[Federal Register Volume 84, Number 210 (Wednesday, October 30, 2019)]
[Proposed Rules]
[Pages 58090-58095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23626]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-472]


Schedules of Controlled Substances: Placement of FUB-AMB in 
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 methyl 2-
(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other 
names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), 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 make 
permanent the existing 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 FUB-AMB.

DATES: Interested persons may file written comments on this proposal in 
accordance with 21 CFR 1308.43(g). Comments must be submitted 
electronically or postmarked on or before November 29, 2019. 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.
    Interested persons, defined at 21 CFR 1300.01 as those ``adversely 
affected or aggrieved by any rule or proposed rule issuable pursuant to 
section 201 of the Act (21 U.S.C. 811),'' 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 November 29, 
2019.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-472'' 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.
     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 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: Scott Brinks, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-
8209.

SUPPLEMENTARY INFORMATION: 

[[Page 58091]]

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. 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

    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. Interested persons may file requests for a hearing or 
notices of intent to participate in a hearing in conformity with the 
requirements of 21 CFR 1308.44(a) or (b), and include a statement of 
interest of the person in the proceeding and the objections or issues, 
if any, concerning which the person desires to be heard. Any interested 
person may file a waiver of an opportunity for a hearing or to 
participate in a hearing together with a written statement regarding 
the interested person's position on the matters of fact and law 
involved in any hearing as set forth in 21 CFR 1308.44(c).
    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 of participation must be 
sent to the DEA using the address information provided above.

Legal Authority

    The Controlled Substances Act (CSA) provides that proceedings for 
the issuance, amendment, or repeal of the scheduling of any drug or 
other substance may be initiated by the Attorney General (1) on his own 
motion; (2) at the request of the Secretary of the Department of Health 
and Human Services (HHS); \1\ or (3) on the petition of any interested 
party. 21 U.S.C. 811(a). This proposed action is supported by a 
recommendation from the Assistant Secretary for Health of the HHS 
(Assistant Secretary) and an evaluation of all other relevant data by 
the DEA. If finalized, this action would continue \2\ to impose the 
regulatory controls and administrative, civil, and criminal sanctions 
of schedule I controlled substances on any person who handles or 
proposes to handle FUB-AMB.
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    \1\ As discussed 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.
    \2\ FUB-AMB is currently subject to schedule I controls on a 
temporary basis, pursuant to 21 U.S.C. 811(h). 82 FR 51154, Nov. 3, 
2017.
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Background

    On November 3, 2017, the DEA published an order in the Federal 
Register amending 21 CFR 1308.11(h) to temporarily place methyl 2-(1-
(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other 
names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA) in schedule I of the CSA 
pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 82 
FR 51154. 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 (SC) 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 is November 3, 2019. 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 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), has initiated proceedings under 21 U.S.C. 811(a)(1) to 
permanently schedule FUB-AMB. 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 March 9, 2018, 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 FUB-AMB, in accordance 
with 21 U.S.C. 811(b) and (c). Upon evaluating the scientific and 
medical evidence, on September 19,

[[Page 58092]]

2019, 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 FUB-AMB in accordance with 21 U.S.C. 811(c).

Proposed Determination to Schedule FUB-AMB

    As discussed in the background section, the Acting Administrator 
initiated proceedings, pursuant to 21 U.S.C. 811(a)(1), to add FUB-AMB 
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 FUB-AMB 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 September 19, 2019, 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-472.''
    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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    (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 to 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.
    Epidemiological data reviewed by HHS has concluded that individuals 
are taking FUB-AMB in sufficient amounts as to create a hazard to the 
health and safety of both the individual users and others within the 
community. Adverse effects observed following the ingestion of FUB-AMB 
include nausea, persistent vomiting, agitation, altered mental status, 
seizures, convulsions, loss of consciousness and cardiotoxicity. SCs 
like FUB-AMB are easily accessible and difficult to detect in standard 
urine drug screens, which contributes to their popularity and high 
rates of abuse.
    The HHS stated in their letter dated June 9, 2017 that there are 
currently no approved new drug applications or active investigational 
new drug applications for FUB-AMB. In addition, HHS stated that since 
FUB-AMB is not a Food and Drug Administration (FDA)-approved drug 
product for treatment in the United States and there appear to be no 
legitimate sources for FUB-AMB as a marketed drug or as a subject of 
scientific investigations, this characteristic of abuse potential is 
not applicable.
    HHS has determined that since FUB-AMB is not approved for medical 
use and is not formulated or available for clinical use, the human use 
of this substance 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. Further, published scientific and medical 
literature and law enforcement reports indicate that individuals are 
taking FUB-AMB on their own initiative, rather than on the basis of 
medical advice of a licensed practitioner.
    As stated by HHS, in vitro and in vivo data for FUB-AMB indicate 
that it has a pharmacological profile similar to other schedule I SCs 
of various structural classes, including tetrahydrocannabinols (such as 
[Delta]9-THC), bicyclic cannabinoid analogs (e.g., CP55, 940), 
aminoalkylindoles (e.g., WIN55, 212-2), and other indole- and pyrol-
derived cannabinoids (e.g., JWH-018, schedule I) (see Factor 2 DEA 8-
Factor Analysis). In in vitro receptor binding and functional assays, 
FUB-AMB, similar to JWH-018 and WIN 55,212-2, acts as a CB1 receptor 
agonist. In drug discrimination studies sponsored by the National 
Institute on Drug Abuse (NIDA), FUB-AMB, similar to other schedule I 
SCs (e.g., JWH-018; AM2201; ADB-PINACA, AB-FUBINACA etc.), fully 
substitutes for THC in animals trained to discriminate THC from vehicle 
control (see Factor 2 DEA 8-Factor Analysis). Based on these 
pharmacological similarities, HHS stated that FUB-AMB would present 
with an abuse potential similar to these and other cannabinoids. HHS 
further stated that in terms of overall potency, FUB-AMB appears to be 
more potent than JWH-018 and WIN 55,212-2.
    2. Scientific Evidence of the Drug's Pharmacological Effects, if 
Known: As described by HHS, receptor binding and drug discrimination 
studies with FUB-AMB demonstrate findings that are consistent with 
findings from the testing of other schedule I SCs. In vitro receptor 
binding and functional assays and in vivo drug discrimination studies 
were conducted with FUB-AMB. These results indicate that FUB-AMB, 
similar to other schedule I SCs, binds to CB1 receptors and acts as an 
agonist at CB1 receptors. Treatment with FUB-AMB (0.1--1 mg/kg), 
similar to THC, resulted in time- and dose-dependent depression of 
locomotor activity. Depressant effects of 0.1 to 0.5 mg/kg FUB-AMB 
occurred within 10 minutes following intraperitoneal (i.p.) injection 
and lasted 40 to 100 minutes. Also, tremors were seen 30 minutes 
following 1 mg/kg FUB-AMB in 3 of 8 mice. The drug discrimination assay 
is a well-accepted animal model used to predict subjective effects of 
substances in humans. In the drug discrimination assay, FUB-AMB similar 
to other schedule I SCs (e.g., JWH-018; AM2201; ADB-PINACA, AB-FUBINACA 
etc.), substituted fully for the discriminative stimulus effects 
produced by THC.
    Based on data from CB1 receptor binding (Ki), CB1 receptor 
functional assays, drug discrimination, and locomotor studies, HHS 
stated that FUB-AMB is a full cannabinoid agonist with no antagonist 
activity, and is more potent than [Delta]9-THC, the principal 
psychoactive constituent in marijuana (schedule I).
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance: FUB-AMB is a potent cannabinoid receptor agonist that 
is pharmacologically similar to THC. Emerging in the early 1980's, SCs 
were originally designed to investigate structure activity 
relationships (SAR) based on the potent substance, 9-nor-9[beta]-
hydroxyhexahydrocannabinol (HHC).

[[Page 58093]]

Interest in various structural classes was generated by the mouse vas 
deferens (MVD) and prostaglandin synthetase activity of pravadoline and 
subsequent finding of its affinity to the cannabinoid receptor.
    Neither the DEA nor HHS is aware of any currently accepted medical 
use for FUB-AMB. A letter, dated May 19, 2017, was sent from the DEA 
Acting Administrator to the Assistant Secretary for Health of the HHS 
as notification of intent to temporarily place FUB-AMB in schedule I 
and solicited comments, including whether there is an exemption or 
approval in effect for the substance in question under the Federal 
Food, Drug and Cosmetic Act. The Assistant Secretary for Health 
responded on June 9, 2017 that there are currently no approved new drug 
applications or active investigational new drug applications for FUB-
AMB and that HHS has no objection regarding the temporary placement of 
FUB-AMB in schedule 1 of the CSA. Also, HHS is not aware of any reports 
of clinical studies or claims of an accepted medical use in the United 
States. HHS concluded without further consideration that FUB-AMB has no 
currently accepted medical use in the United States.
    HHS stated in its recommendation that information collected by the 
World Health Organization indicates that FUB-AMB is most commonly 
ingested following inhalation either via smoking an adulterated plant 
material or by manipulating the substance into a liquid form for 
vaporization via an electronic smoking device.
    4. Its History and Current Pattern of Abuse: As described by HHS, 
SCs have been developed by researchers over the last 30 years as tools 
for investigating the endocannabinoid system, (e.g. determining CB1 and 
CB2 receptor activity). The first encounter of SCs within the United 
States occurred in November 2008 by U.S. Customs and Border Protection. 
Since then, the popularity of SCs in general and their associated 
products has increased as evidenced by law enforcement seizures, public 
health information, and media reports. FUB-AMB was first identified in 
June 2014, in seized drug evidence. Up until its temporary control in 
November, 2017, there had been a large increase in its encounters by 
law enforcement (see Factor 5 DEA 8-Factor Analysis). The misuse of 
FUB-AMB has been associated with multiple overdoses requiring emergency 
medical intervention (see Factor 6 DEA 8-Factor Analysis). In recent 
cases of overdoses, FUB-AMB has been encountered in the form of herbal 
products, similar to the SCs that have been previously available (see 
Factor 6 DEA 8-Factor Analysis).
    The designer drug products laced with SCs, including FUB-AMB, 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, or in convenience stores.
    There are incorrect assumptions that these products are safe, that 
they are a synthetic form of marijuana, and that labeling these 
products as ``not for human consumption'' is a legal defense to 
criminal prosecution under the Controlled Substances Analogue 
Enforcement Act.
    Presentations at emergency departments directly linked to the abuse 
of FUB-AMB have resulted in similar symptoms, including nausea, 
persistent vomiting, agitation, altered mental status, seizures, 
convulsions, loss of consciousness, cardio toxicity and/or death (see 
Factor 6 DEA 8-Factor Analysis). Law enforcement has had numerous 
encounters of FUB-AMB and has documented the abuse of this substance 
(see Factor 5 DEA 8-Factor Analysis). SCs and their associated products 
are available over the internet and sold in gas stations, convenience 
stores, and tobacco and head shops. FUB-AMB, similar to the previously 
scheduled SCs, have been seized alone and/or laced on products that are 
marketed under the guise of ``herbal incense'' and promoted as a 
``legal'' alternative to marijuana.
    5. The Scope, Duration, and Significance of Abuse: As described by 
HHS, SCs including FUB-AMB continue to be encountered on the illicit 
market regardless of scheduling actions that attempt to safeguard the 
public from the adverse effects and safety issues associated with these 
substances. Novel SC substances continue to be encountered, differing 
from controlled SCs only by small chemical structural modifications 
intended to avoid prosecution while maintaining the pharmacological 
effects.
    HHS stated that based on FUB-AMB's pharmacological properties, it 
is reasonable to assume that, if uncontrolled, the scope, duration, and 
significance of FUB-AMB abuse would be similar to [Delta]9-THC and 
other SCs that are listed in schedule I. The threat of serious injury 
to the individual following the ingestion of FUB-AMB and other SCs 
persists.
    From June 2014 to the present, the National Forensic Laboratory 
Information System (NFLIS) has documented over 21,000 reports involving 
FUB-AMB across the District of Columbia, Puerto Rico, and the following 
states: Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, 
Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, 
Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, 
New Jersey, New Hampshire, New Mexico, New York, North Dakota, Ohio, 
Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, 
Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin 
and Wyoming.
    6. What, if Any, Risk There is to the Public Health: As shown by 
HHS, FUB-AMB has been identified in overdose cases attributed to its 
abuse. Adverse health effects reported from these incidents involving 
FUB-AMB have included: Nausea, persistent vomiting, agitation, altered 
mental status, seizures, convulsions, loss of consciousness, 
cardiotoxicity and death (see DEA and HHS 8-Factor Analyses in docket 
folder).
    7. Its Psychic or Physiological Dependence Liability: As stated by 
HHS, the pharmacologic and chemical profile of FUB-AMB strongly 
suggests that it possesses a physiological and psychological dependence 
liability that is similar to that of [Delta]9-THC (schedule I) and JWH-
018 (schedule I). Although there are no clinical studies evaluating 
dependence liabilities specific for FUB-AMB, 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: FUB-AMB 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 scheduling 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 FUB-AMB. As such, the DEA hereby proposes to permanently 
schedule FUB-AMB 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

[[Page 58094]]

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 Health 
of HHS and review of all other available data, the Acting Administrator 
of the DEA, pursuant to 21 U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds 
that:
    1. FUB-AMB has a high potential for abuse;
    2. FUB-AMB has no currently accepted medical use in treatment in 
the United States; \5\ and
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    \5\ Although there is no evidence suggesting that FUB-AMB has a 
currently accepted medical use in treatment in the United States, it 
bears noting that a drug cannot be found to have such medical use 
unless DEA concludes that it satisfies a five-part test. 
Specifically, with respect to a drug that has not been approved by 
the FDA, to have a currently accepted medical use in treatment in 
the United States, all of the following must be demonstrated:
     i. the drug's chemistry must be known and reproducible;
     ii. there must be adequate safety studies;
     iii. there must be adequate and well-controlled studies proving 
efficacy;
     iv. the drug must be accepted by qualified experts; and
     v. the scientific evidence must be widely available.
    57 FR 10499 (1992).
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    3. There is a lack of accepted safety for use of FUB-AMB under 
medical supervision.
    Based on these findings, the Acting Administrator of the DEA 
concludes that methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-
3-methylbutanoate (other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA) 
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 FUB-AMB

    If this rule is finalized as proposed, FUB-AMB would continue \6\ 
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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    \6\ FUB-AMB is currently subject to schedule I controls on a 
temporary basis, pursuant to 21 U.S.C. 811(h). 82 FR 51154, Nov. 3, 
2017.
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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) FUB-
AMB, or who desires to handle FUB-AMB, 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. FUB-AMB 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 FUB-AMB 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 FUB-AMB 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 FUB-AMB 
must have an initial inventory of all stocks of controlled substances 
(including FUB-AMB) 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 FUB-AMB) 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 FUB-AMB, 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 FUB-AMB 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 
FUB-AMB 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 FUB-AMB 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

    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

    The Acting Administrator, in accordance with the Regulatory 
Flexibility Act, 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 November 3, 2017, 
the DEA published an order to temporarily place FUB-AMB in schedule I 
of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 
811(h). The DEA

[[Page 58095]]

estimates that all entities handling or planning to handle this 
substance have already established and implemented the systems and 
processes required to handle FUB-AMB. There are currently 22 
registrations authorized to handle FUB-AMB specifically, as well as a 
number of registered analytical labs that are authorized to handle 
schedule I controlled substances generally. These 22 registrations 
represent 20 entities, of which 12 are small entities. Therefore, the 
DEA estimates 12 small entities are affected by this proposed rule.
    A review of the 22 registrations indicates that all entities that 
currently handle FUB-AMB also handle other schedule I controlled 
substances, and have established and implemented (or maintain) the 
systems and processes required to handle FUB-AMB. 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 12 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:

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)(79); and
0
b. Remove and reserve paragraph (h)(18).
    The addition reads as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

 
 
 
(79) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-   (7021)
 methylbutanoate, (FUB-AMB, MMB-FUBINACA, AMB-FUBINACA).......
 

* * * * *

    Dated: October 21, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-23626 Filed 10-29-19; 8:45 am]
 BILLING CODE 4410-09-P