81_FR_22095 81 FR 22023 - Schedules of Controlled Substances: Placement of AH-7921 Into Schedule I

81 FR 22023 - Schedules of Controlled Substances: Placement of AH-7921 Into Schedule I

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 72 (April 14, 2016)

Page Range22023-22025
FR Document2016-08566

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.

Federal Register, Volume 81 Issue 72 (Thursday, April 14, 2016)
[Federal Register Volume 81, Number 72 (Thursday, April 14, 2016)]
[Rules and Regulations]
[Pages 22023-22025]
From the Federal Register Online  [www.thefederalregister.org]
[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 
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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



                                                                                                                                                                                                  22023

                                                  Rules and Regulations                                                                                         Federal Register
                                                                                                                                                                Vol. 81, No. 72

                                                                                                                                                                Thursday, April 14, 2016



                                                  This section of the FEDERAL REGISTER                    Comprehensive Drug Abuse Prevention                   811 to the Administrator of the DEA. 28
                                                  contains regulatory documents having general            and Control Act of 1970, as amended.                  CFR 0.100.
                                                  applicability and legal effect, most of which           Titles II and III are referred to as the
                                                  are keyed to and codified in the Code of                                                                      Background
                                                                                                          ‘‘Controlled Substances Act’’ and the
                                                  Federal Regulations, which is published under                                                                   On May 8, 2015, the Secretary-
                                                                                                          ‘‘Controlled Substances Import and
                                                  50 titles pursuant to 44 U.S.C. 1510.                                                                         General of the United Nations advised
                                                                                                          Export Act,’’ respectively, and are
                                                  The Code of Federal Regulations is sold by              collectively referred to as the                       the Secretary of State of the United
                                                  the Superintendent of Documents. Prices of              ‘‘Controlled Substances Act’’ or the                  States, that during the 58th session of
                                                  new books are listed in the first FEDERAL               ‘‘CSA’’ for the purpose of this action. 21            the Commission on Narcotic Drugs, AH-
                                                  REGISTER issue of each week.                            U.S.C. 801–971. The DEA publishes the                 7921 was added to schedule I of the
                                                                                                          implementing regulations for these                    Single Convention on Narcotic Drugs,
                                                                                                          statutes in title 21 of the Code of Federal           1961. This letter was prompted by a
                                                  DEPARTMENT OF JUSTICE                                   Regulations (CFR), chapter II. The CSA                decision at the 58th session of the
                                                                                                          and its implementing regulations are                  Commission on Narcotic Drugs in
                                                  Drug Enforcement Administration                                                                               March 2015 to schedule AH-7921 under
                                                                                                          designed to prevent, detect, and
                                                                                                                                                                schedule I of the Single Convention on
                                                                                                          eliminate the diversion of controlled
                                                  21 CFR Part 1308                                                                                              Narcotic Drugs. As a signatory Member
                                                                                                          substances and listed chemicals into the
                                                                                                                                                                State to the Single Convention on
                                                  [Docket No. DEA–432]                                    illicit market while providing for the
                                                                                                                                                                Narcotic Drugs, the United States is
                                                                                                          legitimate medical, scientific, research,
                                                  Schedules of Controlled Substances:                                                                           obligated to control AH-7921 under its
                                                                                                          and industrial needs of the United                    national drug control legislation, the
                                                  Placement of AH-7921 Into Schedule I                    States. Controlled substances have the                CSA, in the schedule deemed most
                                                  AGENCY:  Drug Enforcement                               potential for abuse and dependence and                appropriate to carry out its international
                                                  Administration, Department of Justice.                  are controlled to protect the public                  obligations. 21 U.S.C. 811(d)(1).
                                                                                                          health and safety.
                                                  ACTION: Final order.                                                                                          AH-7921
                                                                                                             Under the CSA, controlled substances
                                                  SUMMARY:   With the issuance of this final              are classified into one of five schedules                AH-7921 is an N-substituted
                                                  order, the Administrator of the Drug                    based upon their potential for abuse,                 cyclohexylmethyl benzamide developed
                                                  Enforcement Administration places the                   their currently accepted medical use in               in 1962 by Allen and Hanbury’s, Ltd., a
                                                  substance AH-7921 (Systematic IUPAC                     treatment in the United States, and the               pharmaceutical company in the United
                                                  Name: 3,4-dichloro-N-[(1dimethy                         degree of dependence the substance                    Kingdom. AH-7921 is a m-opioid
                                                  lamino)cyclohexylmethyl]benzamide),                     may cause. 21 U.S.C. 812. The initial                 receptor agonist with analgesic activity
                                                  including its isomers, esters, ethers,                  schedules of controlled substances                    similar to that of morphine. The DEA is
                                                  salts, and salts of isomers, esters and                 established by Congress are found at 21               not aware of any commercial or medical
                                                  ethers, into schedule I of the Controlled               U.S.C. 812(c), and the current list of                uses for this substance. In animals,
                                                  Substances Act. This scheduling action                  scheduled substances is published at 21               withdrawal symptoms are observed
                                                  is pursuant to the Controlled Substances                CFR part 1308.                                        following repeated administration of
                                                  Act and is required in order for the                                                                          AH-7921. Currently, clinical studies
                                                                                                             Section 201(d)(1) of the CSA (21                   evaluating the safety and
                                                  United States to discharge its
                                                                                                          U.S.C. 811(d)(1)) states that, if control of          pharmacological effects of AH-7921 in
                                                  obligations under the Single Convention
                                                                                                          a substance is required ‘‘by United                   humans have not been reported in the
                                                  on Narcotic Drugs, 1961. This action
                                                                                                          States obligations under international                scientific literature. Usage of AH-7921
                                                  imposes the regulatory controls and
                                                                                                          treaties, conventions, or protocols in                for eliciting euphoria and relaxation has
                                                  administrative, civil, and criminal
                                                                                                          effect on October 27, 1970, the Attorney              been documented. There have been
                                                  sanctions applicable to schedule I
                                                                                                          General shall issue an order controlling              several reports of overdoses and deaths
                                                  controlled substances on persons who
                                                                                                          such drug under the schedule he deems                 from AH-7921 reported worldwide
                                                  handle (manufacture, distribute, import,
                                                                                                          most appropriate to carry out such                    including at least one published case
                                                  export, engage in research or conduct
                                                                                                          obligations, without regard to the                    report of a death resulting from AH-
                                                  instructional activities with, or possess),
                                                                                                          findings and procedures required by                   7921 in the United States. Given the
                                                  or propose to handle, AH-7921.
                                                                                                          section 201(a) and (b) (21 U.S.C. 811(a)              increasing abuse of opioid prescription
                                                  DATES: Effective May 16, 2016.                          and (b)) and section 202(b) (21 U.S.C.                drugs (e.g., oxycodone, hydrocodone
                                                  FOR FURTHER INFORMATION CONTACT:                        812(b)) of the Act.’’ 21 U.S.C. 811(d)(1),            and fentanyl) and increased use of
                                                  Barbara J. Boockholdt, Office of                        21 CFR 1308.46. If a substance is added               heroin in the United States, there are
                                                  Diversion Control, Drug Enforcement                     to one of the schedules of the Single                 legitimate concerns about an increased
                                                  Administration; Mailing Address: 8701                   Convention on Narcotic Drugs, 1961,                   potential of abuse of AH-7921.
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  Morrissette Drive, Springfield, Virginia                then, in accordance with article 3,                      DEA is not aware of any claims or any
                                                  22152; Telephone: (202) 598–6812.                       paragraph 7 of the Convention, as a                   medical or scientific literature
                                                  SUPPLEMENTARY INFORMATION:                              signatory Member State, the United                    suggesting that AH-7921 has a currently
                                                                                                          States is obligated to control that                   accepted medical use in treatment in the
                                                  Legal Authority                                         substance under its national drug                     United States. Accordingly, DEA has not
                                                    The Drug Enforcement                                  control legislation, the CSA. The                     requested that HHS conduct a scientific
                                                  Administration (DEA) implements and                     Attorney General has delegated                        and medical evaluation of the
                                                  enforces titles II and III of the                       scheduling authority under 21 U.S.C.                  substance’s medical utility.


                                             VerDate Sep<11>2014   17:42 Apr 13, 2016   Jkt 238001   PO 00000   Frm 00001   Fmt 4700   Sfmt 4700   E:\FR\FM\14APR1.SGM   14APR1


                                                  22024              Federal Register / Vol. 81, No. 72 / Thursday, April 14, 2016 / Rules and Regulations

                                                  Furthermore, DEA is not required under                     3. Security. AH-7921 is subject to                 Regulatory Analyses
                                                  21 U.S.C. 811(d)(1) to make any findings                schedule I security requirements and
                                                  required by 21 U.S.C. 811(a) or 812(b),                 must be handled and stored pursuant to                Administrative Procedure Act
                                                  and is not required to follow the                       21 U.S.C. 821, 823, 871(b), and in                       The CSA provides for an expedited
                                                  procedures prescribed by 21 U.S.C.                      accordance with 21 CFR 1301.71–                       scheduling action where control is
                                                  811(a) and (b). Therefore, consistent                   1301.93, as of May 16, 2016.                          required by the United States
                                                  with the framework of 21 U.S.C. 811(d),                    4. Labeling and packaging. All labels,             obligations under international treaties,
                                                  DEA concludes that AH-7921 has no                       labeling, and packaging for commercial                conventions, or protocols. 21 U.S.C.
                                                  currently accepted medical use in                       containers of AH-7921 must be in                      811(d)(1). If control is required pursuant
                                                  treatment in the United States and is                   compliance with 21 U.S.C. 825, 958(e),                to such international treaty, convention,
                                                  most appropriately placed in schedule I                 and be in accordance with 21 CFR part                 or protocol, the Attorney General must
                                                  of the CSA.                                             1302 as of May 16, 2016.                              issue an order controlling such drug
                                                  Conclusion                                                 5. Quota. A quota assigned pursuant                under the schedule he deems most
                                                                                                                                                                appropriate to carry out such
                                                     In order to meet the obligations of the              to 21 U.S.C. 826 and in accordance with
                                                                                                                                                                obligations, without regard to the
                                                  Single Convention on Narcotic Drugs,                    21 CFR part 1303 is required in order to
                                                                                                                                                                findings or procedures otherwise
                                                  1961 and because AH-7921 has no                         manufacture AH-7921 as of May 16,
                                                                                                                                                                required for scheduling actions. Id.
                                                  currently accepted medical use in                       2016.
                                                  treatment in the United States, the                                                                              To the extent that 21 U.S.C. 811(d)(1)
                                                                                                             6. Inventory. Every DEA registrant
                                                  Administrator of the Drug Enforcement                                                                         directs that if control is required by the
                                                                                                          who possesses any quantity of AH-7921
                                                  Administration has determined that this                                                                       United States obligations under
                                                                                                          on the effective date of this order must
                                                  substance should be placed in schedule                                                                        international treaties, conventions, or
                                                                                                          take an inventory of all stocks of this
                                                  I of the Controlled Substances Act.                                                                           protocols in effect on October 27, 1970,
                                                                                                          substance on hand as of May 16, 2016,
                                                                                                                                                                scheduling actions shall be issued by
                                                  Requirements for Handling                               pursuant to 21 U.S.C. 827 and 958, and
                                                                                                                                                                order (as compared to scheduling
                                                                                                          in accordance with §§ 1304.03, 1304.04,
                                                     Upon the effective date of this final                                                                      pursuant to 21 U.S.C. 811(a) by rule),
                                                                                                          and 1304.11.                                          the DEA believes that the notice and
                                                  order, AH-7921 is subject to the CSA’s
                                                                                                             Any person who becomes registered                  comment requirements of section 553 of
                                                  schedule I regulatory controls and
                                                                                                          with the DEA after May 16, 2016 must                  the Administrative Procedure Act
                                                  administrative, civil, and criminal
                                                                                                          take an initial inventory of all stocks of            (APA), 5 U.S.C. 553, do not apply to this
                                                  sanctions applicable to the manufacture,
                                                                                                          controlled substances (including AH-                  scheduling action. In the alternative,
                                                  distribution, importation, exportation,
                                                                                                          7921) on hand on the date the registrant              even if this action does constitute ‘‘rule
                                                  engagement in research, and conduct of
                                                                                                          first engages in the handling of                      making’’ under 5 U.S.C. 551(5), this
                                                  instructional activities with, and
                                                                                                          controlled substances, pursuant to 21                 action is exempt from the notice and
                                                  possession of schedule I controlled
                                                  substances including the following:                     U.S.C. 827 and 958 and in accordance                  comment requirements of 5 U.S.C. 553
                                                                                                          with 21 CFR 1304.03, 1304.04, and                     pursuant to 21 U.S.C. 553(a)(1) as an
                                                     1. Registration. Any person who
                                                                                                          1304.11.                                              action involving a foreign affairs
                                                  handles (manufactures, distributes,
                                                                                                             After the initial inventory, every DEA             function of the United States given that
                                                  imports, exports, engages in research or
                                                                                                          registrant must take an inventory of all              this action is being done in accordance
                                                  conducts instructional activities with, or
                                                                                                          controlled substances (including AH-                  with 21 U.S.C. 811(d)(1)’s requirement
                                                  possesses), or who desires to handle,
                                                                                                          7921) on hand on a biennial basis,                    that such action be taken to comply
                                                  AH-7921 must be registered with the
                                                                                                          pursuant to 21 U.S.C. 827 and 958, and                with the United States obligations under
                                                  DEA to conduct such activities pursuant
                                                                                                          in accordance with §§ 1304.03, 1304.04,               the specified international agreements.
                                                  to 21 U.S.C. 822, 823, 957, and 958 and
                                                  in accordance with 21 CFR parts 1301                    and 1304.11.                                          Executive Order 12866
                                                  and 1312, as of May 16, 2016. Any                          7. Records and Reports. Every DEA
                                                  person who currently handles AH-7921,                   registrant would be required to maintain                This action is not a significant
                                                  and is not registered with the DEA, must                records and submit reports with respect               regulatory action as defined by
                                                  submit an application for registration                  to AH-7921 pursuant to 21 U.S.C. 827                  Executive Order 12866 (Regulatory
                                                  and may not continue to handle AH-                      and 958, and in accordance with 21 CFR                Planning and Review), section 3(f), and,
                                                  7921 as of May 16, 2016, unless the DEA                 parts 1304 and 1312.                                  accordingly, this action has not been
                                                  has approved that application for                                                                             reviewed by the Office of Management
                                                                                                             8. Order Forms. All DEA registrants                and Budget (OMB).
                                                  registration pursuant to 21 U.S.C. 822,
                                                                                                          who distribute AH-7921 must comply
                                                  823, 957, 958, and in accordance with                                                                         Executive Order 13132
                                                                                                          with order form requirements pursuant
                                                  21 CFR parts 1301 and 1312.
                                                                                                          to 21 U.S.C. 828 and in accordance with
                                                     2. Disposal of stocks. Any person who                21 CFR part 1305 as of May 16, 2016.                    This action does not have federalism
                                                  does not desire or is not able to obtain                                                                      implications warranting the application
                                                  a schedule I registration must surrender                   9. Importation and Exportation. All                of Executive Order 13132. This action
                                                  all quantities of currently held AH-7921,               importation and exportation of AH-7921                will not have substantial direct effects
                                                  or may transfer all quantities of                       must be in compliance with 21 U.S.C.                  on the States, on the relationship
                                                  currently held AH-7921 to a person                      952, 953, 957, 958, and in accordance                 between the national government and
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  registered with the DEA on or before                    with 21 CFR part 1312 as of May 16,                   the States, or on the distribution of
                                                  May 16, 2016 in accordance with all                     2016.                                                 power and responsibilities among the
                                                  applicable federal, state, local, and tribal               10. Liability. Any activity involving              various levels of government. Therefore,
                                                  laws. As of May 16, 2016, controlled                    AH-7921 not authorized by, or in                      in accordance with Executive Order
                                                  substances must be disposed of in                       violation of the CSA, occurring as of                 13132 (Federalism) it is determined that
                                                  accordance with 21 CFR part 1317, in                    May 16, 2016, is unlawful, and may                    this action does not have sufficient
                                                  additional to all other applicable                      subject the person to administrative,                 federalism implications to warrant the
                                                  federal, state, local, and tribal laws.                 civil, and/or criminal sanctions.                     preparation of a Federalism Assessment.


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                                                                     Federal Register / Vol. 81, No. 72 / Thursday, April 14, 2016 / Rules and Regulations                                               22025

                                                  Executive Order 13175                                     *      *     *       *      *                        Need for Correction
                                                    This action does not have tribal                          Dated: April 8, 2016                                  As published, the final preamble
                                                  implications warranting the application                   Chuck Rosenberg,                                     contains an error in a table identifying
                                                  of Executive Order 13175. The action                      Acting Administrator.                                areas subject to the findings of failure to
                                                  does not have substantial direct effects                  [FR Doc. 2016–08566 Filed 4–13–16; 8:45 am]          submit related to the Indiana,
                                                  on one or more Indian tribes, on the                      BILLING CODE 4410–09–P
                                                                                                                                                                 Pennsylvania nonattainment area. The
                                                  relationship between the Federal                                                                               Indiana, Pennsylvania nonattainment
                                                  government and Indian tribes, or on the                                                                        area consists of the entirety of Indiana
                                                  distribution of power and                                                                                      County and part of Armstrong County.
                                                  responsibilities between the Federal                      ENVIRONMENTAL PROTECTION                             See 78 FR 47191, August 5, 2013
                                                  government and Indian tribes.                             AGENCY                                               codified at 40 CFR part 81, subpart C.
                                                  Regulatory Flexibility Act                                                                                     The preamble table mistakenly lists
                                                                                                            40 CFR Part 52                                       Indiana County as a ‘‘partial’’ county
                                                    The Regulatory Flexibility Act (RFA)                                                                         that is part of the Indiana, Pennsylvania
                                                  (5 U.S.C. 601–612) applies to rules that                  [EPA–HQ–OAR–2016–0098; FRL–9944–88–                  nonattainment area subject to a finding
                                                  are subject to notice and comment                         OAR]                                                 of failure to submit, when the full
                                                  under section 553(b) of the APA or any                                                                         county should have been listed as
                                                  other law. As explained above, the CSA                    Findings of Failure To Submit State                  subject to the finding. Additional notice
                                                  exempts this final order from notice and                  Implementation Plans Required for                    and comment for this minor technical
                                                  comment. Consequently, the RFA does                       Attainment of the 2010 1-Hour Primary                correction is unnecessary under 5 U.S.C.
                                                  not apply to this action.                                 Sulfur Dioxide National Ambient Air                  553(b)(3)(B), and the EPA finds that
                                                  Paperwork Reduction Act of 1995                           Quality Standard (NAAQS); Correction                 good cause exists for this minor
                                                                                                            AGENCY:  Environmental Protection                    technical correction to become effective
                                                    This action does not impose a new
                                                                                                            Agency (EPA).                                        at the same time as the final rule.
                                                  collection of information requirement
                                                                                                                                                                 Accordingly, this correction is
                                                  under the Paperwork Reduction Act of                      ACTION: Final rule; correction.
                                                                                                                                                                 incorporated into the final rule and also
                                                  1995. 44 U.S.C. 3501–3521. An agency
                                                                                                            SUMMARY:    The Environmental Protection             becomes effective on April 18, 2016.
                                                  may not conduct or sponsor, and a
                                                  person is not required to respond to, a                   Agency (EPA) is correcting a final rule              Correction of Publication
                                                  collection of information unless it                       that appeared in the Federal Register on
                                                                                                            March 18, 2016 (81 FR 14736). The                       In FR Doc 2016–06063 appearing on
                                                  displays a currently valid OMB control                                                                         page 14736 in the Federal Register of
                                                  number.                                                   document included a listing of areas for
                                                                                                            which states had not submitted State                 Friday, March 18, 2016, the following
                                                  Congressional Review Act                                  Implementation Plans (SIPs) addressing               correction is made:
                                                                                                                                                                    On page 14737, table entitled
                                                    This action is not a major rule as                      nonattainment area SIP requirements for
                                                                                                                                                                 ‘‘STATES AND SO2
                                                  defined by section 804 of the Small                       the 2010 1-hour primary sulfur dioxide
                                                                                                                                                                 NONATTAINMENT AREAS AFFECTED
                                                  Business Regulatory Enforcement                           (SO2) NAAQS. This action corrects that
                                                                                                                                                                 BY THESE FINDINGS OF FAILURE TO
                                                  Fairness Act of 1996 (Congressional                       listing to clarify that the Indiana,
                                                                                                                                                                 SUBMIT,’’ remove from the end of the
                                                  Review Act). However, the DEA has                         Pennsylvania nonattainment area for the
                                                                                                                                                                 fourth entry, under the column titled
                                                  submitted a copy of this final order to                   2010 SO2 NAAQS consists of the
                                                                                                                                                                 ‘‘Nonattainment area’’ the text ‘‘(p)’’.
                                                  both Houses of Congress and to the                        entirety of Indiana County and part of
                                                  Comptroller General.                                      Armstrong County.                                      Dated: April 4, 2016.
                                                                                                            DATES: The effective date of this                    Janet G. McCabe,
                                                  List of Subjects in 21 CFR Part 1308
                                                                                                            document is April 18, 2016.                          Acting Assistant Administrator.
                                                    Administrative practice and                                                                                  [FR Doc. 2016–08509 Filed 4–13–16; 8:45 am]
                                                                                                            FOR FURTHER INFORMATION CONTACT: For
                                                  procedure, Drug traffic control,
                                                  Narcotics, Prescription drugs.                            questions regarding this correction,                 BILLING CODE 6560–50–P
                                                                                                            contact Dr. Larry Wallace, U.S.
                                                    For the reasons set out above, the DEA
                                                                                                            Environmental Protection Agency,
                                                  amends 21 CFR part 1308 as follows:                                                                            ENVIRONMENTAL PROTECTION
                                                                                                            Office of Air Quality Planning and
                                                                                                            Standards, Mail Code C539–01,                        AGENCY
                                                  PART 1308—SCHEDULES OF
                                                  CONTROLLED SUBSTANCES                                     Research Triangle Park, NC 27711,
                                                                                                                                                                 40 CFR Part 52
                                                                                                            phone number (919) 541-0906 or by
                                                  ■ 1. The authority citation for part 1308                 email at wallace.larry@epa.gov.                      [EPA–R09–OAR–2015–0204; FRL–9944–16–
                                                  continues to read as follows:                             SUPPLEMENTARY INFORMATION:
                                                                                                                                                                 Region 9]
                                                    Authority: 21 U.S.C. 811, 812, 871(b),                                                                       Partial Approval and Partial
                                                                                                            Background
                                                  unless otherwise noted.
                                                                                                                                                                 Disapproval of Air Quality State
                                                                                                              The EPA issued the final rule, in FR
                                                  ■ 2. Amend § 1308.11 by redesignating                                                                          Implementation Plans; California;
                                                                                                            Doc 2016–06063 on March 18, 2016 (81
                                                  paragraphs (b)(3) through (55) as (b)(4)                                                                       South Coast; Moderate Area Plan for
                                                                                                            FR 14736). That final rule establishes
                                                  through (56) and adding a new (b)(3)to                                                                         the 2006 PM2.5 NAAQS
                                                                                                            certain Clean Air Act deadlines for the
                                                  read as follows:
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                                                                            EPA to impose sanctions if a state does              AGENCY:  U.S. Environmental Protection
                                                  § 1308.11   Schedule I.                                   not submit a SIP addressing                          Agency (EPA).
                                                  *       *    *       *      *                             nonattainment area SIP requirements to               ACTION: Final rule.
                                                      (b) * * *                                             bring the affected areas into attainment
                                                                                                            of the 2010 1-hour primary SO2 NAAQS                 SUMMARY: The Environmental Protection
                                                  (3) AH-7921 (3,4-dichloro-N-[(1-                          and for the EPA to promulgate a Federal              Agency (EPA) is approving in part and
                                                    dimethylamino)                                          Implementation Plan to address any                   disapproving in part State
                                                    cyclohexylmethyl]benzamide .........             9551   outstanding SIP requirements.                        implementation plan (SIP) revisions


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Document Created: 2018-02-07 13:47:58
Document Modified: 2018-02-07 13:47:58
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 May 16, 2016.
ContactBarbara J. Boockholdt, Office of
FR Citation81 FR 22023 
CFR AssociatedAdministrative Practice and Procedure; Drug Traffic Control; Narcotics and Prescription Drugs

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