This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

32633 

Vol. 86, No. 117 

Tuesday, June 22, 2021 

1 5F–AMB (and its isomers) has been subject to 

schedule I controls since April 2017, first pursuant 

to a temporary scheduling order (April 10, 2017, 82 

FR 17119) and the subsequent one-year extension 

of that order (April 8, 2019, 84 FR 13796), and then 

permanently pursuant to a final rule which 

continued the imposition of those controls (Jan. 24, 

2020, 85 FR 4211). 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–819] 

Specific Listing for 4F–MDMB– 

BINACA, a Currently Controlled 

Schedule I Substance 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: The Drug Enforcement 

Administration is establishing a specific 

listing and Administration Controlled 

Substances Code Number (drug code) 

for 4F–MDMB–BINACA (also known as 

4F–MDMB–BUTINACA or methyl 2-(1- 

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

carboxamido)-3,3-dimethylbutanoate) in 

schedule I of the Controlled Substances 

Act (CSA). Although 4F–MDMB– 

BINACA is not specifically listed in 

schedule I of the CSA with its own 

unique drug code, it has been controlled 

in the United States since April 2017 as 

a positional isomer of 5F–AMB, a 

schedule I hallucinogen. Therefore, DEA 

is simply amending the schedule I 

hallucinogenic substances list in its 

regulations to separately include 4F– 

MDMB–BINACA. 

DATES: Effective June 22, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Terrence L. Boos, Drug and Chemical 

Evaluation, Diversion Control Division, 

Drug Enforcement Administration; 

Telephone: (571) 362–3249. 

SUPPLEMENTARY INFORMATION: 

4F–MDMB–BINACA Control 

4F–MDMB–BINACA (also known as 

4F–MDMB–BUTINACA or methyl 2-(1- 

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

carboxamido)-3,3-dimethylbutanoate) is 

a chemical substance which is 

structurally related to 5F–AMB (also 

known as methyl 2-(1-(5-fluoropentyl)- 

1H-indazole-3-carboxamido)-3- 

methylbutanoate). 5F–AMB is listed as 

a hallucinogenic substance in schedule 

I at 21 CFR 1308.11(d)(74). The 

introductory text to subparagraph (d) 

provides: (1) A listed substance includes 

‘‘any of its salts, isomers, and salts of 

isomers whenever the existence of such 

salts, isomers, and salts of isomers is 

possible,’’ and (2) the term ‘‘isomer’’ 

includes the optical, position[al], and 

geometric isomers. 

When compared to the chemical 

structure of 5F–AMB, 4F–MDMB– 

BINACA meets the statutory definition 

of a positional isomer in 21 CFR 

1300.01(b), which cross-references the 

term ‘‘positional isomer’’ in 21 CFR 

1308.11(d). Both 5F–AMB and 4F– 

MDMB–BINACA possess the same 

molecular formula and core structure, 

and have the same functional groups. 

They only differ from one another by a 

rearrangement of an alkyl moiety 

between functional groups. 

Accordingly, under 21 CFR 1308.11(d), 

4F–MDMB–BINACA, as a positional 

isomer of 5F–AMB, has been and 

continues to be a schedule I controlled 

substance.1

The Drug Enforcement Administration’s 

Authority To Control 4F–MDMB– 

BINACA 

This rule is prompted by a letter dated 

May 7, 2020, in which the United States 

government was informed by the 

Secretary-General of the United Nations 

that 4F–MDMB–BINACA has been 

added to Schedule II of the Convention 

on Psychotropic Substances of 1971 

(1971 Convention). This letter was 

prompted by a decision at the 63rd 

Session of the Commission on Narcotic 

Drugs (CND) in March 2020 to schedule 

4F–MDMB–BINACA under Schedule II 

of the 1971 Convention (CND Dec/63/8). 

Preceding this decision, the Food and 

Drug Administration (FDA), on behalf of 

the Secretary of Health and Human 

Services and pursuant to 21 U.S.C. 

811(d)(2), published two notices in the 

Federal Register with an opportunity to 

submit domestic information and 

opportunity to comment on this action, 

Sept. 10, 2019, 84 FR 47521 and Dec. 

31, 2019, 84 FR 72370. In both 

instances, FDA noted that 4F–MDMB– 

BINACA was already controlled in 

schedule I of the Controlled Substances 

Act (CSA) as a positional isomer of 5F– 

AMB, and the December 2019 notice 

stated that no additional permanent 

controls for 4F–MDMB–BINACA under 

the CSA would be necessary to fulfill 

United States’ obligations as a party to 

the 1971 Convention. 

As discussed above in this final rule, 

4F–MDMB–BINACA—by virtue of being 

a positional isomer of 5F–AMB—has 

been controlled in schedule I of the CSA 

temporarily since April 10, 2017 (82 FR 

17119), and permanently since January 

24, 2020 (85 FR 4211). Therefore, all 

regulations and criminal sanctions 

applicable to schedule I substances have 

been and remain applicable to 4F– 

MDMB–BINACA. Drugs controlled in 

schedule I of the CSA satisfy and exceed 

the required domestic controls of 

Schedule II under Article 2 of the 1971 

Convention. 

Effect of Action 

As discussed above, this rule does not 

affect the continuing status of 4F– 

MDMB–BINACA as a schedule I 

controlled substance in any way. This 

action, as an administrative matter, 

merely establishes a separate, specific 

listing for 4F–MDMB–BINACA in 

schedule I of the CSA and assigns a DEA 

controlled substances code number 

(drug code) for the substance. This 

action will allow DEA to establish an 

aggregate production quota and grant 

individual manufacturing and 

procurement quotas to DEA-registered 

manufacturers of 4F–MDMB–BINACA, 

who had previously been granted 

individual quotas for such purposes 

under the drug code for 5F–AMB. 

Regulatory Analyses 

Administrative Procedure Act 

An agency may find good cause to 

exempt a rule from certain provisions of 

the Administrative Procedure Act (APA) 

(5 U.S.C. 553), including notice of 

proposed rulemaking and the 

opportunity for public comment, if it is 

determined to be unnecessary, 

impracticable, or contrary to the public 

interest. 4F–MDMB–BINACA is 

currently controlled in schedule I as a 

positional isomer of 5F–AMB, and 4F– 

MDMB–BINACA has no currently 

accepted medical use in treatment to 


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32634 Federal Register / Vol. 86, No. 117 / Tuesday, June 22, 2021 / Rules and Regulations 

qualify for placement in a schedule 

other than schedule I (see 21 U.S.C. 

812(b)(2)–(5)). 

Pursuant to 5 U.S.C. 553(b)(3)(B), DEA 

finds that notice and comment 

rulemaking is unnecessary and that 

good cause exists to dispense with these 

procedures. The addition of a separate 

listing 4F–MDMB–BINACA and its DEA 

controlled substances code number in 

the list of schedule I substances in 21 

CFR 1308.11(d) makes no substantive 

difference in the status of this drug as 

a schedule I controlled substance, but 

instead is ‘‘a minor or merely technical 

amendment in which the public is not 

particularly interested.’’ National 

Nutritional Foods Ass’n v. Kennedy, 572 

F.2d 377, 385 (2d Cir. 1978) (quoting S. 

Rep. No. 79–752, at 200 (1945)). See also 

Utility Solid Waste Activities Group v. 

E.P.A., 236 F.3d 749, 755 (D.C. Cir. 

2001) (the ‘‘unnecessary’’ prong ‘‘is 

confined to those situations in which 

the administrative rule is a routine 

determination, insignificant in nature 

and impact, and inconsequential to the 

industry and public’’) (int. quotations 

and citation omitted). This rule is a 

‘‘technical amendment’’ to 21 CFR 

1308.11(d) as it is ‘‘insignificant in 

nature and impact, and inconsequential 

to the industry and public.’’ Therefore, 

publishing a notice of proposed 

rulemaking and soliciting public 

comment are unnecessary. 

In addition, because 4F–MDMB– 

BINACA is already subject to domestic 

control under schedule I as a positional 

isomer of 5F–AMB and no additional 

requirements are being imposed through 

this action, DEA finds good cause exists 

to make this rule effective immediately 

upon publication in accordance with 5 

U.S.C. 553(d)(3). DEA is concerned that 

delaying the effective date of this rule 

potentially could cause confusion 

regarding the regulatory status of 4F– 

MDMB–BINACA. 4F–MDMB–BINACA 

is currently controlled as a schedule I 

controlled substance, and this level of 

control does not change with this 

rulemaking. 

Executive Orders 12866 (Regulatory 

Planning and Review) and 13563 

(Improving Regulation and Regulatory 

Review) 

This regulation has been drafted and 

reviewed in accordance with the 

principles of Executive Orders (E.O.) 

12866 and 13563. This rule is not a 

significant regulatory action under E.O. 

12866. 4F–MDMB–BINACA already is a 

controlled substance in the United 

States under schedule I, as it is a 

positional isomer of a schedule I 

hallucinogen, 5F–AMB. In this final 

rule, DEA is merely making an 

administrative change by amending its 

regulations to separately list 4F– 

MDMB–BINACA in schedule I and to 

assign the DEA controlled substances 

code number 7043 to the substance. A 

separate listing for 4F–MDMB–BINACA 

and its DEA controlled substances code 

number will not alter the status of 4F– 

MDMB–BINACA as a schedule I 

controlled substance. Accordingly, this 

rule has not been reviewed by the Office 

of Management and Budget (OMB). 

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, 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 or other 

laws. As noted in the above section 

regarding the applicability of the APA, 

DEA determined that there was good 

cause to exempt this final rule from 

notice and comment. Consequently, the 

RFA does not apply. 

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 

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. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995, 

2 U.S.C. 1532, 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 $100,000,000 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 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. 

For the reasons set out above, DEA 

amends 21 CFR part 1308 as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for part 1308 

continues to read as follows: 

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

956(b), unless otherwise noted. 

■ 2. Amend § 1308.11 by adding 

paragraph (d)(87) to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(d) * * * 

(87) methyl 2-(1-(4-fluorobutyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (4F–MDMB–BINACA, 4F–MDMB– 

BUTINACA) ............................................................................................................................................................................................... 7043 


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Federal Register / Vol. 86, No. 117 / Tuesday, June 22, 2021 / Rules and Regulations 32635 

* * * * * 

D. Christopher Evans, 

Acting Administrator. 

[FR Doc. 2021–13040 Filed 6–21–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2021–0401] 

Safety Zone; Southern California 

Annual Fireworks for the San Diego 

Captain of the Port Zone 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

a safety zone for the Sea World 

Fireworks for nightly shows from 

Memorial Day to Labor Day in 2021, to 

provide for the safety of life on 

navigable waterways during this event. 

Our regulation for the Southern 

California annual fireworks for the San 

Diego Captain of the Port Zone 

identifies the regulated area for the 

events. During the enforcement period, 

no spectators shall anchor, block, loiter 

in, or impede the transit of official 

patrol vessels in the regulated area 

without the approval of the Captain of 

the Port, or his designated 

representative. 

DATES: The regulations 33 CFR 165.1123 

will be enforced for the location 

identified in Item 7 of Table 1 to 

§ 165.1123 from 8:30 p.m. until 10 p.m., 

each day without actual notice from 

June 22, 2021 through September 6, 

2021. For the purposes of enforcement, 

actual notice will be used from June 15, 

2021 until June 22, 2021. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this notice of 

enforcement, call or email Lieutenant 

Commander John Santorum, Waterways 

Management, U.S. Coast Guard Sector 

San Diego, CA; telephone 619–278– 

7656, email MarineEventsSD@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the regulations in 33 

CFR 165.1123 for a safety zone for the 

Sea World Fireworks on the waters of 

Mission Bay, CA in § 165.1123, Table 1, 

Item 7 of that section, from 8:30 p.m. 

until 10 p.m. on specific evenings from 

Memorial Day to Labor Day in 2021. 

This action is being taken to provide for 

the safety of life on navigable waterways 

during the fireworks events. Our 

regulation for Southern California 

annual fireworks events for the San 

Diego Captain of the Port Zone 

identifies the regulated area for the 

events. Under the provisions of 

§ 165.1123, a vessel may not enter the 

regulated area, unless it receives 

permission from the Captain of the Port, 

or his designated representative. 

Spectator vessels may safely transit 

outside the regulated area but may not 

anchor, block, loiter, or impede the 

transit of participants or official patrol 

vessels. The Coast Guard may be 

assisted by other Federal, State, or Local 

law enforcement agencies in enforcing 

this regulation. 

In addition to this notice of 

enforcement in the Federal Register, the 

Coast Guard plans to provide 

notification of this enforcement period 

via the Local Notice to Mariners. 

Dated: June 15, 2021. 

T.J. Barelli, 

Captain, U. S. Coast Guard, Captain of the 

Port San Diego. 

[FR Doc. 2021–13022 Filed 6–21–21; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2021–0435] 

RIN 1625–AA00 

Safety Zone; Northeast Shelter Island 

Closure, San Diego, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone 

covering the channel closure for the 

Northeast Shelter Island Channel 

Entrance. The safety zone is needed to 

protect personnel, vessels, and the 

marine environment from potential 

hazards created by the California 

Department of Fish and Wildlife 

(CDFW) Oil Spill Prevention and 

Response (OSPR) Sensitive Site Strategy 

Evaluation Program (SSSEP) boom 

deployment exercise. Entry of vessels or 

persons into this zone is prohibited 

unless specifically authorized by the 

Captain of the Port Sector San Diego. 

DATES: This rule is effective from 8:30 

a.m. until 10:30 a.m. on June 22, 2021. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2021– 

0435 in the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associate with this 

rule. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email LCDR John Santorum, Waterways 

Management, U.S. Coast Guard Sector 

San Diego, Coast Guard; telephone 619– 

278–7656, email MarineEventsSD@

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 NPRM 

would be impracticable. The Coast 

Guard did not receive the details of the 

Sensitive Site Strategy Evaluation 

Program boom deployment excersise 

with enough time to solicit and repond 

to public comments on an NPRM. As 

such, the channel closure on June 22, 

2021 would occur before an NPRM and 

final rule could be issued. 

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 contrary to the public 

interest, because action is necessary to 

protect personnel, vessels, and the 

marine environment from the dangers 

associated with the CDFW OSPR SSSEP 

boom deployment exercise on June 22, 

2021. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 46 U.S.C. 70034 

(previously 33 U.S.C. 1231). The 

Captain of the Port Sector San Diego 

(COTP) has determined that potential 

hazards associated with the CDFW 

OSPR SSSEP boom deployment exercise 

will be a safety concern to anyone 


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