[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Rules and Regulations]
[Pages 13796-13798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06851]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-446]
Schedules of Controlled Substances: Extension of Temporary
Placement of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and
MDMB-FUBINACA in Schedule I of the Controlled Substances Act
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Temporary rule; temporary scheduling order; extension.
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SUMMARY: The Acting Administrator of the Drug Enforcement
Administration is issuing this temporary scheduling order to extend the
temporary schedule I status of six synthetic cannabinoids (SC). The
substances are: 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 optical, positional and geometric isomers, salts, and
salts of isomers. The schedule I status of 5F-ADB, 5F-AMB, 5F-APINACA,
ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA will expire on April 10,
2019. This temporary order will extend the temporary scheduling of 5F-
ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA
for one year or until the permanent scheduling action for these six
substances is completed, whichever occurs first.
DATES: This temporary scheduling order, which extends the order (82 FR
17119, April 10, 2017), is effective April 10, 2019 and expires on
April 10, 2020. If DEA publishes a final rule making this scheduling
action permanent, this order will expire on the effective date of that
rule, if the effective date is earlier than April 10, 2020.
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:
Background and Legal Authority
On April 10, 2017, the Acting Administrator of the Drug Enforcement
Administration (DEA) published an order in the Federal Register (82 FR
17119) temporarily 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],
synthetic cannabinoid (SC) substances, in schedule I of the Controlled
Substances Act (CSA) pursuant to the temporary scheduling provisions of
21 U.S.C. 811(h). That order was effective on the date of publication,
and was based on findings by the Acting Administrator of the DEA that
the temporary scheduling of these SCs 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 expires two years from the
effective date of the scheduling order, or on April 10, 2019. However,
the CSA also provides that during the pendency of proceedings under 21
U.S.C. 811(a)(1) with respect to the substance, the temporary
scheduling \1\ of that substance
[[Page 13797]]
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 Health and
Human Services (HHS),\2\ or on the petition of any interested party.
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\1\ Though DEA has used the term ``final order'' with respect to
temporary scheduling orders in the past, this notice adheres to the
statutory language of 21 U.S.C. 811(h), which refers to a
``temporary scheduling order.'' No substantive change is intended.
\2\ The Secretary of HHS has delegated to the Assistant
Secretary for Health of the HHS the authority to make domestic drug
scheduling recommendations.
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The Acting Administrator of the DEA (Acting Administrator), on his
own motion pursuant to 21 U.S.C. 811(a), has initiated proceedings
under 21 U.S.C. 811(a)(1) to permanently schedule 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 DEA submitted a request to the HHS 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). Upon evaluating the scientific and medical evidence, on March
21, 2019, the HHS submitted to the Acting Administrator its scientific
and medical evaluation for these six substances. Upon receipt of the
scientific and medical evaluation and scheduling recommendations 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). The DEA published a notice of
proposed rulemaking for the placement of 5F-ADB, 5F-AMB, 5F-APINACA,
ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA in schedule I elsewhere in
this issue of the Federal Register. If the scheduling of these
substances is made permanent, the DEA will publish a final rule in the
Federal Register.
Pursuant to 21 U.S.C. 811(h)(2), the Acting Administrator orders
that the temporary scheduling of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-
FUBINACA, MDMB-CHMICA and MDMB-FUBINACA, including their optical,
positional and geometric isomers, salts, and salts of isomers, be
extended for one year, or until the permanent scheduling proceeding is
completed, whichever occurs first.
In accordance with this temporary scheduling order, the schedule I
requirements for handling 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA,
MDMB-CHMICA and MDMB-FUBINACA, including their optical, positional and
geometric isomers, salts, and salts of isomers, will remain in effect
for one year, or until the permanent scheduling proceeding is
completed, whichever occurs first.
Regulatory Matters
The CSA provides for an expedited temporary scheduling action where
such action is necessary to avoid an imminent hazard to the public
safety. 21 U.S.C. 811(h). The Attorney General may, by order, schedule
a substance in schedule I on a temporary basis. Id. 21 U.S.C. 811(h)
also provides that the temporary scheduling of a substance shall expire
at the end of two years from the date of the issuance of the order
scheduling such substance, except that the Attorney General may, during
the pendency of proceedings to permanently schedule the substance,
extend the temporary scheduling for up to one year.
To the extent that 21 U.S.C. 811(h) directs that temporary
scheduling actions be issued by order and sets forth the procedures by
which such orders are to be issued and extended, the DEA believes that
the notice and comment requirements of section 553 of the
Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this
extension of the temporary scheduling action. The specific language
chosen by Congress indicates an intention for the DEA to proceed
through the issuance of an order instead of proceeding by rulemaking.
Given that Congress specifically requires the Attorney General to
follow rulemaking procedures for other kinds of scheduling actions, see
section 201(a) of the CSA, 21 U.S.C. 811(a), it is noteworthy that, in
section 201(h), Congress authorized the issuance of temporary
scheduling actions by order rather than by rule. In the alternative,
even assuming that this action might be subject to section 553 of the
APA, the Acting Administrator finds that there is good cause to forgo
the notice and comment and the delayed effective date requirements of
section 553, as any further delays in the process for extending the
temporary scheduling order would be impracticable and contrary to the
public interest in view of the manifest urgency to avoid an imminent
hazard to the public safety. Further, the DEA believes that this order
extending the temporary scheduling action is not a ``rule'' as defined
by 5 U.S.C. 601(2), and, accordingly, is not subject to the
requirements of the Regulatory Flexibility Act (RFA). The requirements
for the preparation of an initial regulatory flexibility analysis in 5
U.S.C. 603(a) are not applicable where, as here, the DEA is not
required by section 553 of the APA or any other law to publish a
general notice of proposed rulemaking.
Additionally, this action is not a significant regulatory action as
defined by Executive Order 12866 (Regulatory Planning and Review),
section 3(f), and, accordingly, this action has not been reviewed by
the Office of Management and Budget (OMB).
This action will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with Executive Order
13132 (Federalism) it is determined that this action does not have
sufficient federalism implications to warrant the preparation of a
Federalism Assessment.
As noted above, this action is an order, not a rule. Accordingly,
the Congressional Review Act (CRA) is inapplicable, as it applies only
to rules. 5 U.S.C. 808(2). It is in the public interest to maintain the
temporary placement of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-
CHMICA and MDMB-FUBINACA in schedule I because they pose a public
health risk. The temporary scheduling action was taken pursuant to 21
U.S.C. 811(h), which is specifically designed to enable the DEA to act
in an expeditious manner to avoid an imminent hazard to the public
safety. Under 21 U.S.C. 811(h), temporary scheduling orders are not
subject to notice and comment rulemaking procedures. The DEA
understands that the CSA frames temporary scheduling actions as orders
rather than rules to ensure that the process moves swiftly, and this
extension of the temporary scheduling order continues to serve that
purpose. For the same reasons that underlie 21 U.S.C. 811(h), that is,
the need to place these substances in schedule I because they pose an
imminent hazard to public safety, it would be contrary to the public
interest to delay implementation of this extension of the temporary
scheduling order. Therefore, in accordance with section 808(2) of the
CRA, this order extending the temporary scheduling order shall take
effect immediately upon
[[Page 13798]]
its publication. The DEA has submitted a copy of this order to both
Houses of Congress and to the Comptroller General, although such filing
is not required under the Congressional Review Act, 5 U.S.C. 801-808
because, as noted above, this action is an order, not a rule.
Dated: April 2, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-06851 Filed 4-5-19; 8:45 am]
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