03-30834. Controlled Substances: Established Initial Aggregate Production Quotas for 2004

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Notice of aggregate production quotas for 2004.

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: [phone].

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 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:

Basic class	Established 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
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
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: [phone].

Dated: December 8, 2003.

Michele M. Leonhart,

Acting Deputy Administrator.