[Federal Register Volume 76, Number 241 (Thursday, December 15, 2011)]
[Notices]
[Pages 78044-78047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-32163]


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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.

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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