Schedules of Controlled Substances: Extension of Temporary Placement of UR-144, XLR11, and AKB48 in Schedule I of the Controlled Substances Act, 27854-27856 [2015-11765]
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Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Rules and Regulations
for statistical purposes. Through the
AES, the Census Bureau collects
Electronic Export Information (EEI), the
electronic equivalent of the export data
formerly collected on the Shipper’s
Export Declaration, pursuant to the
Foreign Trade Regulations (FTR), Title
15, Code of Federal Regulations (CFR),
part 30. Filing in the AES is not
required for shipments excluded in
Section 30.2(d) and shipments
exempted in Subpart D that are not
subject to Section 30.2(a)(1)(iv).
The Census Bureau published a Final
Rule in the Federal Register on March
14, 2013 (78 FR 16366), that removed
the exemptions for Carnets and other
temporary exports and goods previously
imported under a Temporary Import
Bond (TIB) exported in the same
condition. The Department of the
Treasury and members of the trade
community raised concerns about the
new AES filing requirement for Carnets,
which is an international customs and
temporary export-import document that
is used to clear customs without paying
duties and import taxes on merchandise
that will be reexported within 12
months. The concerns centered on
whether mandatory AES filing for
Carnets may be contrary to the ATA
Convention, to which the U.S. is a
contracting party. In addition, there was
concern that unless the exemptions
were reinstated, it would be extremely
difficult to comply with the FTR,
particularly for goods moving on a
foreign Carnet. To address these
concerns, the Census Bureau and U.S.
Customs and Border Protection (CBP)
determined it was necessary to reinstate
the exemptions from filing for
temporary exports, including Carnets,
and goods that were previously
imported under a TIB for return in the
same condition as when exported.
In accordance with the Interim Final
Rule published on September 12, 2014,
this rule clarifies that the reporting
requirement for temporary exports,
which includes Carnets, and goods
previously imported on a TIB is
eliminated. This revision reinstates
exemptions for temporary exports/
Carnets and for goods that were
imported under a TIB for return in the
same condition as when imported. The
U.S. Department of State and the U.S.
Department of Homeland Security
concur with the provision contained in
this rule.
Summary of Comments and Responses
The Census Bureau received one
comment on the Interim Final Rule
published in the Federal Register on
September 12, 2014 (79 FR 54588). A
summary of the comment and the
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Census Bureau’s response is provided
below.
Comment: Clarify if exporters are
required to file Electronic Export
Information (EEI) if items are shipped
into the U.S. under a foreign obtained
ATA Carnet, and then re-exported,
never returning to the U.S. Additionally,
clarify if exporters are required to file
EEI if items are exported under a U.S.
obtained ATA Carnet and will be
returned within 12 months under the
same Carnet.
Response: The Census Bureau
clarifies here that reporting of EEI is not
required for exports moving under
either a U.S. or foreign issued Carnets.
All Carnet shipments are exempt from
EEI filing under Foreign Trade
Regulations, Section 30.37(q) or (r).
Rulemaking Requirements
Administrative Procedure Act
The Census Bureau finds good cause
pursuant to Title 5, U.S.C., 553(b)(3)(B)
to waive prior notice and opportunity
for public comment, as contrary to the
public interest. The Census Bureau is
undertaking this amendment in order to
reduce filing burden on the trade
community and to ensure consistency
with the ATA Carnets for the Temporary
Admission of Goods (ATA Convention).
In particular, this rule reinstates the
previous filing exemptions in § 30.37(q)
and (r) of the FTR for temporary exports,
including Carnets, and goods that were
imported under a TIB for return in the
same condition as when imported,
which will ensure consistency with the
ATA Convention, reduce filing
requirements, avoid confusion, and ease
compliance with the FTR. Additionally,
and for similar reasons, the Census
Bureau finds good cause pursuant to 5
U.S.C. 553(d) to waive the 30-day delay
in effectiveness for this rule. This rule
allows for an exemption to the AES
filing requirements and imposes no
additional requirements or obligations
on any member of the public; therefore,
delaying its effectiveness is
unnecessary.
comments on the certification in the
proposed rule; accordingly, no
Regulatory Flexibility analysis is
required and none has been prepared.
Executive Orders
This rule has been determined to be
not significant for purposes of Executive
Orders 12866 and 13563, and has been
drafted according to the requirements of
those Executive Orders. It has also been
determined that this rule does not
contain policies with federalism
implications as that term is defined
under Executive Order 13132.
Paperwork Reduction Act
This rule does not contain any
information collection subject to the
Paperwork Reduction Act (PRA).
However, notwithstanding any other
provision of law, no person is required
to respond to, nor shall a person be
subject to a penalty for failure to comply
with, a collection of information subject
to the requirements of the PRA, unless
that collection of information displays a
current and valid Office of Management
and Budget (OMB) control number.
List of Subjects in 15 CFR Part 30
Economic statistics, Exports, Foreign
trade, Reporting and recordkeeping
requirements.
PART 30—FOREIGN TRADE
REGULATIONS
Accordingly, as discussed above, the
Interim Final Rule amending 15 CFR
part 30, which was published at 79 FR
54588 on September 12, 2014, is
adopted as a final rule without change.
■
Dated: May 7, 2015.
John H. Thompson,
Director, Bureau of the Census.
[FR Doc. 2015–11809 Filed 5–14–15; 8:45 am]
BILLING CODE 3510–07–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Regulatory Flexibility Act
21 CFR Part 1308
The Chief Counsel for Regulation of
the Department of Commerce certified
to the Chief Counsel for Advocacy of the
Small Business Administration (SBA)
that this rule will not have a significant
impact on a substantial number of small
entities.
The purpose and goal of this rule are
explained in the preamble, and are not
repeated here. This rule does not
mandate any new filing requirements
and does not directly impact any small
or large entities. We received no
[Docket No. DEA–414]
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Schedules of Controlled Substances:
Extension of Temporary Placement of
UR–144, XLR11, and AKB48 in
Schedule I of the Controlled
Substances Act
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
The Administrator of the Drug
Enforcement Administration (DEA) is
SUMMARY:
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Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Rules and Regulations
issuing this final order to extend the
temporary placement of (1-pentyl-1Hindol-3-yl)(2,2,3,3tetramethylcyclopropyl)methanone
(UR–144), [1-(5-fluoro-pentyl)-1H-indol3-yl](2,2,3,3tetramethylcyclopropyl)methanone (5fluoro-UR–144, XLR11) and N-(1adamantyl)-1-pentyl-1H-indazole-3carboxamide (APINACA, AKB48),
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. The current
final order temporarily placing UR–144,
XLR11, and AKB48 in schedule I is due
to expire on May 15, 2015. This final
order will extend the temporary
scheduling of UR–144, XLR11, and
AKB48 to May 15, 2016, or until the
permanent scheduling action for these
three substances is completed,
whichever occurs first.
DATES: This final order is effective May
15, 2015.
FOR FURTHER INFORMATION CONTACT: John
R. Scherbenske, Office of Diversion
Control, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION: On May
16, 2013, the Deputy Administrator of
the Drug Enforcement Administration
published a Final Order in the Federal
Register (78 FR 28735) amending 21
CFR 1308.11(h) to temporarily place
three synthetic cannabinoids, namely
(1-pentyl-1H-indol-3-yl)(2,2,3,3tetramethylcyclopropyl)methanone
(UR–144), [1-(5-fluoro-pentyl)-1H-indol3-yl](2,2,3,3tetramethylcyclopropyl)methanone (5fluoro-UR–144, XLR11), and N-(1adamantyl)-1-pentyl-1H-indazole-3carboxamide (APINACA, AKB48), in
schedule I of the Controlled Substances
Act (CSA) pursuant to the temporary
scheduling provisions of 21 U.S.C.
811(h). That final order, which became
effective on the date of publication, was
based on findings by the Deputy
Administrator of the DEA that the
temporary scheduling of these three
synthetic cannabinoids was necessary to
avoid an imminent hazard to the public
safety pursuant to 21 U.S.C. 811(h)(1).
At the time the final order took effect,
section 201(h)(2) of the CSA, 21 U.S.C.
811(h)(2), required that the temporary
scheduling of a substance expires at the
end of two years from the date of
issuance of the order scheduling the
substance, except that the Attorney
General may, during the pendency of
proceedings under 21 U.S.C. 811(a)(1)
with respect to the substance, extend
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the temporary scheduling of that
substance for up to one year.
Proceedings for the permanent
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 or her own motion,
at the request of the Secretary of Health
and Human Services,1 or on the petition
of any interested party.
In this case, the DEA initiated
permanent scheduling proceedings on
its own motion pursuant to 21 U.S.C.
811(a). 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 three synthetic
cannabinoids. On August 31, 2013, 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 UR–144, XLR11,
and AKB48, pursuant to 21 U.S.C.
811(b) and (c). Upon evaluating the
scientific and medical evidence, the
HHS on May 12, 2015, submitted to the
Administrator of the DEA its three
scientific and medical evaluations
entitled, ‘‘Basis For the
Recommendation to Place 1-pentyl-1Hindol-3-yl 2,2,3,3tetramethylcyclopropyl methanone
(UR–144) and its Salts in schedule I of
the Controlled Substances Act (CSA),’’
‘‘Basis For the Recommendation to
Place 1-(5-fluoro-pentyl)-1H-indol-3yl](2,2,3,3-tetramethylcyclopropyl
methanone (XLR11) and its Salts in
schedule I of the Controlled Substances
Act (CSA),’’ and ‘‘Basis For the
Recommendation to Place N-(1adamantyl)-1-pentyl-1H-indazole-3carboxamide (AKB48) and its Salts in
schedule I of the Controlled Substances
Act (CSA).’’ 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 UR–144,
XLR11, and AKB48 pursuant to 21
U.S.C. 811(c). The DEA is publishing a
Notice of Proposed Rulemaking for the
Placement of UR–144, XLR11, and
AKB48 into schedule I. The
Administrator thereby has initiated
1 Because the Secretary of the Department of
Health and Human Services has delegated to the
Assistant Secretary for Health of the Department of
Health and Human Services the authority to make
domestic drug scheduling recommendations, for
purposes of this Final Order, all subsequent
references to ‘‘Secretary’’ have been replaced with
‘‘Assistant Secretary.’’
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27855
proceedings regarding UR–144, XLR11,
and AKB48 in accordance with 21
U.S.C. 811(a)(1). Therefore, pursuant to
21 U.S.C. 811(h)(2), the Administrator of
the DEA hereby orders that the
temporary scheduling of UR–144,
XLR11, and AKB48, including their
salts, isomers, and salts of isomers
whenever the existence of such salts,
isomers, and salts of isomers is possible,
be extended to May 15, 2016, or until
the proceedings to permanently
schedule these three substances is
completed, whichever occurs first.
In accordance with this final order,
the schedule I requirements for
handling UR–144, XLR11, and AKB48,
including their salts, isomers, and salts
of isomers whenever the existence of
such salts, isomers, and salts of isomers
is possible, will remain in effect until
May 15, 2016, or until the permanent
scheduling proceeding is completed,
whichever occurs first.
Regulatory Matters
Section 201(h) of the CSA, 21 U.S.C.
811(h), provides for an expedited
temporary scheduling action where
such action is necessary to avoid an
imminent hazard to the public safety.
As provided in this subsection, the
Attorney General may, by order,
schedule a substance in schedule I on a
temporary basis. Section 201(h) of the
CSA, 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.
Inasmuch as section 201(h) of the
CSA 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
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 final
order extending the temporary
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Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Rules and Regulations
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.
Pursuant to section 808(2) of the
Congressional Review Act (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 UR–144,
XLR11, and AKB48 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. 21 U.S.C. 811(h)
exempted the temporary scheduling
order from standard notice and
comment rulemaking procedures to
ensure that the process moved 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
DEA’s 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 final
order extending the temporary
scheduling order shall take effect
immediately upon its publication.
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Pursuant to the Small Business
Regulatory Enforcement Fairness Act of
1996 (Congressional Review Act) (5
U.S.C. 801–808), the DEA has submitted
a copy of this final order to both Houses
of Congress and to the Comptroller
General.
Dated: May 12, 2015.
Michele M. Leonhart,
Administrator.
[FR Doc. 2015–11765 Filed 5–14–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF STATE
22 CFR Part 51
[Public Notice: 9133]
RIN 1400–AD83
Passports: Official Passports for
Officials or Employees of State, Local,
Tribal or Territorial Governments
Traveling Abroad and Carrying Out
Official Duties in Support of the U.S.
Government
Department of State.
Interim final rule.
AGENCY:
ACTION:
This rule amends the passport
rules for the Department of State to
authorize issuing an official passport to
an official or employee of a state, local,
tribal, or territorial government traveling
abroad to carry out official duties in
support of the U.S. government.
DATES: This rule is effective May 15,
2015.
The Department of State will accept
comments until July 14, 2015.
ADDRESSES: You may make comments
by any of the following methods, and
you must include the RIN in the subject
line of your message.
• Mail (paper, disk, or CD–ROM
submissions): ATTN: RIN 1400–AD83,
Alice Kottmyer, Attorney-Adviser,
Office of the Legal Adviser (L/M), U.S.
Department of State, Room 4325, 2201
C Street NW., Washington, DC 20520.
• Email: kottmyeram@state.gov.
• Persons with access to the Internet
may view this rule and submit
comments by going to
www.regulations.gov, and searching for
the rule by its RIN, 1400–AD83.
FOR FURTHER INFORMATION CONTACT:
Alice Kottmyer, Attorney-Adviser,
kottmyeram@state.gov, 202–647–2318.
SUPPLEMENTARY INFORMATION: 22 CFR
51.3(b) provides that an ‘‘official
passport’’ may be issued to: An official
or employee of the U.S. government
traveling abroad to carry out official
duties; spouses and family members of
such persons; and, when authorized by
SUMMARY:
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the Department of State, U.S.
government contractors traveling abroad
to carry out official duties on behalf of
the U.S. government.
Increasingly, the federal government
utilizes officials or employees of state,
local, tribal, and territorial governments
in support of federal activities, both
domestically and overseas, such as the
Federal Bureau of Investigation’s Joint
Terrorism Task Force. When required to
travel internationally in support of such
federal activities, these individuals are
not currently eligible for official
passports. Issuance of an official
passport to such individuals signifies to
foreign governments that they are
carrying out official duties in support of
the U.S. government. The activities
undertaken by these officials are often of
pressing national security, law
enforcement, or humanitarian
importance and occur with little
advance notice. It is in the U.S.
government’s interest to provide these
individuals the travel documents
necessary to allow them to travel in a
timely manner.
Under 22 U.S.C. 211a et seq., the
Secretary of State has the authority to
make rules for the granting and issuance
of passports. The Department is
amending section 51.3(b) of 22 CFR to
authorize issuing official passports to an
official or employee of a state, local,
tribal, or territorial government traveling
abroad to carry out official duties in
support of the U.S. government.
Regulatory Findings
Administrative Procedure Act
The Department is publishing this
rule as an interim final rule, effective on
the date of publication, pursuant to the
‘‘good cause’’ exemption of the
Administrative Procedure Act (APA), 5
U.S.C. 553(b)(3)(B). The Department
finds that delaying the effect of this rule
until after notice and comment would
be impractical, unnecessary, and
contrary to public interest. The
Department finds that providing the
necessary travel documents to these
individuals to allow them to travel in
support of U.S. government interests
provides a compelling justification for
immediate approval of this rule.
Therefore, this rule is effective on the
date of publication. See 5 U.S.C. 553(d).
However, the Department solicits—and
welcomes—comments on this
rulemaking, and will address relevant
comments in a final rule.
Regulatory Flexibility Act
The Department, in accordance with
the Regulatory Flexibility Act, 5 U.S.C.
605(b), has reviewed this rule and, by
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]]>Agencies
[Federal Register Volume 80, Number 94 (Friday, May 15, 2015)]
[Rules and Regulations]
[Pages 27854-27856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11765]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-414]
Schedules of Controlled Substances: Extension of Temporary
Placement of UR-144, XLR11, and AKB48 in Schedule I of the Controlled
Substances Act
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Administrator of the Drug Enforcement Administration (DEA)
is
[[Page 27855]]
issuing this final order to extend the temporary placement of (1-
pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-
144), [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11) and N-(1-
adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48),
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. The current final order
temporarily placing UR-144, XLR11, and AKB48 in schedule I is due to
expire on May 15, 2015. This final order will extend the temporary
scheduling of UR-144, XLR11, and AKB48 to May 15, 2016, or until the
permanent scheduling action for these three substances is completed,
whichever occurs first.
DATES: This final order is effective May 15, 2015.
FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of
Diversion Control, Drug Enforcement Administration; Mailing Address:
8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202)
598-6812.
SUPPLEMENTARY INFORMATION: On May 16, 2013, the Deputy Administrator of
the Drug Enforcement Administration published a Final Order in the
Federal Register (78 FR 28735) amending 21 CFR 1308.11(h) to
temporarily place three synthetic cannabinoids, namely (1-pentyl-1H-
indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), [1-(5-
fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone
(5-fluoro-UR-144, XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-
carboxamide (APINACA, AKB48), in schedule I of the Controlled
Substances Act (CSA) pursuant to the temporary scheduling provisions of
21 U.S.C. 811(h). That final order, which became effective on the date
of publication, was based on findings by the Deputy Administrator of
the DEA that the temporary scheduling of these three synthetic
cannabinoids was necessary to avoid an imminent hazard to the public
safety pursuant to 21 U.S.C. 811(h)(1). At the time the final order
took effect, section 201(h)(2) of the CSA, 21 U.S.C. 811(h)(2),
required that the temporary scheduling of a substance expires at the
end of two years from the date of issuance of the order scheduling the
substance, except that the Attorney General may, during the pendency of
proceedings under 21 U.S.C. 811(a)(1) with respect to the substance,
extend the temporary scheduling of that substance for up to one year.
Proceedings for the permanent 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 or her own
motion, at the request of the Secretary of Health and Human
Services,\1\ or on the petition of any interested party.
---------------------------------------------------------------------------
\1\ Because the Secretary of the Department of Health and Human
Services has delegated to the Assistant Secretary for Health of the
Department of Health and Human Services the authority to make
domestic drug scheduling recommendations, for purposes of this Final
Order, all subsequent references to ``Secretary'' have been replaced
with ``Assistant Secretary.''
---------------------------------------------------------------------------
In this case, the DEA initiated permanent scheduling proceedings on
its own motion pursuant to 21 U.S.C. 811(a). 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 three synthetic cannabinoids. On
August 31, 2013, 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 UR-144, XLR11, and AKB48, pursuant
to 21 U.S.C. 811(b) and (c). Upon evaluating the scientific and medical
evidence, the HHS on May 12, 2015, submitted to the Administrator of
the DEA its three scientific and medical evaluations entitled, ``Basis
For the Recommendation to Place 1-pentyl-1H-indol-3-yl 2,2,3,3-
tetramethylcyclopropyl methanone (UR-144) and its Salts in schedule I
of the Controlled Substances Act (CSA),'' ``Basis For the
Recommendation to Place 1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl methanone (XLR11) and its Salts in schedule I of
the Controlled Substances Act (CSA),'' and ``Basis For the
Recommendation to Place N-(1-adamantyl)-1-pentyl-1H-indazole-3-
carboxamide (AKB48) and its Salts in schedule I of the Controlled
Substances Act (CSA).'' 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 UR-144, XLR11, and
AKB48 pursuant to 21 U.S.C. 811(c). The DEA is publishing a Notice of
Proposed Rulemaking for the Placement of UR-144, XLR11, and AKB48 into
schedule I. The Administrator thereby has initiated proceedings
regarding UR-144, XLR11, and AKB48 in accordance with 21 U.S.C.
811(a)(1). Therefore, pursuant to 21 U.S.C. 811(h)(2), the
Administrator of the DEA hereby orders that the temporary scheduling of
UR-144, XLR11, and AKB48, including their salts, isomers, and salts of
isomers whenever the existence of such salts, isomers, and salts of
isomers is possible, be extended to May 15, 2016, or until the
proceedings to permanently schedule these three substances is
completed, whichever occurs first.
In accordance with this final order, the schedule I requirements
for handling UR-144, XLR11, and AKB48, including their salts, isomers,
and salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible, will remain in effect until May 15, 2016,
or until the permanent scheduling proceeding is completed, whichever
occurs first.
Regulatory Matters
Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an
expedited temporary scheduling action where such action is necessary to
avoid an imminent hazard to the public safety. As provided in this
subsection, the Attorney General may, by order, schedule a substance in
schedule I on a temporary basis. Section 201(h) of the CSA, 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.
Inasmuch as section 201(h) of the CSA 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 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 final order extending the temporary
[[Page 27856]]
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.
Pursuant to section 808(2) of the Congressional Review Act (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 UR-
144, XLR11, and AKB48 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. 21
U.S.C. 811(h) exempted the temporary scheduling order from standard
notice and comment rulemaking procedures to ensure that the process
moved 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 DEA's 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 final order extending
the temporary scheduling order shall take effect immediately upon its
publication. Pursuant to the Small Business Regulatory Enforcement
Fairness Act of 1996 (Congressional Review Act) (5 U.S.C. 801-808), the
DEA has submitted a copy of this final order to both Houses of Congress
and to the Comptroller General.
Dated: May 12, 2015.
Michele M. Leonhart,
Administrator.
[FR Doc. 2015-11765 Filed 5-14-15; 8:45 am]
BILLING CODE 4410-09-P
