Schedules of Controlled Substances: Placement of FUB-AMB in Schedule I
| Published date | 30 October 2019 |
| Citation | 84 FR 58090 |
| Record Number | 2019-23626 |
| Section | Proposed rules |
| Court | Drug Enforcement Administration |
Federal Register, Volume 84 Issue 210 (Wednesday, October 30, 2019)
[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
