Proposed Rule2024-21058
Schedules of Controlled Substances: Temporary Placement of N-Pyrrolidino Metonitazene and N-Pyrrolidino Protonitazene in Schedule I
Primary source
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Published
September 17, 2024
Effective
September 17, 2024
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, N-pyrrolidino metonitazene and N-pyrrolidino protonitazene, 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 89 Issue 180 (Tuesday, September 17, 2024)</title>
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[Federal Register Volume 89, Number 180 (Tuesday, September 17, 2024)]
[Proposed Rules]
[Pages 75979-75984]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21058]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1337]
Schedules of Controlled Substances: Temporary Placement of N-
Pyrrolidino Metonitazene and N-Pyrrolidino Protonitazene in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Proposed amendment; notice of intent.
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[[Page 75980]]
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, N-pyrrolidino
metonitazene and N-pyrrolidino protonitazene, 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: This notice of intent is effective September 17, 2024.
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 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, 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-(4-methoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-
1H-benzimidazole (commonly known as, N-pyrrolidino metonitazene or
metonitazepyne), and
<bullet> 5-nitro-2-(4-propoxybenzyl)-1-(2-(pyrrolidin-1-yl)ethyl)-
1H-benzimidazole (commonly known as, N-pyrrolidino protonitazene or
protonitazepyne).
The temporary scheduling order will be published in the Federal
Register on or after October 17, 2024.
Legal Authority
Under 21 U.S.C. 811(h)(1), the CSA provides the Attorney General
(as delegated to the Administrator of DEA (Administrator) pursuant to
28 CFR 0.100) has the authority to temporarily place a substance in
schedule I of the CSA for two years without regard to the evaluation
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.\2\ 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.\3\
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\2\ 21 U.S.C. 811(h)(1).
\3\ 21 U.S.C. 811(h)(2).
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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, 21 U.S.C. 355.\4\
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\4\ 21 U.S.C. 811(h)(1); 21 CFR part 1308.
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Background
The CSA requires the Administrator to notify the Secretary of the
Department of Health and Human Services (HHS) of an intent to
temporarily place a substance in schedule I of the CSA (i.e., to issue
a temporary scheduling order).\5\ By letter dated December 15, 2023,
the Administrator transmitted the required notice to place N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene in schedule I
on a temporary basis to the Assistant Secretary for Health of HHS
(Assistant Secretary).\6\ On December 22, 2023, the Assistant Secretary
responded to this notice and advised DEA 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 N-pyrrolidino metonitazene or N-pyrrolidino
protonitazene. The Assistant Secretary also stated that HHS had no
objection to the temporary placement of these substances in schedule I
of the CSA. N-Pyrrolidino metonitazene and N-pyrrolidino 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
substances.
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\5\ 21 U.S.C. 811(h)(4).
\6\ 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.\7\ This consideration includes any
information indicating actual abuse, diversion from legitimate
channels, and clandestine importation, manufacture, or distribution of
N-Pyrrolidino metonitazene and N-pyrrolidino protonitazene.\8\
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\7\ 21 U.S.C. 811(h)(3).
\8\ 21 U.S.C. 811(h)(3).
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Substances meeting the statutory requirements for temporary
scheduling may only be placed in schedule I.\9\ Substances in schedule
I have high potential for abuse, no currently accepted medical use in
treatment in the United States,\10\ and a lack of accepted
[[Page 75981]]
safety for use under medical supervision.\11\
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\9\ 21 U.S.C. 811(h)(1).
\10\ When finding schedule I placement on a temporary basis is
necessary to avoid imminent hazard to the public, 21 U.S.C. 811(h)
does not require DEA to consider whether the substance has a
currently accepted medical use in treatment in the United States.
Nonetheless, there is no evidence suggesting that N-pyrrolidino
metonitazene or N-pyrrolidino protonitazene have a currently
accepted medical use in treatment in the United States. To determine
whether a drug or other substance has a currently accepted medical
use, DEA has traditionally applied a five-part test to a drug or
substance that has not been approved by the FDA: i. The drug's
chemistry must be known and reproducible; ii. there must be adequate
safety studies; iii. there must be adequate and well-controlled
studies proving efficacy; iv. the drug must be accepted by qualified
experts; and v. the scientific evidence must be widely available.
See Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR
10499 (Mar. 26, 1992), pet. for rev. denied, Alliance for Cannabis
Therapeutics v. Drug Enforcement Admin., 15 F.3d 1131, 1135 (D.C.
Cir. 1994). DEA and HHS applied the traditional five-part test for
currently accepted medical use in this matter. In a recent published
letter in a different context, HHS applied an additional two-part
test to determine currently accepted medical use for substances that
do not satisfy the five-part test: (1) whether there exists
widespread, current experience with medical use of the substance by
licensed health care providers operating in accordance with
implemented jurisdiction-authorized programs, where medical use is
recognized by entities that regulate the practice of medicine, and,
if so, (2) whether there exists some credible scientific support for
at least one of the medical conditions for which part (1) is
satisfied. On April 11, 2024, the Department of Justice's Office of
Legal Counsel (OLC) issued an opinion, which, among other things,
concluded that HHS's two-part test would be sufficient to establish
that a drug has a currently accepted medical use. Office of Legal
Counsel, Memorandum for Merrick B. Garland Attorney General Re:
Questions Related to the Potential Rescheduling of Marijuana at 3
(April 11, 2024). For purposes of this notice of intent, there is no
evidence that health care providers have widespread experience with
medical use of N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene or that the use of N-pyrrolidino metonitazene or N-
pyrrolidino protonitazene is recognized by entities that regulate
the practice of medicine under either the traditional five-part test
or the two-part test.
\11\ 21 U.S.C. 812(b)(1).
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Two Benzimidazole-Opioids: N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene
The continued encounter of novel synthetic opioids on the
recreational drug market poses a threat to public safety. 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 has a similar pharmacological profile
to fentanyl, morphine, and other mu-opioid receptor agonists. Between
August 2020 and March 2024, DEA temporarily controlled ten
benzimidazole-opioids because they posed a threat to public safety.\12\
N-Pyrrolidino metonitazene and N-pyrrolidino protonitazene are some of
the recently encountered ``nitazene'' synthetic opioids identified on
the illicit drug market.
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\12\ Schedules of Controlled Substances: Temporary Placement of
Butonitazene, Etodesnitazene, Flunitazene, Metodesnitazene,
Metonitazene, N-Pyrrolidino etonitazene, and Protonitazene in
Schedule I, 87 FR 21556 (Apr. 12, 2022); Schedules of Controlled
Substances: Temporary Placement of Isotonitazene in Schedule I, 85
FR 51342 (Aug. 20, 2020); Schedules of Controlled Substances:
Temporary Placement of N-Desethyl Isotonitazene and N-Piperidinyl
Etonitazene in Schedule I, 89 FR 60817 (Jul. 29, 2024).
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The continued trafficking and identification of benzimidazole-
opioids in toxicology cases poses 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-pyrrolidino
metonitazene and N-pyrrolidino protonitazene have pharmacological
profiles similar to those of the potent benzimidazole-opioids
metonitazene and protonitazene, schedule I opioid substances. N-
Pyrrolidino metonitazene and N-pyrrolidino protonitazene have been
positively identified in at least 26 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-pyrrolidino metonitazene and
N-pyrrolidino protonitazene, 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-1337.
Factor 4. History and Current Pattern of Abuse
Since 2019, there has been an emergence of benzimidazole-opioid
compounds on the illicit drug market, which have been positively
identified in numerous cases of fatal overdose events. The
benzimidazole-opioids were originally synthesized and studied in the
1950s by the pharmaceutical research laboratories of the Swiss chemical
company Chemical Industries Basel. The research produced 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.
In August 2020, isotonitazene was placed in schedule I of the CSA
(85 FR 51342). Subsequently, nine additional benzimidazole-opioids \13\
have been placed in schedule I of the CSA (87 FR 21556 and 89 FR
60817). Recently, N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene have emerged on the illicit drug market. Law enforcement
officers have encountered N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene 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 December 22, 2023, stated that there are no
FDA-approved NDAs or IND applications for N-pyrrolidino metonitazene
and N-pyrrolidino protonitazene in the United States; hence, there are
no legitimate channels for these substances as marketed drug products.
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\13\ Butonitazene, etodesnitazene, flunitazene, metodesnitazene,
metonitazene, N-pyrrolidino etonitazene, and protonitazene (87 FR
21556, Apr. 12, 2022). N-desethyl isotonitazene and N-piperidinyl
etonitazene (89 FR 60817, Jul. 29 2024).
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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 2023, N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene emerged on the illicit synthetic drug market as evidenced
by their identification in forensic drug seizures and in biological
samples.\14\ Based on NFLIS-Drug data, law enforcement encounters of N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene were found in
combination with other substances of abuse such as heroin, designer
benzodiazepines, cocaine, fentanyl, methamphetamine, and xylazine.
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\14\ NMS Labs, in collaboration with the Center for Forensic
Science Research and Education at the Fredric Rieders Family
Foundation and the Organized Crime Drug Enforcement Task Force at
the United States Department of Justice, has received funding from
the Centers for Disease Control and Prevention to develop systems
for the early identification and notification of novel psychoactive
substances in the drug supply within the United States.
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Factor 5. Scope, Duration and Significance of Abuse
N-Pyrrolidino metonitazene and N-pyrrolidino protonitazene, similar
to etonitazene, metonitazene and protonitazene (schedule I substances),
have been described as potent synthetic opioids, and evidence suggests
they are abused for their opioidergic effects (see Factor 6). The abuse
of these benzimidazole-opioids, similar to other synthetic opioids, has
resulted in serious adverse health effects. According to a public alert
report \15\ published in August 2023, N-pyrrolidino protonitazene has
been positively confirmed in 20 medicolegal death investigation cases
in the United States (n =16) and United Kingdom (n = 4). The cases that
occurred in the United States originated from seven States including
California, Illinois, Maine, Massachusetts, Minnesota, Wisconsin, and
Wyoming. N-Pyrrolidino metonitazene has been identified in six
toxicology cases as of June 2023 in the United States. The cases
occurred in at least three States including Ohio, Illinois, and West
Virginia.\16\
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\15\ Krotulski, AJ; Walton, SE; Papsun, DM; DeBord, J; Fogarty,
MF; Logan, BK. (2023) New Nitazene Analogue N-Pyrrolidino
Protonitazene Impacting Drug Markets In North America and Europe,
Center for Forensic Science Research and Education, United States.
CSFRE Public Alert. August 2023.
\16\ Krotulski, AJ; Horton, KB; Walton, SE; Papsun, DM; DeBord,
J; Fogarty, MF; Logan, BK. (2023) N-Pyrrolidino Metonitazene--NPS
Discovery New Drug Monograph, Center for Forensic Science Research
and Education, United States.
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Data from law enforcement suggest that N-pyrrolidino metonitazene
and N-
[[Page 75982]]
pyrrolidino protonitazene are being abused in the United States as
recreational drugs.\17\ Since 2023, there have been 37 exhibits
reported to the NFLIS-Drug (Federal, State and local laboratories)
database pertaining to the trafficking, distribution, and abuse of
these substances. There were seven encounters of N-pyrrolidino
metonitazene from two States in NFLIS-Drug: Missouri (n = 2) and Ohio
(n = 5). N-Pyrrolidino protonitazene has been identified in 30 exhibits
in NFLIS-Drug from five States: Florida (n = 4), Iowa (n = 10),
Missouri (n = 1), Ohio (n = 13), and Texas (n = 2).\18\
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\17\ While law enforcement data are not direct evidence of
abuse, they can lead to an inference that a drug has been diverted
and abused. See 76 FR 77330, 77332 (Dec. 12, 2011).
\18\ NFLIS-Drug was queried on July 17, 2024.
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Because abusers of N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene 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.\19\ 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,
an overdose event, or death, similar to that of other opioid analgesics
(e.g., fentanyl, morphine, etc.). Law enforcement and toxicology
reports demonstrate that N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene are being illicitly distributed and abused.
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\19\ Jones CM, Logan J, Gladden RM, Bohm MK. Vital Signs:
Demographic and Substance Use Trends Among Heroin Users--United
States, 2002-2013. MMWR Morb Mortal Wkly Rep. 2015 Jul
10;64(26):719-25.
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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-pyrrolidino metonitazene and N-pyrrolidino
protonitazene exhibit pharmacological profiles similar to that of
etonitazene, metonitazene, protonitazene, and other mu-opioid receptor
agonists. These two benzimidazole-opioids bind to and act as agonists
at the mu-opioid receptors.\20\ 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.\21\
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\20\ DEA-VA Interagency Agreement. ``In Vitro Receptor and
Transporter Assays for Abuse Liability Testing for the DEA by the
VA''. Binding and Functional Activity at Delta, Kappa and Mu Opioid
Receptors. 2022.
\21\ Fox LM, Hoffman RS, Vlahov D, Manini AF. Risk factors for
severe respiratory depression from prescription opioid overdose.
Addiction. 2018 Jan;113(1):59-66.
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Consistent with any mu-opioid receptor agonist, the potential
health and safety risks for users of N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene are high. N-Pyrrolidino metonitazene and N-
pyrrolidino protonitazene have been positively identified in forensic
toxicology and post mortem cases. According to a public alert, N-
pyrrolidino protonitazene has been positively identified in 20
medicolegal death investigations in the United States and United
Kingdom as of August 2023. Of the cases, 16 occurred across seven
States in the United States. Decedent ages ranged from mid-20s to mid-
70s. N-Pyrrolidino protonitazene was co-identified with additional
novel psychoactive substances (70 percent), quinine (60 percent), other
benzimidazole-opioids (55 percent), methamphetamine/cocaine (55
percent), fentanyl (55 percent), xylazine (35 percent) and designer
benzodiazepines (30 percent).\22\ Also, N-pyrrolidino metonitazene has
been identified in six toxicology cases in the United States as of June
2023. The introduction of potent synthetic opioids such as N-
pyrrolidino metonitazene and N-pyrrolidino protonitazene into the
illicit market may serve as a portal to problematic opioid use for
those seeking these powerful opioids. As documented by toxicology
reports, polysubstance abuse remains common in fatalities associated
with the abuse of some of these benzimidazole-opioids.
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\22\ Krotulski, AJ; Walton, SE; Papsun, DM; DeBord, J; Fogarty,
MF; Logan, BK. (2023) New Nitazene Analogue N-Pyrrolidino
Protonitazene Impacting Drug Markets In North America and Europe,
Center for Forensic Science Research and Education, United States.
CSFRE Public Alert. August 2023.
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The United States is currently experiencing an opioid epidemic, and
the presence of synthetic opioids on the illicit drug market further
exacerbates the problem. The trafficking and abuse of new synthetic
opioids are deadly trends which pose imminent hazard to the public
safety. Adverse health effects associated with the abuse of synthetic
opioids and the continued evolution and increased popularity of these
substances have been a serious concern in recent years. Because of the
pharmacological similarities of N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene to metonitazene and protonitazene, the use of
these substances presents high risk of abuse and may negatively affect
users and communities. The positive identification of these substances
in toxicology cases is of serious concern to the public safety. Thus,
N-pyrrolidino metonitazene and N-pyrrolidino protonitazene pose
imminent hazard to public safety.
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-
pyrrolidino metonitazene and N-pyrrolidino 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 N-pyrrolidino metonitazene and N-pyrrolidino
protonitazene 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 December 15,
2023, notice of her intent to place N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene 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-
pyrrolidino metonitazene and N-pyrrolidino 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.
[[Page 75983]]
The temporary placement of N-pyrrolidino metonitazene and N-
pyrrolidino protonitazene in schedule I of the CSA will take effect
pursuant to a temporary scheduling order, which will not be issued
before October 17, 2024. 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.\23\ 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-pyrrolidino metonitazene and N-
pyrrolidino 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.
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\23\ 21 U.S.C. 811(h)(1) and (2).
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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.\24\ 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.\25\
Temporary scheduling orders are not subject to judicial review.\26\
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\24\ 21 U.S.C. 811.
\25\ 21 U.S.C. 877.
\26\ 21 U.S.C. 811(h)(6).
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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 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.\27\
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\27\ 21 U.S.C. 811(h)(1).
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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.'' \28\ (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.
---------------------------------------------------------------------------
\28\ 5 U.S.C. 551(6).
---------------------------------------------------------------------------
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 (RFA).
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 RFA 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:
[[Page 75984]]
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)(70) and (71) to read as
follows:
Sec. 1308.11 Schedule I
* * * * *
(h) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(70) 2-(4-methoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)- 9762
1H-benzimidazole, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other names: N-
pyrrolidino metonitazene; metonitazepyne).....................
(71) 5-nitro-2-(4-propoxybenzyl)-1-(2-(pyrrolidin-1-yl)ethyl)- 9763
1H-benzimidazole, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other names: N-
pyrrolidino protonitazene; protonitazepyne)...................
------------------------------------------------------------------------
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 11, 2024, 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. 2024-21058 Filed 9-16-24; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on September 17, 2024.
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