86040 Federal Register / Vol. 88, No. 237 / Tuesday, December 12, 2023 / Rules and Regulations 

1Though DEA has used the term ‘‘final order’’ 

with respect to temporary scheduling orders in the 

past, this order adheres to the statutory language of 

21 U.S.C. 811(h), which refers to a ‘‘temporary 

scheduling order.’’ No substantive change is 

intended. 

2 21 U.S.C. 811(h)(1). 

3 21 U.S.C. 811(h)(2). 

ASO AL D Fort Novosel (Ozark), AL 

[Amended] 

Cairns Army Air Field (Fort Novosel), AL 

(Lat. 31°16′33′′ N, long. 85°42′48′′ W) 

That airspace extending upward from the 

surface to and including 2,800 feet MSL 

within a 5-mile radius of lat. 31°18′30′′ N, 

long. 85°42′20′′ W. This Class D airspace area 

is effective during the specific dates and 

times established in advance by a Notice to 

Air Missions. The effective date and time 

will thereafter be continuously published in 

the Chart Supplement. 

* * * * * 

ASO GA D Columbus, GA [Amended] 

Columbus Airport, GA 

(Lat. 32°30′59′′ N, long. 84°56′20′′ W) 

Lawson AAF (Fort Moore) 

(Lat. 32°19′54′′ N, long. 84°59′14′′ W) 

That airspace extending upward from the 

surface to and including 2,900 feet MSL 

within a 4.4-mile radius of the Columbus 

Airport, and that airspace extending upward 

from the surface to and including 2,700 feet 

MSL within a 5.2-mile radius of Lawson 

Army Airfield (Ft. Moore) and that airspace 

within 1 mile each side of the 145° bearing 

from the AAF extending from the 5.2-mile 

radius to 6.8 miles southeast of the AAF. 

This Class D airspace is effective during the 

specific dates and times established in 

advance by a Notice to Air Missions. The 

effective date and time will thereafter be 

continuously published in the Chart 

Supplement. 

* * * * * 

Paragraph 6002 Class E Surface Airspace. 

* * * * * 

ASO AL E2 Fort Novosel (Ozark), AL 

[Amended] 

Columbus Airport, GA 

(Lat. 32°30′59′′ N, long. 84°56′20′′ W) 

Lawson AAF (Fort Moore) 

(Lat. 32°19′54′′ N, long. 84°59′14′′ W) 

That airspace extending upward from the 

surface to and including 2,900 feet MSL 

within a 4.4-mile radius of the Columbus 

Airport. This Class E airspace area is effective 

during the specific dates and times 

established in advance by a Notice to Air 

Missions. 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. 

* * * * * 

ASO MS E5 Columbus, MS [Amended] 

Columbus AFB, MS 

(Lat. 33°38′43′′ N, long. 88°26′45′′ W) 

Monroe County Airport 

(Lat. 33°52′26′′ N, long. 88°29′23′′ W) 

Columbus-Lowndes County Airport 

(Lat. 33°27′55′′ N, long. 88°22′51′′ W) 

Golden Triangle Regional Airport 

(Lat. 33°26′54′′ N, long. 88°35′29′′ W) 

Oktibbeha Airport 

(Lat. 33°29′52′′ N, long. 88°4′53′′ W) 

McCharen Field 

(Lat. 33°35′03′′ N, long. 88°40′00′′ W) 

That airspace extending upward from 700 

feet above the surface within a 10-mile radius 

of Columbus AFB, a 16-mile radius of 

Monroe County Airport, and within a 6.4- 

mile radius of Columbus-Lowndes County 

Airport, and within a 6.6-mile radius of 

Golden Triangle Regional Airport, and within 

a 6.2-mile radius of Oktibbeha Airport, and 

a 6.3-mile radius of McCharen Field. 

* * * * * 

Issued in College Park, Georgia, on 

December 6, 2023. 

Andreese C. Davis, 

Manager, Airspace & Procedures Team South, 

Eastern Service Center, Air Traffic 

Organization. 

[FR Doc. 2023–27195 Filed 12–11–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–1006] 

Schedules of Controlled Substances: 

Temporary Placement of MDMB–4en– 

PINACA, 4F–MDMB–BUTICA, ADB– 

4en–PINACA, CUMYL–PEGACLONE, 

5F–EDMB–PICA, and MMB–FUBICA 

into Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Temporary amendment; 

temporary scheduling order. 

SUMMARY: The Administrator of the Drug 

Enforcement Administration is issuing 

this temporary order to schedule six 

synthetic cannabinoids and their optical 

and geometric isomers, salts, and salts 

of isomers, whenever the existence of 

such isomers and salts is possible, in 

schedule I under the Controlled 

Substances Act. This action is based on 

a finding by the Administrator that the 

placement of these six substances in 

schedule I is necessary to avoid 

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 on 

persons who handle (manufacture, 

distribute, reverse distribute, import, 

export, engage in research, conduct 

instructional activities or chemical 

analysis with, or possess) or propose to 

handle these six specified controlled 

substances. 

DATES: This temporary scheduling order 

is effective December 12, 2023, until 

December 12, 2025. If this order is 

extended or made permanent, the DEA 

will publish a document in the Federal 

Register. 

FOR FURTHER INFORMATION CONTACT: 

Terrence L. Boos, Ph.D., 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: The Drug 

Enforcement Administration (DEA) 

issues a temporary scheduling order 1

(in the form of a temporary amendment) 

to add the following six substances, 

including their optical and geometric 

isomers, salts, and salts of isomers, 

whenever the existence of such isomers 

and salts is possible, to schedule I under 

the Controlled Substances Act (CSA): 

• Methyl 3,3-dimethyl-2-(1-(pent-4- 

en-1-yl)-1H-indazole-3- 

carboxamido)butanoate (Other name: 

MDMB–4en–PINACA), 

• Methyl 2-[[1-(4-fluorobutyl)indole3-carbonyl]amino]-3,3-dimethylbutanoate (Other names: 4F–MDMB– 

BUTICA; 4F–MDMB–BICA), 

• N-(1-amino-3,3-dimethyl-1- 

oxobutan-2-yl)-1-(pent-4-en-1-yl)-1Hindazole-3-carboxamide (Other name: 

ADB–4en–PINACA), 

• 5-Pentyl-2-(2-phenylpropan-2- 

yl)pyrido[4,3-b]indol-1-one (Other 

name: CUMYL–PEGACLONE; SGT– 

151), 

• Ethyl 2-[[1-(5-fluoropentyl)indole-3- 

carbonyl]amino]-3,3-dimethyl-butanoate 

(Other names: 5F–EDMB–PICA; 5F– 

EDMB–2201), and 

• Methyl 2-(1-(4-fluorobenzyl)-1Hindole-3-carboxamido)-3-methyl 

butanoate (Other name: MMB–FUBICA). 

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 the 

Administrator finds that such action is 

necessary to avoid an imminent hazard 

to the public safety.2 In addition, if 

proceedings to control a substance are 

initiated under 21 U.S.C. 811(a)(1) while 

the substance is temporarily controlled 

under section 811(h), the Administrator 

may extend the temporary scheduling 

for up to one year.3


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4 21 U.S.C. 811(h)(1); 21 CFR part 1308. 

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

6The 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. 

7 88 FR 19896. 

8 21 U.S.C. 811(h)(3). 

9 21 U.S.C. 811(h)(1). 

10 21 U.S.C. 812(b)(1). 

11While law enforcement data are not direct 

evidence of abuse, they can lead to an inference that 

drugs have been diverted and abused. See 76 FR 

77330, 77332, Dec. 12, 2011. 

12Although there is no evidence suggesting that 

MDMB–4en–PINACA, 4F–MDMB–BUTICA, ADB– 

4en–PINACA, CUMYL–PEGACLONE, 5F–EDMB– 

PICA, and MMB–FUBICA have a currently accepted 

medical use in treatment in the United States, it 

bears noting that a drug cannot be found to have 

such medical use unless DEA concludes that it 

satisfies a five-part test. Specifically, with respect 

to a drug that has not been approved by FDA, to 

have a currently accepted medical use in treatment 

in the United States, all of the following must be 

demonstrated: i. The drug’s chemistry must be 

known and reproducible; ii. there must be adequate 

safety studies; iii. there must be adequate and wellcontrolled studies proving efficacy; iv. the drug 

must be accepted by qualified experts; and v. the 

scientific evidence must be widely available. 57 FR 

10499, Mar. 26, 1992, pet. for rev. denied, Alliance 

for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 

1135 (D.C. Cir. 1994). 

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. 355.4

Background 

The CSA requires the Administrator 

to notify the Secretary of the 

Department of Health and Human 

Services (HHS) of an intent to place a 

substance in schedule I of the CSA 

temporarily (i.e., to issue a temporary 

scheduling order).5 The Administrator 

transmitted the required notice to the 

Assistant Secretary for Health of HHS 

(Assistant Secretary),6 by letter dated 

January 24, 2022, regarding MDMB– 

4en–PINACA, 4F–MDMB–BUTICA, 

ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA. The Assistant Secretary 

responded to this notice by letter dated 

March 7, 2022, and advised that, based 

on a review by the Food and Drug 

Administration (FDA), there are 

currently no approved new drug 

applications or investigational new drug 

applications for MDMB–4en–PINACA, 

4F–MDMB–BUTICA, ADB–4en– 

PINACA, CUMYL–PEGACLONE, 5F– 

EDMB–PICA, and MMB–FUBICA. The 

Assistant Secretary also stated that HHS 

has no objection to the temporary 

placement of these substances in 

schedule I of the CSA. 

DEA has taken into consideration the 

Assistant Secretary’s comments as 

required by subsection 811(h)(4). DEA 

has found that the control of these six 

synthetic cannabinoids (SCs) in 

schedule I on a temporary basis is 

necessary to avoid an imminent hazard 

to the public safety. MDMB–4en– 

PINACA, 4F–MDMB–BUTICA, ADB– 

4en–PINACA, CUMYL–PEGACLONE, 

5F–EDMB–PICA, and MMB–FUBICA 

currently are not listed in any schedule 

under the CSA, and no exemptions or 

approvals under 21 U.S.C. 355 are in 

effect for these six substances. 

As required by 21 U.S.C. 811(h)(1)(A), 

DEA published a notice of intent (NOI) 

to temporarily schedule MDMB–4en– 

PINACA, 4F–MDMB–BUTICA, ADB– 

4en–PINACA, CUMYL–PEGACLONE, 

5F–EDMB–PICA, and MMB–FUBICA on 

April 4, 2023.7 That NOI discussed 

findings from DEA’s three-factor 

analysis dated April 2023, which DEA 

made available on www.regulations.gov. 

To find that temporarily placing a 

substance in schedule I of the CSA is 

necessary to avoid an imminent hazard 

to the public safety, the Administrator 

must consider three of the eight factors 

set forth in 21 U.S.C. 811(c): The 

substance’s history and current pattern 

of abuse; the scope, duration and 

significance of abuse; and what, if any, 

risk there is to the public health. 

Consideration of these factors includes 

any information indicating actual abuse, 

diversion from legitimate channels, and 

clandestine importation, manufacture, 

or distribution of these substances.8

Substances meeting the statutory 

requirements for temporary scheduling 

may only be placed in schedule I.9

Substances in schedule I have high 

potential for abuse, no currently 

accepted medical use in treatment in the 

United States, and no accepted safety 

for use under medical supervision.10

The DEA’s three-factor analysis and 

the Assistant Secretary’s March 7, 2022, 

letter are available in their entirety 

under the tab ‘‘Supporting Documents’’ 

of the public docket of this action at 

www.regulations.gov. 

Synthetic Cannabinoids 

Synthetic cannabinoids (SCs) are 

substances synthesized in laboratories 

that mimic the biological effects of 

delta-9-tetrahydrocannabinol (THC, 

schedule I), the main psychoactive 

ingredient in marijuana (schedule I). 

SCs were introduced to the designer 

drug market in several European 

countries as ‘‘herbal incense’’ before the 

initial encounter in the United States by 

the U.S. Customs and Border Protection 

(CBP) in November 2008. From 2009, 

abuse of SCs has escalated in the United 

States as evidenced by large numbers of 

law enforcement encounters of SCs 

applied onto plant material and in other 

designer drug products intended for 

human consumption.11 Recent hospital 

reports, scientific publications, and/or 

law enforcement reports demonstrate 

that MDMB–4en–PINACA, 4F–MDMB– 

BUTICA, ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA, and their associated 

designer drug products, are being 

abused for their psychoactive properties 

(see Factors 5 and 6 in DEA’s threefactor analysis). As with many 

generations of SCs encountered since 

2009, the abuse of MDMB–4en– 

PINACA, 4F–MDMB–BUTICA, ADB– 

4en–PINACA, CUMYL–PEGACLONE, 

5F–EDMB–PICA, and MMB–FUBICA is 

negatively impacting communities in 

the United States. 

As noted by DEA and CBP, SCs 

originate from foreign sources, such as 

China. Substances in bulk powder form 

are smuggled via common carrier into 

the United States and find their way to 

clandestine designer drug product 

manufacturing operations located in 

residential neighborhoods, garages, 

warehouses, and other similar 

destinations throughout the country. 

According to online discussion boards 

and law enforcement encounters, 

spraying or mixing the SCs with plant 

material provides a vehicle for the most 

common route of administration— 

smoking (using a pipe, a water pipe, or 

rolling the drug-laced plant material in 

cigarette papers). 

MDMB–4en–PINACA, 4F–MDMB– 

BUTICA, ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA have no accepted 

medical use in treatment in the United 

States.12 Emergency department 

presentations involving MDMB–4en– 

PINACA or CUMYL–PEGACLONE have 

included seizures, sudden collapse, 

involuntary muscle spasms, jerking 

movements, catatonia, and increased 

violence. Multiple deaths have been 

reported involving MDMB–4en– 

PINACA, 4F–MDMB–BUTICA, and 

CUMYL–PEGACLONE. In addition, all 

six SCs have been seized by law 

enforcement in the United States. Use of 

other schedule I SCs (e.g., JWH–018, 

AB–FUBINACA) has resulted in signs of 

addiction and withdrawal. Based on the 

pharmacological similarities between 

MDMB–4en–PINACA, 4F–MDMB– 

BUTICA, ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA and other schedule I SCs 

(e.g., JWH–018, AB–FUBINACA), these 

six SCs are likely to produce signs of 

addiction and withdrawal similar to 


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86042 Federal Register / Vol. 88, No. 237 / Tuesday, December 12, 2023 / Rules and Regulations 

13https://aapcc.org/track/synthetic-cannabinoids. 

those produced by other schedule I SCs 

(e.g., JWH–018, AB–FUBINACA). 

MDMB–4en–PINACA, 4F–MDMB– 

BUTICA, ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA are SCs that have 

pharmacological effects similar to the 

schedule I hallucinogen THC and other 

temporarily and permanently controlled 

schedule I SCs. With no approved 

medical use and limited safety or 

toxicological information, MDMB–4en– 

PINACA, 4F–MDMB–BUTICA, ADB– 

4en–PINACA, CUMYL–PEGACLONE, 

5F–EDMB–PICA, and MMB–FUBICA 

have emerged in the designer drug 

market, and the abuse of these 

substances for their psychoactive 

properties is concerning. 

Factor 4. History and Current Pattern of 

Abuse 

SCs have been developed by 

researchers over the last 30 years as 

tools for investigating the 

endocannabinoid system (e.g., 

determining CB1 and CB2 receptor 

activity). The first encounter of SCs 

intended for illicit use within the 

United States occurred in November 

2008 by CBP. Since then, the popularity 

of SCs as product adulterants and 

objects of abuse has increased as 

evidenced by law enforcement seizures, 

public health information, and media 

reports. 

Research and clinical reports have 

demonstrated that SCs are applied onto 

plant material so that the material may 

be smoked as users attempt to obtain a 

euphoric and psychoactive ‘‘high,’’ 

believed to be similar to marijuana. The 

adulterated products are marketed as 

‘‘legal’’ alternatives to marijuana. 

The designer drug products laced 

with SCs, including MDMB–4en– 

PINACA, 4F–MDMB–BUTICA, ADB– 

4en–PINACA, CUMYL–PEGACLONE, 

5F–EDMB–PICA, and MMB–FUBICA, 

are often sold under the guise of ‘‘herbal 

incense’’ or ‘‘potpourri,’’ using various 

product names, and are routinely 

labeled ‘‘not for human consumption.’’ 

Additionally, these products are 

marketed as a ‘‘legal high’’ or ‘‘legal 

alternative to marijuana’’ and are readily 

available over the internet, in head 

shops, or sold in convenience stores. 

There are incorrect assumptions that 

these products are safe, that these are 

synthetic forms of marijuana, and that 

labeling these products as ‘‘not for 

human consumption’’ is a legal defense 

to criminal prosecution under the 

Controlled Substances Analogue 

Enforcement Act. 

The powder form of SCs is typically 

dissolved in solvents (e.g., acetone) 

before being applied to plant material, 

or dissolved in a propellant intended for 

use in electronic cigarette devices. Law 

enforcement personnel have 

encountered various application 

methods including buckets or cement 

mixers in which plant material and one 

or more SCs are mixed together, or in 

large areas where the plant material is 

spread out so that a dissolved SC 

mixture can be applied directly. Once 

mixed, the SC plant material is then 

allowed to dry before manufacturers 

package the product for distribution, 

ignoring any quality control 

mechanisms to prevent contamination 

or to ensure a uniform concentration of 

the substance in each package. Adverse 

health consequences may also occur 

from directly ingesting the drug during 

the manufacturing process. The failure 

to adhere to any manufacturing 

standards with regard to amounts, the 

substance(s) included, purity, or 

contamination may further increase the 

risk of adverse events. However, it is 

important to note that adherence to 

manufacturing standards would not 

eliminate their potential to produce 

adverse effects because the toxicity and 

safety profiles of these SCs have not 

been studied. MDMB–4en–PINACA, 

4F–MDMB–BUTICA, ADB–4en– 

PINACA, CUMYL–PEGACLONE, 5F– 

EDMB–PICA, and MMB–FUBICA, 

similar to other schedule I SCs (e.g., 

JWH–018, AB–FUBINACA), have been 

found in powder form or mixed with 

dried leaves or herbal blends that were 

marketed for human use. 

Following their manufacture in China, 

SCs are often encountered in countries, 

including New Zealand, Australia, and 

Russia, before appearing throughout 

Europe and, eventually, in the United 

States. Law enforcement in the United 

States has encountered MDMB–4en– 

PINACA, 4F–MDMB–BUTICA, ADB– 

4en–PINACA, CUMYL–PEGACLONE, 

5F–EDMB–PICA, and MMB–FUBICA, 

and has documented the abuse of these 

substances. SCs and their associated 

products are available over the internet 

and sold in gas stations, convenience 

stores, and tobacco and head shops. 

MDMB–4en–PINACA, 4F–MDMB– 

BUTICA, ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA, similar to the 

previously scheduled SCs, have been 

seized alone and/or laced on products 

that are marketed under the guise of 

‘‘herbal incense’’ and promoted as a 

‘‘legal’’ alternative to marijuana. 

CUMYL–PEGACLONE was detailed 

in a patent published in 2014, was first 

reported as an adulterated plant 

material in Germany in December 2016, 

and appeared in the United States in 

September 2018. These data further 

support the trend that SCs often appear 

in the illicit drug markets of other 

countries, including those in Europe, 

before being reported in the United 

States. Law enforcement has seized 

CUMYL–PEGACLONE, and the 

substance’s abuse has been associated 

with overdoses requiring emergency 

medical intervention. Adverse effects 

reported following the abuse of 

CUMYL–PEGACLONE have included 

seizures followed by collapse and 

deaths. CUMYL–PEGACLONE has also 

been encountered laced onto paper in 

attempts to be smuggled inside of prison 

facilities. 

Users abuse SCs by smoking for the 

purpose of achieving intoxication, 

which has resulted in numerous 

emergency department visits and calls 

to poison centers. As reported by the 

American Association of Poison Control 

Centers (AAPCC), severe, lifethreatening health effects, including 

severe agitation and anxiety, nausea, 

vomiting, seizures, and hallucinations, 

can occur following ingestion of SCs. 

The AAPCC has specifically noted that 

SCs are made specifically to be 

abused.13 Emergency department 

presentations involving MDMB–4en– 

PINACA or CUMYL–PEGACLONE have 

included seizures, sudden collapse, 

involuntary muscle spasms, jerking 

movements, catatonia, or increased 

violence. Multiple deaths have been 

reported involving MDMB–4en– 

PINACA, 4F–MDMB–BUTICA, and 

CUMYL–PEGACLONE (see Factor 6 in 

DEA’s three-factor analysis). 

Factor 5. Scope, Duration, and 

Significance of Abuse 

Novel SCs substances, differing only 

by small chemical structural 

modifications intended to avoid 

prosecution while maintaining the 

pharmacological effects, continue to be 

sold on the illicit drug market as 

evidence by law enforcement 

encounters of these substances. Law 

enforcement and health care 

professionals continue to report the 

abuse of these substances and their 

associated products. The threat of 

serious injury to the individual and the 

imminent threat to public safety 

following the ingestion of MDMB–4en– 

PINACA, 4F–MDMB–BUTICA, ADB– 

4en–PINACA, CUMYL–PEGACLONE, 

5F–EDMB–PICA, MMB–FUBICA, and 

other SCs persist. 

Additional information obtained 

through the National Forensic 

Laboratory Information System 


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14NFLIS is a national forensic laboratory 

reporting system that systematically collects results 

from drug chemistry analyses conducted by State 

and local forensic laboratories in the United States. 

15At the time of query (March 16, 2022), 2021 

and 2022 data were still reporting. 

(NFLIS),14 along with additional data, 

may be found in DEA’s three-factor 

analysis. According to NFLIS data,15

state and local forensic laboratories have 

detected the following information 

about the SCs in question: 

• MDMB–4en–PINACA was 

identified in 9,566 NFLIS reports since 

2019. In addition, MDMB–4en–PINACA 

was identified in five exhibits mixed 

with heroin and/or fentanyl and 

packaged for sale as suspected heroin. 

• 4F–MDMB–BUTICA was identified 

in 385 NFLIS reports since 2020. 4F– 

MDMB–BUTICA was also identified in 

one exhibit in a pill form, mixed with 

methamphetamine and a synthetic 

cathinone known as eutylone. 

• CUMYL–PEGACLONE was 

identified in two CBP drug seizures in 

2018 and 2021, respectively. 

• 5F–EDMB–PICA was identified in 

106 NFLIS reports since 2020. 

• MMB–FUBICA was identified in 

397 NFLIS reports since 2016. 

Factor 6. What, if Any, Risk There Is to 

the Public Health 

Since first being identified in the 

United States in 2008, the ingestion of 

SCs continues to result in serious 

adverse effects. Details of these events 

involving MDMB–4en–PINACA and 

CUMYL–PEGACLONE are summarized 

below (for additional information and 

citations, see Factors 5 and 6 in DEA’s 

three-factor analysis). 

1. In October 2017 in France, two 16- 

year-old juveniles were given a cigarette 

laced with white powder by an 

unknown individual. Upon arrest of the 

dealer, he stated the powder was SGT– 

151. Both juveniles developed seizures 

followed by collapse. Toxicological 

analysis of both victim’s blood and 

blood collected from the arrested dealer 

(who claimed to be a user of the same 

powder) confirmed the presence of 

CUMYL–PEGACLONE (SGT–151) and 

its metabolite, N-dealkyl CUMYL– 

PEGACLONE. 

2. Between January and December 

2017 in Germany, CUMYL– 

PEGACLONE was detected in 34 

forensic serum/blood samples from fatal 

and non-fatal cases. Of these cases, six 

deaths were reported by the Institute of 

Forensic Medicine in Munich and the 

Institute of Forensic Medicine in Mainz, 

respectively. Details of the deaths 

demonstrated multiple factors in 

addition to SCs as possible causes of 

death. 

3. Between July 1, 2018, and 

December 31, 2020, in Northern 

Australia, CUMYL–PEGACLONE was 

detected in five deaths. Concurrent 

alcohol use and underlying 

cardiovascular disease were considered 

relevant factors in most cases. 

4. In September 2019, the Center for 

Forensic Science Research and 

Education released a report detailing the 

identification of MDMB–4en–PINACA 

in biological fluids per their toxicology 

department. 

5. In February 2020, local law 

enforcement in Holyoke, Massachusetts, 

reported serious adverse effects 

following the abuse of the contents in 

glassine bags with suspected heroin. 

Analysis of contents in the bags 

confirmed the presence of MDMB–4en– 

PINACA. Per law enforcement witnesses 

to the overdoses, individuals were 

experiencing involuntary body/muscle 

spasms and movements that appeared 

similar to a seizure, although more 

violent. Victims were alert and 

conscious, and they appeared to be 

under the influence of some unknown 

narcotics at the time, with officers 

noting that what was observed was 

nothing like a typical heroin overdose. 

Victims described it like being under 

the influence of phencyclidine 

(schedule II substance) or something 

similar. In some cases, people were 

violent and emergency personnel were 

having a difficult time providing 

medical attention to these individuals. 

Emergency personnel also described 

very high heart rates and blood 

pressure. Some individuals were acting 

erratic and running in and out of traffic. 

6. In March 2021, a forensic 

toxicology report from the Defense 

Health Agency reported the presence of 

ADB–BUTINACA, ADB–BUTINACA Nbutanoic acid (a metabolite of ADB– 

BUTINACA), and MDMB–4en–PINACA 

3,3-dimethylbutanoic acid (a metabolite 

of MDMB–4en–PINCA) in a submitted 

urine specimen. 

7. MDMB–4en–PINACA and/or its 

metabolite were detected in 25 forensic 

investigation cases between August 

2019 and March 2020. The first positive 

sample was collected in May 2019. The 

majority of cases (n = 16, 64%) were 

submitted from postmortem 

investigations, followed by eight cases 

from suspected clinical toxicology 

investigations, and one case from an 

impaired driving investigation. 

Because they share pharmacological 

similarities with schedule I substances 

(D9-THC, JWH–018, and other 

temporarily and permanently controlled 

schedule I SCs), MDMB–4en–PINACA, 

4F–MDMB–BUTICA, ADB–4en– 

PINACA, CUMYL–PEGACLONE, 5F– 

EDMB–PICA, and MMB–FUBICA pose 

serious risks to an abuser. Tolerance to 

SCs may develop fairly rapidly with 

larger doses being required to achieve 

the desired effect. Acute and chronic 

abuse of SCs in general have been 

linked to adverse health effects 

including signs of addiction and 

withdrawal, numerous reports of 

emergency department admissions, and 

overall toxicity and deaths. Psychiatric 

case reports have been reported in the 

scientific literature detailing the SC 

abuse and associated psychoses (see 

Factor 6 in DEA’s three-factor analysis). 

As abusers obtain these drugs through 

unknown sources, the identity and 

purity of these substances is uncertain 

and inconsistent, thus posing significant 

adverse health risks to users. 

MDMB–4en–PINACA, 4F–MDMB– 

BUTICA, ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA are being encountered 

on the illicit drug market and have no 

accepted medical use in the United 

States. Regardless, these products 

continue to be easily available and 

abused by diverse populations. 

Finding of Necessity of Schedule I 

Placement To Avoid Imminent Hazard 

to Public Safety 

In accordance with 21 U.S.C. 

811(h)(3), based on the available data 

and information summarized above, the 

uncontrolled manufacture, distribution, 

reverse distribution, importation, 

exportation, conduct of research and 

chemical analysis with, possession, 

and/or abuse of MDMB–4en–PINACA, 

4F–MDMB–BUTICA, ADB–4en– 

PINACA, CUMYL–PEGACLONE, 5F– 

EDMB–PICA, and MMB–FUBICA pose 

an imminent hazard to the public safety. 

DEA is not aware of any currently 

accepted medical uses for these 

substances in the United States. A 

substance meeting the statutory 

requirements for temporary scheduling, 

found in 21 U.S.C. 811(h)(1), may only 

be placed in schedule I. Substances in 

schedule I are those that have a high 

potential for abuse, no currently 

accepted medical use in treatment in the 

United States, and a lack of accepted 

safety for use under medical 

supervision. Available data and 

information for MDMB–4en–PINACA, 

4F–MDMB–BUTICA, ADB–4en– 

PINACA, CUMYL–PEGACLONE, 5F– 

EDMB–PICA, and MMB–FUBICA 

indicate that these substances have a 

high potential for abuse, no currently 

accepted medical use in treatment in the 

United States, and a lack of accepted 

safety for use under medical 

supervision. 


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86044 Federal Register / Vol. 88, No. 237 / Tuesday, December 12, 2023 / Rules and Regulations 

16 88 FR 19896. 

17 21 U.S.C. 811(h)(1) and (2). 

18 21 U.S.C. 811. 

19 21 U.S.C. 877. 

20 21 U.S.C. 811(h)(6). 

As required by 21 U.S.C. 811(h)(4), 

the Administrator transmitted to the 

Assistant Secretary for Health, via a 

letter dated January 24, 2022, notice of 

her intent to place MDMB–4en– 

PINACA, 4F–MDMB–BUTICA, ADB– 

4en–PINACA, CUMYL–PEGACLONE, 

5F–EDMB–PICA, and MMB–FUBICA in 

schedule I on a temporary basis. HHS 

had no objection to the temporary 

placement of these substances in 

schedule I. 

DEA subsequently published a NOI in 

the Federal Register on April 4, 2023.16

Conclusion 

In accordance with 21 U.S.C. 

811(h)(1) and (3), the Administrator 

considered available data and 

information, herein set forth the 

grounds for her determination that it is 

necessary to temporarily place MDMB– 

4en–PINACA, 4F–MDMB–BUTICA, 

ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA in schedule I of the CSA, 

and finds that placement of these 

substances in schedule I of the CSA is 

necessary in order to avoid an imminent 

hazard to the public safety. 

This temporary order scheduling 

these substances will be effective on the 

date the order is published in the 

Federal Register and remain in effect for 

two years, with a possible extension of 

one year, pending completion of the 

regular (permanent) scheduling 

process.17

The CSA sets forth specific criteria for 

scheduling a drug or other substance. 

Permanent 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 

557.18 The permanent 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.19 Temporary scheduling orders 

are not subject to judicial review.20

Requirements for Handling 

Upon the effective date of this 

temporary order, MDMB–4en–PINACA, 

4F–MDMB–BUTICA, ADB–4en– 

PINACA, CUMYL–PEGACLONE, 5F– 

EDMB–PICA, and MMB–FUBICA 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 (possesses, manufactures, 

distributes, reverse distributes, imports, 

exports, engages in research, or 

conducts instructional activities or 

chemical analysis with), or desires to 

handle, MDMB–4en–PINACA, 4F– 

MDMB–BUTICA, ADB–4en–PINACA, 

CUMYL–PEGACLONE, 5F–EDMB– 

PICA, or MMB–FUBICA must be 

registered with the 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 

December 12, 2023. Any person who 

currently handles MDMB–4en–PINACA, 

4F–MDMB–BUTICA, ADB–4en– 

PINACA, CUMYL–PEGACLONE, 5F– 

EDMB–PICA, or MMB–FUBICA, and is 

not registered with the DEA, must 

submit an application for registration 

and may not continue to handle 

MDMB–4en–PINACA, 4F–MDMB– 

BUTICA, ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA as of December 12, 2023, 

unless the 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 these 

substances in a manner not authorized 

by the CSA on or after December 12, 

2023 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 

MDMB–4en–PINACA, 4F–MDMB– 

BUTICA, ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, or 

MMB–FUBICA must surrender all 

currently held quantities of these six 

substances. 

3. Security. MDMB–4en–PINACA, 

4F–MDMB–BUTICA, ADB–4en– 

PINACA, CUMYL–PEGACLONE, 5F– 

EDMB–PICA, and MMB–FUBICA are 

subject to schedule I security 

requirements and must be handled in 

accordance with 21 CFR 1301.71– 

1301.93, as of December 12, 2023. 

4. Labeling and Packaging. All labels, 

labeling, and packaging for commercial 

containers of MDMB–4en–PINACA, 4F– 

MDMB–BUTICA, ADB–4en–PINACA, 

CUMYL–PEGACLONE, 5F–EDMB– 

PICA, and MMB–FUBICA must comply 

with 21 U.S.C. 825 and 958(e), and 21 

CFR part 1302. Current DEA registrants 

shall have 30 calendar days from 

December 12, 2023 to comply with all 

labeling and packaging requirements. 

5. Inventory. Every DEA registrant 

who possesses any quantity of MDMB– 

4en–PINACA, 4F–MDMB–BUTICA, 

ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA 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 MDMB–4en– 

PINACA, 4F–MDMB–BUTICA, ADB– 

4en–PINACA, CUMYL–PEGACLONE, 

5F–EDMB–PICA, and MMB–FUBICA) 

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 

MDMB–4en–PINACA, 4F–MDMB– 

BUTICA, ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA pursuant to 21 U.S.C. 

827 and 958(e), and in accordance with 

21 CFR parts 1304, 1312, 1317 and 

section 1307.11. Current DEA registrants 

authorized to handle these six 

substances 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 must 

submit reports with respect to MDMB– 

4en–PINACA, 4F–MDMB–BUTICA, 

ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA pursuant to 21 U.S.C. 

827, and in accordance with 21 CFR 

1304, 1312, and 1317, and sections 

1301.74(c) and 1301.76(b), as of 

December 12, 2023. Manufacturers and 

distributors must also submit reports 

regarding these six substances to the 

Automation of Reports and 

Consolidated Order System pursuant to 

21 U.S.C. 827 and in accordance with 21 

CFR parts 1304 and 1312. 

8. Order Forms. All DEA registrants 

who distribute MDMB–4en–PINACA, 

4F–MDMB–BUTICA, ADB–4en– 

PINACA, CUMYL–PEGACLONE, 5F– 

EDMB–PICA, and MMB–FUBICA must 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 88, No. 237 / Tuesday, December 12, 2023 / Rules and Regulations 86045 

21 21 U.S.C. 811(h)(1). 22 5 U.S.C. 551(6) (emphasis added). 

comply with order form requirements 

pursuant to 21 U.S.C. 828 and in 

accordance with 21 CFR part 1305 as of 

December 12, 2023. 

9. Importation and Exportation. All 

importation and exportation of MDMB– 

4en–PINACA, 4F–MDMB–BUTICA, 

ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA must be in compliance 

with 21 U.S.C. 952, 953, 957, and 958, 

and in accordance with 21 CFR part 

1312 as of December 12, 2023. 

10. Quota. Only DEA registered 

manufacturers may manufacture 

MDMB–4en–PINACA, 4F–MDMB– 

BUTICA, ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA in accordance with a 

quota assigned pursuant to 21 U.S.C. 

826, and in accordance with 21 CFR 

part 1303, as of December 12, 2023. 

11. Liability. Any activity involving 

MDMB–4en–PINACA, 4F–MDMB– 

BUTICA, ADB–4en–PINACA, CUMYL– 

PEGACLONE, 5F–EDMB–PICA, and 

MMB–FUBICA not authorized by, or in 

violation of the CSA, occurring as of 

December 12, 2023, is unlawful and 

may subject the person to 

administrative, civil, and/or criminal 

sanctions. 

Regulatory Matters 

The CSA provides for expedited 

temporary scheduling actions where 

necessary to avoid imminent hazards to 

the public safety. Under 21 U.S.C. 

811(h), the Administrator, as delegated 

by the Attorney General, may, by order, 

temporarily schedule substances in 

schedule I. Such orders may not be 

issued before the expiration of 30 days 

from: (1) the publication of a notice in 

the Federal Register of the intent to 

issue such order and the grounds upon 

which such order is to be issued, and (2) 

the date that notice of the proposed 

temporary scheduling order is 

transmitted to the Assistant Secretary 

for Health of HHS, as delegated by the 

Secretary of HHS.21

Inasmuch as section 811(h) directs 

that temporary scheduling actions be 

issued by order (as distinct from a rule) 

and sets forth the procedures by which 

such orders are to be issued, including 

the requirement to publish in the 

Federal Register a notice of intent, the 

notice-and-comment requirements of 

section 553 of the Administrative 

Procedure Act (APA), 5 U.S.C. 553, 

which are applicable to rulemaking, do 

not apply to this temporary scheduling 

order. The APA expressly differentiates 

between orders and rules, 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.’’ 22 The specific language 

chosen by Congress indicates its intent 

that DEA issue orders instead of 

proceeding by rulemaking when 

temporarily scheduling substances. 

Given that Congress specifically 

requires the Administrator (as delegated 

by the Attorney General) to follow 

rulemaking procedures for other kinds 

of scheduling actions, see 21 U.S.C. 

811(a), it is noteworthy that, in section 

811(h), 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 

Administrator finds that there is good 

cause to forgo its notice-and-comment 

requirements, as any further delays in 

the process for issuing temporary 

scheduling orders would be 

impracticable and contrary to the public 

interest given the manifest urgency to 

avoid imminent hazards to 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 Administrator took 

into consideration comments submitted 

by the Assistant Secretary in response to 

the notices 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 14094, 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, sec. 3(f), as amended by 

E.O. 14094, sec. 1(b), provides the 

definition of a ‘‘significant regulatory 

action,’’ requiring review by the Office 

of Management and Budget. 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. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on December 7, 2023, by Administrator 

Anne Milgram. That document with the 

original signature and date is 

maintained by DEA. For administrative 

purposes only, and in compliance with 

requirements of the Office of the Federal 

Register, the undersigned DEA Federal 

Register Liaison Officer has been 

authorized to sign and submit the 

document in electronic format for 

publication, as an official document of 

DEA. This administrative process in no 

way alters the legal effect of this 

document upon publication in the 

Federal Register. 

Scott Brinks, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

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, the 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 paragraphs (h)(62) 

to (h)(67) to read as follows: 

§ 1308.11 Schedule I 

* * * * * 

(h) * * * 


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86046 Federal Register / Vol. 88, No. 237 / Tuesday, December 12, 2023 / Rules and Regulations 

*******

(62) Methyl 3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-indazole-3-carboxamido)butanoate, its optical and geometric isomers, salts and 

salts of isomers (Other name: MDMB–4en–PINACA) .............................................................................................................................. 7090 

(63) Methyl 2-[[1-(4-fluorobutyl)indole-3-carbonyl]amino]-3,3-dimethyl-butanoate, its optical and geometric isomers, salts and salts 

of isomers (Other names: 4F–MDMB–BUTICA; 4F–MDMB–BICA) ........................................................................................................ 7091 

(64) N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(pent-4-en-1-yl)-1H-indazole-3-carboxamide, its optical and geometric isomers, 

salts and salts of isomers (Other name: ADB–4en–PINACA) .................................................................................................................. 7092 

(65) 5-Pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3-b]indol-1-one, its optical and geometric isomers, salts and salts of isomers (Other 

names: CUMYL–PEGACLONE; SGT–151) ................................................................................................................................................ 7093 

(66) Ethyl 2-[[1-(5-fluoropentyl)indole-3-carbonyl]amino]-3,3-dimethyl-butanoate, its optical and geometric isomers, salts and salts 

of isomers (Other names: 5F–EDMB–PICA; 5F–EDMB–2201) ................................................................................................................. 7094 

(67) Methyl 2-(1-(4-fluorobenzyl)-1H-indole-3-carboxamido)-3-methyl butanoate, its optical and geometric isomers, salts and salts 

of isomers (Other name: MMB–FUBICA) .................................................................................................................................................. 7095 

[FR Doc. 2023–27243 Filed 12–11–23; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2023–0949] 

RIN 1625–AA00 

Safety Zone; Kaneohe Bay, Oahu, HI— 

Navy P8 Aircraft Salvage Operations 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a 0.5 nautical mile radius 

temporary safety zone for navigable 

waters in Kaneohe Bay, HI 

encompassing the partially submerged 

Navy P8 aircraft. The safety zone is 

needed to protect personnel, vessels, 

and the marine environment from 

potential hazards created by salvage 

operations of the Navy P8 aircraft. Entry 

of vessels or persons into this zone is 

prohibited unless specifically 

authorized by the Captain of the Port, 

Sector Honolulu. 

DATES: This rule is effective without 

actual notice from December 12, 2023 

through December 10, 2023. For the 

purposes of enforcement, actual notice 

will be used from December 2, 2023. 

This rule will be enforced each day it is 

in effect from 7 a.m. to 6 p.m. December 

12, 2023. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2023– 

0949 in the search box and click 

‘‘Search.’’ Next, in the Document Type 

column, select ‘‘Supporting & Related 

Material.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this rule, call 

or email Chief Petty Officer Bradley 

Lindsey, Waterways Management 

Division, U.S. Coast Guard Sector 

Honolulu; telephone 808–541–4363, 

bradley.w.lindsey@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule without prior notice and 

opportunity to comment pursuant to 

authority under section 4(a) of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because it 

would be impracticable and contrary to 

the public interest. The Coast Guard was 

unable to publish an NPRM and hold a 

reasonable comment period for this 

rulemaking due to the emergent nature 

and logistical coordination of salvage 

operations. It is impracticable to publish 

an NPRM because we must establish 

this safety zone by December 2, 2023. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. Delaying the effective date of 

this rule would be impracticable 

because immediate action is needed to 

respond to remove the existing threat to 

the environment and safeguard against 

future potential threat to the 

environment as well as safety hazards 

associated with emergency salvage 

operations of the Navy P8 aircraft. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 46 U.S.C. 70034. The 

Captain of the Port Sector Honolulu 

(COTP) has determined that potential 

hazards associated with emergency 

salvage operations starting December 2, 

2023, will be a safety concern for 

anyone within a 0.5 nautical mile radius 

of the Navy P8 aircraft. This rule is 

needed to protect personnel, vessels, 

and the marine environment in the 

navigable waters within the safety zone 

while salvage operations take place. 

IV. Discussion of the Rule 

This rule establishes a safety zone 

from 7 a.m. until 6 p.m. on December 

2, 2023, through December 10, 2023. 

The Coast Guard is establishing a 0.5 

nautical mile radius temporary safety 

zone for navigable waters in Kaneohe 

Bay, HI encompassing the partially 

submerged Navy P8 aircraft. The 

duration of the zone is intended to 

protect personnel, vessels, and the 

marine environment in these navigable 

waters while the aircraft is being 

salvaged. No vessel or person will be 

permitted to enter the safety zone 

without obtaining permission from the 

COTP or a designated representative. 

V. Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

Executive orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

Executive orders, and we discuss First 

Amendment rights of protestors. 

A. Regulatory Planning and Review 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits. 

This rule has not been designated a 

‘‘significant regulatory action,’’ under 

section 3(f) of Executive Order 12866, as 

amended by Executive Order 14094 

(Modernizing Regulatory Review). 


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