[Federal Register Volume 70, Number 236 (Friday, December 9, 2005)]
[Notices]
[Pages 73269-73272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7110]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA  270E]


Controlled Substances: Established Initial Aggregate Production 
Quotas for 2006

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 2006.

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SUMMARY: This notice establishes initial 2006 aggregate production 
quotas for controlled substances in Schedules I and II of the 
Controlled Substances Act (CSA).

DATES: Effective Date: December 9, 2005.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, 
Drug & Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 20537, 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 2006 aggregate production quotas represent those quantities of 
controlled substances that may be produced in the United States in 2006 
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, 2005, a notice of the proposed initial 2006 
aggregate production quotas for certain controlled substances in 
Schedules I and II was published in the Federal Register (FR 61310). 
All interested persons were invited to comment on or object to these 
proposed aggregate production quotas on or before November 14, 2005.
    Eight responses were received resulting in comments on a total of 
24 Schedule I and II controlled substances within the published comment 
period. The responses commented that the proposed aggregate production 
quotas for 4-methoxyamphetamine, amphetamine, codeine (for conversion), 
codeine (for sale), difenoxin, dihydrocodeine, dihydromorphine, 
diphenoxylate, fentanyl, gamma-hydroxybutyric acid (GHB), hydrocodone, 
hydromorphone, meperidine, methamphetamine, methylphenidate, morphine, 
morphine (for conversion), noroxymorphone (for conversion), oxycodone, 
oxymorphone, pentobarbital, remifentanil, sufentanil and 
tetrahydrocannabinols 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 2005 manufacturing quotas, current 2005 sales and inventories, 
2006 export requirements, additional applications received, and 
research and product development requirements. Based on this 
information, the DEA has adjusted the initial aggregate production 
quotas for 3,4-methylenedioxyamphetamine (MDA), 3,4-methylenedioxy-N-
ethylamphetamine (MDEA), 3,4-methylenedioxymethamphetamine (MDMA), 4-
methoxyamphetamine, 4-methyl-2,5-dimethoxyamphetamine (DOM), 
bufotenine, cathinone, codeine-N-oxide, heroin, methaqualone, morphine-
N-oxide, normorphine, psilocybin, alfentanil, amobarbital, amphetamine, 
cocaine, dihydrocodeine, ecgonine, hydrocodone (for sale), levo-
alphacetylmethadol (LAAM), levomethorphan, methadone (for sale), 
methadone intermediate, methamphetamine, methamphetamine (for 
conversion), noroxymorphone (for conversion), pentobarbital, 
phencyclidine, remifentanil and sufentanil to meet the legitimate needs 
of the United States.
    Regarding codeine (for conversion), codeine (for sale), difenoxin, 
dihydromorphine, diphenoxylate, fentanyl, gamma-hydroxybutyric acid 
(GHB), hydromorphone, meperidine, methylphenidate, morphine, morphine 
(for conversion), oxycodone, oxymorphone, and tetrahydrocannabinols, 
the DEA has determined that the proposed initial 2006 aggregate 
production quotas are sufficient to meet the current 2006 estimated 
medical, scientific, research and industrial needs of the United 
States.
    Pursuant to 21 CFR part 1303, the Deputy Administrator of the DEA 
will, in 2006, adjust aggregate production quotas and individual 
manufacturing quotas allocated for the year based upon 2005 year-end 
inventory and actual 2005 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 the 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 2006 initial aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base, be established as follows:

[[Page 73270]]



------------------------------------------------------------------------
                                                          Established
                                                          initial 2006
                                                         quotas (grams)
------------------------------------------------------------------------
Basic Class--Schedule I:
    2,5-Dimethoxyamphetamine.........................          2,801,000
    2,5-Dimethoxy-4-ethylamphetamine (DOET)..........                  2
    3-Methylfentanyl.................................                  2
    3-Methylthiofentanyl.............................                  2
    3,4-Methylenedioxyamphetamine (MDA)..............                 20
    3,4-Methylenedioxy-N-ethylamphetamine (MDEA).....                 10
    3,4-Methylenedioxymethamphetamine (MDMA).........                 22
    3,4,5-Trimethoxyamphetamine......................                  2
    4-Bromo-2,5-dimethoxyamphetamine (DOB)...........                  2
    4-Bromo-2,5-dimethoxyphenethylamine (2-CB).......                  2
    4-Methoxyamphetamine.............................                 77
    4-Methylaminorex.................................                  2
    4-Methyl-2,5-dimethoxyamphetamine (DOM)..........                 12
    5-Methoxy-3,4-methylenedioxyamphetamine..........                  2
    Acetyl-alpha-methylfentanyl......................                  2
    Acetyldihydrocodeine.............................                  2
    Acetylmethadol...................................                  2
    Allylprodine.....................................                  2
    Alphacetylmethadol...............................                  2
    Alpha-ethyltryptamine............................                  2
    Alphameprodine...................................                  2
    Alphamethadol....................................                  3
    Alpha-methylfentanyl.............................                  2
    Alpha-methylthiofentanyl.........................                  2
    Aminorex.........................................                  2
    Benzylmorphine...................................                  2
    Betacetylmethadol................................                  2
    Beta-hydroxy-3-methylfentanyl....................                  2
    Beta-hydroxyfentanyl.............................                  2
    Betameprodine....................................                  2
    Betamethadol.....................................                  2
    Betaprodine......................................                  2
    Bufotenine.......................................                  5
    Cathinone........................................                  3
    Codeine-N-oxide..................................                302
    Diethyltryptamine................................                  2
    Difenoxin........................................              5,000
    Dihydromorphine..................................          1,826,000
    Dimethyltryptamine...............................                  3
    Gamma-hydroxybutyric acid........................          8,000,000
    Heroin...........................................                  5
    Hydromorphinol...................................                  2
    Hydroxypethidine.................................                  2
    Lysergic acid diethylamide (LSD).................                 61
    Marihuana........................................          4,500,000
    Mescaline........................................                  2
    Methaqualone.....................................                 10
    Methcathinone....................................                  4
    Methyldihydromorphine............................                  2
    Morphine-N-oxide.................................                310
    N,N-Dimethylamphetamine..........................                  2
    N-Ethylamphetamine...............................                  2
    N-Hydroxy-3,4-methylenedioxyamphetamine..........                  2
    Noracymethadol...................................                  2
    Norlevorphanol...................................                 52
    Normethadone.....................................                  2
    Normorphine......................................                 16
    Para-fluorofentanyl..............................                  2
    Phenomorphan.....................................                  2
    Pholcodine.......................................                  2
    Psilocybin.......................................                  7
    Psilocyn.........................................                  7
    Tetrahydrocannabinols............................            312,500
    Thiofentanyl.....................................                  2
    Trimeperidine....................................                  2
Basic Class--Schedule II:
    1-Phenylcyclohexylamine..........................                  2
    Alfentanil.......................................              5,000
    Alphaprodine.....................................                  2
    Amobarbital......................................            101,000
    Amphetamine......................................         17,000,000

[[Page 73271]]

 
    Cocaine..........................................            286,000
    Codeine (for sale)...............................         39,605,000
    Codeine (for conversion).........................         55,000,000
    Dextropropoxyphene...............................        167,365,000
    Dihydrocodeine...................................          1,261,000
    Diphenoxylate....................................            828,000
    Ecgonine.........................................             83,000
    Ethylmorphine....................................                  2
    Fentanyl.........................................          1,428,000
    Glutethimide.....................................                  2
    Hydrocodone (for sale)...........................         41,252,000
    Hydrocodone (for conversion).....................          1,500,000
    Hydromorphone....................................          3,300,000
    Isomethadone.....................................                  2
    Levo-alphacetylmethadol (LAAM)...................                  6
    Levomethorphan...................................                  5
    Levorphanol......................................              5,000
    Meperidine.......................................          9,753,000
    Metazocine.......................................                  1
    Methadone (for sale).............................         21,000,000
    Methadone Intermediate...........................         26,000,000
    Methamphetamine..................................          3,130,000
------------------------------------------------------
[680,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
 prescription product; 2,405,000 grams for methamphetamine mostly for
 conversion to a Schedule III product; and 45,000 grams for
 methamphetamine (for sale)]
------------------------------------------------------------------------
    Methylphenidate..................................         35,000,000
    Morphine (for sale)..............................         35,000,000
    Morphine (for conversion)........................        110,774,000
    Nabilone.........................................                  2
    Noroxymorphone (for sale)........................              1,002
    Noroxymorphone (for conversion)..................          5,600,000
    Opium............................................          1,280,000
    Oxycodone (for sale).............................         49,200,000
    Oxycodone (for conversion).......................            920,000
    Oxymorphone......................................            534,000
    Pentobarbital....................................         20,335,000
    Phencyclidine....................................              2,021
    Phenmetrazine....................................                  2
    Racemethorphan...................................                  2
    Remifentanil.....................................              2,700
    Secobarbital.....................................                  2
    Sufentanil.......................................              6,500
    Thebaine.........................................         72,453,000
------------------------------------------------------------------------

    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 
$114,000,000 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

[[Page 73272]]

companies to compete with foreign-based companies in domestic and 
export markets.

    Dated: December 2, 2005.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E5-7110 Filed 12-8-05; 8:45 am]
BILLING CODE 4410-09-P