[Federal Register: December 15, 2003 (Volume 68, Number 240)]
[Notices]               
[Page 69720-69723]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15de03-76]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA 249E]

 
Controlled Substances: Established Initial Aggregate Production 
Quotas for 2004

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 2004.

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SUMMARY: This notice establishes initial 2004 aggregate production 
quotas for controlled substances in Schedules I and II of the 
Controlled Substances Act (CSA).

EFFECTIVE DATE: December 15, 2004.

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 section 0.100 of title 28 of the Code of Federal 
Regulations. The Administrator, in turn, has redelegated this function 
to the Deputy Administrator, pursuant to section 0.104 of title 28 of 
the Code of Federal Regulations.
    The 2004 aggregate production quotas represent those quantities of 
controlled substances that may be produced in the United States in 2004 
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 November 4, 2003, a notice of the proposed initial 2004 
aggregate production quotas for certain controlled substances in 
Schedules I and II was published in the Federal Register (68 FR 62474). 
All interested persons were invited to comment on or object to these 
proposed aggregate production quotas on or before November 25, 2003.
    Five companies commented on a total of 27 Schedules I and II 
controlled substances within the published comment period. The 
companies commented that the proposed aggregate

[[Page 69721]]

production quotas for alfentanil, amphetamine, codeine (for 
conversion), codeine-N-oxide, dextropropoxyphene, dihydrocodeine, 
dihydromorphine, fentanyl, hydrocodone (for sale), hydromorphone, 
levorphanol, meperidine, methadone (for sale), methadone intermediate, 
methamphetamine (for conversion), methylphenidate, morphine (for sale), 
morphine-N-oxide, noroxymorphone (for sale), noroxymorphone (for 
conversion), oxycodone (for sale), oxycodone (for conversion), 
oxymorphone, phenylacetone, sufentanil, tetrahydrocannabinols 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 2003 manufacturing quotas, current 2003 sales and inventories, 
2004 export requirements and research and product development 
requirements. Based on this information, the DEA has adjusted the 
initial aggregate production quotas for 2,5-dimethoxy-4-n-
propylthiophenethylamine (2C-T-7), 5-methoxy-N,N-diisopropyltryptamine 
(5-MeO-DIPT), alfentanil, alpha-methyltryptamine (AMT), codeine (for 
conversion), codeine-N-oxide, dihydrocodeine, levomethorphan, methadone 
intermediate, morphine (for sale), morphine-N-oxide, noroxymorphone 
(for conversion), oxycodone (for sale), oxycodone (for conversion), 
oxymorphone, phencyclidine, phenylacetone, racemethorphan, sufentanil 
and thebaine to meet the legitimate needs of the United States.
    Regarding amphetamine, dextropropoxyphene, dihydromorphine, 
fentanyl, hydrocodone (for sale), hydromorphone, levorphanol, 
meperidine, methadone (for sale), methamphetamine (for conversion), 
methylphenidate, noroxymorphone (for sale), and tetrahydrocannabinols, 
the DEA has determined that the proposed initial 2004 aggregate 
production quotas are sufficient to meet the current 2004 estimated 
medical, scientific, research and industrial needs of the United 
States.
    Pursuant to part 1303 of title 21 of the Code of Federal 
Regulations, the Acting Deputy Administrator of the DEA will, in early 
2004, adjust aggregate production quotas and individual manufacturing 
quotas allocated for the year based upon 2003 year-end inventory and 
actual 2003 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 Controlled Substances Act of 1970 (21 U.S.C. 826), 
and delegated to the Administrator of the DEA by section 0.100 of title 
28 of the Code of Federal Regulations, and redelegated to the Deputy 
Administrator pursuant to section 0.104 of title 28 of the Code of 
Federal Regulations, the Acting Deputy Administrator hereby orders that 
the 2004 initial aggregate production quotas for the following 
controlled substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                            Established
                       Basic class                         initial 2004
                                                              quotas
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................................       3,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET).................               2
2,5-Dimethoxy-4-n-propylthiophenethylamine (2C-T-7).....              10
3-Methylfentanyl........................................               2
3-Methylthiofentanyl....................................               2
3,4-Methylenedioxyamphetamine (MDA).....................              11
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............               5
3,4-Methylenedioxymethamphetamine (MDMA)................              16
3,4,5-Trimethoxyamphetamine.............................               2
4-Bromo-2,5-Dimethoxyamphetamine (DOB)..................               2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)..............               2
4-Methoxyamphetamine....................................               2
4-Methylaminorex........................................               2
4-Methyl-2,5-Dimethoxyamphetamine (DOM).................               2
5-Methoxy-3,4-Methylenedioxyamphetamine.................               2
5-Methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT)........              10
Acetyl-alpha-methylfentanyl.............................               2
Acetyldihydrocodeine....................................               2
Acetylmethadol..........................................               2
Allylprodine............................................               4
Alphacetylmethadol......................................               2
Alpha-ethyltryptamine...................................               2
Alphameprodine..........................................               2
Alphamethadol...........................................               3
Alpha-methyltryptamine (AMT)............................              10
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..............................................               2
Cathinone...............................................               2

[[Page 69722]]


Codeine-N-oxide.........................................             502
Diethyltryptamine.......................................               2
Difenoxin...............................................           9,000
Dihydromorphine.........................................       1,101,000
Dimethyltryptamine......................................               3
Gamma-hydroxybutyric acid...............................      10,000,000
Heroin..................................................               5
Hydromorphinol..........................................               2
Hydroxypethidine........................................               2
Lysergic acid diethylamide (LSD)........................              61
Marihuana...............................................         840,000
Mescaline...............................................               2
Methaqualone............................................               5
Methcathinone...........................................               4
Methyldihydromorphine...................................               2
Morphine-N-oxide........................................             502
N,N-Dimethylamphetamine.................................               2
N-Ethyl-1-Phenylcyclohexylamine (PCE)...................               5
N-Ethylamphetamine......................................               7
N-Hydroxy-3,4-Methylenedioxyamphetamine.................               2
Noracymethadol..........................................               2
Norlevorphanol..........................................              52
Normethadone............................................               2
Normorphine.............................................              12
Para-fluorofentanyl.....................................               2
Phenomorphan............................................               2
Pholcodine..............................................               2
Propiram................................................         210,000
Psilocybin..............................................               2
Psilocyn................................................               2
Tetrahydrocannabinols...................................         176,000
Thiofentanyl............................................               2
Trimeperidine...........................................               2
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................               2
1-Piperidinocyclohexanecarbonitrile (PCC)...............              10
Alfentanil..............................................           2,000
Alphaprodine............................................               2
Amobarbital.............................................               3
Amphetamine.............................................      10,987,000
Cocaine.................................................         186,000
Codeine (for sale)......................................      41,341,000
Codeine (for conversion)................................      43,559,000
Dextropropoxyphene......................................     167,365,000
Dihydrocodeine..........................................         776,000
Diphenoxylate...........................................         716,000
Ecgonine................................................          38,000
Ethylmorphine...........................................               2
Fentanyl................................................         970,000
Glutethimide............................................               2
Hydrocodone (for sale)..................................      30,622,000
Hydrocodone (for conversion)............................       1,500,000
Hydromorphone...........................................       1,651,000
Isomethadone............................................               2
Levo-alphacetylmethadol (LAAM)..........................               2
Levomethorphan..........................................               2
Levorphanol.............................................          15,000
Meperidine..............................................       9,753,000
Metazocine..............................................               1
Methadone (for sale)....................................      14,057,000
Methadone Intermediate..................................      18,296,000
Methamphetamine.........................................       2,275,000

 825,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 1,420,000 grams for methamphetamine for conversion
  to a Schedule III product; and 30,000 grams for methamphetamine (for
                                  sale)

Methylphenidate.........................................      23,726,000
Morphine (for sale).....................................      21,800,000
Morphine (for conversion)...............................     110,774,000
Nabilone................................................               2
Noroxymorphone (for sale)...............................          99,000
Noroxymorphone (for conversion).........................       3,800,000

[[Page 69723]]


Opium...................................................       1,000,000
Oxycodone (for sale)....................................      41,606,000
Oxycodone (for conversion)..............................         920,000
Oxymorphone.............................................         534,000
Pentobarbital...........................................      18,251,000
Phencyclidine...........................................           2,060
Phenmetrazine...........................................               2
Phenylacetone...........................................      11,000,000
Racemethorphan..........................................               2
Secobarbital............................................           1,000
Sufentanil..............................................           4,000
Thebaine................................................      59,437,000
------------------------------------------------------------------------

    The Acting Deputy Administrator further orders that aggregate 
production quotas for all other Schedules I and II controlled 
substances included in sections 1308.11 and 1308.12 of title 21 of the 
Code of Federal Regulations 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 Acting 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 Acting 
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 
$100,000,000 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 companies to 
compete with foreign-based companies in domestic and export markets.
    The Drug Enforcement Administration makes every effort to write 
clearly. If you have suggestions as to how to improve the clarity of 
this regulation, call or write Christine A. Sannerud, Ph.D., Chief, 
Drug & Chemical Evaluation Section, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-
7183.

    Dated: December 8, 2003.
Michele M. Leonhart,
Acting Deputy Administrator.
[FR Doc. 03-30834 Filed 12-12-03; 8:45 am]

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