[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Notices]
[Pages 79404-79407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31849]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA <greek-i>343E]


Controlled Substances: Established Initial Aggregate Production 
Quotas for 2011

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 2011.

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

DATES: Effective Date: December 20, 2010.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, 
Drug & Chemical Evaluation Section, Drug Enforcement Administration, 
Springfield, Virginia 22152, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION: Section 306 of the 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 Administrator, in turn, has redelegated 
this function to the Deputy Administrator, pursuant to 28 CFR 0.104.
    The 2011 aggregate production quotas represent those quantities of 
controlled substances that may be produced in the United States in 2011 
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 September 15, 2010, a notice of the proposed initial 2011 
aggregate production quotas for certain controlled substances in 
schedules I and II was published in the Federal Register (75 FR 56137). 
All interested persons were invited to comment on or object to these 
proposed aggregate production quotas on or before October 15, 2010.
    Seven responses (six from DEA registered manufacturers, and one 
from a non-DEA registrant) were received within the published comment 
period, offering comments on a total of 31 schedules I and II 
controlled substances. The commenters stated that the proposed 
aggregate production quotas for 3,4-methylenedioxyamphetamine, 3,4-
methylenedioxy-N-ethylamphetamine, 3,4-methylenedioxymethamphetamine, 
4-anilino-N-phenethyl-4-piperidine, amphetamine (for sale), cathinone, 
codeine (for sale), dihydromorphine, fentanyl, gamma hydroxybutyric 
acid, heroin, hydrocodone, hydromorphone, marihuana, meperidine, 
methaqualone, methylphenidate, morphine (for conversion), morphine (for 
sale), nabilone, noroxymorphone (for conversion), opium (tincture), 
oxycodone (for sale), pentobarbital, phencyclidine, remifentanil, 
secobarbital, tapentadol, tetrahydrocannabinols, thebaine and tilidine 
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.
    In arriving at the aggregate production quotas, DEA has taken into 
consideration the above comments along with the factors set forth at 21 
CFR 1303.11(b) and other relevant 2010 factors, including 2010 
manufacturing quotas, current 2010 sales and inventories, 2011 export 
requirements, additional applications received, as well as research and 
product development requirements. Based on this information, DEA has 
adjusted the initial aggregate production quotas for 3,4-
methylenedioxyamphetamine, 3,4-methylenedioxy-N-ethylamphetamine, 3,4-
methylenedioxymethamphetamine, amobarbital, cathinone, 
dimethyltryptamine, ibogaine, lysergic

[[Page 79405]]

acid diethylamide, metazocine, methaqualone, nabilone, normorphine, 
noroxymorphone (for sale), phenazocine, phencyclidine, secobarbital, 
and tetrahydrocannabinols to meet the legitimate needs of the United 
States.
    Regarding 4-anilino-N-phenethyl-4-piperidine, amphetamine (for 
sale), codeine (for sale), dihydromorphine, fentanyl, gamma 
hydroxybutyric acid, heroin, hydrocodone, hydromorphone, marihuana, 
meperidine, methylphenidate, morphine (for conversion), morphine (for 
sale), noroxymorphone (for conversion), opium (tincture), oxycodone 
(for sale), pentobarbital, remifentanil, tapentadol, thebaine and 
tilidine DEA has determined that the proposed initial 2011 aggregate 
production quotas are sufficient to meet the current 2011 estimated 
medical, scientific, research, and industrial needs of the United 
States.
    Pursuant to 21 CFR 1303, the Deputy Administrator of DEA will, in 
2011, adjust aggregate production quotas and individual manufacturing 
quotas allocated for the year based upon 2010 year-end inventory and 
actual 2010 disposition data supplied by quota recipients for each 
basic class of schedule I or II controlled substance.
    Therefore, under the authority vested in the Attorney General by 
Section 306 of the CSA (21 U.S.C. 826), and delegated to the 
Administrator of DEA by 28 CFR 0.100, and redelegated to the Deputy 
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby 
orders that the 2011 initial aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base, be established as follows:

------------------------------------------------------------------------
       Basic class--Schedule I              Established 2011 quotas
------------------------------------------------------------------------
1-Methyl-4-phenyl-4-                  2 g
 propionoxypiperidine.
2,5-Dimethoxyamphetamine............  2 g
2,5-Dimethoxy-4-ethylamphetamine      2 g
 (DOET).
2,5-Dimethoxy-4-n-                    2 g
 propylthiophenethylamine.
3-Methylfentanyl....................  2 g
3-Methylthiofentanyl................  2 g
3,4-Methylenedioxyamphetamine (MDA).  22 g
3,4-Methylenedioxy-N-                 15 g
 ethylamphetamine (MDEA).
3,4-Methylenedioxymethamphetamine     22 g
 (MDMA).
3,4,5-Trimethoxyamphetamine.........  2 g
4-Bromo-2,5-dimethoxyamphetamine      2 g
 (DOB).
4-Bromo-2,5-dimethoxyphenethylamine   2 g
 (2-CB).
4-Methoxyamphetamine................  77 g
4-Methylaminorex....................  2 g
4-Methyl-2,5-dimethoxyamphetamine     2 g
 (DOM).
5-Methoxy-3,4-                        2 g
 methylenedioxyamphetamine.
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...........................  3,000 g
Dihydromorphine.....................  3,608,000 g
Dimethyltryptamine..................  7 g
Gamma-hydroxybutyric acid...........  3,000,000 g
Heroin..............................  20 g
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

[[Page 79406]]

 
N-Benzylpiperazine..................  2 g
N,N-Dimethylamphetamine.............  2 g
N-Ethylamphetamine..................  2 g
N-Hydroxy-3,4-                        2 g
 methylenedioxyamphetamine.
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
------------------------------------------------------------------------


------------------------------------------------------------------------
      Basic class--Schedule II              Established 2011 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine.............  2 g
1-piperdinocyclohexanecarbonitrile..  2 g
4-Anilino-N-phenethyl-4-piperidine    2,500,000 g
 (ANPP).
Alfentanil..........................  8,000 g
Alphaprodine........................  2 g
Amobarbital.........................  40,007 g
Amphetamine (for conversion)........  7,500,000 g
Amphetamine (for sale)..............  18,600,000 g
Cocaine.............................  247,000 g
Codeine (for conversion)............  65,000,000 g
Codeine (for sale)..................  39,605,000 g
Dextropropoxyphene..................  92,000,000 g
Dihydrocodeine......................  800,000 g
Diphenoxylate.......................  827,000 g
Ecgonine............................  83,000 g
Ethylmorphine.......................  2 g
Fentanyl............................  1,428,000 g
Glutethimide........................  2 g
Hydrocodone (for sale)..............  55,000,000 g
Hydromorphone.......................  3,455,000 g
Isomethadone........................  11 g
Levo-alphacetylmethadol (LAAM)......  3 g
Levomethorphan......................  5 g
Levorphanol.........................  10,000 g
Lisdexamfetamine....................  9,000,000 g
Meperidine..........................  6,600,000 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
------------------------------------------------------------------------
 [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.....................  50,000,000 g
Morphine (for conversion)...........  83,000,000 g
Morphine (for sale).................  39,000,000 g
Nabilone............................  10,502 g
Noroxymorphone (for conversion).....  9,000,000 g
Noroxymorphone (for sale)...........  401,000 g
Opium (powder)......................  230,000 g
Opium (tincture)....................  1,500,000 g
Oripavine...........................  15,000,000 g
Oxycodone (for conversion)..........  5,600,000 g
Oxycodone (for sale)................  105,500,000 g
Oxymorphone (for conversion)........  12,800,000 g
Oxymorphone (for sale)..............  3,070,000 g
Pentobarbital.......................  28,000,000 g
Phenazocine.........................  5 g

[[Page 79407]]

 
Phencyclidine.......................  24 g
Phenmetrazine.......................  2 g
Phenylacetone.......................  8,000,000 g
Racemethorphan......................  2 g
Remifentanil........................  2,500 g
Secobarbital........................  260,002 g
Sufentanil..........................  7,000 g
Tapentadol..........................  1,000,000 g
Thebaine............................  126,000,000 g
------------------------------------------------------------------------

    The Deputy Administrator further orders that aggregate production 
quotas for all other schedules I and II controlled substances included 
in 21 CFR 1308.11 and 1308.12 be established at zero.
    The Office of Management and Budget has determined that notices of 
aggregate production quotas are not subject to centralized review under 
Executive Order 12866.
    This action does not preempt or modify any provision of State law; 
nor does it impose enforcement responsibilities on any State; nor does 
it diminish the power of any State to enforce its own laws. 
Accordingly, this action does not have federalism implications 
warranting the application of Executive Order 13132.
    The Deputy Administrator hereby certifies that this action will 
have no significant impact upon small entities whose interests must be 
considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. 
The establishment of aggregate production quotas for schedules I and II 
controlled substances is mandated by law and by international treaty 
obligations. The quotas are necessary to provide for the estimated 
medical, scientific, research, and industrial needs of the United 
States, for export requirements and the establishment and maintenance 
of reserve stocks. While aggregate production quotas are of primary 
importance to large manufacturers, their impact upon small entities is 
neither negative nor beneficial. Accordingly, the Deputy Administrator 
has determined that this action does not require a regulatory 
flexibility analysis.
    This action meets the applicable standards set forth in Sections 
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
    This action will not result in the expenditure by State, local, and 
Tribal governments, in the aggregate, or by the private sector, of 
$126,400,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.
    This action is not a major rule as defined by Section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This action 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

    Dated: December 10, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-31849 Filed 12-17-10; 8:45 am]
BILLING CODE 4410-09-P