Schedules of Controlled Substances: Placement of MAB-CHMINACA Into Schedule I

Vol. 83

Tuesday,

No. 20

January 30, 2018

Part II

Department of Justice

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Drug Enforcement Administration

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21 CFR Part 1308

Schedules of Controlled Substances: Placement of MAB-CHMINACA Into

Schedule I; Proposed Rule and Temporary rule

Proposed Rules

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-421]

Schedules of Controlled Substances: Placement of MAB-CHMINACA

Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration proposes placing N-(1-

amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-

carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA), including its

salts, isomers, and salts of isomers whenever the existence of such

salts, isomers, and salts of isomers is possible, in schedule I of the

Controlled Substances Act. If finalized, this action would impose 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 MAB-CHMINACA.

DATES: Comments must be submitted electronically or postmarked on or

before March 1, 2018.

Interested persons may file a request for hearing or waiver of

hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR

1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers

of an opportunity for a hearing or to participate in a hearing must be

received on or before March 1, 2018.

S: Comments must be submitted electronically or postmarked on or

before March 1, 2018.

Interested persons may file a request for hearing or waiver of

hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR

1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers

of an opportunity for a hearing or to participate in a hearing must be

received on or before March 1, 2018.

ADDRESSES: Interested persons may file written comments on this

proposal in accordance with 21 CFR 1308.43(g). Commenters should be

aware that the electronic Federal Docket Management System will not

accept comments after 11:59 p.m. Eastern Time on the last day of the

comment period. To ensure proper handling of comments, please reference

``Docket No. DEA-421'' on all electronic and written correspondence,

including any attachments.

Electronic comments: The Drug Enforcement Administration

encourages that all comments be submitted electronically through the

Federal eRulemaking Portal which provides the ability to type short

comments directly into the comment field on the web page or attach a

file for lengthier comments. Please go to http://www.regulations.gov

and follow the online instructions at that site for submitting

comments. Upon completion of your submission you will receive a Comment

Tracking Number for your comment. Please be aware that submitted

comments are not instantaneously available for public view on

Regulations.gov. If you have received a Comment Tracking Number, your

comment has been successfully submitted and there is no need to

resubmit the same comment.

Paper comments: Paper comments that duplicate the

electronic submission are not necessary. Should you wish to mail a

paper comment, in lieu of an electronic comment, it should be sent via

regular or express mail to: Drug Enforcement Administration, Attn: DEA

Federal Register Representative/ODW, 8701 Morrissette Drive,

Springfield, Virginia 22152

here is no need to

resubmit the same comment.

Paper comments: Paper comments that duplicate the

electronic submission are not necessary. Should you wish to mail a

paper comment, in lieu of an electronic comment, it should be sent via

regular or express mail to: Drug Enforcement Administration, Attn: DEA

Federal Register Representative/ODW, 8701 Morrissette Drive,

Springfield, Virginia 22152.

Hearing requests: All requests for a hearing and waivers

of participation must be sent to: Drug Enforcement Administration,

Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia

22152. All requests for hearing and waivers of participation should

also be sent to: (1) Drug Enforcement Administration, Attn: Hearing

Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2)

Drug Enforcement Administration, Attn: DEA Federal Register

Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia

22152.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control

Division, Drug Enforcement Administration; Mailing Address: 8701

Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-

6812.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

Please note that all comments received in response to this docket

are considered part of the public record. They will, unless reasonable

cause is given, be made available by the Drug Enforcement

Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying

information (such as your name, address, etc.) voluntarily submitted by

the commenter. The Freedom of Information Act (FOIA) applies to all

comments received. If you want to submit personal identifying

information (such as your name, address, etc.) as part of your comment,

but do not want it to be made publicly available, you must include the

phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of

your comment

ddress, etc.) voluntarily submitted by

the commenter. The Freedom of Information Act (FOIA) applies to all

comments received. If you want to submit personal identifying

information (such as your name, address, etc.) as part of your comment,

but do not want it to be made publicly available, you must include the

phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of

your comment. You must also place all of the personal identifying

information you do not want made publicly available in the first

paragraph of your comment and identify what information you want

redacted.

If you want to submit confidential business information as part of

your comment, but do not want it to be made publicly available, you

must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the

first paragraph of your comment. You must also prominently identify the

confidential business information to be redacted within the comment.

Comments containing personal identifying information or

confidential business information identified as directed above will be

made publicly available in redacted form. If a comment has so much

confidential business information that it cannot be effectively

redacted, all or part of that comment may not be made publicly

available. Comments posted to http://www.regulations.gov may include

any personal identifying information (such as name, address, and phone

number) included in the text of your electronic submission that is not

identified as directed above as confidential.

An electronic copy of this document and supplemental information to

this proposed rule are available at http://www.regulations.gov for easy

reference.

Request for Hearing, or Waiver of Participation in Hearing

personal identifying information (such as name, address, and phone

number) included in the text of your electronic submission that is not

identified as directed above as confidential.

An electronic copy of this document and supplemental information to

this proposed rule are available at http://www.regulations.gov for easy

reference.

Request for Hearing, or Waiver of Participation in Hearing

Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking

``on the record after opportunity for a hearing.'' Such proceedings are

conducted pursuant to the provisions of the Administrative Procedure

Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316,

subpart D. Such requests or notices must conform to the requirements of

21 CFR 1308.44(a) or (b), and 1316.47 or 1316.48, as applicable, and

include a statement of the person's interests in the proposed

scheduling action, whether the person is adversely affected or

aggrieved, and the objections or issues, if any, concerning which the

person desires to be heard at a hearing. Any waiver must conform to the

requirements of 21 CFR 1308.44(c) and may include a written statement

regarding the interested person's position on the matters of fact and

law involved in any hearing.

Please note that pursuant to 21 U.S.C. 811(a), the purpose and

subject matter of a hearing held in relation to this rulemaking is

restricted to: ``(A) find[ing] that such drug or other substance has a

potential for abuse, and (B) mak[ing] with respect to such drug or

other substance the findings

prescribed by subsection (b) of section 812 of this title for the

schedule in which such drug is to be placed * * *.'' All requests for

hearing and waivers participation must be sent to the DEA using the

address information provided above.

Legal Authority

ary 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.

\2\ MAB-CHMINACA is currently subject to schedule I controls on

a temporary basis, pursuant to 21 U.S.C. 811(b). 81 FR 8171, Feb. 5,

2016.

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Background

On February 5, 2016, the DEA published an order in the Federal

Register amending 21 CFR 1308.11(h) to temporarily place N-(1-amino-

3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-

carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA) in schedule I of

the CSA pursuant to the temporary scheduling provisions of 21 U.S.C.

811(h). 81 FR 6171. That temporary scheduling order was effective on

the date of publication, and was based on findings by the Acting

Administrator of the DEA (Acting Administrator) that the temporary

scheduling of this synthetic cannabinoid was necessary to avoid an

imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1).

Section 201(h)(2) of the CSA, 21 U.S.C. 811(h)(2), requires that the

temporary control of this substance expire two years from the effective

date of the scheduling order, which was February 5, 2016. However, the

CSA also provides that during the pendency of proceedings under 21

U.S.C. 811(a)(1) with respect to the substance, the temporary

scheduling of that substance could be extended for up to one year.

Proceedings for the scheduling of a substance under 21 U.S.C. 811(a)

may be initiated by the Attorney General (delegated to the

Administrator of the DEA pursuant to 28 CFR 0.100) on his own motion,

at the request of the Secretary of HHS,\3\ or on the petition of any

interested party. An extension of the existing temporary order is being

ordered by the Acting Administrator in a separate action, and is

published elsewhere in this issue of the Federal Register.

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of the DEA pursuant to 28 CFR 0.100) on his own motion,

at the request of the Secretary of HHS,\3\ or on the petition of any

interested party. An extension of the existing temporary order is being

ordered by the Acting Administrator in a separate action, and is

published elsewhere in this issue of the Federal Register.

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\3\ Because the Secretary of HHS has delegated to the Assistant

Secretary the authority to make domestic drug scheduling

recommendations, for purposes of this proposed rulemaking, all

subsequent references to ``Secretary'' have been replaced with

``Assistant Secretary.''

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The Acting Administrator, on his own motion pursuant to 21 U.S.C.

811(a), is initiating proceedings under 21 U.S.C. 811(a)(1) to

permanently schedule MAB-CHMINACA. The DEA has gathered and reviewed

the available information regarding the pharmacology, chemistry,

trafficking, actual abuse, pattern of abuse, and the relative potential

for abuse for this synthetic cannabinoid. On May 18, 2016, the Acting

Administrator submitted a request to the Assistant Secretary to provide

the DEA with a scientific and medical evaluation of available

information and a scheduling recommendation for MAB-CHMINACA, in

accordance with 21 U.S.C. 811(b) and (c). Upon evaluating the

scientific and medical evidence, on January 19, 2018, the Assistant

Secretary submitted to the Acting Administrator HHS's scientific and

medical evaluations for this substance. Upon receipt of the scientific

and medical evaluation and scheduling recommendation from the HHS, the

DEA reviewed the documents and all other relevant data, and conducted

its own eight-factor analysis of the abuse potential of MAB-CHMINACA in

accordance with 21 U.S.C. 811(c).

Proposed Determination to Schedule MAB-CHMINACA

strator HHS's scientific and

medical evaluations for this substance. Upon receipt of the scientific

and medical evaluation and scheduling recommendation from the HHS, the

DEA reviewed the documents and all other relevant data, and conducted

its own eight-factor analysis of the abuse potential of MAB-CHMINACA in

accordance with 21 U.S.C. 811(c).

Proposed Determination to Schedule MAB-CHMINACA

As discussed in the background section, the Acting Administrator is

initiating proceedings, pursuant to 21 U.S.C. 811(a)(1), to add MAB-

CHMINACA permanently to schedule I. The DEA has reviewed the scientific

and medical evaluations and scheduling recommendation, received from

HHS, and all other relevant data and conducted its own eight-factor

analysis of the abuse potential of MAB-CHMINACA pursuant to 21 U.S.C.

811(c). Included below is a brief summary of each factor as analyzed by

the HHS and the DEA, and as considered by the DEA in its proposed

scheduling action. Please note that both the DEA 8-Factor and HHS 8-

Factor analyses and the Assistant Secretary's January 19, 2018, letter,

are available in their entirety under the tab ``Supporting Documents''

of the public docket of this action at http://www.regulations.gov,

under Docket Number ``DEA-421.''

1. The Drug's Actual or Relative Potential for Abuse: The term

``abuse'' is not defined in the CSA. However, the legislative history

of the CSA suggests that the DEA consider the following criteria in

determining whether a particular drug or substance has a potential for

abuse: \4\

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\4\ Comprehensive Drug Abuse Prevention and Control Act of 1970,

H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970

U.S.C.C.A.N. 4566, 4603.

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n

determining whether a particular drug or substance has a potential for

abuse: \4\

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\4\ Comprehensive Drug Abuse Prevention and Control Act of 1970,

H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970

U.S.C.C.A.N. 4566, 4603.

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(a) There is evidence that individuals are taking the drug or drugs

containing such a substance in amounts sufficient to create a hazard to

their health or to the safety of other individuals or of the community;

or

(b) There is significant diversion of the drug or drugs containing

such a substance from legitimate drug channels; or

(c) Individuals are taking the drug or drugs containing such a

substance on their own initiative rather than on the basis of medical

advice from a practitioner licensed by law to administer such drugs in

the course of his professional practice; or

(d) The drug or drugs containing such a substance are new drugs so

related in their action to a drug or drugs already listed as having a

potential for abuse to make it likely that the drug will have the same

potentiality for abuse as such drugs, thus making it reasonable to

assume that there may be significant diversions from legitimate

channels, significant use contrary to or without medical advice, or

that it has a substantial capability of creating hazards to the health

of the user or to the safety of the community.

Review of scientific and medical literature indicates that the

ingestion of synthetic cannabinoids (SCs) leads to adverse health

effects. Specifically, adverse effects following ingestion of MAB-

CHMINACA have included: Tachycardia, aggressive or violent behavior,

confusion, depressed mental status, severe agitation, psychosis, and

death.

health

of the user or to the safety of the community.

Review of scientific and medical literature indicates that the

ingestion of synthetic cannabinoids (SCs) leads to adverse health

effects. Specifically, adverse effects following ingestion of MAB-

CHMINACA have included: Tachycardia, aggressive or violent behavior,

confusion, depressed mental status, severe agitation, psychosis, and

death.

The American Association of Poison Control Centers (AAPCC) reported

7,779 exposures to SCs from January 1 to December 31, 2015. The

significance of this value is based upon reporting of human exposures

to SCs since 2011. While 2012-2014 saw a reduction in exposure calls to

AAPCC, 2015 records demonstrate resurgence in calls to poison centers

regarding SCs. In addition, the largest monthly tally of calls to

poison centers ever recorded by AAPCC in reference to SCs occurred in

April 2015, with 1,512 calls. Overdose data demonstrated that the

largest outbreak from synthetic cannabinoids occurred from March-May,

2015, with MAB-CHMINACA as the primary substance confirmed by forensic

toxicological analysis.

In a letter to DEA dated June 3, 2015, the HHS stated that there

are no approved new drug applications or investigational new drug

applications for MAB-CHMINACA. According to HHS's January 19, 2018,

letter, MAB-CHMINACA is not approved for medical use in treatment in

the United States and is not formulated or available for clinical use.

Therefore the human use of this substance is likely to be on an

individual's own initiative, rather than on the basis of medical advice

from a practitioner licensed by law to administer drugs. Further, AAPCC

reports, published scientific and medical literature, and law

enforcement reports indicate that individuals are taking MAB-CHMINACA

on their own initiative, rather than on the medical advice of a

licensed practitioner

substance is likely to be on an

individual's own initiative, rather than on the basis of medical advice

from a practitioner licensed by law to administer drugs. Further, AAPCC

reports, published scientific and medical literature, and law

enforcement reports indicate that individuals are taking MAB-CHMINACA

on their own initiative, rather than on the medical advice of a

licensed practitioner.

As noted by the HHS, MAB-CHMINACA, similar to schedule I SCs,

displays high affinity binding and potent agonist functional activity

at the cannabinoid (CB1) receptor, while drug discrimination studies

have demonstrated the ability of this substance to substitute for THC

(see factor 2).

2. Scientific Evidence of the Drug's Pharmacological Effects, if

Known: MAB-CHMINACA is a synthetic cannabinoid that has pharmacological

effects similar to the schedule I hallucinogen delta-9-

tetrahydrocannabinol ([Delta]9-THC) and other temporarily and

permanently controlled schedule I SCs. In vitro receptor binding and

functional assays were conducted with MAB-CHMINACA. In addition, drug

discrimination assays using Sprague Dawley rats to identify drugs with

THC-like similar subjective effects demonstrated that MAB-CHMINACA

fully substituted for the discriminative stimulus effects of THC.

Based on results from the receptor binding (Ki), CB1 functional

assay, and drug discrimination studies, the HHS concluded that MAB-

CHMINACA acts as a full psychoactive cannabinoid agonist with no

antagonist activity, and that MAB-CHMINACA is more potent than THC

(schedule I), and is similar in activity to JWH-018, AM2201, ADB-

PINACA, AB-FUBINACA, and AB-CHMINACA (schedule I). As stated by the

HHS, these data indicate that MAB-CHMINACA is more potent than the

schedule I cannabinoid THC in producing behavioral pharmacological

effects and shares pharmacological effects with other SCs in schedule

I, such as JWH-018.

3

B-CHMINACA is more potent than THC

(schedule I), and is similar in activity to JWH-018, AM2201, ADB-

PINACA, AB-FUBINACA, and AB-CHMINACA (schedule I). As stated by the

HHS, these data indicate that MAB-CHMINACA is more potent than the

schedule I cannabinoid THC in producing behavioral pharmacological

effects and shares pharmacological effects with other SCs in schedule

I, such as JWH-018.

3. The State of Current Scientific Knowledge Regarding the Drug or

Other Substance:

MAB-CHMINACA shares structural features with a number of schedule I

SCs such as AKB48, AB-FUBINACA, ADB-PINACA, and AB-CHMINACA. AKB48, AB-

FUBINACA, ADB-PINACA, AB-CHMINACA, and MAB-CHMINACA have the same

indazole core structure with substitutions at the 1- and 3-positions of

the indazole ring. All five substances are substituted at the 3-

position with an amide. MAB-CHMINACA was first reported in the

scientific literature in a Pfizer patent (WO/2009/106980) and

identified as compound 13. A study conducted by the Department of

Veterans Affairs Medical Center (Portland, OR) under the interagency

agreement with the DEA indicated that MAB-CHMINACA binds to the CB1

receptor and acts as an agonist at this receptor, similar to results

reported in the original Pfizer patent for compound 13 (WO/2009/

106980).

The DEA is not aware of any currently accepted medical use in

treatment in the United States for MAB-CHMINACA. The Administrator of

the DEA sent a letter dated May 14, 2015, to the Assistant Secretary

for Health for HHS notifying HHS of DEA's intent to temporarily place

MAB-CHMINACA in schedule I and solicited comments, including whether

there was an exemption or approval in effect for the substance under

the Federal Food, Drug and Cosmetic Act. The Assistant Secretary of

Health for the HHS advised the DEA that there are no approved new drug

applications or investigational new drug applications for MAB-CHMINACA

under section 505 (21 U.S.C. 355) of the Federal Food, Drug, and

Cosmetic Act

solicited comments, including whether

there was an exemption or approval in effect for the substance under

the Federal Food, Drug and Cosmetic Act. The Assistant Secretary of

Health for the HHS advised the DEA that there are no approved new drug

applications or investigational new drug applications for MAB-CHMINACA

under section 505 (21 U.S.C. 355) of the Federal Food, Drug, and

Cosmetic Act. HHS has no objection regarding the temporary placement of

MAB-CHMINACA in schedule 1 of the CSA. In their scheduling

recommendation, HHS stated that MAB-CHMINACA is not approved for

medical use, is not formulated or available for clinical use, and that

all human self-administration is assumed to be on an individual's own

initiative, rather than on the basis of medical advice from a

practitioner licensed by law to administer drugs.

4. Its History and Current Pattern of Abuse: As noted by the HHS,

SCs have been developed over the last 30 years as tools for

investigating the cannabinoid system. The first encounter of SC's

within the United States occurred in November 2008 by the United States

Customs and Border Protection. 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.

Amidst multiple scheduling actions placing SCs found on the illicit

market in schedule I of the CSA, new versions of SCs intended to

circumvent current controls continue to be encountered. MAB-CHMINACA is

a SC that was associated with the hospitalization of 125 individuals

around Baton Rouge and Shreveport, Louisiana in October, 2014. Since

that time, multiple overdoses and deaths involving MAB-CHMINACA have

been reported in Texas (in Bryan and Beaumont), Kansas (in Salina),

Mississippi (in Philadelphia and Jackson), Virginia (in Hampton), and

in Maryland (in Hagerstown)

ered. MAB-CHMINACA is

a SC that was associated with the hospitalization of 125 individuals

around Baton Rouge and Shreveport, Louisiana in October, 2014. Since

that time, multiple overdoses and deaths involving MAB-CHMINACA have

been reported in Texas (in Bryan and Beaumont), Kansas (in Salina),

Mississippi (in Philadelphia and Jackson), Virginia (in Hampton), and

in Maryland (in Hagerstown). Specifically, in April 2015 originating in

Texas, Mississippi and Alabama, the largest nationwide outbreak

involving SCs was reported by multiple news outlets. State public

health entities eventually reported over 2,000 overdoses and at least

33 deaths associated with abuse of SCs across at least 11 States

between April and May of 2015. Of these overdoses and deaths,

toxicology results have determined that a majority of overdoses from

the April/May 2015 cluster were due to ingestion of MAB-CHMINACA. 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 the cases. EMCDDA also reported two

deaths involving MAB-CHMINACA, one in Hungary and the other in Japan.

5. The Scope, Duration, and Significance of Abuse: Following

multiple scheduling actions seeking to safeguard the public from the

adverse effects associated with SCs, law enforcement and health care

professionals continue to encounter novel SCs thereby indicating the

d in at least some of the cases. EMCDDA also reported two

deaths involving MAB-CHMINACA, one in Hungary and the other in Japan.

5. The Scope, Duration, and Significance of Abuse: Following

multiple scheduling actions seeking to safeguard the public from the

adverse effects associated with SCs, law enforcement and health care

professionals continue to encounter novel SCs thereby indicating the

continuing abuse of these substances and their associated products.

After each scheduling action of a SC, drug manufacturers and suppliers

are adapting at an alarming pace to switch to new SCs to circumvent

regulatory controls. Even before temporary control of AB-CHMINACA, AB-

PINACA, and THJ-2201 on January 30, 2015, MAB-CHMINACA was available on

the illicit market. From 2014 through 2016, multiple overdoses and

deaths have been attributed to the abuse of MAB-CHMINACA. From

September 2014 to the present, the National Forensic Laboratory

Information System (NFLIS) has documented over 1,400 reports involving

MAB-CHMINACA across the following states: Arkansas, Arizona,

California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois,

Indiana, Iowa, Indiana, Kansas, Kentucky, Louisiana, Minnesota,

Mississippi, Missouri, North Dakota, New Jersey, Ohio, Oklahoma,

Pennsylvania, Tennessee, Texas, Virginia and Wisconsin.

6. What, if Any, Risk There is to the Public Health: MAB-CHMINACA

was associated with a cluster of 125 subjects who presented to

emergency facilities within the Baton Rouge and Shreveport, Louisiana

areas in October 2014. On October 29, 2014, the Secretary of the

Louisiana Department of Health and Hospitals announced the addition of

MAB-CHMINACA into Schedule I of the Controlled Dangerous Substances

section of the Louisiana Administrative Code (LAC 46:LIII.2704.A.3).

From October 2014 to the present, multiple clusters of overdoses

involving MAB-CHMINACA and at least eight deaths attributed to the

abuse of MAB-CHMINACA have been reported

retary of the

Louisiana Department of Health and Hospitals announced the addition of

MAB-CHMINACA into Schedule I of the Controlled Dangerous Substances

section of the Louisiana Administrative Code (LAC 46:LIII.2704.A.3).

From October 2014 to the present, multiple clusters of overdoses

involving MAB-CHMINACA and at least eight deaths attributed to the

abuse of MAB-CHMINACA have been reported.

Adverse health effects associated with these incidents involving

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.

One case report noted the presence of MAB-CHMINACA within the body

fluids and tissue samples of a recently deceased individual. A

subsequent case report concluded that synergistic toxicity of MAB-

CHMINACA and another SC, 5-fluoro-ADB, led to death.

The abuse of MAB-CHMINACA, a SC with no accepted medical use in

treatment in the United States, poses a serious risk to both the abuser

and those connected to the abuse. HHS noted that by sharing

pharmacological similarities with schedule I substances ([Delta]9-THC,

JWH-018 and other temporarily and permanently controlled schedule I

SCs), SCs pose a risk to the abuser and those connected to the abuse of

these dangerous substances.

7. Its Psychic or Physiological Dependence Liability: As stated by

the HHS, MAB-CHMINACA has a pharmacological profile that is similar to

other schedule I SCs. Although there are no clinical studies evaluating

dependence liabilities specific for MAB-CHMINACA, the pharmacological

profile of this substance strongly suggests that it possesses

dependence liabilities that are qualitatively similar to, and

potentially stronger than, THC (schedule I) or marijuana (schedule I).

8

MINACA has a pharmacological profile that is similar to

other schedule I SCs. Although there are no clinical studies evaluating

dependence liabilities specific for MAB-CHMINACA, the pharmacological

profile of this substance strongly suggests that it possesses

dependence liabilities that are qualitatively similar to, and

potentially stronger than, THC (schedule I) or marijuana (schedule I).

8. Whether the Substance is an Immediate Precursor of a Substance

Already Controlled Under the CSA: MAB-CHMINACA is not an immediate

precursor of any controlled substance of the CSA as defined by 21 U.S.C

802(23).

Conclusion: After considering the scientific and medical evaluation

conducted by the HHS, the HHS's recommendation, and the DEA's own

eight-factor analysis, the DEA finds that the facts and all relevant

data constitute substantial evidence of the potential for abuse of MAB-

CHMINACA. As such, the DEA hereby proposes to permanently schedule MAB-

CHMINACA as a schedule I controlled substance under the CSA.

Proposed 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 Assistant Secretary for HHS and review of all

other available data, the Administrator of the DEA, pursuant to 21

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

1. MAB-CHMINACA has a high potential for abuse;

2. MAB-CHMINACA has no currently accepted medical use in treatment

in the United States; and

3. There is a lack of accepted safety for use of MAB-CHMINACA under

medical supervision

Assistant Secretary for HHS and review of all

other available data, the Administrator of the DEA, pursuant to 21

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

1. MAB-CHMINACA has a high potential for abuse;

2. MAB-CHMINACA has no currently accepted medical use in treatment

in the United States; and

3. There is a lack of accepted safety for use of MAB-CHMINACA under

medical supervision.

Based on these findings, the Administrator of the DEA concludes

that N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-

indazole-3-carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA)

including its salts, isomers and salts of isomers, whenever the

existence of such salts, isomers, and salts of isomers is possible,

warrant continued control in schedule I of the CSA. 21 U.S.C.

812(b)(1).

Requirements for Handling MAB-CHMINACA

If this rule is finalized as proposed, MAB-CHMINACA would continue

\5\ to be subject to the CSA's schedule I regulatory controls and

administrative, civil, and criminal sanctions applicable to the

manufacture, distribution, dispensing, importing, exporting, research,

and conduct of instructional activities, including the following:

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\5\ MAB-CHMINACA is currently subject to schedule I controls on

a temporary basis, pursuant to 21 U.S.C. 811(h). 81 FR 6171, Feb. 5,

2016.

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nsing, importing, exporting, research,

and conduct of instructional activities, including the following:

---------------------------------------------------------------------------

\5\ MAB-CHMINACA is currently subject to schedule I controls on

a temporary basis, pursuant to 21 U.S.C. 811(h). 81 FR 6171, Feb. 5,

2016.

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1. Registration. Any person who handles (manufactures, distributes,

dispenses, imports, exports, engages in research, or conducts

instructional activities or chemical analysis with, or possesses) MAB-

CHMINACA, or who desires to handle MAB-CHMINACA, is required to 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.

2. Security. MAB-CHMINACA is subject to schedule I security

requirements and must be handled and stored pursuant to 21 U.S.C. 821,

823 and in accordance with 21 CFR 1301.71-1301.93.

3. Labeling and Packaging. All labels and labeling for commercial

containers of MAB-CHMINACA 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 MAB-CHMINACA in accordance with a quota assigned pursuant

to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.

5. Inventory. Any person registered with the DEA to handle MAB-

CHMINACA must have an initial inventory of all stocks of controlled

substances (including MAB-CHMINACA) on hand on the date the registrant

first engages in the handling of controlled substances pursuant to 21

U.S.C. 827 and 958, 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 MAB-

CHMINACA) on hand every two years, pursuant to 21 U.S.C. 827 and 958,

and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

6. Records and Reports

ed substances pursuant to 21

U.S.C. 827 and 958, 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 MAB-

CHMINACA) on hand every two years, pursuant to 21 U.S.C. 827 and 958,

and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

6. Records and Reports. Every DEA registrant is required to

maintain records and submit reports with respect to MAB-CHMINACA,

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

accordance with 21 CFR parts 1304 and 1312.

7. Order Forms. Every DEA registrant who distributes MAB-CHMINACA

is required to comply with the order form requirements, pursuant to 21

U.S.C. 828, and 21 CFR part 1305.

8. Importation and Exportation. All importation and exportation of

MAB-CHMINACA must 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 MAB-CHMINACA not authorized

by, or in violation of, the CSA or its implementing regulations is

unlawful, and could subject the person to administrative, civil, and/or

criminal sanctions.

Regulatory Analyses

Executive Orders 12866 and 13563

In accordance with 21 U.S.C. 811(a), this proposed 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 12866 and the principles

reaffirmed in Executive Order 13563.

Executive Order 12988

d 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 12866 and the principles

reaffirmed in Executive Order 13563.

Executive Order 12988

This proposed regulation meets the applicable standards set forth

in sections 3(a) and 3(b)(2) of Executive Order 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

This proposed rulemaking does not have federalism implications

warranting the application of Executive Order 13132. The proposed 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

This proposed rule does not have tribal implications warranting the

application of Executive Order 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.

Executive Order 13771

This proposed rule does not meet the definition of an Executive

Order 13771 regulatory action, and the repeal and cost offset

requirements of Executive Order 13771 have not been triggered. OMB has

previously determined that formal rulemaking actions concerning the

scheduling of controlled substances, such as this rule, are not

significant regulatory actions under Section 3(f) of Executive Order

12866.

Regulatory Flexibility Act

efinition of an Executive

Order 13771 regulatory action, and the repeal and cost offset

requirements of Executive Order 13771 have not been triggered. OMB has

previously determined that formal rulemaking actions concerning the

scheduling of controlled substances, such as this rule, are not

significant regulatory actions under Section 3(f) of Executive Order

12866.

Regulatory Flexibility Act

The Administrator, in accordance with the Regulatory Flexibility

Act (RFA), 5 U.S.C. 601-602, has reviewed this proposed rule and by

approving it certifies that it will not have a significant economic

impact on a substantial number of small entities. On February 5, 2016,

the DEA published a final order to temporarily place MAB-CHMINACA in

schedule I of the CSA pursuant to the temporary scheduling provisions

of 21 U.S.C. 811(h). The DEA estimates that all entities handling or

planning to handle this substance have already established and

implemented the systems and processes required to handle MAB-CHMINACA.

There are currently 16 registrations authorized to handle MAB-CHMINACA

specifically, as well as a number of registered analytical labs that

are authorized to handle schedule I controlled substances generally.

These 16 registrations represent 14 entities, of which 8 are small

entities. Therefore, the DEA estimates eight small entities are

affected by this proposed rule.

A review of the 16 registrations indicates that all entities that

currently handle MAB-CHMINACA also handle other schedule I controlled

substances, and have established and implemented (or maintain) the

systems and processes required to handle MAB-CHMINACA. Therefore, the

DEA anticipates that this proposed rule will impose minimal or no

economic impact on any affected entities; and thus, will not have a

significant economic impact on any of the eight affected small

entities. Therefore, the DEA has concluded that this proposed rule will

not have a significant effect on a substantial number of small

entities.

sses required to handle MAB-CHMINACA. Therefore, the

DEA anticipates that this proposed rule will impose minimal or no

economic impact on any affected entities; and thus, will not have a

significant economic impact on any of the eight affected small

entities. Therefore, the DEA has concluded that this proposed rule will

not have a significant effect 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., the 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 private sector, of $100,000,000 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 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.

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 proposes to amend 21 CFR

part 1308 as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0

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.

0

2. In Sec. 1308.11:

0

a. Add paragraph (d)(72); and

0

b. Remove and reserve paragraph (h)(1).

The addition to read as follows:

Sec. 1308.11 Schedule I.

* * * * *

21 CFR

part 1308 as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0

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.

0

2. In Sec. 1308.11:

0

a. Add paragraph (d)(72); and

0

b. Remove and reserve paragraph (h)(1).

The addition to read as follows:

Sec. 1308.11 Schedule I.

* * * * *

(d) * * *

(72) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1- (7032)

(cyclohexylmethyl)-1H-indazole-3-carboxamide, (MAB-CHMINACA,

ADB-CHMINACA)................................................

* * * * *

Dated: January 24, 2018.

Robert W. Patterson,

Acting Administrator.

[FR Doc. 2018-01747 Filed 1-29-18; 8:45 am]

BILLING CODE 4410-09-P