[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Proposed Rules]
[Pages 13848-13853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06853]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-446]
Schedules of Controlled Substances: Placement of 5F-ADB, 5F-AMB,
5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA 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-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate
[5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-
carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5-
fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-
amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and
methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate [MDMB-FUBINACA], including their 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 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA
and MDMB-FUBINACA.
DATES: Comments must be submitted electronically or postmarked on or
before May 8, 2019.
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 May 8, 2019.
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-446'' 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
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: Lynnette M. Wingert, 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. 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
[[Page 13849]]
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 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).
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 make permanent the existing
temporary regulatory controls and administrative, civil, and criminal
sanctions of schedule I controlled substances on any person who handles
or proposes to handle 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-
CHMICA and MDMB-FUBINACA.
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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.
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Background
On April 10, 2017, the DEA published an order in the Federal
Register amending 21 CFR 1308.11(h) to temporarily place the six
synthetic cannabinoids (SCs) methyl 2-(1-(5-fluoropentyl)-1H-indazole-
3-carboxamido)-3, 3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl
2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-
AMB]; N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
[5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate
[MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA], in
schedule I of the CSA pursuant to the temporary scheduling provisions
of 21 U.S.C. 811(h). 82 FR 17119. 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 these six synthetic cannabinoids (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 these substances expire two
years from the effective date of the scheduling order, which was April
10, 2017. 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,\2\ 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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\2\ Because the Secretary of HHS has delegated to the Assistant
Secretary the authority to make domestic drug scheduling
recommendations, for purposes of this proposed scheduling action,
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 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-
CHMICA and MDMB-FUBINACA. 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 these six SCs. On September 27, 2017, the Acting
Administrator submitted a request to the Acting Assistant Secretary to
provide the DEA with a scientific and medical evaluation of available
information and a scheduling recommendation for 5F-ADB, 5F-AMB, 5F-
APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, and in accordance
with 21 U.S.C. 811(b) and (c). On March 21, 2019, the Assistant
Secretary submitted HHS's scientific and medical evaluation for these
six substances to the Acting Administrator. 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
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA
in accordance with 21 U.S.C. 811(c).
Proposed Determination to Schedule 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and MDMB-FUBINACA
As discussed in the background section, the Acting Administrator is
initiating proceedings, pursuant to 21 U.S.C. 811(a)(1), to add 5F-ADB,
5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA
permanently to schedule I of the CSA. The DEA has reviewed the
scientific and medical evaluation and scheduling recommendations,
received from HHS, and all other relevant data, and conducted its own
eight-factor analysis of the abuse potential of 5F-ADB, 5F-AMB, 5F-
APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA 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 March 21, 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-446.''
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
[[Page 13850]]
particular drug or substance has a potential for abuse \3\:
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\3\ 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.
(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.
HHS noted that people are taking 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA in sufficient amounts to
create a health hazard. Adverse effects observed following the
ingestion of synthetic cannabinoids, including 5F-ADB, 5F-AMB, 5F-
APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, include nausea
and vomiting, shortness of breath or depressed breathing, hypertension,
tachycardia, chest pain, muscle twitching, acute renal failure,
anxiety, agitation, psychosis, suicidal ideation, and/or cognitive
impairment. SCs like 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-
CHMICA and MDMB-FUBINACA are easily accessible and difficult to detect
in standard urine drug screens, which contributes to their popularity
and high rates of abuse. In addition, poison centers continue to report
the abuse of SCs and their associated products demonstrating that these
substances remain a threat to both the short- and long-term public
health and safety.
In their letter dated March 21, 2019, the HHS stated that there are
no Food and Drug Administration (FDA)-approved drug products containing
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA
in the United States and there appear to be no legitimate sources for
these substances as marketed drugs. Because 5F-ADB, 5F-AMB, 5F-APINACA,
ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA are not approved for
medical use and are not formulated or available for clinical use, the
human use of these substances 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 reports from the American
Association of Poison Control Centers (AAPCC) and law enforcement
indicate that individuals are taking these SCs on their own initiative,
rather than on the basis of medical advice of a licensed practitioner.
HHS detailed that 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-
CHMICA and MDMB-FUBINACA, similar to schedule I SCs (e.g., JWH-018),
bind to and activate the CB1 cannabinoid receptor. As stated by HHS,
5F-ADB, 5F-AMB, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA produced
delta-9-tetrahydrocannabinol (THC)-like discriminative stimulus effects
in rats trained to discriminate THC from vehicle control. DEA further
notes that in drug discrimination studies conducted under the
interagency agreement between DEA and FDA, 5F-APINACA also produced
THC-like discriminative stimulus effects in rats trained to
discriminate THC from vehicle control.
The abuse of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA
and MDMB-FUBINACA, similar to schedule I SCs, has been associated with
various adverse health effects. As stated by the HHS, it is reasonable
to assume that these six SCs have substantial capability to be a hazard
to the health of the user and to the safety of the community.
2. Scientific Evidence of the Drug's Pharmacological Effects, if
Known: 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-
FUBINACA are SCs that have pharmacological effects similar to the
schedule I hallucinogen THC and other temporarily and permanently
controlled schedule I SCs. HHS reported on in vitro receptor binding
and functional assays that were conducted with 5F-ADB, 5F-AMB, 5F-
APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA. In addition, drug
discrimination studies using Sprague Dawley rats investigating the THC-
like stimulus effects of these SCs have been completed. These results
indicate that 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and
MDMB-FUBINACA, similar to other schedule I SCs, bind to CB1 receptors,
act as agonists at CB1 receptors, and produce THC-like discriminative
stimulus effects.
3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance: HHS noted that chemically, 5F-ADB, 5F-AMB, 5F-APINACA,
ADB-FUBINACA, and MDMB-FUBINACA can be described as 3-carboxamide
indazole derivatives while MDMB-CHMICA belongs to the 3-carboxamide
indol family. The DEA is not aware of any currently accepted medical
uses for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-
FUBINACA. As mentioned by the HHS, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and MDMB-FUBINACA have not been approved by FDA
for medical use in the United States. Absent an FDA approval, according
to established DEA procedure and case law, ``a drug has a currently
accepted medical use if all of the following five elements have been
satisfied.'' (57 FR 10499; March 26, 1992).
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.
v. The scientific evidence must be widely available.
HHS evaluated these six SCs using this five-part test and
determined that none of the six SCs has a ``currently accepted medical
use'' in the United States.
4. Its History and Current Pattern of Abuse: All 6 SCs were
identified internationally prior to their discovery within the United
States. 5F-ADB was first identified in November 2014, in Japan in
postmortem samples of an individual who died following use of an herbal
product containing this substance. 5F-AMB was first identified in
herbal smoking mixtures in Japan between November 2013 and May 2014.
5F-APINACA was first identified in South Korea beginning in late 2012.
ADB-FUBINACA was first reported in the scientific literature in a
patent by Pfizer in 2009 (compound 1) followed by popularity in Turkey
in 2011 prior to its emergence on the United States illicit drug market
in March, 2014. According to the European Monitoring Centre for Drugs
and Drug Addiction (EMCDDA), the first seizure of MDMB-CHMICA was on
September 12, 2014. Germany also reported 9 deaths and 34 non-fatal
intoxications involving MDMB-
[[Page 13851]]
CHMICA from September 2014 through October 2014. According to the
United Nations Office on Drugs and Crime, 40 kilograms of MDMB-CHMICA
was identified in a seizure by Luxembourg Customs in December 2014.
MDMB-FUBINACA was first identified as ``MDMB/N/-Bz F'' by Russian media
outlets following the reported overdoses of 700 people and 25 deaths in
October 2014.
In recent cases of overdoses or deaths, 5F-ADB, 5F-AMB, 5F-APINACA,
ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA have been encountered in
the form of herbal products, similar to the SCs that have been
previously encountered.
5. The Scope, Duration, and Significance of Abuse: Following
multiple scheduling actions controlling SCs, law enforcement and health
care professionals have encountered novel SCs including 5F-ADB, 5F-AMB,
5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA differing only
by small structural modifications intended to avoid prosecution while
maintaining the pharmacological effects. National Forensic Laboratory
Information System (NFLIS \4\) details over 31,512 reports from
forensic laboratories identifying 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and MDMB-FUBINACA for a period from August 2012
through February 2019. In addition, System to Retrieve Information from
Drug Evidence (STRIDE \5\) and STARLiMS \6\ have 1,685 reports
involving 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and
MDMB-FUBINACA from 2012 through February 2019.
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\4\ NFLIS is a DEA program and a national forensic laboratory
reporting system that systematically collects results from drug
chemistry analyses conducted by state and local forensic
laboratories in the United States. The NFLIS database also contains
Federal data from U.S. Customs and Border Protection (CBP). NFLIS
only includes drug chemistry results from completed analyses.
\5\ STRIDE is a database of drug exhibits sent to DEA
laboratories for analysis. Exhibits from the database are from the
DEA, other federal agencies, and some local law enforcement
agencies.
\6\ STARLiMS is a laboratory information management system that
systematically collects results from drug chemistry analyses
conducted by DEA laboratories. On October 1, 2014, STARLiMS replaced
System to Retrieve Information from Drug Evidence (STRIDE) as the
DEA laboratory drug evidence data system of record.
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6. What, if Any, Risk There is to the Public Health: The HHS and
DEA documented multiple cases where 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and MDMB-FUBINACA have been identified in
overdoses and/or cases involving death attributed to their abuse.
Adverse health effects reported from these incidents involving 5F-ADB,
5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA
included nausea, persistent vomiting, agitation, altered mental status,
seizures, convulsions, loss of consciousness, cardio toxicity and/or
death. By sharing pharmacological similarities with schedule I
substances (THC, JWH-018 and other temporarily and permanently
controlled schedule I SCs), 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA,
MDMB-CHMICA and/or MDMB-FUBINACA, SCs with no approved medical use,
pose serious risk to the abuser.
7. Its Psychic or Physiological Dependence Liability: As stated by
HHS, 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-
FUBINACA have pharmacological profiles that are similar to other
schedule I SCs (e.g., JWH-018, XLR11 and AKB-48) and therefore it is
reasonable to assume that these six SCs possess physiological and
psychological dependence liability similar to that of these schedule I
SCs. There are no clinical studies evaluating psychic or physiological
dependence liabilities specific for 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and MDMB-FUBINACA.
8. Whether the Substance is an Immediate Precursor of a Substance
Already Controlled Under the CSA: 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and MDMB-FUBINACA are not immediate precursors 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 5F-
ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA.
As such, the DEA hereby proposes to permanently schedule 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA as
controlled substances 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 Acting Administrator of the DEA, pursuant to
21 U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:
1. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-
FUBINACA have a high potential for abuse that is comparable to other
schedule I substances such as THC and JWH-018;
2. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-
FUBINACA have no currently accepted medical use in treatment in the
United States; and
3. There is a lack of accepted safety for use of 5F-ADB, 5F-AMB,
5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA under medical
supervision.
Based on these findings, the Acting Administrator of the DEA
concludes that methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-
3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N-
(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide [5F-
APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate
[MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA],
including their salts, isomers and salts of isomers, whenever the
existence of such salts, isomers, and salts of isomers is possible,
warrant control in schedule I of the CSA. 21 U.S.C. 812(b)(1).
Requirements for Handling 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA,
MDMB-CHMICA and MDMB-FUBINACA
If this rule is finalized as proposed, 5F-ADB, 5F-AMB, 5F-APINACA,
ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA would continue \7\ to be
subject to the CSA's schedule I regulatory controls and administrative,
civil, and criminal sanctions applicable to the manufacture,
distribution,
[[Page 13852]]
dispensing, importing, exporting, research, and conduct of
instructional activities, including the following:
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\7\ 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and
MDMB-FUBINACA are currently subject to schedule I controls on a
temporary basis, pursuant to 21 U.S.C. 811(h). 82 FR 17119, April
10, 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) 5F-
ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA,
or who desires to handle 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA,
MDMB-CHMICA and MDMB-FUBINACA, 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. 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA
or MDMB-FUBINACA are 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 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and
MDMB-FUBINACA 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 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and
MDMB-FUBINACA 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 5F-ADB,
5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA must
have an initial inventory of all stocks of controlled substances
(including 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and
MDMB-FUBINACA) 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 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA) 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 5F-ADB, 5F-AMB, 5F-
APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA 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 5F-ADB, 5F-
AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA 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
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA
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 5F-ADB, 5F-AMB, 5F-APINACA,
ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA 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 (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 April 10,
2017, the DEA published an order to temporarily place these six SCs 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 these SCs have already established and implemented
the systems and processes required to handle 5F-ADB, 5F-AMB, 5F-
APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA. There are
currently 28 registrations authorized to handle 5F-ADB, 5F-AMB, 5F-
APINACA, ADB-FUBINACA, MDMB-CHMICA and/or MDMB-FUBINACA specifically,
as well as a number of registered analytical labs that are authorized
to handle schedule I controlled substances generally. These 28
registrations represent 24 entities, of which 14 are small entities.
Therefore, the DEA estimates 14 small entities are affected by this
proposed rule.
A review of the 28 registrations indicates that all entities that
currently handle 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA
or MDMB-FUBINACA also handle other schedule I controlled substances,
and have established and
[[Page 13853]]
implemented (or maintain) the systems and processes required to handle
5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA or MDMB-FUBINACA.
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 14 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, add paragraphs (d)(73) through (78) and remove and
reserve paragraphs (h)(6) through (11) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(73) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- 7034
carboxamido)-3,3-dimethylbutanoate (Other names: 5F-ADB;
5F-MDMB-PINACA)...........................................
(74) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- 7033
carboxamido)-3-methylbutanoate (Other names: 5F-AMB)......
(75) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3- 7049
carboxamide (Other names: 5F-APINACA, 5F-AKB48)...........
(76) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4- 7010
fluorobenzyl)-1H-indazole-3-carboxamide (Other names: ADB-
FUBINACA).................................................
(77) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3- 7042
carboxamido)-3,3-dimethylbutanoate (Other names: MDMB-
CHMICA, MMB-CHMINACA).....................................
(78) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3- 7020
carboxamido)-3,3-dimethylbutanoate (Other names: MDMB-
FUBINACA).................................................
* * * * *
Dated: April 2, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-06853 Filed 4-5-19; 8:45 am]
BILLING CODE 4410-09-P