Schedules of Controlled Substances: Temporary Placement of Isotonitazene in Schedule I

Published date18 June 2020
Citation85 FR 36819
Record Number2020-12304
SectionProposed rules
CourtDrug Enforcement Administration
Federal Register, Volume 85 Issue 118 (Thursday, June 18, 2020)
[Federal Register Volume 85, Number 118 (Thursday, June 18, 2020)]
                [Proposed Rules]
                [Pages 36819-36823]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-12304]
                [[Page 36819]]
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                DEPARTMENT OF JUSTICE
                Drug Enforcement Administration
                21 CFR Part 1308
                [Docket No. DEA-631]
                Schedules of Controlled Substances: Temporary Placement of
                Isotonitazene in Schedule I
                AGENCY: Drug Enforcement Administration, Department of Justice.
                ACTION: Proposed amendment; notice of intent.
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                SUMMARY: The Acting Administrator of the Drug Enforcement
                Administration is issuing this notice of intent to publish a temporary
                order to schedule N,N-diethyl-2-(2-(4 isopropoxybenzyl)-5-nitro-1H-
                benzimidazol-1-yl)ethan-1-amine (commonly known as isotonitazene),
                including its isomers, esters, ethers, salts, and salts of isomers,
                esters, and ethers whenever the existence of such isomers, esters,
                ethers, and salts is possible, in schedule I of the Controlled
                Substances Act. When it is issued, the temporary scheduling order will
                impose the regulatory controls and administrative, civil, and criminal
                sanctions applicable to schedule I controlled substances on persons who
                handle (manufacture, distribute, reverse distribute, import, export,
                engage in research, conduct instructional activities or chemical
                analysis, or possess), or propose to handle isotonitazene.
                DATES: June 18, 2020.
                FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
                and Policy Support Section, Diversion Control Division, Drug
                Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
                Springfield, Virginia 22152; Telephone: (571) 362-3261.
                SUPPLEMENTARY INFORMATION: This document is issued pursuant to the
                temporary scheduling provisions of 21 U.S.C. 811(h). The Drug
                Enforcement Administration (DEA) intends to issue a temporary
                scheduling order (in the form of a temporary amendment) to add
                isotonitazene to schedule I under the Controlled Substances Act
                (CSA).\1\ The temporary scheduling order will be published in the
                Federal Register on or after July 20, 2020.
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                 \1\ Though DEA has used the term ``final order'' with respect to
                temporary scheduling orders in the past, this notice of intent
                adheres to the statutory language of 21 U.S.C. 811(h), which refers
                to a ``temporary scheduling order.'' No substantive change is
                intended.
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                Legal Authority
                 Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney
                General with the authority to temporarily place a substance in schedule
                I of the CSA for two years without regard to the requirements of 21
                U.S.C. 811(b), if he finds that such action is necessary to avoid an
                imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition,
                if proceedings to control a substance are initiated under 21 U.S.C.
                811(a)(1) while the substance is temporarily controlled under section
                811(h), the Attorney General may extend the temporary scheduling for up
                to one year. 21 U.S.C. 811(h)(2).
                 Where the necessary findings are made, a substance may be
                temporarily scheduled if it is not listed in any other schedule under
                section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or
                approval in effect for the substance under section 505 of the Federal
                Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C.
                811(h)(1); 21 CFR part 1308. The Attorney General has delegated
                scheduling authority under 21 U.S.C. 811 to the Administrator of DEA
                (Administrator). 28 CFR 0.100.
                Background
                 Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the
                Administrator to notify the Secretary of the Department of Health and
                Human Services (HHS) of his intention to temporarily place a substance
                in schedule I of the CSA.\2\ The Acting Administrator transmitted
                notice of his intent to place isotonitazene in schedule I on a
                temporary basis to the Assistant Secretary for Health of HHS (Assistant
                Secretary) by letter dated March 2, 2020. The Assistant Secretary
                responded to this notice by letter dated March 31, 2020, and advised
                that based on a review by the Food and Drug Administration (FDA), there
                are currently no investigational new drug applications (INDs) or
                approved new drug applications (NDAs) for isotonitazene. The Assistant
                Secretary also stated that HHS had no objection to the temporary
                placement of isotonitazene in schedule I of the CSA. Isotonitazene is
                not currently listed in any schedule under the CSA, and no exemptions
                or approvals are in effect for isotonitazene under section 505 of the
                FDCA, 21 U.S.C. 355.
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                 \2\ The Secretary of HHS has delegated to the Assistant
                Secretary for Health of HHS the authority to make domestic drug
                scheduling recommendations. 58 FR 35460, July 1, 1993.
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                 To find that placing a substance temporarily in schedule I of the
                CSA is necessary to avoid an imminent hazard to the public safety, the
                Administrator is required to consider three of the eight factors set
                forth in 21 U.S.C. 811(c): The substance's history and current pattern
                of abuse; the scope, duration and significance of abuse; and what, if
                any, risk there is to the public health. 21 U.S.C. 811(h)(3).
                Consideration of these factors includes actual abuse, diversion from
                legitimate channels, and clandestine importation, manufacture, or
                distribution. 21 U.S.C. 811(h)(3).
                 A substance meeting the statutory requirements for temporary
                scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1).
                Substances in schedule I are those that have a high potential for
                abuse, no currently accepted medical use in treatment in the United
                States, and a lack of accepted safety for use under medical
                supervision. 21 U.S.C. 812(b)(1).
                Isotonitazene
                 The availability of synthetic opioids in the illicit drug market
                continues to pose an imminent hazard to the public safety. Adverse
                health effects associated with the abuse of synthetic opioids and the
                continued evolution and increased popularity of these substances have
                been a serious concern in recent years. As the United States continues
                to experience an unprecedented epidemic of opioid misuse and abuse, the
                presence of new synthetic opioids with no approved medical use
                exacerbates the epidemic. The trafficking and abuse of new synthetic
                opioids are deadly new trends.
                 The identification of isotonitazene in the illicit drug market has
                been reported in Canada, Estonia, Germany, Latvia, Sweden, and the
                United States (see Factor 4 below). Data obtained from preclinical
                pharmacology studies show that isotonitazene has the pharmacological
                profile similar to that of the potent synthetic opioid etonitazene, a
                schedule I controlled substance. Because of the pharmacological
                similarities of isotonitazene to etonitazene, the use of isotonitazene
                presents a high risk of abuse and may negatively affect users and
                communities. The abuse of isotonitazene has been associated with at
                least 19 fatalities in the United States (see Factor 5 below). The
                positive identification of this substance in post-mortem cases is a
                serious concern for public safety. Thus, isotonitazene poses an
                imminent hazard to public safety.
                 Available data and information for isotonitazene, as summarized
                below, indicates that this substance has a high potential for abuse, no
                currently accepted medical use in treatment in the
                [[Page 36820]]
                United States, and a lack of accepted safety for use under medical
                supervision. DEA's three-factor analysis is available in its entirety
                under ``Supporting and Related Material'' of the public docket for this
                action at www.regulations.gov under Docket Number DEA-631.
                Factor 4. History and Current Pattern of Abuse
                 The chemical syntheses of isotonitazene (a benzimidazole
                derivative) and other benzimidazole derivatives (including schedule I
                substances such as synthetic opioids etonitazene and clonitazene) were
                first reported in the scientific literature in 1957. Isotonitazene is
                not an approved pharmaceutical product and is not approved for medical
                use anywhere in the world. As discussed in the background section, the
                Assistant Secretary stated in a March 31, 2020 letter to DEA that there
                are no INDs or FDA-approved NDAs for isotonitazene in the United
                States. Hence, DEA notes there is no legitimate channel for
                isotonitazene as a marketed drug product.
                 Since 2014, numerous synthetic opioids structurally related to
                fentanyl and several opioids from other structural classes have begun
                to emerge in the illicit drug market as evidenced by the identification
                of these drugs in forensic drug exhibits and toxicology samples.
                Beginning in April 2019, isotonitazene emerged on the illicit synthetic
                drug market in the United States as evidenced by its identification in
                drug seizures and in biological samples collected and submitted to
                National Medical Services (NMS) Laboratory \3\ in August 2019. In
                August 2019, isotonitazene was first reported in a drug case in Belgium
                and toxicology casework in Canada (toxicological sample was collected
                in March 2019). In the United States, the Center for Forensic Science
                Research and Education (under the novel psychoactive substances
                discovery program) first reported isotonitazene in November 2019.
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                 \3\ NMS Labs, in collaboration with the Center for Forensic
                Science Research and Education at the Fredric Rieders Family
                Foundation and the Organized Crime Drug Enforcement Task Force at
                the U.S. Department of Justice, has received funding from the
                Centers for Disease Control and Prevention to develop systems for
                the early identification and notification of novel psychoactive
                substances in the drug supply within the United States.
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                 According to a report by the European Monitoring Center for Drugs
                and Drug addiction and Europol,\4\ between April 2019 and January 2020,
                four member states (Estonia, Latvia, Germany, and Sweden) have reported
                24 isotonitazene cases involving 109.6 g of powder (22 cases) and 4.5 g
                of liquid (two cases). Isotonitazene has been encountered by US law
                enforcement primarily in powder form. In March 2020, Canada law
                enforcement also encountered isotonitazene in tablet form as a white
                triangular tablet with `M' logo on one side and `8' logo on the other
                side and as a blue tablet in Dilaudid counterfeit pills. Identification
                of isotonitazene in counterfeit pills is deeply concerning because the
                identity, purity, and quantity of isotonitazene in this formulation are
                uncertain, thus presenting additional safety concerns for unsuspecting
                users.
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                 \4\ European Monitoring Centre for Drugs and Drug Addiction and
                Europol (2020), EMCDDA initial report on the new psychoactive
                substance N,N-diethyl-2-[[4-(1-methylethoxy)phenyl]methyl]-5-nitro-
                1H-benzimidazole-1-ethanamine (isotonitazene). In accordance with
                Article 5b of Regulation (EC) No. 1920/2006 (as amended),
                Publications Office of the European Union, Luxembourg.
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                 In the United States, isotonitazene has been identified as a single
                substance or in combination with other substances. In April 2019, the
                United States Customs and Border Protection (CBP) seized 1.6 grams of
                isotonitazene in California. In addition, Wisconsin State Crime
                Laboratories identified isotonitazene mixed with heroin and bromazolam,
                a nonscheduled benzodiazepine, in seized powder. Further, isotonitazene
                was identified in a substance obtained from the scene of a death
                investigation case in Iowa. Evidence suggests that individuals are
                using isotonitazene as a replacement to heroin or other opioids, either
                knowingly or unknowingly.
                Factor 5. Scope, Duration, and Significance of Abuse
                 Isotonitazene, similar to etonitazene (schedule I), has been
                described as a potent synthetic opioid and evidence suggests it is
                being abused for its opioidergic effects (see Factor 6). The abuse of
                isotonitazene, similar to other synthetic opioids, has resulted in
                adverse health effects. Isotonitazene has been positively identified in
                18 death investigation cases spanning between August 2019 and January
                2020. These reports were from four states--Illinois (9), Indiana (7),
                Minnesota (1), and Wisconsin (1). Most (n = 12) of the decedents were
                male. The ages ranged from 24 to 66 years old with an average age of
                41. Other substances identified in postmortem blood specimens obtained
                from these decedents include etizolam (6); flualprazolam, a
                nonscheduled benzodiazepine (7); fentanyl (6); heroin (3); tramadol, a
                schedule IV substance (2); and U-47700, a schedule I substance (1). The
                average concentration of isotonitazene in these biological samples
                (blood) was 2.2 2.1 nanogram/milliliter (ng/ml) (range 0.4
                to 9.5 ng/ml). Isotonitazene was detected as the only opioid in 50
                percent (n = 9) of the specimens for these decedents. DEA is aware of
                another postmortem case in Pennsylvania where isotonitazene was
                identified in a biological sample. In total, isotonitazene has been
                positively identified in 19 postmortem cases.
                 Law enforcement data indicate that isotonitazene has appeared in
                the United States' illicit drug market. According to the National
                Forensic Laboratory Information System (NFLIS) \5\ database, which
                collects drug identification results from drug cases submitted to and
                analyzed by Federal, State and local forensic laboratories, there have
                been eight encounters of isotonitazene in the United States (queried
                March 5, 2020). These eight encounters were in 2019 and in two states,
                Tennessee (7) and California (1). One of these encounters consisted of
                1.6 grams of isotonitazene seized by the CBP in California in April
                2019.
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                 \5\ NFLIS represents an important resource in monitoring illicit
                drug trafficking, including the diversion of legally manufactured
                pharmaceuticals into illegal markets. NFLIS-Drug is a comprehensive
                information system that includes data from forensic laboratories
                that handle the nation's drug analysis cases. NFLIS-Drug
                participation rate, defined as the percentage of the national drug
                caseload represented by laboratories that have joined NFLIS, is
                currently 98.5 percent. NFLIS includes drug chemistry results from
                completed analyses only. While NFLIS data is not direct evidence of
                abuse, it can lead to an inference that a drug has been diverted and
                abused. See 76 FR 77330, 77332, Dec. 12, 2011. NFLIS data was
                queried on March 5, 2020.
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                 The population likely to abuse isotonitazene appears to be the same
                as those abusing prescription opioid analgesics, heroin, tramadol,
                fentanyl, and other synthetic opioid substances. This is evidenced by
                the types of other drugs co-identified in isotonitazene fatal overdose
                cases. Because abusers of isotonitazene are likely to obtain it through
                unregulated sources, the identity, purity, and quantity are uncertain
                and inconsistent, thus posing significant adverse health risks to the
                end user. The misuse and abuse of opioids have been demonstrated and
                are well characterized. According to the most recent data from the
                National Survey on Drug Use and Health (NSDUH),\6\ as of 2018, an
                estimated 10.3
                [[Page 36821]]
                million people aged 12 years or older had misused opioids in the past
                year, including 9.9 million prescription pain reliever misusers and
                808,000 heroin users. In 2018, an estimated 2.0 million people had an
                opioid use disorder which included 1.7 million people with a
                prescription pain reliever use disorder and 0.5 million people with
                heroin use disorder. This population abusing opioids is likely to be at
                risk of abusing isotonitazene. Individuals who initiate (i.e., use a
                drug for the first time) use of isotonitazene are likely to be at risk
                of developing substance use disorder, overdose, and death similar to
                that of other opioid analgesics (e.g., fentanyl, morphine, etc.). Law
                enforcement and toxicology reports demonstrate that isotonitazene is
                being illicitly distributed and abused.
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                 \6\ The National Survey on Drug Use and Health (NSDUH), formerly
                known as the National Household Survey on Drug Abuse (NHSDA), is
                conducted annually by HHS' Substance Abuse and Mental Health
                Services Administration (SAMHSA). It is the primary source of
                estimates of the prevalence and incidence of nonmedical use of
                pharmaceutical drugs, illicit drugs, alcohol, and tobacco use in the
                United States. The survey is based on a nationally representative
                sample of the civilian, non-institutionalized population 12 years of
                age and older. The survey excludes homeless people who do not use
                shelters, active military personnel, and residents of institutional
                group quarters such as jails and hospitals. The NSDUH provides
                yearly national and state level estimates of drug abuse, and
                includes prevalence estimates by lifetime (i.e., ever used), past
                year, and past month abuse or dependence. The 2018 NSDUH annual
                report is available at https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHNationalFindingsReport2018/NSDUHNationalFindingsReport2018.pdf (last accessed April 9, 2020).
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                Factor 6. What, if Any, Risk There Is to the Public Health
                 The increase in opioid overdose deaths in the United States has
                been exacerbated recently by the availability of potent synthetic
                opioids in the illicit drug market. Data obtained from pre-clinical
                studies demonstrate that isotonitazene exhibits a pharmacological
                profile similar to that of etonitazene and other mu-opioid receptor
                agonists. In an in vivo (in mice) study, isotonitazene was 500 times
                more potent than morphine as an analgesic in a tail-flick assay. The
                tail-flick assay is useful in evaluating antinociceptive effect. Data
                from in vitro studies showed that isotonitazene activated the mu-opioid
                receptor and acted as a mu-opioid receptor agonist. Isotonitazene,
                similar to hydromorphone and fentanyl, activated the mu-opioid receptor
                and acted as an agonist via interaction at the mu-opioid receptor with
                [beta]-arrestin-2, a regulatory protein, in a live cell-based receptor
                assay. Naloxone, an opioid receptor antagonist, blocked isotonitazene's
                activation of the mu-opioid receptor. Substances that act as an agonist
                at the mu-opioid receptors have a high potential for addiction and can
                induce dose-dependent respiratory depression.
                 As with any mu-opioid receptor agonist, the potential health and
                safety risks for users are high. The public health risks attendant to
                the abuse of heroin and other mu-opioid receptor agonists are well
                established and have resulted in large numbers of drug treatment
                admissions, emergency department visits, and fatal overdoses. According
                to the Centers for Disease Control and Prevention (CDC), opioids,
                mainly synthetic opioids other than methadone, are predominantly
                responsible for drug overdose deaths in recent years. A CDC report
                shows that from 2013 to 2018,\7\ opioid-related overdose deaths in the
                United States increased from 25,052 to 46,802. Of the drug overdose
                death data for 2018, opioids were involved in about 69.5 percent of all
                drug-involved overdose deaths.
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                 \7\ CDC--National Center for Health Statistics (NCHS), National
                Vital Statistics System, Mortality. NCHS Data Brief, Number 356,
                January 2020.
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                 Isotonitazene has been co-identified with other substances in 18
                postmortem cases and DEA is aware of an additional death case that
                occurred in January 2020 involving isotonitazene in the United States.
                These deaths associated with isotonitazene occurred in five states-
                Illinois (9), Indiana (7), Minnesota (1), Pennsylvania (1), and
                Wisconsin (1). Information gathered from case histories and autopsy
                findings shows that isotonitazene use is similar to that of classic
                opioid agonists. Evidence obtained from reported cases of death scenes
                suggests that isotonitazene, similar to heroin, can be used
                intravenously.\8\
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                 \8\ Krotulski AJ, Papsun DM, Kacinko SL, and Logan BK (2020).
                Isotonitazene Quantitation and Metabolite Discovery in Authentic
                Forensic Casework. Journal of Analytical Toxicology. [Epub ahead of
                print].
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                 The introduction of potent synthetic opioids such as isotonitazene
                into the illicit market is a portal to problematic opioid use for those
                seeking these powerful opioids. As documented by a published toxicology
                report, poly-substance abuse remains common in fatalities associated
                with the abuse of isotonitazene.\9\
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                 \9\ Id.
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                Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard
                to Public Safety
                 In accordance with 21 U.S.C. 811(h)(3), based on the available data
                and information summarized above, the uncontrolled manufacture,
                distribution, reverse distribution, importation, exportation, conduct
                of research and chemical analysis, possession, and abuse of
                isotonitazene pose an imminent hazard to the public safety. DEA is not
                aware of any currently accepted medical uses for isotonitazene in the
                United States. A substance meeting the statutory requirements for
                temporary scheduling, found in 21 U.S.C. 811(h)(1), may only be placed
                in schedule I. Substances in schedule I are those that have a high
                potential for abuse, no currently accepted medical use in treatment in
                the United States, and a lack of accepted safety for use under medical
                supervision. Available data and information for isotonitazene indicate
                that this substance has a high potential for abuse, no currently
                accepted medical use in treatment in the United States, and a lack of
                accepted safety for use under medical supervision. As required by 21
                U.S.C. 811(h)(4), the Acting Administrator, through a letter dated
                March 2, 2020, notified the Assistant Secretary for Health of DEA's
                intention to temporarily place isotonitazene in schedule I.
                Conclusion
                 This notice of intent provides the 30-day notice pursuant to 21
                U.S.C. 811(h)(1) of DEA's intent to issue a temporary scheduling order.
                In accordance with 21 U.S.C. 811(h)(1) and (3), the Acting
                Administrator considered available data and information, herein set
                forth the grounds for his determination that it is necessary to
                temporarily schedule isotonitazene in schedule I of the CSA, and finds
                that placement of this substance in schedule I of the CSA is necessary
                in order to avoid an imminent hazard to the public safety.
                 The temporary placement of isotonitazene in schedule I of the CSA
                will take effect pursuant to a temporary scheduling order, which will
                not be issued before July 20, 2020. Because the Acting Administrator
                hereby finds that it is necessary to temporarily place isotonitazene in
                schedule I to avoid an imminent hazard to the public safety, the
                temporary order scheduling this substance will be effective on the date
                the order is published in the Federal Register, and will be in effect
                for a period of two years, with a possible extension of one additional
                year, pending completion of the regular (permanent) scheduling process.
                21 U.S.C. 811(h)(1) and (2). It is the intention of the Acting
                Administrator to issue a temporary scheduling order as soon as possible
                after the expiration of 30 days from the date of publication of this
                document. Upon publication of the temporary order, isotonitazene will
                then be subject to the CSA's schedule I
                [[Page 36822]]
                regulatory controls and administrative, civil, and criminal sanctions
                applicable to the manufacture, distribution, reverse distribution,
                importation, exportation, research, conduct of instructional activities
                and chemical analysis, and possession.
                 The CSA sets forth specific criteria for scheduling a drug or other
                substance. Regular scheduling actions in accordance with 21 U.S.C.
                811(a) are subject to formal rulemaking procedures done ``on the record
                after opportunity for a hearing'' conducted pursuant to the provisions
                of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process
                of formal rulemaking affords interested parties with appropriate
                process and the government with any additional relevant information
                needed to make a determination. Final decisions that conclude the
                regular scheduling process of formal rulemaking are subject to judicial
                review. 21 U.S.C. 877. Temporary scheduling orders are not subject to
                judicial review. 21 U.S.C. 811(h)(6).
                Regulatory Analyses
                 21 U.S.C. 811(h) provides for a temporary scheduling action where
                such action is necessary to avoid an imminent hazard to the public
                safety. As provided in this subsection, the Attorney General may, by
                order, schedule a substance in schedule I on a temporary basis. Such an
                order may not be issued before the expiration of 30 days from: (1) The
                publication of a notice in the Federal Register of the intention to
                issue such order and the grounds upon which such order is to be issued,
                and (2) the date that notice of the proposed temporary scheduling order
                is transmitted to the Assistant Secretary of HHS. 21 U.S.C. 811(h)(1).
                 Inasmuch as 21 U.S.C. 811(h) directs that temporary scheduling
                actions be issued by order and sets forth the procedures by which such
                orders are to be issued, including the requirement of a publication in
                the Federal Register of a notice of intent, the notice-and-comment
                requirements of section 553 of the Administrative Procedure Act (APA),
                5 U.S.C. 553, do not apply to this Notice of Intent. The APA expressly
                differentiates between an order and a rule, as it defines an ``order''
                to mean a ``final disposition, whether affirmative, negative,
                injunctive, or declaratory in form, of an agency in a matter other than
                rule making.'' 5 U.S.C. 551(6) (emphasis added). The specific language
                chosen by Congress indicates an intention for DEA to proceed through
                the issuance of an order instead of proceeding by rulemaking. Given
                that Congress specifically requires the Attorney General to follow
                rulemaking procedures for other kinds of scheduling actions, see 21
                U.S.C. 811(a), it is noteworthy that, in 21 U.S.C. 811(h), Congress
                authorized the issuance of temporary scheduling actions by order rather
                than by rule.
                 In the alternative, even assuming that this notice of intent might
                be subject to section 553 of the APA, the Acting Administrator finds
                that there is good cause to forgo the notice-and-comment requirements
                of section 553, as any further delays in the process for issuance of
                temporary scheduling orders would be impracticable and contrary to the
                public interest in view of the manifest urgency to avoid an imminent
                hazard to the public safety.
                 Although DEA believes this notice of intent to issue a temporary
                scheduling order is not subject to the notice-and-comment requirements
                of section 553 of the APA, DEA notes that in accordance with 21 U.S.C.
                811(h)(4), the Acting Administrator took into consideration comments
                submitted by the Assistant Secretary in response to the notice that DEA
                transmitted to the Assistant Secretary pursuant to such subsection.
                 Further, DEA believes that this temporary scheduling action is not
                a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not
                subject to the requirements of the Regulatory Flexibility Act. The
                requirements for the preparation of an initial regulatory flexibility
                analysis in 5 U.S.C. 603(a) are not applicable where, as here, DEA is
                not required by section 553 of the APA or any other law to publish a
                general notice of proposed rulemaking.
                 In accordance with the principles of Executive Orders 12866, 13563,
                and 13771, this action is not a significant regulatory action.
                Executive Order 12866 directs agencies to assess all costs and benefits
                of available regulatory alternatives and, if regulation is necessary,
                to select regulatory approaches that maximize net benefits (including
                potential economic, environmental, public health, and safety effects;
                distributive impacts; and equity). Executive Order 13563 is
                supplemental to and reaffirms the principles, structures, and
                definitions governing regulatory review as established in Executive
                Order 12866. Executive Order 12866 classifies a ``significant
                regulatory action,'' requiring review by the Office of Management and
                Budget (OMB), as any regulatory action that is likely to result in a
                rule that may: (1) Have an annual effect on the economy of $100 million
                or more or adversely affect in a material way the economy; a sector of
                the economy; productivity; competition; jobs; the environment; public
                health or safety; or State, local, or tribal governments or
                communities; (2) create a serious inconsistency or otherwise interfere
                with an action taken or planned by another agency; (3) materially alter
                the budgetary impact of entitlements, grants, user fees, or loan
                programs, or the rights and obligations of recipients thereof; or (4)
                raise novel legal or policy issues arising out of legal mandates, the
                President's priorities, or the principles set forth in the Executive
                Order. Because this is not a rulemaking action, this is not a
                significant regulatory action as defined in Section 3(f) of Executive
                Order 12866. In addition, this action does not meet the definition of
                an Executive Order 13771 regulatory action, and the repeal and cost
                offset requirements of Executive Order 13771 have not been triggered.
                 This action will not have substantial direct effects on the States,
                on the relationship between the national government and the States, or
                on the distribution of power and responsibilities among the various
                levels of government. Therefore, in accordance with Executive Order
                13132 (Federalism), it is determined that this action does not have
                sufficient federalism implications to warrant the preparation of a
                Federalism Assessment.
                List of Subjects in 21 CFR Part 1308
                 Administrative practice and procedure, Drug traffic control,
                Reporting and recordkeeping requirements.
                 For the reasons set out above, DEA proposes to amend 21 CFR part
                1308 as follows:
                PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
                0
                1. The authority citation for part 1308 continues to read as follows:
                 Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
                noted.
                0
                2. In Sec. 1308.11, add paragraph (h)(48) to read as follows:
                Sec. 1308.11 Schedule I
                * * * * *
                 (h) * * *
                
                
                
                (48) N,N-diethyl-2-(2-(4 isopropoxybenzyl)-5-nitro-1H- 9614
                 benzimidazol-1-yl)ethan-1-amine, its isomers, esters, ethers,
                 salts and salts of isomers, esters and ethers (Other name:
                 Isotonitazene)...............................................
                
                [[Page 36823]]
                * * * * *
                Timothy J. Shea,
                Acting Administrator.
                [FR Doc. 2020-12304 Filed 6-17-20; 8:45 am]
                BILLING CODE 4410-09-P
                

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