[Federal Register Volume 81, Number 72 (Thursday, April 14, 2016)]
[Rules and Regulations]
[Pages 22023-22025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08566]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register / Vol. 81, No. 72 / Thursday, April 14, 2016 / Rules 
and Regulations  

[[Page 22023]]



DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-432]


Schedules of Controlled Substances: Placement of AH-7921 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 AH-7921 
(Systematic IUPAC Name: 3,4-dichloro-N-
[(1dimethylamino)cyclohexylmethyl]benzamide), including its isomers, 
esters, ethers, salts, and salts of isomers, esters and ethers, 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, AH-7921.

DATES: Effective May 16, 2016.

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

SUPPLEMENTARY INFORMATION: 

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. Titles II and III are referred to as 
the ``Controlled Substances Act'' and the ``Controlled Substances 
Import and Export Act,'' respectively, and are collectively referred to 
as the ``Controlled Substances Act'' or the ``CSA'' for the purpose of 
this action. 21 U.S.C. 801-971. The DEA publishes the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), chapter II. The CSA and its implementing regulations 
are designed to prevent, detect, and eliminate the diversion of 
controlled substances and listed chemicals into the illicit market 
while providing for the legitimate medical, scientific, research, and 
industrial needs of the United States. Controlled substances have the 
potential for abuse and dependence and are controlled to protect the 
public health and safety.
    Under the CSA, controlled substances are classified into one of 
five schedules based upon their potential for abuse, their currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the substance may cause. 21 U.S.C. 812. The initial 
schedules of controlled substances established by Congress are found at 
21 U.S.C. 812(c), and the current list of scheduled substances is 
published at 21 CFR part 1308.
    Section 201(d)(1) of the 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 and procedures required by 
section 201(a) and (b) (21 U.S.C. 811(a) and (b)) and section 202(b) 
(21 U.S.C. 812(b)) of the Act.'' 21 U.S.C. 811(d)(1), 21 CFR 1308.46. 
If a substance is added to one of the schedules of the Single 
Convention on Narcotic Drugs, 1961, then, in accordance with article 3, 
paragraph 7 of the Convention, as a signatory Member State, the United 
States is obligated to control that 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 8, 2015, the Secretary-General of the United Nations advised 
the Secretary of State of the United States, that during the 58th 
session of the Commission on Narcotic Drugs, AH-7921 was added to 
schedule I of the Single Convention on Narcotic Drugs, 1961. This 
letter was prompted by a decision at the 58th session of the Commission 
on Narcotic Drugs in March 2015 to schedule AH-7921 under schedule I of 
the Single Convention on Narcotic Drugs. As a signatory Member State to 
the Single Convention on Narcotic Drugs, the United States is obligated 
to control AH-7921 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).

AH-7921

    AH-7921 is an N-substituted cyclohexylmethyl benzamide developed in 
1962 by Allen and Hanbury's, Ltd., a pharmaceutical company in the 
United Kingdom. AH-7921 is a [micro]-opioid receptor agonist with 
analgesic activity similar to that of morphine. The DEA is not aware of 
any commercial or medical uses for this substance. In animals, 
withdrawal symptoms are observed following repeated administration of 
AH-7921. Currently, clinical studies evaluating the safety and 
pharmacological effects of AH-7921 in humans have not been reported in 
the scientific literature. Usage of AH-7921 for eliciting euphoria and 
relaxation has been documented. There have been several reports of 
overdoses and deaths from AH-7921 reported worldwide including at least 
one published case report of a death resulting from AH-7921 in the 
United States. Given the increasing abuse of opioid prescription drugs 
(e.g., oxycodone, hydrocodone and fentanyl) and increased use of heroin 
in the United States, there are legitimate concerns about an increased 
potential of abuse of AH-7921.
    DEA is not aware of any claims or any medical or scientific 
literature suggesting that AH-7921 has a currently accepted medical use 
in treatment in the United States. Accordingly, DEA has not requested 
that HHS conduct a scientific and medical evaluation of the substance's 
medical utility.

[[Page 22024]]

Furthermore, 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), DEA 
concludes that AH-7921 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 Single Convention on 
Narcotic Drugs, 1961 and because AH-7921 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, AH-7921 is subject to 
the CSA's schedule I regulatory controls and administrative, civil, and 
criminal sanctions applicable to the manufacture, distribution, 
importation, exportation, engagement in research, and conduct of 
instructional activities with, 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, AH-7921 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 May 16, 2016. Any person who currently handles AH-7921, 
and is not registered with the DEA, must submit an application for 
registration and may not continue to handle AH-7921 as of May 16, 2016, 
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 must surrender all quantities 
of currently held AH-7921, or may transfer all quantities of currently 
held AH-7921 to a person registered with the DEA on or before May 16, 
2016 in accordance with all applicable federal, state, local, and 
tribal laws. As of May 16, 2016, controlled substances must be disposed 
of in accordance with 21 CFR part 1317, in additional to all other 
applicable federal, state, local, and tribal laws.
    3. Security. AH-7921 is 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 May 16, 2016.
    4. Labeling and packaging. All labels, labeling, and packaging for 
commercial containers of AH-7921 must be in compliance with 21 U.S.C. 
825, 958(e), and be in accordance with 21 CFR part 1302 as of May 16, 
2016.
    5. Quota. A quota assigned pursuant to 21 U.S.C. 826 and in 
accordance with 21 CFR part 1303 is required in order to manufacture 
AH-7921 as of May 16, 2016.
    6. Inventory. Every DEA registrant who possesses any quantity of 
AH-7921 on the effective date of this order must take an inventory of 
all stocks of this substance on hand as of May 16, 2016, pursuant to 21 
U.S.C. 827 and 958, and in accordance with Sec. Sec.  1304.03, 1304.04, 
and 1304.11.
    Any person who becomes registered with the DEA after May 16, 2016 
must take an initial inventory of all stocks of controlled substances 
(including AH-7921) on hand on the date the registrant first engages in 
the handling of controlled substances, 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 controlled substances (including AH-7921) on hand on a 
biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance 
with Sec. Sec.  1304.03, 1304.04, and 1304.11.
    7. Records and Reports. Every DEA registrant would be required to 
maintain records and submit reports with respect to AH-7921 pursuant to 
21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304 and 
1312.
    8. Order Forms. All DEA registrants who distribute AH-7921 must 
comply with order form requirements pursuant to 21 U.S.C. 828 and in 
accordance with 21 CFR part 1305 as of May 16, 2016.
    9. Importation and Exportation. All importation and exportation of 
AH-7921 must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in 
accordance with 21 CFR part 1312 as of May 16, 2016.
    10. Liability. Any activity involving AH-7921 not authorized by, or 
in violation of the CSA, occurring as of May 16, 2016, is unlawful, and 
may subject the person to administrative, civil, and/or criminal 
sanctions.

Regulatory Analyses

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. Id.
    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 agreements.

Executive Order 12866

    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

    This action does not have federalism implications warranting the 
application of Executive Order 13132. This action will not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government. Therefore, 
in accordance with Executive Order 13132 (Federalism) it is determined 
that this action does not have sufficient federalism implications to 
warrant the preparation of a Federalism Assessment.

[[Page 22025]]

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.

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 
requirement 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). However, the DEA has submitted a copy of 
this final 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, 
Narcotics, Prescription drugs.

    For the reasons set out above, the DEA amends 21 CFR part 1308 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), unless otherwise noted.


0
2. Amend Sec.  1308.11 by redesignating paragraphs (b)(3) through (55) 
as (b)(4) through (56) and adding a new (b)(3)to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (b) * * *

 
 
 
(3) AH-7921 (3,4-dichloro-N-[(1-dimethylamino)                      9551
 cyclohexylmethyl]benzamide....................................
 

* * * * *

    Dated: April 8, 2016
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-08566 Filed 4-13-16; 8:45 am]
 BILLING CODE 4410-09-P