Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Rules and Regulations 6171 

(e), and 15, Pub. L. 98–460, 98 Stat. 1802 (42 

U.S.C. 421 note); sec. 202, Pub. L. 108–203, 

118 Stat. 509 (42 U.S.C. 902 note). 

■ 2. In § 404.976, revise paragraph (b)(1) 

to read as follows: 

§ 404.976 Procedures before Appeals 

Council on review. 

* * * * * 

(b) * * * (1) The Appeals Council 

will consider all the evidence in the 

administrative law judge hearing record 

as well as any new and material 

evidence submitted to it that relates to 

the period on or before the date of the 

administrative law judge hearing 

decision. If you submit evidence that 

does not relate to the period on or before 

the date of the administrative law judge 

hearing decision, the Appeals Council 

will explain why it did not accept the 

additional evidence and will advise you 

of your right to file a new application. 

The notice will also advise you that if 

you file a new application within 6 

months after the date of the Appeals 

Council’s notice, your request for review 

will constitute a written statement 

indicating an intent to claim benefits in 

accordance with § 404.630. If you file a 

new application within 6 months of the 

date of this notice, we will use the date 

of the request for review as the filing 

date for your application. 

* * * * * 

PART 416—SUPPLEMENTAL 

SECURITY INCOME FOR THE AGED, 

BLIND, AND DISABLED 

Subpart N—Determinations, 

Administrative Review Process, and 

Reopening of Determinations and 

Decisions 

■ 3. The authority citation for subpart N 

of part 416 continues to read as follows: 

Authority: Secs. 702(a)(5), 1631, and 1633 

of the Social Security Act (42 U.S.C. 

902(a)(5), 1383, and 1383b); sec. 202, Pub. L. 

108–203, 118 Stat. 509 (42 U.S.C. 902 note). 

■ 4. In § 416.1476, revise paragraph 

(b)(1) to read as follows: 

§ 416.1476 Procedures before Appeals 

Council on review. 

* * * * * 

(b) * * * (1) In reviewing decisions 

based on an application for benefits, the 

Appeals Council will consider the 

evidence in the administrative law 

judge hearing record as well as any new 

and material evidence submitted to it 

that relates to the period on or before 

the date of the administrative law judge 

hearing decision. If you submit evidence 

that does not relate to the period on or 

before the date of the administrative law 

judge hearing decision, the Appeals 

Council will explain why it did not 

accept the additional evidence and will 

advise you of your right to file a new 

application. The notice will also advise 

you that if you file a new application 

within 60 days after the date of the 

Appeals Council’s notice, your request 

for review will constitute a written 

statement indicating an intent to claim 

benefits in accordance with § 416.340. If 

you file a new application within 60 

days of the date of this notice, we will 

use the date of the request for review as 

the filing date for your application. 

* * * * * 

[FR Doc. 2016–02267 Filed 2–4–16; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–421F] 

Schedules of Controlled Substances: 

Temporary Placement of the Synthetic 

Cannabinoid MAB-CHMINACA Into 

Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final order. 

SUMMARY: The Administrator of the Drug 

Enforcement Administration is issuing 

this final order to temporarily schedule 

the synthetic cannabinoid N-(1-amino3,3-dimethyl-1-oxobutan-2-yl)-1- 

(cyclohexylmethyl)-1H-indazole-3- 

carboxamide (common names, MABCHMINACA and ADB-CHMINACA), 

and its optical, positional, and 

geometric isomers, salts, and salts of 

isomers into schedule I pursuant to the 

temporary scheduling provisions of the 

Controlled Substances Act. This action 

is based on a finding by the 

Administrator that the placement of this 

synthetic cannabinoid into schedule I of 

the Controlled Substances Act is 

necessary to avoid an imminent hazard 

to the public safety. As a result of this 

order, the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to schedule I 

controlled substances will be imposed 

on persons who handle (manufacture, 

distribute, reverse distribute, import, 

export, engage in research, conduct 

instructional activities or chemical 

analysis, or possess), or propose to 

handle, MAB-CHMINACA. 

DATES: This final order is effective 

February 5, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Barbara J. Boockholdt, Office of 

Diversion Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

The Drug Enforcement 

Administration (DEA) implements and 

enforces titles II and III of the 

Comprehensive Drug Abuse Prevention 

and Control Act of 1970, as amended. 

Titles II and III are referred to as the 

‘‘Controlled Substances Act’’ and the 

‘‘Controlled Substances Import and 

Export Act,’’ respectively, and are 

collectively referred to as the 

‘‘Controlled Substances Act’’ or the 

‘‘CSA’’ for the purpose of this action. 21 

U.S.C. 801–971. The DEA publishes the 

implementing regulations for these 

statutes in title 21 of the Code of Federal 

Regulations (CFR), chapter II. The CSA 

and its implementing regulations are 

designed to prevent, detect, and 

eliminate the diversion of controlled 

substances and listed chemicals into the 

illicit market while ensuring an 

adequate supply is available for the 

legitimate medical, scientific, research, 

and industrial needs of the United 

States. Controlled substances have the 

potential for abuse and dependence and 

are controlled to protect the public 

health and safety. 

Under the CSA, every controlled 

substance is classified into one of five 

schedules based upon its potential for 

abuse, its currently accepted medical 

use in treatment in the United States, 

and the degree of dependence the drug 

or other substance may cause. 21 U.S.C. 

812. The initial schedules of controlled 

substances established by Congress are 

found at 21 U.S.C. 812(c), and the 

current list of all scheduled substances 

is published at 21 CFR part 1308. 

Section 201 of the CSA, 21 U.S.C. 811, 

provides the Attorney General with the 

authority to temporarily place a 

substance into schedule I of the CSA for 

two years without regard to the 

requirements of 21 U.S.C. 811(b) if she 

finds that such action is necessary to 

avoid an imminent hazard to the public 

safety. 21 U.S.C. 811(h)(1). In addition, 

if proceedings to control a substance are 

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

Attorney General may extend the 

temporary scheduling for up to one 

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

Where the necessary findings are 

made, a substance may be temporarily 

scheduled if it is not listed in any other 

schedule under section 202 of the CSA, 

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 


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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), the FDA acts as the lead agency within the 

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 the HHS has delegated to the 

Assistant Secretary for Health of the HHS the 

authority to make domestic drug scheduling 

recommendations. 58 FR 35460, July 1, 1993. 

Accordingly, all subsequent references to 

‘‘Secretary’’ have been replaced with ‘‘Assistant 

Secretary.’’ 

2Although the published notice of intent stated 

that such items had been placed into the docket on 

regulations.gov, the Administration discovered in 

preparing this final order that they had in fact not 

been posted. However, those documents were 

available for review at the DEA. The DEA posted 

the cited analysis and letter to regulations.gov upon 

discovery of the omission. 

(FDCA), 21 U.S.C. 355. 21 U.S.C. 

811(h)(1). The Attorney General has 

delegated her authority under 21 U.S.C. 

811 to the Administrator of the DEA. 28 

CFR 0.100. 

Background 

Section 201(h)(4) of the CSA, 21 

U.S.C. 811(h)(4), requires the 

Administrator to notify the Secretary of 

the Department of Health and Human 

Services (HHS) of the Administrator’s 

intention to temporarily place a 

substance into schedule I of the CSA.1

The Administrator transmitted the 

notice of intent to place N-(1-amino-3,3- 

dimethyl-1-oxobutan-2-yl)-1- 

(cyclohexylmethyl)-1H-indazole-3- 

carboxamide (hereinafter referred to as 

MAB-CHMINACA) into schedule I on a 

temporary basis to the Assistant 

Secretary by letter dated May 14, 2015. 

The Assistant Secretary responded to 

this notice by letter dated June 3, 2015, 

and advised that based on review by the 

Food and Drug Administration (FDA), 

there are currently no investigational 

new drug applications or approved new 

drug applications for MAB-CHMINACA. 

The Assistant Secretary also stated that 

the HHS had no objection to the 

temporary placement of MABCHMINACA into schedule I of the CSA. 

The DEA has taken into consideration 

the Assistant Secretary’s comments. 

MAB-CHMINACA is not currently listed 

in any schedule under the CSA, and no 

exemptions or approvals are in effect for 

MAB-CHMINACA under section 505 of 

the FDCA. 21 U.S.C. 355. The DEA has 

found that the control of MABCHMINACA in schedule I on a 

temporary basis is necessary to avoid an 

imminent hazard to public safety, and 

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

notice of intent to temporarily schedule 

MAB-CHMINACA was published in the 

Federal Register on September 16, 2015. 

80 FR 55565. 

To find that placing a substance 

temporarily into schedule I of the CSA 

is necessary to avoid an imminent 

hazard to the public safety, the 

Administrator is required to consider 

three of the eight factors set forth in 

section 201(c) of the CSA, 21 U.S.C. 

811(c): The substance’s history and 

current pattern of abuse; the scope, 

duration and significance of abuse; and 

what, if any, risk there is to the public 

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

Consideration of these factors includes 

actual abuse, diversion from legitimate 

channels, and clandestine importation, 

manufacture, or distribution. 21 U.S.C. 

811(h)(3). 

A substance meeting the statutory 

requirements for temporary scheduling 

may only be placed in schedule I. 21 

U.S.C. 811(h)(1). Substances in schedule 

I 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. 21 U.S.C. 

812(b)(1). 

Available data and information for 

MAB-CHMINACA, summarized below, 

indicate that this synthetic cannabinoid 

(SC) has a high potential for abuse, no 

currently accepted medical use in 

treatment in the United States, and a 

lack of accepted safety for use under 

medical supervision. The DEA 3-Factor 

analysis and the Assistant Secretary’s 

June 3, 2015, letter are available in their 

entirety under the tab ‘‘Supporting 

Documents’’ of the public docket of this 

action at www.regulations.gov under 

Docket Number DEA–421.2

Synthetic Cannabinoids 

Synthetic cannabinoids (SCs) are 

substances synthesized in laboratories 

that mimic the biological effects of 

delta-9-tetrahydrocannabinol (THC), the 

main psychoactive ingredient in 

marijuana. It is believed SCs were first 

introduced into the designer drug 

market in several European countries as 

‘‘herbal incense’’ before the initial 

encounter in the United States by U.S. 

Customs and Border Protection (CBP) in 

November 2008. From 2009 to present, 

misuse of SCs has increased in the 

United States with law enforcement 

encounters describing plant material 

laced with SCs intended for human 

consumption. It has been demonstrated 

that the substances and the associated 

designer products are abused for their 

psychoactive properties. With many 

generations of SCs being encountered 

since 2009, MAB-CHMINACA is one of 

the latest, and based upon reports from 

public health sources and law 

enforcement, the misuse and abuse of 

this substance is negatively impacting 

the public health and communities. 

The designer drug products laced 

with SCs, including MAB-CHMINACA, 

are often sold under the guise of ‘‘herbal 

incense’’ or ‘‘potpourri,’’ use 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, and sold in convenience stores. 

There is an incorrect assumption that 

these products are safe, and that 

labeling these products as ‘‘not for 

human consumption’’ is a legal defense 

to criminal prosecution. 

MAB-CHMINACA is an SC that has 

pharmacological effects similar to the 

schedule I hallucinogen THC and other 

temporarily and permanently controlled 

schedule I substances. MABCHMINACA has been shown to cause 

severe toxicity and adverse health 

effects following ingestion, including 

seizures, excited delirium, 

cardiotoxicity and death. With no 

approved medical use and limited safety 

or toxicological information, MABCHMINACA has emerged on the illicit 

drug market and is being abused for its 

psychoactive properties. 

Factor 4. History and Current Pattern of 

Abuse 

SCs were first encountered by CBP 

within the United States in November 

2008. Since then, the popularity of SCs 

and their associated products has 

increased steadily as evidenced by law 

enforcement seizures, public health 

information, and media reports. Despite 

multiple administrative and legislative 

actions to place SCs found on the illicit 

market into schedule I of the CSA, new 

generations of SCs intended to 

circumvent current law continue to be 

encountered with serious outcomes. 

Traffickers of these dangerous 

substances continue to attempt to skirt 

the law even after multiple control 

actions demonstrating a lack of regard 

for public health and safety. MABCHMINACA is an SC that was 

encountered following the 

hospitalization of 125 individuals 

around the Baton Rouge, Louisiana area 

in October 2014 (see factor 6 of the DEA 

3-Factor). Since that time, multiple 

overdoses and deaths involving MABCHMINACA have been reported. For 

example, overdose clusters attributed to 

MAB-CHMINACA have been reported 

in Shreveport, Louisiana; Bryan, Texas; 

Beaumont, Texas; Hampton, Virginia; 

Hagerstown, Maryland; and multiple 

cities in the State of Mississippi (see 

factor 6 of the DEA 3-Factor). 


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3National Forensic Laboratory Information 

System (NFLIS) is a national drug forensic 

laboratory reporting system that systematically 

collects results from drug chemistry analyses 

conducted by state and local forensic laboratories 

in the United States. 

Specifically, in April 2015, the largest 

nationwide outbreak involving SCs was 

reported by multiple news outlets. In 

addition, State public health entities 

have collectively reported over 2,000 

overdoses and at least 33 deaths across 

at least 11 States attributed to the 

misuse of SCs. Of these overdoses and 

deaths, currently available toxicology 

results have determined that a number 

of overdoses from this most recent 

cluster were connected to the ingestion 

of MAB-CHMINACA (see factor 6 of the 

DEA 3-Factor). 

On April 29, 2015, the European 

Monitoring Centre for Drugs and Drug 

Addiction (EMCDDA) reported multiple 

outbreaks of intoxications within the 

United States resulting from the 

ingestion of products believed to 

contain SCs. EMCDDA further reported 

that MAB-CHMINACA had been 

implicated in at least some of those 

cases. EMCDDA also reported on two 

deaths involving MAB-CHMINACA, one 

in Hungary and the other in Japan. 

A major concern, as reiterated by 

public health officials and medical 

professionals, remains the targeting and 

direct marketing of SCs and SCcontaining products to adolescents and 

youth. This is supported by law 

enforcement encounters and reports 

from emergency departments; however, 

all age groups have been reported by the 

media as abusing these substances and 

related products. Individuals, including 

minors, are purchasing SCs from the 

Internet, gas stations, convenience 

stores, and head shops. 

Smoking mixtures of these substances 

for the purpose of achieving 

intoxication have resulted in numerous 

emergency department visits and calls 

to poison control centers. As reported 

by the American Association of Poison 

Control Centers (AAPCC), adverse 

effects including severe agitation, 

anxiety, racing heartbeat, high blood 

pressure, nausea, vomiting, seizures, 

tremors, intense hallucinations, 

psychotic episodes, suicide, and other 

harmful thoughts and/or actions can 

occur following ingestion of SCs. 

Presentations at emergency departments 

directly linked to the abuse of MABCHMINACA have resulted in similar 

symptoms, including severe agitation, 

seizures and/or death (see factor 6 of 

DEA 3-Factor). 

As discussed previously, it is believed 

most abusers of SCs or SC-related 

products smoke the product following 

application to plant material. Until 

recently, this was the preferred route of 

administration. Law enforcement has 

also begun to encounter new variations 

of SCs in liquid form. It is believed 

abusers have been applying the liquid to 

hookahs and ‘‘e-cigarettes,’’ which allow 

the user to administer a vaporized 

liquid that can be inhaled. 

Factor 5. Scope, Duration and 

Significance of Abuse 

Following multiple scheduling 

actions designed to safeguard the public 

from the adverse effects and safety 

issues associated with SCs, encounters 

by law enforcement and health care 

professionals indicate the continued 

abuse of these substances and their 

associated products. With each action to 

control SCs, illicit drug manufacturers 

and suppliers are adapting at an 

alarmingly quick pace to design new 

SCs in an attempt to circumvent 

regulatory controls. Even before DEA 

temporarily controlled the latest group 

of SCs, AB-CHMINACA, AB-PINACA, 

and THJ-2201, on January 30, 2015, 

MAB-CHMINACA was already available 

on the illicit market and responsible for 

overdoses and deaths (see factor 6 of 

DEA 3-Factor). From October 2014 to 

the present, multiple overdoses and 

deaths have been attributed to the abuse 

of MAB-CHMINACA. 

On October 29, 2014, the State of 

Louisiana issued an emergency rule 

adding N-(1-amino-3,3-dimethyl-1- 

oxobutan-2-yl)-1-(cyclohexylmethyl)- 

1H-indazole-3-carboxamide (MABCHMINACA) to the list of schedule I 

Controlled Dangerous Substances 

section of the Louisiana Administrative 

Code (La. Admin. Code tit. 46, § 2704 

(2014)), upon the determination that it 

had a high potential for abuse and 

should be scheduled as a controlled 

substance to avoid an imminent peril to 

the public health, safety, and welfare. 

Poison control centers continue to 

report the abuse of SCs and their 

associated products. These substances 

remain a threat to both the short- and 

long-term public health and safety. 

Exposures to SCs were first reported to 

the AAPCC in 2011. The most alarming 

report via the AAPCC was published on 

April 23, 2015. The AAPCC reported a 

dramatic spike in poison center 

exposure calls throughout the United 

States in 2015. The AAPCC reported 

1,512 exposure calls in April 2015, 

representing an almost three-fold 

increase in exposures to SCs as 

compared to the previous largest 

monthly tally (657 exposures in January 

2012) since reporting began in 2011. It 

is likely that many of the calls are 

directly attributable to the abuse of 

MAB-CHMINACA based on its high 

prevalence in drug seizure reports and 

specimen test reports (see factor 6 and 

table 3 of DEA 3-Factor). Further, 

exposure calls to the AAPCC from 

within the first five months of 2015 

(January 1 to June 1) are greater than the 

total exposure calls involving SCs from 

all of 2014. In addition, a majority of 

exposure incidents from 2011 to the 

present resulted in individuals seeking 

medical attention at health care 

facilities. 

The following information regarding 

MAB-CHMINACA was obtained through 

NFLIS 3 (queried on May 27, 2015): 

MAB-CHMINACA: NFLIS-451 reports; first 

encountered in September 2014; locations 

include Arkansas, Indiana, Kansas, 

Louisiana, Missouri, Oklahoma, Texas, 

Virginia, and Wisconsin. 

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

the Public Health 

MAB-CHMINACA was identified in a 

cluster of 125 subjects that presented to 

emergency facilities within the Baton 

Rouge and Shreveport, Louisiana areas 

in October 2014. On October 29, 2014, 

the Louisiana Secretary of the 

Department of Health and Hospitals 

announced the addition of MABCHMINACA into schedule I of the 

Controlled Dangerous Substances 

section of the Louisiana Administrative 

Code (La. Admin. Code tit. 46, § 2704 

(2014)). From October 2014 to the 

present, multiple clusters of overdoses 

involving MAB-CHMINACA and at least 

four deaths attributed to the misuse and 

abuse of MAB-CHMINACA have been 

reported (see factor 6 and table 3 of the 

DEA 3-Factor). Adverse health effects 

reported from use of MAB-CHMINACA 

have included: Seizures, coma, severe 

agitation, loss of motor control, loss of 

consciousness, difficulty breathing, 

altered mental status, and convulsions 

that in some cases resulted in death. 

Since abusers obtain these drugs 

through unknown sources, the identity, 

purity, and quantity of these substances 

is uncertain and inconsistent, thus 

posing significant adverse health risks 

to users. The SCs encountered on the 

illicit drug market have no accepted 

medical use within the United States. 

Regardless, SC products continue to be 

easily available and abused by diverse 

populations. Unknown factors including 

detailed product analysis and dosage 

variations between various packages 

and batches present a significant danger 

to an abusing individual. Similar to 

previous SCs, MAB-CHMINACA has 

been found on plant material. Designer 

drug products have been found to vary 

in the amount and type of SC that plant 

material is laced with, which could be 


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6174 Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Rules and Regulations 

one explanation for the numerous 

emergency department admissions that 

have been connected to these 

substances. 

Finding of Necessity of Schedule I 

Placement To Avoid Imminent Hazard 

to Public Safety 

Based on the data and information 

summarized above, the continued 

uncontrolled handling and abuse of 

MAB-CHMINACA poses an imminent 

hazard to the public safety. The DEA is 

not aware of any currently accepted 

medical uses for MAB-CHMINACA in 

the United States. A substance meeting 

the statutory requirements for temporary 

scheduling may only be placed in 

schedule I of the CSA. 21 U.S.C. 

811(h)(1). 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 MABCHMINACA indicate that this substance 

has a high potential for abuse, no 

currently accepted medical use in 

treatment in the United States, and a 

lack of accepted safety for use under 

medical supervision. As required by 

section 201(h)(4) of the CSA, 21 U.S.C. 

811(h)(4), the Administrator, through a 

letter dated May 14, 2015, notified the 

Assistant Secretary of the DEA’s 

intention to temporarily place this 

substance in schedule I. The Assistant 

Secretary responded to this notice by 

letter dated June 3, 2015, and stated that 

the HHS had no objection to the 

temporary placement of MABCHMINACA into schedule I. A notice of 

intent was subsequently published in 

the Federal Register on September 16, 

2015. 80 FR 55565. 

Conclusion 

In accordance with the provisions of 

section 201(h) of the CSA, 21 U.S.C. 

811(h), the Administrator considered 

available data and information, herein 

set forth the grounds for his 

determination that it is necessary to 

temporarily schedule MAB-CHMINACA 

into schedule I of the CSA, and finds 

that placement of this SC into schedule 

I of the CSA is necessary to avoid an 

imminent hazard to the public safety. 

Because the Administrator hereby 

finds that it is necessary to temporarily 

place this SC into schedule I of the CSA 

to avoid an imminent hazard to the 

public safety, the final order temporarily 

scheduling this substance will be 

effective on the date of publication in 

the Federal Register, and will be in 

effect for a period of two years, with a 

possible extension of one additional 

year, pending completion of the regular 

(permanent) scheduling process. 21 

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

The CSA sets forth specific criteria for 

scheduling a drug or other substance. 

Regular scheduling actions in 

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

subject to formal rulemaking procedures 

done ‘‘on the record after opportunity 

for a hearing’’ conducted pursuant to 

the provisions of 5 U.S.C. 556 and 557. 

21 U.S.C. 811. The regular scheduling 

process of formal rulemaking affords 

interested parties with appropriate 

process and the government with any 

additional relevant information needed 

to make a determination. Final 

decisions that conclude the regular 

scheduling process of formal 

rulemaking are subject to judicial 

review. 21 U.S.C. 877. Temporary 

scheduling orders are not subject to 

judicial review. 21 U.S.C. 811(h)(6). 

Requirements for Handling 

Upon the effective date of this final 

order, MAB-CHMINACA will be subject 

to the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, reverse distribution, 

importation, exportation, engagement in 

research, and conduct of instructional 

activities or chemical analysis with, and 

possession of schedule I controlled 

substances including the following: 

1. Registration. Any person who 

handles (manufactures, distributes, 

reverse distributes, imports, exports, 

engages in research, or conducts 

instructional activities or chemical 

analysis with, or possesses), or who 

desires to handle, MAB-CHMINACA 

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 February 5, 2016. Any 

person who currently handles MABCHMINACA and is not registered with 

the DEA, must submit an application for 

registration and may not continue to 

handle MAB-CHMINACA as of February 

5, 2016, unless the DEA has approved 

that application for registration. Retail 

sales of schedule I controlled substances 

to the general public are not allowed 

under the CSA. Possession of any 

quantity of this substance in a manner 

not authorized by the CSA on or after 

February 5, 2016 is unlawful and those 

in possession of any quantity of this 

substance 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 MABCHMINACA, must surrender all 

quantities of currently held MABCHMINACA. 

3. Security. MAB-CHMINACA is 

subject to schedule I security 

requirements and must be handled and 

stored pursuant to 21 U.S.C. 821, 823, 

871(b), and in accordance with 21 CFR 

1301.71–1301.93, as of February 5, 

2016. 

4. Labeling and Packaging. All labels, 

labeling, and packaging for commercial 

containers of MAB-CHMINACA must be 

in compliance with 21 U.S.C. 825, 

958(e), and be in accordance with 21 

CFR part 1302. Current DEA registrants 

shall have 30 calendar days from 

February 5, 2016, to comply with all 

labeling and packaging requirements. 

5. Quota. Only registered 

manufacturers may manufacture MABCHMINACA in accordance with a quota 

assigned pursuant to 21 U.S.C. 826 and 

in accordance with 21 CFR part 1303 as 

of February 5, 2016. 

6. Inventory. Every DEA registrant 

who possesses any quantity of MABCHMINACA on the effective date of this 

order, must take an inventory of all 

stocks of this substance 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 shall 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 MABCHMINACA) 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. 

7. Records. All DEA registrants must 

maintain records with respect to MABCHMINACA pursuant to 21 U.S.C. 827 

and 958(e), and in accordance with 21 

CFR parts 1304 and 1312, 1317 and 

§ 1307.11. Current DEA registrants 

authorized to handle MAB-CHMINACA 

shall have 30 calendar days from the 

effective date of this order to be in 

compliance with all recordkeeping 

requirements. 

8. Reports. All DEA registrants who 

manufacture or distribute MABCHMINACA must submit reports 

pursuant to 21 U.S.C. 827 and in 

accordance with 21 CFR 1304 and 1312 

as of February 5, 2016. 

9. Order Forms. All DEA registrants 

who distribute MAB-CHMINACA must 

comply with order form requirements 

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

accordance with 21 CFR part 1305 as of 

February 5, 2016. 

10. Importation and Exportation. All 

importation and exportation of MABCHMINACA must be in compliance 


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Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Rules and Regulations 6175 

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

in accordance with 21 CFR part 1312 as 

of February 5, 2016. 

11. Liability. Any activity involving 

MAB-CHMINACA not authorized by, or 

in violation of the CSA, occurring as of 

February 5, 2016, is unlawful, and may 

subject the person to administrative, 

civil, and/or criminal sanctions. 

Regulatory Analyses 

Section 201(h) of the CSA, 21 U.S.C. 

811(h), provides for an expedited 

temporary scheduling action where 

such action is necessary to avoid an 

imminent hazard to the public safety. 

As provided in this subsection, the 

Attorney General may, by order, 

schedule a substance in schedule I on a 

temporary basis. Such an order may not 

be issued before the expiration of 30 

days from (1) the publication of a notice 

in the Federal Register of the intention 

to issue such order and the grounds 

upon which such order is to be issued, 

and (2) the date that notice of the 

proposed temporary scheduling order is 

transmitted to the Assistant Secretary. 

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

Inasmuch as section 201(h) of the 

CSA directs that temporary scheduling 

actions be issued by order and sets forth 

the procedures by which such orders are 

to be issued, the DEA believes that the 

notice and comment requirements of the 

Administrative Procedure Act (APA) at 

5 U.S.C. 553, do not apply to this 

temporary scheduling action. In the 

alternative, even assuming that this 

action might be subject to 5 U.S.C. 553, 

the Administrator finds that there is 

good cause to forgo the notice and 

comment requirements of 5 U.S.C. 553, 

as any further delays in the process for 

issuance of temporary scheduling orders 

would be impracticable and contrary to 

the public interest in view of the 

manifest urgency to avoid an imminent 

hazard to the public safety. 

Further, the DEA believes that this 

temporary scheduling action final order 

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 (RFA). The requirements 

for the preparation of an initial 

regulatory flexibility analysis in 5 U.S.C. 

603(a) are not applicable where, as here, 

the DEA is not required by the APA or 

any other law to publish a general 

notice of proposed rulemaking. 

Additionally, this action is not a 

significant regulatory action as defined 

by Executive Order 12866 (Regulatory 

Planning and Review), section 3(f), and, 

accordingly, this action has not been 

reviewed by the Office of Management 

and Budget (OMB). 

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 Executive Order 13132 

(Federalism) it is determined that this 

action does not have sufficient 

federalism implications to warrant the 

preparation of a Federalism Assessment. 

As noted above, this action is an 

order, not a rule. Accordingly, the 

Congressional Review Act (CRA) is 

inapplicable, as it applies only to rules. 

5 U.S.C. 808(2). It is in the public 

interest to schedule this substance 

immediately because it poses a public 

health risk. This temporary scheduling 

action is taken pursuant to 21 U.S.C. 

811(h), which is specifically designed to 

enable the DEA to act in an expeditious 

manner to avoid an imminent hazard to 

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

811(h), temporary scheduling orders are 

not subject to notice and comment 

rulemaking procedures. The DEA 

understands that the CSA frames 

temporary scheduling actions as orders 

rather than rules to ensure that the 

process moves swiftly. For the same 

reasons that underlie 21 U.S.C. 811(h), 

that is, the need to move quickly to 

place this substance into schedule I 

because it poses an imminent hazard to 

public safety, it would be contrary to the 

public interest to delay implementation 

of the temporary scheduling order. 

Therefore, this order shall take effect 

immediately upon its publication. 

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), 

unless otherwise noted. 

■ 2. Amend § 1308.11 by adding 

paragraph (h)(25) to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(h) * * * 

(25) N-(1-amino-3,3-dimethyl-1- 

oxobutan-2-yl)-1-(cyclohexylmethyl)- 

1H-indazole-3-carboxamide, its optical, 

positional, and geometric isomers, salts 

and salts of isomers (Other names: 

MAB-CHMINACA; ADB-CHMINACA) 

(7032) 

Dated: February 2, 2016. 

Chuck Rosenberg, 

Acting Administrator. 

[FR Doc. 2016–02302 Filed 2–4–16; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–385E] 

Schedules of Controlled Substances: 

Extension of Temporary Placement of 

PB-22, 5F-PB-22, AB-FUBINACA and 

ADB-PINACA in Schedule I of the 

Controlled Substances Act 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final order. 

SUMMARY: The Administrator of the Drug 

Enforcement Administration is issuing 

this final order to extend the temporary 

schedule I status of four synthetic 

cannabinoids pursuant to the temporary 

scheduling provisions of the Controlled 

Substances Act. The substances are: 

quinolin-8-yl 1-pentyl-1H-indole-3- 

carboxylate (PB-22; QUPIC); quinolin-8- 

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

carboxylate (5-fluoro-PB-22; 5F-PB-22); 

N-(1-amino-3-methyl-1-oxobutan-2-yl)- 

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

carboxamide (AB-FUBINACA); and N- 

(1-amino-3,3-dimethyl-1-oxobutan-2-yl)- 

1-pentyl-1H-indazole-3-carboxamide 

(ADB-PINACA), including their optical, 

positional and geometric isomers, salts, 

and salts of isomers. The current final 

order temporarily placing PB-22, 5F-PB22, AB-FUBINACA, and ADB-PINACA 

into schedule I is in effect through 

February 9, 2016. This final order will 

extend the temporary scheduling of PB22, 5F-PB-22, AB-FUBINACA, and ADBPINACA for one year, or until the 

permanent scheduling action for these 

four substances is completed, whichever 

occurs first. 

DATES: This final order is effective 

February 5, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Barbara J. Boockholdt, Office of 

Diversion Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598-6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

The Drug Enforcement 

Administration (DEA) implements and 


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