80_FR_27948 80 FR 27854 - Schedules of Controlled Substances: Extension of Temporary Placement of UR-144, XLR11, and AKB48 in Schedule I of the Controlled Substances Act

80 FR 27854 - Schedules of Controlled Substances: Extension of Temporary Placement of UR-144, XLR11, and AKB48 in Schedule I of the Controlled Substances Act

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 94 (May 15, 2015)

Page Range27854-27856
FR Document2015-11765

The Administrator of the Drug Enforcement Administration (DEA) is 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.

Federal Register, Volume 80 Issue 94 (Friday, May 15, 2015)
[Federal Register Volume 80, Number 94 (Friday, May 15, 2015)]
[Rules and Regulations]
[Pages 27854-27856]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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



                                                27854                 Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Rules and Regulations

                                                for statistical purposes. Through the                   Census Bureau’s response is provided                  comments on the certification in the
                                                AES, the Census Bureau collects                         below.                                                proposed rule; accordingly, no
                                                Electronic Export Information (EEI), the                   Comment: Clarify if exporters are                  Regulatory Flexibility analysis is
                                                electronic equivalent of the export data                required to file Electronic Export                    required and none has been prepared.
                                                formerly collected on the Shipper’s                     Information (EEI) if items are shipped
                                                                                                                                                              Executive Orders
                                                Export Declaration, pursuant to the                     into the U.S. under a foreign obtained
                                                Foreign Trade Regulations (FTR), Title                  ATA Carnet, and then re-exported,                       This rule has been determined to be
                                                15, Code of Federal Regulations (CFR),                  never returning to the U.S. Additionally,             not significant for purposes of Executive
                                                part 30. Filing in the AES is not                       clarify if exporters are required to file             Orders 12866 and 13563, and has been
                                                required for shipments excluded in                      EEI if items are exported under a U.S.                drafted according to the requirements of
                                                Section 30.2(d) and shipments                           obtained ATA Carnet and will be                       those Executive Orders. It has also been
                                                exempted in Subpart D that are not                      returned within 12 months under the                   determined that this rule does not
                                                subject to Section 30.2(a)(1)(iv).                      same Carnet.                                          contain policies with federalism
                                                   The Census Bureau published a Final                     Response: The Census Bureau                        implications as that term is defined
                                                Rule in the Federal Register on March                   clarifies here that reporting of EEI is not           under Executive Order 13132.
                                                14, 2013 (78 FR 16366), that removed                    required for exports moving under
                                                the exemptions for Carnets and other                                                                          Paperwork Reduction Act
                                                                                                        either a U.S. or foreign issued Carnets.
                                                temporary exports and goods previously                  All Carnet shipments are exempt from                    This rule does not contain any
                                                imported under a Temporary Import                       EEI filing under Foreign Trade                        information collection subject to the
                                                Bond (TIB) exported in the same                         Regulations, Section 30.37(q) or (r).                 Paperwork Reduction Act (PRA).
                                                condition. The Department of the                                                                              However, notwithstanding any other
                                                Treasury and members of the trade                       Rulemaking Requirements                               provision of law, no person is required
                                                community raised concerns about the                     Administrative Procedure Act                          to respond to, nor shall a person be
                                                new AES filing requirement for Carnets,                                                                       subject to a penalty for failure to comply
                                                which is an international customs and                      The Census Bureau finds good cause                 with, a collection of information subject
                                                temporary export-import document that                   pursuant to Title 5, U.S.C., 553(b)(3)(B)             to the requirements of the PRA, unless
                                                is used to clear customs without paying                 to waive prior notice and opportunity                 that collection of information displays a
                                                duties and import taxes on merchandise                  for public comment, as contrary to the                current and valid Office of Management
                                                that will be reexported within 12                       public interest. The Census Bureau is                 and Budget (OMB) control number.
                                                months. The concerns centered on                        undertaking this amendment in order to
                                                                                                        reduce filing burden on the trade                     List of Subjects in 15 CFR Part 30
                                                whether mandatory AES filing for
                                                Carnets may be contrary to the ATA                      community and to ensure consistency                      Economic statistics, Exports, Foreign
                                                Convention, to which the U.S. is a                      with the ATA Carnets for the Temporary                trade, Reporting and recordkeeping
                                                contracting party. In addition, there was               Admission of Goods (ATA Convention).                  requirements.
                                                concern that unless the exemptions                      In particular, this rule reinstates the
                                                were reinstated, it would be extremely                  previous filing exemptions in § 30.37(q)              PART 30—FOREIGN TRADE
                                                difficult to comply with the FTR,                       and (r) of the FTR for temporary exports,             REGULATIONS
                                                particularly for goods moving on a                      including Carnets, and goods that were
                                                                                                        imported under a TIB for return in the                ■ Accordingly, as discussed above, the
                                                foreign Carnet. To address these
                                                                                                        same condition as when imported,                      Interim Final Rule amending 15 CFR
                                                concerns, the Census Bureau and U.S.
                                                                                                        which will ensure consistency with the                part 30, which was published at 79 FR
                                                Customs and Border Protection (CBP)
                                                                                                        ATA Convention, reduce filing                         54588 on September 12, 2014, is
                                                determined it was necessary to reinstate
                                                                                                        requirements, avoid confusion, and ease               adopted as a final rule without change.
                                                the exemptions from filing for
                                                temporary exports, including Carnets,                   compliance with the FTR. Additionally,                  Dated: May 7, 2015.
                                                and goods that were previously                          and for similar reasons, the Census                   John H. Thompson,
                                                imported under a TIB for return in the                  Bureau finds good cause pursuant to 5                 Director, Bureau of the Census.
                                                same condition as when exported.                        U.S.C. 553(d) to waive the 30-day delay               [FR Doc. 2015–11809 Filed 5–14–15; 8:45 am]
                                                   In accordance with the Interim Final                 in effectiveness for this rule. This rule             BILLING CODE 3510–07–P
                                                Rule published on September 12, 2014,                   allows for an exemption to the AES
                                                this rule clarifies that the reporting                  filing requirements and imposes no
                                                requirement for temporary exports,                      additional requirements or obligations
                                                                                                                                                              DEPARTMENT OF JUSTICE
                                                which includes Carnets, and goods                       on any member of the public; therefore,
                                                previously imported on a TIB is                         delaying its effectiveness is                         Drug Enforcement Administration
                                                eliminated. This revision reinstates                    unnecessary.
                                                exemptions for temporary exports/                       Regulatory Flexibility Act                            21 CFR Part 1308
                                                Carnets and for goods that were
                                                imported under a TIB for return in the                    The Chief Counsel for Regulation of                 [Docket No. DEA–414]
                                                same condition as when imported. The                    the Department of Commerce certified
                                                                                                        to the Chief Counsel for Advocacy of the              Schedules of Controlled Substances:
                                                U.S. Department of State and the U.S.
                                                                                                        Small Business Administration (SBA)                   Extension of Temporary Placement of
                                                Department of Homeland Security
                                                                                                        that this rule will not have a significant            UR–144, XLR11, and AKB48 in
                                                concur with the provision contained in
                                                                                                        impact on a substantial number of small               Schedule I of the Controlled
                                                this rule.
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                                                                                                        entities.                                             Substances Act
                                                Summary of Comments and Responses                         The purpose and goal of this rule are               AGENCY:  Drug Enforcement
                                                  The Census Bureau received one                        explained in the preamble, and are not                Administration, Department of Justice.
                                                comment on the Interim Final Rule                       repeated here. This rule does not                     ACTION: Final order.
                                                published in the Federal Register on                    mandate any new filing requirements
                                                September 12, 2014 (79 FR 54588). A                     and does not directly impact any small                SUMMARY: The Administrator of the Drug
                                                summary of the comment and the                          or large entities. We received no                     Enforcement Administration (DEA) is


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                                                                      Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Rules and Regulations                                         27855

                                                issuing this final order to extend the                  the temporary scheduling of that                      proceedings regarding UR–144, XLR11,
                                                temporary placement of (1-pentyl-1H-                    substance for up to one year.                         and AKB48 in accordance with 21
                                                indol-3-yl)(2,2,3,3-                                    Proceedings for the permanent                         U.S.C. 811(a)(1). Therefore, pursuant to
                                                tetramethylcyclopropyl)methanone                        scheduling of a substance under 21                    21 U.S.C. 811(h)(2), the Administrator of
                                                (UR–144), [1-(5-fluoro-pentyl)-1H-indol-                U.S.C. 811(a) may be initiated by the                 the DEA hereby orders that the
                                                3-yl](2,2,3,3-                                          Attorney General (delegated to the                    temporary scheduling of UR–144,
                                                tetramethylcyclopropyl)methanone (5-                    Administrator of the DEA pursuant to                  XLR11, and AKB48, including their
                                                fluoro-UR–144, XLR11) and N-(1-                         28 CFR 0.100) on his or her own motion,               salts, isomers, and salts of isomers
                                                adamantyl)-1-pentyl-1H-indazole-3-                      at the request of the Secretary of Health             whenever the existence of such salts,
                                                carboxamide (APINACA, AKB48),                           and Human Services,1 or on the petition               isomers, and salts of isomers is possible,
                                                including their salts, isomers, and salts               of any interested party.                              be extended to May 15, 2016, or until
                                                of isomers whenever the existence of                       In this case, the DEA initiated                    the proceedings to permanently
                                                such salts, isomers, and salts of isomers               permanent scheduling proceedings on                   schedule these three substances is
                                                is possible, in schedule I of the                       its own motion pursuant to 21 U.S.C.                  completed, whichever occurs first.
                                                Controlled Substances Act. The current                  811(a). The DEA has gathered and                         In accordance with this final order,
                                                final order temporarily placing UR–144,                 reviewed the available information                    the schedule I requirements for
                                                XLR11, and AKB48 in schedule I is due                   regarding the pharmacology, chemistry,                handling UR–144, XLR11, and AKB48,
                                                to expire on May 15, 2015. This final                   trafficking, actual abuse, pattern of                 including their salts, isomers, and salts
                                                order will extend the temporary                         abuse, and the relative potential for                 of isomers whenever the existence of
                                                scheduling of UR–144, XLR11, and                        abuse for these three synthetic                       such salts, isomers, and salts of isomers
                                                AKB48 to May 15, 2016, or until the                     cannabinoids. On August 31, 2013, the                 is possible, will remain in effect until
                                                permanent scheduling action for these                   DEA submitted a request to the HHS to                 May 15, 2016, or until the permanent
                                                three substances is completed,                          provide the DEA with a scientific and                 scheduling proceeding is completed,
                                                whichever occurs first.                                 medical evaluation of available                       whichever occurs first.
                                                DATES: This final order is effective May                information and a scheduling
                                                                                                                                                              Regulatory Matters
                                                15, 2015.                                               recommendation for UR–144, XLR11,
                                                                                                        and AKB48, pursuant to 21 U.S.C.                        Section 201(h) of the CSA, 21 U.S.C.
                                                FOR FURTHER INFORMATION CONTACT: John
                                                                                                        811(b) and (c). Upon evaluating the                   811(h), provides for an expedited
                                                R. Scherbenske, Office of Diversion                                                                           temporary scheduling action where
                                                Control, Drug Enforcement                               scientific and medical evidence, the
                                                                                                        HHS on May 12, 2015, submitted to the                 such action is necessary to avoid an
                                                Administration; Mailing Address: 8701                                                                         imminent hazard to the public safety.
                                                Morrissette Drive, Springfield, Virginia                Administrator of the DEA its three
                                                                                                        scientific and medical evaluations                    As provided in this subsection, the
                                                22152; Telephone: (202) 598–6812.                                                                             Attorney General may, by order,
                                                                                                        entitled, ‘‘Basis For the
                                                SUPPLEMENTARY INFORMATION: On May                                                                             schedule a substance in schedule I on a
                                                                                                        Recommendation to Place 1-pentyl-1H-
                                                16, 2013, the Deputy Administrator of                   indol-3-yl 2,2,3,3-                                   temporary basis. Section 201(h) of the
                                                the Drug Enforcement Administration                     tetramethylcyclopropyl methanone                      CSA, 21 U.S.C. 811(h) also provides that
                                                published a Final Order in the Federal                  (UR–144) and its Salts in schedule I of               the temporary scheduling of a substance
                                                Register (78 FR 28735) amending 21                      the Controlled Substances Act (CSA),’’                shall expire at the end of two years from
                                                CFR 1308.11(h) to temporarily place                     ‘‘Basis For the Recommendation to                     the date of the issuance of the order
                                                three synthetic cannabinoids, namely                    Place 1-(5-fluoro-pentyl)-1H-indol-3-                 scheduling such substance, except that
                                                (1-pentyl-1H-indol-3-yl)(2,2,3,3-                       yl](2,2,3,3-tetramethylcyclopropyl                    the Attorney General may, during the
                                                tetramethylcyclopropyl)methanone                        methanone (XLR11) and its Salts in                    pendency of proceedings to
                                                (UR–144), [1-(5-fluoro-pentyl)-1H-indol-                schedule I of the Controlled Substances               permanently schedule the substance,
                                                3-yl](2,2,3,3-                                          Act (CSA),’’ and ‘‘Basis For the                      extend the temporary scheduling for up
                                                tetramethylcyclopropyl)methanone (5-                    Recommendation to Place N-(1-                         to one year.
                                                fluoro-UR–144, XLR11), and N-(1-                        adamantyl)-1-pentyl-1H-indazole-3-                      Inasmuch as section 201(h) of the
                                                adamantyl)-1-pentyl-1H-indazole-3-                      carboxamide (AKB48) and its Salts in                  CSA directs that temporary scheduling
                                                carboxamide (APINACA, AKB48), in                        schedule I of the Controlled Substances               actions be issued by order and sets forth
                                                schedule I of the Controlled Substances                 Act (CSA).’’ Upon receipt of the                      the procedures by which such orders are
                                                Act (CSA) pursuant to the temporary                                                                           to be issued and extended, the DEA
                                                                                                        scientific and medical evaluation and
                                                scheduling provisions of 21 U.S.C.                                                                            believes that the notice and comment
                                                                                                        scheduling recommendations from the
                                                811(h). That final order, which became                                                                        requirements of section 553 of the
                                                                                                        HHS, the DEA reviewed the documents
                                                effective on the date of publication, was                                                                     Administrative Procedure Act (APA), 5
                                                                                                        and all other relevant data, and
                                                based on findings by the Deputy                                                                               U.S.C. 553, do not apply to this
                                                                                                        conducted its own eight-factor analysis
                                                Administrator of the DEA that the                                                                             extension of the temporary scheduling
                                                                                                        of the abuse potential of UR–144,
                                                temporary scheduling of these three                                                                           action. In the alternative, even assuming
                                                                                                        XLR11, and AKB48 pursuant to 21
                                                synthetic cannabinoids was necessary to                                                                       that this action might be subject to
                                                                                                        U.S.C. 811(c). The DEA is publishing a
                                                avoid an imminent hazard to the public                                                                        section 553 of the APA, the
                                                                                                        Notice of Proposed Rulemaking for the
                                                safety pursuant to 21 U.S.C. 811(h)(1).                                                                       Administrator finds that there is good
                                                                                                        Placement of UR–144, XLR11, and
                                                At the time the final order took effect,                                                                      cause to forgo the notice and comment
                                                                                                        AKB48 into schedule I. The
                                                section 201(h)(2) of the CSA, 21 U.S.C.                                                                       requirements of section 553, as any
                                                                                                        Administrator thereby has initiated
                                                811(h)(2), required that the temporary                                                                        further delays in the process for
mstockstill on DSK4VPTVN1PROD with RULES




                                                scheduling of a substance expires at the                   1 Because the Secretary of the Department of       extending the temporary scheduling
                                                end of two years from the date of                       Health and Human Services has delegated to the        order would be impracticable and
                                                issuance of the order scheduling the                    Assistant Secretary for Health of the Department of   contrary to the public interest in view
                                                substance, except that the Attorney                     Health and Human Services the authority to make       of the manifest urgency to avoid an
                                                                                                        domestic drug scheduling recommendations, for
                                                General may, during the pendency of                     purposes of this Final Order, all subsequent
                                                                                                                                                              imminent hazard to the public safety.
                                                proceedings under 21 U.S.C. 811(a)(1)                   references to ‘‘Secretary’’ have been replaced with   Further, the DEA believes that this final
                                                with respect to the substance, extend                   ‘‘Assistant Secretary.’’                              order extending the temporary


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                                                27856                 Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Rules and Regulations

                                                scheduling action is not a ‘‘rule’’ as                  Pursuant to the Small Business                        the Department of State, U.S.
                                                defined by 5 U.S.C. 601(2), and,                        Regulatory Enforcement Fairness Act of                government contractors traveling abroad
                                                accordingly, is not subject to the                      1996 (Congressional Review Act) (5                    to carry out official duties on behalf of
                                                requirements of the Regulatory                          U.S.C. 801–808), the DEA has submitted                the U.S. government.
                                                Flexibility Act (RFA). The requirements                 a copy of this final order to both Houses                Increasingly, the federal government
                                                for the preparation of an initial                       of Congress and to the Comptroller                    utilizes officials or employees of state,
                                                regulatory flexibility analysis in 5 U.S.C.             General.                                              local, tribal, and territorial governments
                                                603(a) are not applicable where, as here,                Dated: May 12, 2015.                                 in support of federal activities, both
                                                the DEA is not required by section 553                                                                        domestically and overseas, such as the
                                                                                                        Michele M. Leonhart,
                                                of the APA or any other law to publish                                                                        Federal Bureau of Investigation’s Joint
                                                                                                        Administrator.
                                                a general notice of proposed                                                                                  Terrorism Task Force. When required to
                                                rulemaking.                                             [FR Doc. 2015–11765 Filed 5–14–15; 8:45 am]
                                                                                                                                                              travel internationally in support of such
                                                   Additionally, this action is not a                   BILLING CODE 4410–09–P                                federal activities, these individuals are
                                                significant regulatory action as defined                                                                      not currently eligible for official
                                                by Executive Order 12866 (Regulatory                                                                          passports. Issuance of an official
                                                Planning and Review), section 3(f), and,                DEPARTMENT OF STATE                                   passport to such individuals signifies to
                                                accordingly, this action has not been                                                                         foreign governments that they are
                                                reviewed by the Office of Management                    22 CFR Part 51                                        carrying out official duties in support of
                                                and Budget (OMB).                                       [Public Notice: 9133]                                 the U.S. government. The activities
                                                   This action will not have substantial                                                                      undertaken by these officials are often of
                                                direct effects on the States, on the                    RIN 1400–AD83
                                                                                                                                                              pressing national security, law
                                                relationship between the national                                                                             enforcement, or humanitarian
                                                government and the States, or on the                    Passports: Official Passports for
                                                                                                        Officials or Employees of State, Local,               importance and occur with little
                                                distribution of power and                                                                                     advance notice. It is in the U.S.
                                                responsibilities among the various                      Tribal or Territorial Governments
                                                                                                        Traveling Abroad and Carrying Out                     government’s interest to provide these
                                                levels of government. Therefore, in                                                                           individuals the travel documents
                                                accordance with Executive Order 13132                   Official Duties in Support of the U.S.
                                                                                                        Government                                            necessary to allow them to travel in a
                                                (Federalism) it is determined that this                                                                       timely manner.
                                                action does not have sufficient                         AGENCY:    Department of State.                          Under 22 U.S.C. 211a et seq., the
                                                federalism implications to warrant the                  ACTION:   Interim final rule.                         Secretary of State has the authority to
                                                preparation of a Federalism Assessment.                                                                       make rules for the granting and issuance
                                                   Pursuant to section 808(2) of the                    SUMMARY:    This rule amends the passport             of passports. The Department is
                                                Congressional Review Act (CRA), ‘‘any                   rules for the Department of State to                  amending section 51.3(b) of 22 CFR to
                                                rule for which an agency for good cause                 authorize issuing an official passport to             authorize issuing official passports to an
                                                finds * * * that notice and public                      an official or employee of a state, local,            official or employee of a state, local,
                                                procedure thereon are impracticable,                    tribal, or territorial government traveling           tribal, or territorial government traveling
                                                unnecessary, or contrary to the public                  abroad to carry out official duties in                abroad to carry out official duties in
                                                interest, shall take effect at such time as             support of the U.S. government.                       support of the U.S. government.
                                                the Federal agency promulgating the                     DATES: This rule is effective May 15,
                                                rule determines.’’ 5 U.S.C. 808(2). It is               2015.                                                 Regulatory Findings
                                                in the public interest to maintain the                     The Department of State will accept
                                                temporary placement of UR–144,                                                                                Administrative Procedure Act
                                                                                                        comments until July 14, 2015.
                                                XLR11, and AKB48 in schedule I                                                                                   The Department is publishing this
                                                                                                        ADDRESSES: You may make comments                      rule as an interim final rule, effective on
                                                because they pose a public health risk.
                                                The temporary scheduling action was                     by any of the following methods, and                  the date of publication, pursuant to the
                                                taken pursuant to 21 U.S.C. 811(h),                     you must include the RIN in the subject               ‘‘good cause’’ exemption of the
                                                which is specifically designed to enable                line of your message.                                 Administrative Procedure Act (APA), 5
                                                the DEA to act in an expeditious manner                    • Mail (paper, disk, or CD–ROM                     U.S.C. 553(b)(3)(B). The Department
                                                to avoid an imminent hazard to the                      submissions): ATTN: RIN 1400–AD83,                    finds that delaying the effect of this rule
                                                public safety. 21 U.S.C. 811(h)                         Alice Kottmyer, Attorney-Adviser,                     until after notice and comment would
                                                exempted the temporary scheduling                       Office of the Legal Adviser (L/M), U.S.               be impractical, unnecessary, and
                                                order from standard notice and                          Department of State, Room 4325, 2201                  contrary to public interest. The
                                                comment rulemaking procedures to                        C Street NW., Washington, DC 20520.                   Department finds that providing the
                                                ensure that the process moved swiftly,                     • Email: kottmyeram@state.gov.                     necessary travel documents to these
                                                and this extension of the temporary                        • Persons with access to the Internet
                                                                                                                                                              individuals to allow them to travel in
                                                scheduling order continues to serve that                may view this rule and submit
                                                                                                                                                              support of U.S. government interests
                                                purpose. For the same reasons that                      comments by going to
                                                                                                                                                              provides a compelling justification for
                                                underlie 21 U.S.C. 811(h), that is, the                 www.regulations.gov, and searching for
                                                                                                                                                              immediate approval of this rule.
                                                DEA’s need to place these substances in                 the rule by its RIN, 1400–AD83.
                                                                                                                                                              Therefore, this rule is effective on the
                                                schedule I because they pose an                         FOR FURTHER INFORMATION CONTACT:                      date of publication. See 5 U.S.C. 553(d).
                                                imminent hazard to public safety, it                    Alice Kottmyer, Attorney-Adviser,                     However, the Department solicits—and
                                                would be contrary to the public interest                kottmyeram@state.gov, 202–647–2318.                   welcomes—comments on this
mstockstill on DSK4VPTVN1PROD with RULES




                                                to delay implementation of this                         SUPPLEMENTARY INFORMATION: 22 CFR                     rulemaking, and will address relevant
                                                extension of the temporary scheduling                   51.3(b) provides that an ‘‘official                   comments in a final rule.
                                                order. Therefore, in accordance with                    passport’’ may be issued to: An official
                                                section 808(2) of the CRA, this final                   or employee of the U.S. government                    Regulatory Flexibility Act
                                                order extending the temporary                           traveling abroad to carry out official                  The Department, in accordance with
                                                scheduling order shall take effect                      duties; spouses and family members of                 the Regulatory Flexibility Act, 5 U.S.C.
                                                immediately upon its publication.                       such persons; and, when authorized by                 605(b), has reviewed this rule and, by


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Document Created: 2018-02-21 10:27:20
Document Modified: 2018-02-21 10:27:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal order.
DatesThis final order is effective May 15, 2015.
ContactJohn R. Scherbenske, Office of
FR Citation80 FR 27854 

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