[Federal Register Volume 85, Number 233 (Thursday, December 3, 2020)]
[Proposed Rules]
[Pages 78047-78050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26301]



[[Page 78047]]

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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: Proposed amendment; notice of intent.

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SUMMARY: The Acting Administrator of the Drug Enforcement 
Administration is issuing this notice of intent to publish a 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. When it is issued, the temporary scheduling order will 
impose the regulatory controls and administrative, civil, and criminal 
sanctions applicable to schedule I controlled substances on persons who 
handle (manufacture, distribute, reverse distribute, import, export, 
engage in research, conduct instructional activities or chemical 
analysis, or possess) or propose to handle brorphine.

DATES: December 3, 2020.

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) 362-8207.

SUPPLEMENTARY INFORMATION: 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 
brorphine to schedule I under the Controlled Substances Act (CSA).\1\ 
The temporary scheduling order will be published in the Federal 
Register on or after January 4, 2021.
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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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Legal Authority

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

    Section 811(h)(4) requires the Administrator to notify the 
Secretary of the Department of Health and Human Services (HHS) of his 
intention to temporarily place a substance in schedule I of the CSA.\2\ 
The Acting Administrator transmitted notice of his intent to place 
brorphine in schedule I on a temporary basis 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 or approved new drug applications for brorphine. The 
Assistant Secretary also stated that HHS had no objection to the 
temporary placement of brorphine in schedule I of the CSA. 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.
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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 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 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. 21 U.S.C. 812(b)(1).

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 been serious concerns in 
recent years. The presence of new synthetic opioids with no approved 
medical use exacerbates the unprecedented opioid epidemic 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 2020 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.

[[Page 78048]]

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 new drug 
applications or investigational new drug applications for brorphine in 
the United States; hence, 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 U.S. illicit, 
synthetic drug market as evidenced by brorphine's identification in 
drug seizures. Between July and September of 2019, brorphine was first 
reported in drug casework in Canada and was first reported in police 
seizures in Sweden in March 2020.\3\
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    \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.
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    Brorphine has been encountered by U.S. law enforcement in powder 
form. In the United States, brorphine has been identified as a single 
substance and in combination with other substances. Twenty reports of 
brorphine have been reported in the National Forensic Laboratory 
Information System (NFLIS) in 2019 and 2020 from three different states 
(see Factor 5).\4\ In several NFLIS encounters, brorphine was found in 
combination 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\
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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-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.
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    Post-mortem toxicology samples collected and submitted to National 
Medical Services (NMS) Laboratory \6\ in June and July 2020 verified 
the appearance 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 2020 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.
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    \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.
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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, 
brorphine has been positively identified in seven death investigation 
cases spanning between June 2020 and July 2020. These cases correspond 
to 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 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.
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    \7\ 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.

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[[Page 78049]]

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 ([micro])-opioid receptor agonists. Data 
from in vitro studies completed in 2020 showed that brorphine binds to 
and activates the [micro]-opioid receptors. In the [\35\S]GTP[gamma]S 
cell-based receptor assay, brorphine, similar to fentanyl, acted as a 
[micro]-opioid receptor agonist. Brorphine's activation of [micro]-
opioid receptor was also shown to involve recruitment of beta-arrestin-
2, a regulatory protein whose interaction with the [micro]-opioid 
receptor has been implicated in the adverse effects of [micro]-opioid 
receptor activation. Brorphine binds to and activates the [micro]-
opioid receptor and has efficacy on scale with fentanyl. It is well 
established that substances that act as [micro]-opioid receptor 
agonists have a high potential for addiction and can induce dose-
dependent respiratory depression.
    As with any [micro]-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 [micro]-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 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 of 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. 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.

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 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's safety.
    The temporary placement of brorphine in schedule I of the CSA will 
take effect pursuant to a temporary scheduling order, which will not be 
issued before January 4, 2021. Because the Acting Administrator hereby 
finds that it is necessary to temporarily place brorphine in schedule I 
to avoid an imminent hazard to the public safety, the 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). It is the intention of the Acting 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, brorphine 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, 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. 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).

Regulatory Analyses

    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) 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 intention 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 Secretary of HHS.
    Inasmuch as 21 U.S.C. 811(h)(1) 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

[[Page 78050]]

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.'' 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), 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.
    In the alternative, even assuming that this notice of intent might 
be 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 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 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 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, 
13563, and 13771, 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 (OMB), 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 Executive Order. Because this is not a rulemaking action, this is 
not a significant regulatory action as defined in Section 3(f) of E.O. 
12866. In addition, this action does not meet the definition of an E.O. 
13771 regulatory action, and the repeal and cost offset requirements of 
E.O. 13771 have not been triggered.
    This action will not have substantial direct effects on the states, 
on the relationship between the national government and the states, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with E.O. 13132 
(Federalism), it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.

List of Subjects in 21 CFR Part 1308

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

    For the reasons set out above, DEA proposes to amend 21 CFR part 
1308 as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1308 continues to read as follows:

    Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.

0
2. In Sec.  1308.11, add 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-     9098
 2H-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)................................
 

* * * * *

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-26301 Filed 12-2-20; 8:45 am]
BILLING CODE 4410-09-P