Proposed Rule2021-26263
Schedules of Controlled Substances: Temporary Placement of Butonitazene, Etodesnitazene, Flunitazene, Metodesnitazene, Metonitazene, N-pyrrolidino etonitazene, and Protonitazene 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
December 7, 2021
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 seven 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 seven specified controlled substances.
Full Text
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<title>Federal Register, Volume 86 Issue 232 (Tuesday, December 7, 2021)</title>
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[Federal Register Volume 86, Number 232 (Tuesday, December 7, 2021)]
[Proposed Rules]
[Pages 69182-69187]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26263]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-900]
Schedules of Controlled Substances: Temporary Placement of
Butonitazene, Etodesnitazene, Flunitazene, Metodesnitazene,
Metonitazene, N-pyrrolidino etonitazene, and Protonitazene 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
seven 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 seven specified controlled substances.
DATES: December 7, 2021.
ADDRESSES: Drug Enforcement Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152.
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 seven 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> 2-(2-(4-butoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)-N,N-
diethylethan-1-amine (butonitazene),
<bullet> 2-(2-(4-ethoxybenzyl)-1H-benzimidazol-1-yl)-N,N-
diethylethan-1-amine (etodesnitazene; etazene),
<bullet> N,N-diethyl-2-(2-(4-fluorobenzyl)-5-nitro-1H-benzimidazol-
1-yl)ethan-1-amine) (flunitazene),
<bullet> N,N-diethyl-2-(2-(4-methoxybenzyl)-1H-benzimidazol-1-
yl)ethan-1-amine (metodesnitazene),
<bullet> N,N-diethyl-2-(2-(4-methoxybenzyl)-5-nitro-1H-
[[Page 69183]]
benzimidazol-1-yl)ethan-1-amine (metonitazene),
<bullet> 2-(4-ethoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-
1H-benzimidazole (N-pyrrolidino etonitazene; etonitazepyne), and
<bullet> N,N-diethyl-2-(5-nitro-2-(4-propoxybenzyl)-1H-
benzimidazol-1-yl)ethan-1-amine (protonitazene).
The temporary scheduling order will be published in the Federal
Register on or after January 6, 2022.
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
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, 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 then-Acting
Administrator transmitted the required notice to the Assistant
Secretary for Health of HHS (Assistant Secretary),\2\ by letter dated
June 16, 2021, regarding butonitazene, etodesnitazene, flunitazene,
metodesnitazene, metonitazene, and protonitazene. In a subsequent
letter dated August 25, 2021, the Administrator transmitted the
required notice to the Assistant Secretary for N-pyrrolidino
etonitazene. The Assistant Secretary responded to these notices by
letters dated July 7 and September 10, 2021, and advised that based on
a review by the Food and Drug Administration (FDA), there are currently
no investigational new drug applications (IND) or approved new drug
applications (NDA) for butonitazene, etodesnitazene, flunitazene,
metodesnitazene, metonitazene, N-pyrrolidino etonitazene, and
protonitazene. The Assistant Secretary also stated that HHS had no
objection to the temporary placement of these substances in schedule I.
Butonitazene, etodesnitazene, flunitazene, metodesnitazene,
metonitazene, N-pyrrolidino etonitazene, and protonitazene 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 seven
benzimidazole-opioids.
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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 no accepted
safety for use under medical supervision. 21 U.S.C. 812(b)(1).
Seven Benzimidazole-Opioids: Butonitazene, Etodesnitazene, Flunitazene,
Metodesnitazene, Metonitazene, N-Pyrrolidino Etonitazene, and
Protonitazene
The United States currently is experiencing an opioid overdose
epidemic, and the presence of synthetic opioids in the illicit drug
market threatens to exacerbate this. The trafficking, continued
evolution, and abuse of new synthetic opioids are deadly trends posing
imminent hazards to public safety. Adverse health effects associated
with abuse of synthetic opioids and increased popularity of these
substances have been serious concerns in recent years. Butonitazene,
etodesnitazene, flunitazene, metodesnitazene, metonitazene, N-
pyrrolidino etonitazene, and protonitazene are synthetic opioids
recently identified on the illicit drug market in the United States.
Data obtained from preclinical pharmacology studies show that
butonitazene, etodesnitazene, flunitazene, metodesnitazene,
metonitazene, N-pyrrolidino etonitazene, and protonitazene have
pharmacological profiles similar to those of the potent benzimidazole-
opioids etonitazene and isotonitazene, both schedule I controlled
substances. Because of their pharmacological similarities, use of these
seven benzimidazole-opioid substances presents a high risk of abuse and
may negatively affect users and communities. They have been identified
in at least 44 toxicology and post-mortem cases in the United States
between November 2020 and July 2021. Specifically, butonitazene has
been identified in one case, etodesnitazene in five cases, flunitazene
in four cases, metodesnitazene in one case, metonitazene in twenty
cases, N-pyrrolidino etonitazene in eight cases, and protonitazene in
five cases, which together create serious public safety concerns.
Available data and information for butonitazene, etodesnitazene,
flunitazene, metodesnitazene, metonitazene, N-pyrrolidino etonitazene,
and protonitazene, summarized below, indicate that these substances
have high potential for abuse, no currently accepted medical use in
treatment in the United States, and 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-
900.
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
benzimidazole derivatives with analgesic properties; however, the
research did not lead to any medically approved analgesic products.
These benzimidazole derivatives include schedule I substances such as
synthetic opioids clonitazene, etonitazene, and isotonitazene. In 2019,
isotonitazene emerged on the illicit drug market and was involved in
numerous fatal overdose events. In August 2020, DEA temporarily
controlled it as a schedule I substance under the CSA (85 FR 51342).
[[Page 69184]]
Subsequently, the benzimidazole-opioids at issue here have emerged
on the illicit drug market. Law enforcement agencies have encountered
etodesnitazene, flunitazene, metonitazene, and protonitazene in several
solid (e.g., powder and rock) and liquid forms. These substances are
not approved for medical use anywhere in the world. The Assistant
Secretary, by letters dated July 7 and September 10, 2021, informed DEA
that there are no FDA-approved NDAs or INDs for them in the United
States. Hence, there are no legitimate channels for these substances as
marketed drug products. Their appearance on the illicit drug market is
similar to other synthetic opioids trafficked for their psychoactive
effects. These seven opioid substances are likely to be abused in the
same manner as schedule I opioids such as etonitazene, isotonitazene,
and heroin. They have been identified as white to beige powders or in
liquid forms, typically of unknown purity or concentration.
In 2020 and 2021, butonitazene, etodesnitazene, flunitazene,
metodesnitazene, metonitazene, and protonitazene emerged on the illicit
synthetic drug market as evidenced by their identification in forensic
drug seizures or biological samples. In July 2020, metonitazene was
first reported seized as a white powdery substance in a North Carolina
case. Based on data from the National Forensic Laboratory Information
System (NFLIS),\3\ law enforcement often encounters etodesnitazene,
flunitazene, metonitazene, and protonitazene in mixtures. Substances
found in combination with some of these benzimidazole-opioids include
cutting agents (caffeine, xylazine, etc.) or other substances of abuse
such as heroin, fentanyl (schedule II), fentanyl analogs, and tramadol
(schedule IV).
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\3\ NFLIS represents an important resource in monitoring illicit
drug trafficking, including the diversion of legally manufactured
pharmaceuticals into illegal markets. NFLIS is a comprehensive
information system that includes data from forensic laboratories
that handle more than 96% of an estimated 1.0 million distinct
annual state and local drug analysis cases. 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.
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In the United States, butonitazene, etodesnitazene, flunitazene,
metonitazene, N-pyrrolidino etonitazene, and protonitazene have been
identified alone or in combination with other substances such as
designer benzodiazepines and fentanyl (see Factors 5 and 6). Evidence
suggests that individuals are using these substances as a replacement
for other opioids, either knowingly or unknowingly. Information
gathered from case histories and autopsy findings show that deaths
involving metonitazene were similar to those of opioid-related deaths.
Identified material or paraphernalia from death-scene investigations
also were consistent with opioid use. The seven substances are likely
to be abused in the same manner as schedule I opioids such as
isotonitazene and heroin.
Factor 5. Scope, Duration, and Significance of Abuse
The subject substances have been described as synthetic opioids,
and evidence suggests they are abused for their opioidergic effects
(see Factor 6). Their abuse has resulted in their identification in
toxicology and post-mortem cases. Between January and February of 2021,
metonitazene has been positively identified in 20 forensic post-mortem
cases from seven different states: Tennessee (10), Illinois (5),
Florida (1), Iowa (1), Ohio (1), South Carolina (1), and Wisconsin (1).
Most (18) of the decedents were male, with ages ranging from 19 to 63
years and an average age of 41 years. Metonitazene was identified as
the sole drug detected in only three cases, and the only opioid in six
cases.
Detection of N-pyrrolidino etonitazene in a toxicology case first
was reported \4\ in May 2021. It has been identified in a total of
eight post-mortem cases from five different states (Colorado (1),
Florida (1), New York (1), Pennsylvania (1), and West Virginia (4))
between January and April 2021. The decedents' ages spanned their 20s
to 50s. N-Pyrrolidino etonitazene was the only drug of interest in one
of these cases. In the other cases, it was co-identified with designer
benzodiazepines (7), fentanyl (4), and methamphetamine (4). Data from
law enforcement encounters suggests that etodesnitazene, flunitazene,
metonitazene, and protonitazene are abused \5\ in the United States as
recreational drugs. Law enforcement encounters of etodesnitazene,
flunitazene, metonitazene, and protonitazene as reported to NFLIS
(Federal, State, and local laboratories) includes 270 exhibits since
2020 (queried 08/04/2021). NFLIS registered one encounter of
etodesnitazene from one state, five encounters of flunitazene from four
states, 262 encounters of metonitazene from eight states, and two
encounters of protonitazene from two states. Data from NFLIS show that
561.55 grams of metonitazene has been encountered by law enforcement
since 2020, and it was often suspected as heroin or fentanyl. This
suggests that metonitazene might be presented as a substitute for
heroin or fentanyl and likely abused in the same manner as either of
these substances. The lack of identification of butonitazene,
metodesnitazene, and N-pyrrolidino etonitazene in law enforcement
reports might be due to the rapid appearance of these benzimidazole-
opioids and under-reporting as forensic laboratories try to secure
reference standards for these substances. However, butonitazene,
metodesnitazene, and N-pyrrolidino etonitazene have been identified in
toxicology cases.
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\4\ Center for Forensic Science Research and Education. Public
Alert: New High Potency Synthetic Opioid N-Pyrrolidino Etonitazene
(Etonitazepyne) Linked to Overdoses across United States. June 17,
2021.
\5\ While law enforcement data are not direct evidence of abuse,
they can lead to an inference that drugs have been diverted and
abused. See 76 FR 77330, 77332, Dec. 12, 2011.
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The population likely to abuse these seven benzimidazole-opioids
appears to be the same as those abusing other opioid substances such as
heroin, tramadol, fentanyl, and other synthetic opioids. This is
evidenced by the types of other drugs co-identified in biological
samples and law enforcement encounters. Because abusers are likely to
obtain these substances through unregulated sources, their identity,
purity, and quantity are uncertain and likely to be 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 2019, an estimated 10.1 million people
aged 12 years or older misused opioids in the past year, including 9.7
million prescription pain reliever misusers and 745,000 heroin users.
In 2019, an estimated 1.6 million people had an opioid use disorder,
including 1.4 million people with a
[[Page 69185]]
prescription pain reliever use disorder and 438,000 people with heroin
use disorder. This population likely is at risk of abusing
butonitazene, etodesnitazene, flunitazene, metodesnitazene,
metonitazene, N-pyrrolidino etonitazene, and protonitazene. 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 death similar to that of other opioid
analgesics (e.g., fentanyl, morphine, etc.). Law enforcement or
toxicology reports demonstrate that the seven substances at issue are
being distributed illicitly and abused.
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\6\ 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 non-medical 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 2019 NSDUH Annual
Report. (Last accessed July 26, 2021).
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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 butonitazene, etodesnitazene, flunitazene,
metodesnitazene, metonitazene, N-pyrrolidino etonitazene, and
protonitazene exhibit pharmacological profiles similar to that of
schedule I substances such as etonitazene, isotonitazene, and other mu-
opioid receptor agonists. These seven benzimidazole-opioids bind to and
act as agonists at the mu-opioid receptors. It is well established that
substances that act as mu-opioid receptor agonists have a high
potential for abuse and addiction and can induce dose-dependent
respiratory depression.
As with any mu-opioid receptor agonist, the potential health and
safety risks for users of butonitazene, etodesnitazene, flunitazene,
metodesnitazene, metonitazene, N-pyrrolidino etonitazene, and
protonitazene are high. Consistently, these substances have been
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 data, synthetic opioid-related
overdose deaths in the United States increased from 36,359 in 2019, to
56,688 in 2020 (CDC, 2021).\7\ Of the drug overdose death data (70,630)
for 2019, synthetic opioids were involved in about 51.4 percent
(36,359) of all drug-involved overdose deaths.
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\7\ 12 Month-ending Provisional Number of Drug Overdose Deaths.
Reported provisional data as of July 4, 2021. <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>.
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According to a recent publication, since November 2020, there has
been an increase in metonitazene-related adverse events, including
deaths.\8\ Metonitazene has been co-identified with other substances in
biological samples from 20 post-mortem cases from seven different
states: Florida (1), Illinois (5), Iowa (1), Ohio (1), South Carolina
(1), Tennessee (10), and Wisconsin (1). Information gathered from case
histories and autopsy findings show that deaths involving metonitazene
were similar to those of opioid-related deaths. Identified material or
paraphernalia from death-scene investigations were consistent with
opioid use. Reports obtained from autopsy findings showed that deaths
involving metonitazene presented pulmonary and cerebral edema, as well
as distended bladder and signs of intravenous drug use. Of the cases
for which death certificate data were available, metonitazene was
reported as a cause of death in four cases, of which three cases listed
metonitazene as the only cause.
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\8\ Krotulski AJ, Papsun DM, Walton SE, Logan BK. Metonitazene
in the United States-Forensic toxicology assessment of a potent new
synthetic opioid using liquid chromatography mass spectrometry. Drug
Test Anal. 2021 Jun 16. doi: 10.1002/dta.3115. Epub ahead of print.
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According to recent reports, butonitazene (1 instance),
etodesnitazene (5), flunitazene (4), metodesnitazene (1), metonitazene
(20), protonitazene (5), and N-pyrrolidino etonitazene (10) have been
identified in toxicology cases in the United States.\9\ For cases
involving N-pyrrolidino etonitazene, it was co-identified with fentanyl
in four cases and with novel benzodiazepines (e.g., flualprazolam,
etizolam, and clonazolam) in six others.
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\9\ Center for Forensic Science Research and Education. NPS
Opioids in the United States--Trend Report Q1 and Q2, 2021.
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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
butonitazene, etodesnitazene, flunitazene, metodesnitazene,
metonitazene, N-pyrrolidino etonitazene, and protonitazene 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 butonitazene, etodesnitazene, flunitazene,
metodesnitazene, metonitazene, N-pyrrolidino etonitazene, and
protonitazene indicate that these substances meet the three statutory
criteria. As required by 21 U.S.C. 811(h)(4), the then-Acting
Administrator transmitted to the Assistant Secretary for Health, via
letter dated June 16, 2021, notice of his intent to place butonitazene,
etodesnitazene, flunitazene, metodesnitazene, metonitazene, and
protonitazene in schedule I on a temporary basis. In a letter to the
Assistant Secretary for Health dated August 25, 2021, the Administrator
transmitted notice of her intent to place N-pyrrolidino etonitazene in
schedule I on a temporary basis.
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
butonitazene, etodesnitazene, flunitazene, metodesnitazene,
metonitazene, N-pyrrolidino etonitazene, and protonitazene 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 butonitazene, etodesnitazene,
flunitazene, metodesnitazene, metonitazene, N-pyrrolidino etonitazene,
and protonitazene in schedule I of the CSA will take effect pursuant to
a temporary scheduling order, which will not be issued before January
6, 2022. 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
[[Page 69186]]
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,
butonitazene, etodesnitazene, flunitazene, metodesnitazene,
metonitazene, N-pyrrolidino etonitazene, and protonitazene 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
determinations. 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), 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 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 for Health of HHS, 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). 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), 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.
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 classifies a
``significant regulatory action,'' requiring review by the Office of
Management and Budget, 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 E.O. 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
(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 paragraphs (h)(50) through (56) to read as
follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
[[Page 69187]]
(50) 2-(2-(4-butoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)-N,N- 9654
diethylethan-1-amine, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other name:
butonitazene)................................................
(51) 2-(2-(4-ethoxybenzyl)-1H-benzimidazol-1-yl)-N,N- 9665
diethylethan-1-amine, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other names:
etodesnitazene; etazene).....................................
(52) N,N-diethyl-2-(2-(4-fluorobenzyl)-5-nitro-1H-benzimidazol- 9656
1-yl)ethan-1-amine, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other name: flunitazene)
(53) N,N-diethyl-2-(2-(4-methoxybenzyl)-1H-benzimidazol-1- 9664
yl)ethan-1-amine, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other name:
metodesnitazene).............................................
(54) N,N-diethyl-2-(2-(4-methoxybenzyl)-5-nitro-1H- 9657
benzimidazol-1-yl)ethan-1-amine, its isomers, esters, ethers,
salts, and salts of isomers, esters and ethers (Other name:
metonitazene)................................................
(55) 2-(4-ethoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)- 9658
1H-benzimidazole, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other names: N-
pyrrolidino etonitazene; etonitazepyne)......................
(56) N,N-diethyl-2-(5-nitro-2-(4-propoxybenzyl)-1H- 9659
benzimidazol-1-yl)ethan-1-amine, its isomers, esters, ethers,
salts, and salts of isomers, esters and ethers (Other name:
protonitazene)...............................................
Anne Milgram,
Administrator.
[FR Doc. 2021-26263 Filed 12-6-21; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on December 7, 2021.
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