81_FR_6199 81 FR 6175 - Schedules of Controlled Substances: Extension of Temporary Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA in Schedule I of the Controlled Substances Act

81 FR 6175 - Schedules of Controlled Substances: Extension of Temporary Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA in Schedule I of the Controlled Substances Act

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 24 (February 5, 2016)

Page Range6175-6177
FR Document2016-02308

The Administrator of the Drug Enforcement Administration is issuing this final order to extend the temporary schedule I status of four synthetic cannabinoids pursuant to the temporary scheduling provisions of the Controlled Substances Act. The substances are: quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC); quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB- 22; 5F-PB-22); N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)- 1H-indazole-3-carboxamide (AB-FUBINACA); and N-(1-amino-3,3-dimethyl-1- oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA), including their optical, positional and geometric isomers, salts, and salts of isomers. The current final order temporarily placing PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA into schedule I is in effect through February 9, 2016. This final order will extend the temporary scheduling of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA for one year, or until the permanent scheduling action for these four substances is completed, whichever occurs first.

Federal Register, Volume 81 Issue 24 (Friday, February 5, 2016)
[Federal Register Volume 81, Number 24 (Friday, February 5, 2016)]
[Rules and Regulations]
[Pages 6175-6177]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02308]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-385E]


Schedules of Controlled Substances: Extension of Temporary 
Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA 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 is 
issuing this final order to extend the temporary schedule I status of 
four synthetic cannabinoids pursuant to the temporary scheduling 
provisions of the Controlled Substances Act. The substances are: 
quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC); 
quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-
22; 5F-PB-22); N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-
1H-indazole-3-carboxamide (AB-FUBINACA); and N-(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA), 
including their optical, positional and geometric isomers, salts, and 
salts of isomers. The current final order temporarily placing PB-22, 
5F-PB-22, AB-FUBINACA, and ADB-PINACA into schedule I is in effect 
through February 9, 2016. This final order will extend the temporary 
scheduling of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA for one 
year, or until the permanent scheduling action for these four 
substances is completed, whichever occurs first.

DATES: This final order is effective February 5, 2016.

FOR FURTHER INFORMATION CONTACT: Barbara J. Boockholdt, Office of 
Diversion Control, Drug Enforcement Administration; Mailing Address: 
8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 
598-6812.

SUPPLEMENTARY INFORMATION: 

Legal Authority

    The Drug Enforcement Administration (DEA) implements and

[[Page 6176]]

enforces titles II and III of the Comprehensive Drug Abuse Prevention 
and Control Act of 1970, as amended. Titles II and III are referred to 
as the ``Controlled Substances Act'' and the ``Controlled Substances 
Import and Export Act,'' respectively, and are collectively referred to 
as the ``Controlled Substances Act'' or the ``CSA'' for purpose of this 
action. 21 U.S.C. 801-971. The DEA published the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), chapter II.
    The CSA and its implementing regulations are designed to prevent, 
detect, and eliminate the diversion of controlled substances and listed 
chemicals into the illicit market while ensuring an adequate supply is 
available for the legitimate medical, scientific, research, and 
industrial needs of the United States. Controlled substances have the 
potential for abuse and dependence and are controlled to protect the 
public health and safety.
    Under the CSA, every controlled substance is classified into one of 
five schedules based upon its potential for abuse, its currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the drug or other substance may cause. 21 U.S.C. 812. The 
initial schedules of controlled substances established by Congress are 
found at 21 U.S.C. 812(c), and the current list of all scheduled 
substances is published at 21 CFR part 1308.
    Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney 
General with the authority to temporarily place a substance into 
schedule I of the CSA for two years without regard to the requirements 
of 21 U.S.C. 811(b) if she finds that such action is necessary to avoid 
an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In 
addition, if proceedings to control a substance are initiated under 21 
U.S.C. 811(a)(1), the Attorney General may extend the temporary 
scheduling for up to one year. 21 U.S.C. 811(h)(2).
    Where the necessary findings are made, a substance may be 
temporarily scheduled if it is not listed in any other schedule under 
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or 
approval in effect for the substance under section 505 of the Federal 
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 
811(h)(1). The Attorney General has delegated her scheduling authority 
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Background

    On February 10, 2014, the DEA published a final order in the 
Federal Register amending 21 CFR 1308.11(h) to temporarily place the 
four synthetic cannabinoids quinolin-8-yl 1-pentyl-1H-indole-3-
carboxylate (PB-22; QUPIC); quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-
3-carboxylate (5-fluoro-PB-22; 5F-PB-22); N-(1-amino-3-methyl-1-
oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-
FUBINACA); and N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-
indazole-3-carboxamide (ADB-PINACA), into schedule I of the CSA 
pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 79 
FR 7577. That final order was effective on the date of publication, and 
was based on findings by the Deputy Administrator of the DEA that the 
temporary scheduling of these four synthetic cannabinoids 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 expire two years from 
the effective date of the scheduling order, which was February 10, 
2014. 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 of that substance could be extended for up to 
one year. Proceedings for the scheduling of a substance under 21 U.S.C. 
811(a) may be initiated by the Attorney General (delegated to the 
Administrator of the DEA pursuant to 28 CFR 0.100) on his 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.''
---------------------------------------------------------------------------

    The Administrator of the DEA, 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 PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA. 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 four synthetic 
cannabinoids. On December 30, 2014, 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 PB-22, 5F-PB-
22, AB-FUBINACA, and ADB-PINACA, and in accordance with 21 U.S.C. 811 
(b) and (c). Upon evaluating the scientific and medical evidence, on 
January 19, 2016, the HHS submitted to the Administrator of the DEA its 
four scientific and medical evaluations for these 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 PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA in 
accordance with 21 U.S.C. 811(c). The DEA published a notice of 
proposed rulemaking for the placement of PB-22, 5F-PB-22, AB-FUBINACA, 
and ADB-PINACA into schedule I elsewhere in this issue of the Federal 
Register.
    Pursuant to 21 U.S.C. 811(h)(2), the Administrator of the DEA 
orders that the temporary scheduling of PB-22, 5F-PB-22, AB-FUBINACA 
and ADB-PINACA, 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 final order, the schedule I requirements 
for handling PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA, 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

[[Page 6177]]

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 
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 PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA 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 final 
order extending the temporary scheduling order shall take effect 
immediately upon its publication. The DEA has submitted a copy of this 
final order to both Houses of Congress and to the Comptroller General, 
although such filing is not required under the Small Business 
Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 
5 U.S.C. 801-808 because, as noted above, this action is an order, not 
a rule.

    Dated: February 2, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-02308 Filed 2-4-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                              Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Rules and Regulations                                               6175

                                           with 21 U.S.C. 952, 953, 957, 958, and                    This action will not have substantial               MAB-CHMINACA; ADB-CHMINACA)
                                           in accordance with 21 CFR part 1312 as                  direct effects on the States, on the                  (7032)
                                           of February 5, 2016.                                    relationship between the national                       Dated: February 2, 2016.
                                             11. Liability. Any activity involving                 government and the States, or on the                  Chuck Rosenberg,
                                           MAB-CHMINACA not authorized by, or                      distribution of power and
                                                                                                                                                         Acting Administrator.
                                           in violation of the CSA, occurring as of                responsibilities among the various
                                                                                                                                                         [FR Doc. 2016–02302 Filed 2–4–16; 8:45 am]
                                           February 5, 2016, is unlawful, and may                  levels of government. Therefore, in
                                                                                                   accordance with Executive Order 13132                 BILLING CODE 4410–09–P
                                           subject the person to administrative,
                                           civil, and/or criminal sanctions.                       (Federalism) it is determined that this
                                                                                                   action does not have sufficient
                                           Regulatory Analyses                                                                                           DEPARTMENT OF JUSTICE
                                                                                                   federalism implications to warrant the
                                              Section 201(h) of the CSA, 21 U.S.C.                 preparation of a Federalism Assessment.               Drug Enforcement Administration
                                           811(h), provides for an expedited                         As noted above, this action is an
                                           temporary scheduling action where                       order, not a rule. Accordingly, the                   21 CFR Part 1308
                                           such action is necessary to avoid an                    Congressional Review Act (CRA) is
                                           imminent hazard to the public safety.                   inapplicable, as it applies only to rules.            [Docket No. DEA–385E]
                                           As provided in this subsection, the                     5 U.S.C. 808(2). It is in the public
                                           Attorney General may, by order,                                                                               Schedules of Controlled Substances:
                                                                                                   interest to schedule this substance
                                           schedule a substance in schedule I on a                                                                       Extension of Temporary Placement of
                                                                                                   immediately because it poses a public
                                           temporary basis. Such an order may not                                                                        PB-22, 5F-PB-22, AB-FUBINACA and
                                                                                                   health risk. This temporary scheduling
                                           be issued before the expiration of 30                                                                         ADB-PINACA in Schedule I of the
                                                                                                   action is taken pursuant to 21 U.S.C.
                                           days from (1) the publication of a notice                                                                     Controlled Substances Act
                                                                                                   811(h), which is specifically designed to
                                           in the Federal Register of the intention                enable the DEA to act in an expeditious               AGENCY:  Drug Enforcement
                                           to issue such order and the grounds                     manner to avoid an imminent hazard to                 Administration, Department of Justice.
                                           upon which such order is to be issued,                  the public safety. Under 21 U.S.C.                    ACTION: Final order.
                                           and (2) the date that notice of the                     811(h), temporary scheduling orders are
                                           proposed temporary scheduling order is                  not subject to notice and comment                     SUMMARY:    The Administrator of the Drug
                                           transmitted to the Assistant Secretary.                 rulemaking procedures. The DEA                        Enforcement Administration is issuing
                                           21 U.S.C. 811(h)(1).                                    understands that the CSA frames                       this final order to extend the temporary
                                              Inasmuch as section 201(h) of the                    temporary scheduling actions as orders                schedule I status of four synthetic
                                           CSA directs that temporary scheduling                   rather than rules to ensure that the                  cannabinoids pursuant to the temporary
                                           actions be issued by order and sets forth               process moves swiftly. For the same                   scheduling provisions of the Controlled
                                           the procedures by which such orders are                 reasons that underlie 21 U.S.C. 811(h),               Substances Act. The substances are:
                                           to be issued, the DEA believes that the                 that is, the need to move quickly to                  quinolin-8-yl 1-pentyl-1H-indole-3-
                                           notice and comment requirements of the                  place this substance into schedule I                  carboxylate (PB-22; QUPIC); quinolin-8-
                                           Administrative Procedure Act (APA) at                   because it poses an imminent hazard to                yl 1-(5-fluoropentyl)-1H-indole-3-
                                           5 U.S.C. 553, do not apply to this                      public safety, it would be contrary to the            carboxylate (5-fluoro-PB-22; 5F-PB-22);
                                           temporary scheduling action. In the                     public interest to delay implementation               N-(1-amino-3-methyl-1-oxobutan-2-yl)-
                                           alternative, even assuming that this                    of the temporary scheduling order.                    1-(4-fluorobenzyl)-1H-indazole-3-
                                           action might be subject to 5 U.S.C. 553,                Therefore, this order shall take effect               carboxamide (AB-FUBINACA); and N-
                                           the Administrator finds that there is                   immediately upon its publication.                     (1-amino-3,3-dimethyl-1-oxobutan-2-yl)-
                                           good cause to forgo the notice and                                                                            1-pentyl-1H-indazole-3-carboxamide
                                                                                                   List of Subjects in 21 CFR Part 1308                  (ADB-PINACA), including their optical,
                                           comment requirements of 5 U.S.C. 553,
                                           as any further delays in the process for                  Administrative practice and                         positional and geometric isomers, salts,
                                           issuance of temporary scheduling orders                 procedure, Drug traffic control,                      and salts of isomers. The current final
                                           would be impracticable and contrary to                  Reporting and recordkeeping                           order temporarily placing PB-22, 5F-PB-
                                           the public interest in view of the                      requirements.                                         22, AB-FUBINACA, and ADB-PINACA
                                           manifest urgency to avoid an imminent                     For the reasons set out above, the DEA              into schedule I is in effect through
                                           hazard to the public safety.                            amends 21 CFR part 1308 as follows:                   February 9, 2016. This final order will
                                              Further, the DEA believes that this                                                                        extend the temporary scheduling of PB-
                                           temporary scheduling action final order                 PART 1308—SCHEDULES OF                                22, 5F-PB-22, AB-FUBINACA, and ADB-
                                           is not a ‘‘rule’’ as defined by 5 U.S.C.                CONTROLLED SUBSTANCES                                 PINACA for one year, or until the
                                           601(2), and, accordingly, is not subject                                                                      permanent scheduling action for these
                                           to the requirements of the Regulatory                   ■ 1. The authority citation for part 1308             four substances is completed, whichever
                                           Flexibility Act (RFA). The requirements                 continues to read as follows:                         occurs first.
                                           for the preparation of an initial                         Authority: 21 U.S.C. 811, 812, 871(b),              DATES: This final order is effective
                                           regulatory flexibility analysis in 5 U.S.C.             unless otherwise noted.                               February 5, 2016.
                                           603(a) are not applicable where, as here,               ■ 2. Amend § 1308.11 by adding                        FOR FURTHER INFORMATION CONTACT:
                                           the DEA is not required by the APA or                   paragraph (h)(25) to read as follows:                 Barbara J. Boockholdt, Office of
                                           any other law to publish a general                                                                            Diversion Control, Drug Enforcement
                                           notice of proposed rulemaking.                          § 1308.11    Schedule I.                              Administration; Mailing Address: 8701
                                              Additionally, this action is not a                   *     *     *    *     *                              Morrissette Drive, Springfield, Virginia
Lhorne on DSK5TPTVN1PROD with RULES




                                           significant regulatory action as defined                  (h) * * *                                           22152; Telephone: (202) 598-6812.
                                           by Executive Order 12866 (Regulatory                      (25) N-(1-amino-3,3-dimethyl-1-                     SUPPLEMENTARY INFORMATION:
                                           Planning and Review), section 3(f), and,                oxobutan-2-yl)-1-(cyclohexylmethyl)-
                                           accordingly, this action has not been                   1H-indazole-3-carboxamide, its optical,               Legal Authority
                                           reviewed by the Office of Management                    positional, and geometric isomers, salts                The Drug Enforcement
                                           and Budget (OMB).                                       and salts of isomers (Other names:                    Administration (DEA) implements and


                                      VerDate Sep<11>2014   14:51 Feb 04, 2016   Jkt 238001   PO 00000   Frm 00017   Fmt 4700   Sfmt 4700   E:\FR\FM\05FER1.SGM   05FER1


                                           6176               Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Rules and Regulations

                                           enforces titles II and III of the                       Background                                            available information and a scheduling
                                           Comprehensive Drug Abuse Prevention                       On February 10, 2014, the DEA                       recommendation for PB-22, 5F-PB-22,
                                           and Control Act of 1970, as amended.                    published a final order in the Federal                AB-FUBINACA, and ADB-PINACA, and
                                           Titles II and III are referred to as the                Register amending 21 CFR 1308.11(h) to                in accordance with 21 U.S.C. 811 (b)
                                           ‘‘Controlled Substances Act’’ and the                   temporarily place the four synthetic                  and (c). Upon evaluating the scientific
                                           ‘‘Controlled Substances Import and                      cannabinoids quinolin-8-yl 1-pentyl-1H-               and medical evidence, on January 19,
                                           Export Act,’’ respectively, and are                     indole-3-carboxylate (PB-22; QUPIC);                  2016, the HHS submitted to the
                                           collectively referred to as the                         quinolin-8-yl 1-(5-fluoropentyl)-1H-                  Administrator of the DEA its four
                                           ‘‘Controlled Substances Act’’ or the                    indole-3-carboxylate (5-fluoro-PB-22;                 scientific and medical evaluations for
                                           ‘‘CSA’’ for purpose of this action. 21                  5F-PB-22); N-(1-amino-3-methyl-1-                     these substances. Upon receipt of the
                                           U.S.C. 801-971. The DEA published the                   oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-                 scientific and medical evaluation and
                                           implementing regulations for these                      indazole-3-carboxamide (AB-                           scheduling recommendations from the
                                           statutes in title 21 of the Code of Federal             FUBINACA); and N-(1-amino-3,3-                        HHS, the DEA reviewed the documents
                                           Regulations (CFR), chapter II.                          dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-                and all other relevant data, and
                                                                                                   indazole-3-carboxamide (ADB-                          conducted its own eight-factor analysis
                                              The CSA and its implementing                                                                               of the abuse potential of PB-22, 5F-PB-
                                           regulations are designed to prevent,                    PINACA), into schedule I of the CSA
                                                                                                   pursuant to the temporary scheduling                  22, AB-FUBINACA, and ADB-PINACA
                                           detect, and eliminate the diversion of                                                                        in accordance with 21 U.S.C. 811(c).
                                                                                                   provisions of 21 U.S.C. 811(h). 79 FR
                                           controlled substances and listed                                                                              The DEA published a notice of proposed
                                                                                                   7577. That final order was effective on
                                           chemicals into the illicit market while                                                                       rulemaking for the placement of PB-22,
                                                                                                   the date of publication, and was based
                                           ensuring an adequate supply is available                on findings by the Deputy                             5F-PB-22, AB-FUBINACA, and ADB-
                                           for the legitimate medical, scientific,                 Administrator of the DEA that the                     PINACA into schedule I elsewhere in
                                           research, and industrial needs of the                   temporary scheduling of these four                    this issue of the Federal Register.
                                           United States. Controlled substances                    synthetic cannabinoids was necessary to                 Pursuant to 21 U.S.C. 811(h)(2), the
                                           have the potential for abuse and                        avoid an imminent hazard to the public                Administrator of the DEA orders that
                                           dependence and are controlled to                        safety pursuant to 21 U.S.C. 811(h)(1).               the temporary scheduling of PB-22, 5F-
                                           protect the public health and safety.                   Section 201(h)(2) of the CSA, 21 U.S.C.               PB-22, AB-FUBINACA and ADB-
                                                                                                   811(h)(2), requires that the temporary                PINACA, including their optical,
                                              Under the CSA, every controlled
                                                                                                   control of these substances expire two                positional and geometric isomers, salts,
                                           substance is classified into one of five
                                                                                                   years from the effective date of the                  and salts of isomers, be extended for one
                                           schedules based upon its potential for
                                                                                                   scheduling order, which was February                  year, or until the permanent scheduling
                                           abuse, its currently accepted medical                                                                         proceeding is completed, whichever
                                           use in treatment in the United States,                  10, 2014. However, the CSA also
                                                                                                   provides that during the pendency of                  occurs first.
                                           and the degree of dependence the drug                                                                           In accordance with this final order,
                                           or other substance may cause. 21 U.S.C.                 proceedings under 21 U.S.C. 811(a)(1)
                                                                                                                                                         the schedule I requirements for
                                           812. The initial schedules of controlled                with respect to the substance, the
                                                                                                                                                         handling PB-22, 5F-PB-22, AB-
                                           substances established by Congress are                  temporary scheduling of that substance
                                                                                                                                                         FUBINACA and ADB-PINACA,
                                           found at 21 U.S.C. 812(c), and the                      could be extended for up to one year.
                                                                                                                                                         including their optical, positional and
                                           current list of all scheduled substances                Proceedings for the scheduling of a
                                                                                                                                                         geometric isomers, salts, and salts of
                                           is published at 21 CFR part 1308.                       substance under 21 U.S.C. 811(a) may
                                                                                                   be initiated by the Attorney General                  isomers, will remain in effect for one
                                              Section 201 of the CSA, 21 U.S.C. 811,               (delegated to the Administrator of the                year, or until the permanent scheduling
                                           provides the Attorney General with the                  DEA pursuant to 28 CFR 0.100) on his                  proceeding is completed, whichever
                                           authority to temporarily place a                        or her own motion, at the request of the              occurs first.
                                           substance into schedule I of the CSA for                Secretary of Health and Human                         Regulatory Matters
                                           two years without regard to the                         Services,1 or on the petition of any
                                           requirements of 21 U.S.C. 811(b) if she                                                                         The CSA provides for an expedited
                                                                                                   interested party.                                     temporary scheduling action where
                                           finds that such action is necessary to                    The Administrator of the DEA, on his
                                           avoid an imminent hazard to the public                                                                        such action is necessary to avoid an
                                                                                                   own motion pursuant to 21 U.S.C.
                                           safety. 21 U.S.C. 811(h)(1). In addition,                                                                     imminent hazard to the public safety. 21
                                                                                                   811(a), has initiated proceedings under
                                           if proceedings to control a substance are                                                                     U.S.C. 811(h). The Attorney General
                                                                                                   21 U.S.C. 811(a)(1) to permanently
                                           initiated under 21 U.S.C. 811(a)(1), the                                                                      may, by order, schedule a substance in
                                                                                                   schedule PB-22, 5F-PB-22, AB-
                                           Attorney General may extend the                                                                               schedule I on a temporary basis. Id. 21
                                                                                                   FUBINACA, and ADB-PINACA. The
                                                                                                                                                         U.S.C. 811(h) also provides that the
                                           temporary scheduling for up to one                      DEA has gathered and reviewed the
                                                                                                                                                         temporary scheduling of a substance
                                           year. 21 U.S.C. 811(h)(2).                              available information regarding the
                                                                                                   pharmacology, chemistry, trafficking,                 shall expire at the end of two years from
                                              Where the necessary findings are                                                                           the date of the issuance of the order
                                           made, a substance may be temporarily                    actual abuse, pattern of abuse, and the
                                                                                                   relative potential for abuse for these four           scheduling such substance, except that
                                           scheduled if it is not listed in any other                                                                    the Attorney General may, during the
                                           schedule under section 202 of the CSA,                  synthetic cannabinoids. On December
                                                                                                   30, 2014, the DEA submitted a request                 pendency of proceedings to
                                           21 U.S.C. 812, or if there is no                                                                              permanently schedule the substance,
                                           exemption or approval in effect for the                 to the HHS to provide the DEA with a
                                                                                                   scientific and medical evaluation of                  extend the temporary scheduling for up
                                           substance under section 505 of the                                                                            to one year.
                                           Federal Food, Drug, and Cosmetic Act                                                                            To the extent that 21 U.S.C. 811(h)
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                                                                                                      1 Because the Secretary of the Department of
                                           (FDCA), 21 U.S.C. 355. 21 U.S.C.                        Health and Human Services has delegated to the        directs that temporary scheduling
                                           811(h)(1). The Attorney General has                     Assistant Secretary for Health of the Department of   actions be issued by order and sets forth
                                           delegated her scheduling authority                      Health and Human Services the authority to make       the procedures by which such orders are
                                                                                                   domestic drug scheduling recommendations, for
                                           under 21 U.S.C. 811 to the                              purposes of this final order, all subsequent
                                                                                                                                                         to be issued and extended, the DEA
                                           Administrator of the DEA. 28 CFR                        references to ‘‘Secretary’’ have been replaced with   believes that the notice and comment
                                           0.100.                                                  ‘‘Assistant Secretary.’’                              requirements of section 553 of the


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                                                              Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Rules and Regulations                                         6177

                                           Administrative Procedure Act (APA), 5                   process moves swiftly, and this                       of Cooperative and State Programs,
                                           U.S.C. 553, do not apply to this                        extension of the temporary scheduling                 Room N–3700, U.S. Department of
                                           extension of the temporary scheduling                   order continues to serve that purpose.                Labor, 200 Constitution Avenue NW.,
                                           action. In the alternative, even assuming               For the same reasons that underlie 21                 Washington, DC 20210; telephone (202)
                                           that this action might be subject to                    U.S.C. 811(h), that is, the need to place             693–2200; email: kalinowski.doug@
                                           section 553 of the APA, the                             these substances in schedule I because                dol.gov.
                                           Administrator finds that there is good                  they pose an imminent hazard to public                SUPPLEMENTARY INFORMATION:
                                           cause to forgo the notice and comment                   safety, it would be contrary to the public
                                           requirements of section 553, as any                     interest to delay implementation of this              A. Background
                                           further delays in the process for                       extension of the temporary scheduling                    On May 20, 2015, OSHA published a
                                           extending the temporary scheduling                      order. Therefore, in accordance with                  notice in the Federal Register (80 FR
                                           order would be impracticable and                        section 808(2) of the CRA, this final                 28890) concerning the submission of the
                                           contrary to the public interest in view                 order extending the temporary                         Maine State and Local Government
                                           of the manifest urgency to avoid an                     scheduling order shall take effect                    Only State Plan, announcing that initial
                                           imminent hazard to the public safety.                   immediately upon its publication. The                 Federal approval of the Plan was at
                                           Further, the DEA believes that this final               DEA has submitted a copy of this final                issue, and offering interested parties an
                                           order extending the temporary                           order to both Houses of Congress and to               opportunity to review the Plan and
                                           scheduling action is not a ‘‘rule’’ as                  the Comptroller General, although such                submit data, views, arguments or
                                           defined by 5 U.S.C. 601(2), and,                        filing is not required under the Small                requests for a hearing concerning the
                                           accordingly, is not subject to the                      Business Regulatory Enforcement                       Plan. No comments were received.
                                           requirements of the Regulatory                          Fairness Act of 1996 (Congressional                      OSHA, after carefully reviewing the
                                           Flexibility Act (RFA). The requirements                 Review Act), 5 U.S.C. 801–808 because,                Maine State Plan for the development
                                           for the preparation of an initial                       as noted above, this action is an order,              and enforcement of state standards
                                           regulatory flexibility analysis in 5 U.S.C.             not a rule.                                           applicable to state and local government
                                           603(a) are not applicable where, as here,                                                                     employers and the record developed
                                                                                                     Dated: February 2, 2016.
                                           the DEA is not required by section 553                                                                        during the above described proceedings,
                                           of the APA or any other law to publish                  Chuck Rosenberg,
                                                                                                                                                         determined that the requirements and
                                           a general notice of proposed                            Acting Administrator.                                 criteria for initial approval of a
                                           rulemaking.                                             [FR Doc. 2016–02308 Filed 2–4–16; 8:45 am]            developmental State Plan were met. The
                                             Additionally, this action is not a                    BILLING CODE 4410–09–P                                Plan was approved as a developmental
                                           significant regulatory action as defined                                                                      State Plan for State and Local
                                           by Executive Order 12866 (Regulatory                                                                          Government Only under Section 18 of
                                           Planning and Review), section 3(f), and,                DEPARTMENT OF LABOR                                   the OSH Act on August 5, 2015. (80 FR
                                           accordingly, this action has not been                                                                         46487).
                                           reviewed by the Office of Management                    Occupational Safety and Health
                                           and Budget (OMB).                                       Administration                                        B. Notice of Publication of the
                                             This action will not have substantial                                                                       Regulatory Description of the Maine
                                           direct effects on the States, on the                    29 CFR Part 1952                                      State Plan
                                           relationship between the national                                                                                In light of the reorganization of the
                                                                                                   [Docket No. OSHA–2015–0003]
                                           government and the States, or on the                                                                          State Plan regulations through the
                                           distribution of power and                               RIN 1218–AC97                                         streamlining of 29 CFR part 1952 and 29
                                           responsibilities among the various                                                                            CFR part 1956, OSHA deferred any
                                           levels of government. Therefore, in                     Maine State Plan for State and Local                  change to those regulatory provisions
                                           accordance with Executive Order 13132                   Government Employers                                  relating to the Maine State Plan until the
                                           (Federalism) it is determined that this                                                                       streamlining changes took effect. (80 FR
                                                                                                   AGENCY:  Occupational Safety and Health
                                           action does not have sufficient                                                                               46487, 46492). These streamlining
                                                                                                   Administration (OSHA), Department of
                                           federalism implications to warrant the                                                                        changes took effect October 19, 2015.
                                                                                                   Labor.
                                           preparation of a Federalism Assessment.                                                                       (80 FR 49897, Aug. 18, 2015). Therefore
                                             As noted above, this action is an                     ACTION: Final rule.                                   OSHA is now amending 29 CFR part
                                           order, not a rule. Accordingly, the                                                                           1952 to incorporate the description of
                                                                                                   SUMMARY:   This document announces the
                                           Congressional Review Act (CRA) is                                                                             the Maine State Plan.
                                                                                                   publication of the regulatory provisions
                                           inapplicable, as it applies only to rules.
                                                                                                   which formalize the initial approval of               C. Regulatory Flexibility Act
                                           5 U.S.C. 808(2). It is in the public
                                                                                                   the Maine State and Local Government                    OSHA certifies pursuant to the
                                           interest to maintain the temporary
                                           placement of PB-22, 5F-PB-22, AB-                       Only State Plan.                                      Regulatory Flexibility Act of 1980 (5
                                           FUBINACA and ADB-PINACA in                              DATES: Effective February 5, 2016. Initial            U.S.C. 601 et seq.) that the initial
                                           schedule I because they pose a public                   approval of the Maine State Plan was                  approval of the Maine State Plan will
                                           health risk. The temporary scheduling                   granted on August 5, 2015.                            not have a significant economic impact
                                           action was taken pursuant to 21 U.S.C.                  FOR FURTHER INFORMATION CONTACT:                      on a substantial number of small
                                           811(h), which is specifically designed to                 For press inquiries: Contact Francis                entities. By its own terms, the Plan will
                                           enable the DEA to act in an expeditious                 Meilinger, Office of Communications,                  have no effect on private sector
                                           manner to avoid an imminent hazard to                   Room N–3647, OSHA, U.S. Department                    employment, but is limited to the state
                                           the public safety. Under 21 U.S.C.                      of Labor, 200 Constitution Avenue NW.,                and its political subdivisions. Moreover,
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                                           811(h), temporary scheduling orders are                 Washington, DC 20210; telephone (202)                 Title 26, Labor and Industry, of the
                                           not subject to notice and comment                       693–1999; email meilinger.francis2@                   Maine Revised Statutes was enacted in
                                           rulemaking procedures. The DEA                          dol.gov.                                              1971. This legislation established the
                                           understands that the CSA frames                           For general and technical                           Board, whose purpose is to formulate
                                           temporary scheduling actions as orders                  information: Contact Douglas J.                       rules that shall, at a minimum, conform
                                           rather than rules to ensure that the                    Kalinowski, Director, OSHA Directorate                with Federal standards of occupational


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Document Created: 2016-02-05 00:17:44
Document Modified: 2016-02-05 00:17:44
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 February 5, 2016.
ContactBarbara J. Boockholdt, Office of
FR Citation81 FR 6175 

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