[Federal Register Volume 88, Number 205 (Wednesday, October 25, 2023)]
[Proposed Rules]
[Pages 73293-73297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23379]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-1143]


Schedules of Controlled Substances: Temporary Placement of N-
Desethyl Isotonitazene and N-Piperidinyl Etonitazene in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Proposed amendment; notice of intent.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this notice of intent to publish a temporary order to schedule 
two synthetic benzimidazole-opioid substances, including their 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 these two specified substances.

DATES: October 25, 2023.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical 
Evaluation Section, Diversion Control Division, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION: The notice of intent contained in 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 \1\ (in the form of a temporary 
amendment) to add the following two substances, including their 
isomers, esters, ethers, salts, and salts of isomers, esters, and 
ethers whenever the existence of such isomers, esters, ethers, and 
salts is possible, to schedule I under the Controlled Substances Act 
(CSA):
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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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     N-ethyl-2-(2-(4-isopropoxybenzyl)-5-nitro-1H-benzimidazol-
1-yl)ethan-1-amine (commonly known as N-desethyl isotonitazene), and
     2-(4-ethoxybenzyl)-5-nitro-1-(2-(piperidin-1-yl)ethyl)-1H-
benzimidazole (commonly known as either N-piperidinyl etonitazene or 
etonitazepipne).
    The temporary scheduling order will be published in the Federal 
Register on or after November 24, 2023.

Legal Authority

    The CSA provides the Attorney General (as delegated to the 
Administrator of DEA (Administrator) pursuant to 28 CFR 0.100) 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 
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,

[[Page 73294]]

21 U.S.C. 355. 21 U.S.C. 811(h)(1); 21 CFR part 1308.

Background

    The CSA requires the Administrator to notify the Secretary of the 
Department of Health and Human Services (HHS) of an intent to place a 
substance in schedule I of the CSA temporarily (i.e., to issue a 
temporary scheduling order). 21 U.S.C. 811(h)(4). The Administrator 
transmitted the required notice to the Assistant Secretary for Health 
of HHS (Assistant Secretary),\2\ by letter dated April 3, 2023, 
regarding N-desethyl isotonitazene and N-piperidinyl etonitazene. The 
Assistant Secretary responded to this notice by letter dated May 11, 
2023, 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 N-
desethyl isotonitazene and N-piperidinyl etonitazene. The Assistant 
Secretary also stated that HHS had no objection to the temporary 
placement of these substances in schedule I. N-Desethyl isotonitazene 
and N-piperidinyl etonitazene currently are not listed in any schedule 
under the CSA, and no exemptions or approvals under 21 U.S.C. 355 are 
in effect for these substances.
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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 temporarily placing a substance in schedule I of the 
CSA is necessary to avoid an imminent hazard to the public safety, the 
Administrator must 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). This consideration 
includes any information indicating actual abuse, diversion from 
legitimate channels, and clandestine importation, manufacture, or 
distribution of these substances. 21 U.S.C. 811(h)(3).
    Substances 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 have 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).

Two Benzimidazole-Opioids: N-Desethyl Isotonitazene and N-Piperidinyl 
Etonitazene

    The continued encounter of novel psychoactive substances (NPS) on 
the recreational drug market poses a threat to public safety. Following 
the class-wide scheduling of fentanyl-related substances, there has 
been an increase in the emergence of synthetic opioids that are not 
structurally related to fentanyl. Beginning in 2019, a new class of 
synthetic opioids known as benzimidazole-opioids, commonly referred to 
as ``nitazenes,'' emerged on the recreational drug market. This class 
of substances was first synthesized in the 1950s by CIBA 
Aktiengesellschaft in Switzerland, and it has a similar pharmacological 
profile to fentanyl, morphine, and other mu-opioid receptor agonists. 
Between August 2020 and April 2022, DEA temporarily controlled eight 
benzimidazole-opioids because they posed a threat to public safety. 87 
FR 21556 (Apr. 12, 2022); 85 FR 51342 (Aug. 20, 2020). Recently, 
additional benzimidazole-opioids have been identified within the 
rapidly expanding class of ``nitazene'' compounds on the recreational 
drug market. N-Desethyl isotonitazene and N-piperidinyl etonitazene are 
some of the recently encountered ``nitazene'' synthetic opioids 
identified on the illicit drug market.
    The continued trafficking and identification of benzimidazole-
opioids in toxicology cases pose a significant threat to public health 
and safety. Adverse health effects associated with the misuse and abuse 
of synthetic opioids have led to devastating consequences including 
death. Preclinical pharmacology data demonstrate that N-desethyl 
isotonitazene and N-piperidinyl etonitazene have pharmacological 
profiles similar to those of the potent benzimidazole-opioids 
etonitazene and isotonitazene, schedule I opioid substances. N-Desethyl 
isotonitazene, an active metabolite of isotonitazene, has been 
positively identified in postmortem cases that involved isotonitazene. 
N-Piperidinyl etonitazene has been positively identified in at least 
three toxicology cases. As the United States continues to experience a 
high number of opioid-involved overdoses and mortalities, the 
introduction of new designer opioids further exacerbates the current 
opioid epidemic.
    Available data and information for N-desethyl isotonitazene and N-
piperidinyl etonitazene, summarized below, indicate that these 
substances have high potentials for abuse, no currently accepted 
medical uses in treatment in the 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-1143.

Factor 4. History and Current Pattern of Abuse

    In the late 1950s, pharmaceutical research laboratories of the 
Swiss chemical company CIBA Aktiengesellschaft synthesized a group of 
structurally unique benzimidazole derivatives with analgesic 
properties; however, the research effort did not produce any medically 
approved analgesic products. These benzimidazole derivatives include 
schedule I substances, such as synthetic opioids clonitazene, 
etonitazene, and isotonitazene.
    Since 2019, there has been an emergence of nitazene compounds on 
the illicit drug market, which have been positively identified in 
numerous cases of fatal overdose events. In August 2020, isotonitazene 
was placed in schedule I of the CSA (85 FR 51342). Subsequently, seven 
additional benzimidazole-opioids \3\ have been placed in schedule I of 
the CSA (87 FR 21556).
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    \3\ Butonitazene, etodesnitazene, flunitazene, metodesnitazene, 
metonitazene, N-pyrrolidino etonitazene, and protonitazene
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    Recently, two additional benzimidazole-opioids have emerged on the 
illicit drug market. Law enforcement officers have encountered N-
desethyl isotonitazene and N-piperidinyl etonitazene in several solid 
forms (e.g., powder and tablets). These substances are not approved 
pharmaceutical products and are not approved for medical use anywhere 
in the world. The Assistant Secretary in a letter to DEA dated May 11, 
2023, stated that there are no FDA-approved NDAs or INDs for N-desethyl 
isotonitazene and N-piperidinyl etonitazene in the United States; 
hence, there are no legitimate channels for these substances as 
marketed drug products.
    The appearance of benzimidazole-opioids on the illicit drug market 
is similar to other designer opioid drugs that are trafficked for their 
psychoactive effects. These substances are likely to be abused in the 
same manner as schedule I opioids, such as etonitazene, isotonitazene, 
and heroin.
    In 2022, N-desethyl isotonitazene was identified in counterfeit 
tablets in the United States and United Kingdom. Recent reporting by 
Center for Forensic

[[Page 73295]]

Science Research and Education (CFSRE) indicates that in the United 
States, N-desethyl isotonitazene was identified in counterfeit 
oxycodone round blue tablets in Florida.\4\ Further, in December 2022, 
N-desethyl isotonitazene was identified in samples called ``dope'' in 
the Philadelphia drug supply. N-Desethyl isotonitazene was also co-
identified in ``dope'' samples containing xylazine, fentanyl, para-
fluorofentanyl, and designer benzodiazepines (e.g., flubromazepam and 
bromazolam).
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    \4\ CFSRE NPS Discovery Public Alert 2023. Case Example--N-
desethyl isotonitazene. January 2023.
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    In 2021, N-piperidinyl etonitazene emerged on the illicit synthetic 
drug market, as evidenced by its identification in toxicological 
analysis of biological samples.\5\ In addition, there have been 
encounters of N-piperidinyl etonitazene in Europe. As reported in 
January 2022 by the European Monitoring Center for Drugs and Drug 
Addiction (EMCDDA), the European Union Early Warning System Network 
identified N-piperidinyl etonitazene in Germany in October 2021. As of 
January 23, 2023, a total of four European countries have reported 
identifications of N-piperidinyl etonitazene in powder form to the 
EMCDDA.\6\
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    \5\ A partnership between the American College of Medical 
Toxicology (ACMT) and the Center for Forensic Science Research and 
Education (CFSRE) was established to comprehensively assess the role 
and prevalence of synthetic opioids and other drugs among suspected 
overdose events in the United States. CFSRE NPS Monograph. N-
Piperidinyl etonitazene. November 22, 2021.
    \6\ Email communication with EMCDDA dated January 23, 2023.
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Factor 5. Scope, Duration and Significance of Abuse

    N-Desethyl isotonitazene and N-piperidinyl etonitazene, similar to 
etonitazene and isotonitazene (schedule I substances), have been 
described as potent synthetic opioids, and evidence suggests they are 
abused for their opioidergic effects. The abuse of these benzimidazole-
opioids, similar to other synthetic opioids, has resulted in serious 
adverse health effects. Between October 2019 and January 2020, N-
desethyl isotonitazene was positively identified in 13 postmortem 
samples and 64 driving-under-the-influence-of-drugs (DUID) cases 
involving isotonitazene in the United States. Although, N-desethyl 
isotonitazene has only been identified as a metabolite of isotonitazene 
in toxicology cases, the pharmacological profile of this substance 
demonstrates it is a highly potent synthetic opioid similar to 
etonitazene, isotonitazene, and fentanyl. As such, the identification 
of this substance as a parent drug in the recreational drug market is 
worrisome.
    Data from law enforcement suggest that N-desethyl isotonitazene and 
N-piperidinyl etonitazene are being abused in the United States as 
recreational drugs.\7\ Since 2022, there have been three encounters 
reported to DEA's National Forensic Laboratory Information System 
(NFLIS)-Drug \8\ (Federal, State, and local laboratories) database 
pertaining to the trafficking, distribution, and abuse of N-desethyl 
isotonitazene. These three encounters of N-desethyl isotonitazene were 
reported to NFLIS-Drug from two states: Florida (2) and Kansas (1).
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    \7\ While law enforcement data are 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).
    \8\ NFLIS-Drug 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-
Drug, is currently 98.5 percent. NFLIS-Drug includes drug chemistry 
results from completed analyses only. While NFLIS-Drug 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. NFLIS-Drug 
data was queried on January 19, 2023.
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    Based on information collected from NFLIS-Drug, N-desethyl 
isotonitazene was identified in tablet form or as residue. Reporting 
from CFSRE show that N-desethyl isotonitazene was identified in a 
counterfeit oxycodone tablet in Florida,\9\ suggestive that it might be 
presented as a substitute for heroin or fentanyl and likely abused in 
the same manner as either of those substances.
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    \9\ CFSRE NPS Discovery Public Alert January 2023. Accessed 
January 25, 2023.
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    The lack of identification of N-piperidinyl etonitazene in NFLIS-
Drug may be due to the rapid appearance of these benzimidazole-opioids 
and under reporting as forensic laboratories try to secure reference 
standards for this substance. However, N-piperidinyl etonitazene has 
been positively identified in toxicology cases in the United States and 
encountered by law enforcement in Europe.
    The population likely to abuse these benzimidazole-opioids appears 
to be the same as those abusing prescription opioid analgesics, 
fentanyl, and other synthetic drugs. This is evidenced by the types of 
other drugs co-identified in biological samples and law enforcement 
encounters. Because abusers of N-desethyl isotonitazene and N-
piperidinyl etonitazene are likely to obtain these substances through 
unregulated sources, the identity, purity, and quantity of these 
substances 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),\10\ as of 2021, an estimated 9.2 million people aged 12 years 
or older misused opioids in the past year, including 8.7 million 
prescription pain reliever misusers and 1.1 million heroin users. In 
2021, an estimated 5.6 million people had an opioid use disorder in the 
past year, which included 5.0 million people with a prescription pain 
reliever use disorder and 1.0 million people with heroin use disorder. 
This population abusing opioids is likely to be at risk of abusing N-
desethyl isotonitazene and N-piperidinyl etonitazene. Individuals who 
initiate (i.e., use a drug for the first time) use of these 
benzimidazole-opioids are likely to be at risk of developing substance 
use disorder, overdose, and/or death, similar to that of other opioid 
analgesics (e.g., fentanyl, morphine, etc.). Law enforcement and 
toxicology reports demonstrate that N-desethyl isotonitazene and N-
piperidinyl etonitazene are being illicitly distributed and abused.
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    \10\ NSDUH, formerly known as the National Household Survey on 
Drug Abuse (NHSDA), is conducted annually by the Department of 
Health and Human Services' 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 2021 NSDUH annual 
report is available at Key Substance Use and Mental Health 
Indicators in the United States: Results from the 2021 National 
Survey on Drug Use and Health (samhsa.gov) (last accessed January 
24, 2023).
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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 on the illicit drug market. Data obtained from pre-clinical 
studies demonstrate that N-desethyl isotonitazene and N-piperidinyl 
etonitazene exhibit pharmacological profiles similar to that of 
etonitazene, isotonitazene, and other mu-opioid receptor agonists. 
These two

[[Page 73296]]

benzimidazole-opioids bind to and act as an agonist at the [micro]-
opioid receptors. It is well established that substances that act as 
mu-opioid receptor agonists have a high potential for addiction and can 
induce dose-dependent respiratory depression.
    Consistent with any mu-opioid receptor agonist, the potential 
health and safety risks for users of N-desethyl isotonitazene and N-
piperidinyl etonitazene are high. N-Desethyl isotonitazene and N-
piperidinyl etonitazene have been positively identified in toxicology 
cases. The public health risks attendant to the abuse of mu-opioid 
receptor agonists are well established. These risks include 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. According to CDC provisional data, synthetic opioid-
related overdose deaths in the United States increased from 57,834 in 
2020 to 71,238 in 2021.\11\ Overdose deaths involving opioids increased 
from an estimated 70,029 in 2020, to 80,816 in 2021. In 2021, according 
to Drug Abuse Warning Network (DAWN), preliminary findings indicate 
1.03 million drug-related emergency department visits involved opioids 
(fentanyl, heroin, and other opioid pain medications taken alone or in 
combination with other opioids and/or other drugs).\12\
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    \11\ 12 Month-ending August 2022 Provisional Number of Drug 
Overdose Deaths. Reported provisional data as of January 4, 2023. 
https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. Accessed 
January 24, 2023.
    \12\ DAWN. Preliminary Findings from Drug-Related Emergency 
Department Visits, 2021. Preliminary Findings from Drug-Related 
Emergency Department Visits, 2021 (samhsa.gov). Accessed January 25, 
2023.
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    N-Piperidinyl etonitazene was detected in suspected opioid overdose 
cases in three patients from New Jersey over a period of three days in 
July 2021. Of those patients, two reported the use of cocaine; one 
reported the use of heroin and alprazolam. Similarly, according to a 
2021 CFSRE report, N-piperidinyl etonitazene was co-identified with 
fentanyl in two cases and para-fluorofentanyl in one other case.\13\
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    \13\ NPS Discovery Program at the Center for Forensic Science 
Research and Education: Monograph. N-Piperidinyl etonitazene 
Toxicology Analytical Report. November 22, 2021.
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    Between October 2019 and January 2020, N-desethyl isotonitazene, an 
active metabolite of isotonitazene was identified in numerous 
toxicology cases involving isotonitazene. In DUID cases, N-desethyl 
isotonitazene was present in 64 samples containing isotonitazene and 
was found with isotonitazene in 13 postmortem samples. Although, N-
desethyl isotonitazene was only identified as a metabolite of 
isotonitazene in these cases, the pharmacological profile of this 
substance demonstrate that it is a highly potent synthetic opioid 
similar to etonitazene, isotonitazene, and fentanyl. As such, the 
identification of this substance as a parent drug in the recreational 
drug market is worrisome.

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 N-desethyl 
isotonitazene and N-piperidinyl etonitazene pose imminent hazards to 
public safety. DEA is not aware of any currently accepted medical uses 
for these substances 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 
must 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 N-
desethyl isotonitazene and N-piperidinyl etonitazene indicate that 
these substances meet the three statutory criteria. As required by 21 
U.S.C. 811(h)(4), the Administrator transmitted to the Assistant 
Secretary, via letter dated April 3, 2023, notice of her intent to 
place N-desethyl isotonitazene and N-piperidinyl etonitazene in 
schedule I on a temporary basis. HHS had no objection to the temporary 
placement of these substances 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 Administrator 
considered available data and information, herein set forth the grounds 
for her determination that it is necessary to temporarily schedule N-
desethyl isotonitazene and N-piperidinyl etonitazene in schedule I of 
the CSA, and finds that placement of these substances in schedule I is 
necessary to avoid an imminent hazard to the public safety.
    The temporary placement of N-desethyl isotonitazene and N-
piperidinyl etonitazene in schedule I of the CSA will take effect 
pursuant to a temporary scheduling order, which will not be issued 
before November 24, 2023. Because the Administrator hereby finds this 
temporary scheduling order necessary to avoid an imminent hazard to the 
public safety, it will take effect on the date the order is published 
in the Federal Register and remain in effect for two years, with a 
possible extension of one year, pending completion of the regular 
(permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2). The 
Administrator intends 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 the temporary order's publication, N-desethyl 
isotonitazene and N-piperidinyl etonitazene will then be subject to the 
CSA's schedule I regulatory controls and to administrative, civil, and 
criminal sanctions applicable to their manufacture, distribution, 
reverse distribution, importation, exportation, research, conduct of 
instructional activities and chemical analysis, and possession.
    The CSA sets forth specific criteria for scheduling drugs or other 
substances. Regular scheduling actions in accordance with 21 U.S.C. 
811(a) are subject to formal rulemaking procedures ``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 appropriate process and 
the government 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

    The CSA provides for expedited temporary scheduling actions where 
necessary to avoid an imminent hazard to the public safety. Under 21 
U.S.C. 811(h)(1), the Administrator, as delegated by the Attorney 
General, may, by order, temporarily place substances in schedule I. 
Such orders may not be issued before the expiration of 30 days from: 
(1) The publication of a notice in the Federal Register of the intent 
to

[[Page 73297]]

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, as delegated by the 
Secretary of HHS. 21 U.S.C. 811(h)(1).
    Inasmuch as section 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 to publish in the 
Federal Register 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 orders and rules, 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). This contrasts with 
permanent scheduling actions, which are subject to formal rulemaking 
procedures done ``on the record after opportunity for a hearing,'' and 
final decisions that conclude the scheduling process and are subject to 
judicial review. 21 U.S.C. 811(a) and 877. The specific language chosen 
by Congress indicates its intent that DEA issue orders instead of 
proceeding by rulemaking when temporarily scheduling substances. Given 
that Congress specifically requires the Administrator (as delegated by 
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 
section 811(h)(1), Congress authorized the issuance of temporary 
scheduling actions by order rather than by rule.
    Even assuming that this Notice of Intent is subject to section 553 
of the APA, the Administrator finds that there is good cause to forgo 
its notice-and-comment requirements, as any further delays in the 
process for issuing temporary scheduling orders would be impracticable 
and contrary to the public interest given 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 Administrator took into consideration comments submitted 
by the Assistant Secretary in response to the notices 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. As discussed above, DEA is 
issuing this notice of intent pursuant to DEA's authority to issue a 
temporary scheduling order. 21 U.S.C. 811(h)(1). Therefore, in this 
instance, since DEA believes this temporary scheduling action is not a 
``rule,'' it is not subject to the requirements of the Regulatory 
Flexibility Act when issuing this temporary action.
    In accordance with the principles of Executive Orders (E.O.) 12866 
and 13563, this action is not a significant regulatory action. E.O. 
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). E.O. 13563 is supplemental to and 
reaffirms the principles, structures, and definitions governing 
regulatory review as established in E.O. 12866. E.O. 12866, sec. 3(f), 
as amended by E.O. 14094, sec. 1(b), provides the definition of a 
``significant regulatory action,'' requiring review by the Office of 
Management and Budget. Because this is not a rulemaking action, this is 
not a significant regulatory action as defined in Section 3(f) of E.O. 
12866.
    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 E.O. 13132, 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 paragraphs (h)(62) and (63) to read as 
follows:


Sec.  1308.11  Schedule I

* * * * *
    (h) * * *

------------------------------------------------------------------------
 
------------------------------------------------------------------------
 
                              * * * * * * *
(62) N-ethyl-2-(2-(4-isopropoxybenzyl)-5-nitro-1H-                  9760
 benzimidazol-1-yl)ethan-1-amine, its isomers,
 esters, ethers, salts, and salts of isomers, esters
 and ethers (Other name: N-desethyl isotonitazene)...
(63) 2-(4-ethoxybenzyl)-5-nitro-1-(2-(piperidin-1-                  9761
 yl)ethyl)-1H-benzimidazole, its isomers, esters,
 ethers, salts, and salts of isomers, esters and
 ethers (Other names: N-piperidinyl etonitazene;
 etonitazepipne).....................................
------------------------------------------------------------------------

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
October 16, 2023, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-23379 Filed 10-24-23; 8:45 am]
BILLING CODE 4410-09-P