30772 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules and Regulations 

contains a stage 7 port, P/N 2614M30P01, 

with a port casting serial number (S/N) listed 

in Table 1 in Planning Information, 

Paragraph 3.A., of CFM Service Bulletin (SB) 

LEAP–1A–72–00–0421–01A–930A–D, Issue 

001, dated October 22, 2020. 

(d) Subject 

Joint Aircraft System Component (JASC) 

Code 7250, Turbine Section. 

(e) Unsafe Condition 

This AD was prompted by a report of a 

manufacturing quality escape found during 

inspection of an HPT case. The FAA is 

issuing this AD to prevent failure of the HPT 

case. The unsafe condition, if not addressed, 

could result in failure of the HPT case, 

uncontained rotor release, damage to the 

engine, and damage to the airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Required Actions 

Before the HPT case exceeds the cycles 

since new limit in Table 1, Planning 

Information, Paragraph 3.A., of CFM SB 

LEAP–1A–72–00–0421–01A–930A–D, Issue 

001, dated October 22, 2020, or during the 

next piece part exposure, whichever occurs 

first after the effective date of this AD, 

remove the affected HPT case from service 

and replace with a part eligible for 

installation. 

(h) Definitions 

For the purpose of this AD: 

(1) A part eligible for installation is an HPT 

case, P/N 2668M94G01, that contains a stage 

7 port, P/N 2614M30P01, with an S/N that 

is not listed in Table 1 in Planning 

Information, Paragraph 3.A., of CFM SB 

LEAP–1A–72–00–0421–01A–930A–D, Issue 

001, dated October 22, 2020. 

(2) Piece-part exposure is when the HPT 

case is removed from the engine and fully 

disassembled. 

(i) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, ECO Branch, FAA, has 

the authority to approve AMOCs for this AD, 

if requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the certification office, 

send it to the attention of the person 

identified in Related Information. You may 

email your request to: ANE-AD-AMOC@

faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(j) Related Information 

For more information about this AD, 

contact Christopher McGuire, Aviation Safety 

Engineer, ECO Branch, FAA, 1200 District 

Avenue, Burlington, MA 01803; phone: (781) 

238–7120; fax: (781) 238–7199; email: 

Chris.McGuire@faa.gov. 

(k) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(i) CFM Service Bulletin LEAP–1A–72–00– 

0421–01A–930A–D, Issue 001, dated October 

22, 2020. 

(ii) [Reserved] 

(3) For CFM service information identified 

in this AD, contact CFM International, S.A., 

Aviation Operations Center, 1 Neumann 

Way, M/D Room 285, Cincinnati, OH 45125; 

phone: (877) 432–3272; email: 

aviation.fleetsupport@ge.com. 

(4) You may view this service information 

at FAA, Airworthiness Products Section, 

Operational Safety Branch, 1200 District 

Avenue, Burlington, MA 01803. For 

information on the availability of this 

material at the FAA, call (781) 238–7759. 

(5) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, 

email: fedreg.legal@nara.gov, or go to: 

https://www.archives.gov/federal-register/cfr/ 

ibr-locations.html. 

Issued on May 21, 2021. 

Lance T. Gant, 

Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2021–12137 Filed 6–9–21; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–715] 

Schedules of Controlled Substances: 

Placement of Oliceridine in Schedule II 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: This final rule adopts, with a 

change as mentioned below, an interim 

final rule with request for comments 

published in the Federal Register on 

October 30, 2020, placing oliceridine, N- 

[(3-methoxythiophen-2-yl)methyl]({2- 

[(9R)-9-(pyridin-2-yl)-6- 

oxaspiro[4.5]decan-9-yl]ethyl})amine 

fumarate, 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 II of the Controlled 

Substances Act. In response to an error 

in the chemical name of oliceridine as 

noted by one of the commenters to the 

interim final rule, the Drug Enforcement 

Administration makes a correction to 

the above mentioned chemical name of 

oliceridine by removing the word 

‘‘fumarate’’ to read as N-[(3- 

methoxythiophen-2-yl)methyl]({2-[(9R)- 

9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9- 

yl]ethyl}amine. This change clarifies the 

control of oliceridine free base and its 

salts, to include the fumarate salt, by 

definition. 

DATES: Effective July 12, 2021. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Terrence L. Boos, Drug and Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

3249. 

SUPPLEMENTARY INFORMATION: 

Background and Legal Authority 

On October 30, 2020, the Drug 

Enforcement Administration (DEA), 

pursuant to 21 U.S.C. 811(j), published 

an interim final rule (IFR) to place 

oliceridine (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), a medication 

approved recently by the Food and Drug 

Administration (FDA) for medical use as 

an intravenous drug for the management 

of acute pain severe enough to require 

an intravenous opioid analgesic and for 

patients for whom alternative treatments 

are inadequate, in schedule II of the 

Controlled Substances Act (CSA). 85 FR 

68749. The IFR provided an opportunity 

for interested persons to submit 

comments, as well as file a request for 

hearing or waiver of hearing, on or 

before November 30, 2020. DEA 

received three comments and did not 

receive any requests for hearing or 

waiver of hearing. 

Comments Received 

In response to the IFR, DEA received 

three comments. The submissions were 

from individuals or anonymous 

commenters. One commenter suggested 

that oliceridine be placed in schedule III 

rather than schedule II, one commenter 

had a statement on the controlled name, 

and the third commenter discussed 

another substance entirely that was 

unrelated to oliceridine. As such, the 

third comment was outside the scope of 

this current scheduling action. 

Comment: One commenter suggested 

that oliceridine be placed in schedule III 

of the CSA, rather than schedule II. The 

commenter mentioned that placement of 

oliceridine in schedule II will limit its 

medical applications and limit access to 

the drug due to schedule II 

manufacturing quotas. The commenter 

stated that oliceridine has the potential 


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to revolutionize gastrointestinal 

endoscopy because it does not cause 

respiratory depression. Lastly, the 

commenter stated that since oliceridine 

is not indicated for home-use, abuse of 

the medication by drug users would be 

difficult. 

DEA Response: DEA notes that FDA 

approved a New Drug Application 

(NDA) for oliceridine and provided DEA 

with a scheduling recommendation for 

oliceridine. The scheduling 

recommendation by Health and Human 

Services (HHS) and their notification to 

DEA regarding the FDA approval of the 

NDA initiated the DEA review and 

scheduling action. As stated in the IFR, 

after careful consideration of data from 

preclinical and clinical studies, DEA 

concurred with the HHS 

recommendation that oliceridine has 

abuse potential comparable to other 

schedule II opioids and therefore 

supported—and continues to support 

through this final rule—placement of 

oliceridine in schedule II under the 

CSA. Contrary to the commenter’s 

opinion about schedule II controls on a 

drug limiting its medical applications 

and access due to manufacturing quota 

requirements, DEA notes that currently 

several schedule II drugs (oxycodone, 

hydrocodone etc.) are extensively 

prescribed and used in medical practice. 

Comment: One commenter stated that 

the chemical name provided in the 

interim final rule indicates oliceridine is 

‘‘N-[(3-methoxythiophen-2- 

yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6- 

oxaspiro[4.5]decan-9-yl]ethyl})amine 

fumarate’’, though this is the name of 

the fumarate salt of oliceridine. The 

commenter noted that the other 

substances listed in 21 CFR 1308.12, 

and in most other sections of the CSA 

list only the base form of the drug, and 

control salts by definition. The 

commenter suggested to provide the 

chemical name for oliceridine base, and 

the fumarate salt would be controlled 

under the preamble in 12 CFR 1308.12. 

DEA Response: DEA agrees with 

commenter regarding the error in the 

chemical name of oliceridine and 

corrects appropriately by removing the 

word ‘‘fumarate’’ to read oliceridine as, 

N-[(3-methoxythiophen-2-yl)methyl]({2- 

[(9R)-9-(pyridin-2-yl)-6- 

oxaspiro[4.5]decan-9-yl]ethyl})amine. 

The correction will make clear precisely 

which substance is being controlled 

because the fumarate salt was not the 

accurate designation for the controlled 

substance. The listing of the base form 

and removal of the salt designation is 

consistent with other controlled 

substance listings under the CFR and 

the substance designated for control 

remains unchanged. The base form 

listing minus the salt designation 

(‘‘fumarate’’) is readily understood by 

those registered to handle the substance 

and would not be misunderstood by the 

public. For this reason, DEA believes 

the change will not have an impact. 

Based on the rationale set forth in the 

interim final rule, DEA adopts the IFR, 

with the above mentioned correction to 

the chemical name of oliceridine. 

Requirements for Handling Oliceridine 

As indicated above, oliceridine has 

been a schedule II controlled substance 

by virtue of an IFR issued by DEA in 

October 2020. Thus, this final rule does 

not alter the regulatory requirements 

applicable to handlers of oliceridine 

that have been in place since that time. 

Nonetheless, for informational 

purposes, we restate here those 

requirements. Oliceridine is subject to 

the CSA’s schedule II regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to the 

manufacture, distribution, reverse 

distribution, dispensing, importing, 

exporting, research, and conduct of 

instructional activities and chemical 

analysis with, and possession involving 

schedule II substances, including the 

following: 

1. Registration. Any person who 

handles (manufactures, distributes, 

reverse distributes, dispenses, imports, 

exports, engages in research, or 

conducts instructional activities or 

chemical analysis with, or possesses) 

oliceridine, or who desires to handle 

oliceridine, 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. Any person who currently 

handles or intends to handle 

oliceridine, and is not registered with 

DEA, must submit an application for 

registration and may not continue to 

handle oliceridine, unless DEA has 

approved the application for 

registration, pursuant to 21 U.S.C. 822, 

823, 957, and 958, and in accordance 

with 21 CFR parts 1301 and 1312. These 

registration requirements, however, are 

not applicable to patients (end users) 

who possess oliceridine pursuant to a 

lawful prescription. 

2. Quota. Only registered 

manufacturers are permitted to 

manufacture oliceridine in accordance 

with a quota assigned pursuant to 21 

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

CFR part 1303. 

3. Disposal of stocks. Any person who 

does not desire or is not able to 

maintain a schedule II registration must 

surrender all quantities of currently 

held oliceridine, or may transfer all 

quantities of currently held oliceridine 

to a person registered with DEA in 

accordance with 21 CFR part 1317, in 

addition to all other applicable Federal, 

State, local, and tribal laws. 

4. Security. Oliceridine is subject to 

schedule II security requirements and 

must be handled and stored pursuant to 

21 U.S.C. 821 and 823 and in 

accordance with 21 CFR 1301.71– 

1301.93. Non-practitioners handling 

oliceridine must also comply with the 

employee screening requirements of 21 

CFR 1301.90–1301.93. 

5. Labeling and Packaging. All labels, 

labeling, and packaging for commercial 

containers of oliceridine must comply 

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

accordance with 21 CFR part 1302. 

6. Inventory. Every DEA registrant 

who possesses any quantity of 

oliceridine must take an inventory of 

oliceridine on hand, pursuant to 21 

U.S.C. 827 and 958(e), and in 

accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

Any person who becomes registered 

with DEA to handle oliceridine must 

take an initial inventory of all stocks of 

controlled substances containing 

oliceridine on hand on the date the 

registrant first engages in the handling 

of controlled substances, pursuant to 21 

U.S.C. 827 and 958(e), and in 

accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

After the initial inventory, every DEA 

registrant must take a new inventory of 

all stocks of controlled substances 

(including oliceridine) on hand every 

two years, pursuant to 21 U.S.C. 827 

and 958(e), and in accordance with 21 

CFR 1304.03, 1304.04, and 1304.11. 

7. Records and Reports. DEA 

registrants must maintain records and 

submit reports for oliceridine, pursuant 

to 21 U.S.C. 827 and 958(e), and in 

accordance with 21 CFR parts 1304, 

1312, and 1317. 

8. Orders for oliceridine. Every DEA 

registrant who distributes oliceridine is 

required to comply with order form 

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

and in accordance with 21 CFR part 

1305. 

9. Prescriptions. All prescriptions for 

oliceridine or products containing 

oliceridine must comply with 21 U.S.C. 

829, and be issued in accordance with 

21 CFR parts 1306 and 1311, subpart C. 

10. Manufacturing and Distributing. 

In addition to the general requirements 

of the CSA and DEA regulations that are 

applicable to manufacturers and 

distributors of schedule II controlled 

substances, such registrants should be 

advised that (consistent with the 

foregoing considerations) any 

manufacturing or distribution of 

oliceridine may only be for the 


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legitimate purposes consistent with the 

drug’s labeling, or for research activities 

authorized by the Federal Food, Drug, 

and Cosmetic Act, as applicable, and the 

CSA. 

11. Importation and Exportation. All 

importation and exportation of 

oliceridine must be in compliance with 

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

in accordance with 21 CFR part 1312. 

12. Liability. Any activity involving 

oliceridine 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 

Administrative Procedure Act 

This final rule, with a correction in 

the chemical name of oliceridine as 

discussed above, affirms the amendment 

made by the IFR that is already in effect. 

Section 553 of the Administrative 

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

generally requires notice and comment 

for rulemaking. However, 21 U.S.C. 

811(j) provides that in cases where a 

certain new drug is: (1) Approved by 

HHS and (2) HHS recommends control 

in CSA schedule II–V, DEA shall issue 

an IFR scheduling the drug within 90 

days. Additionally, subsection (j) 

specifies that the rulemaking shall 

become immediately effective as an 

interim final rule without requiring DEA 

to demonstrate good cause. DEA issued 

an IFR on October 30, 2020, and 

solicited public comments on that rule. 

Subsection (j) further provides that after 

giving interested persons the 

opportunity to comment and to request 

a hearing, the Attorney General, as 

delegated to the Administrator of DEA, 

shall issue a final rule in accordance 

with the scheduling criteria of 21 U.S.C. 

811(b) through (d) and 812(b). DEA is 

now responding to the comments 

submitted by the public and issuing the 

final rule, in conformity with the APA 

and the procedure required by 21 U.S.C. 

811. 

Executive Orders 12866 (Regulatory 

Planning and Review) and 13563 

(Improving Regulation and Regulatory 

Review) 

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

and (j), this 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 procedures and 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 

on 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 Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612) applies to rules that 

are subject to notice and comment 

under section 553(b) of the APA. Under 

21 U.S.C. 811(j), DEA is not required to 

publish a general notice of proposed 

rulemaking. Consequently, the RFA 

does not apply. 

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 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 private sector, of 

$100 million or more (adjusted for 

inflation) in any one year.’’ Therefore, 

neither a Small Government Agency 

Plan nor any other action is required 

under UMRA of 1995. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information requirement 

under the Paperwork Reduction Act of 

1995. 44 U.S.C. 3501–3521. This action 

does 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. 

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 both Houses 

of Congress and to the Comptroller 

General. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

Accordingly, the interim final rule 

amending 21 CFR part 1308, which 

published on October 30, 2020 (85 FR 

68749), is adopted as a final rule with 

the following amendment: 

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. Amend § 1308.12 by revising 

paragraph (c)(18) to read as follows: 

§ 1308.12 Schedule II. 

* * * * * 

(c) * * * 

(18) Oliceridine (N-[(3-methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-yl]ethyl})amine) .................... 9245 


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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. 

* * * * * 

D. Christopher Evans, 

Acting Administrator. 

[FR Doc. 2021–11981 Filed 6–9–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–479] 

Schedules of Controlled Substances: 

Placement of NM2201, 5F-AB-PINACA, 

4-CN-CUMYL-BUTINACA, MMBCHMICA, and 5F-CUMYL-P7AICA 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 June 10, 2021. 

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: 

• naphthalen-1-yl 1-(5-fluoropentyl)- 

1H-indole-3-carboxylate (other names: 

NM2201 or CBL2201), 

• N-(1-amino-3-methyl-1-oxobutan-2- 

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

carboxamide (other name: 5F–ABPINACA), 

• 1-(4-cyanobutyl)-N-(2- 

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

carboxamide (other names: 4-CNCUMYL-BUTINACA, 4-cyano-CUMYLBUTINACA; 4-CN-CUMYL BINACA, 

CUMYL-4CN-BINACA, or SGT-78), 

• methyl 2-(1-(cyclohexylmethyl)-1Hindole-3-carboxamido)-3- 

methylbutanoate (other names: MMBCHMICA or AMB-CHMICA), and 

• 1-(5-fluoropentyl)-N-(2- 

phenylpropan-2-yl)-1H-pyrrolo[2,3- 

b]pyridine-3-carboxamide (other name: 

5F-CUMYL-P7AICA). 

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 Attorney General initiated this 

action on his own motion, as delegated 

to the Administrator of DEA, and is 

supported by, inter alia, a 

recommendation from the Assistant 

Secretary for Health of HHS (Assistant 

Secretary) 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 NM2201, 5F-ABPINACA, 4-CN-CUMYL-BUTINACA, 

MMB-CHMICA, and 5F-CUMYLP7AICA will continue to apply as a 

result of this action. 

Background 

On July 10, 2018, DEA published an 

order in the Federal Register amending 

21 CFR 1308.11(h) to temporarily place 

naphthalen-1-yl 1-(5-fluoropentyl)-1Hindole-3-carboxylate (other names: 

NM2201 or CBL2201); N-(1-amino-3- 

methyl-1-oxobutan-2-yl)-1-(5- 

fluoropentyl)-1H-indazole-3- 

carboxamide (other name: 5F-ABPINACA); 1-(4-cyanobutyl)-N-(2- 

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

carboxamide (other names: 4-CNCUMYL-BUTINACA, 4-cyano-CUMYLBUTINACA, 4-CN-CUMYL BINACA, 

CUMYL-4CN-BINACA or SGT-78); 

methyl 2-(1-(cyclohexylmethyl)-1Hindole-3-carboxamido)-3- 

methylbutanoate (other names: MMBCHMICA or AMB-CHMICA) and 1-(5- 

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

1H-pyrrolo[2,3-b]pyridine-3- 

carboxamide (other name: 5F-CUMYLP7AICA) in schedule I of the CSA 

pursuant to the temporary scheduling 

provisions of 21 U.S.C. 811(h). 83 FR 

31877. That temporary scheduling order 

took effect on the date of publication, 

and was based on findings by the former 

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 July 13, 2020, DEA published an 

order to extend the temporary 

scheduling of the five SCs by one year, 

until July 10, 2021. 85 FR 42296. Also, 

on that same date and in the same issue 

of the Federal Register, DEA published 

a notice of proposed rulemaking 

(NPRM) to permanently control the five 

SCs in schedule I of the CSA. 85 FR 

42290. Specifically, DEA proposed to 

add these five SCs to the hallucinogenic 

substances list under 21 CFR 

1308.11(d). 

DEA and HHS Eight Factor Analyses 

On May 29, 2020, 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 

Naphthalen-1-yl 1-(5-fluoropentyl)-lHindole-3-carboxylate [NM2201; 

CBL2201], N-(1-amino-3-methyl-1- 

oxobutan-2-yl)-1-(5-fluoropentyl)-lHindazole-3-carboxamide [5F-ABPINACA], 1-(4-cyanobutyl)-N-(2- 

phenylpropan-2-yl)lH-indazole-3- 

carboxamide (4-CN-CUMYLBUTINACA; 4-cyano-CUMYLBUTINACA; 4-CN-CUMYL BINACA; 

CUMYL-4CN-BINACA; SGT-78], methyl 

2-(1-(cyclohexylmethyl)-lH-indole-3- 

carboxamido)-3-methylbutanoate 

[MMB-CHMICA; AMB-CHMICA], and 1- 

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

yl)-1H-pyrrolo[2,3-b]pyridine-3- 

carboxamide [5F-CUMYL-P7AICA; 

CUMYL-5F-P7AICA; SGT-263] and 

Their Salts in Schedule I of the 

Controlled Substances Act.’’ 

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. 


khammond on DSKJM1Z7X2PROD with RULES