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 Department of Justice Drug Enforcement Administration [Docket No. DEA-249F]
 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.
 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.


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:
                    ( print page 67173) Basic class
Established final 2004 quotas**Schedule I**2,5-Dimethoxyamphetamine
3,501,0002,5-Dimethoxy-4-ethylamphetamine (DOET)
22,5-Dimethoxy-4-n-proplythiophenetyhlamine (2C-T-7)
103-Methylfentanyl
23-Methylthiofentanyl
23,4-Methylenedioxyamphetamine(MDA)
113,4-Methylenedioxy-N-ethylamphetamine (MDEA)
53,4-Methylenedioxymethamphetamine (MDMA)
163,4,5-Trimethoxyamphetamine
24-Bromo-2,5-Dimethoxyamphetamine (DOB)
24-Bromo-2,5-Dimethoxyphenethylamine (2-CB)
24-Methoxyamphetamine
24-Methylaminorex
24-Methyl-2,5-Dimethoxyamphetamine (DOM)
25-Methoxy-3,4-Methylenedioxyamphetamine
25-Methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT)
10Acetyl-alpha-methylfentanyl
2Acetyldihydrocodeine
2Acetylmethadol
2Allylprodine
4Alphacetylmethadol
2Alpha-ethyltryptamine
2Alphameprodine
2Alphamethadol
3Alpha-methyltryptamine (AMT)
10Alpha-methylfentanyl
2Alpha-methylthiofentanyl
2Aminorex
2Benzylmorphine
2Betacetylmethadol
2Beta-hydroxy-3-methylfentanyl
2Beta-hydroxyfentanyl
2Betameprodine
2Betamethadol
2Betaprodine
2Bufotenine
2Cathinone
2Codeine-N-oxide
502Diethyltryptamine
2Difenoxin
8,000Dihydromorphine
1,101,000Dimethyltryptamine
3Gamma-hydroxybutyric acid
8,000,000Heroin
5Hydromorphinol
2Hydroxypethidine
2Lysergic acid diethylamide (LSD)
61Marihuana
840,020Mescaline
2Methaqualone
5Methcathinone
4Methyldihydromorphine
2Morphine-N-oxide
502N,N-Dimethylamphetamine
2N-Ethyl-1-Phenylcyclohexylamine (PCE)
5N-Ethylamphetamine
7N-Hydroxy-3,4-Methylenedioxyamphetamine
2Noracymethadol
2Norlevorphanol
52Normethadone
2Normorphine
12Para-fluorofentanyl
2Phenomorphan
2Pholcodine
2Propiram
210,000Psilocybin
2Psilocyn
2Tetrahydrocannabinols
180,000Thiofentanyl
2Trimeperidine
2( print page 67174)**Schedule II**1-Phenylcyclohexylamine
21-Piperidinocyclohexanecarbonitrile (PCC)
10Alfentanil
2,000Alphaprodine
2Amobarbital
3Amphetamine
12,700,000Cocaine
200,000Codeine (for sale)
41,341,000Codeine (for conversion)
48,252,000Dextropropoxyphene
167,365,000Dihydrocodeine
776,000Diphenoxylate
836,000Ecgonine
38,000Ethylmorphine
2Fentanyl
1,428,000Glutethimide
2Hydrocodone (for sale)
34,000,000Hydrocodone (for conversion)
1,500,000Hydromorphone
1,724,000Isomethadone
2Levo-alphacetylmethadol (LAAM)
2Levomethorphan
2Levorphanol
15,000Meperidine
9,753,000Metazocine
1Methadone (for sale)
14,720,000Methadone Intermediate
18,296,000Methamphetamine [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)]
2,250,000Methylphenidate
28,693,000Morphine (for sale)
35,021,000Morphine (for conversion)
110,774,000Nabilone
2Noroxymorphone (for sale)
99,000Noroxymorphone (for conversion)
3,800,000Opium
1,300,000Oxycodone (for sale)
49,200,000Oxycodone (for conversion)
920,000Oxymorphone
534,000Pentobarbital
18,251,000Phencyclidine
2,060Phenmetrazine
2Phenylacetone
11,000,000Racemethorphan
2Secobarbital
2Sufentanil
4,000Thebaine
72,453,000
 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 
                    ( print page 67175)
                    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: November 5, 2004. Michele M. Leonhart, Deputy Administrator.


[FR Doc. 04-25340 Filed 11-15-04; 8:45 am] BILLING CODE 4410-09-P