11862 Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Rules and Regulations 

1Though 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. 

impact is so minimal. Since this is a 

routine matter that will only affect air 

traffic procedures and air navigation, it 

is certified that this rule, when 

promulgated, would not have a 

significant economic impact on a 

substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

Environmental Review 

The FAA has determined that this 

action qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with FAA 

Order 1050.1F, ‘‘Environmental 

Impacts: Policies and Procedures,’’ 

paragraph 5–6.5a. This airspace action 

is not expected to cause any potentially 

significant environmental impacts, and 

no extraordinary circumstances exist 

that warrant preparation of an 

environmental assessment. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for 14 CFR 

part 71 continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order 7400.11E, 

Airspace Designations and Reporting 

Points, dated July 21, 2020, and 

effective September 15, 2020, is 

amended as follows: 

Paragraph 5000 Class D Airspace. 

* * * * * 

AWP CA D Palmdale, CA [Amended] 

Palmdale USAF Plant 42 Airport, CA 

(Lat. 34°37′46′′ N, long. 118°05′04′′ W) 

That airspace extending upward from the 

surface to and including 5,000 feet MSL 

within a 4.3-mile radius of Palmdale USAF 

Plant 42 Airport. This Class D airspace area 

is effective during the specific dates and 

times established, in advance, by a Notice to 

Airmen. The effective date and time will 

thereafter be continuously published in the 

Chart Supplement. 

Paragraph 6004 Class E Airspace Areas 

Designated as an Extension to a Class D or 

Class E Surface Area. 

* * * * * 

AWP CA E4 Palmdale, CA [Amended] 

Palmdale USAF Plant 42 Airport, CA 

(Lat. 34°37′46′′ N, long. 118°05′04′′ W) 

That airspace extending upward from the 

surface within 1 mile each side of the 270° 

bearing from the airport, extending from the 

4.3-mile radius to 7.5 miles west of Palmdale 

USAF Plant 42 Airport. This Class E airspace 

area is effective during the specific dates and 

times established, in advance, by a Notice to 

Airmen. The effective date and time will 

thereafter be continuously published in the 

Chart Supplement. 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

AWP CA E5 Palmdale, CA [Amended] 

Palmdale USAF Plant 42 Airport, CA 

(Lat. 34°37′46′′ N, long. 118°05′04′′ W) 

That airspace extending upward from 700 

feet above the surface within a 6.8-mile 

radius of the airport, and within 6.1 miles 

each side of the 080° bearing from the airport, 

extending from the 6.8-mile radius to 12.9 

miles east of the airport, and within 4 miles 

north and 8 miles south of the 086° bearing 

from the airport, extending from the airport 

to 14.3 miles east of the airport, and within 

2 miles each side of the 274° bearing from the 

airport, extending from the 6.8-mile radius to 

13.4 miles west of Palmdale USAF Plant 42 

Airport. 

Issued in Seattle, Washington, on February 

16, 2021. 

B.G. Chew, 

Acting Group Manager, Operations Support 

Group, Western Service Center. 

[FR Doc. 2021–03904 Filed 2–26–21; 8:45 am] 

BILLING CODE 4910–13–P 

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)piperidin4-yl)-1,3-dihydro-2H-benzo[d]imidazol2-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). 

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 

Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Rules and Regulations 11863 

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. 

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. 

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. 

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

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 

11864 Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Rules and Regulations 

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. 

7NSDUH, 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. 

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 nonscheduled 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 

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 postmortem 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. 

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 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 

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. 

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 muopioid receptor agonists. Data from in 

vitro studies showed that brorphine 

binds to and activates the mu-opioid 

receptors. In the [35S]GTPgS 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 muopioid 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 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 

Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Rules and Regulations 11865 

8Although 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). 

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. 

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. Nonpractitioners 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 

11866 Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Rules and Regulations 

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-andcomment 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 

■ 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-dihydro-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) .................................................................................................................................................................................................................. 9098 

Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Rules and Regulations 11867 

1EPA has revoked the 1979 and 1997 ozone 

standards. See 69 FR 23951 (April 30, 2004) and 80 

FR 12264 (March 6, 2015), respectively. 

2EPA revised the level of the 8-hour ozone 

standard to 0.070 ppm in 2015 and designated the 

entire state as attainment/unclassifiable for that 

NAAQS in 2017. See 80 FR 65296 (October 22, 

2015) and 82 FR 54232 (November 16, 2017). 

3EPA designated the following geographic areas 

in North Carolina as nonattainment for the 1979 

ozone standard: Davidson, Durham, Forsyth, 

Gaston, Guilford, Mecklenburg, and Wake Counties, 

the Dutchville Township in Granville County, and 

that part of Davie County bounded by the Yadkin 

River, Dutchmans Creek, North Carolina Highway 

801, Fulton Creek and back to the Yadkin River. 

4The geographic areas designated as 

nonattainment in North Carolina for the 1997 ozone 

standard included all geographic areas designated 

as nonattainment for the 1979 ozone standard as 

well as additional areas. The 1997 Charlotte Area 

consists of Cabarrus, Gaston, Lincoln, Mecklenburg, 

Rowan, and Union Counties and Davidson 

Township and Coddle Creek Township in Iredell 

County. 

5The 2008 Charlotte Area is a subset of the 1997 

Charlotte Area and consists of Central Cabarrus 

Township, Concord Township, Georgeville 

Township, Harrisburg Township, Kannapolis 

Township, Midland Township, Mount Pleasant 

Township, New Gilead Township, Odell Township, 

Poplar Tent Township, and Rimertown Township 

in Cabarrus County; Crowders Mountain Township, 

Dallas Township, Gastonia Township, Riverbend 

Township, and South Point Township in Gaston 

County; Davidson Township and Coddle Creek 

Township in Iredell County; Catawba Springs 

Township, Ironton Township, and Lincolnton 

Township in Lincoln County; Atwell Township, 

China Grove Township, Franklin Township, Gold 

Hill Township, Litaker Township, Locke Township, 

Providence Township, Salisbury Township, Steele 

Township, and Unity Township in Rowan County; 

and Goose Creek Township, Marshville Township, 

Monroe Township, Sandy Ridge Township, and 

Vance Township in Union County. 

6See 58 FR 47391 (November 9, 1993), 59 FR 

18300 (April 18, 1994), and 60 FR 34859 (July 5, 

1995). 

* * * * * 

D. Christopher Evans, 

Acting Administrator. 

[FR Doc. 2021–04242 Filed 2–26–21; 8:45 am] 

BILLING CODE 4410–09–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2019–0613; FRL–10019– 

20–Region 4] 

Air Plan Approval; North Carolina: 

Revisions to Annual Emissions 

Reporting 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving a State 

Implementation Plan (SIP) revision 

submitted by the State of North 

Carolina, through the North Carolina 

Department of Environmental Quality, 

Division of Air Quality (DAQ), on July 

10, 2019. The SIP revision modifies the 

State’s annual emissions reporting 

regulation by removing the annual 

emissions reporting requirement for 

certain non-Title V facilities in 

geographic areas that have been 

redesignated to attainment for the 1979 

1-hour ozone national ambient air 

quality standards (‘‘NAAQS’’ or 

‘‘standards’’) and in the areas listed in 

the rule that have been redesignated to 

attainment for the 1997 8-hour ozone 

NAAQS, with the exception of the 

geographic areas that have been 

redesignated to attainment for the 2008 

8-hour ozone NAAQS. The SIP revision 

also makes minor changes that do not 

significantly alter the meaning of the 

regulation. EPA is approving this 

revision pursuant to the Clean Air Act 

(CAA or Act). 

DATES: This rule is effective March 31, 

2021. 

ADDRESSES: EPA has established a 

docket for this action under Docket 

Identification No. EPA–R04–OAR– 

2019–0613. All documents in the docket 

are listed on the www.regulations.gov 

website. Although listed in the index, 

some information may not be publicly 

available, i.e., Confidential Business 

Information or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials can 

either be retrieved electronically via 

www.regulations.gov or in hard copy at 

the Air Regulatory Management Section, 

Air Planning and Implementation 

Branch, Air and Radiation Division, 

U.S. Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW, Atlanta, 

Georgia 30303–8960. EPA requests that, 

if at all possible, you contact the person 

listed in the FOR FURTHER INFORMATION

CONTACT section to schedule your 

inspection. The Regional Office’s 

official hours of business are Monday 

through Friday 8:30 a.m. to 4:30 p.m., 

excluding Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Tiereny Bell, Air Regulatory 

Management Section, Air Planning and 

Implementation Branch, Air and 

Radiation Division, Region 4, U.S. 

Environmental Protection Agency, 61 

Forsyth Street SW, Atlanta, Georgia 

30303–8960. The telephone number is 

(404) 562–9088. Ms. Bell can also be 

reached via electronic mail at 

bell.tiereny@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In 1979, EPA promulgated a NAAQS 

for ozone, setting the standard at 0.12 

parts per million (ppm) averaged over a 

1-hour time frame. See 44 FR 8202 

(February 8, 1979). In 1997, EPA 

promulgated a revised NAAQS for 

ozone, setting the standard at 0.08 ppm 

averaged over an 8-hour time frame. See 

62 FR 38856 (July 18, 1997).1 In 2008, 

EPA revised the level of the 8-hour 

ozone standard to 0.075 ppm. See 73 FR 

16436 (March 27, 2008).2 The 

promulgation of a new or revised 

NAAQS triggers a CAA requirement for 

EPA to designate as nonattainment any 

area that violates the NAAQS or 

contributes to a violation in a nearby 

area. On November 6, 1991, EPA 

published designations and 

classifications for the 1979 1-hour ozone 

NAAQS.3 See 56 FR 56694. EPA initially 

published designations and 

classifications for the revised 1997 8- 

hour and revised 2008 8-hour ozone 

standards on April 30, 2004 (69 FR 

23858) and May 21, 2012 (77 FR 30088), 

respectively. The geographic areas 

designated as nonattainment in North 

Carolina for the 1997 8-hour ozone 

standard included the CharlotteGastonia-Rock Hill, NC-SC Area (the 

North Carolina portion is hereinafter the 

‘‘1997 Charlotte Area’’).4 The geographic 

areas designated as nonattainment in 

North Carolina for the 2008 ozone 

standard are part of an area known as 

the Charlotte-Rock Hill, NC-SC Area 

(the North Carolina portion is 

hereinafter the ‘‘2008 Charlotte Area’’).5

EPA redesignated North Carolina’s 1979 

ozone nonattainment areas to 

attainment in a series of actions from 

1993 to 1995,6 redesignated the 1997 

Charlotte Area to attainment on 

December 2, 2013 (78 FR 72036), and 

redesignated the 2008 Charlotte Area to 

attainment on July 28, 2015 (80 FR 

44873). 

North Carolina was required to 

develop nonattainment SIP revisions 

addressing the CAA requirements for its 

ozone nonattainment areas. Among 

other things, North Carolina was 

required to address the annual 

emissions reporting requirement in CAA 

section 182(a)(3)(B), which requires 

each state with an ozone nonattainment 

area to submit a SIP revision requiring 

stationary sources that emit 25 tons per 

year (tpy) or more of nitrogen oxides 

(NOX) or volatile organic compounds 

(VOC) within the nonattainment area to 

provide certified annual emissions 

statements to the state showing actual 

annual NOX and VOC emissions from 

the sources.