Controlled Substances: Established Aggregate Production Quotas for 2012, 78044-78047 [2011-32163]
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78044
Federal Register / Vol. 76, No. 241 / Thursday, December 15, 2011 / Notices
15 U.S.C. 4301 et seq. (‘‘the Act’’),
Toyota Motor Corporation and Ford
Motor Company Collaboration (‘‘Toyota
and Ford’’) has filed written
notifications simultaneously with the
Attorney General and the Federal Trade
Commission disclosing (1) The
identities of the parties to the venture
and (2) the nature and objectives of the
venture. The notifications were filed for
the purpose of invoking the Act’s
provisions limiting the recovery of
antitrust plaintiffs to actual damages
under specified circumstances.
Pursuant to Section 6(b) of the Act,
the identities of the parties to the
venture are: Toyota Motor Corporation,
Toyota City, JAPAN; and Ford Motor
Company, Dearborn, MI.
The general area of Toyota and Ford’s
planned activity is the research and
development of (a) A hybrid system
initially targeted for use in sport utility
vehicles and light trucks, and (b)
standards and/or enabling technologies
for vehicle telematics. The parties may
subsequently agree to expand the scope
of the collaboration to include
production.
Patricia A. Brink,
Director of Civil Enforcement, Antitrust
Division.
[FR Doc. 2011–32113 Filed 12–14–11; 8:45 am]
DEPARTMENT OF JUSTICE
Antitrust Division
mstockstill on DSK4VPTVN1PROD with NOTICES
Notice Pursuant to the National
Cooperative Research and Production
Act of 1993—Petroleum Environmental
Research Forum
Notice is hereby given that, on
November 1, 2011, pursuant to Section
6(a) of the National Cooperative
Research and Production Act of 1993,
15 U.S.C. 4301 et seq. (‘‘the Act’’),
Petroleum Environmental Research
Forum (‘‘PERF’’) has filed written
notifications simultaneously with the
Attorney General and the Federal Trade
Commission disclosing changes in its
membership. The notifications were
filed for the purpose of extending the
Act’s provisions limiting the recovery of
antitrust plaintiffs to actual damages
under specified circumstances.
Specifically, Nalco Environmental
Solutions, LLC, Sugarland, TX, has been
added as a party to this venture.
No other changes have been made in
either the membership or planned
activity of the group research project.
Membership in this group research
project remains open, and PERF intends
16:49 Dec 14, 2011
Jkt 226001
Patricia A. Brink,
Director of Civil Enforcement, Antitrust
Division.
[FR Doc. 2011–32114 Filed 12–14–11; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA 358E]
Controlled Substances: Established
Aggregate Production Quotas for 2012
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Notice.
AGENCY:
This notice establishes the
initial 2012 aggregate production quotas
for controlled substances in Schedules I
and II of the Controlled Substances Act
(CSA).
DATES: Effective Date: December 15,
2011.
SUMMARY:
BILLING CODE P
VerDate Mar<15>2010
to file additional written notifications
disclosing all changes in membership.
On February 10, 1986, PERF filed its
original notification pursuant to Section
6(a) of the Act. The Department of
Justice published a notice in the Federal
Register pursuant to Section 6(b) of the
Act on March 14, 1986 (51 FR 8903).
The last notification was filed with
the Department on June 2, 2010. A
notice was published in the Federal
Register pursuant to Section 6(b) of the
Act on August 2, 2010 (75 FR 45156).
John
W. Partridge, Office of Diversion
Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (202)
307–4654.
SUPPLEMENTARY INFORMATION: Section
306 of the Controlled Substances Act
(CSA) (21 U.S.C. 826) requires that the
Attorney General establish aggregate
production quotas for each basic class of
controlled substance listed in Schedules
I and II. This responsibility has been
delegated to the Administrator of the
DEA by 28 CFR 0.100.
The 2012 aggregate production quotas
represent those quantities of Schedule I
and II controlled substances that may be
produced in the United States in 2012
to provide adequate supplies of each
substance for the estimated medical,
scientific, research, and industrial needs
of the United States, lawful export
requirements, and the establishment
and maintenance of reserve stocks. 21
U.S.C. 826(a) and 21 CFR 1303.11.
These quotas do not include imports of
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
controlled substances for use in
industrial processes.
On October 21, 2011, a notice entitled
‘‘Controlled Substances: Proposed
Aggregate Production Quotas for 2012’’
was published in the Federal Register
(76 FR 65537). That notice proposed the
2012 aggregate production quotas for
each basic class of controlled substance
listed in Schedules I and II. All
interested persons were invited to
comment on or object to the proposed
aggregate production quotas on or before
November 21, 2011.
Sixteen responses (eleven from DEA
registered manufacturers, and five from
other members of the public) were
received within the published comment
period, offering comments on a total of
37 Schedule I and II controlled
substances. Several comments discussed
the national prescription drug abuse
epidemic and urged DEA to reduce
quotas for prescription painkillers and
opioids. Addressing prescription drug
abuse requires a multi-faceted approach
which includes education, treatment,
and enforcement.
The quota system is specifically
designed to operate within the statutory
framework of the CSA, in conjunction
with other controls to enable DEA to
monitor the movement of controlled
substances and certain chemicals into
and through the closed system of
distribution to help prevent diversion of
such substances into the illicit market.
Through the quota system, DEA limits
the amount of those substances and
chemicals manufactured each year to
those quantities that will provide for the
estimated medical, scientific, research,
and industrial needs, lawful export
requirements, and the establishment
and maintenance of reserve stocks for
the United States. All aspects of the
closed system of distribution must work
together to reduce or eliminate the
diversion of controlled substances.
Other commenters stated that the
proposed aggregate production quotas
for alfentanil, amphetamine (for sale),
codeine (for conversion), codeine (for
sale), dihydrocodeine,
dihydromorphine, diphenoxylate,
hydrocodone (for sale),
hydromorphinol, levorphanol,
lisdexamfetamine, meperidine,
meperidine intermediate A, meperidine
intermediate B, meperidine
intermediate C, methadone, methadone
intermediate, methamphetamine,
methylphenidate, morphine (for
conversion), morphine (for sale),
morphine-N-oxide, nabilone,
noroxymorphone (for conversion),
noroxymorphone (for sale), opium
(tincture), oripavine, oxycodone (for
conversion), oxycodone (for sale),
E:\FR\FM\15DEN1.SGM
15DEN1
Federal Register / Vol. 76, No. 241 / Thursday, December 15, 2011 / Notices
oxymorphone (for conversion),
oxymorphone (for sale), pentobarbital,
phenylacetone, properidine, sufentanil,
tapentadol, and thebaine 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.
In determining the aggregate
production quotas, DEA has taken into
consideration the above comments
along with the factors set forth at 21
CFR 1303.11(b), in accordance with 21
U.S.C. 826(a) and other relevant factors,
including the consideration of 2011
manufacturing quotas, current 2011
sales and inventories, 2012 export
requirements, additional applications
for quotas, as well as information on
research and product development
requirements. Based on this
information, DEA determined that
adjustments to the proposed aggregate
production quotas for alfentanil,
dihydrocodeine, diphenoxylate,
hydromorphinol, lisdexamfetamine,
meperidine, meperidine intermediate A,
meperidine intermediate B, meperidine
intermediate C, morphine-N-oxide,
nabilone, pentobarbital, phenylacetone,
properidine, and tapentadol are
warranted. This notice reflects those
adjustments.
When DEA published the Proposed
Aggregate Production Quotas for 2012
on October 21, 2011, that notice
proposed that all Schedule I and II
controlled substances included in 21
CFR 1308.11 and 1308.21 but not
specifically referenced in that notice be
established at zero. That reference
extended to the three synthetic
cathinones (4-methyl-Nmethylcathinone; 3,4-methylenedioxyN-methylcathinone; and
3,4,methylenedioxypyrovalerone) that
were temporarily placed in Schedule I
pursuant to the final order also
published on October 21, 2011, at 76 FR
65371. No comments were received
within the published comment period
regarding the proposed quota for the
three synthetic cathinones, however,
DEA has determined, based on the
information described above, that an
increase from the proposed quota of
zero is warranted for all three
substances. This notice reflects those
adjustments.
78045
Regarding amphetamine (for sale),
codeine (for conversion), codeine (for
sale), dihydromorphine, hydrocodone
(for sale), levorphanol, methadone,
methadone intermediate,
methamphetamine, methylphenidate,
morphine (for conversion), morphine
(for sale), noroxymorphone (for
conversion), noroxymorphone (for sale),
opium (tincture), oripavine, oxycodone
(for conversion), oxycodone (for sale),
oxymorphone (for conversion),
oxymorphone (for sale), sufentanil, and
thebaine, DEA has determined that the
proposed initial 2012 aggregate
production quotas are sufficient to meet
the current 2012 estimated medical,
scientific, research, and industrial needs
of the United States. This notice
finalizes these aggregate production
quotas at the same amounts as
proposed.
In accordance with 21 U.S.C. 826 and
21 CFR 1303.11, the Administrator
hereby determines that the 2012
aggregate production quotas for the
following controlled substances,
expressed in grams of anhydrous acid or
base, be established as follows:
Established 2012
Quotas
mstockstill on DSK4VPTVN1PROD with NOTICES
Basic Class—Schedule I
1-[2-(4–Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200) ........................................................................................................
1–Butyl-3-(1-naphthoyl)indole (JWH–073) ....................................................................................................................................
1–Methyl-4-phenyl-4-propionoxypiperidine ....................................................................................................................................
1–Pentyl-3-(1-naphthoyl)indole (JWH–018) ..................................................................................................................................
2,5–Dimethoxyamphetamine .........................................................................................................................................................
2,5–Dimethoxy-4-ethylamphetamine (DOET) ................................................................................................................................
2,5–Dimethoxy-4-n-propylthiophenethylamine ..............................................................................................................................
3–Methylfentanyl ............................................................................................................................................................................
3–Methylthiofentanyl ......................................................................................................................................................................
3,4–Methylenedioxyamphetamine (MDA) ......................................................................................................................................
3,4–Methylenedioxy-N-ethylamphetamine (MDEA) .......................................................................................................................
3,4–Methylenedioxy-N-methylcathinone (methylone) ....................................................................................................................
3,4–Methylenedioxymethamphetamine (MDMA) ...........................................................................................................................
3,4–Methylenedioxypyrovalerone (MDPV) ....................................................................................................................................
3,4,5–Trimethoxyamphetamine .....................................................................................................................................................
4–Bromo-2,5-dimethoxyamphetamine (DOB) ...............................................................................................................................
4–Bromo-2,5-dimethoxyphenethylamine (2–CB) ...........................................................................................................................
4–Methoxyamphetamine ................................................................................................................................................................
4–Methylaminorex ..........................................................................................................................................................................
4–Methyl-2,5-dimethoxyamphetamine (DOM) ...............................................................................................................................
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 .....................................................................................................
5–Methoxy-3,4-methylenedioxyamphetamine ...............................................................................................................................
5–Methoxy-N,N-diisopropyltryptamine ...........................................................................................................................................
Acetyl-alpha-methylfentanyl ...........................................................................................................................................................
Acetyldihydrocodeine .....................................................................................................................................................................
Acetylmethadol ..............................................................................................................................................................................
Allylprodine ....................................................................................................................................................................................
Alphacetylmethadol ........................................................................................................................................................................
Alpha-ethyltryptamine ....................................................................................................................................................................
Alphameprodine .............................................................................................................................................................................
Alphamethadol ...............................................................................................................................................................................
Alpha-methylfentanyl .....................................................................................................................................................................
Alpha-methylthiofentanyl ................................................................................................................................................................
Alpha-methyltryptamine (AMT) ......................................................................................................................................................
VerDate Mar<15>2010
16:49 Dec 14, 2011
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PO 00000
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E:\FR\FM\15DEN1.SGM
15DEN1
45 g
45 g
2g
45 g
2g
2g
2g
2g
2g
22 g
15 g
8g
22 g
8g
2g
2g
2g
77 g
2g
2g
8g
68 g
53 g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
2g
78046
Federal Register / Vol. 76, No. 241 / Thursday, December 15, 2011 / Notices
Established 2012
Quotas
Aminorex ........................................................................................................................................................................................
Benzylmorphine .............................................................................................................................................................................
Betacetylmethadol .........................................................................................................................................................................
Beta-hydroxy-3-methylfentanyl ......................................................................................................................................................
Beta-hydroxyfentanyl .....................................................................................................................................................................
Betameprodine ...............................................................................................................................................................................
Betamethadol .................................................................................................................................................................................
Betaprodine ....................................................................................................................................................................................
Bufotenine ......................................................................................................................................................................................
Cathinone .......................................................................................................................................................................................
Codeine-N-oxide ............................................................................................................................................................................
Diethyltryptamine ...........................................................................................................................................................................
Difenoxin ........................................................................................................................................................................................
Dihydromorphine ............................................................................................................................................................................
Dimethyltryptamine ........................................................................................................................................................................
Gamma-hydroxybutyric acid ..........................................................................................................................................................
Heroin ............................................................................................................................................................................................
Hydromorphinol ..............................................................................................................................................................................
Hydroxypethidine ...........................................................................................................................................................................
Ibogaine .........................................................................................................................................................................................
Lysergic acid diethylamide (LSD) ..................................................................................................................................................
Marihuana ......................................................................................................................................................................................
Mescaline .......................................................................................................................................................................................
Methaqualone ................................................................................................................................................................................
Methcathinone ...............................................................................................................................................................................
Methyldihydromorphine ..................................................................................................................................................................
Morphine-N-oxide ..........................................................................................................................................................................
N–Benzylpiperazine .......................................................................................................................................................................
N,N–Dimethylamphetamine ...........................................................................................................................................................
N–Ethylamphetamine .....................................................................................................................................................................
N–Hydroxy-3,4-methylenedioxyamphetamine ...............................................................................................................................
Noracymethadol .............................................................................................................................................................................
Norlevorphanol ...............................................................................................................................................................................
Normethadone ...............................................................................................................................................................................
Normorphine ..................................................................................................................................................................................
Para-fluorofentanyl .........................................................................................................................................................................
Phenomorphan ..............................................................................................................................................................................
Pholcodine .....................................................................................................................................................................................
Properidine .....................................................................................................................................................................................
Psilocybin .......................................................................................................................................................................................
Psilocyn ..........................................................................................................................................................................................
Tetrahydrocannabinols ..................................................................................................................................................................
Thiofentanyl ...................................................................................................................................................................................
Tilidine ............................................................................................................................................................................................
Trimeperidine .................................................................................................................................................................................
2
2
2
2
2
2
2
2
3
4
602
2
50
3,608,000
7
47,000,000
20
54
2
5
16
21,000
5
10
4
2
655
2
2
2
2
2
52
2
18
2
2
2
2
2
2
393,000
2
10
2
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
2
2
1,800,000
15,000
2
40,007
8,500,000
25,300,000
216,000
65,000,000
39,605,000
7
400,000
900,000
83,000
2
1,428,000
2
59,000,000
3,455,000
4
3
5
3,600
12,000,000
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
mstockstill on DSK4VPTVN1PROD with NOTICES
Basic Class—Schedule II
1–Phenylcyclohexylamine ..............................................................................................................................................................
1-piperdinocyclohexanecarbonitrile ...............................................................................................................................................
4–Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................................
Alfentanil ........................................................................................................................................................................................
Alphaprodine ..................................................................................................................................................................................
Amobarbital ....................................................................................................................................................................................
Amphetamine (for conversion) ......................................................................................................................................................
Amphetamine (for sale) .................................................................................................................................................................
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 ..........................................................................................................................................................................
VerDate Mar<15>2010
16:49 Dec 14, 2011
Jkt 226001
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E:\FR\FM\15DEN1.SGM
15DEN1
Federal Register / Vol. 76, No. 241 / Thursday, December 15, 2011 / Notices
78047
Established 2012
Quotas
Meperidine .....................................................................................................................................................................................
Meperidine Intermediate-A ............................................................................................................................................................
Meperidine Intermediate-B ............................................................................................................................................................
Meperidine Intermediate-C ............................................................................................................................................................
Metazocine .....................................................................................................................................................................................
Methadone (for sale) .....................................................................................................................................................................
Methadone Intermediate ................................................................................................................................................................
Methamphetamine .........................................................................................................................................................................
5,500,000
5
9
5
5
20,000,000
26,000,000
3,130,000
g
g
g
g
g
g
g
g
[750,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,331,000 grams for methamphetamine mostly
for conversion to a Schedule III product; and 49,000 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 ........................................................................................................................................................................................
The Administrator further determines
that aggregate production quotas for all
other Schedule I and II controlled
substances included in 21 CFR 1308.11
and 1308.12 be established at zero. All
aggregate production quotas are subject
to adjustment pursuant to 21 CFR
1303.13.
Dated: December 8, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–32163 Filed 12–14–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
mstockstill on DSK4VPTVN1PROD with NOTICES
National Institute of Corrections
Solicitation for a Cooperative
Agreement: Strategic Essentials for
the Advancement of Women
Executives in Corrections
National Institute of
Corrections, U.S. Department of Justice.
ACTION: Solicitation for a Cooperative
Agreement.
AGENCY:
The National Institute of
Corrections (NIC) is soliciting proposals
SUMMARY:
VerDate Mar<15>2010
19:28 Dec 14, 2011
Jkt 226001
from organizations, groups, or
individuals to enter into an 18-month
cooperative agreement to provide for the
revision of Strategic Development of the
Executive Woman, and to plan and
deliver the program in 2012. NIC
continues to build upon the success of
its women’s-only programming, where
gender barriers are eliminated and
acceleration of learning is possible. The
award recipient will become familiar
with the work currently being done at
NIC that provides for an understanding
of the history and future development
goals for this series.
The award includes responsibility for
the updated Instructional Theory into
Practice (ITIP) formatted curriculum,
and in collaboration with the NIC
Research and Information Services
Division, an evaluation of the initial
program delivery using the NIC training
evaluation protocol. This should
represent a minimal cost to the award
recipient. The project will also address
strategies for additional learning and
networking upon training completion.
Applications must be received
by 2 p.m. EDT on Thursday, February
15, 2012.
DATES:
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
56,000,000 g
83,000,000 g
39,000,000 g
20,502 g
7,200,000 g
401,000 g
63,000 g
1,000,000 g
9,800,000 g
5,600,000 g
98,000,000 g
12,800,000 g
5,500,000 g
34,000,000 g
5g
24g
2g
16,000,000 g
2g
2,500 g
336,002 g
5,000 g
5,400,000 g
116,000,000 g
Mailed applications must be
sent to: Director, National Institute of
Corrections, 320 First Street NW., Room
5002, Washington, DC 20534.
Applicants are encouraged to use
Federal Express, UPS, or similar service
to ensure delivery by the due date.
Hand delivered applications should
be brought to 500 First Street NW.,
Washington, DC 20534. At the front
desk, dial 73106, extension 0 for pickup.
Faxed applications will NOT be
accepted. Electronic applications can be
submitted only via www.grants.gov.
FOR FURTHER INFORMATION CONTACT: A
copy of this announcement can be
downloaded from the NIC Web page at
www.nicic.gov.
All technical or programmatic
questions concerning this
announcement should be directed to
Evelyn Bush, Correctional Program
Specialist, National Institute of
Corrections. She can be reached at
e1bush@bop.gov.
SUPPLEMENTARY INFORMATION:
Curriculum Design: The curriculum
design for Executive Leadership for
Women was based on research done
with corrections practitioners and
women in senior positions in
ADDRESSES:
E:\FR\FM\15DEN1.SGM
15DEN1
]]>Agencies
[Federal Register Volume 76, Number 241 (Thursday, December 15, 2011)]
[Notices]
[Pages 78044-78047]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32163]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA 358E]
Controlled Substances: Established Aggregate Production Quotas
for 2012
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice establishes the initial 2012 aggregate production
quotas for controlled substances in Schedules I and II of the
Controlled Substances Act (CSA).
DATES: Effective Date: December 15, 2011.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Office of Diversion
Control, Drug Enforcement Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (202) 307-4654.
SUPPLEMENTARY INFORMATION: Section 306 of the Controlled Substances Act
(CSA) (21 U.S.C. 826) requires that the Attorney General establish
aggregate production quotas for each basic class of controlled
substance listed in Schedules I and II. This responsibility has been
delegated to the Administrator of the DEA by 28 CFR 0.100.
The 2012 aggregate production quotas represent those quantities of
Schedule I and II controlled substances that may be produced in the
United States in 2012 to provide adequate supplies of each substance
for the estimated medical, scientific, research, and industrial needs
of the United States, lawful export requirements, and the establishment
and maintenance of reserve stocks. 21 U.S.C. 826(a) and 21 CFR 1303.11.
These quotas do not include imports of controlled substances for use in
industrial processes.
On October 21, 2011, a notice entitled ``Controlled Substances:
Proposed Aggregate Production Quotas for 2012'' was published in the
Federal Register (76 FR 65537). That notice proposed the 2012 aggregate
production quotas for each basic class of controlled substance listed
in Schedules I and II. All interested persons were invited to comment
on or object to the proposed aggregate production quotas on or before
November 21, 2011.
Sixteen responses (eleven from DEA registered manufacturers, and
five from other members of the public) were received within the
published comment period, offering comments on a total of 37 Schedule I
and II controlled substances. Several comments discussed the national
prescription drug abuse epidemic and urged DEA to reduce quotas for
prescription painkillers and opioids. Addressing prescription drug
abuse requires a multi-faceted approach which includes education,
treatment, and enforcement.
The quota system is specifically designed to operate within the
statutory framework of the CSA, in conjunction with other controls to
enable DEA to monitor the movement of controlled substances and certain
chemicals into and through the closed system of distribution to help
prevent diversion of such substances into the illicit market. Through
the quota system, DEA limits the amount of those substances and
chemicals manufactured each year to those quantities that will provide
for the estimated medical, scientific, research, and industrial needs,
lawful export requirements, and the establishment and maintenance of
reserve stocks for the United States. All aspects of the closed system
of distribution must work together to reduce or eliminate the diversion
of controlled substances.
Other commenters stated that the proposed aggregate production
quotas for alfentanil, amphetamine (for sale), codeine (for
conversion), codeine (for sale), dihydrocodeine, dihydromorphine,
diphenoxylate, hydrocodone (for sale), hydromorphinol, levorphanol,
lisdexamfetamine, meperidine, meperidine intermediate A, meperidine
intermediate B, meperidine intermediate C, methadone, methadone
intermediate, methamphetamine, methylphenidate, morphine (for
conversion), morphine (for sale), morphine-N-oxide, nabilone,
noroxymorphone (for conversion), noroxymorphone (for sale), opium
(tincture), oripavine, oxycodone (for conversion), oxycodone (for
sale),
[[Page 78045]]
oxymorphone (for conversion), oxymorphone (for sale), pentobarbital,
phenylacetone, properidine, sufentanil, tapentadol, and thebaine 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.
In determining the aggregate production quotas, DEA has taken into
consideration the above comments along with the factors set forth at 21
CFR 1303.11(b), in accordance with 21 U.S.C. 826(a) and other relevant
factors, including the consideration of 2011 manufacturing quotas,
current 2011 sales and inventories, 2012 export requirements,
additional applications for quotas, as well as information on research
and product development requirements. Based on this information, DEA
determined that adjustments to the proposed aggregate production quotas
for alfentanil, dihydrocodeine, diphenoxylate, hydromorphinol,
lisdexamfetamine, meperidine, meperidine intermediate A, meperidine
intermediate B, meperidine intermediate C, morphine-N-oxide, nabilone,
pentobarbital, phenylacetone, properidine, and tapentadol are
warranted. This notice reflects those adjustments.
When DEA published the Proposed Aggregate Production Quotas for
2012 on October 21, 2011, that notice proposed that all Schedule I and
II controlled substances included in 21 CFR 1308.11 and 1308.21 but not
specifically referenced in that notice be established at zero. That
reference extended to the three synthetic cathinones (4-methyl-N-
methylcathinone; 3,4-methylenedioxy-N-methylcathinone; and
3,4,methylenedioxypyrovalerone) that were temporarily placed in
Schedule I pursuant to the final order also published on October 21,
2011, at 76 FR 65371. No comments were received within the published
comment period regarding the proposed quota for the three synthetic
cathinones, however, DEA has determined, based on the information
described above, that an increase from the proposed quota of zero is
warranted for all three substances. This notice reflects those
adjustments.
Regarding amphetamine (for sale), codeine (for conversion), codeine
(for sale), dihydromorphine, hydrocodone (for sale), levorphanol,
methadone, methadone intermediate, methamphetamine, methylphenidate,
morphine (for conversion), morphine (for sale), noroxymorphone (for
conversion), noroxymorphone (for sale), opium (tincture), oripavine,
oxycodone (for conversion), oxycodone (for sale), oxymorphone (for
conversion), oxymorphone (for sale), sufentanil, and thebaine, DEA has
determined that the proposed initial 2012 aggregate production quotas
are sufficient to meet the current 2012 estimated medical, scientific,
research, and industrial needs of the United States. This notice
finalizes these aggregate production quotas at the same amounts as
proposed.
In accordance with 21 U.S.C. 826 and 21 CFR 1303.11, the
Administrator hereby determines that the 2012 aggregate production
quotas for the following controlled substances, expressed in grams of
anhydrous acid or base, be established as follows:
------------------------------------------------------------------------
Established 2012
Quotas
------------------------------------------------------------------------
Basic Class--Schedule I
------------------------------------------------------------------------
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 45 g
200)................................................
1-Butyl-3-(1-naphthoyl)indole (JWH-073).............. 45 g
1-Methyl-4-phenyl-4-propionoxypiperidine............. 2 g
1-Pentyl-3-(1-naphthoyl)indole (JWH-018)............. 45 g
2,5-Dimethoxyamphetamine............................. 2 g
2,5-Dimethoxy-4-ethylamphetamine (DOET).............. 2 g
2,5-Dimethoxy-4-n-propylthiophenethylamine........... 2 g
3-Methylfentanyl..................................... 2 g
3-Methylthiofentanyl................................. 2 g
3,4-Methylenedioxyamphetamine (MDA).................. 22 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)......... 15 g
3,4-Methylenedioxy-N-methylcathinone (methylone)..... 8 g
3,4-Methylenedioxymethamphetamine (MDMA)............. 22 g
3,4-Methylenedioxypyrovalerone (MDPV)................ 8g
3,4,5-Trimethoxyamphetamine.......................... 2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB)............... 2 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)........... 2 g
4-Methoxyamphetamine................................. 77 g
4-Methylaminorex..................................... 2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM).............. 2 g
4-Methyl-N-methylcathinone (mephedrone).............. 8 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..............................................
5-Methoxy-3,4-methylenedioxyamphetamine.............. 2 g
5-Methoxy-N,N-diisopropyltryptamine.................. 2 g
Acetyl-alpha-methylfentanyl.......................... 2 g
Acetyldihydrocodeine................................. 2 g
Acetylmethadol....................................... 2 g
Allylprodine......................................... 2 g
Alphacetylmethadol................................... 2 g
Alpha-ethyltryptamine................................ 2 g
Alphameprodine....................................... 2 g
Alphamethadol........................................ 2 g
Alpha-methylfentanyl................................. 2 g
Alpha-methylthiofentanyl............................. 2 g
Alpha-methyltryptamine (AMT)......................... 2 g
[[Page 78046]]
Aminorex............................................. 2 g
Benzylmorphine....................................... 2 g
Betacetylmethadol.................................... 2 g
Beta-hydroxy-3-methylfentanyl........................ 2 g
Beta-hydroxyfentanyl................................. 2 g
Betameprodine........................................ 2 g
Betamethadol......................................... 2 g
Betaprodine.......................................... 2 g
Bufotenine........................................... 3 g
Cathinone............................................ 4 g
Codeine-N-oxide...................................... 602 g
Diethyltryptamine.................................... 2 g
Difenoxin............................................ 50 g
Dihydromorphine...................................... 3,608,000 g
Dimethyltryptamine................................... 7 g
Gamma-hydroxybutyric acid............................ 47,000,000 g
Heroin............................................... 20 g
Hydromorphinol....................................... 54 g
Hydroxypethidine..................................... 2 g
Ibogaine............................................. 5 g
Lysergic acid diethylamide (LSD)..................... 16 g
Marihuana............................................ 21,000 g
Mescaline............................................ 5 g
Methaqualone......................................... 10 g
Methcathinone........................................ 4 g
Methyldihydromorphine................................ 2 g
Morphine-N-oxide..................................... 655 g
N-Benzylpiperazine................................... 2 g
N,N-Dimethylamphetamine.............................. 2 g
N-Ethylamphetamine................................... 2 g
N-Hydroxy-3,4-methylenedioxyamphetamine.............. 2 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............................................. 2 g
Tetrahydrocannabinols................................ 393,000 g
Thiofentanyl......................................... 2 g
Tilidine............................................. 10 g
Trimeperidine........................................ 2 g
------------------------------------------------------------------------
Basic Class--Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.............................. 2 g
1-piperdinocyclohexanecarbonitrile................... 2 g
4-Anilino-N-phenethyl-4-piperidine (ANPP)............ 1,800,000 g
Alfentanil........................................... 15,000 g
Alphaprodine......................................... 2 g
Amobarbital.......................................... 40,007 g
Amphetamine (for conversion)......................... 8,500,000 g
Amphetamine (for sale)............................... 25,300,000 g
Cocaine.............................................. 216,000 g
Codeine (for conversion)............................. 65,000,000 g
Codeine (for sale)................................... 39,605,000 g
Dextropropoxyphene................................... 7 g
Dihydrocodeine....................................... 400,000 g
Diphenoxylate........................................ 900,000 g
Ecgonine............................................. 83,000 g
Ethylmorphine........................................ 2 g
Fentanyl............................................. 1,428,000 g
Glutethimide......................................... 2 g
Hydrocodone (for sale)............................... 59,000,000 g
Hydromorphone........................................ 3,455,000 g
Isomethadone......................................... 4 g
Levo-alphacetylmethadol (LAAM)....................... 3 g
Levomethorphan....................................... 5 g
Levorphanol.......................................... 3,600 g
Lisdexamfetamine..................................... 12,000,000 g
[[Page 78047]]
Meperidine........................................... 5,500,000 g
Meperidine Intermediate-A............................ 5 g
Meperidine Intermediate-B............................ 9 g
Meperidine Intermediate-C............................ 5 g
Metazocine........................................... 5 g
Methadone (for sale)................................. 20,000,000 g
Methadone Intermediate............................... 26,000,000 g
Methamphetamine...................................... 3,130,000 g
------------------------------------------------------------------------
[750,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 2,331,000 grams for methamphetamine mostly for
conversion to a Schedule III product; and 49,000 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate...................................... 56,000,000 g
Morphine (for conversion)............................ 83,000,000 g
Morphine (for sale).................................. 39,000,000 g
Nabilone............................................. 20,502 g
Noroxymorphone (for conversion)...................... 7,200,000 g
Noroxymorphone (for sale)............................ 401,000 g
Opium (powder)....................................... 63,000 g
Opium (tincture)..................................... 1,000,000 g
Oripavine............................................ 9,800,000 g
Oxycodone (for conversion)........................... 5,600,000 g
Oxycodone (for sale)................................. 98,000,000 g
Oxymorphone (for conversion)......................... 12,800,000 g
Oxymorphone (for sale)............................... 5,500,000 g
Pentobarbital........................................ 34,000,000 g
Phenazocine.......................................... 5 g
Phencyclidine........................................ 24g
Phenmetrazine........................................ 2 g
Phenylacetone........................................ 16,000,000 g
Racemethorphan....................................... 2 g
Remifentanil......................................... 2,500 g
Secobarbital......................................... 336,002 g
Sufentanil........................................... 5,000 g
Tapentadol........................................... 5,400,000 g
Thebaine............................................. 116,000,000 g
------------------------------------------------------------------------
The Administrator further determines that aggregate production
quotas for all other Schedule I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 be established at zero. All aggregate
production quotas are subject to adjustment pursuant to 21 CFR 1303.13.
Dated: December 8, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-32163 Filed 12-14-11; 8:45 am]
BILLING CODE 4410-09-P
