[Federal Register Volume 86, Number 59 (Tuesday, March 30, 2021)]
[Proposed Rules]
[Pages 16553-16558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06553]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-491]


Schedules of Controlled Substances: Placement of 5F-EDMB-PINACA, 
5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 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 ethyl 2-
(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate 
(trivial name: 5F-EDMB-PINACA); methyl 2-(1-(5-fluoropentyl)-1H-indole-
3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA); N-
(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (trivial 
names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-fluorobenzyl)); 1-(5-
fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide 
(trivial names: 5F-CUMYL-PINACA; SGT-25); and (1-(4-fluorobenzyl)-1H-
indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (trivial name: 
FUB-144), 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 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144.

DATES: Comments must be submitted electronically or postmarked on or 
before April 29, 2021.
    Requests for hearing and waivers of an opportunity for a hearing or 
to participate in a hearing must be received on or before April 29, 
2021.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-491'' on all electronic and written correspondence, 
including any attachments.
     Electronic comments: Interested persons may file written 
comments on this proposal in accordance with 21 CFR 1308.43(g). 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 on-line instructions at 
that site for submitting comments. Upon completion of your submission, 
you will receive a Comment Tracking Number. Please be aware that 
submitted comments are not instantaneously available for public view on 
http://www.regulations.gov. If you have received a Comment Tracking 
Number, your comment has been submitted successfully, and there is no 
need to resubmit the same comment. 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.
     Paper comments: Paper comments that duplicate electronic 
submissions are not necessary and are discouraged. Should you wish to 
mail a paper comment in lieu of an electronic comment, send 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, together with a written statement of position on the 
matters of fact and law asserted in the hearing, 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/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical 
Evaluation Section, Drug Enforcement Administration; Telephone: (571) 
362-3249.

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

[[Page 16554]]

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 
to make it 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 to make it 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.
    DEA will generally make available in publicly redacted form 
comments containing personal identifying information and confidential 
business information identified as directed above. If a comment has so 
much confidential business information that it cannot be effectively 
redacted, DEA may not make available publicly all or part of that 
comment. 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 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. 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 they shall include a 
statement of interest in the proceeding and the objections or issues, 
if any, concerning which the person desires to be heard. 21 CFR 
1316.47(a). 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, together 
with a written statement of position on the matters of fact and law 
involved in such hearing, 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. 21 U.S.C. 811(a). This proposed action is supported by a 
recommendation from the Acting Assistant Secretary for Health of the 
Department of Health and Human Services (HHS) 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 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144.

Background

    On April 16, 2019, pursuant to 21 U.S.C. 811(h)(1), DEA published 
an order in the Federal Register (84 FR 15505) temporarily placing 
ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate (trivial name: 5F-EDMB-PINACA); methyl 2-(1-(5-
fluoropentyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate (trivial 
name: 5F-MDMB-PICA); N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-
3-carboxamide (trivial names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-
FLUOROBENZYL)); 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-
3-carboxamide (trivial names: 5F-CUMYL-PINACA; SGT-25); and (1-(4-
fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone 
(trivial name: FUB-144) in schedule I of the CSA upon finding that 
these five synthetic cannabinoids (SCs) pose an imminent hazard to the 
public safety. That temporary order was effective on the date of 
publication. Pursuant to 21 U.S.C. 811(h)(2), the temporary control of 
these substances is set to expire on April 16, 2021. 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,\1\ or on the petition of any 
interested party. An extension of the existing temporary order is being 
ordered by the Acting Administrator of DEA (Acting Administrator) in a 
separate action, and is being simultaneously published elsewhere in 
this issue of the Federal Register.
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    \1\ Because the Secretary of HHS has delegated to the Assistant 
Secretary for Health of HHS (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 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144. DEA 
gathered the available information regarding the pharmacology, 
chemistry, trafficking, actual abuse, pattern of abuse, and the 
relative potential for abuse for these five SCs. On December 4, 2019, 
the former Acting Administrator submitted this data to the Assistant 
Secretary for Health of HHS (Assistant Secretary), and requested that 
HHS provide DEA with a scientific and medical evaluation and a 
scheduling recommendation for 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 
5F-CUMYL-PINACA and FUB-144, in accordance with 21 U.S.C. 811(b) and 
(c). Upon evaluating the scientific and medical evidence, on February 
26, 2021, the Acting 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 5F-EDMB-PINACA, 5F-
MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, in accordance with 
21 U.S.C. 811(c).

Proposed Determination To Schedule 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-
AKB48, 5F-CUMYL-PINACA and FUB-144

    As discussed in the background section, the Acting Administrator is 
initiating proceedings, pursuant to 21

[[Page 16555]]

U.S.C. 811(a)(1), to add 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-
CUMYL-PINACA and FUB-144 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 5F-
EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, 
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 Acting Assistant Secretary's February 
26, 2021, 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-491.''
    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 drug or substance has a potential for 
abuse: \2\
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    \2\ 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 the abuse of 5F-EDMB-PINACA, 
5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 is creating a 
hazard to the health and safety of both the individual users and others 
within the community. Adverse effects have been observed following the 
ingestion of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA 
or FUB-144 (see factor 6). SCs, including 5F-EDMB-PINACA, 5F-MDMB-PICA, 
FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, are easily accessible and 
difficult to detect in standard urine drug screens. These factors are 
contributing to their popularity and high rates of abuse, while 
resulting in serious harm to users. In addition, poison centers 
continue to report the abuse and harm of SCs in general and their 
associated products. SCs continue to remain a threat to both the short- 
and long-term public health and safety.
    HHS stated in their letter to DEA dated September 6, 2018, and 
reiterated in their recommendation dated February 26, 2021, that there 
are no Food and Drug Administration (FDA)-approved drug products 
containing 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or 
FUB-144 in the United States and there appear to be no legitimate 
sources for these substances as marketed drugs. In their recommendation 
dated February 26, 2021, HHS stated that FDA is not aware of any 
diversion, from schedule I research or manufacturing activities, 
related to these five SCs for the purpose of legitimate drug research.
    HHS stated that because 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 
5F-CUMYL-PINACA and FUB-144 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 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.
    HHS noted that 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-
PINACA and FUB-144, similar to schedule I SCs (e.g., JWH-018), bind to 
and activate the cannabinoid type 1 (CB1) receptors (see factor 2). In 
addition, drug discrimination studies conducted in rodents demonstrate 
that these five SCs, similar to other schedule I SCs (e.g., JWH-018; 
AM2201; ADB-PINACA, AB-FUBINACA, etc.), fully substitute for delta-9-
tetrahydrocannabinol (THC) in animals trained to discriminate THC from 
vehicle control (see factor 2).
    2. Scientific Evidence of the Drug's Pharmacological Effects, if 
Known: In their recommendation, HHS described in vitro receptor binding 
and functional assays that were conducted using 5F-EDMB-PINACA, 5F-
MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144. These results 
indicate that 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA 
and FUB-144, similar to other schedule I SCs, bind to CB1 receptors and 
act as agonists at CB1 receptors. HHS also noted that drug 
discrimination studies were conducted in animals to evaluate whether 
the five SCs have cannabinoid characteristics similar to other 
substances in schedule I of the CSA. Each of the five SCs were shown to 
fully substitute for the discriminative stimulus effects produced by 
delta-9-THC. No human studies involving 5F-EDMB-PINACA, 5F-MDMB-PICA, 
FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 have been reported.
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance: HHS stated that it is important to highlight the fact 
that the five SCs are structurally unrelated to THC, the principle 
psychoactive chemical in marijuana. Instead, they are potent 
cannabinoids that are reported to be smoked for recreational purposes. 
5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 
are all CB1 receptor agonists that are pharmacologically similar to 
THC.
    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: \3\
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    \3\ 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 the HHS recommendation, none of the five SCs has 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

[[Page 16556]]

cannabinoids. In addition, there is no evidence by qualified experts 
that any of the five cannabinoids are accepted as having therapeutic 
uses. Therefore, 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-
PINACA and FUB-144 have no currently accepted medical use for treatment 
in the United States.
    4. Its History and Current Pattern of Abuse: FUB-144 was first 
identified in seized drug evidence in January, 2014, followed by FUB-
AKB48 (March 2014), 5F-MDMB-PICA (July 2014), 5F-EDMB-PINACA (October 
2017) and 5F-CUMYL-PINACA (February 2018) (National Forensic Laboratory 
Information System [NFLIS], 2021).\4\ Following their manufacture in 
China, SCs are often encountered in countries including New Zealand, 
Australia and Russia before appearing throughout Europe and eventually 
in the United States. 5F-CUMYL-PINACA was first reported in the German 
and Swiss illicit drug market in 2015 but did not appear in the United 
States until February 2018. 5F-EDMB-PINACA was reported in China in 
2016 but didn't appear in the United States until October 2017. 5F-
MDMB-PICA was first reported in the scientific literature in Germany 
and Belgium in late 2016. While two reports of 5F-MDMB-PICA were noted 
in NFLIS occurring in 2014 and 2016, it was not until 2017 and 2018 
that there was a dramatic increase in 5F-MDMB-PICA reports in the 
United States. These data further support that based upon trends, SCs 
appear in the illicit drug markets of other countries including those 
in Europe often before being reported in the United States. Law 
enforcement has seized 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-
CUMYL-PINACA and FUB-144 and misuse of these SCs has been associated 
with overdoses requiring emergency medical intervention (see Factor 6).
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    \4\ NFLIS is 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.
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    The powder form of SCs is typically dissolved in solvents (e.g., 
acetone) before being applied to plant material, or dissolved in a 
propellant intended for use in electronic cigarette devices. In 
addition, 5F-EDMB-PINACA was identified as an adulterant on pieces of 
paper that were smuggled into a detention facility and later found 
partially burned (see Factor 6). 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-
AKB48, 5F-CUMYL-PINACA and FUB-144, similar to other SCs, have been 
found in powder form or mixed with dried leaves or herbal blends that 
were marketed for human use.
    5. The Scope, Duration, and Significance of Abuse: According to 
HHS, SCs continue to be encountered on the illicit market despite 
scheduling actions that attempt to safeguard the public from the 
adverse effects and safety issues associated with these substances. 
Novel SCs continue to be encountered that differ only by small chemical 
structural modifications intended to avoid prosecution, while 
maintaining the pharmacological effects. Law enforcement and health 
care professionals continue to report the abuse of these substances and 
their associated products. NFLIS detailed 8,207 reports from forensic 
laboratories for these five substances as follows: 667 reports of 5F-
EDMB-PINACA, 6,014 reports of 5F-MDMB-PICA, 411 reports of FUB-AKB48, 
117 reports of 5F-CUMYL-PINACA, and 998 reports of FUB-144 for a period 
from 2014 through 2020.\5\ A full presentation of the NFLIS reports by 
substance and year are available in DEA's eight-factor analysis within 
the Supporting Documents section of the public docket available at 
http://www.regulations.gov.
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    \5\ Query date February 12, 2021.
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    6. What, if Any, Risk There is to the Public Health: HHS and DEA 
documented multiple cases where 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-
AKB48, 5F-CUMYL-PINACA and FUB-144 have been identified in overdoses 
and/or cases involving death attributed to their abuse in the United 
States and abroad. Emergency medical intervention has been required as 
well as serious adverse health effects reported from these incidents 
involving 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and 
FUB-144. Adverse effects have included seizures, diaphoresis, 
hypertension, tachycardia, cerebral edema and/or death. By sharing 
pharmacological similarities with other schedule I substances (THC, 
JWH-018 and other temporarily and permanently controlled schedule I 
SCs), 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-
144 pose serious risk to the abuser.
    7. Its Psychic or Physiological Dependence Liability: There are no 
clinical studies evaluating dependence liabilities specific for 5F-
EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144. 
However, scientific data indicate that 5F-EDMB-PINACA, 5F-MDMB-PICA, 
FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 have pharmacological profiles 
that are similar to other schedule I SCs. HHS stated that based upon 
this similar pharmacological profile, it is reasonable to assume that 
these cannabinoids retain a physiological and psychological dependence 
liability that is similar to that of [Delta]9-THC (a schedule I drug) 
and to other schedule I synthetic cannabinoids, such as JWH-018, XLR11, 
and AKB-48.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled Under the CSA: As noted by HHS, 5F-EDMB-PINACA, 5F-
MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 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 5F-EDMB-PINACA, 5F-
MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144. As such, DEA hereby 
proposes to permanently schedule 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-
AKB48, 5F-CUMYL-PINACA and FUB-144 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 Acting 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. 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and 
FUB-144 have a high potential for abuse that is comparable to other 
schedule I substances such as THC and JWH-018;
    2. 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and 
FUB-144 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-EDMB-PINACA, 
5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 under medical 
supervision.
    Based on these findings, the Acting Administrator of DEA concludes 
that 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-
144, including their salts, isomers, and salts of isomers, whenever the 
existence of such salts, isomers, and salts of isomers is possible, 
warrant

[[Page 16557]]

control in schedule I of the CSA. 21 U.S.C. 812(b)(1).

Requirements for Handling 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-
CUMYL-PINACA and FUB-144

    If this rule is finalized as proposed, 5F-EDMB-PINACA, 5F-MDMB-
PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 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, reverse distribution, import, export, engagement in 
research, conduct of instructional activities or chemical analysis 
with, and possession of schedule I controlled substances, including the 
following:
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    \6\ 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and 
FUB-144 are currently subject to schedule I controls on a temporary 
basis, pursuant to 21 U.S.C. 811(h). 84 FR 15505, April 16, 2019.
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    1. Registration. Any person who handles (manufactures, distributes, 
reverse distributes, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses), or 
who desires to handle, 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-
CUMYL-PINACA or FUB-144 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. 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-
PINACA and FUB-144 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 1301.71-1301.76. 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, labeling, and packaging for 
commercial containers of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-
CUMYL-PINACA or FUB-144 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-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or 
FUB-144 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 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 must have 
an initial inventory of all stocks of controlled substances (including 
5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144) 
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-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144) 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-EDMB-PINACA, 5F-
MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 pursuant to 21 U.S.C. 
827 and 958(e), and in accordance with 21 CFR 1301.74(b) and (c) and 
parts 1304, 1312, and 1317.
    7. Order Forms. Every DEA registrant who distributes 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 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-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 
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-EDMB-PINACA, 5F-MDMB-PICA, 
FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 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 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    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.

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 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, 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 16, 2019, 
DEA published an order to temporarily place 5F-EDMB-PINACA, 5F-MDMB-
PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 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 5F-EDMB-
PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 have 
already established and implemented the systems and processes required 
to handle these substances. There are currently 28 unique registrations 
authorized to specifically handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-
AKB48, 5F-CUMYL-PINACA or FUB-144, 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

[[Page 16558]]

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 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-
PINACA or FUB-144 also handle other schedule I controlled substances, 
and have established and implemented (or maintain) the systems and 
processes required to handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 
5F-CUMYL-PINACA and FUB-144. 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 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)(87) through (d)(91); and
0
b. Remove and reserve paragraphs (h)(37) through (41).
    The additions to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

 
(87) ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                     7036
 carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-
 EDMB-PINACA)...........................................
(88) methyl 2-(1-(5-fluoropentyl)-1H-indole-3-                      7041
 carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-
 MDMB-PICA).............................................
(89) N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-           7047
 carboxamide (trivial names: FUB-AKB48; FUB-APINACA;
 AKB48 N-(4-FLUOROBENZYL))..............................
(90) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-                 7083
 indazole-3-carboxamide (trivial names: 5F-CUMYL-PINACA;
 SGT-25)................................................
(91) (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-                    7014
 tetramethylcyclopropyl)methanone (trivial name: FUB-
 144)...................................................
 

* * * * *

D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-06553 Filed 3-29-21; 8:45 am]
BILLING CODE 4410-09-P