[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:
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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