[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Proposed Rules]
[Pages 42290-42295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14901]
[[Page 42289]]
Vol. 85
Monday,
No. 134
July 13, 2020
Part V
Department of Justice
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Drug Enforcement Administration
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21 CFR Part 1308
Schedules of Controlled Substances: Placement of NM2201, 5F-AB-PINACA,
4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA in Schedule I;
Proposed Rule and Temporary Rule
Federal Register / Vol. 85, No. 134 / Monday, July 13, 2020 /
Proposed Rules
[[Page 42290]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-479]
Schedules of Controlled Substances: Placement of NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA and 5F-CUMYL-P7AICA in Schedule
I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration (DEA) proposes placing
naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (trivial
names: NM2201; CBL2201), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-
fluoropentyl)-1H-indazole-3-carboxamide (trivial name: 5F-AB-PINACA),
1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide
(trivial names: 4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-CUMYL
BINACA; CUMYL-4CN-BINACA, SGT-78), methyl 2-(1-(cyclohexylmethyl)-1H-
indole-3-carboxamido)-3-methylbutanoate (trivial names: MMB-CHMICA,
AMB-CHMICA), and 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-
pyrrolo[2,3-b]pyridine-3-carboxamide (trivial name: 5F-CUMYL-P7AICA),
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 with, or possess) or propose to handle NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA.
DATES: Comments must be submitted electronically or postmarked on or
before August 12, 2020.
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.
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 August 12, 2020.
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-479'' on all electronic and written correspondence,
including any attachments.
Electronic comments: The Drug Enforcement Administration
(DEA) 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/DPW, 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: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 362-3261.
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 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 a Hearing
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking
``on the
[[Page 42291]]
record after opportunity for a hearing.'' Such proceedings are
conducted pursuant to the provisions of the Administrative Procedure
Act, 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316,
subpart D. Such requests or notices must conform to the requirements of
21 CFR 1308.44(a) or (b), as applicable, and include a statement of the
person's interests in the proceeding and the objections or issues, if
any, concerning which the person desires to be heard. Any waiver must
conform to the requirements of 21 CFR 1308.44(c) and may include a
written statement regarding the interested person's position on the
matters of fact and law involved in any hearing.
All requests for hearing and waivers of participation must be sent
to 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 HHS
(Assistant Secretary) and an evaluation of all other relevant data by
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 NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA, and 5F-CUMYL-P7AICA.
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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), FDA acts as the lead agency within 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 HHS has delegated to the Assistant Secretary for Health
of HHS the authority to make domestic drug scheduling
recommendations. 58 FR 35460, July 1, 1993.
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Background
On July 10, 2018, DEA published an order in the Federal Register
amending 21 CFR 1308.11(h) to temporarily place naphthalen-1-yl 1-(5-
fluoropentyl)-1H-indole-3-carboxylate (trivial names: NM2201; CBL2201),
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-
carboxamide (trivial name: 5F-AB-PINACA), 1-(4-cyanobutyl)-N-(2-
phenylpropan-2-yl)-1H-indazole-3-carboxamide (trivial names: 4-CN-
CUMYL-BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-
BINACA, SGT-78), methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3-methylbutanoate (trivial names: MMB-CHMICA, AMB-CHMICA),
and 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-
b]pyridine-3-carboxamide (trivial name: 5F-CUMYL-P7AICA) in schedule I
of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C.
811(h). 83 FR 31877. That temporary scheduling order was effective on
the date of publication, and was based on findings by the former Acting
Administrator of DEA (Acting Administrator) that the temporary
scheduling of these five synthetic cannabinoids (SCs) was necessary to
avoid an imminent hazard to the public safety pursuant to 21 U.S.C.
811(h)(1). Subsection 811(h)(2) requires that the temporary control of
these substances expire two years from the effective date of the
scheduling order, which for these five substances had an effective date
of July 10, 2018. However, this same subsection also provides that
during the pendency of proceedings under 21 U.S.C. 811(a)(1) with
respect to a substance, the temporary scheduling of that substance may
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 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 being simultaneously 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, is initiating
proceedings under 21 U.S.C. 811(a)(1) to permanently schedule NM2201,
5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA. 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 five SCs. On February 4,
2019, the Acting Administrator submitted a request to the Assistant
Secretary to provide DEA with a scientific and medical evaluation of
available information and a scheduling recommendation for NM2201, 5F-
AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA, in
accordance with 21 U.S.C. 811(b) and (c). Upon evaluating the
scientific and medical evidence, on May 29, 2020, the Assistant
Secretary submitted HHS's scientific and medical evaluation and
scheduling recommendation for these five substances to the Acting
Administrator. Upon receipt of the scientific and medical evaluation
and scheduling recommendation from HHS, DEA reviewed the documents and
all other relevant data, and conducted its own eight-factor analysis of
the abuse potential of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA, and 5F-CUMYL-P7AICA, in accordance with 21 U.S.C. 811(c).
Proposed Determination to Schedule NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA
As discussed in the background section, the Acting Administrator is
initiating proceedings, pursuant to 21 U.S.C. 811(a)(1), to add NM2201,
5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA
permanently to schedule I of the CSA. DEA has reviewed the scientific
and medical evaluation and scheduling recommendation received from HHS,
and all other relevant data, and conducted its own eight-factor
analysis of the abuse potential of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA, pursuant to 21 U.S.C.
811(c). Included below is a brief summary of each factor as analyzed by
HHS and DEA, and as considered by DEA in its proposed scheduling
action. Please note that both DEA Eight-Factor and HHS Eight-Factor
analyses and the Assistant Secretary's May 29, 2020, 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-479.''
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 DEA consider the following criteria in
determining whether a particular
[[Page 42292]]
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 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.
In its recommendation, HHS noted that abuse of NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA has a
substantial capability to create a hazard to the health of the
individual users and the safety of others within the community. Adverse
effects observed following the ingestion of NM2201, 5F-AB-PINACA, or 4-
CN-CUMYL-BUTINACA included diaphoresis, tachycardia, hypertension,
seizures, agitation, violence, nausea, and memory impairment (see
factor 6). SCs, including NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA, and 5F-CUMYL-P7AICA, have been generally found to be easily
accessible and difficult to detect in standard urine drug screens,
which contributes to their popularity and high rates of abuse.
As stated by HHS, there are no Food and Drug Administration (FDA)-
approved drug products containing NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA for treatment in the United
States, and there appear to be no legitimate sources for these
substances as marketed drugs. In addition, HHS stated that the human
use of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-
CUMYL-P7AICA 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, since these SCs are not approved for medical use
and are not formulated or available for clinical use. As noted by HHS,
individuals may be using these five SCs on their own initiative,
possibly because they are seeking the same cannabinoid-like effects as
other schedule I cannabinoids while avoiding the criminal penalties
associated with those substances. Further, published scientific and
medical literature and law enforcement reports indicate that
individuals are taking these SCs on their own initiative, rather than
on the basis of medical advice of a licensed practitioner.
As stated by HHS, the pharmacological data for NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA show that
these substances, similar to other schedule I SCs, bind to and activate
the CB1 cannabinoid receptors. In drug discrimination studies either
sponsored by the National Institute on Drug Abuse or conducted by FDA's
National Center for Toxicological Research under an Interagency
Agreement, NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and
5F-CUMYL-P7AICA, similar to other schedule I SCs (e.g., JWH-018,
AM2201, ADB-PINACA, AB-FUBINACA), fully substitute for delta-9-
tetrahydrocannabinol (THC) in animals trained to discriminate THC from
vehicle control. Documented adverse effects associated with NM2201, 5F-
AB-PINACA, and 4-CN-CUMYL-BUTINACA in the United States and abroad, and
5F-CUMYL-P7AICA in Europe, similar to other schedule I SCs, include
tachycardia, aggressive or violent behavior, confusion, depressed
mental status, severe agitation, psychosis, and/or death in some
instances (see factors 4 and 6). HHS stated that because of the
psychological and cognitive disturbances associated with such
responses, it is reasonable to assume that these five SCs have a
substantial capability to be a hazard to the health of the user and to
the safety of the community.
The above information collectively indicates that the relative
potential for abuse of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA, and 5F-CUMYL-P7AICA is similar to other schedule I CB1 receptor
agonists.
2. Scientific Evidence of the Drug's Pharmacological Effects, if
Known: Within its recommendation, HHS described in vitro receptor
binding and functional assays that were conducted with NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA. These
results indicate that NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA, and 5F-CUMYL-P7AICA, similar to other schedule I SCs, bind to
CB1 receptors and act as full cannabinoid agonists at CB1 receptors.
Drug discrimination studies were conducted in animals to evaluate
whether the five SCs have cannabinoid characteristics similar to
substances in schedule I of the CSA. Each of the five SCs were shown to
fully substitute for the discriminative stimulus effects produced by
THC, a schedule I substance.
3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance:
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-
CUMYL-P7AICA are all potent cannabinoid agonists that are
pharmacologically similar to THC and several schedule I SCs.
As stated by HHS, when FDA approves a drug under the Federal Food,
Drug, and Cosmetic Act for human or animal medical use, such drug
is considered to have a currently accepted medical use in the United
States. In the absence of such approval by FDA, a drug may be
considered to have a currently accepted medical use in the United
States if DEA concludes that the drug satisfies all of the following
five elements: \4\
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\4\ 57 FR 10492 (1992), pet. for rev. denied, Alliance for
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).
a. The drug's chemistry is known and reproducible;
b. There are adequate safety studies;
c. There are adequate and well-controlled studies proving
efficacy;
d. The drug is accepted by qualified experts; and
e. The scientific evidence is widely available.
According to HHS, NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA, and 5F-CUMYL-P7AICA have not been approved by FDA as a human or
animal drug product in the United States or, to FDA's knowledge, been
approved for medical use in any other country. Moreover, there are no
well-controlled clinical studies showing safety or efficacy for any of
these cannabinoids. In addition, there is no evidence by qualified
experts that the five cannabinoids are accepted as having therapeutic
uses. Therefore, NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA,
and 5F-CUMYL-P7AICA have no
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currently accepted medical use for treatment in the United States.
4. Its History and Current Pattern of Abuse: NM2201 was first
identified in the United States in November 2012 in seized drug
evidence, followed by 5F-AB-PINCA (August 2013), MMB-CHMICA (December
2015), 4-CN-CUMYL BUTINACA (January 2016), and most recently 5F-CUMYL-
P7AICA (February 2018). The European Monitoring Centre for Drugs and
Drug Addiction reported a seizure of 50 kg of 4-CN-CUMYL-BUTINACA in
Europe in 2016. According to the National Forensic Laboratory
Information System \5\ (NFLIS), although the first encounter of 4-CN-
CUMYL-BUTINACA in the United States occurred in January 2016, the
increase in encounters did not occur until later in 2017. Similarly,
prior to the first encounter of 5F-CUMYL-P7AICA in the United States in
February 2018, two deaths related to the use of this substance had
already been documented in Europe in November and December 2016 (see
factor 6). The data also show that SCs originate in China and these
substances are often abused in Europe and other countries before being
trafficked in the United States.
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\5\ 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.
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HHS stated that compared to cannabis, acute fatal poisoning appears
to be more prevalent with SCs. As demonstrated by NFLIS, law
enforcement encounters of these five SCs have decreased following their
placement in schedule I (see Factor 5).
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 NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA, that
differ from previously scheduled SCs and one another only by small
structural modifications intended to avoid prosecution while
maintaining the pharmacological effects. NFLIS detailed 5,259 reports
from forensic laboratories for these five substances as follows: 2,938
reports of NM2201, 1,200 reports of 5F-AB-PINACA, 797 reports of 4-CN-
CUMYL-BUTINACA, 323 reports of MMB-CHMICA, and 1 report of 5F-CUMYL-
P7AICA for a period from November 2012 through June 2020.\6\ Reports
peaked for NM2201 and 5F-AB-PINACA in 2015, for MMB-CHMICA in 2017, and
for 4-CN-CUMYL-BUTINACA in 2018. The report of 5F-CUMYL-P7AICA also
occurred in 2018. In addition, the System to Retrieve Drug Evidence
(STRIDE) \7\ and STARLiMS \8\ have 644 reports involving NM2201 (311
reports), 5F-AB-PINACA (202 reports), 4-CN-CUMYL-BUTINACA (13 reports),
and MMB-CHMICA (118 reports) from 2013 through June 2020. A full
presentation of the NFLIS and STRIDE/STARLiMS reports by substance and
by year are available in the Supporting Documents of the public docket
available at http://www.regulations.gov.
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\6\ Query date June 3, 2020.
\7\ STRIDE is a database of drug exhibits sent to DEA
laboratories for analysis. Exhibits from the database are from DEA,
other federal agencies, and some local law enforcement agencies.
\8\ 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
STRIDE as DEA's laboratory drug evidence data system of record.
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6. What, if Any, Risk There is to the Public Health: HHS and DEA
documented multiple cases where NM2201, 5F-AB-PINACA, and 4-CN-CUMYL-
BUTINACA have been identified in overdoses and/or cases involving death
attributed to their abuse in the United States and abroad. In addition,
HHS and DEA reported exposure to 5F-CUMYL-P7AICA resulted in two deaths
in November and December 2016 in Europe. Adverse health effects
reported from these incidents involving NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, and 5F-CUMYL-P7AICA included diaphoresis, tachycardia,
hypertension, seizures, agitation, violence, nausea, and memory
impairment, and/or death. By sharing pharmacological similarities with
schedule I substances (THC, JWH-018, and other temporarily and
permanently controlled schedule I SCs), NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA are SCs with no
approved medical use that pose serious risk to the abuser. While no
adverse event information is currently available for MMB-CHMICA,
substantial law enforcement seizures and the pharmacological similarity
of MMB-CHMICA to other currently controlled schedule I SCs with known
risks to public health (i.e., AB-CHMINACA, AB-FUBINACA, JWH-018)
demonstrate an imminent hazard to public safety (see factor 5).
7. Its Psychic or Physiological Dependence Liability: As stated by
HHS, NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-
CUMYL-P7AICA have pharmacological profiles that are similar to other
schedule I SCs. There are no clinical studies evaluating dependence
liabilities specific to NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-
CHMICA, and 5F-CUMYL-P7AICA. HHS noted that while the five SCs are
pharmacologically related to several current schedule I SCs such as
JWH-018, XLR11, and AKB-48, there are still no specific studies
examining their respective psychic or dependence liability. HHS stated
that it is reasonable to assume, given the pharmacology of the five
SCs, the likelihood of such a withdrawal effect being associated with
the use of these cannabinoids as well.
8. Whether the Substance is an Immediate Precursor of a Substance
Already Controlled Under the CSA: As noted by HHS, NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA 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 HHS, HHS's recommendation, and DEA's own eight-factor
analysis, DEA finds that the facts and all relevant data constitute
substantial evidence of the potential for abuse of NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA. As such,
DEA hereby proposes to permanently schedule NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA 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 Health of HHS and review
of all other available data, the Acting Administrator of DEA, pursuant
to 21 U.S.C. 811(a) and 812(b)(1), finds that:
1. NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-
CUMYL-P7AICA have a high potential for abuse that is comparable to
other schedule I substances such as THC and JWH-018;
2. NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-
CUMYL-P7AICA have no
[[Page 42294]]
currently accepted medical use in treatment in the United States; and
3. There is a lack of accepted safety for use of NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA under
medical supervision.
Based on these findings, the Acting Administrator of DEA concludes
that naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate
(trivial names: NM2201; CBL2201); N-(1-amino-3-methyl-1-oxobutan-2-yl)-
1-(5-fluoropentyl)-1H-indazole-3-carboxamide (trivial name: 5F-AB-
PINACA); 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-
carboxamide (trivial names: 4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-
BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA, SGT-78); methyl 2-(1-
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate (trivial
names: MMB-CHMICA, AMB-CHMICA), and 1-(5-fluoropentyl)-N-(2-
phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide (trivial
name: 5F-CUMYL-P7AICA), 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 NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA, and 5F-CUMYL-P7AICA
If this rule is finalized as proposed, NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA would continue \9\ 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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\9\ NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and
5F-CUMYL-P7AICA are currently subject to schedule I controls on a
temporary basis, pursuant to 21 U.S.C. 811(h). 83 FR 31877, July 10,
2018.
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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)
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-
P7AICA, or who desires to handle NM2201, 5F-AB-PINACA, 4-CN-CUMYL-
BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA, is required to be registered
with 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. NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA,
and 5F-CUMYL-P7AICA 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. Non-practitioners handling
these five substances must also comply with the employee screening
requirements of 21 CFR 1301.90-1301.93.
3. Labeling and Packaging. All labels and labeling for commercial
containers of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA,
and 5F-CUMYL-P7AICA 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 NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and
5F-CUMYL-P7AICA 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 DEA to handle NM2201, 5F-
AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA must
have an initial inventory of all stocks of controlled substances
(including NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and
5F-CUMYL-P7AICA) 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 NM2201, 5F-
AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA) 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 NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA 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 NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA 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
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-
P7AICA 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 NM2201, 5F-AB-PINACA, 4-CN-
CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA 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, 13563, and 13771, Regulatory Planning and
Review, Improving Regulation and Regulatory Review, and Reducing
Regulation and Controlling Regulatory Costs
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 (E.O.) 12866 and the
principles reaffirmed in E.O. 13563.
This proposed rule does not meet the definition of an E.O. 13771
regulatory action, and the repeal and cost offset requirements of E.O.
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 E.O. 12866.
Executive Order 12988, Civil Justice Reform
This proposed regulation meets the applicable standards set forth
in sections 3(a) and 3(b)(2) of E.O. 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, Federalism
This proposed rulemaking does not have federalism implications
warranting the application of E.O. 13132. The proposed rule does not
have substantial direct effects on the States, on the
[[Page 42295]]
relationship between the national government and the States, or the
distribution of power and responsibilities among the various levels of
government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This proposed rule does not have tribal implications warranting the
application of E.O. 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.
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 July 10,
2018, DEA published an order to temporarily place NM2201, 5F-AB-PINACA,
4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA in schedule I of
the CSA pursuant to the temporary scheduling provisions of 21 U.S.C.
811(h). DEA estimates that all entities handling or planning to handle
NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-
P7AICA have already established and implemented the systems and
processes required to handle these substances. There are currently 28
unique registrations authorized to specifically handle NM2201, 5F-AB-
PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, or 5F-CUMYL-P7AICA, as well as
a number of registered analytical labs that are authorized to handle
schedule I controlled substances generally. From a review of entity
names, DEA estimates these 28 registrations represent 22 entities. Some
of these entities are likely to be large entities. However, since DEA
does not have information of registrant size and the majority of DEA
registrants are small entities or are employed by small entities, DEA
estimates a maximum of 22 entities are small entities. Therefore, DEA
conservatively estimates as many as 22 small entities are affected by
this proposed rule.
A review of the 28 registrations indicates that all entities that
currently handle NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA,
and 5F-CUMYL-P7AICA also handle other schedule I controlled substances,
and have established and implemented (or maintain) the systems and
processes required to handle NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA,
MMB-CHMICA, and 5F-CUMYL-P7AICA. Therefore, 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 22 affected small entities. Therefore, 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., 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 million or more (adjusted annually
for inflation) in any 1 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, DEA proposes to amend 21 CFR part
1308 as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 21 CFR Part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. In Sec. 1308.11,
0
a. Add paragraphs (d)(81) through (85); and
0
b. Remove and reserve paragraphs (h)(31) through (35);
The additions read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(81) Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate 7221
(NM2201; CBL2201).............................................
(82) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H- 7025
indazole-3-carboxamide (5F-AB-PINACA).........................
(83) 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3- 7089
carboxamide (4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-
CUMYL BINACA; CUMYL-4CN-BINACA; SGT-78).......................
(84) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3- 7044
methylbutanoate (MMB-CHMICA, AMB-CHMICA)......................
(85) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3- 7085
b]pyridine-3-carboxamide (5F-CUMYL-P7AICA)....................
* * * * *
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-14901 Filed 7-9-20; 10:00 am]
BILLING CODE 4410-09-P