Proposed Rule2023-23379
Schedules of Controlled Substances: Temporary Placement of N-Desethyl Isotonitazene and N-Piperidinyl Etonitazene in Schedule I
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 25, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 205 (Wednesday, October 25, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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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<bullet> N-ethyl-2-(2-(4-isopropoxybenzyl)-5-nitro-1H-benzimidazol-
1-yl)ethan-1-amine (commonly known as N-desethyl isotonitazene), and
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a> 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 (<a href="http://samhsa.gov">samhsa.gov</a>) (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.
<a href="https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm">https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm</a>. Accessed
January 24, 2023.
\12\ DAWN. Preliminary Findings from Drug-Related Emergency
Department Visits, 2021. Preliminary Findings from Drug-Related
Emergency Department Visits, 2021 (<a href="http://samhsa.gov">samhsa.gov</a>). 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
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</html>Indexed from Federal Register on October 25, 2023.
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