Established 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 2017, 69079-69083 [2016-23988]
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Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Notices
request by a Commissioner or
Commission staff.
In accordance with sections 201.16(c)
and 207.3 of the Commission’s rules,
each document filed by a party to the
reviews must be served on all other
parties to the reviews (as identified by
either the public or BPI service list), and
a certificate of service must be timely
filed. The Secretary will not accept a
document for filing without a certificate
of service.
The Commission has determined that
these reviews are extraordinarily
complicated and therefore has
determined to exercise its authority to
extend the review period by up to 90
days pursuant to 19 U.S.C.
1675(c)(5)(B).
Authority: These reviews are being
conducted under authority of title VII of the
Tariff Act of 1930; this notice is published
pursuant to section 207.62 of the
Commission’s rules.
By order of the Commission.
Issued: September 30, 2016.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2016–24059 Filed 10–4–16; 8:45 am]
751(c) of the Act (19 U.S.C. 1675(c)). It
completed and filed its determination in
this review on September 29, 2016. The
views of the Commission are contained
in USITC Publication 4639 (September
2016), entitled Hot-Rolled Flat-Rolled
Carbon-Quality Steel Products from
Russia: Investigation No. 731–TA–808
(Third Review).
By order of the Commission.
Issued: September 29, 2016.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2016–23994 Filed 10–4–16; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–443F]
Established 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 2017
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
BILLING CODE 7020–02–P
AGENCY:
INTERNATIONAL TRADE
COMMISSION
SUMMARY:
[Investigation No. 731–TA–808 (Third
Review)]
Hot-Rolled Flat-Rolled Carbon-Quality
Steel Products From Russia
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Determination
On the basis of the record1 developed
in the subject five-year review, the
United States International Trade
Commission (‘‘Commission’’)
determines, pursuant to the Tariff Act of
1930 (‘‘the Act’’), that revocation of the
antidumping duty order on hot-rolled
flat-rolled carbon-quality steel products
from Russia would be likely to lead to
continuation or recurrence of material
injury to an industry in the United
States within a reasonably foreseeable
time.
Background
The Commission, pursuant to section
751(c) of the Act (19 U.S.C. 1675(c)),
instituted this review on May 2, 2016
(81 FR 26256) and determined on
August 5, 2016 that it would conduct an
expedited review (81 FR 58531, August
25, 2016).
The Commission made this
determination pursuant to section
1 The
record is defined in sec. 207.2(f) of the
Commission’s Rules of Practice and Procedure (19
CFR 207.2(f)).
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This final order establishes
the initial 2017 aggregate production
quotas for controlled substances in
schedules I and II of the Controlled
Substances Act (CSA) and the
assessment of annual needs for the list
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine.
DATES: Effective October 5, 2016.
FOR FURTHER INFORMATION CONTACT:
Michael J. Lewis, Diversion Control
Division, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (202)
598–6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
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.
Background
The 2017 aggregate production quotas
and assessment of annual needs
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69079
represent those quantities of schedule I
and II controlled substances and the list
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine that may be
manufactured in the United States in
2017 to provide for the estimated
medical, scientific, research, and
industrial needs of the United States,
lawful export requirements, and the
establishment and maintenance of
reserve stocks. These quotas include
imports of ephedrine, pseudoephedrine,
and phenylpropanolamine, but do not
include imports of controlled
substances for use in industrial
processes.
On July 22, 2016, a notice titled
‘‘Proposed 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 2017’’ was
published in the Federal Register. 81 FR
47821. This notice proposed the 2017
aggregate production quotas for each
basic class of controlled substance listed
in schedules I and II and the 2017
assessment of annual needs for the list
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine. All interested
persons were invited to comment on or
object to the proposed aggregate
production quotas and the proposed
assessment of annual needs on or before
August 22, 2016.
Comments Received
Thirteen comments were received
from five DEA-registered manufacturers
and four non-DEA registered entities
within the published comment period
regarding 22 different schedule I and II
controlled substances. The DEA
received two comments from two nonDEA registered entities within the
published comment period regarding
the proposed assessment of annual
needs for the list I chemical ephedrine
(for sale). Commenters stated that the
proposed aggregate production quotas
for acetyl fentanyl, AH-7921,
amphetamine (for conversion),
amphetamine (for sale), betahydroxythiofentanyl, butyryl fentanyl,
cocaine, codeine (for conversion),
codeine (for sale), dihydrocodeine,
ecgonine, hydrocodone (for sale),
hydromorphone, levorphanol,
lisdexamfetamine, marihuana,
meperidine, methylphenidate, nabilone,
opium tincture, oxycodone (for sale),
and sufentanil, as well as, the proposed
assessment of annual needs for
ephedrine (for sale) were insufficient to
provide for the estimated medical,
scientific, research, and industrial needs
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Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Notices
of the United States, export
requirements, and the establishment
and maintenance of reserve stocks.
The DEA received one comment from
a DEA-registrant and three comments by
non-DEA registered entities regarding
the proposed removal of the additional
25% of the estimated medical,
scientific, and research needs for the
United States. Two of the commenters
requested that the DEA continue to
include the additional 25%, one
commenter requested transparency in
the process of setting aggregate
production quotas, and the last
commenter agreed with the DEA that
the additional 25% should not be
included in aggregate production quotas
values. The DEA has considered these
comments, as well as the ones for
specific controlled substances and
ephedrine (for sale), in establishing the
2017 aggregate production quotas and
assessment of annual needs.
Determination of 2017 Aggregate
Production Quotas and Assessment of
Annual Needs
In determining the 2017 aggregate
production quotas and assessment of
annual needs, the DEA has taken into
consideration the above comments
along with the factors set forth in 21
CFR 1303.11 and 21 CFR 1315.11, in
accordance with 21 U.S.C. 826(a), and
other relevant factors, including the
2016 manufacturing quotas, current
2016 sales and inventories, anticipated
2017 export requirements, industrial
use, and additional applications for
2017 quotas, as well as information on
research and product development
requirements. Based on this
information, the DEA has removed the
additional 25% from the aggregate
production quotas before determining
that adjustments to the proposed
aggregate production quotas for 4anilino-n-phenethyl-piperidine,
amphetamine (for conversion),
amphetamine (for sale), cocaine,
dihydrocodeine, ecgonine, etorphine
hydrochloride, hydromorphone,
levorphanol, lysergic acid
dimethylamide, nabilone, opium
tincture, and oripavine are warranted.
Adjustment to the proposed annual
assessment of needs for ephedrine (for
sale) was also determined to be
warranted. This final order reflects
those adjustments.
Regarding acetyl fentanyl, AH-7921,
beta-hydroxythiofentanyl, butyryl
fentanyl, codeine (for conversion),
codeine (for sale), hydrocodone (for
sale), lisdexamfetamine, marihuana,
meperidine, methylphenidate,
oxycodone (for sale), and sufentanil, the
DEA has determined that the proposed
aggregate production quotas are
sufficient to provide for the 2017
estimated medical, scientific, research,
and industrial needs of the United
States, export requirements, and the
establishment and maintenance of
reserve stocks. This final order
establishes these aggregate production
quotas at the same amounts as
proposed.
In accordance with 21 U.S.C. 826, 21
CFR 1303.11, and 21 CFR 1315.11, the
Administrator hereby establishes the
2017 aggregate production quotas for the
following schedule I and II controlled
substances and the 2017 assessment of
annual needs for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine, expressed in
grams of anhydrous acid or base, as
follows:
2017
Established
quotas
(g)
Basic class
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Schedule I
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) ......................................................................................
1-(1-Phenylcyclohexyl)pyrrolidine ........................................................................................................................................................
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ............................................................................................................................
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ...........................................................................................................................
1-[1-(2-Thienyl)cyclohexyl]piperidine ...................................................................................................................................................
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200) ...............................................................................................................
1-Benzylpiperazine ..............................................................................................................................................................................
1-Butyl-3-(1-naphthoyl)indole (JWH-073) ............................................................................................................................................
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and RCS-8) ...........................................................................................
1-Hexyl-3-(1-naphthoyl)indole (JWH-019) ...........................................................................................................................................
1-Methyl-4-phenyl-4-propionoxypiperidine ...........................................................................................................................................
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678) ......................................................................................................................
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203) ............................................................................................................................
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250) ........................................................................................................................
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398) ............................................................................................................................
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122) ...........................................................................................................................
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4) ....................................................................................................................
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081) .......................................................................................................................
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; Cimbi-36) .......................
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; Cimbi-82) ........................
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 ............................................................................................................................................................
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10
30
30
15
35
25
45
45
45
2
35
30
30
30
30
30
30
30
30
30
30
30
25
30
25
30
5
25
25
25
30
30
25
Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Notices
2017
Established
quotas
(g)
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Basic class
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-FMC; Flephedrone ............................................................................................................................................................................
4-Methoxyamphetamine ......................................................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (DOM) ......................................................................................................................................
4-Methylaminorex ................................................................................................................................................................................
4-MEC; 4-Methyl-N-ethylcathinone ......................................................................................................................................................
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) ...........................
5-Fluoro-UR144, XLR11 ......................................................................................................................................................................
5-Methoxy-3,4-methylenedioxyamphetamine ......................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine ..................................................................................................................................................
5-Methoxy-N,N-dimethyltryptamine .....................................................................................................................................................
AB-PINACA ..........................................................................................................................................................................................
Acetyl-alpha-methylfentanyl .................................................................................................................................................................
Acetyldihydrocodeine ...........................................................................................................................................................................
Acetylmethadol ....................................................................................................................................................................................
AH-7921 ...............................................................................................................................................................................................
Allylprodine ..........................................................................................................................................................................................
alpha-Ethyltryptamine ..........................................................................................................................................................................
alpha-Methylfentanyl ............................................................................................................................................................................
alpha-Methylthiofentanyl ......................................................................................................................................................................
alpha-Methyltryptamine (AMT) ............................................................................................................................................................
alpha-Pyrrolidinobutiophenone (a-PBP) ..............................................................................................................................................
alpha-Pyrrolidinopentiophenone (a-PVP) ............................................................................................................................................
Alphacetylmethadol ..............................................................................................................................................................................
Alphameprodine ...................................................................................................................................................................................
Alphamethadol .....................................................................................................................................................................................
Aminorex ..............................................................................................................................................................................................
APINCA, AKB48 ..................................................................................................................................................................................
Benzylmorphine ...................................................................................................................................................................................
beta-Hydroxy-3-methylfentanyl ............................................................................................................................................................
beta-Hydroxyfentanyl ...........................................................................................................................................................................
beta-Hydroxythiofentanyl .....................................................................................................................................................................
Betacetylmethadol ...............................................................................................................................................................................
Betameprodine .....................................................................................................................................................................................
Betamethadol .......................................................................................................................................................................................
Betaprodine ..........................................................................................................................................................................................
Bufotenine ............................................................................................................................................................................................
Butylone ...............................................................................................................................................................................................
Butyryl fentanyl ....................................................................................................................................................................................
Cathinone .............................................................................................................................................................................................
Codeine methylbromide .......................................................................................................................................................................
Codeine-N-oxide ..................................................................................................................................................................................
Desomorphine ......................................................................................................................................................................................
Diethyltryptamine .................................................................................................................................................................................
Difenoxin ..............................................................................................................................................................................................
Dihydromorphine ..................................................................................................................................................................................
Dimethyltryptamine ..............................................................................................................................................................................
Dipipanone ...........................................................................................................................................................................................
Fenethylline ..........................................................................................................................................................................................
gamma-Hydroxybutyric acid ................................................................................................................................................................
Heroin ..................................................................................................................................................................................................
Hydromorphinol ....................................................................................................................................................................................
Hydroxypethidine .................................................................................................................................................................................
Ibogaine ...............................................................................................................................................................................................
Lysergic acid diethylamide (LSD) ........................................................................................................................................................
Marihuana ............................................................................................................................................................................................
Mescaline .............................................................................................................................................................................................
Methaqualone ......................................................................................................................................................................................
Methcathinone .....................................................................................................................................................................................
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05OCN1
55
50
40
40
35
25
2
2
25
25
25
150
25
25
25
45
25
50
40
25
25
25
25
15
2
2
2
30
2
25
2
2
25
25
25
2
2
2
25
25
2
2
2
30
2
2
4
2
3
25
30
24
5
305
25
25
8,750
1,566,000
35
5
5
56,200,000
25
2
2
5
15
472,000
25
10
25
69082
Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Notices
2017
Established
quotas
(g)
Basic class
Methyldesorphine .................................................................................................................................................................................
Methyldihydromorphine ........................................................................................................................................................................
Morphine methylbromide .....................................................................................................................................................................
Morphine methylsulfonate ....................................................................................................................................................................
Morphine-N-oxide ................................................................................................................................................................................
N,N-Dimethylamphetamine ..................................................................................................................................................................
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA) .....................................................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) ..........................................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA) ....................................
N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl) ....................................................................................................
N-Ethyl-1-phenylcyclohexylamine ........................................................................................................................................................
N-Ethylamphetamine ...........................................................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ......................................................................................................................................
Naphyrone ...........................................................................................................................................................................................
Noracymethadol ...................................................................................................................................................................................
Norlevorphanol .....................................................................................................................................................................................
Normethadone .....................................................................................................................................................................................
Normorphine ........................................................................................................................................................................................
Para-fluorofentanyl ...............................................................................................................................................................................
Parahexyl .............................................................................................................................................................................................
Pentedrone ..........................................................................................................................................................................................
Pentylone .............................................................................................................................................................................................
Phenomorphan ....................................................................................................................................................................................
Pholcodine ...........................................................................................................................................................................................
Psilocybin .............................................................................................................................................................................................
Psilocyn ................................................................................................................................................................................................
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22) ........................................................................
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC) ........................................................................................................
Tetrahydrocannabinols ........................................................................................................................................................................
Thiofentanyl .........................................................................................................................................................................................
Tilidine ..................................................................................................................................................................................................
Trimeperidine .......................................................................................................................................................................................
UR-144 .................................................................................................................................................................................................
5
2
5
5
350
25
50
50
15
100
5
24
24
25
2
52
2
40
5
5
25
25
2
5
30
50
20
20
409,000
2
25
2
25
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Schedule II
1-Phenylcyclohexylamine ....................................................................................................................................................................
1-Piperidinocyclohexanecarbonitrile ....................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .........................................................................................................................................
Alfentanil ..............................................................................................................................................................................................
Alphaprodine ........................................................................................................................................................................................
Amobarbital ..........................................................................................................................................................................................
Amphetamine (for conversion) ............................................................................................................................................................
Amphetamine (for sale) .......................................................................................................................................................................
Carfentanil ............................................................................................................................................................................................
Cocaine ................................................................................................................................................................................................
Codeine (for conversion) .....................................................................................................................................................................
Codeine (for sale) ................................................................................................................................................................................
Dextropropoxyphene ............................................................................................................................................................................
Dihydrocodeine ....................................................................................................................................................................................
Dihydroetorphine ..................................................................................................................................................................................
Diphenoxylate (for conversion) ............................................................................................................................................................
Diphenoxylate (for sale) .......................................................................................................................................................................
Ecgonine ..............................................................................................................................................................................................
Ethylmorphine ......................................................................................................................................................................................
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 ...........................................................................................................................................................................................
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4
4
1,750,000
4,200
2
20,100
12,000,000
42,400,000
10
103,400
40,000,000
45,000,000
15
281,100
2
15,000
820,000
99,000
2
32
1,750,000
2
122,000
58,410,000
5,140,800
4
3
10
8,300
19,000,000
3,706,000
5
9
5
15
Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Notices
69083
2017
Established
quotas
(g)
Basic class
Methadone (for sale) ...........................................................................................................................................................................
Methadone Intermediate ......................................................................................................................................................................
Methamphetamine ...............................................................................................................................................................................
23,700,000
25,600,000
1,539,100
[900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 600,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 39,100 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 ..............................................................................................................................................................................................
73,000,000
27,300,000
41,000,000
19,000
17,700,000
400,000
90,000
907,200
22,000,000
2,610,000
108,510,000
22,300,000
4,200,000
27,500,000
5
20
2
20
2
2
3,000
172,002
4,000
21,000,000
100,000,000
List I Chemicals
Ephedrine (for conversion) ..................................................................................................................................................................
Ephedrine (for sale) .............................................................................................................................................................................
Phenylpropanolamine (for conversion) ................................................................................................................................................
Phenylpropanolamine (for sale) ...........................................................................................................................................................
Pseudoephedrine (for conversion) ......................................................................................................................................................
Pseudoephedrine (for sale) .................................................................................................................................................................
The Administrator also establishes
aggregate production quotas for all other
schedule I and II controlled substances
included in 21 CFR 1308.11 and
1308.12 at zero. In accordance with 21
CFR 1303.13 and 21 CFR 1315.13, upon
consideration of the relevant factors, the
Administrator may adjust the 2017
aggregate production quotas and
assessment of annual needs as needed.
Dated: September 26, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016–23988 Filed 10–4–16; 8:45 am]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act
On September 29, 2016, the
Department of Justice lodged a proposed
VerDate Sep<11>2014
18:15 Oct 04, 2016
Jkt 241001
Consent Decree with the United States
District Court for the Northern District
of California in the lawsuit entitled
United States v. Chemoil Corporation,
Civil Action No. 16–5538.
The United States alleges that in 2011,
2012, and 2013 Chemoil violated
Section 211(o) of the Clean Air Act
(‘‘CAA’’), 42 U.S.C. § 7545(o), and the
Renewable Fuel Standard, 40 CFR part
80 (‘‘RFS2’’), by exporting renewable
fuel without retiring at least 72.7
million Biomass-Based Diesel (D4)
credits (Renewable Identification
Numbers or ‘‘RINs’’) which it was
required to do in order to meet its
Renewable Volume Obligation (‘‘RVO’’).
The United States further alleges that
Chemoil failed to submit to the
Environmental Protection Agency
required reports related to its export
activity. To remedy these alleged
violations, the proposed Consent Decree
requires Chemoil to pay a civil penalty
of $27 million and retire 65 million D4
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
50,000
5,360,000
15,000,000
8,500,000
40
200,000,000
RINs in addition to the 7.7 million RINs
Chemoil retired in March of this year.
The publication of this notice opens
a period for public comment on the
Consent Decree. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, Environmental
Enforcement Section and should refer to
United States v. Chemoil Corporation,
D.J. Ref. No. 90–5–2–1–11066. All
comments must be submitted no later
than thirty (30) days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
To submit
comments:
Send them to:
By email .......
pubcommentees.enrd@usdoj.gov.
E:\FR\FM\05OCN1.SGM
05OCN1
Agencies
[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
[Notices]
[Pages 69079-69083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23988]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-443F]
Established 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 2017
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: This final order establishes the initial 2017 aggregate
production quotas for controlled substances in schedules I and II of
the Controlled Substances Act (CSA) and the assessment of annual needs
for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: Effective October 5, 2016.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control
Division, Drug Enforcement Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (202) 598-6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
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.
Background
The 2017 aggregate production quotas and assessment of annual needs
represent those quantities of schedule I and II controlled substances
and the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine that may be manufactured in the United States in
2017 to provide for the estimated medical, scientific, research, and
industrial needs of the United States, lawful export requirements, and
the establishment and maintenance of reserve stocks. These quotas
include imports of ephedrine, pseudoephedrine, and phenylpropanolamine,
but do not include imports of controlled substances for use in
industrial processes.
On July 22, 2016, a notice titled ``Proposed 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 2017'' was published in the Federal Register.
81 FR 47821. This notice proposed the 2017 aggregate production quotas
for each basic class of controlled substance listed in schedules I and
II and the 2017 assessment of annual needs for the list I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine. All interested
persons were invited to comment on or object to the proposed aggregate
production quotas and the proposed assessment of annual needs on or
before August 22, 2016.
Comments Received
Thirteen comments were received from five DEA-registered
manufacturers and four non-DEA registered entities within the published
comment period regarding 22 different schedule I and II controlled
substances. The DEA received two comments from two non-DEA registered
entities within the published comment period regarding the proposed
assessment of annual needs for the list I chemical ephedrine (for
sale). Commenters stated that the proposed aggregate production quotas
for acetyl fentanyl, AH-7921, amphetamine (for conversion), amphetamine
(for sale), beta-hydroxythiofentanyl, butyryl fentanyl, cocaine,
codeine (for conversion), codeine (for sale), dihydrocodeine, ecgonine,
hydrocodone (for sale), hydromorphone, levorphanol, lisdexamfetamine,
marihuana, meperidine, methylphenidate, nabilone, opium tincture,
oxycodone (for sale), and sufentanil, as well as, the proposed
assessment of annual needs for ephedrine (for sale) were insufficient
to provide for the estimated medical, scientific, research, and
industrial needs
[[Page 69080]]
of the United States, export requirements, and the establishment and
maintenance of reserve stocks.
The DEA received one comment from a DEA-registrant and three
comments by non-DEA registered entities regarding the proposed removal
of the additional 25% of the estimated medical, scientific, and
research needs for the United States. Two of the commenters requested
that the DEA continue to include the additional 25%, one commenter
requested transparency in the process of setting aggregate production
quotas, and the last commenter agreed with the DEA that the additional
25% should not be included in aggregate production quotas values. The
DEA has considered these comments, as well as the ones for specific
controlled substances and ephedrine (for sale), in establishing the
2017 aggregate production quotas and assessment of annual needs.
Determination of 2017 Aggregate Production Quotas and Assessment of
Annual Needs
In determining the 2017 aggregate production quotas and assessment
of annual needs, the DEA has taken into consideration the above
comments along with the factors set forth in 21 CFR 1303.11 and 21 CFR
1315.11, in accordance with 21 U.S.C. 826(a), and other relevant
factors, including the 2016 manufacturing quotas, current 2016 sales
and inventories, anticipated 2017 export requirements, industrial use,
and additional applications for 2017 quotas, as well as information on
research and product development requirements. Based on this
information, the DEA has removed the additional 25% from the aggregate
production quotas before determining that adjustments to the proposed
aggregate production quotas for 4-anilino-n-phenethyl-piperidine,
amphetamine (for conversion), amphetamine (for sale), cocaine,
dihydrocodeine, ecgonine, etorphine hydrochloride, hydromorphone,
levorphanol, lysergic acid dimethylamide, nabilone, opium tincture, and
oripavine are warranted. Adjustment to the proposed annual assessment
of needs for ephedrine (for sale) was also determined to be warranted.
This final order reflects those adjustments.
Regarding acetyl fentanyl, AH-7921, beta-hydroxythiofentanyl,
butyryl fentanyl, codeine (for conversion), codeine (for sale),
hydrocodone (for sale), lisdexamfetamine, marihuana, meperidine,
methylphenidate, oxycodone (for sale), and sufentanil, the DEA has
determined that the proposed aggregate production quotas are sufficient
to provide for the 2017 estimated medical, scientific, research, and
industrial needs of the United States, export requirements, and the
establishment and maintenance of reserve stocks. This final order
establishes these aggregate production quotas at the same amounts as
proposed.
In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR
1315.11, the Administrator hereby establishes the 2017 aggregate
production quotas for the following schedule I and II controlled
substances and the 2017 assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine,
expressed in grams of anhydrous acid or base, as follows:
------------------------------------------------------------------------
2017
Basic class Established
quotas (g)
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1- 15
yl)methanone (THJ-2201)................................
1-(1-Phenylcyclohexyl)pyrrolidine....................... 10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)....... 30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)...... 30
1-[1-(2-Thienyl)cyclohexyl]piperidine................... 15
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 35
200)...................................................
1-Benzylpiperazine...................................... 25
1-Butyl-3-(1-naphthoyl)indole (JWH-073)................. 45
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 45
and RCS-8).............................................
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)................. 45
1-Methyl-4-phenyl-4-propionoxypiperidine................ 2
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)...... 35
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)....... 30
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)...... 30
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)....... 30
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)....... 30
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)... 30
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)..... 30
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)........ 30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)....... 30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)....... 30
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)..... 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)................ 30
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- 25
methoxybenzyl)ethanamine (25B-NBOMe; 2C-;B-NBOMe; 25B;
Cimbi-36)..............................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)....... 30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2- 25
methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
Cimbi-82)..............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)......... 30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2- 5
methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
Cimbi-5)...............................................
2,5-Dimethoxy-4-ethylamphetamine (DOET)................. 25
2,5-Dimethoxy-4-n-propylthiophenethylamine.............. 25
2,5-Dimethoxyamphetamine................................ 25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) 30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C- 30
T-4)...................................................
3,4,5-Trimethoxyamphetamine............................. 25
[[Page 69081]]
3,4-Methylenedioxyamphetamine (MDA)..................... 55
3,4-Methylenedioxymethamphetamine (MDMA)................ 50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............ 40
3,4-Methylenedioxy-N-methylcathinone (methylone)........ 40
3,4-Methylenedioxypyrovalerone (MDPV)................... 35
3-FMC; 3-Fluoro-N-methylcathinone....................... 25
3-Methylfentanyl........................................ 2
3-Methylthiofentanyl.................................... 2
4-Bromo-2,5-dimethoxyamphetamine (DOB).................. 25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB).............. 25
4-FMC; Flephedrone...................................... 25
4-Methoxyamphetamine.................................... 150
4-Methyl-2,5-dimethoxyamphetamine (DOM)................. 25
4-Methylaminorex........................................ 25
4-MEC; 4-Methyl-N-ethylcathinone........................ 25
4-Methyl-N-methylcathinone (mephedrone)................. 45
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP)..... 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 50
phenol.................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 40
phenol (cannabicyclohexanol or CP-47,497 C8-homolog)...
5-Fluoro-UR144, XLR11................................... 25
5-Methoxy-3,4-methylenedioxyamphetamine................. 25
5-Methoxy-N,N-diisopropyltryptamine..................... 25
5-Methoxy-N,N-dimethyltryptamine........................ 25
AB-PINACA............................................... 15
Acetyl-alpha-methylfentanyl............................. 2
Acetyldihydrocodeine.................................... 2
Acetylmethadol.......................................... 2
AH-7921................................................. 30
Allylprodine............................................ 2
alpha-Ethyltryptamine................................... 25
alpha-Methylfentanyl.................................... 2
alpha-Methylthiofentanyl................................ 2
alpha-Methyltryptamine (AMT)............................ 25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP)............. 25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............ 25
Alphacetylmethadol...................................... 2
Alphameprodine.......................................... 2
Alphamethadol........................................... 2
Aminorex................................................ 25
APINCA, AKB48........................................... 25
Benzylmorphine.......................................... 2
beta-Hydroxy-3-methylfentanyl........................... 2
beta-Hydroxyfentanyl.................................... 2
beta-Hydroxythiofentanyl................................ 30
Betacetylmethadol....................................... 2
Betameprodine........................................... 2
Betamethadol............................................ 4
Betaprodine............................................. 2
Bufotenine.............................................. 3
Butylone................................................ 25
Butyryl fentanyl........................................ 30
Cathinone............................................... 24
Codeine methylbromide................................... 5
Codeine-N-oxide......................................... 305
Desomorphine............................................ 25
Diethyltryptamine....................................... 25
Difenoxin............................................... 8,750
Dihydromorphine......................................... 1,566,000
Dimethyltryptamine...................................... 35
Dipipanone.............................................. 5
Fenethylline............................................ 5
gamma-Hydroxybutyric acid............................... 56,200,000
Heroin.................................................. 25
Hydromorphinol.......................................... 2
Hydroxypethidine........................................ 2
Ibogaine................................................ 5
Lysergic acid diethylamide (LSD)........................ 15
Marihuana............................................... 472,000
Mescaline............................................... 25
Methaqualone............................................ 10
Methcathinone........................................... 25
[[Page 69082]]
Methyldesorphine........................................ 5
Methyldihydromorphine................................... 2
Morphine methylbromide.................................. 5
Morphine methylsulfonate................................ 5
Morphine-N-oxide........................................ 350
N,N-Dimethylamphetamine................................. 25
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H- 50
indazole-3-carboxamide (ADB-PINACA)....................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)- 50
1H-indazole-3-carboxamide (AB-FUBINACA)................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1- 15
(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-
CHMINACA)..............................................
N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl 100
fentanyl)..............................................
N-Ethyl-1-phenylcyclohexylamine......................... 5
N-Ethylamphetamine...................................... 24
N-Hydroxy-3,4-methylenedioxyamphetamine................. 24
Naphyrone............................................... 25
Noracymethadol.......................................... 2
Norlevorphanol.......................................... 52
Normethadone............................................ 2
Normorphine............................................. 40
Para-fluorofentanyl..................................... 5
Parahexyl............................................... 5
Pentedrone.............................................. 25
Pentylone............................................... 25
Phenomorphan............................................ 2
Pholcodine.............................................. 5
Psilocybin.............................................. 30
Psilocyn................................................ 50
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate 20
(5-fluoro-PB-22; 5F-PB-22).............................
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; 20
QUPIC).................................................
Tetrahydrocannabinols................................... 409,000
Thiofentanyl............................................ 2
Tilidine................................................ 25
Trimeperidine........................................... 2
UR-144.................................................. 25
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................................. 4
1-Piperidinocyclohexanecarbonitrile..................... 4
4-Anilino-N-phenethyl-4-piperidine (ANPP)............... 1,750,000
Alfentanil.............................................. 4,200
Alphaprodine............................................ 2
Amobarbital............................................. 20,100
Amphetamine (for conversion)............................ 12,000,000
Amphetamine (for sale).................................. 42,400,000
Carfentanil............................................. 10
Cocaine................................................. 103,400
Codeine (for conversion)................................ 40,000,000
Codeine (for sale)...................................... 45,000,000
Dextropropoxyphene...................................... 15
Dihydrocodeine.......................................... 281,100
Dihydroetorphine........................................ 2
Diphenoxylate (for conversion).......................... 15,000
Diphenoxylate (for sale)................................ 820,000
Ecgonine................................................ 99,000
Ethylmorphine........................................... 2
Etorphine hydrochloride................................. 32
Fentanyl................................................ 1,750,000
Glutethimide............................................ 2
Hydrocodone (for conversion)............................ 122,000
Hydrocodone (for sale).................................. 58,410,000
Hydromorphone........................................... 5,140,800
Isomethadone............................................ 4
Levo-alphacetylmethadol (LAAM).......................... 3
Levomethorphan.......................................... 10
Levorphanol............................................. 8,300
Lisdexamfetamine........................................ 19,000,000
Meperidine.............................................. 3,706,000
Meperidine Intermediate-A............................... 5
Meperidine Intermediate-B............................... 9
Meperidine Intermediate-C............................... 5
Metazocine.............................................. 15
[[Page 69083]]
Methadone (for sale).................................... 23,700,000
Methadone Intermediate.................................. 25,600,000
Methamphetamine......................................... 1,539,100
------------------------------------------------------------------------
[900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 600,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 39,100 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate......................................... 73,000,000
Morphine (for conversion)............................... 27,300,000
Morphine (for sale)..................................... 41,000,000
Nabilone................................................ 19,000
Noroxymorphone (for conversion)......................... 17,700,000
Noroxymorphone (for sale)............................... 400,000
Opium (powder).......................................... 90,000
Opium (tincture)........................................ 907,200
Oripavine............................................... 22,000,000
Oxycodone (for conversion).............................. 2,610,000
Oxycodone (for sale).................................... 108,510,000
Oxymorphone (for conversion)............................ 22,300,000
Oxymorphone (for sale).................................. 4,200,000
Pentobarbital........................................... 27,500,000
Phenazocine............................................. 5
Phencyclidine........................................... 20
Phenmetrazine........................................... 2
Phenylacetone........................................... 20
Racemethorphan.......................................... 2
Racemorphan............................................. 2
Remifentanil............................................ 3,000
Secobarbital............................................ 172,002
Sufentanil.............................................. 4,000
Tapentadol.............................................. 21,000,000
Thebaine................................................ 100,000,000
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion).............................. 50,000
Ephedrine (for sale).................................... 5,360,000
Phenylpropanolamine (for conversion).................... 15,000,000
Phenylpropanolamine (for sale).......................... 8,500,000
Pseudoephedrine (for conversion)........................ 40
Pseudoephedrine (for sale).............................. 200,000,000
------------------------------------------------------------------------
The Administrator also establishes aggregate production quotas for
all other schedule I and II controlled substances included in 21 CFR
1308.11 and 1308.12 at zero. In accordance with 21 CFR 1303.13 and 21
CFR 1315.13, upon consideration of the relevant factors, the
Administrator may adjust the 2017 aggregate production quotas and
assessment of annual needs as needed.
Dated: September 26, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-23988 Filed 10-4-16; 8:45 am]
BILLING CODE 4410-09-P