82_FR_58795 82 FR 58557 - Schedules of Controlled Substances: Placement of MT-45 Into Schedule I

82 FR 58557 - Schedules of Controlled Substances: Placement of MT-45 Into Schedule I

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 238 (December 13, 2017)

Page Range58557-58559
FR Document2017-26853

With the issuance of this final order, the Administrator of the Drug Enforcement Administration places the substance MT-45 (Systematic IUPAC Name: 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine), including its salts, isomers, and salts of isomers into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act and is required in order for the United States to discharge its obligations under the Single Convention on Narcotic Drugs, 1961. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle, MT-45.

Federal Register, Volume 82 Issue 238 (Wednesday, December 13, 2017)
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Rules and Regulations]
[Pages 58557-58559]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26853]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-451]


Schedules of Controlled Substances: Placement of MT-45 Into 
Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: With the issuance of this final order, the Administrator of 
the Drug Enforcement Administration places the substance MT-45 
(Systematic IUPAC Name: 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine), 
including its salts, isomers, and salts of isomers into schedule I of 
the Controlled Substances Act. This scheduling action is pursuant to 
the Controlled Substances Act and is required in order for the United 
States to discharge its obligations under the Single Convention on 
Narcotic Drugs, 1961. This action imposes the regulatory controls and 
administrative, civil, and criminal sanctions applicable to schedule I 
controlled substances on persons who handle (manufacture, distribute, 
import, export, engage in research or conduct instructional activities 
with, or possess), or propose to handle, MT-45.

DATES: Effective January 12, 2018.

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

SUPPLEMENTARY INFORMATION:

Legal Authority

    Section 201(d)(1) of the Controlled Substances Act (CSA) (21 U.S.C. 
811(d)(1)) states that, if control of a substance is required ``by 
United States obligations under international treaties, conventions, or 
protocols in effect on October 27, 1970, the Attorney General shall 
issue an order controlling such drug under the schedule he deems most 
appropriate to carry out such obligations, without regard to the 
findings required by subsection (a) of this section [811(a)] or section 
812(b) . . . and without regard to the procedures prescribed by 
subsections (a) and (b) of this section [21 U.S.C. 811(a) and (b)] . . 
. .'' If a substance is added to one of the schedules of the Single 
Convention on Narcotic Drugs, 1961 (``Single Convention''), then, in 
accordance with article 3, paragraph 7 of the Convention, as a 
signatory Member State, the United States is obligated to control the 
substance under its national drug control legislation, the CSA. The 
Attorney General has delegated scheduling authority under 21 U.S.C. 811 
to the Administrator of the DEA. 28 CFR 0.100.

Background

    On May 17, 2016, the Secretary-General of the United Nations 
advised the Secretary of State of the United States, by letter, that 
during the 59th session of the Commission on Narcotic Drugs, MT-45 was 
added to schedule I of the Single Convention. This letter was prompted 
by a decision at the 59th session of the Commission on Narcotic Drugs 
in March 2016 to schedule MT-45 under schedule I of the Single 
Convention. As a signatory Member State to the Single Convention, the 
United States is obligated to control MT-45 under its national drug 
control legislation, the CSA, in the schedule deemed most appropriate 
to carry out its international obligations. 21 U.S.C. 811(d)(1).

MT-45

    MT-45 is an opioid analgesic drug with pharmacological effects 
similar to morphine. MT-45 was demonstrated to produce physical 
dependence in mice. This compound is a piperazine derivative and is 
structurally unrelated to most other opioids. There are two enantiomers 
of MT-45 (R and S). Both enantiomers bind to opioid receptors, however 
(S)-(+)-MT-45 binds with a greater affinity than that of (R)-(-)-MT-45. 
In functional studies, (S)-(+)-MT-45 has an analgesic effect similar to 
morphine. In comparison, the analgesic effect of (R)-(-)-MT-45 is low.
    Starting in 2013, MT-45 began appearing on the internet for sale as 
a `legal' opioid. Recent reports from Japan have indicated that MT-45 
is present in herbal and chemical mixtures containing synthetic 
cannabinoids and/or synthetic cathinones. Deaths associated with MT-45 
abuse have occurred in the United States and in Europe. In addition, 
there have been at least 13 non-fatal overdoses associated with abuse 
of MT-45. There are no published studies as to the safety of MT-45 for 
human use. The DEA is not aware of any claims or any medical or 
scientific literature suggesting that MT-45 has a currently accepted 
medical use in treatment in the United States. Accordingly, the DEA has 
not requested that the Department of Health and Human Services (HHS) 
conduct a scientific and medical evaluation of the substance's medical 
utility. Furthermore, the DEA is not required under 21 U.S.C. 811(d)(1) 
to make any findings required by 21 U.S.C. 811(a) or 812(b), and is not 
required to follow the procedures prescribed by 21 U.S.C. 811(a) and 
(b). Therefore, consistent with the framework of 21 U.S.C. 811(d), the 
DEA concludes that MT-45 has no currently accepted medical use in 
treatment in the United States and is most appropriately placed in 
schedule I of the CSA.

Conclusion

    In order to meet the obligations of the United States under the 
Single Convention on Narcotic Drugs, 1961, and because MT-45 has no 
currently accepted medical use in treatment in the United States, the 
Administrator of the Drug Enforcement Administration has determined 
that this substance should be placed in schedule I of the Controlled 
Substances Act.

Requirements for Handling

    Upon the effective date of this final order, MT-45 will become 
subject to the regulatory controls and administrative, civil, and 
criminal sanctions applicable to the manufacture, distribution, 
importation, exportation, engagement in research, and conduct of 
instructional

[[Page 58558]]

activities, and possession of schedule I controlled substances 
including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
imports, exports, engages in research or conducts instructional 
activities with, or possesses), or who desires to handle, MT-45 must be 
registered with the DEA to conduct such activities pursuant to 21 
U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 
and 1312, as of January 12, 2018. Any person who currently handles MT-
45, and is not registered with the DEA, must submit an application for 
registration and may not continue to handle MT-45 as of January 12, 
2018, unless the DEA has approved that application for registration 
pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR 
parts 1301 and 1312.
    2. Disposal of stocks. Any person who does not desire or is not 
able to obtain a schedule I registration to handle MT-45 must surrender 
all quantities of currently held MT-45, or may transfer all quantities 
of currently held MT-45 to a person registered with the DEA on or 
before January 12, 2018 in accordance with all applicable federal, 
state, local, and tribal laws. As of January 12, 2018, MT-45 must be 
disposed of in accordance with 21 CFR part 1317, in addition to all 
other applicable federal, state, local, and tribal laws.
    3. Security. MT-45 will be subject to schedule I security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821, 
823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of 
January 12, 2018.
    4. Labeling and packaging. As of January 12, 2018, all labels, 
labeling, and packaging for commercial containers of MT-45 must be in 
compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR 
part 1302.
    5. Inventory. Every DEA registrant who possesses any quantity of 
MT-45 on the effective date of this order must take an inventory of all 
stocks of this substance on hand, pursuant to 21 U.S.C. 827 and 958, 
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. After the 
initial inventory, every DEA registrant must take an inventory of all 
MT-45 on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, 
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    6. Records. All DEA registrants must maintain records with respect 
to MT-45 pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 
CFR parts 1304, and 1312, and 1317 as of January 12, 2018.
    7. Reports. All DEA registrants who manufacture or distribute MT-45 
must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 
CFR parts 1304 and 1312 as of January 12, 2018.
    8. Order Forms. All DEA registrants who distribute MT-45 must 
comply with order form requirements pursuant to 21 U.S.C. 828 and in 
accordance with 21 CFR part 1305 as of January 12, 2018.
    9. Importation and Exportation. All importation and exportation of 
MT-45 must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in 
accordance with 21 CFR part 1312 as of January 12, 2018.
    10. Quota. Only DEA registered manufacturers may manufacture MT-45 
in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in 
accordance with 21 CFR part 1303 as of January 12, 2018.
    11. Liability. Any activity involving MT-45 not authorized by, or 
in violation of the CSA, occurring as of January 12, 2018, is unlawful, 
and may subject the person to administrative, civil, and/or criminal 
sanctions.

Regulatory Analyses

Executive Order 12866, Regulatory Planning and Review

    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).

Executive Order 13132, Federalism

    This action does not have federalism implications warranting the 
application of Executive Order 13132. The action does not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or the distribution of power 
and responsibilities among the various levels of government.

Executive Order 13175

    This action does not have tribal implications warranting the 
application of Executive Order 13175. The action does not have 
substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
government and Indian tribes.

Administrative Procedure Act

    The CSA provides for an expedited scheduling action where control 
is required by the United States obligations under international 
treaties, conventions, or protocols. 21 U.S.C. 811(d)(1). If control is 
required pursuant to such international treaty, convention, or 
protocol, the Attorney General must issue an order controlling such 
drug under the schedule he deems most appropriate to carry out such 
obligations, without regard to the findings or procedures otherwise 
required for scheduling actions.
    To the extent that 21 U.S.C. 811(d)(1) directs that if control is 
required by the United States obligations under international treaties, 
conventions, or protocols in effect on October 27, 1970, scheduling 
actions shall be issued by order (as compared to scheduling pursuant to 
21 U.S.C. 811(a) by rule), 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 scheduling action. In the 
alternative, even if this action does constitute ``rule making'' under 
5 U.S.C. 551(5), this action is exempt from the notice and comment 
requirements of 5 U.S.C. 553 pursuant to 21 U.S.C. 553(a)(1) as an 
action involving a foreign affairs function of the United States given 
that this action is being done in accordance with 21 U.S.C. 811(d)(1)'s 
requirement that such action be taken to comply with the United States 
obligations under the specified international agreement.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to 
rules that are subject to notice and comment under section 553(b) of 
the APA or any other law. As explained above, the CSA exempts this 
final order from notice and comment. Consequently, the RFA does not 
apply to this action.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information under 
the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. An agency may 
not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
control number.

Congressional Review Act

    This action is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act (CRA)). This order will not result in: ``an 
annual effect on the economy of $100,000,000 or more; a major increase 
in costs or prices for consumers, individual industries, Federal, 
State, or local government agencies, or geographic regions; or 
significant adverse effects on

[[Page 58559]]

competition, employment, investment, productivity, innovation, or on 
the ability of United States-based enterprises to compete with foreign 
based enterprises in domestic and export markets.'' However, pursuant 
to the CRA, the DEA has submitted a copy of this order to both Houses 
of Congress and to the Comptroller General.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, 21 CFR part 1308 is amended as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1308 continues to read as follows:

    Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.


0
2. Amend Sec.  1308.11 by:
0
a. Redesignating paragraphs (b)(40) through (57) as (b)(41) through 
(58);
0
b. Adding new paragraph (b)(40).
    The addition reads as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (b) * * *
    (40) MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine) . . . 
(9560)
* * * * *

    Dated: December 5, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-26853 Filed 12-12-17; 8:45 am]
BILLING CODE 4410-09-P



                                                           Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations                                        58557

                                              treated as often as necessary to prevent                distribute, import, export, engage in                 produce physical dependence in mice.
                                              growth of fungi. Do not use formalin                    research or conduct instructional                     This compound is a piperazine
                                              which has been subjected to                             activities with, or possess), or propose              derivative and is structurally unrelated
                                              temperatures below 40 °F, or allowed to                 to handle, MT–45.                                     to most other opioids. There are two
                                              freeze. Treatments in tanks and                         DATES: Effective January 12, 2018.                    enantiomers of MT–45 (R and S). Both
                                              raceways should never exceed 1 hour                     FOR FURTHER INFORMATION CONTACT:                      enantiomers bind to opioid receptors,
                                              for fish or 4 hours for penaeid shrimp                  Michael J. Lewis, Diversion Control                   however (S)-(+)-MT–45 binds with a
                                              (even if they show no sign of distress),                Division, Drug Enforcement                            greater affinity than that of (R)-(¥)-MT–
                                              nor should it exceed 15 minutes for fish                Administration; Mailing Address: 8701                 45. In functional studies, (S)-(+)-MT–45
                                              eggs. Do not apply formalin to ponds                    Morrissette Drive, Springfield, Virginia              has an analgesic effect similar to
                                              with water warmer than 27 °C (80 °F),                   22152; Telephone: (202) 598–6812.                     morphine. In comparison, the analgesic
                                              when a heavy bloom of phytoplankton                     SUPPLEMENTARY INFORMATION:                            effect of (R)-(¥)-MT–45 is low.
                                              is present, or when the concentration of                                                                         Starting in 2013, MT–45 began
                                              dissolved oxygen is less than 5                         Legal Authority
                                                                                                                                                            appearing on the internet for sale as a
                                              milligrams per liter.                                      Section 201(d)(1) of the Controlled                ‘legal’ opioid. Recent reports from Japan
                                                                                                      Substances Act (CSA) (21 U.S.C.                       have indicated that MT–45 is present in
                                              PART 558—NEW ANIMAL DRUGS FOR                           811(d)(1)) states that, if control of a
                                              USE IN ANIMAL FEEDS                                                                                           herbal and chemical mixtures
                                                                                                      substance is required ‘‘by United States              containing synthetic cannabinoids and/
                                              ■ 13. The authority citation for part 558               obligations under international treaties,             or synthetic cathinones. Deaths
                                              continues to read as follows:                           conventions, or protocols in effect on                associated with MT–45 abuse have
                                                                                                      October 27, 1970, the Attorney General                occurred in the United States and in
                                                Authority: 21 U.S.C. 354, 360b, 360ccc,
                                              360ccc–1, 371.                                          shall issue an order controlling such                 Europe. In addition, there have been at
                                                                                                      drug under the schedule he deems most                 least 13 non-fatal overdoses associated
                                              § 558.58    [Amended]                                   appropriate to carry out such                         with abuse of MT–45. There are no
                                              ■  14. In § 558.58, remove paragraphs                   obligations, without regard to the                    published studies as to the safety of
                                              (f)(4) and (5).                                         findings required by subsection (a) of                MT–45 for human use. The DEA is not
                                                                                                      this section [811(a)] or section 812(b)               aware of any claims or any medical or
                                              § 558.366   [Amended]                                   . . . and without regard to the                       scientific literature suggesting that
                                              ■ 15. In § 558.366, remove paragraph                    procedures prescribed by subsections (a)              MT–45 has a currently accepted medical
                                              (e).                                                    and (b) of this section [21 U.S.C. 811(a)             use in treatment in the United States.
                                                Dated: December 5, 2017.                              and (b)] . . . .’’ If a substance is added            Accordingly, the DEA has not requested
                                              Leslie Kux,
                                                                                                      to one of the schedules of the Single                 that the Department of Health and
                                                                                                      Convention on Narcotic Drugs, 1961                    Human Services (HHS) conduct a
                                              Associate Commissioner for Policy.
                                                                                                      (‘‘Single Convention’’), then, in                     scientific and medical evaluation of the
                                              [FR Doc. 2017–26753 Filed 12–12–17; 8:45 am]            accordance with article 3, paragraph 7                substance’s medical utility.
                                              BILLING CODE 4164–01–P                                  of the Convention, as a signatory                     Furthermore, the DEA is not required
                                                                                                      Member State, the United States is                    under 21 U.S.C. 811(d)(1) to make any
                                                                                                      obligated to control the substance under              findings required by 21 U.S.C. 811(a) or
                                              DEPARTMENT OF JUSTICE                                   its national drug control legislation, the            812(b), and is not required to follow the
                                                                                                      CSA. The Attorney General has                         procedures prescribed by 21 U.S.C.
                                              Drug Enforcement Administration
                                                                                                      delegated scheduling authority under 21               811(a) and (b). Therefore, consistent
                                                                                                      U.S.C. 811 to the Administrator of the                with the framework of 21 U.S.C. 811(d),
                                              21 CFR Part 1308
                                                                                                      DEA. 28 CFR 0.100.                                    the DEA concludes that MT–45 has no
                                              [Docket No. DEA–451]                                                                                          currently accepted medical use in
                                                                                                      Background
                                              Schedules of Controlled Substances:                                                                           treatment in the United States and is
                                                                                                        On May 17, 2016, the Secretary-                     most appropriately placed in schedule I
                                              Placement of MT–45 Into Schedule I                      General of the United Nations advised                 of the CSA.
                                              AGENCY:  Drug Enforcement                               the Secretary of State of the United
                                              Administration, Department of Justice.                  States, by letter, that during the 59th               Conclusion
                                              ACTION: Final order.                                    session of the Commission on Narcotic
                                                                                                      Drugs, MT–45 was added to schedule I                    In order to meet the obligations of the
                                              SUMMARY:   With the issuance of this final              of the Single Convention. This letter                 United States under the Single
                                              order, the Administrator of the Drug                    was prompted by a decision at the 59th                Convention on Narcotic Drugs, 1961,
                                              Enforcement Administration places the                   session of the Commission on Narcotic                 and because MT–45 has no currently
                                              substance MT–45 (Systematic IUPAC                       Drugs in March 2016 to schedule                       accepted medical use in treatment in the
                                              Name: 1-cyclohexyl-4-(1,2-                              MT–45 under schedule I of the Single                  United States, the Administrator of the
                                              diphenylethyl)piperazine), including its                Convention. As a signatory Member                     Drug Enforcement Administration has
                                              salts, isomers, and salts of isomers into               State to the Single Convention, the                   determined that this substance should
                                              schedule I of the Controlled Substances                 United States is obligated to control                 be placed in schedule I of the Controlled
                                              Act. This scheduling action is pursuant                 MT–45 under its national drug control                 Substances Act.
                                              to the Controlled Substances Act and is                 legislation, the CSA, in the schedule                 Requirements for Handling
                                              required in order for the United States                 deemed most appropriate to carry out its
sradovich on DSK3GMQ082PROD with RULES




                                              to discharge its obligations under the                  international obligations. 21 U.S.C.                    Upon the effective date of this final
                                              Single Convention on Narcotic Drugs,                    811(d)(1).                                            order, MT–45 will become subject to the
                                              1961. This action imposes the regulatory                                                                      regulatory controls and administrative,
                                              controls and administrative, civil, and                 MT–45                                                 civil, and criminal sanctions applicable
                                              criminal sanctions applicable to                          MT–45 is an opioid analgesic drug                   to the manufacture, distribution,
                                              schedule I controlled substances on                     with pharmacological effects similar to               importation, exportation, engagement in
                                              persons who handle (manufacture,                        morphine. MT–45 was demonstrated to                   research, and conduct of instructional


                                         VerDate Sep<11>2014   16:39 Dec 12, 2017   Jkt 244001   PO 00000   Frm 00025   Fmt 4700   Sfmt 4700   E:\FR\FM\13DER1.SGM   13DER1


                                              58558        Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations

                                              activities, and possession of schedule I                  7. Reports. All DEA registrants who                 conventions, or protocols. 21 U.S.C.
                                              controlled substances including the                     manufacture or distribute MT–45 must                  811(d)(1). If control is required pursuant
                                              following:                                              submit reports pursuant to 21 U.S.C.                  to such international treaty, convention,
                                                 1. Registration. Any person who                      827 and in accordance with 21 CFR                     or protocol, the Attorney General must
                                              handles (manufactures, distributes,                     parts 1304 and 1312 as of January 12,                 issue an order controlling such drug
                                              imports, exports, engages in research or                2018.                                                 under the schedule he deems most
                                              conducts instructional activities with, or                8. Order Forms. All DEA registrants                 appropriate to carry out such
                                              possesses), or who desires to handle,                   who distribute MT–45 must comply                      obligations, without regard to the
                                              MT–45 must be registered with the DEA                   with order form requirements pursuant                 findings or procedures otherwise
                                              to conduct such activities pursuant to                  to 21 U.S.C. 828 and in accordance with               required for scheduling actions.
                                              21 U.S.C. 822, 823, 957, and 958 and in                 21 CFR part 1305 as of January 12, 2018.                 To the extent that 21 U.S.C. 811(d)(1)
                                              accordance with 21 CFR parts 1301 and                     9. Importation and Exportation. All                 directs that if control is required by the
                                              1312, as of January 12, 2018. Any                       importation and exportation of MT–45                  United States obligations under
                                              person who currently handles MT–45,                     must be in compliance with 21 U.S.C.                  international treaties, conventions, or
                                              and is not registered with the DEA, must                952, 953, 957, 958, and in accordance                 protocols in effect on October 27, 1970,
                                              submit an application for registration                  with 21 CFR part 1312 as of January 12,               scheduling actions shall be issued by
                                              and may not continue to handle MT–45                    2018.                                                 order (as compared to scheduling
                                              as of January 12, 2018, unless the DEA                    10. Quota. Only DEA registered                      pursuant to 21 U.S.C. 811(a) by rule),
                                              has approved that application for                       manufacturers may manufacture MT–45                   the DEA believes that the notice and
                                              registration pursuant to 21 U.S.C. 822,                 in accordance with a quota assigned                   comment requirements of section 553 of
                                              823, 957, 958, and in accordance with                   pursuant to 21 U.S.C. 826 and in                      the Administrative Procedure Act
                                              21 CFR parts 1301 and 1312.                             accordance with 21 CFR part 1303 as of                (APA), 5 U.S.C. 553, do not apply to this
                                                                                                      January 12, 2018.                                     scheduling action. In the alternative,
                                                 2. Disposal of stocks. Any person who                  11. Liability. Any activity involving
                                              does not desire or is not able to obtain                                                                      even if this action does constitute ‘‘rule
                                                                                                      MT–45 not authorized by, or in                        making’’ under 5 U.S.C. 551(5), this
                                              a schedule I registration to handle                     violation of the CSA, occurring as of
                                              MT–45 must surrender all quantities of                                                                        action is exempt from the notice and
                                                                                                      January 12, 2018, is unlawful, and may                comment requirements of 5 U.S.C. 553
                                              currently held MT–45, or may transfer                   subject the person to administrative,
                                              all quantities of currently held MT–45                                                                        pursuant to 21 U.S.C. 553(a)(1) as an
                                                                                                      civil, and/or criminal sanctions.                     action involving a foreign affairs
                                              to a person registered with the DEA on
                                              or before January 12, 2018 in accordance                Regulatory Analyses                                   function of the United States given that
                                              with all applicable federal, state, local,                                                                    this action is being done in accordance
                                                                                                      Executive Order 12866, Regulatory                     with 21 U.S.C. 811(d)(1)’s requirement
                                              and tribal laws. As of January 12, 2018,                Planning and Review
                                              MT–45 must be disposed of in                                                                                  that such action be taken to comply
                                              accordance with 21 CFR part 1317, in                      This action is not a significant                    with the United States obligations under
                                              addition to all other applicable federal,               regulatory action as defined by                       the specified international agreement.
                                              state, local, and tribal laws.                          Executive Order 12866 (Regulatory
                                                                                                                                                            Regulatory Flexibility Act
                                                 3. Security. MT–45 will be subject to                Planning and Review), section 3(f), and,
                                                                                                      accordingly, this action has not been                   The Regulatory Flexibility Act (RFA)
                                              schedule I security requirements and
                                                                                                      reviewed by the Office of Management                  (5 U.S.C. 601–612) applies to rules that
                                              must be handled and stored pursuant to
                                                                                                      and Budget (OMB).                                     are subject to notice and comment
                                              21 U.S.C. 821, 823, 871(b), and in
                                                                                                                                                            under section 553(b) of the APA or any
                                              accordance with 21 CFR 1301.71–                         Executive Order 13132, Federalism                     other law. As explained above, the CSA
                                              1301.93, as of January 12, 2018.
                                                                                                        This action does not have federalism                exempts this final order from notice and
                                                 4. Labeling and packaging. As of                                                                           comment. Consequently, the RFA does
                                                                                                      implications warranting the application
                                              January 12, 2018, all labels, labeling,                                                                       not apply to this action.
                                                                                                      of Executive Order 13132. The action
                                              and packaging for commercial
                                                                                                      does not have substantial direct effects
                                              containers of MT–45 must be in                                                                                Paperwork Reduction Act of 1995
                                                                                                      on the States, on the relationship
                                              compliance with 21 U.S.C. 825, 958(e),                                                                          This action does not impose a new
                                                                                                      between the national government and
                                              and be in accordance with 21 CFR part                                                                         collection of information under the
                                                                                                      the States, or the distribution of power
                                              1302.                                                                                                         Paperwork Reduction Act of 1995. 44
                                                                                                      and responsibilities among the various
                                                 5. Inventory. Every DEA registrant                   levels of government.                                 U.S.C. 3501–3521. An agency may not
                                              who possesses any quantity of MT–45                                                                           conduct or sponsor, and a person is not
                                              on the effective date of this order must                Executive Order 13175                                 required to respond to, a collection of
                                              take an inventory of all stocks of this                   This action does not have tribal                    information unless it displays a
                                              substance on hand, pursuant to 21                       implications warranting the application               currently valid OMB control number.
                                              U.S.C. 827 and 958, and in accordance                   of Executive Order 13175. The action
                                              with 21 CFR 1304.03, 1304.04, and                                                                             Congressional Review Act
                                                                                                      does not have substantial direct effects
                                              1304.11. After the initial inventory,                   on one or more Indian tribes, on the                    This action is not a major rule as
                                              every DEA registrant must take an                       relationship between the Federal                      defined by section 804 of the Small
                                              inventory of all MT–45 on hand on a                     government and Indian tribes, or on the               Business Regulatory Enforcement
                                              biennial basis, pursuant to 21 U.S.C. 827               distribution of power and                             Fairness Act of 1996 (Congressional
                                              and 958, and in accordance with 21 CFR                  responsibilities between the Federal                  Review Act (CRA)). This order will not
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                                              1304.03, 1304.04, and 1304.11.                          government and Indian tribes.                         result in: ‘‘an annual effect on the
                                                 6. Records. All DEA registrants must                                                                       economy of $100,000,000 or more; a
                                              maintain records with respect to MT–45                  Administrative Procedure Act                          major increase in costs or prices for
                                              pursuant to 21 U.S.C. 827 and 958, and                    The CSA provides for an expedited                   consumers, individual industries,
                                              in accordance with 21 CFR parts 1304,                   scheduling action where control is                    Federal, State, or local government
                                              and 1312, and 1317 as of January 12,                    required by the United States                         agencies, or geographic regions; or
                                              2018.                                                   obligations under international treaties,             significant adverse effects on


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                                                           Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations                                        58559

                                              competition, employment, investment,                    1977 (SMCRA or the Act). Oklahoma                     II. Submission of the Amendment
                                              productivity, innovation, or on the                     proposed revisions to its regulations                    By letter dated September 25, 2015
                                              ability of United States-based                          regarding: Permit eligibility for permits             (Administrative Record No. OK–1003),
                                              enterprises to compete with foreign                     with violations on lands eligible for                 Oklahoma sent us an amendment to its
                                              based enterprises in domestic and                       remining; permit suspension or                        program under SMCRA (30 U.S.C. 1201
                                              export markets.’’ However, pursuant to                  rescission posting locations and appeal               et seq.). Oklahoma submitted the
                                              the CRA, the DEA has submitted a copy                   procedures; requiring GPS coordinates                 proposed amendment on its own
                                              of this order to both Houses of Congress                for aspects of permit maps; topsoil                   initiative.
                                              and to the Comptroller General.                         removal distances; blasting records                      We announced receipt of the
                                              List of Subjects in 21 CFR Part 1308                    requirements; annual reporting                        proposed amendment in the February 8,
                                                                                                      requirements; temporary cessation of                  2016, Federal Register (81 FR 6477). In
                                                Administrative practice and                           operations requirements; casing and                   the same document, we opened the
                                              procedure, Drug traffic control,                        sealing temporary underground                         public comment period and provided an
                                              Reporting and recordkeeping                             openings; right of entry requirements;                opportunity for a public hearing or
                                              requirements.                                           surface drainage associated with auger                meeting on the adequacy of the
                                                For the reasons set out above, 21 CFR                 mining; correcting reference errors;                  amendment. We did not hold a public
                                              part 1308 is amended as follows:                        updating addresses; and correcting                    hearing or meeting because no one
                                                                                                      spelling and grammatical errors.                      requested one. The public comment
                                              PART 1308—SCHEDULES OF                                  Oklahoma intended to revise its                       period ended on March 9, 2016. We did
                                              CONTROLLED SUBSTANCES                                   program to be no less effective than the              not receive any comments.
                                                                                                      Federal regulations and to improve
                                              ■ 1. The authority citation for part 1308                                                                     III. OSMRE’s Findings
                                                                                                      operational efficiency.
                                              continues to read as follows:                                                                                    We are approving the amendment as
                                                Authority: 21 U.S.C. 811, 812, 871(b),                DATES:   The effective date is January 12,            described below. The following are the
                                              956(b), unless otherwise noted.                         2018.                                                 findings we made concerning
                                              ■ 2. Amend § 1308.11 by:                                FOR FURTHER INFORMATION CONTACT:      Bill            Oklahoma’s amendment under SMCRA
                                              ■ a. Redesignating paragraphs (b)(40)                   Joseph, Director, Tulsa Field Office,                 and the Federal regulations at 30 CFR
                                              through (57) as (b)(41) through (58);                   Office of Surface Mining Reclamation                  732.15 and 732.17. Any revisions that
                                              ■ b. Adding new paragraph (b)(40).                      and Enforcement, 1645 South 101st East                we do not specifically discuss below
                                                The addition reads as follows:                        Avenue, Suite 145, Tulsa, Oklahoma                    concerning non-substantive wording or
                                                                                                      74128–4629. Telephone: 918–581–6431                   editorial changes can be found in the
                                              § 1308.11   Schedule I.                                 ext. 230. Email: bjoseph@osmre.gov.                   full text of the program amendment
                                              *     *    *    *    *                                                                                        available at www.regulations.gov.
                                                (b) * * *                                             SUPPLEMENTARY INFORMATION:
                                                                                                                                                            1. Subchapter 15. Requirements for
                                                (40) MT–45 (1-cyclohexyl-4-(1,2-                      I. Background on the Oklahoma Program                 Permits and Permit Processing
                                              diphenylethyl)piperazine) . . . (9560)                  II. Submission of the Amendment
                                                                                                      III. OSMRE’s Findings
                                                                                                                                                               Oklahoma removed paragraphs
                                              *     *    *    *    *                                                                                        460:20–15–6.7(a)(2)(A) and (B)
                                                                                                      IV. Summary and Disposition of Comments
                                                Dated: December 5, 2017.                                                                                    regarding permit eligibility and
                                                                                                      V. OSMRE’s Decision
                                              Robert W. Patterson,                                    VI. Procedural Determinations                         unabated violations at remining sites
                                              Acting Administrator.                                                                                         issued before September 30, 2004, and
                                              [FR Doc. 2017–26853 Filed 12–12–17; 8:45 am]            I. Background on the Oklahoma                         added language to paragraph (a)(2) to
                                              BILLING CODE 4410–09–P
                                                                                                      Program                                               substantively match the Federal
                                                                                                                                                            requirements of 30 CFR 773.13(a)(2).
                                                                                                        Section 503(a) of the Act permits a                    Oklahoma modified section 460:20–
                                                                                                      State to assume primacy for the                       15–10.1(c) regarding the suspension and
                                              DEPARTMENT OF THE INTERIOR                              regulation of surface coal mining and                 rescission appeal process so that it
                                                                                                      reclamation operations on non-Federal                 substantively matches the counterpart
                                              Office of Surface Mining Reclamation                    and non-Indian lands within its borders
                                              and Enforcement                                                                                               Federal regulations at 30 CFR 773.23(c).
                                                                                                      by demonstrating that its program                     Additionally, Oklahoma modified
                                                                                                      includes, among other things, State laws              460:20–15–10.1(d) and added paragraph
                                              30 CFR Part 936                                         and regulations that govern surface coal              (e) to substantively match the
                                              [SATS No. OK–037–FOR; Docket ID: OSM–                   mining and reclamation operations in                  requirements of 30 CFR 773.23 (d).
                                              2015–0006; S1D1S SS08011000 SX064A000                   accordance with the Act and consistent                   We find that Oklahoma’s changes to
                                              189S180110; S2D2S SS08011000                            with the Federal regulations. See 30                  this subchapter substantively match the
                                              SX064A000 18XS501520]                                   U.S.C. 1253(a)(1) and (7). On the basis               counterpart Federal requirements and
                                                                                                      of these criteria, the Secretary of the               do not make its rules or regulations less
                                              Oklahoma Regulatory Program
                                                                                                      Interior conditionally approved the                   effective than the Federal requirements.
                                              AGENCY:  Office of Surface Mining                       Oklahoma program on January 19, 1981.                 Therefore, we are approving Oklahoma’s
                                              Reclamation and Enforcement, Interior.                  You can find background information                   revisions.
                                              ACTION: Final rule; approval of                         on the Oklahoma program, including
                                                                                                      the Secretary’s findings, the disposition             2. Subchapter 29. Underground Mining
                                              amendment.
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                                                                                                      of comments, and the conditions of                    Permit Applications: Minimum
                                              SUMMARY:  We, the Office of Surface                     approval of the Oklahoma program in                   Requirements for Information on
                                              Mining Reclamation and Enforcement                      the January 19, 1981, Federal Register                Environmental Resources
                                              (OSMRE), are approving an amendment                     (46 FR 4902). You can also find later                    Oklahoma added the requirement for
                                              to the Oklahoma regulatory program                      actions concerning the Oklahoma                       GPS coordinates for each building on
                                              (Oklahoma program) under the Surface                    program and program amendments at 30                  permit application maps in section
                                              Mining Control and Reclamation Act of                   CFR 936.10, 936.15, and 936.16.                       460:20–29–10(4). Although there is no


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Document Created: 2017-12-13 01:23:55
Document Modified: 2017-12-13 01:23:55
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.
DatesEffective January 12, 2018.
ContactMichael J. Lewis, Diversion Control
FR Citation82 FR 58557 
CFR AssociatedAdministrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements

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