Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2018, 42690-42696 [2018-18265]
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42690
Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
INTERNATIONAL TRADE
COMMISSION
[Investigation No. 337–TA–1012
(Consolidated Modification and
Enforcement Proceeding)]
Certain Magnetic Data Storage Tapes
and Cartridges Containing the Same
Notice of Institution of Modification
Proceeding
U.S. International Trade
Commission.
ACTION: Notice.
AGENCY:
Notice is hereby given that
the U.S. International Trade
Commission has determined to institute
a modification proceeding relating to
the March 8, 2018 limited exclusion
order and cease and desist orders issued
in the above-referenced investigation.
FOR FURTHER INFORMATION CONTACT:
Megan M. Valentine, Office of the
General Counsel, U.S. International
Trade Commission, 500 E Street SW,
Washington, DC 20436, telephone (202)
708–2301. Copies of non-confidential
documents filed in connection with this
investigation are or will be available for
inspection during official business
hours (8:45 a.m. to 5:15 p.m.) in the
Office of the Secretary, U.S.
International Trade Commission, 500 E
Street SW, Washington, DC 20436,
telephone (202) 205–2000. General
information concerning the Commission
may also be obtained by accessing its
internet server at https://www.usitc.gov.
The public record for this investigation
may be viewed on the Commission’s
electronic docket (EDIS) at https://
edis.usitc.gov. Hearing-impaired
persons are advised that information on
this matter can be obtained by
contacting the Commission’s TDD
terminal on (202) 205–1810.
SUPPLEMENTARY INFORMATION: The
Commission instituted the original
investigation on July 1, 2016, based on
a complaint filed by Fujifilm
Corporation of Tokyo, Japan, and
Fujifilm Recording Media U.S.A., Inc. of
Bedford, Massachusetts (collectively,
‘‘Fujifilm’’). 81 FR 43243–44 (July 1,
2016). Pertinent to this action, the
complaint alleged violations of section
337 of the Tariff Act of 1930, as
amended, 19 U.S.C. 1337 (‘‘section
337’’), in the sale for importation,
importation, and sale within the United
States after importation of certain
magnetic data storage tapes and
cartridges containing the same by reason
of infringement of, inter alia, claims 1,
4–9, 11 and 14 of U.S. Patent No.
6,641,891 (‘‘the ’891 patent’’). The
Commission’s Notice of Investigation
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SUMMARY:
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named as respondents Sony Corporation
of Tokyo, Japan, Sony Corporation of
America of New York, New York, and
Sony Electronics Inc. of San Diego,
California (collectively, ‘‘the Sony
respondents’’). The Office of Unfair
Import Investigations (‘‘OUII’’) was also
named as a party to the investigation.
On March 8, 2018, the Commission
found a section 337 violation as to the
’891 patent and issued a limited
exclusion order (‘‘LEO’’) and cease and
desist orders (‘‘CDOs’’) to each of the
Sony respondents. 83 FR 11245–47
(March 14, 2018). The LEO generally
prohibits the Sony respondents from
importing certain magnetic data storage
tapes and cartridges containing the same
that infringe the ’891 patent, with
certain exceptions related to service and
repair and verification testing. The
CDOs prohibit the Sony respondents
from importing, selling, marketing,
advertising, distributing, transferring
(except for exportation) certain magnetic
data storage tapes and cartridges
containing the same that infringe the
’891 patent, and soliciting United States
agents or distributors for these activities.
On May 9, 2018, Fujifilm filed a
complaint requesting that the
Commission institute a formal
enforcement proceeding under
Commission Rule 210.75 to investigate
alleged violation of the CDOs by the
Sony Respondents, as well as Sony
Storage Media Solutions Corporation,
Sony Storage Media Manufacturing
Corporation, Sony DADC US Inc., and
Sony Latin America Inc. (collectively,
‘‘Sony’’). On June 13, 2018, the
Commission instituted the enforcement
proceeding. 83 FR 27626–27 (June 13,
2018). OUII was also named as a party
in the enforcement proceeding.
On July 23, 2018, Sony filed a request
for an advisory opinion and a petition
for modification of the remedial orders
to clarify that certain of its redesigned
tape products are outside the scope of
the remedial orders. On August 2, 2018,
Fujifilm filed a response, opposing both
Sony’s request and petition.
Having examined the request and
petition, as well as the supporting
documents, the Commission has
determined to institute a modification
proceeding, pursuant to Commission
Rule 210.76(b) (19 CFR. 210.76(b)), to
determine whether the LEO and CDOs
issued in the underlying investigation
should be modified to exclude certain of
Sony’s redesigned tape products. The
Commission has further determined to
delegate the modification proceeding to
the presiding administrative law judge
and to consolidate that proceeding with
the ongoing enforcement proceeding.
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The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), and in Part
210 of the Commission’s Rules of
Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: August 17, 2018.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2018–18155 Filed 8–22–18; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–471P]
Proposed Adjustments to the
Aggregate Production Quotas for
Schedule I and II Controlled
Substances and Assessment of
Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2018
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice with request for
comments.
AGENCY:
The Drug Enforcement
Administration (DEA) proposes to
adjust the 2018 aggregate production
quotas for several controlled substances
in schedules I and II of the Controlled
Substances Act and assessment of
annual needs for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: Interested persons may file
written comments on this notice in
accordance with 21 CFR 1303.13(c) and
1315.13(d). Electronic comments must
be submitted, and written comments
must be postmarked, on or before
September 24, 2018. Commenters
should be aware that the electronic
Federal Docket Management System
will not accept comments after 11:59
p.m. Eastern Time on the last day of the
comment period.
Based on comments received in
response to this notice, the
Administrator may hold a public
hearing on one or more issues raised. In
the event the Administrator decides in
his sole discretion to hold such a
hearing, the Administrator will publish
a notice of any such hearing in the
Federal Register. After consideration of
any comments or objections, or after a
hearing, if one is held, the
Administrator will publish in the
Federal Register a final order
establishing the 2018 adjusted aggregate
SUMMARY:
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Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
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production quotas for schedule I and II
controlled substances, and an
assessment of annual needs for the list
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–471P’’ on all correspondence,
including any attachments. The Drug
Enforcement Administration encourages
that all comments be submitted
electronically through the Federal
eRulemaking Portal, which provides the
ability to type short comments directly
into the comment field on the web page
or attach a file for lengthier comments.
Please go to https://www.regulations.gov
and follow the online instructions at
that site for submitting comments. Upon
completion of your submission you will
receive a Comment Tracking Number for
your comment. Please be aware that
submitted comments are not
instantaneously available for public
view on regulations.gov. If you have
received a Comment Tracking Number,
your comment has been successfully
submitted and there is no need to
resubmit the same comment. Paper
comments that duplicate electronic
submissions are not necessary and are
discouraged. Should you wish to mail a
paper comment in lieu of an electronic
comment, it should be sent via regular
or express mail to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
FOR FURTHER INFORMATION CONTACT:
Thomas D. Sonnen, Diversion Control
Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152, Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments
received in response to this docket are
considered part of the public record.
They will, unless reasonable cause is
given, be made available by the Drug
Enforcement Administration (DEA) for
public inspection online at https://
www.regulations.gov. Such information
includes personal identifying
information (such as your name,
address, etc.) voluntarily submitted by
the commenter.
The Freedom of Information Act
(FOIA) applies to all comments
received. If you want to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not want it to be made
publicly available, you must include the
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19:43 Aug 22, 2018
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phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also place
all the personal identifying information
you do not want made publicly
available in the first paragraph of your
comment and identify what information
you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want it to be made
publicly available, you must include the
phrase ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify confidential
business information to be redacted
within the comment.
Comments containing personal
identifying information or confidential
business information identified and
located as directed above will generally
be made available in redacted form. If a
comment contains so much confidential
business information or personal
identifying information that it cannot be
effectively redacted, all or part of that
comment may not be made publicly
available. Comments posted to https://
www.regulations.gov may include any
personal identifying information (such
as name, address, and phone number)
included in the text of your electronic
submission that is not identified as
directed above as confidential.
An electronic copy of this document
is available at https://
www.regulations.gov for easy reference.
Legal Authority and Background
Section 306 of the Controlled
Substances Act (CSA) (21 U.S.C. 826)
requires the Attorney General to
establish aggregate production quotas
for each basic class of controlled
substance listed in schedules I and II
and for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine. The Attorney
General has delegated this function to
the Administrator of the DEA pursuant
to 28 CFR 0.100.
The DEA established the 2018
aggregate production quotas for
substances in schedules I and II and the
assessment of annual needs for the list
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine on November 8,
2017 (82 FR 51873). That notice
stipulated that, in accordance with 21
CFR 1303.13 and 1315.13, all aggregate
production quotas and assessments of
annual need are subject to adjustment.
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42691
Analysis for Proposed Adjusted 2018
Aggregate Production Quotas and
Assessment of Annual Needs
The DEA proposes to adjust the
established 2018 aggregate production
quotas and assessment of annual needs
for certain schedule I and II controlled
substances, and the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine, to be
manufactured in the United States in
2018 to provide for the estimated
medical, scientific, research, and
industrial needs of the United States, for
lawful export requirements, and for the
establishment and maintenance of
reserve stocks. These quotas do not
include imports of controlled
substances for use in industrial
processes.
In determining the proposed
adjustment, the Acting Administrator
has taken into account the criteria in
accordance with 21 CFR 1303.13
(adjustment of aggregate production
quotas for controlled substances) and 21
CFR 1315.13 (adjustment of the
assessment of annual needs for
ephedrine, pseudoephedrine, and
phenylpropanolamine). The DEA
determined whether to propose an
adjustment of the aggregate production
quotas and assessment of annual needs
for 2018 by considering: (1) Changes in
the demand for that class or chemical,
changes in the national rate of net
disposal of the class or chemical, and
changes in the rate of net disposal of the
class or chemical by registrants holding
individual manufacturing quotas for the
class; (2) whether any increased demand
for that class or chemical, the national
and/or individual rates of net disposal
of that class or chemical are temporary,
short term, or long term; (3) whether any
increased demand for that class or
chemical can be met through existing
inventories, increased individual
manufacturing quotas, or increased
importation, without increasing the
aggregate production quota; (4) whether
any decreased demand for that class or
chemical will result in excessive
inventory accumulation by all persons
registered to handle that class or
chemical; and (5) other factors affecting
medical, scientific, research, and
industrial needs in the United States
and lawful export requirements, as the
Acting Administrator finds relevant.
These quotas do not include imports of
controlled substances for use in
industrial processes.
The Acting Administrator also
considered updated information
obtained from 2017 year-end
inventories, 2017 disposition data
submitted by quota applicants,
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Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
estimates of the medical needs of the
United States, product development,
and other information made available to
the DEA after the initial aggregate
production quotas and assessment of
annual needs had been established.
Other factors the Acting Administrator
considered in calculating the aggregate
production quotas, but not the
assessment of annual needs, include
product development requirements of
both bulk and finished dosage form
manufacturers, and other pertinent
information. In determining the
proposed adjusted 2018 assessment of
annual needs, the DEA used the
calculation methodology previously
described in the 2010 and 2011
established assessment of annual needs
(74 FR 60294, Nov. 20, 2009, and 75 FR
79407, Dec. 20, 2010, respectively).
The Acting Administrator, therefore,
proposes to adjust the 2018 aggregate
production quotas for certain schedule I
and II controlled substances and the
assessment of annual needs for the list
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine, expressed in
grams of anhydrous acid or base, as
follows:
Established
2018 quotas
(g)
Basic class
Proposed
revised 2018
quotas
(g)
Temporarily Scheduled Substances
1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide ..................................................................
1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide .............................................
Cyclopropyl Fentanyl ...............................................................................................................................................
Fentanyl related substances ...................................................................................................................................
Isobutyryl Fentanyl ..................................................................................................................................................
Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate ......................................................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide ..........................................
Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate .....................................................................................
Ocfentanil ................................................................................................................................................................
Para-flourobutyryl fentanyl .......................................................................................................................................
Tetrahydrofuranyl fentanyl .......................................................................................................................................
Valeryl fentanyl ........................................................................................................................................................
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
25.
25.
20.
25.
25.
25.
25.
25.
25.
25.
5.
25.
daltland on DSKBBV9HB2PROD with NOTICES
Schedule I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine ......................................................................................................................
1-(1-Phenylcyclohexyl)pyrrolidine ............................................................................................................................
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine ......................................................................................................
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ................................................................................................
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ..............................................................................................
1-[1-(2-Thienyl)cyclohexyl]piperidine .......................................................................................................................
1-Benzylpiperazine ..................................................................................................................................................
1-Methyl-4-phenyl-4-propionoxypiperidine ..............................................................................................................
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E) ...............................................................................................
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D) ............................................................................................
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N) ..............................................................................................
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P) .........................................................................................
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H) ...........................................................................................................
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi36).
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C) ............................................................................................
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi82).
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I) .................................................................................................
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) ......
2,5-Dimethoxy-4-ethylamphetamine (DOET) ..........................................................................................................
2,5-Dimethoxy-4-n-propylthiophenethylamine .........................................................................................................
2,5-Dimethoxyamphetamine ....................................................................................................................................
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) ....................................................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4) ..............................................................................
3,4,5-Trimethoxyamphetamine ................................................................................................................................
3,4-Methylenedioxyamphetamine (MDA) ................................................................................................................
3,4-Methylenedioxymethamphetamine (MDMA) .....................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) .................................................................................................
3,4-Methylenedioxy-N-methylcathinone (methylone) ..............................................................................................
3,4-Methylenedioxypyrovalerone (MDPV) ...............................................................................................................
3-FMC; 3-Fluoro-N-methylcathinone .......................................................................................................................
3-Methylfentanyl ......................................................................................................................................................
3-Methylthiofentanyl ................................................................................................................................................
4-Bromo-2,5-dimethoxyamphetamine (DOB) ..........................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine (2-CB) ......................................................................................................
4-Fluoroisobutyryl fentanyl ......................................................................................................................................
4-FMC; Flephedrone ...............................................................................................................................................
4-MEC; 4-Methyl-N-ethylcathinone .........................................................................................................................
4-Methoxyamphetamine ..........................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (DOM) .........................................................................................................
4-Methylaminorex ....................................................................................................................................................
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Zero
10
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30
30
15
25
2
30
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30
30
20.
15.
10.
no change.
no change.
no change.
no change.
10.
no change.
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no change.
no change.
no change.
no change.
30
25
no change.
no change.
30
30
25
25
25
30
30
30
55
50
40
40
35
25
30
30
30
25
30
25
25
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25
25
no
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change.
42693
Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
Established
2018 quotas
(g)
daltland on DSKBBV9HB2PROD with NOTICES
Basic class
4-Methyl-N-methylcathinone (mephedrone) ............................................................................................................
4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) ...................................................................................................
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol .............................................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) .......................................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) ............................
5-Fluoro-PB-22; 5F-PB-22 .......................................................................................................................................
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol- ...........................................................................................
3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ......................................................................................................
5-Methoxy-3,4-methylenedioxyamphetamine ..........................................................................................................
5-Methoxy-N,N-diisopropyltryptamine .....................................................................................................................
5-Methoxy-N,N-dimethyltryptamine .........................................................................................................................
AB-CHMINACA .......................................................................................................................................................
AB-FUBINACA ........................................................................................................................................................
AB-PINACA .............................................................................................................................................................
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) .....
Acetyl Fentanyl ........................................................................................................................................................
Acetyl-alpha-methylfentanyl .....................................................................................................................................
Acetyldihydrocodeine ..............................................................................................................................................
Acetylmethadol ........................................................................................................................................................
Acryl Fentanyl ..........................................................................................................................................................
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) ..........................
AH-7921 ..................................................................................................................................................................
Allylprodine ..............................................................................................................................................................
Alphacetylmethadol .................................................................................................................................................
alpha-Ethyltryptamine ..............................................................................................................................................
Alphameprodine ......................................................................................................................................................
Alphamethadol .........................................................................................................................................................
alpha-Methylfentanyl ...............................................................................................................................................
alpha-Methylthiofentanyl ..........................................................................................................................................
alpha-Methyltryptamine (AMT) ................................................................................................................................
alpha-Pyrrolidinobutiophenone (a-PBP) ..................................................................................................................
alpha-Pyrrolidinopentiophenone (a-PVP) ................................................................................................................
Aminorex .................................................................................................................................................................
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) .............................................................
Benzylmorphine .......................................................................................................................................................
Betacetylmethadol ...................................................................................................................................................
beta-Hydroxy-3-methylfentanyl ................................................................................................................................
beta-Hydroxyfentanyl ...............................................................................................................................................
beta-Hydroxythiofentanyl .........................................................................................................................................
Betameprodine ........................................................................................................................................................
Betamethadol ..........................................................................................................................................................
Betaprodine .............................................................................................................................................................
Bufotenine ...............................................................................................................................................................
Butylone ...................................................................................................................................................................
Butyryl fentanyl ........................................................................................................................................................
Cathinone ................................................................................................................................................................
Codeine methylbromide ...........................................................................................................................................
Codeine-N-oxide ......................................................................................................................................................
Desomorphine .........................................................................................................................................................
Diapromide ..............................................................................................................................................................
Diethylthiambutene ..................................................................................................................................................
Diethyltryptamine .....................................................................................................................................................
Difenoxin ..................................................................................................................................................................
Dihydromorphine .....................................................................................................................................................
Dimethyltryptamine ..................................................................................................................................................
Dipipanone ..............................................................................................................................................................
Etorphine .................................................................................................................................................................
Fenethylline .............................................................................................................................................................
Furanyl fentanyl .......................................................................................................................................................
gamma-Hydroxybutyric acid ....................................................................................................................................
Heroin ......................................................................................................................................................................
Hydromorphinol .......................................................................................................................................................
Hydroxypethidine .....................................................................................................................................................
Ibogaine ...................................................................................................................................................................
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) ..........................................................................................
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) ...............................................................................................................
JWH-073 (1-Butyl-3-(1-naphthoyl)indole) ................................................................................................................
JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole) ...........................................................................................
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole) ...............................................................................................
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45
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50
30
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2
4
2
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25
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192
25
Zero
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25
8,225
1,000,160
35
5
30
30
30
37,130,000
45
40
2
30
35
45
45
30
30
Proposed
revised 2018
quotas
(g)
no
no
no
no
no
no
no
no
no
change.
change.
change.
change.
change.
change.
change.
change.
change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
20.
20.
no change.
no change.
no change.
50.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
42694
Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
Established
2018 quotas
(g)
Basic class
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ...................................................................................
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) ................................................................................................
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) ............................................................................................
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole) ................................................................................................
Lysergic acid diethylamide (LSD) ............................................................................................................................
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide).
MDMB-CHMICA;
MMB-CHMINACA(methyl
2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3dimethylbutanoate).
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ...............
Marihuana ................................................................................................................................................................
Mecloqualone ..........................................................................................................................................................
Mescaline ................................................................................................................................................................
Methaqualone ..........................................................................................................................................................
Methcathinone .........................................................................................................................................................
Methyldesorphine ....................................................................................................................................................
Methyldihydromorphine ...........................................................................................................................................
Morphine methylbromide .........................................................................................................................................
Morphine methylsulfonate .......................................................................................................................................
Morphine-N-oxide ....................................................................................................................................................
N,N-Dimethylamphetamine ......................................................................................................................................
Naphyrone ...............................................................................................................................................................
N-Ethyl-1-phenylcyclohexylamine ............................................................................................................................
N-Ethyl-3-piperidyl benzilate ....................................................................................................................................
N-Ethylamphetamine ...............................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ..........................................................................................................
Noracymethadol ......................................................................................................................................................
Norlevorphanol ........................................................................................................................................................
Normethadone .........................................................................................................................................................
Normorphine ............................................................................................................................................................
Para-fluorofentanyl ..................................................................................................................................................
Parahexyl .................................................................................................................................................................
PB-22; QUPIC .........................................................................................................................................................
Pentedrone ..............................................................................................................................................................
Pentylone .................................................................................................................................................................
Phenomorphan ........................................................................................................................................................
Pholcodine ...............................................................................................................................................................
Psilocybin ................................................................................................................................................................
Psilocyn ...................................................................................................................................................................
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) ..............................................................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) ..................................................................................
Tetrahydrocannabinols ............................................................................................................................................
Thiofentanyl .............................................................................................................................................................
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) ........................................................
Tilidine .....................................................................................................................................................................
Trimeperidine ...........................................................................................................................................................
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone ..........................................................
U-47700 ...................................................................................................................................................................
Proposed
revised 2018
quotas
(g)
35
30
30
30
40
30
no
no
no
no
no
no
change.
change.
change.
change.
change.
change.
30
no change.
30
443,680
30
25
60
25
5
2
5
5
150
25
25
5
Zero
24
24
2
55
2
40
25
5
20
25
25
2
5
30
50
45
30
384,460
25
30
25
2
25
30
no change.
1,140,216.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
10.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
4
4
1,342,320
6,200
2
20,100
11,280,000
39,856,000
Zero
20
92,120
15,040,000
40,015,000
35
264,140
2
14,100
770,800
88,134
30
15.
25.
no change.
no change.
no change.
no change.
12,700,000.
no change.
20.
no change.
no change.
12,900,000.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
daltland on DSKBBV9HB2PROD with NOTICES
Schedule II
1-Phenylcyclohexylamine ........................................................................................................................................
1-Piperidinocyclohexanecarbonitrile ........................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .............................................................................................................
Alfentanil ..................................................................................................................................................................
Alphaprodine ...........................................................................................................................................................
Amobarbital .............................................................................................................................................................
Amphetamine (for conversion) ................................................................................................................................
Amphetamine (for sale) ...........................................................................................................................................
Anileridine ................................................................................................................................................................
Carfentanil ...............................................................................................................................................................
Cocaine ...................................................................................................................................................................
Codeine (for conversion) .........................................................................................................................................
Codeine (for sale) ....................................................................................................................................................
Dextropropoxyphene ...............................................................................................................................................
Dihydrocodeine ........................................................................................................................................................
Dihydroetorphine .....................................................................................................................................................
Diphenoxylate (for conversion) ................................................................................................................................
Diphenoxylate (for sale) ..........................................................................................................................................
Ecgonine ..................................................................................................................................................................
Ethylmorphine ..........................................................................................................................................................
VerDate Sep<11>2014
19:43 Aug 22, 2018
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PO 00000
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Fmt 4703
Sfmt 4703
E:\FR\FM\23AUN1.SGM
23AUN1
Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
Established
2018 quotas
(g)
Basic class
Etorphine hydrochloride ..........................................................................................................................................
Fentanyl ...................................................................................................................................................................
Glutethimide ............................................................................................................................................................
Hydrocodone (for conversion) .................................................................................................................................
Hydrocodone (for sale) ............................................................................................................................................
Hydromorphone .......................................................................................................................................................
Isomethadone ..........................................................................................................................................................
Levo-alphacetylmethadol (LAAM) ...........................................................................................................................
Levomethorphan ......................................................................................................................................................
Levorphanol .............................................................................................................................................................
Lisdexamfetamine ...................................................................................................................................................
Meperidine ...............................................................................................................................................................
Meperidine Intermediate-A ......................................................................................................................................
Meperidine Intermediate-B ......................................................................................................................................
Meperidine Intermediate-C ......................................................................................................................................
Metazocine ..............................................................................................................................................................
Methadone (for sale) ...............................................................................................................................................
Methadone Intermediate .........................................................................................................................................
Methamphetamine ...................................................................................................................................................
32
1,342,320
2
114,680
50,348,280
4,547,720
30
5
30
12,126
17,869,000
2,717,540
5
30
5
15
22,278,000
24,064,000
1,446,754
42695
Proposed
revised 2018
quotas
(g)
no change.
no change.
no change.
no change.
44,710,000.
no change.
no change.
no change.
2,200.
38,000.
19,000,000.
1,913,148.
30.
no change.
30.
no change.
no change.
no change.
no change.
[846,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 564,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 36,754 grams for methamphetamine (for sale)]
Methylphenidate ......................................................................................................................................................
Morphine (for conversion) .......................................................................................................................................
Morphine (for sale) ..................................................................................................................................................
Nabilone ..................................................................................................................................................................
Noroxymorphone (for conversion) ...........................................................................................................................
Noroxymorphone (for sale) ......................................................................................................................................
Opium (powder) .......................................................................................................................................................
Opium (tincture) .......................................................................................................................................................
Oripavine .................................................................................................................................................................
Oxycodone (for conversion) ....................................................................................................................................
Oxycodone (for sale) ...............................................................................................................................................
Oxymorphone (for conversion) ................................................................................................................................
Oxymorphone (for sale) ...........................................................................................................................................
Pentobarbital ...........................................................................................................................................................
Phenazocine ............................................................................................................................................................
Phencyclidine ..........................................................................................................................................................
Phenmetrazine ........................................................................................................................................................
Phenylacetone .........................................................................................................................................................
Racemethorphan .....................................................................................................................................................
Racemorphan ..........................................................................................................................................................
Remifentanil .............................................................................................................................................................
Secobarbital .............................................................................................................................................................
Sufentanil .................................................................................................................................................................
Tapentadol ...............................................................................................................................................................
Thebaine ..................................................................................................................................................................
64,600,000
4,089,000
33,958,440
31,000
14,044,540
376,000
84,600
564,000
24,534,000
2,453,400
95,692,000
20,962,000
3,395,280
25,850,000
5
35
25
40
5
5
2,820
161,682
1,880
18,388,280
94,000,000
no change.
no change.
31,456,000.
62,000.
16,440,000.
no change.
no change.
no change.
no change.
no change.
85,578,000.
no change.
3,137,240.
no change.
no change.
no change.
no change.
no change.
no change.
no change.
3,000.
172,100.
no change.
no change.
86,200,000.
47,000
4,136,000
14,100,000
7,990,000
40
180,000,000
no change.
no change.
no change.
no change.
1,000.
no change.
List I Chemicals
daltland on DSKBBV9HB2PROD with NOTICES
Ephedrine (for conversion) ......................................................................................................................................
Ephedrine (for sale) .................................................................................................................................................
Phenylpropanolamine (for conversion) ....................................................................................................................
Phenylpropanolamine (for sale) ..............................................................................................................................
Pseudoephedrine (for conversion) ..........................................................................................................................
Pseudoephedrine (for sale) .....................................................................................................................................
The Acting Administrator further
proposes that aggregate production
quotas for all other schedule I and II
controlled substances included in 21
CFR 1308.11 and 1308.12 remain at
zero. In accordance with 21 CFR
1303.13 and 21 CFR 1315.13, upon
consideration of the relevant factors, the
Acting Administrator may adjust the
VerDate Sep<11>2014
19:43 Aug 22, 2018
Jkt 244001
2018 aggregate production quotas and
assessment of annual needs as needed.
Conclusion
After consideration of any comments
or objections, or after a hearing, if one
is held, the Acting Administrator will
issue and publish in the Federal
Register a final order establishing any
adjustment of 2018 aggregate production
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
quotas for each basic class of controlled
substances in schedules I and II and
established assessment of annual needs
for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine, 21 CFR
1303.13(c) and 1315.13(f).
E:\FR\FM\23AUN1.SGM
23AUN1
42696
Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
Dated: August 17, 2018.
Uttam Dhillon,
Acting Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Administration (DEA) as importers of
various classes of schedule I or II
controlled substances.
[FR Doc. 2018–18265 Filed 8–22–18; 8:45 am]
[Docket No. DEA–392]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–09–P
The
companies listed below applied to be
registered as importers of various basic
classes of controlled substances.
Information on previously published
notices is listed in the table below. No
comments or objections were submitted
and no requests for hearing were
submitted for these notices.
Importer of Controlled Substances
Registration
ACTION:
Notice of registration.
Registrants listed below have
applied for and been granted
registration by the Drug Enforcement
SUMMARY:
Company
FR docket
Fisher Clinical Services, Inc ..........................................................................................
Unither Manufacturing LLC ............................................................................................
83 FR 28663 ......................
83 FR 29136 ......................
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823, 952(a) and
958(a) and determined that the
registration of the listed registrants to
import the applicable basic classes of
schedule I or II controlled substances is
consistent with the public interest and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971. The
DEA investigated each company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
granted a registration as an importer for
schedule I or II controlled substances to
the above listed companies.
Dated: August 17, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–18266 Filed 8–22–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
daltland on DSKBBV9HB2PROD with NOTICES
Greg N. Rampey, D.O.; Dismissal of
Proceedings
On October 27, 2017, the Acting
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause to Greg N. Rampey, D.O.
(Registrant), of Tulsa, Oklahoma. The
Show Cause Order proposed the
revocation of Registrant’s DEA
Certificate of Registration No.
BR7006085 on the ground that he has
VerDate Sep<11>2014
19:43 Aug 22, 2018
Jkt 244001
‘‘no state authority to handle controlled
substances’’ in the State of Oklahoma,
the State in which he is registered with
the DEA. Order to Show Cause,
Government Exhibit (GX) 2, at 1, 2
(citing 21 U.S.C. 824(a)(3)). For the same
reason, the Order also proposed the
denial of any of Registrant’s
‘‘applications for renewal or
modification of such registration and
any applications for any other DEA
registrations.’’ Id. at 1.
With respect to the Agency’s
jurisdiction, the Show Cause Order
alleged that Registrant is the holder of
Certificate of Registration No.
BR7006085, pursuant to which he is
authorized to dispense controlled
substances as a practitioner in schedules
II through V, at the registered address of
8596 E. 101st, Ste. B, Tulsa, Oklahoma.
Id. The Order also alleged that this
registration does not expire until April
30, 2018. Id.
As the substantive ground for the
proceeding, the Show Cause Order
alleged that ‘‘on September 21, 2017, the
Oklahoma State Board of Osteopathic
Examiners cancelled [Registrant’s]
osteopathic medical license’’ and his
‘‘Oklahoma Bureau of Narcotics and
Dangerous Drugs registration is
inactive.’’ Id. at 1–2. The Show Cause
Order thus alleged that Registrant is
‘‘currently without authority to practice
medicine or handle controlled
substances in the State of Oklahoma, the
[S]tate in which [he is] registered with
the DEA,’’ and that, as a consequence,
‘‘DEA must revoke’’ his registration. Id.
at 2.
The Show Cause Order notified
Registrant of (1) his right to request a
hearing on the allegations or to submit
a written statement in lieu of a hearing,
(2) the procedure for electing either
option, and (3) the consequence for
failing to elect either option. Id. (citing
21 CFR 1301.43). The Order also
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Published
June 20, 2018.
June 22, 2018.
notified Registrant of his right to submit
a corrective action plan. Id. at 2–3
(citing 21 U.S.C. 824(c)(2)(C)).
According to an Affidavit of Service
filed in this matter, on October 30, 2017,
personnel from DEA’s Office of Chief
Counsel, Diversion and Regulatory
Litigation Section, attempted to serve
the Show Cause Order on the Registrant
by regular first class mail addressed to
the Registrant at his registered address.
GX 6. The Government represents that
its mailing was not returned as
undeliverable. Id. On January 10, 2018,
the Government submitted a Request for
Final Agency Action (RFAA)
representing that Registrant did not
request a hearing and ‘‘ha[d] not filed
any written statement in lieu of a
hearing’’ within 30 days of service and
seeking a final order revoking his
registration. GX 7, at 2.
On February 6, 2018, the then-Acting
Administrator issued an Order noting
that the Government’s effort at service
in this case was ‘‘a departure from the
Agency’s traditional practice.’’ GX 8.
The Order further noted that ‘‘the
Government cites to no authority
establishing that a sole effort of mailing
by first class mail (with no evidence of
delivery to the address) is sufficient to
provide constitutionally adequate
service for initiating a proceeding under
the Due Process Clause.’’ Id. As a result,
the then-Acting Administrator directed
the Government to either address why
its effort was consistent with the Due
Process Clause or to engage in
additional reasonable efforts to serve
Registrant. Id.
On March 29, 2018, my office
received the Government’s Second
Request for Final Agency Action
(SRFAA) describing a Diversion
Investigator’s additional attempts to
serve the Show Cause Order and again
seeking a final order revoking
Registrant’s registration. SRFAA, at 2.
E:\FR\FM\23AUN1.SGM
23AUN1
]]>Agencies
[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42690-42696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18265]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-471P]
Proposed Adjustments to the Aggregate Production Quotas for
Schedule I and II Controlled Substances and Assessment of Annual Needs
for the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2018
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice with request for comments.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) proposes to adjust
the 2018 aggregate production quotas for several controlled substances
in schedules I and II of the Controlled Substances Act and assessment
of annual needs for the list I chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine.
DATES: Interested persons may file written comments on this notice in
accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments
must be submitted, and written comments must be postmarked, on or
before September 24, 2018. Commenters should be aware that the
electronic Federal Docket Management System will not accept comments
after 11:59 p.m. Eastern Time on the last day of the comment period.
Based on comments received in response to this notice, the
Administrator may hold a public hearing on one or more issues raised.
In the event the Administrator decides in his sole discretion to hold
such a hearing, the Administrator will publish a notice of any such
hearing in the Federal Register. After consideration of any comments or
objections, or after a hearing, if one is held, the Administrator will
publish in the Federal Register a final order establishing the 2018
adjusted aggregate
[[Page 42691]]
production quotas for schedule I and II controlled substances, and an
assessment of annual needs for the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-471P'' on all correspondence, including any
attachments. The Drug Enforcement Administration encourages that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the online
instructions at that site for submitting comments. Upon completion of
your submission you will receive a Comment Tracking Number for your
comment. Please be aware that submitted comments are not
instantaneously available for public view on regulations.gov. If you
have received a Comment Tracking Number, your comment has been
successfully submitted and there is no need to resubmit the same
comment. Paper comments that duplicate electronic submissions are not
necessary and are discouraged. Should you wish to mail a paper comment
in lieu of an electronic comment, it should be sent via regular or
express mail to: Drug Enforcement Administration, Attention: DEA
Federal Register Representative/DRW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Thomas D. Sonnen, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. They will, unless reasonable
cause is given, be made available by the Drug Enforcement
Administration (DEA) for public inspection online at https://www.regulations.gov. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter.
The Freedom of Information Act (FOIA) applies to all comments
received. If you want to submit personal identifying information (such
as your name, address, etc.) as part of your comment, but do not want
it to be made publicly available, you must include the phrase
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your
comment. You must also place all the personal identifying information
you do not want made publicly available in the first paragraph of your
comment and identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be made publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify
confidential business information to be redacted within the comment.
Comments containing personal identifying information or
confidential business information identified and located as directed
above will generally be made available in redacted form. If a comment
contains so much confidential business information or personal
identifying information that it cannot be effectively redacted, all or
part of that comment may not be made publicly available. Comments
posted to https://www.regulations.gov may include any personal
identifying information (such as name, address, and phone number)
included in the text of your electronic submission that is not
identified as directed above as confidential.
An electronic copy of this document is available at https://www.regulations.gov for easy reference.
Legal Authority and Background
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826)
requires the Attorney General to establish aggregate production quotas
for each basic class of controlled substance listed in schedules I and
II and for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine. The Attorney General has delegated this function
to the Administrator of the DEA pursuant to 28 CFR 0.100.
The DEA established the 2018 aggregate production quotas for
substances in schedules I and II and the assessment of annual needs for
the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine on November 8, 2017 (82 FR 51873). That notice
stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all
aggregate production quotas and assessments of annual need are subject
to adjustment.
Analysis for Proposed Adjusted 2018 Aggregate Production Quotas and
Assessment of Annual Needs
The DEA proposes to adjust the established 2018 aggregate
production quotas and assessment of annual needs for certain schedule I
and II controlled substances, and the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine, to be manufactured in the
United States in 2018 to provide for the estimated medical, scientific,
research, and industrial needs of the United States, for lawful export
requirements, and for the establishment and maintenance of reserve
stocks. These quotas do not include imports of controlled substances
for use in industrial processes.
In determining the proposed adjustment, the Acting Administrator
has taken into account the criteria in accordance with 21 CFR 1303.13
(adjustment of aggregate production quotas for controlled substances)
and 21 CFR 1315.13 (adjustment of the assessment of annual needs for
ephedrine, pseudoephedrine, and phenylpropanolamine). The DEA
determined whether to propose an adjustment of the aggregate production
quotas and assessment of annual needs for 2018 by considering: (1)
Changes in the demand for that class or chemical, changes in the
national rate of net disposal of the class or chemical, and changes in
the rate of net disposal of the class or chemical by registrants
holding individual manufacturing quotas for the class; (2) whether any
increased demand for that class or chemical, the national and/or
individual rates of net disposal of that class or chemical are
temporary, short term, or long term; (3) whether any increased demand
for that class or chemical can be met through existing inventories,
increased individual manufacturing quotas, or increased importation,
without increasing the aggregate production quota; (4) whether any
decreased demand for that class or chemical will result in excessive
inventory accumulation by all persons registered to handle that class
or chemical; and (5) other factors affecting medical, scientific,
research, and industrial needs in the United States and lawful export
requirements, as the Acting Administrator finds relevant. These quotas
do not include imports of controlled substances for use in industrial
processes.
The Acting Administrator also considered updated information
obtained from 2017 year-end inventories, 2017 disposition data
submitted by quota applicants,
[[Page 42692]]
estimates of the medical needs of the United States, product
development, and other information made available to the DEA after the
initial aggregate production quotas and assessment of annual needs had
been established. Other factors the Acting Administrator considered in
calculating the aggregate production quotas, but not the assessment of
annual needs, include product development requirements of both bulk and
finished dosage form manufacturers, and other pertinent information. In
determining the proposed adjusted 2018 assessment of annual needs, the
DEA used the calculation methodology previously described in the 2010
and 2011 established assessment of annual needs (74 FR 60294, Nov. 20,
2009, and 75 FR 79407, Dec. 20, 2010, respectively).
The Acting Administrator, therefore, proposes to adjust the 2018
aggregate production quotas for certain schedule I and II controlled
substances and the assessment of annual needs for the list I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams
of anhydrous acid or base, as follows:
------------------------------------------------------------------------
Established
Basic class 2018 quotas Proposed revised 2018
(g) quotas (g)
------------------------------------------------------------------------
Temporarily Scheduled Substances
------------------------------------------------------------------------
1-(4-Cyanobutyl)-N-(2- N/A 25.
phenylpropan-2-yl)-1H-indazole-
3-carboximide.
1-(5-Fluoropentyl)-N-(2- N/A 25.
phenylpropan-2-yl)-1H-
pyrrolo[2,3-b]pyridine-
3carboximide.
Cyclopropyl Fentanyl............ N/A 20.
Fentanyl related substances..... N/A 25.
Isobutyryl Fentanyl............. N/A 25.
Methyl-2-(1-(cyclohexylmethyl)- N/A 25.
1H-indole-3-carboxamido)-3-
methylbutanoate.
N-(1-Amino-3-methyl-1-oxobutan-2- N/A 25.
yl)-1-(5-fluoropentyl)-1H-
indazole-3-carboxamide.
Naphthalen-1-yl 1-(5- N/A 25.
fluorpentyl)-1H-indole-3-
carboxylate.
Ocfentanil...................... N/A 25.
Para-flourobutyryl fentanyl..... N/A 25.
Tetrahydrofuranyl fentanyl...... N/A 5.
Valeryl fentanyl................ N/A 25.
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
1-[1-(2- Zero 20.
Thienyl)cyclohexyl]pyrrolidine.
1-(1- 10 15.
Phenylcyclohexyl)pyrrolidine.
1-(2-Phenylethyl)-4-phenyl-4- zero 10.
acetoxypiperidine.
1-(5-Fluoropentyl)-3-(1- 30 no change.
naphthoyl)indole (AM2201).
1-(5-Fluoropentyl)-3-(2- 30 no change.
iodobenzoyl)indole (AM694).
1-[1-(2- 15 no change.
Thienyl)cyclohexyl]piperidine.
1-Benzylpiperazine.............. 25 no change.
1-Methyl-4-phenyl-4- 2 10.
propionoxypiperidine.
2-(2,5-Dimethoxy-4- 30 no change.
ethylphenyl)ethanamine (2C-E).
2-(2,5-Dimethoxy-4- 30 no change.
methylphenyl)ethanamine (2C-D).
2-(2,5-Dimethoxy-4-nitro- 30 no change.
phenyl)ethanamine (2C-N).
2-(2,5-Dimethoxy-4-n- 30 no change.
propylphenyl)ethanamine (2C-P).
2-(2,5- 30 no change.
Dimethoxyphenyl)ethanamine (2C-
H).
2-(4-Bromo-2,5-dimethoxyphenyl)- 30 no change.
N-(2-methoxybenzyl)ethanamine
(25B-NBOMe; 2C-B-NBOMe; 25B;
Cimbi-36).
2-(4-Chloro-2,5- 30 no change.
dimethoxyphenyl)ethanamine (2C-
C).
2-(4-Chloro-2,5-dimethoxyphenyl)- 25 no change.
N-(2-methoxybenzyl)ethanamine
(25C-NBOMe; 2C-C-NBOMe; 25C;
Cimbi-82).
2-(4-Iodo-2,5- 30 no change.
dimethoxyphenyl)ethanamine (2C-
I).
2-(4-Iodo-2,5-dimethoxyphenyl)-N- 30 no change.
(2-methoxybenzyl)ethanamine
(25I-NBOMe; 2C-I-NBOMe; 25I;
Cimbi-5).
2,5-Dimethoxy-4-ethylamphetamine 25 no change.
(DOET).
2,5-Dimethoxy-4-n- 25 no change.
propylthiophenethylamine.
2,5-Dimethoxyamphetamine........ 25 no change.
2-[4-(Ethylthio)-2,5- 30 no change.
dimethoxyphenyl]ethanamine (2C-
T-2).
2-[4-(Isopropylthio)-2,5- 30 no change.
dimethoxyphenyl]ethanamine (2C-
T-4).
3,4,5-Trimethoxyamphetamine..... 30 no change.
3,4-Methylenedioxyamphetamine 55 no change.
(MDA).
3,4- 50 no change.
Methylenedioxymethamphetamine
(MDMA).
3,4-Methylenedioxy-N- 40 no change.
ethylamphetamine (MDEA).
3,4-Methylenedioxy-N- 40 no change.
methylcathinone (methylone).
3,4-Methylenedioxypyrovalerone 35 no change.
(MDPV).
3-FMC; 3-Fluoro-N- 25 no change.
methylcathinone.
3-Methylfentanyl................ 30 no change.
3-Methylthiofentanyl............ 30 no change.
4-Bromo-2,5-dimethoxyamphetamine 30 no change.
(DOB).
4-Bromo-2,5- 25 no change.
dimethoxyphenethylamine (2-CB).
4-Fluoroisobutyryl fentanyl..... 30 no change.
4-FMC; Flephedrone.............. 25 no change.
4-MEC; 4-Methyl-N-ethylcathinone 25 no change.
4-Methoxyamphetamine............ 150 no change.
4-Methyl-2,5- 25 no change.
dimethoxyamphetamine (DOM).
4-Methylaminorex................ 25 no change.
[[Page 42693]]
4-Methyl-N-methylcathinone 45 no change.
(mephedrone).
4-Methyl-[alpha]- 25 no change.
pyrrolidinopropiophenone (4-
MePPP).
5-(1,1-Dimethylheptyl)-2- 50 no change.
[(1R,3S)-3-hydroxycyclohexyl]-
phenol.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)- 40 no change.
3-hydroxycyclohexyl]-phenol
(cannabicyclohexanol or CP-
47,497 C8-homolog).
5F-ADB; 5F-MDMB-PINACA (methyl 2- 30 no change.
(1-(5-fluoropentyl)-1H-indazole-
3-carboxamido)-3,3-
dimethylbutanoate).
5F-AMB (methyl 2-(1-(5- 30 no change.
fluoropentyl)-1H-indazole-3-
carboxamido)-3-methylbutanoate).
5F-APINACA; 5F-AKB48 (N- 30 no change.
(adamantan-1-yl)-1-(5-
fluoropentyl)-1H-indazole-3-
carboxamide).
5-Fluoro-PB-22; 5F-PB-22........ 20 no change.
5-Fluoro-UR144, XLR11 ([1-(5- 25 no change.
fluoro-pentyl)-1Hindol-.
3-yl](2,2,3,3-
tetramethylcyclopropyl)methanon
e.
5-Methoxy-3,4- 25 no change.
methylenedioxyamphetamine.
5-Methoxy-N,N- 25 no change.
diisopropyltryptamine.
5-Methoxy-N,N-dimethyltryptamine 25 no change.
AB-CHMINACA..................... 30 no change.
AB-FUBINACA..................... 50 no change.
AB-PINACA....................... 30 no change.
ADB-FUBINACA (N-(1-amino-3,3- 30 no change.
dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-
carboxamide).
Acetyl Fentanyl................. 100 no change.
Acetyl-alpha-methylfentanyl..... 30 no change.
Acetyldihydrocodeine............ 30 no change.
Acetylmethadol.................. 2 no change.
Acryl Fentanyl.................. 25 no change.
ADB-PINACA (N-(1-amino-3,3- 50 no change.
dimethyl-1-oxobutan-2-yl)-1-
pentyl-1H-indazole-3-
carboxamide).
AH-7921......................... 30 no change.
Allylprodine.................... 2 no change.
Alphacetylmethadol.............. 2 no change.
alpha-Ethyltryptamine........... 25 no change.
Alphameprodine.................. 2 no change.
Alphamethadol................... 2 no change.
alpha-Methylfentanyl............ 30 no change.
alpha-Methylthiofentanyl........ 30 no change.
alpha-Methyltryptamine (AMT).... 25 no change.
alpha-Pyrrolidinobutiophenone 25 no change.
([alpha]-PBP).
alpha-Pyrrolidinopentiophenone 25 no change.
([alpha]-PVP).
Aminorex........................ 25 no change.
APINCA, AKB48 (N-(1-adamantyl)-1- 25 no change.
pentyl-1H-indazole-3-
carboxamide).
Benzylmorphine.................. 30 no change.
Betacetylmethadol............... 2 no change.
beta-Hydroxy-3-methylfentanyl... 30 no change.
beta-Hydroxyfentanyl............ 30 no change.
beta-Hydroxythiofentanyl........ 30 no change.
Betameprodine................... 2 no change.
Betamethadol.................... 4 no change.
Betaprodine..................... 2 no change.
Bufotenine...................... 3 no change.
Butylone........................ 25 no change.
Butyryl fentanyl................ 30 no change.
Cathinone....................... 24 no change.
Codeine methylbromide........... 30 no change.
Codeine-N-oxide................. 192 no change.
Desomorphine.................... 25 no change.
Diapromide...................... Zero 20.
Diethylthiambutene.............. Zero 20.
Diethyltryptamine............... 25 no change.
Difenoxin....................... 8,225 no change.
Dihydromorphine................. 1,000,160 no change.
Dimethyltryptamine.............. 35 50.
Dipipanone...................... 5 no change.
Etorphine....................... 30 no change.
Fenethylline.................... 30 no change.
Furanyl fentanyl................ 30 no change.
gamma-Hydroxybutyric acid....... 37,130,000 no change.
Heroin.......................... 45 no change.
Hydromorphinol.................. 40 no change.
Hydroxypethidine................ 2 no change.
Ibogaine........................ 30 no change.
JWH-018 and AM678 (1-Pentyl-3-(1- 35 no change.
naphthoyl)indole).
JWH-019 (1-Hexyl-3-(1- 45 no change.
naphthoyl)indole).
JWH-073 (1-Butyl-3-(1- 45 no change.
naphthoyl)indole).
JWH-081 (1-Pentyl-3-[1-(4- 30 no change.
methoxynaphthoyl)]indole).
JWH-122 (1-Pentyl-3-(4-methyl-1- 30 no change.
naphthoyl)indole).
[[Page 42694]]
JWH-200 (1-[2-(4- 35 no change.
Morpholinyl)ethyl]-3-(1-
naphthoyl)indole).
JWH-203 (1-Pentyl-3-(2- 30 no change.
chlorophenylacetyl)indole).
JWH-250 (1-Pentyl-3-(2- 30 no change.
methoxyphenylacetyl)indole).
JWH-398 (1-Pentyl-3-(4-chloro-1- 30 no change.
naphthoyl)indole).
Lysergic acid diethylamide (LSD) 40 no change.
MAB-CHMINACA; ADB-CHMINACA (N-(1- 30 no change.
amino-3,3-dimethyl-1-oxobutan-2-
yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide).
MDMB-CHMICA; MMB-CHMINACA(methyl 30 no change.
2-(1-(cyclohexylmethyl)-1H-
indole-3-carboxamido)-3,3-
dimethylbutanoate).
MDMB-FUBINACA (methyl 2-(1-(4- 30 no change.
fluorobenzyl)-1H-indazole-3-
carboxamido)-3,3-
dimethylbutanoate).
Marihuana....................... 443,680 1,140,216.
Mecloqualone.................... 30 no change.
Mescaline....................... 25 no change.
Methaqualone.................... 60 no change.
Methcathinone................... 25 no change.
Methyldesorphine................ 5 no change.
Methyldihydromorphine........... 2 no change.
Morphine methylbromide.......... 5 no change.
Morphine methylsulfonate........ 5 no change.
Morphine-N-oxide................ 150 no change.
N,N-Dimethylamphetamine......... 25 no change.
Naphyrone....................... 25 no change.
N-Ethyl-1-phenylcyclohexylamine. 5 no change.
N-Ethyl-3-piperidyl benzilate... Zero 10.
N-Ethylamphetamine.............. 24 no change.
N-Hydroxy-3,4- 24 no change.
methylenedioxyamphetamine.
Noracymethadol.................. 2 no change.
Norlevorphanol.................. 55 no change.
Normethadone.................... 2 no change.
Normorphine..................... 40 no change.
Para-fluorofentanyl............. 25 no change.
Parahexyl....................... 5 no change.
PB-22; QUPIC.................... 20 no change.
Pentedrone...................... 25 no change.
Pentylone....................... 25 no change.
Phenomorphan.................... 2 no change.
Pholcodine...................... 5 no change.
Psilocybin...................... 30 no change.
Psilocyn........................ 50 no change.
SR-18 and RCS-8 (1- 45 no change.
Cyclohexylethyl-3-(2-
methoxyphenylacetyl)indole).
SR-19 and RCS-4 (1-Pentyl-3-[(4- 30 no change.
methoxy)-benzoyl]indole).
Tetrahydrocannabinols........... 384,460 no change.
Thiofentanyl.................... 25 no change.
THJ-2201 ( [1-(5-fluoropentyl)- 30 no change.
1H-indazol-3-yl](naphthalen-1-
yl)methanone).
Tilidine........................ 25 no change.
Trimeperidine................... 2 no change.
UR-144 (1-pentyl-1H-indol-3- 25 no change.
yl)(2,2,3,3-
tetramethylcyclopropyl)methanon
e.
U-47700......................... 30 no change.
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine......... 4 15.
1- 4 25.
Piperidinocyclohexanecarbonitri
le.
4-Anilino-N-phenethyl-4- 1,342,320 no change.
piperidine (ANPP).
Alfentanil...................... 6,200 no change.
Alphaprodine.................... 2 no change.
Amobarbital..................... 20,100 no change.
Amphetamine (for conversion).... 11,280,000 12,700,000.
Amphetamine (for sale).......... 39,856,000 no change.
Anileridine..................... Zero 20.
Carfentanil..................... 20 no change.
Cocaine......................... 92,120 no change.
Codeine (for conversion)........ 15,040,000 12,900,000.
Codeine (for sale).............. 40,015,000 no change.
Dextropropoxyphene.............. 35 no change.
Dihydrocodeine.................. 264,140 no change.
Dihydroetorphine................ 2 no change.
Diphenoxylate (for conversion).. 14,100 no change.
Diphenoxylate (for sale)........ 770,800 no change.
Ecgonine........................ 88,134 no change.
Ethylmorphine................... 30 no change.
[[Page 42695]]
Etorphine hydrochloride......... 32 no change.
Fentanyl........................ 1,342,320 no change.
Glutethimide.................... 2 no change.
Hydrocodone (for conversion).... 114,680 no change.
Hydrocodone (for sale).......... 50,348,280 44,710,000.
Hydromorphone................... 4,547,720 no change.
Isomethadone.................... 30 no change.
Levo-alphacetylmethadol (LAAM).. 5 no change.
Levomethorphan.................. 30 2,200.
Levorphanol..................... 12,126 38,000.
Lisdexamfetamine................ 17,869,000 19,000,000.
Meperidine...................... 2,717,540 1,913,148.
Meperidine Intermediate-A....... 5 30.
Meperidine Intermediate-B....... 30 no change.
Meperidine Intermediate-C....... 5 30.
Metazocine...................... 15 no change.
Methadone (for sale)............ 22,278,000 no change.
Methadone Intermediate.......... 24,064,000 no change.
Methamphetamine................. 1,446,754 no change.
------------------------------------------------------------------------
[846,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 564,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 36,754 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate................. 64,600,000 no change.
Morphine (for conversion)....... 4,089,000 no change.
Morphine (for sale)............. 33,958,440 31,456,000.
Nabilone........................ 31,000 62,000.
Noroxymorphone (for conversion). 14,044,540 16,440,000.
Noroxymorphone (for sale)....... 376,000 no change.
Opium (powder).................. 84,600 no change.
Opium (tincture)................ 564,000 no change.
Oripavine....................... 24,534,000 no change.
Oxycodone (for conversion)...... 2,453,400 no change.
Oxycodone (for sale)............ 95,692,000 85,578,000.
Oxymorphone (for conversion).... 20,962,000 no change.
Oxymorphone (for sale).......... 3,395,280 3,137,240.
Pentobarbital................... 25,850,000 no change.
Phenazocine..................... 5 no change.
Phencyclidine................... 35 no change.
Phenmetrazine................... 25 no change.
Phenylacetone................... 40 no change.
Racemethorphan.................. 5 no change.
Racemorphan..................... 5 no change.
Remifentanil.................... 2,820 3,000.
Secobarbital.................... 161,682 172,100.
Sufentanil...................... 1,880 no change.
Tapentadol...................... 18,388,280 no change.
Thebaine........................ 94,000,000 86,200,000.
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)...... 47,000 no change.
Ephedrine (for sale)............ 4,136,000 no change.
Phenylpropanolamine (for 14,100,000 no change.
conversion).
Phenylpropanolamine (for sale).. 7,990,000 no change.
Pseudoephedrine (for conversion) 40 1,000.
Pseudoephedrine (for sale)...... 180,000,000 no change.
------------------------------------------------------------------------
The Acting Administrator further proposes that aggregate production
quotas for all other schedule I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR
1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors,
the Acting Administrator may adjust the 2018 aggregate production
quotas and assessment of annual needs as needed.
Conclusion
After consideration of any comments or objections, or after a
hearing, if one is held, the Acting Administrator will issue and
publish in the Federal Register a final order establishing any
adjustment of 2018 aggregate production quotas for each basic class of
controlled substances in schedules I and II and established assessment
of annual needs for the list I chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine, 21 CFR 1303.13(c) and 1315.13(f).
[[Page 42696]]
Dated: August 17, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-18265 Filed 8-22-18; 8:45 am]
BILLING CODE 4410-09-P
