Established Aggregate Production Quotas for Schedule I and II Controlled Substances and Established Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2013, 59980-59983 [2012-24089]
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59980
Federal Register / Vol. 77, No. 190 / Monday, October 1, 2012 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–365]
Established Aggregate Production
Quotas for Schedule I and II Controlled
Substances and Established
Assessment of Annual Needs for the
List I Chemicals Ephedrine,
Pseudoephedrine, and
Phenylpropanolamine for 2013
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Notice.
AGENCY:
This notice establishes the
initial 2013 aggregate production quotas
for controlled substances in schedules I
and II of the Controlled Substances Act
(CSA) and assessment of annual needs
for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine.
SUMMARY:
Effective Date: October 1, 2012.
John
W. Partridge, Executive Assistant, Office
of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (202)
307–4654.
SUPPLEMENTARY INFORMATION: Section
306 of the 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. This
responsibility has been delegated to the
Administrator of the DEA by 28 CFR
0.100. The Administrator, in turn, has
redelegated this function to the Deputy
Administrator pursuant to 28 CFR
0.104.
The 2013 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 to be
manufactured in the United States in
2013 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 August 3, 2012, a notice titled,
‘‘Proposed Aggregate Production Quotas
DATES:
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
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Jkt 226001
for Schedule I and II Controlled
Substances and Proposed Assessment of
Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2013,’’ was
published in the Federal Register (77
FR 46519). That notice proposed the
2013 aggregate production quotas for
each basic class of controlled substance
listed in schedules I and II and the 2013
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
September 4, 2012.
Five comments (four from DEAregistered manufacturers and one from a
non-registrant) were received within the
published comment period, offering
comments on a total of 20 schedule I
and II controlled substances and one list
I chemical. Commenters stated that the
proposed aggregate production quotas
for amphetamine (for conversion),
amphetamine (for sale), codeine (for
conversion), codeine (for sale), gamma
hydroxybutyric acid, hydrocodone (for
sale), hydromorphone,
lisdexamfetamine, meperidine,
methamphetamine, methylphenidate,
morphine (for conversion), morphine
(for sale), noroxymorphone (for
conversion), oripavine, oxycodone (for
sale), oxymorphone (for conversion),
oxymorphone (for sale), remifentanil,
and sufentanil were insufficient to
provide for the estimated medical,
scientific, research, and industrial needs
of the United States, export
requirements, and the establishment
and maintenance of reserve stocks. One
commenter stated that the proposed
assessment of annual needs quota for
phenylpropanolamine (for conversion)
was insufficient to provide for the
estimated medical, scientific, research,
and industrial needs of the United
States, export requirements, and the
establishment and maintenance of
reserve stocks.
In determining the 2013 aggregate
production quotas and assessment of
annual needs, DEA has taken into
consideration the above comments
along with the factors set forth at 21
CFR 1303.11 and 21 CFR 1315.11, in
accordance with 21 U.S.C. 826(a), and
other relevant factors, including the
consideration of 2012 manufacturing
quotas, current 2012 sales and
inventories, 2013 export requirements,
industrial use, additional applications
for quotas, as well as information on
research and product development
requirements. Based on this
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information, DEA has determined that
adjustments to the proposed aggregate
production quotas and assessment of
annual needs for 3,4-methylenedioxy-Nmethylcathinone (methylone),
3,4,methylenedioxypyrovalerone
(MDPV), 4-methyl-N-methylcathinone
(mephedrone), N-benzylpiperazine,
amphetamine (for conversion),
amphetamine (for sale), hydrocodone
(for sale), hydromorphone,
lisdexamfetamine, methylphenidate,
morphine (for sale), oxycodone (for
sale), oxymorphone (for conversion),
remifentanil, sufentanil, tapentadol,
ephedrine (for conversion), ephedrine
(for sale), phenylpropanolamine (for
sale), and pseudoephedrine (for sale) are
warranted. This notice reflects those
adjustments.
Regarding codeine (for conversion),
codeine (for sale), gamma
hydroxybutyric acid, meperidine,
methamphetamine, morphine (for
conversion), noroxymorphone (for
conversion), oripavine, oxymorphone
(for sale), and phenylpropanolamine (for
conversion), DEA has determined that
the proposed initial 2013 aggregate
production quotas and assessment of
annual needs are sufficient to meet the
current 2013 estimated medical,
scientific, research, and industrial needs
of the United States. This notice
finalizes these aggregate production
quotas at the same amounts as
proposed.
DEA also specifically considered that
inventory allowances granted to
individual manufacturers may not
always result in the availability of
sufficient quantities to maintain an
adequate reserve stock pursuant to 21
U.S.C. 826(a), as intended. See 21 CFR
1303.24. This would be concerning if a
natural disaster or other unforeseen
event resulted in substantial disruption
to the amount of controlled substances
available to provide for legitimate
public need. As such, DEA included in
all schedule II aggregate production
quotas, and certain schedule I aggregate
production quotas, an additional 25% of
the estimated medical, scientific, and
research needs as part of the amount
necessary to ensure the establishment
and maintenance of reserve stocks. The
established aggregate production quotas
reflect these included amounts. This
action will not affect the ability of
manufacturers to maintain inventory
allowances as specified by regulation.
DEA expects that maintaining this
reserve in certain established aggregate
production quotas will mitigate adverse
public effects if an unforeseen event
resulted in substantial disruption to the
amount of controlled substances
available to provide for legitimate
E:\FR\FM\01OCN1.SGM
01OCN1
Federal Register / Vol. 77, No. 190 / Monday, October 1, 2012 / Notices
public need, as determined by DEA.
DEA does not anticipate utilizing the
reserve in the absence of these
circumstances.
In accordance with 21 U.S.C. 826, 21
CFR 1303.11, and 21 CFR 1315.11, the
Deputy Administrator hereby
establishes the 2013 aggregate
production quotas for the following
schedule I and II controlled substances
and the 2013 assessment of annual
59981
needs for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine, expressed in
grams of anhydrous acid or base, as
follows:
Established
2013 quotas
Basic class
mstockstill on DSK4VPTVN1PROD with NOTICES
Schedule I
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-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-(n)-propylphenyl)ethanamine (2C–P) ............................................................................................................
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-Dimethoxyphenyl)ethanamine (2C–H) ................................................................................................................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C) ..................................................................................................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I) .......................................................................................................................
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-Methylfentanyl .............................................................................................................................................................................
3-Methylthiofentanyl .......................................................................................................................................................................
4-Bromo-2,5-dimethoxyamphetamine (DOB) ................................................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine (2–CB) ...........................................................................................................................
4-Methoxyamphetamine ................................................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (DOM) ................................................................................................................................
4-Methylaminorex ..........................................................................................................................................................................
4-Methyl-N-methylcathinone (mephedrone) ..................................................................................................................................
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-Methoxy-3,4-methylenedioxyamphetamine ................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine ............................................................................................................................................
5-Methoxy-N,N-dimethyltryptamine ...............................................................................................................................................
Acetyl-alpha-methylfentanyl ...........................................................................................................................................................
Acetyldihydrocodeine .....................................................................................................................................................................
Acetylmethadol ..............................................................................................................................................................................
Allylprodine ....................................................................................................................................................................................
Alphacetylmethadol ........................................................................................................................................................................
Alpha-ethyltryptamine ....................................................................................................................................................................
Alphameprodine .............................................................................................................................................................................
Alphamethadol ...............................................................................................................................................................................
Alpha-methylfentanyl .....................................................................................................................................................................
Alpha-methylthiofentanyl ................................................................................................................................................................
Alpha-methyltryptamine (AMT) ......................................................................................................................................................
Aminorex ........................................................................................................................................................................................
Benzylmorphine .............................................................................................................................................................................
Betacetylmethadol .........................................................................................................................................................................
Beta-hydroxy-3-methylfentanyl ......................................................................................................................................................
Beta-hydroxyfentanyl .....................................................................................................................................................................
Betameprodine ...............................................................................................................................................................................
Betamethadol .................................................................................................................................................................................
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15
15
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15
15
12
12
12
15
15
12
30
35
24
35
25
2
2
12
12
88
12
12
25
68
53
12
12
10
2
2
2
2
2
12
2
2
2
2
12
12
2
2
2
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59982
Federal Register / Vol. 77, No. 190 / Monday, October 1, 2012 / Notices
Established
2013 quotas
Basic class
Betaprodine ....................................................................................................................................................................................
Bufotenine ......................................................................................................................................................................................
Cathinone .......................................................................................................................................................................................
Codeine-N-oxide ............................................................................................................................................................................
Desomorphine ................................................................................................................................................................................
Diethyltryptamine ...........................................................................................................................................................................
Difenoxin ........................................................................................................................................................................................
Dihydromorphine ............................................................................................................................................................................
Dimethyltryptamine ........................................................................................................................................................................
Gamma-hydroxybutyric acid ..........................................................................................................................................................
Heroin ............................................................................................................................................................................................
Hydromorphinol ..............................................................................................................................................................................
Hydroxypethidine ...........................................................................................................................................................................
Ibogaine .........................................................................................................................................................................................
Lysergic acid diethylamide (LSD) ..................................................................................................................................................
Marihuana ......................................................................................................................................................................................
Mescaline .......................................................................................................................................................................................
Methaqualone ................................................................................................................................................................................
Methcathinone ...............................................................................................................................................................................
Methyldihydromorphine ..................................................................................................................................................................
Morphine-N-oxide ..........................................................................................................................................................................
N,N-Dimethylamphetamine ............................................................................................................................................................
N-Benzylpiperazine ........................................................................................................................................................................
N-Ethylamphetamine .....................................................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ................................................................................................................................
Noracymethadol .............................................................................................................................................................................
Norlevorphanol ...............................................................................................................................................................................
Normethadone ...............................................................................................................................................................................
Normorphine ..................................................................................................................................................................................
Para-fluorofentanyl .........................................................................................................................................................................
Phenomorphan ..............................................................................................................................................................................
Pholcodine .....................................................................................................................................................................................
Properidine .....................................................................................................................................................................................
Psilocybin .......................................................................................................................................................................................
Psilocyn ..........................................................................................................................................................................................
Tetrahydrocannabinols ..................................................................................................................................................................
Thiofentanyl ...................................................................................................................................................................................
Tilidine ............................................................................................................................................................................................
Trimeperidine .................................................................................................................................................................................
2
3
12
602
5
12
50
3,300,000
18
46,250,000
25
54
2
5
30
21,000
13
10
14
2
655
12
15
12
12
2
52
2
18
2
2
2
2
2
4
491,000
2
10
2
g
g
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g
g
g
g
g
g
g
g
g
g
g
g
g
3
21
2,250,000
38,250
3
9
22,875,000
42,625,000
6
240,000
81,250,000
49,506,250
19
250,000
750,000
127,500
3
2,108,750
3
99,625,000
5,968,750
5
4
6
4,500
21,000,000
6,875,000
6
11
6
6
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mstockstill on DSK4VPTVN1PROD with NOTICES
Schedule II
1-Phenylcyclohexylamine ..............................................................................................................................................................
1-Piperdinocyclohexanecarbonitrile ...............................................................................................................................................
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 ..............................................................................................................................................................................
Diphenoxylate ................................................................................................................................................................................
Ecgonine ........................................................................................................................................................................................
Ethylmorphine ................................................................................................................................................................................
Fentanyl .........................................................................................................................................................................................
Glutethimide ...................................................................................................................................................................................
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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Federal Register / Vol. 77, No. 190 / Monday, October 1, 2012 / Notices
59983
Established
2013 quotas
Basic class
Methadone (for sale) .....................................................................................................................................................................
Methadone Intermediate ................................................................................................................................................................
Methamphetamine .........................................................................................................................................................................
25,000,000 g
32,500,000 g
3,912,500 g
[987,500 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,863,750 grams for methamphetamine mostly
for conversion to a schedule III product; and 61,250 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 ...........................................................................................................................................................................
Remifentanil ...................................................................................................................................................................................
Secobarbital ...................................................................................................................................................................................
Sufentanil .......................................................................................................................................................................................
Tapentadol .....................................................................................................................................................................................
Thebaine ........................................................................................................................................................................................
80,750,000
103,750,000
60,250,000
25,628
9,000,000
508,750
91,250
1,287,500
22,750,000
10,250,000
131,500,000
18,375,000
6,875,000
42,500,000
6
30
3
20,000,000
3
3,750
215,003
6,255
13,750,000
145,000,000
g
g
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15,100,000
3,500,000
25,700,000
6,100,000
225,000,000
g
g
g
g
g
List I Chemicals
Ephedrine (for conversion) ............................................................................................................................................................
Ephedrine (for sale) .......................................................................................................................................................................
Phenylpropanolamine (for conversion) ..........................................................................................................................................
Phenylpropanolamine (for sale) .....................................................................................................................................................
Pseudoephedrine (for sale) ...........................................................................................................................................................
The Deputy 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. Pursuant to 21 CFR
1303.13 and 21 CFR 1315.13, upon
consideration of the relevant factors, the
Deputy Administrator may adjust the
2013 aggregate production quotas and
assessment of annual needs as needed.
Dated: September 25, 2012.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2012–24089 Filed 9–28–12; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4410–09–P
VerDate Mar<15>2010
16:56 Sep 28, 2012
Jkt 226001
DEPARTMENT OF LABOR
Employment and Training
Administration
[TA–W–81,791]
Fasco, a Division of Regal Beloit
Corporation, Including On-Site Leased
Workers From Penmac Personnel
Services, Eldon, MI; Notice of
Affirmative Determination Regarding
Application for Reconsideration
By application dated August 30, 2012,
workers requested administrative
reconsideration of the negative
determination regarding workers’
eligibility to apply for Trade Adjustment
Assistance (TAA) applicable to workers
and former workers of Fasco, a division
of Regal Beloit Corporation, Eldon,
Missouri (Fasco). The determination
was issued on August 7, 2012. The
Department’s Notice of determination
was published in the Federal Register
on August 23, 2012 (77 FR 51066).
Fasco is a warehouse and distribution
center for electric motors. The subject
PO 00000
Frm 00096
Fmt 4703
Sfmt 4703
worker group includes workers engaged
in activities related to the supply of
warehousing and distribution of electric
motors, as well as engineering, customer
service and information technology
services. The worker group includes onsite leased workers from Penmac
Personnel Services.
The initial investigation resulted in a
negative determination based on the
findings that there were no shifts to/
acquisition from a foreign country by
Fasco in the supply of services like or
directly competitive with those
supplied by the subject workers; that
there were no increased imports of
services like or directly competitive
with those supplied by the subject
workers; that Fasco is neither a Supplier
to nor a Downstream Producer of a firm
that employed a worker group eligible to
apply for TAA; and that the workers of
Fasco have not met the criteria set forth
in Section 222(e) of the Trade Act, as
amended.
The request for reconsideration states
that workers of the Engineering Services
Department provide engineering
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 77, Number 190 (Monday, October 1, 2012)]
[Notices]
[Pages 59980-59983]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24089]
[[Page 59980]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-365]
Established Aggregate Production Quotas for Schedule I and II
Controlled Substances and Established Assessment of Annual Needs for
the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2013
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice establishes the initial 2013 aggregate production
quotas for controlled substances in schedules I and II of the
Controlled Substances Act (CSA) and assessment of annual needs for the
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
DATES: Effective Date: October 1, 2012.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive
Assistant, Office of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive, Springfield, VA 22152,
Telephone: (202) 307-4654.
SUPPLEMENTARY INFORMATION: Section 306 of the 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. This responsibility has been delegated to the
Administrator of the DEA by 28 CFR 0.100. The Administrator, in turn,
has redelegated this function to the Deputy Administrator pursuant to
28 CFR 0.104.
The 2013 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 to be manufactured in the United States in 2013 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 August 3, 2012, a notice titled, ``Proposed Aggregate Production
Quotas for Schedule I and II Controlled Substances and Proposed
Assessment of Annual Needs for the List I Chemicals Ephedrine,
Pseudoephedrine, and Phenylpropanolamine for 2013,'' was published in
the Federal Register (77 FR 46519). That notice proposed the 2013
aggregate production quotas for each basic class of controlled
substance listed in schedules I and II and the 2013 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 September 4, 2012.
Five comments (four from DEA-registered manufacturers and one from
a non-registrant) were received within the published comment period,
offering comments on a total of 20 schedule I and II controlled
substances and one list I chemical. Commenters stated that the proposed
aggregate production quotas for amphetamine (for conversion),
amphetamine (for sale), codeine (for conversion), codeine (for sale),
gamma hydroxybutyric acid, hydrocodone (for sale), hydromorphone,
lisdexamfetamine, meperidine, methamphetamine, methylphenidate,
morphine (for conversion), morphine (for sale), noroxymorphone (for
conversion), oripavine, oxycodone (for sale), oxymorphone (for
conversion), oxymorphone (for sale), remifentanil, and sufentanil were
insufficient to provide for the estimated medical, scientific,
research, and industrial needs of the United States, export
requirements, and the establishment and maintenance of reserve stocks.
One commenter stated that the proposed assessment of annual needs quota
for phenylpropanolamine (for conversion) was insufficient to provide
for the estimated medical, scientific, research, and industrial needs
of the United States, export requirements, and the establishment and
maintenance of reserve stocks.
In determining the 2013 aggregate production quotas and assessment
of annual needs, DEA has taken into consideration the above comments
along with the factors set forth at 21 CFR 1303.11 and 21 CFR 1315.11,
in accordance with 21 U.S.C. 826(a), and other relevant factors,
including the consideration of 2012 manufacturing quotas, current 2012
sales and inventories, 2013 export requirements, industrial use,
additional applications for quotas, as well as information on research
and product development requirements. Based on this information, DEA
has determined that adjustments to the proposed aggregate production
quotas and assessment of annual needs for 3,4-methylenedioxy-N-
methylcathinone (methylone), 3,4,methylenedioxypyrovalerone (MDPV), 4-
methyl-N-methylcathinone (mephedrone), N-benzylpiperazine, amphetamine
(for conversion), amphetamine (for sale), hydrocodone (for sale),
hydromorphone, lisdexamfetamine, methylphenidate, morphine (for sale),
oxycodone (for sale), oxymorphone (for conversion), remifentanil,
sufentanil, tapentadol, ephedrine (for conversion), ephedrine (for
sale), phenylpropanolamine (for sale), and pseudoephedrine (for sale)
are warranted. This notice reflects those adjustments.
Regarding codeine (for conversion), codeine (for sale), gamma
hydroxybutyric acid, meperidine, methamphetamine, morphine (for
conversion), noroxymorphone (for conversion), oripavine, oxymorphone
(for sale), and phenylpropanolamine (for conversion), DEA has
determined that the proposed initial 2013 aggregate production quotas
and assessment of annual needs are sufficient to meet the current 2013
estimated medical, scientific, research, and industrial needs of the
United States. This notice finalizes these aggregate production quotas
at the same amounts as proposed.
DEA also specifically considered that inventory allowances granted
to individual manufacturers may not always result in the availability
of sufficient quantities to maintain an adequate reserve stock pursuant
to 21 U.S.C. 826(a), as intended. See 21 CFR 1303.24. This would be
concerning if a natural disaster or other unforeseen event resulted in
substantial disruption to the amount of controlled substances available
to provide for legitimate public need. As such, DEA included in all
schedule II aggregate production quotas, and certain schedule I
aggregate production quotas, an additional 25% of the estimated
medical, scientific, and research needs as part of the amount necessary
to ensure the establishment and maintenance of reserve stocks. The
established aggregate production quotas reflect these included amounts.
This action will not affect the ability of manufacturers to maintain
inventory allowances as specified by regulation. DEA expects that
maintaining this reserve in certain established aggregate production
quotas will mitigate adverse public effects if an unforeseen event
resulted in substantial disruption to the amount of controlled
substances available to provide for legitimate
[[Page 59981]]
public need, as determined by DEA. DEA does not anticipate utilizing
the reserve in the absence of these circumstances.
In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR
1315.11, the Deputy Administrator hereby establishes the 2013 aggregate
production quotas for the following schedule I and II controlled
substances and the 2013 assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine,
expressed in grams of anhydrous acid or base, as follows:
------------------------------------------------------------------------
Established 2013
Basic class quotas
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201).... 45 g
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)... 45 g
1-[1-(2-Thienyl)cyclohexyl]piperidine................ 5 g
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 45 g
200)................................................
1-Butyl-3-(1-naphthoyl)indole (JWH-073).............. 45 g
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR- 45 g
18 and RCS-8).......................................
1-Hexyl-3-(1-naphthoyl)indole (JWH-019).............. 45 g
1-Methyl-4-phenyl-4-propionoxypiperidine............. 2 g
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)... 45 g
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203).... 45 g
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)... 45 g
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398).... 45 g
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122).... 45 g
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4) 45 g
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081).. 45 g
2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P) 15 g
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)..... 15 g
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).... 15 g
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).... 15 g
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)............. 15 g
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).... 15 g
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)...... 15 g
2,5-Dimethoxy-4-ethylamphetamine (DOET).............. 12 g
2,5-Dimethoxy-4-n-propylthiophenethylamine........... 12 g
2,5-Dimethoxyamphetamine............................. 12 g
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T- 15 g
2)..................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine 15 g
(2C-T-4)............................................
3,4,5-Trimethoxyamphetamine.......................... 12 g
3,4-Methylenedioxyamphetamine (MDA).................. 30 g
3,4-Methylenedioxymethamphetamine (MDMA)............. 35 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)......... 24 g
3,4-Methylenedioxy-N-methylcathinone (methylone)..... 35 g
3,4-Methylenedioxypyrovalerone (MDPV)................ 25 g
3-Methylfentanyl..................................... 2 g
3-Methylthiofentanyl................................. 2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB)............... 12 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)........... 12 g
4-Methoxyamphetamine................................. 88 g
4-Methyl-2,5-dimethoxyamphetamine (DOM).............. 12 g
4-Methylaminorex..................................... 12 g
4-Methyl-N-methylcathinone (mephedrone).............. 25 g
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3- 68 g
hydroxycyclohexyl]-phenol...........................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 53 g
phenol (cannabicyclohexanol or CP-47, 497 C8-
homolog)............................................
5-Methoxy-3,4-methylenedioxyamphetamine.............. 12 g
5-Methoxy-N,N-diisopropyltryptamine.................. 12 g
5-Methoxy-N,N-dimethyltryptamine..................... 10 g
Acetyl-alpha-methylfentanyl.......................... 2 g
Acetyldihydrocodeine................................. 2 g
Acetylmethadol....................................... 2 g
Allylprodine......................................... 2 g
Alphacetylmethadol................................... 2 g
Alpha-ethyltryptamine................................ 12 g
Alphameprodine....................................... 2 g
Alphamethadol........................................ 2 g
Alpha-methylfentanyl................................. 2 g
Alpha-methylthiofentanyl............................. 2 g
Alpha-methyltryptamine (AMT)......................... 12 g
Aminorex............................................. 12 g
Benzylmorphine....................................... 2 g
Betacetylmethadol.................................... 2 g
Beta-hydroxy-3-methylfentanyl........................ 2 g
Beta-hydroxyfentanyl................................. 2 g
Betameprodine........................................ 2 g
Betamethadol......................................... 2 g
[[Page 59982]]
Betaprodine.......................................... 2 g
Bufotenine........................................... 3 g
Cathinone............................................ 12 g
Codeine-N-oxide...................................... 602 g
Desomorphine......................................... 5 g
Diethyltryptamine.................................... 12 g
Difenoxin............................................ 50 g
Dihydromorphine...................................... 3,300,000 g
Dimethyltryptamine................................... 18 g
Gamma-hydroxybutyric acid............................ 46,250,000 g
Heroin............................................... 25 g
Hydromorphinol....................................... 54 g
Hydroxypethidine..................................... 2 g
Ibogaine............................................. 5 g
Lysergic acid diethylamide (LSD)..................... 30 g
Marihuana............................................ 21,000 g
Mescaline............................................ 13 g
Methaqualone......................................... 10 g
Methcathinone........................................ 14 g
Methyldihydromorphine................................ 2 g
Morphine-N-oxide..................................... 655 g
N,N-Dimethylamphetamine.............................. 12 g
N-Benzylpiperazine................................... 15 g
N-Ethylamphetamine................................... 12 g
N-Hydroxy-3,4-methylenedioxyamphetamine.............. 12 g
Noracymethadol....................................... 2 g
Norlevorphanol....................................... 52 g
Normethadone......................................... 2 g
Normorphine.......................................... 18 g
Para-fluorofentanyl.................................. 2 g
Phenomorphan......................................... 2 g
Pholcodine........................................... 2 g
Properidine.......................................... 2 g
Psilocybin........................................... 2 g
Psilocyn............................................. 4 g
Tetrahydrocannabinols................................ 491,000 g
Thiofentanyl......................................... 2 g
Tilidine............................................. 10 g
Trimeperidine........................................ 2 g
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.............................. 3 g
1-Piperdinocyclohexanecarbonitrile................... 21 g
4-Anilino-N-phenethyl-4-piperidine (ANPP)............ 2,250,000 g
Alfentanil........................................... 38,250 g
Alphaprodine......................................... 3 g
Amobarbital.......................................... 9 g
Amphetamine (for conversion)......................... 22,875,000 g
Amphetamine (for sale)............................... 42,625,000 g
Carfentanil.......................................... 6 g
Cocaine.............................................. 240,000 g
Codeine (for conversion)............................. 81,250,000 g
Codeine (for sale)................................... 49,506,250 g
Dextropropoxyphene................................... 19 g
Dihydrocodeine....................................... 250,000 g
Diphenoxylate........................................ 750,000 g
Ecgonine............................................. 127,500 g
Ethylmorphine........................................ 3 g
Fentanyl............................................. 2,108,750 g
Glutethimide......................................... 3 g
Hydrocodone (for sale)............................... 99,625,000 g
Hydromorphone........................................ 5,968,750 g
Isomethadone......................................... 5 g
Levo-alphacetylmethadol (LAAM)....................... 4 g
Levomethorphan....................................... 6 g
Levorphanol.......................................... 4,500 g
Lisdexamfetamine..................................... 21,000,000 g
Meperidine........................................... 6,875,000 g
Meperidine Intermediate-A............................ 6 g
Meperidine Intermediate-B............................ 11 g
Meperidine Intermediate-C............................ 6 g
Metazocine........................................... 6 g
[[Page 59983]]
Methadone (for sale)................................. 25,000,000 g
Methadone Intermediate............................... 32,500,000 g
Methamphetamine...................................... 3,912,500 g
------------------------------------------------------------------------
[987,500 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 2,863,750 grams for methamphetamine mostly for
conversion to a schedule III product; and 61,250 grams for
methamphetamine (for sale)].
------------------------------------------------------------------------
Methylphenidate...................................... 80,750,000 g
Morphine (for conversion)............................ 103,750,000 g
Morphine (for sale).................................. 60,250,000 g
Nabilone............................................. 25,628 g
Noroxymorphone (for conversion)...................... 9,000,000 g
Noroxymorphone (for sale)............................ 508,750 g
Opium (powder)....................................... 91,250 g
Opium (tincture)..................................... 1,287,500 g
Oripavine............................................ 22,750,000 g
Oxycodone (for conversion)........................... 10,250,000 g
Oxycodone (for sale)................................. 131,500,000 g
Oxymorphone (for conversion)......................... 18,375,000 g
Oxymorphone (for sale)............................... 6,875,000 g
Pentobarbital........................................ 42,500,000 g
Phenazocine.......................................... 6 g
Phencyclidine........................................ 30 g
Phenmetrazine........................................ 3 g
Phenylacetone........................................ 20,000,000 g
Racemethorphan....................................... 3 g
Remifentanil......................................... 3,750 g
Secobarbital......................................... 215,003 g
Sufentanil........................................... 6,255 g
Tapentadol........................................... 13,750,000 g
Thebaine............................................. 145,000,000 g
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)........................... 15,100,000 g
Ephedrine (for sale)................................. 3,500,000 g
Phenylpropanolamine (for conversion)................. 25,700,000 g
Phenylpropanolamine (for sale)....................... 6,100,000 g
Pseudoephedrine (for sale)........................... 225,000,000 g
------------------------------------------------------------------------
The Deputy 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. Pursuant to 21 CFR 1303.13 and
21 CFR 1315.13, upon consideration of the relevant factors, the Deputy
Administrator may adjust the 2013 aggregate production quotas and
assessment of annual needs as needed.
Dated: September 25, 2012.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2012-24089 Filed 9-28-12; 8:45 am]
BILLING CODE 4410-09-P
