Schedules of Controlled Substances: Placement of MT-45 Into Schedule I, 58557-58559 [2017-26853]
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Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations
treated as often as necessary to prevent
growth of fungi. Do not use formalin
which has been subjected to
temperatures below 40 °F, or allowed to
freeze. Treatments in tanks and
raceways should never exceed 1 hour
for fish or 4 hours for penaeid shrimp
(even if they show no sign of distress),
nor should it exceed 15 minutes for fish
eggs. Do not apply formalin to ponds
with water warmer than 27 °C (80 °F),
when a heavy bloom of phytoplankton
is present, or when the concentration of
dissolved oxygen is less than 5
milligrams per liter.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
13. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
§ 558.58
[Amended]
14. In § 558.58, remove paragraphs
(f)(4) and (5).
■
§ 558.366
[Amended]
15. In § 558.366, remove paragraph
(e).
■
Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26753 Filed 12–12–17; 8:45 am]
BILLING CODE 4164–01–P
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
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
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-(1,2diphenylethyl)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,
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SUMMARY:
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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 SecretaryGeneral 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
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58557
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
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Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations
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.
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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,
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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
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Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations
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
1. The authority citation for part 1308
continues to read as follows:
■
DATES:
Authority: 21 U.S.C. 811, 812, 871(b),
956(b), unless otherwise noted.
Bill
Joseph, Director, Tulsa Field Office,
Office of Surface Mining Reclamation
and Enforcement, 1645 South 101st East
Avenue, Suite 145, Tulsa, Oklahoma
74128–4629. Telephone: 918–581–6431
ext. 230. Email: bjoseph@osmre.gov.
FOR FURTHER INFORMATION CONTACT:
2. Amend § 1308.11 by:
a. Redesignating paragraphs (b)(40)
through (57) as (b)(41) through (58);
■ b. Adding new paragraph (b)(40).
The addition reads as follows:
Schedule I.
*
*
*
*
*
(b) * * *
(40) MT–45 (1-cyclohexyl-4-(1,2diphenylethyl)piperazine) . . . (9560)
*
*
*
*
*
SUPPLEMENTARY INFORMATION:
I. Background on the Oklahoma Program
II. Submission of the Amendment
III. OSMRE’s Findings
IV. Summary and Disposition of Comments
V. OSMRE’s Decision
VI. Procedural Determinations
Dated: December 5, 2017.
Robert W. Patterson,
Acting Administrator.
I. Background on the Oklahoma
Program
[FR Doc. 2017–26853 Filed 12–12–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
30 CFR Part 936
[SATS No. OK–037–FOR; Docket ID: OSM–
2015–0006; S1D1S SS08011000 SX064A000
189S180110; S2D2S SS08011000
SX064A000 18XS501520]
Oklahoma Regulatory Program
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Final rule; approval of
amendment.
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AGENCY:
We, the Office of Surface
Mining Reclamation and Enforcement
(OSMRE), are approving an amendment
to the Oklahoma regulatory program
(Oklahoma program) under the Surface
Mining Control and Reclamation Act of
SUMMARY:
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The effective date is January 12,
2018.
■
■
§ 1308.11
1977 (SMCRA or the Act). Oklahoma
proposed revisions to its regulations
regarding: Permit eligibility for permits
with violations on lands eligible for
remining; permit suspension or
rescission posting locations and appeal
procedures; requiring GPS coordinates
for aspects of permit maps; topsoil
removal distances; blasting records
requirements; annual reporting
requirements; temporary cessation of
operations requirements; casing and
sealing temporary underground
openings; right of entry requirements;
surface drainage associated with auger
mining; correcting reference errors;
updating addresses; and correcting
spelling and grammatical errors.
Oklahoma intended to revise its
program to be no less effective than the
Federal regulations and to improve
operational efficiency.
Section 503(a) of the Act permits a
State to assume primacy for the
regulation of surface coal mining and
reclamation operations on non-Federal
and non-Indian lands within its borders
by demonstrating that its program
includes, among other things, State laws
and regulations that govern surface coal
mining and reclamation operations in
accordance with the Act and consistent
with the Federal regulations. See 30
U.S.C. 1253(a)(1) and (7). On the basis
of these criteria, the Secretary of the
Interior conditionally approved the
Oklahoma program on January 19, 1981.
You can find background information
on the Oklahoma program, including
the Secretary’s findings, the disposition
of comments, and the conditions of
approval of the Oklahoma program in
the January 19, 1981, Federal Register
(46 FR 4902). You can also find later
actions concerning the Oklahoma
program and program amendments at 30
CFR 936.10, 936.15, and 936.16.
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58559
II. Submission of the Amendment
By letter dated September 25, 2015
(Administrative Record No. OK–1003),
Oklahoma sent us an amendment to its
program under SMCRA (30 U.S.C. 1201
et seq.). Oklahoma submitted the
proposed amendment on its own
initiative.
We announced receipt of the
proposed amendment in the February 8,
2016, Federal Register (81 FR 6477). In
the same document, we opened the
public comment period and provided an
opportunity for a public hearing or
meeting on the adequacy of the
amendment. We did not hold a public
hearing or meeting because no one
requested one. The public comment
period ended on March 9, 2016. We did
not receive any comments.
III. OSMRE’s Findings
We are approving the amendment as
described below. The following are the
findings we made concerning
Oklahoma’s amendment under SMCRA
and the Federal regulations at 30 CFR
732.15 and 732.17. Any revisions that
we do not specifically discuss below
concerning non-substantive wording or
editorial changes can be found in the
full text of the program amendment
available at www.regulations.gov.
1. Subchapter 15. Requirements for
Permits and Permit Processing
Oklahoma removed paragraphs
460:20–15–6.7(a)(2)(A) and (B)
regarding permit eligibility and
unabated violations at remining sites
issued before September 30, 2004, and
added language to paragraph (a)(2) to
substantively match the Federal
requirements of 30 CFR 773.13(a)(2).
Oklahoma modified section 460:20–
15–10.1(c) regarding the suspension and
rescission appeal process so that it
substantively matches the counterpart
Federal regulations at 30 CFR 773.23(c).
Additionally, Oklahoma modified
460:20–15–10.1(d) and added paragraph
(e) to substantively match the
requirements of 30 CFR 773.23 (d).
We find that Oklahoma’s changes to
this subchapter substantively match the
counterpart Federal requirements and
do not make its rules or regulations less
effective than the Federal requirements.
Therefore, we are approving Oklahoma’s
revisions.
2. Subchapter 29. Underground Mining
Permit Applications: Minimum
Requirements for Information on
Environmental Resources
Oklahoma added the requirement for
GPS coordinates for each building on
permit application maps in section
460:20–29–10(4). Although there is no
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]]>Agencies
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Rules and Regulations]
[Pages 58557-58559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
