used the term ‘‘final order’’ temporarily in schedule I of the CSA is Available data and information for with respect to temporary scheduling orders in the isotonitazene, as summarized below, past, this notice of intent adheres to the statutory 2 The Secretary of HHS has delegated to the language of 21 U.S.C. 811(h), which refers to a Assistant Secretary for Health of HHS the authority indicates that this substance has a high ‘‘temporary scheduling order.’’ No substantive to make domestic drug scheduling potential for abuse, no currently change is intended. recommendations. 58 FR 35460, July 1, 1993. accepted medical use in treatment in the VerDate Sep<11>2014 17:14 Jun 17, 2020 Jkt 250001 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 E:\FR\FM\18JNP1.SGM 18JNP1 36820 Federal Register / Vol. 85, No. 118 / Thursday, June 18, 2020 / Proposed Rules United States, and a lack of accepted 2019 and January 2020, four member (2); and U–47700, a schedule I safety for use under medical states (Estonia, Latvia, Germany, and substance (1). The average concentration supervision. DEA’s three-factor analysis Sweden) have reported 24 isotonitazene of isotonitazene in these biological is available in its entirety under cases involving 109.6 g of powder (22 samples (blood) was 2.2 ± 2.1 ‘‘Supporting and Related Material’’ of cases) and 4.5 g of liquid (two cases). nanogram/milliliter (ng/ml) (range 0.4 to the public docket for this action at Isotonitazene has been encountered by 9.5 ng/ml). Isotonitazene was detected www.regulations.gov under Docket US law enforcement primarily in as the only opioid in 50 percent (n = 9) Number DEA–631. powder form. In March 2020, Canada of the specimens for these decedents. law enforcement also encountered DEA is aware of another postmortem Factor 4. History and Current Pattern of isotonitazene in tablet form as a white case in Pennsylvania where Abuse triangular tablet with ‘M’ logo on one isotonitazene was identified in a The chemical syntheses of side and ‘8’ logo on the other side and biological sample. In total, isotonitazene isotonitazene (a benzimidazole as a blue tablet in Dilaudid counterfeit has been positively identified in 19 derivative) and other benzimidazole pills. Identification of isotonitazene in postmortem cases. derivatives (including schedule I counterfeit pills is deeply concerning Law enforcement data indicate that substances such as synthetic opioids because the identity, purity, and isotonitazene has appeared in the etonitazene and clonitazene) were first quantity of isotonitazene in this United States’ illicit drug market. reported in the scientific literature in formulation are uncertain, thus According to the National Forensic 1957. Isotonitazene is not an approved presenting additional safety concerns Laboratory Information System pharmaceutical product and is not for unsuspecting users. (NFLIS) 5 database, which collects drug approved for medical use anywhere in In the United States, isotonitazene has identification results from drug cases the world. As discussed in the been identified as a single substance or submitted to and analyzed by Federal, background section, the Assistant in combination with other substances. State and local forensic laboratories, Secretary stated in a March 31, 2020 In April 2019, the United States there have been eight encounters of letter to DEA that there are no INDs or Customs and Border Protection (CBP) isotonitazene in the United States FDA-approved NDAs for isotonitazene seized 1.6 grams of isotonitazene in (queried March 5, 2020).