Federal Register / Vol. 85, No. 233 / Thursday, December 3, 2020 / Proposed Rules 78047 

1Though 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. 

2The 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. 

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. 

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. 

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. 

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. 


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78048 Federal Register / Vol. 85, No. 233 / Thursday, December 3, 2020 / Proposed Rules 

3Health 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. 

4NFLIS 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. 

5Email communications with Northeastern 

Illinois Regional Crime Laboratory, dated 7/1/2020 

and 6/11/2020. 

6NMS 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. 

7The 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, noninstitutionalized 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 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

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

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. 

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 postmortem 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 wellcharacterized. 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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Federal Register / Vol. 85, No. 233 / Thursday, December 3, 2020 / Proposed Rules 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 preclinical studies demonstrate that 

brorphine exhibits a pharmacological 

profile similar to that of other mu (m)- 

opioid receptor agonists. Data from in 

vitro studies completed in 2020 showed 

that brorphine binds to and activates the 

m-opioid receptors. In the [35S]GTPgS 

cell-based receptor assay, brorphine, 

similar to fentanyl, acted as a m-opioid 

receptor agonist. Brorphine’s activation 

of m-opioid receptor was also shown to 

involve recruitment of beta-arrestin-2, a 

regulatory protein whose interaction 

with the m-opioid receptor has been 

implicated in the adverse effects of mopioid receptor activation. Brorphine 

binds to and activates the m-opioid 

receptor and has efficacy on scale with 

fentanyl. It is well established that 

substances that act as m-opioid receptor 

agonists have a high potential for 

addiction and can induce dosedependent respiratory depression. 

As with any m-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 m-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 


khammond on DSKJM1Z7X2PROD with PROPOSALS
78050 Federal Register / Vol. 85, No. 233 / Thursday, December 3, 2020 / Proposed Rules 

of a publication in the Federal Register 

of a notice of intent, the notice-andcomment 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-andcomment 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 

■ 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. 

■ 2. In § 1308.11, add paragraph (h)(49) 

to read as follows: 

§ 1308.11 Schedule I 

* * * * * 

(h) * * * 

(49) 1-(1-(1-(4-bromophenyl)

ethyl)piperidin-4-yl)-1,3-dihydro2H-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-2Hbenzimidazol-2-one) .................... 9098 

* * * * * 

Timothy J. Shea, 

Acting Administrator. 

[FR Doc. 2020–26301 Filed 12–2–20; 8:45 am] 

BILLING CODE 4410–09–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2020–0534; FRL–10016– 

98–Region 9] 

Approval and Promulgation of Air 

Quality State Implementation Plans; 

California; Plumas County; Moderate 

Area Plan for the 2012 PM2.5 NAAQS 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve 

through parallel processing a state 

implementation plan (SIP) revision 

submitted by the State of California to 

address Clean Air Act (CAA or ‘‘Act’’) 

requirements for the 2012 annual fine 

particulate matter (PM2.5) national 

ambient air quality standard (NAAQS or 

‘‘standard’’) in the Plumas County 

Moderate PM2.5 nonattainment area 

(‘‘Portola nonattainment area’’). The 

submitted SIP revision is the State’s 

‘‘Proposed Portola PM2.5 Plan 

Contingency Measure SIP Submittal’’ 

(‘‘Proposed PM2.5 Plan Revision’’), 

which includes a revised City of Portola 

ordinance regulating PM2.5 emission 

sources and the State’s demonstration 

that this submission meets the Moderate 

area contingency measure requirement 

for the 2012 annual PM2.5 NAAQS in the 

Portola nonattainment area. The EPA is 

also proposing to approve the 

contingency measure element of the 

Moderate area attainment plan for the 

Portola nonattainment area, as revised 

and supplemented by the Proposed 

PM2.5 Plan Revision. Because the EPA is 

proceeding by parallel processing, the 

agency is proposing, in the alternative, 

to disapprove the contingency measure 

element of the Moderate area attainment 


khammond on DSKJM1Z7X2PROD with PROPOSALS