20318 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Rules and Regulations 

1As set forth in a memorandum of understanding 

entered into by the Food and Drug Administration 

(FDA) and the National Institute on Drug Abuse 

(NIDA), FDA acts as the lead agency within HHS 

in carrying out the Secretary’s scheduling 

responsibilities under the CSA, with the 

concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. 

The Secretary of HHS has delegated to the Assistant 

Secretary for Health of HHS the authority to make 

domestic drug scheduling recommendations. 58 FR 

35460, July 1, 1993. 

Authority: 21 U.S.C. 811, 812, 871(b), 

956(b) unless otherwise noted. 

■ 2. In § 1308.14: 

■ a. Redesignate paragraphs (c)(16) 

through (58) as (c)(17) through (59); and 

■ b. Add new paragraph (c)(16). 

■ The addition reads as follows: 

§ 1308.14 Schedule IV. 

* * * * * 

(c) * * * 

(16) Daridorexant ......................................... 2410 

* * * * * 

Anne Milgram, 

Administrator. 

[FR Doc. 2022–07322 Filed 4–6–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–491] 

Schedules of Controlled Substances: 

Placement of 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA, and FUB-144 in Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: By this rule, the Drug 

Enforcement Administration 

permanently places five synthetic 

cannabinoids, as identified in this final 

rule, in schedule I of the Controlled 

Substances Act. These five substances 

are currently listed in schedule I 

pursuant to a temporary scheduling 

order. As a result of this rule, the 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to schedule I controlled substances on 

persons who handle (manufacture, 

distribute, import, export, engage in 

research, conduct instructional 

activities or chemical analysis, or 

possess), or propose to handle these five 

specified controlled substances will 

continue to apply. 

DATES: Effective April 7, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Terrence L. Boos, Drug & Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

3249. 

SUPPLEMENTARY INFORMATION: 

In this final rule, the Drug 

Enforcement Administration (DEA) is 

permanently scheduling the following 

five controlled substances in schedule I 

of the Controlled Substances Act (CSA), 

including their salts, isomers, and salts 

of isomers whenever the existence of 

such salts, isomers, and salts of isomers 

is possible within the specific chemical 

designation: 

• Ethyl 2-(1-(5-fluoropentyl)-1Hindazole-3-carboxamido)-3,3- 

dimethylbutanoate (other name: 5FEDMB-PINACA), 

• Methyl 2-(1-(5-fluoropentyl)-1Hindole-3-carboxamido)-3,3- 

dimethylbutanoate (other names: 5FMDMB-PICA; 5F-MDMB-2201), 

• N-(Adamantan-1-yl)-1-(4- 

fluorobenzyl)-1H-indazole-3- 

carboxamide (other names: FUB-AKB48; 

FUB-APINACA; AKB48 N-(4- 

fluorobenzyl)), 

• 1-(5-Fluoropentyl)-N-(2- 

phenylpropan-2-yl)-1H-indazole-3- 

carboxamide (other names: 5F-CUMYLPINACA; SGT-25), and 

• (1-(4-Fluorobenzyl)-1H-indol-3- 

yl)(2,2,3,3- 

tetramethylcyclopropyl)methanone 

(other name: FUB-144). 

Legal Authority 

The CSA provides that issuing, 

amending, or repealing of the 

scheduling of any drug or other 

substance may be initiated by the 

Attorney General (1) on his own motion; 

(2) at the request of the Secretary of the 

Department of Health and Human 

Services (HHS); 1 or (3) on the petition 

of any interested party. 21 U.S.C. 811(a). 

The then-Acting Administrator of DEA 

(as delegated by the Attorney General to 

the Administrator of DEA) initiated this 

action on his own motion, and is 

supported by, inter alia, a 

recommendation from the then-Acting 

Assistant Secretary for Health of HHS 

and an evaluation of all relevant data by 

DEA. The regulatory controls and 

administrative, civil, and criminal 

sanctions of schedule I controlled 

substances on any person who handles 

(manufactures, distributes, imports, 

exports, engages in research, or 

conducts instructional activities or 

chemical analysis with, or possesses) or 

proposes to handle 5F-EDMB-PINACA, 

5F-MDMB-PICA, FUB-AKB48, 5FCUMYL-PINACA, and FUB-144 will 

continue to apply as a result of this 

action. 

Background 

On April 16, 2019, DEA published an 

order in the Federal Register amending 

21 CFR 1308.11(h) to temporarily place 

ethyl 2-(1-(5-fluoropentyl)-1H-indazole3-carboxamido)-3,3-dimethylbutanoate 

(trivial name: 5F-EDMB-PINACA); 

methyl 2-(1-(5-fluoropentyl)-1H-indole3-carboxamido)-3,3-dimethylbutanoate 

(trivial name: 5F-MDMB-PICA); N- 

(adamantan-1-yl)-1-(4-fluorobenzyl)-1Hindazole-3-carboxamide (trivial names: 

FUB-AKB48; FUB-APINACA; AKB48 N- 

(4-FLUOROBENZYL)); 1-(5- 

fluoropentyl)-N-(2-phenylpropan-2-yl)- 

1H-indazole-3-carboxamide (trivial 

names: 5F-CUMYL-PINACA; SGT-25); 

and (1-(4-fluorobenzyl)-1H-indol-3- 

yl)(2,2,3,3- 

tetramethylcyclopropyl)methanone 

(trivial name: FUB-144) in schedule I of 

the CSA pursuant to the temporary 

scheduling provisions of 21 U.S.C. 

811(h). 84 FR 15505. That temporary 

scheduling order took effect on the date 

of publication, and was based on 

findings by the then-Acting 

Administrator of DEA that the 

temporary scheduling of these five 

synthetic cannabinoids (SCs) was 

necessary to avoid an imminent hazard 

to the public safety pursuant to 21 

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

On March 30, 2021, DEA published a 

notice of proposed rulemaking (NPRM) 

in the Federal Register to permanently 

control the five SCs in schedule I of the 

CSA. 86 FR 16553. On March 31, 2021, 

DEA published an order to extend the 

temporary scheduling of the five SCs by 

one year, until April 16, 2022. 86 FR 

16669. 

DEA and HHS Eight Factor Analyses 

On February 26, 2021, HHS provided 

DEA with a scientific and medical 

evaluation and scheduling 

recommendation, prepared by the Food 

and Drug Administration (FDA), 

entitled ‘‘Basis for the Recommendation 

to Place Ethyl 2-(1-(5-fluoropentyl)-1Hindazole-3-carboxamido)-3,3- 

dimethylbutanoate [5F-EDMB-PINACA]; 

methyl 2-(1-(5-fluoropentyl)-1H-indole3-carboxamido)-3,3-dimethylbutanoate 

[5F-MDMB-PICA]; N-(adamantan-1-yl)- 

1-(4-fluorobenzyl)-1H-indazole-3- 

carboxamide [FUB-AKB48;FUBAPINACA; AKB48 N-(4-fluorobenzyl)]; 

1-(5-fluoropentyl)-N-(2-phenylpropan-2- 

yl)-1H-indazole-3-carboxamide [5FCUMYL-PINACA; SGT-25]; and (1-(4- 

fluorobenzyl)-1H-indol-3-yl)(2,2,3,3- 

tetramethylcyclopropyl)methanone 

[FUB-144; FUB-UR-144] and Their Salts, 

Isomers, and Salts of Isomers in 

Schedule I of the Controlled Substances 

Act.’’ 


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Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Rules and Regulations 20319 

2Although there is no evidence suggesting that 

5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 

5F-CUMYL-PINACA, and FUB-144 have currently 

accepted medical uses 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). 

3 5F-EDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA, and FUB-144 have 

been subject to schedule I controls on a temporary 

basis, pursuant to 21 U.S.C. 811(h), by virtue of the 

April 16, 2019 temporary scheduling order (84 FR 

15505) and the subsequent one year extension of 

that order (March 31, 2021, 86 FR 16669). 

After considering the eight factors in 

21 U.S.C. 811(c), each substance’s abuse 

potential, lack of legitimate medical use 

in the United States, and lack of 

accepted safety for use under medical 

supervision pursuant to 21 U.S.C. 

812(b), the then-Acting Assistant 

Secretary for Health of HHS 

recommended that 5F-EDMB-PINACA, 

5F-MDMB-PICA, FUB-AKB48, 5FCUMYL-PINACA, and FUB-144 be 

placed in schedule I of the CSA. In 

response, DEA conducted its own 

eightfactor analysis of 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 

5F-CUMYL-PINACA, and FUB-144. 

Both DEA and HHS eight-factor 

analyses are available in their entirety in 

the public docket for this rule (Docket 

Number DEA–491) at http://

www.regulations.gov under ‘‘Supporting 

Documents.’’ 

NPRM To Schedule 5F-EDMB-PINACA, 

5F-MDMB-PICA, FUB-AKB48, 5FCUMYL-PINACA and FUB-144 

On March 30, 2021, DEA published 

an NPRM entitled ‘‘Schedules of 

Controlled Substances: Placement of 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA and FUB144 in Schedule I.’’ 86 FR 16553. 

Specifically, the NPRM proposed to add 

the five SCs to the hallucinogenic 

substances list under 21 CFR 

1308.11(d), and assign them paragraph 

numbers 87 through 91 under paragraph 

(d). In addition, the NPRM listed these 

five SCs by their chemical and trivial 

names as follows: 

• (87) Ethyl 2-(1-(5-fluoropentyl)-1Hindazole-3-carboxamido)-3,3- 

dimethylbutanoate (trivial name: 5FEDMB-PINACA); 

• (88) methyl 2-(1-(5-fluoropentyl)- 

1H-indole-3-carboxamido)-3,3- 

dimethylbutanoate (trivial name: 5FMDMB-PICA); 

• (89) N-(adamantan-1-yl)-1-(4- 

fluorobenzyl)-1H-indazole-3- 

carboxamide (trivial names: FUBAKB48; FUB-APINACA; AKB48 N-(4- 

fluorobenzyl)); 

• (90) 1-(5-fluoropentyl)-N-(2- 

phenylpropan-2-yl)-1H-indazole-3- 

carboxamide (trivial names: 5F-CUMYLPINACA; SGT-25); and 

• (91) (1-(4-fluorobenzyl)-1H-indol-3- 

yl)(2,2,3,3- 

tetramethylcyclopropyl)methanone 

(trivial name: FUB-144). 

The NPRM provided an opportunity 

for interested persons to file a request 

for hearing in accordance with DEA 

regulations, as well as to submit 

comments on the proposed rule, on or 

before April 29, 2021. DEA did not 

receive any requests for such a hearing 

or any public comments on the 

proposed rule. 

Scheduling Conclusion 

After considering the scientific and 

medical evaluations and accompanying 

recommendation of HHS, and 

conducting an independent eight-factor 

analysis, DEA finds substantial evidence 

of abuse potential for 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 

5F-CUMYL-PINACA, and FUB-144. 

DEA is therefore permanently 

scheduling 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA, and FUB-144 as controlled 

substances under the CSA. 

Determination of Appropriate Schedule 

The CSA establishes five schedules of 

controlled substances known as 

schedules I, II, III, IV, and V. The CSA 

also outlines the findings required to 

place a drug or other substance in any 

particular schedule. 21 U.S.C. 812(b). 

After consideration of the analysis and 

recommendation of the then-Acting 

Assistant Secretary for Health of HHS 

and review of all other available data, 

the Administrator of DEA, pursuant to 

21 U.S.C. 811(a) and 812(b)(1), finds 

that: 

(1) 5F-EDMB-PINACA, 5F-MDMBPICA, FUB-AKB48, 5F-CUMYLPINACA, and FUB-144 have a high 

potential for abuse that is comparable to 

other schedule I substances such as 

delta-9-tetrahydrocannabinol (D9-THC) 

and JWH-018; 

(2) 5F-EDMB-PINACA, 5F-MDMBPICA, FUB-AKB48, 5F-CUMYLPINACA, and FUB-144 currently have 

no accepted medical use in treatment in 

the United States; 2 and 

(3) There is a lack of accepted safety 

for use of 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA, and FUB-144 under medical 

supervision. 

Based on these findings, the 

Administrator concludes that ethyl 2-(1- 

(5-fluoropentyl)-1H-indazole-3- 

carboxamido)-3,3-dimethylbutanoate 

(other name: 5F-EDMB-PINACA); 

methyl 2-(1-(5-fluoropentyl)-1H-indole3-carboxamido)-3,3-dimethylbutanoate 

(other names: 5F-MDMB-PICA; 5FMDMB-2201); N-(adamantan-1-yl)-1-(4- 

fluorobenzyl)-1H-indazole-3- 

carboxamide (other names: FUB-AKB48; 

FUB-APINACA; AKB48 N-(4- 

fluorobenzyl)); 1-(5-fluoropentyl)-N-(2- 

phenylpropan-2-yl)-1H-indazole-3- 

carboxamide (other names: 5F-CUMYLPINACA; SGT-25); and (1-(4- 

fluorobenzyl)-1H-indol-3-yl)(2,2,3,3- 

tetramethylcyclopropyl)methanone 

(other name: FUB-144), including their 

salts, isomers, and salts of isomers 

whenever the existence of such salts, 

isomers, and salts of isomers is possible 

within the specific chemical 

designation, warrant control in schedule 

I of the CSA. 21 U.S.C. 812(b)(1). 

Summary of Minor Changes in the 

Final Rule 

As discussed in the above NPRM 

section, DEA proposed to place 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA, and FUB144 in 21 CFR 1308.11(d) as paragraphs 

87 through 91, respectively. The NPRM 

listed chemical, as well as trivial, names 

for the five substances. Regarding the 

substance methyl 2-(1-(5-fluoropentyl)- 

1H-indole-3-carboxamido)-3,3- 

dimethylbutanoate, the NPRM listed 

only one trivial name (5F-MDMB-PICA). 

Since the publication of the NPRM, DEA 

has found another trivial name (5FMDMB-2201) for this substance. In 

addition, DEA has issued several final 

rules which updated the numbering of 

listed hallucinogenic substances in 

paragraph (d). As a result, this final rule 

assigns paragraphs 89 through 93 to 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA, and FUB144, respectively. This final rule now 

refers to ‘‘trivial’’ names as ‘‘other’’ 

names, and lists both 5F-MDMB-PICA 

and 5F-MDMB-2201 as other names for 

methyl 2-(1-(5-fluoropentyl)-1H-indole3-carboxamido)-3,3-dimethylbutanoate. 

Requirements for Handling 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 

5F-CUMYL-PINACA, and FUB-144 

5F-EDMB-PINACA, 5F-MDMB-PICA, 

FUB-AKB48, 5F-CUMYL-PINACA, and 

FUB-144 will continue 3 to be subject to 

the CSA’s schedule I regulatory controls 

and administrative, civil, and criminal 

sanctions applicable to the manufacture, 


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20320 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Rules and Regulations 

distribution, dispensing, importing, 

exporting, research, and conduct of 

instructional activities, including the 

following: 

1. Registration. Any person who 

handles, or desires to handle, 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 

5F-CUMYL-PINACA, or FUB-144 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. 

2. Security. 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA, and FUB-144 are subject to 

schedule I security requirements and 

must be handled in accordance with 21 

CFR 1301.71–1301.76. Non-practitioners 

handling these five substances must also 

comply with the employee screening 

requirements of 21 CFR 1301.90– 

1301.93. 

3. Labeling and Packaging. All labels, 

labeling, and packaging for commercial 

containers of 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA, and FUB-144 must be in 

compliance with 21 U.S.C. 825 and 

958(e), and be in accordance with 21 

CFR part 1302. 

4. Quota. Only registered 

manufacturers are permitted to 

manufacture 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA, or FUB-144 in accordance 

with a quota assigned pursuant to 21 

U.S.C. 826 and in accordance with 21 

CFR part 1303. 

5. Inventory. Every DEA registrant 

who possesses any quantity of 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA, and FUB144 was required to keep an inventory 

of all stocks of these substances on hand 

as of April 16, 2019, pursuant to 21 

U.S.C. 827 and 958 and in accordance 

with 21 CFR 1304.03, 1304.04, and 

1304.11(a) and (d). 

6. Records and Reports. Every DEA 

registrant must maintain records and 

submit reports with respect to 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA, and/or 

FUB-144, pursuant to 21 U.S.C. 827 and 

958(e), and in accordance with 21 CFR 

1301.74(b) and (c) and parts 1304, 1312, 

and 1317. Manufacturers and 

distributors must submit reports 

regarding 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA, and/or FUB-144 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. 

7. Order Forms. Every DEA registrant 

who distributes 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA, or FUB-144 must continue to 

comply with the order form 

requirements, pursuant to 21 U.S.C. 828 

and in accordance with 21 CFR part 

1305. 

8. Importation and Exportation. All 

importation and exportation of 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA, and FUB144 must continue to be in compliance 

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

and in accordance with 21 CFR part 

1312. 

9. Liability. Any activity involving 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA, or FUB144 not authorized by, or in violation of, 

the CSA or its implementing regulations 

is unlawful, and may subject the person 

to administrative, civil, and/or criminal 

sanctions. 

Regulatory Analyses 

Executive Orders 12866 (Regulatory 

Planning and Review) and 13563 

(Improving Regulation and Regulatory 

Review) 

In accordance with 21 U.S.C. 811(a), 

this final scheduling action is subject to 

formal rulemaking procedures 

performed ‘‘on the record after 

opportunity for a hearing,’’ which are 

conducted pursuant to the provisions of 

5 U.S.C. 556 and 557. The CSA sets 

forth the criteria for scheduling a drug 

or other substance. Such actions are 

exempt from review by the Office of 

Management and Budget (OMB) 

pursuant to section 3(d)(1) of Executive 

Order (E.O.) 12866 and the principles 

reaffirmed in E.O. 13563. 

Executive Order 12988, Civil Justice 

Reform 

This regulation meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of E.O. 12988 to eliminate 

drafting errors and ambiguity, minimize 

litigation, provide a clear legal standard 

for affected conduct, and promote 

simplification and burden reduction. 

Executive Order 13132, Federalism 

This rulemaking does not have 

federalism implications warranting the 

application of E.O. 13132. The rule does 

not have substantial direct effects on the 

States, on the relationship between the 

national government and the states, or 

the distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

This rule does not have tribal 

implications warranting the application 

of E.O. 13175. It does not have 

substantial direct effects on one or more 

Indian tribes, on the relationship 

between the Federal government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal government and Indian tribes. 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act, 5 

U.S.C. 601–612, has reviewed this final 

rule and by approving it certifies that it 

will not have a significant economic 

impact on a substantial number of small 

entities. On April 16, 2019, DEA 

published an order to temporarily place 

these five substances in schedule I of 

the CSA pursuant to the temporary 

scheduling provisions of 21 U.S.C. 

811(h). 

DEA estimates that all entities 

handling or planning to handle these 

substances have already established and 

implemented the systems and processes 

required to handle 5F-EDMB-PINACA, 

5F-MDMB-PICA, FUB-AKB48, 5FCUMYL-PINACA, and FUB-144 as 

schedule I controlled substances. There 

are currently 28 registrations authorized 

to handle 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA, and/or FUB-144 specifically, 

as well as a number of registered 

analytical labs that are authorized to 

handle schedule I controlled substances 

generally. DEA estimates these 28 

registrations encompass 22 entities. 

Some of these entities are likely to be 

large entities. However, DEA does not 

have information of registrant size and 

the majority of DEA registrants are small 

entities or are employed by small 

entities. Therefore, DEA conservatively 

estimates as many as 22 small entities 

are affected by this rule. 

A review of the 28 registrations 

indicates that all entities that currently 

handle 5F-EDMB-PINACA, 5F-MDMBPICA, FUB-AKB48, 5F-CUMYLPINACA, or FUB-144 also handle other 

schedule I controlled substances, and 

have established and implemented (or 

maintain) the systems and processes 

required to handle 5F-EDMB-PINACA, 

5F-MDMB-PICA, FUB-AKB48, 5FCUMYL-PINACA, or FUB-144. 

Therefore, DEA anticipates that this rule 

will impose minimal or no economic 

impact on a substantial number of small 

entities. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995, 

2 U.S.C. 1501 et seq., DEA has 

determined and certifies that this action 

would not result in any Federal 

mandate that may result ‘‘in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 


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Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Rules and Regulations 20321 

1The regulations implementing WIOA Section 

188 (29 CFR part 38) use the phrases ‘‘on the basis 

of . . . sex’’ and ‘‘based on sex.’’ The relevant 

statutory language (at 29 U.S.C. 3248(a)(2)) uses the 

phrase ‘‘because of . . . sex.’’ These phrases are 

used interchangeably in this notification. 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

1 year * * *.’’ Therefore, neither a 

Small Government Agency Plan nor any 

other action is required under UMRA of 

1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by the Congressional Review 

Act (CRA), 5 U.S.C. 804. However, 

pursuant to the CRA, DEA is submitting 

a copy of this final rule to the 

Government Accountability Office, the 

House, and the Senate under the CRA. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information under the 

Paperwork Reduction Act of 1995. 44 

U.S.C. 3501–3521. This action would 

not impose recordkeeping or reporting 

requirements on state or local 

governments, individuals, businesses, or 

organizations. An agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

Determination To Make Rule Effective 

Immediately 

As indicated above, this rule finalizes 

the schedule I control status of 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA, and FUB144 that has already been in effect for 

over two years by virtue of the April 16, 

2019, temporary scheduling order (84 

FR 15505) and the subsequent one-year 

extension of that order (March 31, 2021, 

86 FR 16669). The April 2019 order was 

effective on the date of publication, and 

was based on findings by the thenActing Administrator that the temporary 

scheduling of these substances was 

necessary to avoid an imminent hazard 

to the public safety pursuant to 21 

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

Because this rule finalizes the control 

status of 5F-EDMB-PINACA, 5F-MDMBPICA, FUB-AKB48, 5F-CUMYLPINACA, and FUB-144 that has already 

been in effect for over two years, it does 

not alter the legal obligations of any 

person who handles these substances. 

Rather, it merely makes permanent the 

current scheduling status and 

corresponding legal obligations. 

Therefore, DEA is making the rule 

effective on the date of publication in 

the Federal Register, as any delay in the 

effective date is unnecessary and would 

be contrary to the public interest. See 5 

U.S.C. 553(d). 

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, 21 CFR 

part 1308 is amended as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

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: 

■ a. Add paragraphs (d)(89) through 

(d)(93); and 

■ b. Remove and reserve paragraphs 

(h)(37) through (41); 

The additions read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(d) * * * 

(89) ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3- 

dimethylbutanoate (other name: 5FEDMB-PINACA) ........................................ 7036 

(90) methyl 2-(1-(5-fluoropentyl)-1Hindole-3-carboxamido)-3,3- 

dimethylbutanoate (other names: 5FMDMB-PICA; 5F-MDMB-2201) ................ 7041 

(91) N-(adamantan-1-yl)-1-(4-fluorobenzyl)- 

1H-indazole-3-carboxamide (other 

names: FUB-AKB48; FUB-APINACA; 

AKB48 N-(4-FLUOROBENZYL)) ............. 7047 

(92) 1-(5-fluoropentyl)-N-(2-phenylpropan2-yl)-1H-indazole-3-carboxamide (other 

names: 5F-CUMYL-PINACA; SGT-25) .... 7083 

(93) (1-(4-fluorobenzyl)-1H-indol-3- 

yl)(2,2,3,3- 

tetramethylcyclopropyl)methanone 

(other name: FUB-144) ............................. 7014 

* * * * * 

Anne Milgram, 

Administrator. 

[FR Doc. 2022–07320 Filed 4–6–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Office of the Secretary 

29 CFR Part 38 

Notification of Interpretation of Section 

188 of the Workforce Innovation and 

Opportunity Act 

AGENCY: Office of the Secretary, Labor. 

ACTION: Notification of interpretation. 

SUMMARY: This Notification is to inform 

the public that, consistent with the 

Supreme Court’s 2020 decision in 

Bostock v. Clayton County and Title IX 

of the Education Amendments of 1972, 

the U.S. Department of Labor (DOL), 

beginning April 7, 2022, will interpret 

the prohibition on discrimination on the 

basis of sex that is codified in Section 

188 of the Workforce Innovation and 

Opportunity Act to include 

discrimination on the basis of sexual 

orientation. DOL will continue to 

interpret and enforce Section 188’s 

prohibition on discrimination on the 

basis of sex to include discrimination on 

the basis of gender identity and 

transgender status. This interpretation 

will guide DOL’s Civil Rights Center in 

processing complaints and conducting 

investigations and compliance reviews, 

but does not determine the outcome in 

any particular case or set of facts. 

DATES: This notification is effective 

April 7, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Naomi Barry-Perez, Director, Civil 

Rights Center, U.S. Department of Labor, 

200 Constitution Ave. NW, Room 

N–4123, Washington, DC 20210. 

SUPPLEMENTARY INFORMATION: DOL is 

informing the public that, consistent 

with the Supreme Court’s decision in 

Bostock v. Clayton County, 140 S. Ct. 

1731 (2020), and Title IX of the 

Education Amendments of 1972, 20 

U.S.C. 1681 et seq., DOL, beginning 

April 7, 2022, will interpret the 

prohibition on discrimination on the 

basis of sex in Section 188 of the 

Workforce Innovation and Opportunity 

Act (WIOA), 29 U.S.C. 3248, to include 

discrimination on the basis of sexual 

orientation.1 DOL will continue to 

interpret and enforce Section 188’s 

prohibition on discrimination on the 

basis of sex to include discrimination on 

the basis of gender identity and 

transgender status, as set forth in the 

regulations issued under Section 188.29 

CFR 38.7. 

The Civil Rights Center (CRC) at DOL 

is responsible for enforcing Section 188 

of WIOA and regulations issued under 

Section 188, which prohibit exclusion 

of an individual from participation in, 

denial of the benefits of, discrimination 

in, or denial of employment in the 

administration of or in connection with, 

any programs and activities funded or 

otherwise financially assisted in whole 

or in part under Title I of WIOA on 

various bases, including sex. 29 U.S.C. 

3248(a). 

On June 15, 2020, the U.S. Supreme 

Court held that the prohibition on 

employment discrimination based on 

sex in Title VII of the Civil Rights Act 

of 1964, 42 U.S.C. 2000e et seq., 

encompasses discrimination based on 

sexual orientation, gender identity, and 

transgender status. The Court concluded 

that the plain meaning of ‘‘because of 


khammond on DSKJM1Z7X2PROD with RULES