[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