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, 13796-13798 [2019-06851]
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Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Rules and Regulations
than an assessment every two years) due
to concerns not meeting several VWP
requirements. In 2016, DHS extended
Greece’s VWP designation on a
provisional basis through March 31,
2017, to address concerns over migrant
vetting, information-sharing gaps, and
passport-issuance practices.
Additionally, DHS reduced Greece’s
ESTA validity period from two years to
one year and committed Greece to
implement five lines of effort specified
in a Joint Statement in order to remove
Greece from a provisional VWP status.
In 2017, DHS sent correspondence to
Greece defining a set of actions that
would justify ESTA normalization.
Greece has made successful progress in
all five lines of effort and has completed
all of the elements required for ESTA
normalization that had been
communicated in 2017. Greece has
enacted necessary legislation to
authorize issuance and replacement of
national identification cards (biometric
chip), expanded systematic refugee
vetting at all migrant processing centers,
and enacted Passenger Name
Recognition (PNR) legislation to
implement the EU PNR Directive. For
these reasons, DHS is publishing this
document announcing that it is
increasing Greece’s ESTA validity
period to two years.
Claire Grady,
Senior Official Performing the Duties of the
Deputy Secretary, Department of Homeland
Security.
[FR Doc. 2019–06750 Filed 4–5–19; 8:45 am]
BILLING CODE P
SECURITIES AND EXCHANGE
COMMISSION
17 CFR Parts 229, 230, 232, 239, 240,
249, 270, 274, and 275
[Release No. 33–10618; 34–85381; IA–5206;
IC–33426; File No. S7–08–17]
RIN 3235–AM00
FAST Act Modernization and
Simplification of Regulation S–K
jbell on DSK30RV082PROD with RULES
Correction
In rule document 2019–05695,
appearing on pages 12674 through
12738, in the issue of Tuesday, April 2,
2019, make the following corrections:
1. On page 12675, in the table, in the
second column, in the tenth line from
the top of the page, the text entry that
reads ‘‘§ 249.218’’ should read
‘‘§ 249.220f’’.
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PART 249—FORMS, SECURITIES
EXCHANGE ACT OF 1934 [Corrected]
2. On page 12729, in the second
column, five asterisks (* * * * *)
indicating the existence of text not
listed and unchanged should appear
above the text reading ‘‘INSTRUCTIONS
AS TO EXHIBITS’’.
■
[FR Doc. C1–2019–05695 Filed 4–5–19; 8:45 am]
BILLING CODE 1301–00–D
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
Drug Enforcement
Administration, Department of Justice.
ACTION: Temporary rule; temporary
scheduling order; extension.
AGENCY:
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-(5fluoropentyl)-1H-indazole-3carboxamido)-3,3-dimethylbutanoate
[5F–ADB; 5F–MDMB–PINACA]; methyl
2-(1-(5-fluoropentyl)-1H-indazole-3carboxamido)-3-methylbutanoate [5F–
AMB]; N-(adamantan-1-yl)-1-(5fluoropentyl)-1H-indazole-3carboxamide [5F–APINACA, 5F–
AKB48]; N-(1-amino-3,3-dimethyl-1oxobutan-2-yl)-1-(4-fluorobenzyl)-1Hindazole-3-carboxamide [ADB–
FUBINACA]; methyl 2-(1(cyclohexylmethyl)-1H-indole-3carboxamido)-3,3-dimethylbutanoate
[MDMB–CHMICA, MMB–CHMINACA]
and methyl 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3,3dimethylbutanoate [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
SUMMARY:
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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-3carboxamido)-3,3-dimethylbutanoate
[5F–ADB; 5F–MDMB–PINACA], methyl
2-(1-(5-fluoropentyl)-1H-indazole-3carboxamido)-3-methylbutanoate [5F–
AMB], N-(adamantan-1-yl)-1-(5fluoropentyl)-1H-indazole-3carboxamide [5F–APINACA, 5F–
AKB48], N-(1-amino-3,3-dimethyl-1oxobutan-2-yl)-1-(4-fluorobenzyl)-1Hindazole-3-carboxamide [ADB–
FUBINACA], methyl 2-(1(cyclohexylmethyl)-1H-indole-3carboxamido)-3,3-dimethylbutanoate
[MDMB–CHMICA, MMB–CHMINACA]
and methyl 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3,3dimethylbutanoate [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
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
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jbell on DSK30RV082PROD with RULES
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.
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,
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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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
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13797
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
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Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Rules and Regulations
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]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Bureau of Alcohol, Tobacco, Firearms,
and Explosives
27 CFR Part 555
[Docket No. ATF 2017R–21; AG Order No.
4425–2019]
Removal of Expired Regulations
Bureau of Alcohol, Tobacco,
Firearms, and Explosives, Department of
Justice.
ACTION: Final rule.
AGENCY:
This final rule makes
technical amendments to the Bureau of
Alcohol, Tobacco, Firearms, and
Explosives (ATF) regulations in the
Code of Federal Regulations (CFR).
These technical changes are being made
to remove expired, obsolete, or
unnecessary regulations; correct dates,
titles, addresses, and telephone
numbers; and to reflect changes to
nomenclature resulting from the transfer
of ATF to the Department of Justice
from the Department of the Treasury
pursuant to the Homeland Security Act
of 2002. The changes are designed to
update and provide clarity throughout
these regulations.
DATES: This rule is effective April 8,
2019.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
jbell on DSK30RV082PROD with RULES
Shermaine Kenner, Office of Regulatory
Affairs, Enforcement Programs and
Services, Bureau of Alcohol, Tobacco,
Firearms, and Explosives, U.S.
Department of Justice, 99 New York
Avenue NE, Washington, DC 20226;
telephone: (202) 648–7070 (this is not a
toll-free number).
SUPPLEMENTARY INFORMATION:
I. Backgrounds
ATF administers regulations
published in 27 CFR part 555,
concerning commerce in explosives.
ATF identified several technical
amendments that are needed to update
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16:38 Apr 05, 2019
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and to provide clarity to these
regulations.
Rather than make substantive changes
to the regulations, these amendments
focus on improving the clarity and
accuracy of the regulations. Many of the
technical changes reflect the removal of
expired or obsolete regulations; removal
of regulations that are no longer
necessary; and the correction of dates,
titles, addresses, and telephone
numbers. Additionally, technical
changes to § 555.11 reflect a change in
nomenclature resulting from the transfer
of ATF to the Department of Justice
from the Department of the Treasury
pursuant to the Homeland Security Act
of 2002.
Section 555.11 is being amended to
remove paragraph (a) and revise
paragraph (b) in the definitions of
‘‘ATF’’, ‘‘ATF Officer’’, ‘‘Bureau’’, and
‘‘Director’’ as the information in the
regulations is obsolete, to revise the
definition of ‘‘Director, Industry
Operations’’ for accuracy, and to replace
‘‘Bureau of Alcohol, Tobacco and
Firearms’’ with ‘‘Bureau of Alcohol,
Tobacco, Firearms, and Explosives,
Department of Justice’’ in the definition
of ‘‘Region’’ as the current definition
references the name of the agency under
the Department of the Treasury, prior to
the Homeland Security Act of 2002.
Section 555.27 is being removed and
reserved as the requirement in the
statute that this regulation implemented
is expired and obsolete.
Section 555.30 is being amended to
reflect the correct nationwide toll-free
telephone number, and the reference to
Form 4712 is being removed as this
information is no longer necessary and
is obsolete.
Sections 555.33, 555.142, and 555.165
are being amended to remove the
effective dates, which are no longer
necessary.
Sections 555.41, 555.49, 555.51,
555.103, and 555.125 are being
amended to remove and reserve
paragraph (a) in each of these sections
as the information in those paragraphs
is obsolete.
Section 555.45 is being amended to
remove and reserve paragraphs (a) and
(b) as the information in those
paragraphs is obsolete.
Section 555.57 is being amended to
remove ‘‘For all licenses or permits
issued on and after May 24, 2003’’ as
this delineation is no longer necessary.
Section 555.102 is being amended to
remove paragraph (b)(1) and revise
paragraph (b)(2) as the information in
those paragraphs is obsolete.
Section 555.105 is being amended to
remove the reference to nonlicensees
and nonpermittees in the heading of the
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section, and to remove and reserve
paragraph (a) as the information in the
regulation is obsolete.
Section 555.126 is being amended to
revise the heading of the section, and to
remove and reserve paragraph (a) as the
information in the regulation is
obsolete.
Section 555.201 is being amended to
remove and reserve paragraph (e) as the
application of this paragraph is obsolete.
Section 555.202 is being amended to
remove ‘‘See also § 555.201(e).’’ as the
referenced sentence is obsolete.
Section 555.218 is being amended to
remove the date ‘‘July, 1991’’ from the
table title and replace it with ‘‘June
1991’’, the correct date.
Section 555.219 is being amended to
add the title of the table, as the title was
incorrectly added to the table in 555.220
when published in the Federal Register.
Section 555.220 is being amended to
remove the title above the table and
remove the address for the Fertilizer
Institute, as this information is
incorrect.
Section 555.224 is being amended to
remove ‘‘(30 days from the date of
publication of the final rule in the
Federal Register)’’ and to add the
effective date in the third footnote.
II. Statutory Orders and Executive
Review
A. Executive Orders 12866, 13563, and
13771
This rule has been drafted and
reviewed in accordance with Executive
Order 12866, ‘‘Regulatory Planning and
Review,’’ section 1(b), The Principles of
Regulation; Executive Order 13563,
‘‘Improving Regulation and Regulatory
Review,’’ section 1(b), General
Principles of Regulation; and Executive
Order 13771, ‘‘Reducing Regulation and
Controlling Regulatory Costs.’’
The rule makes technical corrections
to eliminate outdated and incorrect
terminology and improve the clarity of
the regulations, and makes no
substantive changes. The Department
has determined that this final rule is not
a ‘‘significant regulatory action’’ as
defined in Executive Order 12866,
section 3(f). Accordingly, this final rule
has not been reviewed by the Office of
Management and Budget.
Finally, because this rule is not a
significant regulatory action, it is not
subject to the requirements of Executive
Order 13771. There are no costs
associated with this regulation;
however, it benefits the industry in that
it removes numerous outdated
regulations and provides clarity for the
regulated industry. Because there are no
costs associated with this final rule,
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4410-09-P
