[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Proposed Rules]
[Pages 19896-19901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06893]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-1006]


Schedules of Controlled Substances: Temporary Placement of MDMB-
4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-
PICA, and MMB-FUBICA in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Proposed amendment; notice of intent.

-----------------------------------------------------------------------

SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this notice of intent to publish a temporary order to schedule 
six synthetic cannabinoids and their optical and geometric isomers, 
salts, and salts of isomers, whenever the existence of such isomers and 
salts is possible, in schedule I under 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 six specified controlled 
substances.

DATES: This notice of intent is effective April 4, 2023.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug & Chemical 
Evaluation Section, Diversion Control Division, Drug Enforcement 
Administration; 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 (in the form of a temporary 
amendment) to add the following six substances, including their 
optical, positional, and geometric isomers, salts, and salts of isomers 
whenever the existence of such isomers and salts is possible, to 
schedule I under the Controlled Substances Act (CSA): \1\
---------------------------------------------------------------------------

    \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.


[[Page 19897]]


---------------------------------------------------------------------------

 Methyl 3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-indazole-3-
carboxamido)butanoate (Other name: MDMB-4en-PINACA),
 Methyl 2-[[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3-
dimethyl-butanoate (Other names: 4F-MDMB-BUTICA; 4F-MDMB-BICA),
 N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(pent-4-en-1-yl)-
1H-indazole-3-carboxamide (Other name: ADB-4en-PINACA),
 5-Pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3-b]indol-1-one 
(Other name: CUMYL-PEGACLONE; SGT-151),
 Ethyl 2-[[1-(5-fluoropentyl)indole-3-carbonyl]amino]-3,3-
dimethyl-butanoate (Other names: 5F-EDMB-PICA; 5F-EDMB-2201),
 Methyl 2-(1-(4-fluorobenzyl)-1H-indole-3-carboxamido)-3-methyl 
butanoate (Other name: MMB-FUBICA)

    The temporary scheduling order will be published in the Federal 
Register on or after May 4, 2023.

Legal Authority

    The CSA provides the Attorney General (as delegated to the 
Administrator of DEA (Administrator) pursuant to 28 CFR 0.100) with the 
authority to temporarily place a substance in schedule I of the CSA for 
two years without regard to the requirements of 21 U.S.C. 811(b), if he 
finds that such action is necessary to avoid an imminent hazard to the 
public safety.\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 Administrator may 
extend the temporary scheduling for up to one year.\3\
---------------------------------------------------------------------------

    \2\ 21 U.S.C. 811(h)(1).
    \3\ 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).\4\ The Administrator transmitted the 
required notice to the Assistant Secretary for Health of HHS (Assistant 
Secretary) \5\ by letter dated January 24, 2022 regarding MDMB-4en-
PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, 
and MMB-FUBICA. The Assistant Secretary responded to this notice by 
letter dated March 7, 2022, and advised that based on a review by the 
Food and Drug Administration, there are currently no approved new drug 
applications or investigational new drug applications for MDMB-4en-
PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, 
or MMB-FUBICA. The Assistant Secretary also stated that HHS has no 
objection to the temporary placement of these substances in schedule I 
of the CSA. MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-
PEGACLONE, 5F-EDMB-PICA, or MMB-FUBICA 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 six substances.
---------------------------------------------------------------------------

    \4\ 21 U.S.C. 811(h)(4).
    \5\ 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.
---------------------------------------------------------------------------

    Under 21 U.S.C. 811(h)(3), 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. This consideration includes any information indicating actual 
abuse; diversion from legitimate channels; and clandestine importation, 
manufacture, or distribution of these substances.
    A substance meeting the statutory requirements for temporary 
scheduling may only be placed in schedule I.\6\ Substances in schedule 
I have a high potential for abuse, no currently accepted medical use 
for treatment in the United States, and no accepted safety for use 
under medical supervision.\7\
---------------------------------------------------------------------------

    \6\ 21 U.S.C. 811(h)(1).
    \7\ 21 U.S.C. 812(b)(1).
---------------------------------------------------------------------------

Synthetic Cannabinoids

    Synthetic cannabinoids (SCs) are substances synthesized in 
laboratories that mimic the biological effects of delta-9-
tetrahydrocannabinol (THC, schedule I), the main psychoactive 
ingredient in marijuana (schedule I). SCs were introduced to the 
designer drug market in several European countries as ``herbal 
incense'' before the initial encounter in the United States by the 
United States Customs and Border Protection (CBP) in November 2008. 
From 2009, abuse of SCs has escalated in the United States as evidenced 
by large numbers of law enforcement encounters of SCs applied onto 
plant material and in other designer drug products intended for human 
consumption.\8\ Recent hospital reports, scientific publications and/or 
law enforcement reports demonstrate that MDMB-4en-PINACA, 4F-MDMB-
BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA, 
and their associated designer drug products, are being abused for their 
psychoactive properties (see Factors 5 and 6). As with many generations 
of SCs encountered since 2009, the abuse of MDMB-4en-PINACA, 4F-MDMB-
BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA 
is negatively impacting communities in the United States.
---------------------------------------------------------------------------

    \8\ 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.
---------------------------------------------------------------------------

    As noted by DEA and CBP, SCs originate from foreign sources, such 
as China. Substances in bulk powder form are smuggled via common 
carrier into the United States and find their way to clandestine 
designer drug product manufacturing operations located in residential 
neighborhoods, garages, warehouses, and other similar destinations 
throughout the country. According to online discussion boards and law 
enforcement encounters, spraying or mixing the SCs with plant material 
provides a vehicle for the most common route of administration--smoking 
(using a pipe, a water pipe, or rolling the drug-laced plant material 
in cigarette papers).
    MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 
5F-EDMB-PICA, and MMB-FUBICA have no accepted medical use in treatment 
in the United States.\9\ Emergency department

[[Page 19898]]

presentations involving MDMB-4en-PINACA or CUMYL-PEGACLONE have 
included seizures, sudden collapse, involuntary muscle spasms, jerking 
movements, catatonia, and increased violence. Multiple deaths have been 
reported involving MDMB-4en-PINACA, 4F-MDMB-BUTICA and CUMYL-PEGACLONE. 
In addition, all six SCs have been seized by law enforcement in the 
United States. Use of other schedule I SCs (e.g., JWH-018, AB-FUBINACA) 
has resulted in signs of addiction and withdrawal. Based on the 
pharmacological similarities between MDMB-4en-PINACA, 4F-MDMB-BUTICA, 
ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA and other 
schedule I SCs (e.g., JWH-018, AB-FUBINACA), these six SCs are likely 
to produce signs of addiction and withdrawal similar to those produced 
by other schedule I SCs (e.g., JWH-018, AB-FUBINACA).
---------------------------------------------------------------------------

    \9\ Although there is no evidence suggesting that MDMB-4en-
PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-
PICA, and MMB-FUBICA have 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, Mar. 26, 
1992, pet. for rev. denied, Alliance for Cannabis Therapeutics v. 
DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).
---------------------------------------------------------------------------

    MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 
5F-EDMB-PICA, and MMB-FUBICA are SCs that have pharmacological effects 
similar to the schedule I hallucinogen THC and other temporarily and 
permanently controlled schedule I SCs. With no approved medical use and 
limited safety or toxicological information, MDMB-4en-PINACA, 4F-MDMB-
BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA 
have emerged in the designer drug market, and the abuse of these 
substances for their psychoactive properties is concerning.

Factor 4. History and Current Pattern of Abuse

    SCs have been developed by researchers over the last 30 years as 
tools for investigating the endocannabinoid system (e.g., determining 
CB1 and CB2 receptor activity). The first encounter of SCs intended for 
illicit use within the United States occurred in November 2008 by CBP. 
Since then, the popularity of SCs as product adulterants and objects of 
abuse has increased as evidenced by law enforcement seizures, public 
health information, and media reports.
    Research and clinical reports have demonstrated that SCs are 
applied onto plant material so that the material may be smoked as users 
attempt to obtain a euphoric and psychoactive ``high,'' believed to be 
similar to marijuana. The adulterated products are marketed as 
``legal'' alternatives to marijuana.
    The designer drug products laced with SCs, including MDMB-4en-
PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, 
and MMB-FUBICA, are often sold under the guise of ``herbal incense'' or 
``potpourri,'' using various product names, and are routinely labeled 
``not for human consumption.'' Additionally, these products are 
marketed as a ``legal high'' or ``legal alternative to marijuana'' and 
are readily available over the internet, in head shops, or sold in 
convenience stores. There are incorrect assumptions that these products 
are safe, that these are synthetic forms of marijuana, and that 
labeling these products as ``not for human consumption'' is a legal 
defense to criminal prosecution under the Controlled Substances 
Analogue Enforcement Act.
    The powder form of SCs is typically dissolved in solvents (e.g., 
acetone) before being applied to plant material, or dissolved in a 
propellant intended for use in electronic cigarette devices. Law 
enforcement personnel have encountered various application methods 
including buckets or cement mixers in which plant material and one or 
more SCs are mixed together, or in large areas where the plant material 
is spread out so that a dissolved SC mixture can be applied directly. 
Once mixed, the SC plant material is then allowed to dry before 
manufacturers package the product for distribution, ignoring any 
quality control mechanisms to prevent contamination or to ensure a 
uniform concentration of the substance in each package. Adverse health 
consequences may also occur from directly ingesting the drug during the 
manufacturing process. The failure to adhere to any manufacturing 
standards with regard to amounts, the substance(s) included, purity, or 
contamination may further increase the risk of adverse events. However, 
it is important to note that adherence to manufacturing standards would 
not eliminate their potential to produce adverse effects because the 
toxicity and safety profiles of these SCs have not been studied. MDMB-
4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-
PICA, and MMB-FUBICA, similar to other schedule I SCs (e.g., JWH-018, 
AB-FUBINACA), have been found in powder form or mixed with dried leaves 
or herbal blends that were marketed for human use.
    Following their manufacture in China, SCs are often encountered in 
countries including New Zealand, Australia, and Russia before appearing 
throughout Europe and eventually in the United States. Law enforcement 
in the United States has encountered MDMB-4en-PINACA, 4F-MDMB-BUTICA, 
ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA and has 
documented the abuse of these substances. SCs and their associated 
products are available over the internet and sold in gas stations, 
convenience stores, and tobacco and head shops. MDMB-4en-PINACA, 4F-
MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-
FUBICA, similar to the previously scheduled SCs, have been seized alone 
and/or laced on products that are marketed under the guise of ``herbal 
incense'' and promoted as a ``legal'' alternative to marijuana.
    CUMYL-PEGACLONE was detailed in a patent published in 2014, was 
first reported as an adulterated plant material in Germany in December 
2016, and appeared in the United States in September 2018. These data 
further support the trend that SCs often appear in the illicit drug 
markets of other countries including those in Europe before being 
reported in the United States. Law enforcement has seized CUMYL-
PEGACLONE and its abuse has been associated with overdoses requiring 
emergency medical intervention. Adverse effects reported following the 
abuse of CUMYL-PEGACLONE have included seizures followed by collapse 
and deaths. CUMYL-PEGACLONE has also been encountered laced onto paper 
in attempts to be smuggled inside of prison facilities.
    Users abuse SCs by smoking for the purpose of achieving 
intoxication, which has resulted in numerous emergency department 
visits and calls to poison centers. As reported by the American 
Association of Poison Control Centers (AAPCC), severe, life-threatening 
health effects including severe agitation and anxiety, nausea, 
vomiting, seizures, and hallucinations can occur following ingestion of 
SCs. The AAPCC has specifically noted that SCs are made specifically to 
be abused.\10\ Emergency department presentations involving MDMB-4en-
PINACA or CUMYL-PEGACLONE have included seizures, sudden collapse, 
involuntary muscle spasms, jerking movements, catatonia, or increased 
violence. Multiple deaths have been reported involving MDMB-4en-PINACA, 
4F-MDMB-BUTICA, and CUMYL-PEGACLONE (See DEA Factor 6 in Three Factor 
Analysis).
---------------------------------------------------------------------------

    \10\ https://aapcc.org/track/synthetic-cannabinoids.

---------------------------------------------------------------------------

[[Page 19899]]

Factor 5. Scope, Duration, and Significance of Abuse

    Novel SCs substances, differing only by small chemical structural 
modifications intended to avoid prosecution while maintaining the 
pharmacological effects, continue to be sold on the illicit drug market 
as evidenced by law enforcement encounters of these substances. Law 
enforcement and health care professionals continue to report the abuse 
of these substances and their associated products. The threat of 
serious injury to the individual and the imminent threat to public 
safety following the ingestion of MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-
4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, MMB-FUBICA, and other SCs 
persist.
    Additional information obtained through the National Forensic 
Laboratory Information System (NFLIS) \11\ along with additional data 
may be found in DEA's Three Factor Analysis. According to NFLIS 
data,\12\ state and local forensic laboratories have detected the 
following information about the SCs in question:
---------------------------------------------------------------------------

    \11\ NFLIS is a national forensic laboratory reporting system 
that systematically collects results from drug chemistry analyses 
conducted by State and local forensic laboratories in the United 
States.
    \12\ At the time of query (March 16, 2022), 2021 and 2022 data 
were still reporting.
---------------------------------------------------------------------------

     MDMB-4en-PINACA was identified in 9,566 NFLIS reports 
since 2019. In addition, MDMB-4en-PINACA was identified in five 
exhibits mixed with heroin and/or fentanyl and packaged for sale as 
suspected heroin.
     4F-MDMB-BUTICA was identified in 385 NFLIS reports since 
2020. 4F-MDMB-BUTICA was also identified in one exhibit in a pill form, 
mixed with methamphetamine and a synthetic cathinone known as eutylone.
     CUMYL-PEGACLONE was identified in two CBP drug seizures in 
2018 and 2021, respectively.
     5F-EDMB-PICA was identified in 106 NFLIS reports since 
2020.
     MMB-FUBICA was identified in 397 NFLIS reports since 2016.

Factor 6. What, if Any, Risk There is to the Public Health

    Since first being identified in the United States in 2008, the 
ingestion of SCs continues to result in serious adverse effects. 
Details of these events involving MDMB-4en-PINACA and CUMYL-PEGACLONE 
are summarized below. (For additional information and citations, see 
DEA Factors 5 and 6 in Three Factor Analysis.)
    1. In October 2017 in France, two 16-year old juveniles were given 
a cigarette laced with white powder by an unknown individual. Upon 
arrest of the dealer, he stated the powder was SGT-151. Both juveniles 
developed seizures followed by collapse. Toxicological analysis of both 
victim's blood and blood collected from the arrested dealer (who 
claimed to be a user of the same powder) confirmed the presence of 
CUMYL-PEGACLONE (SGT-151) and its metabolite, N-dealkyl CUMYL-PEGACLONE 
(SGT-151).
    2. Between January and December 2017 in Germany, CUMYL-PEGACLONE 
was detected in 34 forensic serum/blood samples from fatal and non-
fatal cases. Of these cases, six deaths were reported by the Institute 
of Forensic Medicine in Munich and the Institute of Forensic Medicine 
in Mainz, respectively. Details of the deaths demonstrated multiple 
factors in addition to SCs as possible causes of death.
    3. Between July 1, 2018 and December 31, 2020 in Northern 
Australia, CUMYL-PEGACLONE was detected in five deaths. Concurrent 
alcohol use and underlying cardiovascular disease were considered 
relevant factors in most cases. Toxicological Significance Scoring 
(TSS) was carefully considered in all five cases, and in four cases, 
the presence of CUMYL-PEGACLONE was considered to be highly significant 
(TSS = 3).
    4. In September 2019, the Center for Forensic Science Research and 
Education released a report detailing the identification of MDMB-4en-
PINACA in biological fluids per their toxicology department.
    5. In February 2020, local law enforcement in Holyoke, MA, reported 
serious adverse effects following the abuse of the contents in glassine 
bags with suspected heroin. Analysis of contents in the bags confirmed 
the presence of MDMB-4en-PINACA. Per law enforcement witnesses to the 
overdoses, individuals were experiencing involuntary body/muscle spasms 
and movements that appeared similar to a seizure, although more 
violent. Victims were alert and conscious and they appeared to be under 
the influence of some unknown narcotics at the time, with officers 
noting that what was observed was nothing like a typical heroin 
overdose. Victims described it like being under the influence of PCP 
(schedule II substance) or something similar. In some cases, people 
were violent and emergency personnel were having a difficult time 
providing medical attention to these individuals. Emergency personnel 
also described very high heart rates and blood pressure. Some 
individuals were acting erratic and running in and out of traffic.
    6. In March 2021, a forensic toxicology report from the Defense 
Health Agency reported the presence of ADB-BUTINACA, ADB-BUTINACA N-
butanoic acid (a metabolite of ADB-BUTINACA), and MDMB-4en-PINACA 3,3-
dimethylbutanoic acid (a metabolite of MDMB-4en-PINCA) in a submitted 
urine specimen.
    7. MDMB-4en-PINACA and/or its metabolite were detected in 25 
forensic investigation cases between August 2019 and March 2020. The 
first positive sample was collected in May 2019. The majority of cases 
(n = 16, 64%) were submitted from postmortem investigations, followed 
by eight cases from suspected clinical toxicology investigations, and 
one case from an impaired driving investigation.
    Because they share pharmacological similarities with schedule I 
substances ([Delta]\9\-THC, JWH-018, and other temporarily and 
permanently controlled schedule I SCs), MDMB-4en-PINACA, 4F-MDMB-
BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA 
pose serious risks to an abuser. Tolerance to SCs may develop fairly 
rapidly with larger doses being required to achieve the desired effect. 
Acute and chronic abuse of SCs in general have been linked to adverse 
health effects including signs of addiction and withdrawal, numerous 
reports of emergency department admissions, and overall toxicity and 
deaths. Psychiatric case reports have been reported in the scientific 
literature detailing the SC abuse and associated psychoses (See DEA 
Factor 6 in Three Factor Analysis). As abusers obtain these drugs 
through unknown sources, the identity and purity of these substances is 
uncertain and inconsistent, thus posing significant adverse health 
risks to users.
    MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 
5F-EDMB-PICA, and MMB-FUBICA are being encountered on the illicit drug 
market and have no accepted medical use in the United States. 
Regardless, these products continue to be easily available and abused 
by diverse populations.

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 with, possession, and

[[Page 19900]]

abuse of MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-
PEGACLONE, 5F-EDMB-PICA, or MMB-FUBICA, resulting from the lack of 
control of these substances, pose an imminent hazard to the 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 
are those that 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 MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-
PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA indicate that these substances 
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. As required by 21 U.S.C. 811(h)(4), the 
Administrator, through a letter dated January 24, 2022, notified the 
Assistant Secretary of DEA's intention to temporarily place MDMB-4en-
PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, 
and MMB-FUBICA 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 
MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-
EDMB-PICA, and MMB-FUBICA in schedule I of the CSA, and finds that 
placement of these substances in schedule I of the CSA is necessary in 
order to avoid an imminent hazard to the public's safety.
    The temporary placement of MDMB-4en-PINACA, 4F-MDMB-BUTICA, ADB-
4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA in schedule I 
of the CSA will take effect pursuant to a temporary scheduling order, 
which will not be issued before May 4, 2023. Because the Administrator 
hereby finds that it is necessary to temporarily place MDMB-4en-PINACA, 
4F-MDMB-BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-
FUBICA in schedule I to avoid an imminent hazard to the public safety, 
the temporary order scheduling these substances will be effective on 
the date the order is published in the Federal Register, and will be in 
effect for a period of two years, with a possible extension of one 
additional year, pending completion of the regular (permanent) 
scheduling process.\13\ It is the intention of the Administrator 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 publication of the temporary order, MDMB-4en-PINACA, 4F-MDMB-
BUTICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 5F-EDMB-PICA, and MMB-FUBICA 
will then be subject to the CSA's schedule I regulatory controls and 
administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, reverse distribution, importation, 
exportation, research, conduct of instructional activities and chemical 
analysis with, and possession. The CSA sets forth specific criteria for 
scheduling a drug or other substance. Regular scheduling actions in 
accordance with 21 U.S.C. 811(a) are subject to formal rulemaking 
procedures done ``on the record after opportunity for a hearing'' 
conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The 
regular scheduling process of formal rulemaking affords interested 
parties with appropriate process and the government with 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. Temporary scheduling orders are not subject 
to judicial review.\14\
---------------------------------------------------------------------------

    \13\ 21 U.S.C. 811(h)(1) and (2).
    \14\ 21 U.S.C. 811(h)(6). 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 are subject to 
judicial review. See 21 U.S.C. 811(a) and 877.
---------------------------------------------------------------------------

Regulatory Analyses

    The CSA provides for expedited temporary scheduling action where 
such action is necessary to avoid an imminent hazard to the public 
safety.\15\ As provided in 21 U.S.C. 811(h)(1), the Administrator (as 
delegated by the Attorney General) may, by order, schedule a substance 
in schedule I on a temporary basis. Such an order 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.
---------------------------------------------------------------------------

    \15\ 21 U.S.C. 811(h)(1).
---------------------------------------------------------------------------

    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 of a publication in the 
Federal Register of 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 an order and a rule, 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.'' \16\ The specific language chosen by Congress indicates 
an intention for DEA to proceed through the issuance of an order 
instead of proceeding by rulemaking when temporarily scheduling 
substances. Given that Congress specifically requires the Administrator 
to follow rulemaking procedures for other kinds of scheduling actions, 
see 21 U.S.C. 811(a), it is noteworthy that, in 21 U.S.C. 811(h)(1), 
Congress authorized the issuance of temporary scheduling actions by 
order rather than by rule.
---------------------------------------------------------------------------

    \16\ 5 U.S.C. 551(6) (emphasis added).
---------------------------------------------------------------------------

    In the alternative, even assuming that this notice of intent might 
be subject to section 553 of the APA, the Administrator finds that 
there is good cause to forgo the notice-and-comment requirements of 
section 553, as any further delays in the process for issuance of 
temporary scheduling orders would be impracticable and contrary to the 
public interest in view of 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) only apply when DEA is required, under 5 U.S.C. 553, to 
issue a

[[Page 19901]]

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. See 21 U.S.C. 811(h)(1). Therefore, because DEA 
believes this temporary scheduling action is not a ``rule,'' DEA is not 
subject to the requirements of the Regulatory Flexibility Act when 
issuing this temporary action.
    In accordance with the principles of Executive Orders (E.O.) 12866 
and 13563, this 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.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
March 29, 2023, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

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)(57) through (62) to read as 
follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *

(57) Methyl 3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-indazole-3-       7090
 carboxamido)butanoate, its optical and geometric isomers,
 salts and salts of isomers (Other name: MDMB-4en-PINACA)......
(58) Methyl 2-[[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3-      7091
 dimethyl-butanoate, its optical and geometric isomers, salts
 and salts of isomers (Other names: 4F-MDMB-BUTICA; 4F-MDMB-
 BICA).........................................................
(59) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(pent-4-en-1-       7092
 yl)-1H-indazole-3-carboxamide, its optical and geometric
 isomers, salts and salts of isomers (Other name: ADB-4en-
 PINACA).......................................................
(60) 5-Pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3-b]indol-1-one,      7093
 its optical and geometric isomers, salts and salts of isomers
 (Other names: CUMYL-PEGACLONE; SGT-151).......................
(61) Ethyl 2-[[1-(5-fluoropentyl)indole-3-carbonyl]amino]-3,3-      7094
 dimethyl-butanoate, its optical and geometric isomers, salts
 and salts of isomers (Other names: 5F-EDMB-PICA; 5F-EDMB-2201)
(62) Methyl 2-(1-(4-fluorobenzyl)-1H-indole-3-carboxamido)-3-       7095
 methyl butanoate, its optical and geometric isomers, salts and
 salts of isomers (Other name: MMB-FUBICA).....................
 

* * * * *

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-06893 Filed 4-3-23; 8:45 am]
BILLING CODE 4410-09-P