[Federal Register Volume 76, Number 237 (Friday, December 9, 2011)]
[Notices]
[Pages 77016-77019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31621]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-343F]


Controlled Substances: Final Adjusted Aggregate Production Quotas 
for 2011

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice.

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SUMMARY: This notice establishes final adjusted 2011 aggregate 
production quotas for controlled substances in Schedules I and II of 
the Controlled Substances Act (CSA).

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and 
Policy Section, Drug Enforcement Administration, 8701 Morrissette 
Drive, Springfield, VA 22152, Telephone: (202) 307-4564.

SUPPLEMENTARY INFORMATION: 

Background

    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. In accordance with 21 U.S.C. 826 and 21 CFR 
1303.11, DEA published in the Federal Register on December 20, 2010, 
notice of the established 2011 aggregate production quotas for 
controlled substances in Schedules I and II (75 FR 79404). That notice 
stated that the Administrator would adjust, as needed, the established 
aggregate production quotas in 2011 as provided for in 21 CFR 1303.13. 
The 2011 proposed adjusted aggregate production quotas were 
subsequently published in the Federal Register on September 14, 2011, 
(76 FR 56810) in consideration of the outlined criteria. All interested 
persons were invited to comment on or object to the proposed adjusted 
aggregate production quotas on or before October 14, 2011.
    The September 14, 2011, proposed adjusted aggregate production 
quotas also included proposed aggregate production quotas for five 
newly scheduled substances. On March 1, 2011, the DEA Administrator 
published a final order (76 FR 11075) which temporarily placed five 
synthetic cannabinoids in Schedule I: 1-[2-(4-Morpholinyl)ethyl]-3-(1-
naphthoyl)indole (JWH-200); 1-Butyl-3-(1-naphthoyl)indole (JWH-073); 1-
Pentyl-3-(1-naphthoyl)indole (JWH-018); 5-(1,1-Dimethylheptyl)-2-
[(1R,3S)-3-hydroxycyclohexyl]-phenol; and 5-(1,1-Dimethyloctyl)-2-
[(1R,3S)-3-hydroxycyclohexyl]-phenol. That final order stated that 
quotas for the five substances would be ``established based on 
registrations granted and quota applications received pursuant to part 
1303 of Title 21 of the Code of Federal Regulations.'' 76 FR 11077. 
Aggregate production quotas for these newly scheduled substances had 
not been previously established and were initially proposed in the 
above referenced notice published in the Federal Register on September 
14, 2011 (76 FR 56810). All interested persons were invited to comment 
on or object to the proposed aggregate production quotas on or before 
October 14, 2011.

Analysis for Final Adjusted 2011 Aggregate Production Quotas

    Consideration has been given to the criteria outlined in the 
September 14, 2011, notice of proposed adjusted aggregate production 
quotas in accordance with 21 CFR 1303.13. In addition, six companies, 
four DEA registered manufacturers and two non-registrants, submitted 
timely comments regarding a total of 22 Schedule I and II controlled 
substances. Comments received proposed that the aggregate production 
quotas for 4-anilino-N-phenethyl-4-piperidine (ANPP), alfentanil, 
amphetamine (for sale), diphenoxylate, fentanyl, gamma hydroxybutyric 
acid, hydrocodone, meperidine, methadone, methadone

[[Page 77017]]

intermediate, methylphenidate, morphine (for conversion), morphine (for 
sale), noroxymorphone (for conversion), noroxymorphone (for sale), 
oxycodone (for sale), oxymorphone (for conversion), oxymorphone (for 
sale), pentobarbital, secobarbital, sufentanil, and thebaine were 
insufficient to provide for the estimated medical, scientific, 
research, and industrial needs of the United States, for export 
requirements, and for the establishment and maintenance of reserve 
stocks. DEA has taken into consideration the above comments along with 
the relevant 2010 year-end inventories, initial 2011 manufacturing 
quotas, 2011 export requirements, actual and projected 2011 sales, 
research and product development requirements, and additional 
applications received.
    Based on all of the above, the Administrator has determined that 
the proposed adjusted 2011 aggregate production quotas for alfentanil, 
diphenoxylate, gamma hydroxybutyric acid, meperidine, and pentobarbital 
required additional consideration and hereby further adjusts the 2011 
aggregate production quotas for those substances.
    Regarding 4-anilino-N-phenethyl-4-piperidine (ANPP), amphetamine 
(for sale), fentanyl, hydrocodone, methadone, methadone intermediate, 
methylphenidate, morphine (for conversion), morphine (for sale), 
noroxymorphone (for conversion), noroxymorphone (for sale), oxycodone 
(for sale), oxymorphone (for conversion), oxymorphone (for sale), 
secobarbital, sufentanil, and thebaine, the Administrator hereby 
determines that the proposed adjusted 2011 aggregate production quotas 
for these substances as published on September 14, 2011, at 76 FR 56810 
are sufficient to meet the current 2011 estimated medical, scientific, 
research, and industrial needs of the United States and to provide for 
adequate inventories.
    Pursuant to the above, the Administrator hereby establishes the 
2011 final aggregate production quotas for Schedule I and II controlled 
substances, including the five newly scheduled substances previously 
referenced, expressed in grams of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                          Final adjusted
                Basic class--Schedule I                    2011 quotas
------------------------------------------------------------------------
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-Methylenedioxymethamphetamine (MDMA)...............             22 g
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
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-             68 g
 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
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..............................      5,772,000 g
Heroin.................................................             20 g

[[Page 77018]]

 
Hydromorphinol.........................................              2 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.......................................            605 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
Psilocybin.............................................              2 g
Psilocyn...............................................              2 g
Tetrahydrocannabinols..................................        393,000 g
Thiofentanyl...........................................              2 g
Tilidine...............................................             10 g
Trimeperidine..........................................              2 g
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                          Final adjusted
                Basic class--Schedule II                   2011 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine................................              2 g
1-Piperdinocyclohexanecarbonitrile.....................              2 g
4-Anilino-N-phenethyl-4-piperidine (ANPP)..............      1,800,000 g
Alfentanil.............................................         12,800 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.........................................        255,000 g
Diphenoxylate..........................................        730,000 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...........................................              2 g
Levo-alphacetylmethadol (LAAM).........................              3 g
Levomethorphan.........................................              2 g
Levorphanol............................................          3,600 g
Lisdexamfetamine.......................................     10,400,000 g
Meperidine.............................................      5,500,000 g
Meperidine Intermediate-A..............................              3 g
Meperidine Intermediate-B..............................              7 g
Meperidine Intermediate-C..............................              3 g
Metazocine.............................................              5 g
Methadone (for sale)...................................     20,000,000 g
Methadone Intermediate.................................     26,000,000 g
Methamphetamine........................................      3,130,000 g
Methylphenidate........................................     56,000,000 g
Morphine (for conversion)..............................     70,000,000 g
Morphine (for sale)....................................     39,000,000 g
Nabilone...............................................         10,502 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..............................................      8,000,000 g

[[Page 77019]]

 
Oxycodone (for conversion).............................      5,600,000 g
Oxycodone (for sale)...................................     98,000,000 g
Oxymorphone (for conversion)...........................     12,800,000 g
Oxymorphone (for sale).................................      3,070,000 g
Pentobarbital..........................................     34,000,000 g
Phenazocine............................................              5 g
Phencyclidine..........................................             24 g
Phenmetrazine..........................................              2 g
Phenylacetone..........................................      8,000,000 g
Racemethorphan.........................................              2 g
Remifentanil...........................................          2,500 g
Secobarbital...........................................        336,002 g
Sufentanil.............................................          5,000 g
Tapentadol.............................................        403,000 g
Thebaine...............................................    116,000,000 g
------------------------------------------------------------------------

    Aggregate production quotas for all other Schedule I and II 
controlled substances included in 21 CFR 1308.11 and 1308.12 remain at 
zero.

    Dated: December 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-31621 Filed 12-8-11; 8:45 am]
BILLING CODE 4410-09-P