Schedules of Controlled Substances: Placement of MT-45 Into Schedule I, 58557-58559 [2017-26853]

Download as PDF 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, sradovich on DSK3GMQ082PROD with RULES SUMMARY: VerDate Sep<11>2014 16:39 Dec 12, 2017 Jkt 244001 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 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 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 E:\FR\FM\13DER1.SGM 13DER1 sradovich on DSK3GMQ082PROD with RULES 58558 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. VerDate Sep<11>2014 15:49 Dec 12, 2017 Jkt 244001 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, PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 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 E:\FR\FM\13DER1.SGM 13DER1 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. sradovich on DSK3GMQ082PROD with RULES 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: VerDate Sep<11>2014 15:49 Dec 12, 2017 Jkt 244001 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. PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 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 E:\FR\FM\13DER1.SGM 13DER1

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.

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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