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Notice

Controlled Substances: Final Revised Aggregate Production Quotas for 2004

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Information about this document as published in the Federal Register.

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AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Notice of final aggregate production quotas for 2004.

SUMMARY:

This notice establishes final 2004 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA). The DEA has taken into consideration comments received in response to a notice of the proposed revised aggregate production quotas for 2004 published September 9, 2004 (69 FR 54703).

EFFECTIVE DATE:

November 16, 2004.

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FOR FURTHER INFORMATION CONTACT:

Christine A. Sannerud, Ph.D., Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183.

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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 in Schedules I and II 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.

On September 9, 2004 a notice of the proposed revised 2004 aggregate production quotas for certain controlled substances in Schedules I and II was published in the Federal Register (69 FR 54703). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before September 30, 2004.

Eight companies commented on a total of 15 Schedules I and II controlled substances within the published comment period. The companies commented that the proposed aggregate production quotas for amphetamine, codeine (for conversion), fentanyl, hydrocodone, hydromorphone, marihuana, methamphetamine (for conversion), methamphetamine (for sale), methylphenidate, morphine (for conversion), morphine (for sale), opium, 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 year-end inventories, initial 2004 manufacturing quotas, 2004 export requirements, actual and projected 2004 sales and use, and research and product development requirements. Based on this information, the DEA has adjusted the final 2004 aggregate production quotas for codeine (for conversion), fentanyl, hydromorphone, methamphetamine (for conversion), methamphetamine (for sale), methylphenidate, morphine (for sale), tetrahydrocannabinols, and thebaine to meet the legitimate needs of the United States.

Regarding amphetamine, hydrocodone, marihuana, morphine (for conversion), and opium the DEA has determined that the proposed revised 2004 aggregate production quotas are sufficient to meet the current 2004 estimated medical, scientific, research, and industrial needs of the United States and to provide for adequate inventories.

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 Deputy Administrator hereby orders that the 2004 final aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:Start Printed Page 67173

Basic classEstablished final 2004 quotas
Schedule I
2,5-Dimethoxyamphetamine3,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET)2
2,5-Dimethoxy-4-n-proplythiophenetyhlamine (2C-T-7)10
3-Methylfentanyl2
3-Methylthiofentanyl2
3,4-Methylenedioxyamphetamine(MDA)11
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)5
3,4-Methylenedioxymethamphetamine (MDMA)16
3,4,5-Trimethoxyamphetamine2
4-Bromo-2,5-Dimethoxyamphetamine (DOB)2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)2
4-Methoxyamphetamine2
4-Methylaminorex2
4-Methyl-2,5-Dimethoxyamphetamine (DOM)2
5-Methoxy-3,4-Methylenedioxyamphetamine2
5-Methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT)10
Acetyl-alpha-methylfentanyl2
Acetyldihydrocodeine2
Acetylmethadol2
Allylprodine4
Alphacetylmethadol2
Alpha-ethyltryptamine2
Alphameprodine2
Alphamethadol3
Alpha-methyltryptamine (AMT)10
Alpha-methylfentanyl2
Alpha-methylthiofentanyl2
Aminorex2
Benzylmorphine2
Betacetylmethadol2
Beta-hydroxy-3-methylfentanyl2
Beta-hydroxyfentanyl2
Betameprodine2
Betamethadol2
Betaprodine2
Bufotenine2
Cathinone2
Codeine-N-oxide502
Diethyltryptamine2
Difenoxin8,000
Dihydromorphine1,101,000
Dimethyltryptamine3
Gamma-hydroxybutyric acid8,000,000
Heroin5
Hydromorphinol2
Hydroxypethidine2
Lysergic acid diethylamide (LSD)61
Marihuana840,020
Mescaline2
Methaqualone5
Methcathinone4
Methyldihydromorphine2
Morphine-N-oxide502
N,N-Dimethylamphetamine2
N-Ethyl-1-Phenylcyclohexylamine (PCE)5
N-Ethylamphetamine7
N-Hydroxy-3,4-Methylenedioxyamphetamine2
Noracymethadol2
Norlevorphanol52
Normethadone2
Normorphine12
Para-fluorofentanyl2
Phenomorphan2
Pholcodine2
Propiram210,000
Psilocybin2
Psilocyn2
Tetrahydrocannabinols180,000
Thiofentanyl2
Trimeperidine2
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Schedule II
1-Phenylcyclohexylamine2
1-Piperidinocyclohexanecarbonitrile (PCC)10
Alfentanil2,000
Alphaprodine2
Amobarbital3
Amphetamine12,700,000
Cocaine200,000
Codeine (for sale)41,341,000
Codeine (for conversion)48,252,000
Dextropropoxyphene167,365,000
Dihydrocodeine776,000
Diphenoxylate836,000
Ecgonine38,000
Ethylmorphine2
Fentanyl1,428,000
Glutethimide2
Hydrocodone (for sale)34,000,000
Hydrocodone (for conversion)1,500,000
Hydromorphone1,724,000
Isomethadone2
Levo-alphacetylmethadol (LAAM)2
Levomethorphan2
Levorphanol15,000
Meperidine9,753,000
Metazocine1
Methadone (for sale)14,720,000
Methadone Intermediate18,296,000
Methamphetamine [675,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 1,525,000 grams for methamphetamine mostly for conversion to a Schedule III product; and 50,000 grams for methamphetamine (for sale)]2,250,000
Methylphenidate28,693,000
Morphine (for sale)35,021,000
Morphine (for conversion)110,774,000
Nabilone2
Noroxymorphone (for sale)99,000
Noroxymorphone (for conversion)3,800,000
Opium1,300,000
Oxycodone (for sale)49,200,000
Oxycodone (for conversion)920,000
Oxymorphone534,000
Pentobarbital18,251,000
Phencyclidine2,060
Phenmetrazine2
Phenylacetone11,000,000
Racemethorphan2
Secobarbital2
Sufentanil4,000
Thebaine72,453,000

The 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 remain 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 $113,000,000 or more in any one year, and will not significantly or uniquely affect small Start Printed Page 67175governments. 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.

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Dated: November 5, 2004.

Michele M. Leonhart,

Deputy Administrator.

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[FR Doc. 04-25340 Filed 11-15-04; 8:45 am]

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