[Federal Register Volume 84, Number 210 (Wednesday, October 30, 2019)]
[Rules and Regulations]
[Pages 58045-58047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23372]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-472a]
Schedules of Controlled Substances: Extension of Temporary
Placement of FUB-AMB 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 a synthetic cannabinoid, methyl 2-(1-(4-
fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other
names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), including its optical,
positional and geometric isomers, salts, and salts of isomers. The
schedule I status of FUB-AMB currently is in effect until November 4,
2019. This temporary order will extend the temporary scheduling of FUB-
AMB for one year, or until the permanent scheduling action for this
substance is completed, whichever occurs first.
DATES: This temporary scheduling order, which extends the order (82 FR
51154, November 3, 2017), is effective November 3, 2019 and expires on
November 3, 2020. If the Drug Enforcement Administration 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 November 3, 2020.
FOR FURTHER INFORMATION CONTACT: Scott Brinks, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-
8209.
SUPPLEMENTARY INFORMATION:
Background and Legal Authority
On November 3, 2017, the Acting Administrator of the Drug
Enforcement Administration (DEA) published a temporary scheduling order
in the Federal Register (82 FR 51154) placing methyl 2-(1-(4-
fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other
names: FUB-
[[Page 58046]]
AMB, MMB-FUBINACA, AMB-FUBINACA), a synthetic cannabinoid (SC)
substance, 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 this 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 this
substance expires two years from the effective date of the scheduling
order, or on November 3, 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 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 document 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\ Because the Secretary of the Department of Health and Human
Services (HHS) has delegated to the Assistant Secretary for Health
of the HHS the authority to make domestic drug scheduling
recommendations, for purposes of this temporary scheduling order,
all subsequent references to ``Secretary'' have been replaced with
``Assistant Secretary.''
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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 FUB-AMB. 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 this SC. On March 9, 2018, 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 FUB-AMB, and in accordance with 21 U.S.C. 811(b) and
(c). Upon evaluating the scientific and medical evidence, on September
19, 2019, the HHS submitted to the Acting Administrator of the DEA its
scientific and medical evaluation and a scheduling recommendation for
FUB-AMB. 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 FUB-AMB in accordance with 21 U.S.C.
811(c). The DEA published a notice of proposed rulemaking for the
placement of FUB-AMB in schedule I elsewhere in this issue of the
Federal Register. If the scheduling of this substance 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 FUB-AMB, including its 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 the temporary scheduling order in this document,
the schedule I requirements for handling FUB-AMB, including its
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. 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 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. However, if this were a rule, pursuant to the CRA, ``any rule
for which an agency for good cause finds that notice and public
procedure thereon are impracticable, unnecessary, or contrary to the
public interest, shall take effect at such time as the federal agency
promulgating the rule determines.'' 5 U.S.C. 808(2). It is in the
public interest to maintain the temporary placement of FUB-AMB in
schedule I because it poses 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 this
substance in schedule
[[Page 58047]]
I because it poses 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 its publication.
The DEA has submitted a copy of this temporary scheduling 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: October 21, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-23372 Filed 10-29-19; 8:45 am]
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