Proposed Rule2022-27278
Schedules of Controlled Substances: Temporary Placement of Etizolam, Flualprazolam, Clonazolam, Flubromazolam, and Diclazepam 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 23, 2022
Effective
December 23, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Administrator of the Drug Enforcement Administration is providing this notice of intent to publish a temporary order to schedule five synthetic benzodiazepine substances, as identified in this notice, 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 with, or possess) or propose to handle these five specified controlled substances.
Full Text
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<title>Federal Register, Volume 87 Issue 246 (Friday, December 23, 2022)</title>
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[Federal Register Volume 87, Number 246 (Friday, December 23, 2022)]
[Proposed Rules]
[Pages 78887-78892]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27278]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-989]
Schedules of Controlled Substances: Temporary Placement of
Etizolam, Flualprazolam, Clonazolam, Flubromazolam, and Diclazepam 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
providing this notice of intent to publish a temporary order to
schedule five synthetic benzodiazepine substances, as identified in
this notice, 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 with, or possess)
or propose to handle these five specified controlled substances.
DATES: This notice of intent is effective December 23, 2022.
FOR FURTHER INFORMATION CONTACT: Dr. 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 five substances, including their salts,
isomers, and salts of isomers, whenever the existence of such salts,
isomers, and salts of isomers 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> 4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-thieno[3,2-
f][1,2,4]triazolo[4,3-a][1,4]diazepine (commonly known as etizolam),
<bullet> 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine (commonly known as
flualprazolam),
<bullet> 6-(2-chlorophenyl)-1-methyl-8-nitro-4H-
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine (commonly known as
clonazolam),
<bullet> 8-bromo-6-(2-fluorophenyl)-1-methyl-4H-
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine (alternate chemical name:
8-bromo-6-(2-fluorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-
a][1,4]benzodiazepine and commonly known as, flubromazolam), and
<bullet> 7-chloro-5-(2-chlorophenyl)-1-methyl-1,3-dihydro-2H-
benzo[e][1,4]diazepin-2-one (commonly known as diclazepam).
[[Page 78888]]
The temporary scheduling order will be published in the Federal
Register on or after January 23, 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
the Administrator 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 Administrator 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, 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 October 25, 2021,
regarding etizolam, flualprazolam, clonazolam, flubromazolam, and
diclazepam. The Assistant Secretary responded to this notice by a
letter dated January 3, 2022, 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 etizolam, flualprazolam, clonazolam,
flubromazolam, and diclazepam. The Assistant Secretary also stated that
HHS had no objection to the temporary placement of these substances in
schedule I. Etizolam, flualprazolam, clonazolam, flubromazolam, and
diclazepam 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
five benzodiazepine 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.
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).
Five Benzodiazepine Substances: Etizolam, Flualprazolam, Clonazolam,
Flubromazolam, and Diclazepam
The dramatic increase in trafficking and abuse associated with
novel psychoactive substances (NPS) of the benzodiazepine class in the
United States has become a national public health concern in recent
years. The availability of NPS benzodiazepine substances in the illicit
drug market continues to pose an imminent hazard to the public safety.
The Centers for Disease Control and Prevention (CDC) highlights this
issue in their Morbidity and Mortality Weekly Report (MMWR) published
on August 27, 2021.\3\ CDC indicated that, from April 2019 to June
2020, prescription and illicit benzodiazepine-involved overdose deaths
increased by 21.8% and 519.6% respectively. Additionally,
benzodiazepines were involved in nearly 7,000 overdose deaths in 23
states from January 2019 to June 2020, accounting for 17% of all drug
overdose deaths. Adverse health effects associated with the abuse of
such substances known collectively as the ``designer benzodiazepines,''
their continued evolution, and increased popularity of these substances
have been a serious concern in recent years. The increase in the co-use
of opioids with the ``designer benzodiazepines'' has become a
particular concern as the United States continues to experience an
unprecedented epidemic of opioid misuse and abuse. CDC's 2021 MMWR
further states that between January and June 2020, 92.7% of
benzodiazepine-involved deaths also involved opioids and 66.7% involved
illicitly manufactured fentanyl. It is well known that the combination
of benzodiazepines with opioids substantially enhances the potential
for lethality. Etizolam, flualprazolam, clonazolam, flubromazolam, and
diclazepam are benzodiazepine substances recently identified on the
illicit drug market in the United States.
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\3\ Centers for Disease Control and Prevention Morbidity and
Mortality Weekly Report: Trends in Nonfatal and Fatal Overdoses
Involving Benzodiazepines--38 States and the District of Columbia,
2019-2020. Vol. 70, No. 34. August 27, 2021.
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The abuse of etizolam, flualprazolam, clonazolam, flubromazolam,
and diclazepam has been associated with numerous fatalities in recent
years in the United States. The positive identification of these five
substances in post-mortem cases is a serious concern to the public
safety. Additionally, law enforcement data indicate that the substances
at issue here have significant presence in the United States illicit
drug market. In light of the law enforcement encounters and fatalities
associated with the abuse of etizolam, flualprazolam, clonazolam,
flubromazolam, and diclazepam these substances pose an imminent hazard
to public safety.
Available data and information for etizolam, flualprazolam,
clonazolam, flubromazolam, and diclazepam, 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-989.
Factor 4. History and Current Pattern of Abuse
The chemical synthesis of etizolam, flualprazolam, clonazolam,
flubromazolam, and diclazepam were previously reported in the
scientific literature; however, the research did not lead to any
medically approved products in the United States. Since 2012, numerous
synthetic drugs belonging to the benzodiazepine class have begun to
emerge in the illicit drug market as evidenced by the identification of
these drugs in forensic drug exhibits from the National Forensic
Laboratory Information System (NFLIS),\4\ and toxicology samples.
[[Page 78889]]
Beginning in 2012, etizolam emerged on the illicit synthetic drug
market as evidenced by its identification in drug seizures in the
United States. In recent years, there has been a rise in the
recreational use of etizolam. As evidenced by their identification in
NFLIS-Drug, diclazepam emerged in the United States' illicit drug
market in 2014, flubromazolam and clonazolam in 2015, and flualprazolam
in 2017. While these substances are not approved for medical use in the
United States, etizolam is approved for medical use in Italy, India,
and Japan.\5\ In a letter dated January 3, 2022, the Assistant
Secretary informed DEA that there are no INDs or FDA-approved NDAs for
etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam in
the United States. Hence, there are no legitimate channels for these
substances as marketed drug products in the United States. These five
benzodiazepine substances are likely to be abused in the same manner as
other sedative hypnotics. They have been identified in tablet form, as
white to beige powders, or in liquid forms, typically of unknown purity
or concentration.
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\4\ 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.
\5\ Although there is no evidence suggesting that etizolam,
flualprazolam, clonazolam, flubromazolam, or diclazepam has a
currently accepted medical use in treatment in the United States, it
bears noting that a drug cannot be found to have such medical use
unless DEA concludes that it satisfies a five-part test.
Specifically, with respect to a drug that has not been approved by
FDA, to have a currently accepted medical use in treatment in the
United States, all of the following must be demonstrated: 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. 57 FR 10499 (1992), pet. for rev. denied, Alliance for
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).
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Based on data from NFLIS, law enforcement often encountered
etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam in
counterfeit pills, liquid, or powder. Substances often found in
combination with some of these benzodiazepines include substances of
abuse such as heroin (schedule I), fentanyl (schedule II), other
substances structurally related to fentanyl (schedule I and other non-
controlled substances), other benzodiazepines (both FDA-approved
schedule IV benzodiazepines and other novel non-controlled
benzodiazepines), and tramadol (schedule IV). Evidence suggests that
individuals are using these substances to obtain ``legal highs'' or to
self-medicate. Information gathered from case histories and autopsy
findings shows that deaths involving etizolam, flualprazolam,
clonazolam, flubromazolam, and diclazepam were predominantly associated
with poly-drug use.
Factor 5. Scope, Duration, and Significance of Abuse
Etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam
are novel benzodiazepines, and evidence suggests they are abused for
their sedative effects (see Factor 6). In death investigations
involving polysubstance use, the co-appearance of benzodiazepines and
opioids in toxicological analysis was common. Between August 2019 and
January 2020, flualprazolam and etizolam were identified in seven and
six postmortem blood specimens, respectively, out of 18 deaths
associated with the abuse of isotonitazene, a schedule I opioid that
was recently controlled. These cases corresponded to four states--
Illinois (9), Indiana (7), Minnesota (1), and Wisconsin (1). Most (n =
12) of the decedents were male. The ages ranged from 24 to 66 years old
with an average age of 41 years.\6\
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\6\ Krotulski AJ, Papsun DM, Kacinko SL, and Logan BK.
Isotonitazene Quantitation and Metabolite Discovery in Authentic
Forensic Casework. Journal of Analytical Toxicology, 2020,
44(6):521-530.
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In another recent publication, 20 forensic postmortem cases were
reviewed and analyzed for the presence of metonitazine, NPS
benzodiazepines, and opioids. Results indicated that NPS
benzodiazepines were the most commonly identified substances found in
combination with metonitazene. Specifically, clonazolam was positively
identified in four cases, etizolam in two cases, flualprazolam in two
cases, and pyrazolam in one case.\7\ Law enforcement encounters of
etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam as
reported to NFLIS (Federal, State and local laboratories) include
34,781 drug reports since 2014 (queried 01/13/2022). NFLIS-Drug
registered three encounters of etizolam in 2012 (first year of
encounter) and 3,022 reports in 2021. Flualprazolam was first
encountered in 2017 when one report was identified in NFLIS-Drug, and
then in 2021, 1,305 encounters were reported. A similar trend was seen
with clonazolam. During 2015 (its first year of encounter), 57 cases
were reported in NFLIS-Drug, while 3,994 drug reports were identified
in 2021. NFLIS-Drug registered five diclazepam encounters in 2014 (its
first year of encounter) and 54 encounters in 2021. Flubromazolam
encounters totaled 14 in 2015 (its first year of encounter) and 414 in
2021.
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\7\ Krotulski AJ, Papsun DM, Walton SE, and Logan BK.
Metonitazene in the United States-Forensic toxicology assessment of
a potent new synthetic opioid using liquid chromatography mass
spectrometry. Drug Testing Analysis, 2021, 13(10):1697-1711.
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The population likely to abuse etizolam, flualprazolam, clonazolam,
flubromazolam, and diclazepam appears to be the same as those abusing
prescription benzodiazepines, barbiturates, and other sedative hypnotic
substances. This is evidenced by drug user reports associated with
these substances. Because abusers of etizolam, flualprazolam,
clonazolam, flubromazolam, and diclazepam 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 benzodiazepines have been demonstrated and
are well-characterized.\8\ According to the most recent data from the
National Survey on Drug Use and Health (NSDUH),\9\ as of 2020, an
estimated 4.8 million people aged 12 years or older misused
prescription benzodiazepines in the past year. This included 1.1
million young adults aged 18 to 25, 3.5 million adults aged 26 or
older, and 157,000 adolescents aged 12 to 17. This population abusing
prescription benzodiazepines is likely to be at risk of abusing
etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam.
Individuals who initiate
[[Page 78890]]
use of these five substances (i.e., use a drug for the first time) are
likely to be at risk of developing substance use disorder, overdose,
and death at rates similar to that of other sedative hypnotics (e.g.,
alprazolam, clonazolam, etc.). Law enforcement or toxicology reports
demonstrate that the five substances at issue are being distributed and
abused.
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\8\ Votaw VR, Geyer R, Rieselbach MM, and McHugh RK. The
epidemiology of benzodiazepine misuse: A systematic review. Drug
Alcohol Dependence, 2019, 200:95-114.
\9\ The National Survey on Drug Use and Health (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 2020 NSDUH annual report is available at <a href="https://www.samhsa.gov/data/">https://www.samhsa.gov/data/</a> (last accessed February 8, 2022).
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Factor 6. What, if Any, Risk There Is to the Public Health
The increase in benzodiazepine-related overdose deaths in the
United States has been exacerbated recently by the availability of NPS
benzodiazepines in the illicit drug market. Etizolam, flualprazolam,
clonazolam, flubromazolam, and diclazepam have been described as
derivatives of other known benzodiazepines, each possessing various
degrees of potency. Evidence suggests these substances are being abused
for their sedative/hypnotic effects (see DEA 3-Factor Analysis). Public
health risks associated with the five substances at issue here relate
to their pharmacological similarities with known benzodiazepines. Thus,
risk to the public health is associated with adverse reactions in
humans, which are expected to include CNS depressant-like effects, such
as slurred speech, ataxia, altered mental state, and respiratory
depression.
Etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam
have been increasingly identified in toxicology reports, death
investigations, and driving under the influence of drugs (DUID) cases
since their first appearance in law enforcement seizures. According to
the Center for Forensic Science Research and Education (CFSRE), a non-
profit organization in collaboration with the Department of Justice and
Centers for Disease Control, between 2020 and 2021, etizolam was the
most identified NPS benzodiazepine accounting for 697 total toxicology
cases in 2020, many of which were co-identified with fentanyl. In 2021,
etizolam was identified in 1,012 toxicology cases, while flualprazolam,
clonazolam, flubromazolam, and diclazepam were associated with 432,
331, 170, and four toxicology cases, respectively (CSFRE Quarterly
Trend Reports: NPS Benzodiazepines in the United States).
Death investigations associated with four of the five NPS
benzodiazepines at issue here have increased in recent years. In a 2021
publication by the Orange County Crime Lab in Santa Ana, California,
flualprazolam was identified as serving a contributory role in the
death of 13 of 24 cases analyzed in the study.\10\ In another recently
published study, between August 2019 and January 2020, flualprazolam
and etizolam were identified in seven and six postmortem blood
specimens respectively, out of 18 deaths associated with the abuse of
isotonitazene, a schedule I opioid.\11\ Then, a study published in 2021
which compiled data from 254 reports published between 2008 and 2021,
identified: 33 deaths associated with etizolam, 20 flualprazolam-
related deaths, six emergency department (ED) visits associated with
clonazolam, 14 flubromazolam-related ED visits, and one death, 12 DUID
cases, and four ED visits associated with diclazepam.\12\ Additionally,
in 2020, the European Monitoring Centre for Drugs and Drug Addiction
reported 34 deaths associated with diclazepam use, which were
determined through the analysis of biological samples.\13\ Furthermore,
the National Poison Data System reported that between January 2014 and
December 2017, clonazolam was the second most common benzodiazepine
associated with poison control center calls, accounting for 50
incidents.\14\
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\10\ Ha HH and Mata DC. Flualprazolam distribution in postmortem
samples. Journal of Forensic Sciences, 2022, 67(1): 297-308.
\11\ Krotulski AJ, Papsun DM, Kacinko SL, and Logan BK.
Isotonitazene Quantitation and Metabolite Discovery in Authentic
Forensic Casework. Journal of Analytical Toxicology, 2020, 44(6):
521-530.
\12\ Brunetti P, Giorgetti R, Tagliabracci A, Huestis MA,
Busard[ograve] FP. Designer Benzodiazepines: A Review of Toxicology
and Public Health Risks. Pharmaceuticals (Basel). 2021 Jun
11;14(6):560.
\13\ EMCDDA (2020). EMCDDA response to WHO request for
information on the new psychoactive substances, eutylone, [alpha]-
PHiP, 4F-furanylfentanyl, 2-methyl-AP-237, and, diclazepam.
\14\ Carpenter JE, Murray BP, Dunkley C, Kazzi ZN, Gittinger MH.
Designer benzodiazepines: a report of exposures recorded in the
National Poison Data System, 2014-2017. Clin Toxicol (Phila). 2019
Apr;57(4):282-286.
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Impaired driving is another risk factor associated with the use and
abuse of etizolam, flualprazolam, clonazolam, flubromazolam, and
diclazepam. In a recent published report from the Sedgwick County
Regional Forensic Science Center in Wichita, Kansas, 12 DUID case
samples were analyzed. Etizolam was positively identified in three
cases, while flubromazolam was identified in nine of these cases.\15\
In a 2021 publication, similar involvement of flubromazolam in drug-
impaired driving was reported in Canada where flubromazolam was
detected in 10 percent of 113 case samples.\16\ Diclazepam has also
been implicated in DUID cases domestically and internationally. In a
Norwegian study conducted between July 2013 and May 2016, diclazepam
was identified in 15 of 77 analyzed samples taken from impaired drivers
and individuals involved in other criminal offenses. Then, in 2019, a
study of Norwegian drivers was conducted using 575 samples taken
predominantly from intoxicated drivers and individuals who committed
other criminal offenses.\17\ Notably, 334 samples were found to contain
diclazepam. Additionally, in a 2021 publication, researchers identified
22 samples that tested positive for flualprazolam in samples obtained
from DUID investigations between August 2018 and September 2020.\18\
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\15\ Rohrig TP, Osawa KA, Baird TR, Youso KB. Driving Impairment
Cases Involving Etizolam and Flubromazolam. J Anal Toxicol. 2021 Feb
6;45(1):93-98.
\16\ Vaillancourt L, Viel E, Dombrowski C, Desharnais B,
Mireault P. Drugs and driving prior to cannabis legalization: A 5-
year review from DECP (DRE) cases in the province of Quebec, Canada.
Accid Anal Prev. 2021 Jan;149:105832.
\17\ Heide G, H[oslash]iseth G, Middelkoop G, and [Oslash]iestad
[Aring]ML. Blood concentrations of designer benzodiazepines:
Relation to impairment and findings in forensic cases. Journal of
Analytical Toxicology, 2020, 44(8): 905-914.
\18\ Ha HH and Mata DC. Flualprazolam distribution in postmortem
samples. Journal of Forensic Sciences, 2022, 67(1): 297-308.
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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 etizolam,
flualprazolam, clonazolam, flubromazolam, and diclazepam pose imminent
hazards to public safety. DEA is not aware of any currently accepted
medical uses for these substances in the United States. As required by
21 U.S.C. 811(h)(4), the Administrator transmitted to the Assistant
Secretary for Health, via a letter dated October 25, 2021, notice of
her intent to place etizolam, flualprazolam, clonazolam, flubromazolam,
and diclazepam 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
[[Page 78891]]
available data and information, herein set forth the grounds for her
determination that it is necessary to temporarily schedule etizolam,
flualprazolam, clonazolam, flubromazolam, and diclazepam 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 etizolam, flualprazolam, clonazolam,
flubromazolam, and diclazepam in schedule I of the CSA will take effect
pursuant to a temporary scheduling order, which will not be issued
before January 23, 2023. Because the Administrator hereby finds this
temporary scheduling order is 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,
etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam 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)(1), the Administrator (as delegated by the Attorney
General) may, by order, temporarily schedule 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.
Inasmuch as this section 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 notice that DEA
transmitted to the Assistant Secretary pursuant to such subsection.
Further, DEA believes that this notice of intent 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 notice of intent 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, 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.
[[Page 78892]]
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)(63) through (67) to read as
follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
(63) 4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-thieno[3,2- 2780
f][1,2,4]triazolo[4,3-a][1,4]diazepine, its salts, isomers, and
salts of isomers (Other name: etizolam).........................
(64) 8-chloro-6-(2-fluorophenyl)-1-methyl-4H- 2785
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine, its salts,
isomers, and salts of isomers (Other name: flualprazolam).......
(65) 6-(2-chlorophenyl)-1-methyl-8-nitro-4H- 2786
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine, its salts,
isomers, and salts of isomers (Other name: clonazolam)..........
(66) 8-bromo-6-(2-fluorophenyl)-1-methyl-4H- 2788
benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine, its salts,
isomers, and salts of isomers (Other name: flubromazolam).......
(67) 7-chloro-5-(2-chlorophenyl)-1-methyl-1,3-dihydro-2H- 2789
benzo[e][1,4]diazepin-2-one, its salts, isomers, and salts of
isomers (Other name: diclazepam)................................
Signing Authority
This document of the Drug Enforcement Administration was signed on
December 12, 2022, 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.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-27278 Filed 12-22-22; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on December 23, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.