```

[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Rules and Regulations]
[Pages 11862-11867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04242]

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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-716]

Schedules of Controlled Substances: Temporary Placement of 
Brorphine in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Temporary amendment; temporary scheduling order.

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

SUMMARY: The Acting Administrator of the Drug Enforcement 
Administration is issuing this temporary order to schedule 1-(1-(1-(4-
bromophenyl)ethyl)piperidin-4-yl)-1,3-dihydro-2H-benzo[d]imidazol-2-one 
(commonly known as brorphine), including its 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 . This action is based on a finding by 
the Acting Administrator that the placement of brorphine in schedule I 
of the Controlled Substances Act is necessary to avoid an imminent 
hazard to the public safety. As a result of this order, the regulatory 
controls and administrative, civil, and criminal sanctions applicable 
to schedule I controlled substances will be imposed 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 brorphine.

DATES: This temporary scheduling order is effective March 1, 2021, 
until March 1, 2023. If this order is extended or made permanent, DEA 
will publish a document in the Federal Register.

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:

Legal Authority

    The Controlled Substances Act (CSA) provides the Attorney General 
(as delegated to the Administrator of Drug Enforcement Administrator 
(DEA) pursuant to 28 CFR 0.100) with the authority to temporarily place 
a substance in schedule I of the CSA for two years without regard to 
the requirements of 21 U.S.C. 811(b), if he finds that such action is 
necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 
811(h)(1). In addition, if proceedings to control a substance are 
initiated under 21 U.S.C. 811(a)(1) while the substance is temporarily 
controlled \1\ under section 811(h), the Administrator may extend the 
temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).
---------------------------------------------------------------------------

    \1\ Though DEA has used the term ``final order'' with respect to 
temporary scheduling orders in the past, this document adheres to 
the statutory language of 21 U.S.C. 811(h), which refers to a 
``temporary scheduling order.'' No substantive change is intended.
---------------------------------------------------------------------------

    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

[[Page 11863]]

Department of Health and Human Services (HHS) of his intention to 
temporarily place a substance in schedule I.\2\ 21 U.S.C. 811(h)(4). 
The Acting Administrator transmitted such notice regarding brorphine to 
the Assistant Secretary for Health of HHS (Assistant Secretary) by 
letter dated September 22, 2020. The Assistant Secretary responded to 
this notice by letter dated October 27, 2020, 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 brorphine. The Assistant Secretary also stated 
that HHS had no objection to the temporary placement of brorphine in 
schedule I of the CSA.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    DEA has taken into consideration the Assistant Secretary's comments 
as required by subsection 811(h)(4). Brorphine is not currently listed 
in any schedule under the CSA, and no exemptions or approvals are in 
effect for brorphine under 21 U.S.C. 355. DEA has found that the 
control of brorphine in schedule I on a temporary basis is necessary to 
avoid an imminent hazard to the public safety.
    As required by 21 U.S.C. 811(h)(1)(A), DEA published a notice of 
intent to temporarily schedule brorphine on December 3, 2020. 85 FR 
78047. That notice of intent discussed findings from DEA's three-factor 
analysis dated August 2020, which DEA made available on 
www.regulations.gov.
    To find that placing a substance temporarily in schedule I of the 
CSA is necessary to avoid an imminent hazard to the public safety, the 
Administrator is required to 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). 
Consideration of these factors includes actual abuse diversion from 
legitimate channels; and clandestine importation, manufacture, or 
distribution. 21 U.S.C. 811(h)(3).
    A substance 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 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. 21 U.S.C. 812(b)(1).
    Available data and information for brorphine summarized below 
indicate that it has 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. DEA's August 2020 three-
factor analysis and the Assistant Secretary's October 27, 2020, letter 
are available in their entirety under the tab ``Supporting Documents'' 
of the public docket of this action at www.regulations.gov.

Brorphine

    The availability of synthetic opioids on the illicit drug market 
continues to pose an imminent hazard to the public safety. Adverse 
health effects associated with the abuse of synthetic opioids and the 
increased popularity of these substances have posed serious health 
concerns in recent years. The presence of new synthetic opioids with no 
approved medical use exacerbates the unprecedented opioid epidemic in 
the United States continues to experience. The trafficking and abuse of 
new synthetic opioids are deadly new trends.
    The identification of brorphine on the illicit drug market has been 
reported in the United States, Canada, Belgium, and Sweden. Data 
obtained from preclinical pharmacology studies show that brorphine has 
a pharmacological profile similar to that of other potent opioids such 
as morphine and fentanyl, schedule II controlled substances. Because of 
the pharmacological similarities between brorphine and other potent 
opioids, the use of brorphine presents a high risk of abuse and may 
negatively affect users and their communities. The positive 
identification of this substance in law enforcement seizures and post-
mortem toxicology reports is a serious concern to the public safety. 
The abuse of brorphine has been associated with at least seven 
fatalities between June and July 2020 in the United States. Thus, 
brorphine poses an imminent hazard to public safety.
    Available data and information for brorphine, as summarized below, 
indicates that this substance has 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. DEA's three-
factor analysis is available in its entirety under ``Supporting and 
Related Material'' of the public docket for this action at 
www.regulations.gov under Docket Number DEA-716.

Factor 4. History and Current Pattern of Abuse

    Brorphine is part of a structural class of compounds known as 
substituted piperidine benzimidazolones. The general synthesis of 
brorphine was first reported in the literature in 2018. Brorphine is 
not an approved pharmaceutical product and is not approved for medical 
use anywhere in the world. The Assistant Secretary, by a letter to DEA 
dated October 27, 2020, stated that there are no FDA-approved NDAs or 
INDs for brorphine in the United States. Hence, DEA notes there is no 
legitimate channel for brorphine as a marketed drug product. The 
appearance of brorphine on the illicit drug market is similar to other 
designer drugs trafficked for their psychoactive effects.
    Since 2014, numerous synthetic opioids structurally related to 
fentanyl and several synthetic opioids from other structural classes 
have begun to emerge on the illicit drug market as evidenced by the 
identification of these drugs in forensic drug exhibits and toxicology 
samples. Beginning in June 2019, brorphine emerged in the United States 
illicit, synthetic drug market as evidenced by brorphine's 
identification in drug seizures. Authorities Between July and September 
2019, brorphine was first reported in drug casework in Canada and was 
first reported in police seizures in Sweden in March 2020.\3\
---------------------------------------------------------------------------

    \3\ Health Canada Drug Analysis Service (2019); Analyzed Drug 
Report Canada 2019--Q3 (July to September); European Monitoring 
Centre for Drugs and Drug Addiction (EMCDDA) (2020); EU Early 
Warning System Situation Report, Situation report 1--June 2020.
---------------------------------------------------------------------------

    Brorphine has been encountered by United States law enforcement in 
powder form. In the United States, brorphine has been identified as a 
single substance and in combination with other substances. Between June 
2019 and August 2020, there are twenty reports of brorphine in the 
National Forensic Laboratory Information System (NFLIS) from three 
different states (see Factor 5).\4\ In several NFLIS encounters, 
brorphine was found in combination

[[Page 11864]]

with heroin (a schedule I substance) and fentanyl (a schedule II 
substance). In reports from the Northeastern Illinois Regional Crime 
Laboratory, suspected heroin/fentanyl powders were analyzed and found 
to be brorphine in combination with flualprazolam, a non-scheduled 
benzodiazepine, and diphenhydramine, an over-the-counter 
antihistamine.\5\
---------------------------------------------------------------------------

    \4\ NFLIS represents an important resource in monitoring illicit 
drug trafficking, including the diversion of legally manufactured 
pharmaceuticals into illegal markets. NFLIS-Drug is a comprehensive 
information system that includes data from forensic laboratories 
that handle the nation's drug analysis cases. NFLIS-Drug 
participation rate, defined as the percentage of the national drug 
caseload represented by laboratories that have joined NFLIS, is 
currently 98.5 percent. 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, December 12, 2011. NFLIS data was 
queried on August 18, 2020.
    \5\ Email communications with Northeastern Illinois Regional 
Crime Laboratory, dated 7/1/2020 and 6/11/2020.
---------------------------------------------------------------------------

    Post-mortem toxicology samples collected and submitted to National 
Medical Services (NMS) Laboratory \6\ in June and July 2020 verified 
the identification of brorphine. Brorphine was first reported by the 
Center for Forensic Science Research and Education (CFSRE)--Novel 
Psychoactive Substance (NPS) Discovery Program (under the novel 
psychoactive substances discovery program, in collaboration with NMS 
Labs) in July 2020. In seven post-mortem toxicology reports in June and 
July 2020, brorphine was found in combination with fentanyl, 
flualprazolam, and heroin. Evidence suggests that individuals are using 
brorphine as a replacement to heroin or other opioids, either knowingly 
or unknowingly.
---------------------------------------------------------------------------

    \6\ 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.
---------------------------------------------------------------------------

Factor 5. Scope, Duration, and Significance of Abuse

    Brorphine has been described as a potent synthetic opioid, and 
evidence suggests it is being abused for its opioidergic effects (see 
Factor 6). According to a recent publication by CFSRE--NPS Discovery 
Program, brorphine has been positively identified in seven death 
investigation cases spanning between June and July 2020. These cases 
occurred in three states--Illinois (3), Minnesota (3), and Arizona (1). 
Most (n=6) of the decedents were male. The decedents' ages ranged 
between 40's and 60's with an average age of 52 years. Other substances 
identified in postmortem blood specimens obtained from these decedents 
include flualprazolam, a nonscheduled benzodiazepine (n=5), fentanyl, a 
schedule II substance (n=7), and heroin, a schedule I substance (n=4). 
The appearance of benzodiazepines and other opioids is common with 
polysubstance abuse.
    NFLIS registered 20 reports of brorphine from Ohio (4), 
Pennsylvania (1), and Wisconsin (15) in 2019 and 2020. NFLIS was 
queried on August 18, 2020, for brorphine. Due to the rapid appearance 
of the drug, brorphine is most likely under reported as forensic 
laboratories secure reference standards for the confirmative 
identification and reporting of this substance.
    The population likely to abuse brorphine appears to be the same as 
those abusing prescription opioid analgesics, heroin, tramadol, 
fentanyl, and other synthetic opioid substances. This is evidenced by 
the types of other drugs co-identified in samples obtained from 
brorphine seizures and post-mortem toxicology reports. Because abusers 
of brorphine are likely to obtain it through unregulated sources, the 
identity, purity, and quantity of brorphine are uncertain and 
inconsistent, thus posing significant adverse health risks to the end 
user. The misuse and abuse of opioids have been demonstrated and are 
well-characterized. According to the most recent data from the National 
Survey on Drug Use and Health (NSDUH),\7\ as of 2019, an estimated 10.1 
million people aged 12 years or older misused opioids in the past year, 
including 9.7 million prescription pain reliever misusers and 745,000 
heroin users. In 2019, an estimated 1.6 million people had an opioid 
use disorder, which included 1.4 million people with a prescription 
pain reliever use disorder and 438,000 people with heroin use disorder. 
In 2018, an estimated 10.3 million people aged 12 years or older 
misused opioids in the past year, including 9.9 million prescription 
pain reliever misusers and 808,000 heroin users. In 2018, an estimated 
2 million people had an opioid use disorder, which included 1.7 million 
people with a prescription pain reliever use disorder and 500,000 
people with heroin use disorder. This population abusing opioids is 
likely to be at risk of abusing brorphine. Individuals who initiate use 
(i.e., use a drug for the first time) of brorphine are likely to be at 
risk of developing substance use disorder, overdose, and death similar 
to that of other opioid analgesics (e.g., fentanyl, morphine, etc.). 
Law enforcement reports demonstrate that brorphine is being illicitly 
distributed and abused.
---------------------------------------------------------------------------

    \7\ 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.
---------------------------------------------------------------------------

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 brorphine exhibits a pharmacological profile 
similar to that of other mu-opioid receptor agonists. Data from in 
vitro studies showed that brorphine binds to and activates the mu-
opioid receptors. In the [\35\S]GTP[gamma]S cell-based receptor assay, 
brorphine, similar to fentanyl, acted as a mu-opioid receptor agonist. 
Brorphine's activation of the mu-opioid receptor was also shown to 
involve recruitment of beta-arrestin-2, a regulatory protein whose 
interaction with the mu-opioid receptor has been implicated in the 
adverse effects of mu-opioid receptor activation. Brorphine binds to 
and activates the mu-opioid receptor and has efficacy on scale with 
fentanyl in in vitro studies. 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.
    As with any mu-opioid receptor agonist, the potential health and 
safety risks for users of brorphine are high. The public health risks 
associated to the abuse of heroin and other [mu]-opioid receptor 
agonists are well established and have resulted in large numbers of 
drug treatment admissions, emergency department visits, and fatal 
overdoses. According to the Centers for Disease Control and Prevention 
(CDC), opioids, mainly synthetic opioids other than methadone, are 
predominantly responsible for drug overdose deaths in recent years. A 
CDC report shows that, from 2013 to 2018, opioid-related overdose 
deaths in the United States increased from 25,052 to 46,802. Of the 
drug overdose deaths for 2018, opioids were involved in about 69.5 
percent of all drug-involved overdose deaths.
    In the United States, the abuse of opioid analgesics has resulted 
in large numbers of treatment admissions, emergency department visits, 
and fatal overdoses. The introduction of potent synthetic opioids such 
as brorphine into

[[Page 11865]]

the illicit market may serve as a portal to problematic opioid use for 
those seeking these powerful opioids.
    Brorphine has been co-identified with other substances in seven 
post-mortem toxicology cases in June and July 2020. These substances 
include other opioids such as fentanyl and heroin, and other substance 
classes such as benzodiazepines. These deaths occurred in three states: 
Illinois, Arizona, and Minnesota. Information gathered from case 
history findings shows that brorphine use is similar to that of classic 
opioid agonists. As documented by toxicology reports, poly-substance 
abuse remains common in fatalities associated with the abuse of 
brorphine.

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 brorphine 
pose an imminent hazard to the public safety. DEA is not aware of any 
currently accepted medical uses for brorphine in the United States.\8\ 
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 brorphine indicate that 
this substance has 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 Acting Administrator, through a letter dated September 
22, 2020, notified the Assistant Secretary of DEA's intention to 
temporarily place brorphine in schedule I. DEA subsequently published a 
notice of intent on December 3, 2020. 85 FR 78047.
---------------------------------------------------------------------------

    \8\ Although there is no evidence suggesting that brorphine 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).
---------------------------------------------------------------------------

Conclusion

    In accordance with 21 U.S.C. 811(h)(1) and (3), the Acting 
Administrator considered available data and information, herein set 
forth the grounds for his determination that it is necessary to 
temporarily schedule brorphine in schedule I of the CSA and finds that 
placement of this substance in schedule I of the CSA is necessary in 
order to avoid an imminent hazard to the public safety.
    This temporary order scheduling this substance 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. 21 U.S.C. 811(h)(1) and (2).
    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. 21 U.S.C. 811. 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. 21 U.S.C. 877. Temporary scheduling orders are not subject to 
judicial review. 21 U.S.C. 811(h)(6).

Requirements for Handling

    Upon the effective date of this temporary order, brorphine will be 
subject to the regulatory controls and administrative, civil, and 
criminal sanctions applicable to the manufacture, distribution, reverse 
distribution, importation, exportation, engagement in research, and 
conduct of instructional activities or chemical analysis with, and 
possession of schedule I controlled substances, including the 
following:
    1. Registration. Any person who handles (manufactures, distributes, 
reverse distributes, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses), or 
who desires to handle, brorphine must be registered with DEA to conduct 
such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in 
accordance with 21 CFR parts 1301 and 1312, as of March 1, 2021. Any 
person who currently handles brorphine, and is not registered with DEA, 
must submit an application for registration and may not continue to 
handle brorphine as of March 1, 2021, unless DEA has approved that 
application for registration pursuant to 21 U.S.C. 822, 823, 957, and 
958, and in accordance with 21 CFR parts 1301 and 1312. Retail sales of 
schedule I controlled substances to the general public are not allowed 
under the CSA. Possession of any quantity of this substance in a manner 
not authorized by the CSA on or after March 1, 2021 is unlawful and 
those in possession of any quantity of these substances may be subject 
to prosecution pursuant to the CSA.
    2. Disposal of stocks. Any person who does not desire or is not 
able to obtain a schedule I registration to handle brorphine must 
surrender all currently held quantities of brorphine.
    3. Security. Brorphine is subject to schedule I security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821, 
823, 871(b) and in accordance with 21 CFR 1301.71-1301.93, as of March 
1, 2021. Non-practitioners handling brorphine must also comply with the 
employee screening requirements of 21 CFR 1301.90-1301.93.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of brorphine must be in compliance with 21 U.S.C. 
825, 958(e) and be in accordance with 21 CFR part 1302. Current DEA 
registrants will have 30 calendar days from March 1, 2021 to comply 
with all labeling and packaging requirements.
    5. Inventory. Every DEA registrant who possesses any quantity of 
brorphine on the effective date of this order must take an inventory of 
all stocks of these substances on hand, pursuant to 21 U.S.C. 827 and 
958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. 
Current DEA registrants will have 30 calendar days from the effective 
date of this order to be in compliance with all inventory requirements. 
After the initial inventory, every DEA registrant must take an 
inventory of all controlled substances (including brorphine) on hand on 
a biennial basis, pursuant to 21 U.S.C. 827 and 958 and in accordance 
with 21 CFR 1304.03, 1304.04, and 1304.11.
    6. Records. All DEA registrants must maintain records with respect 
to brorphine, pursuant to 21 U.S.C. 827

[[Page 11866]]

and 958 and in accordance with 21 CFR parts 1304, 1312, and 1317, and 
section 1307.11. Current DEA registrants authorized to handle brorphine 
shall have 30 calendar days from the effective date of this order to be 
in compliance with all recordkeeping requirements.
    7. Reports. All DEA registrants who manufacture or distribute 
brorphine must submit reports pursuant to 21 U.S.C. 827 and in 
accordance with 21 CFR parts 1304 and 1312 as of March 1, 2021.
    8. Order Forms. All DEA registrants who distribute brorphine must 
comply with order form requirements pursuant to 21 U.S.C. 828 and in 
accordance with 21 CFR part 1305 as of March 1, 2021.
    9. Importation and Exportation. All importation and exportation of 
brorphine must be in compliance with 21 U.S.C. 952, 953, 957, and 958, 
and in accordance with 21 CFR part 1312 as of March 1, 2021.
    10. Quota. Only DEA registered manufacturers may manufacture 
brorphine in accordance with a quota assigned pursuant to 21 U.S.C. 826 
and in accordance with 21 CFR part 1303 as of March 1, 2021.
    11. Liability. Any activity involving brorphine not authorized by, 
or in violation of the CSA, occurring as of March 1, 2021, is unlawful 
and may subject the person to administrative, civil, and/or criminal 
sanctions.

Regulatory Matters

    The CSA provides for a temporary scheduling action where such 
action is necessary to avoid an imminent hazard to the public safety. 
21 U.S.C. 811(h)(1). As provided in this subsection, the Administrator 
(as delegated by the Attorney General) by order may 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 intention to issue such order and 
the grounds upon which such order is to be issued, and (2) the date 
that comment requirements of section 553 of the Administrative 
Procedure Act (APA), 5 U.S.C. 553, do not apply to this temporary 
scheduling order. 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.'' 5 U.S.C. 551(6) 
(emphasis added). The specific language chosen by Congress indicates an 
intention for DEA to proceed through the issuance of an order instead 
of proceeding by rulemaking. Given that Congress specifically requires 
the Administrator to follow rulemaking procedures for other kinds of 
scheduling actions, see 21 U.S.C. 811(a), note that in 21 U.S.C. 
811(h)(1), Congress authorized the issuance of temporary scheduling 
actions by order rather than by rule.
    Alternatively, even if this action was subject to section 553 of 
the APA, the Acting 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 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 Acting 
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 temporary scheduling action is not 
a ``rule'' as defined by 5 U.S.C. 601(2), and accordingly, is not 
subject to the requirements of the Regulatory Flexibility Act. The 
requirements for the preparation of an initial regulatory flexibility 
analysis in 5 U.S.C. 603(a) are not applicable here, as DEA is not 
required by section 553 of the APA or any other law to publish a 
general notice of proposed rulemaking.
    In accordance with the principles of Executive Orders (E.O.) 12866 
and 13563, this action is not a significant regulatory action. E.O. 
12866 directs agencies to assess all costs and benefits of available 
regulatory alternatives and, if regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health, and safety effects; 
distributive impacts; and equity). E.O. 13563 is supplemental to and 
reaffirms the principles, structures, and definitions governing 
regulatory review as established in E.O. 12866. E.O. 12866 classifies a 
``significant regulatory action,'' requiring review by the Office of 
Management and Budget, as any regulatory action that is likely to 
result in a rule that may: (1) Have an annual effect on the economy of 
$100 million or more or adversely affect in a material way the economy; 
a sector of the economy; productivity; competition; jobs; the 
environment; public health or safety; or State, local, or tribal 
governments or communities; (2) create a serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
(3) materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs, or the rights and obligations of recipients 
thereof; or (4) raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the E.O. Because this is not a rulemaking action, this is not a 
significant regulatory action as defined in Section 3(f) of E.O. 12866.
    This action will not have substantial direct effects on the states, 
on the relationship between the national government and the states, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with E.O. 13132 
(Federalism), it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, DEA amends 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 paragraph (h)(49) to read as follows:

Sec.  1308.11   Schedule I

* * * * *
    (h) * * *

(49) 1-(1-(1-(4-bromophenyl)ethyl)piperidin-4-yl)-1,3-dihydro-2H-   9098
 benzo[d]imidazol-2-one, its isomers, esters, ethers, salts and
 salts of isomers, esters and ethers (Other names: brorphine; 1-
 [1-[1-(4-bromophenyl)ethyl]-4-piperidinyl]-1,3-dihydro-2H-
 benzimidazol-2-one).............................................
 

[[Page 11867]]

* * * * *

D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-04242 Filed 2-26-21; 8:45 am]
BILLING CODE 4410-09-P
```