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 Department of Justice Drug Enforcement Administration [Docket No. DEA-259P]
 AGENCY: Drug Enforcement Administration (DEA), Justice.
 ACTION: Notice of proposed year 2005 aggregate production quotas.
 SUMMARY: This notice proposes initial year 2005 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).
 DATES: Comments or objections must be received on or before December 27, 2004.
 ADDRESSES: To ensure proper handling of comments, please reference “Docket No. DEA-259P” on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301. Comments may be directly sent to DEA electronically by sending an electronic message to 
                        *dea.diversion.policy@usdoj.gov*. Comments may also be sent electronically through 
                        *http://www.regulations.gov*
                         using the electronic comment form provided on that site. An electronic copy of this document is also available at the 
                        *http://www.regulations.gov*
                         Web site. DEA will accept attachments to electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file format other than those specifically listed here.
 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 proposed year 2005 aggregate production quotas represent those quantities of controlled substances that may be produced in the United States in 2005 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. These quotas do not include imports of controlled substances for use in industrial processes. In determining the proposed year 2005 aggregate production quotas, the Deputy Administrator considered the following factors: total actual 2003 and estimated 2004 and 2005 net disposals of each substance by all manufacturers; estimates of 2004 year-end inventories of each substance and of any substance manufactured from it and trends in accumulation of such inventories; 
                    ( print page 70285)
                    product development requirements of both bulk and finished dosage form manufacturers; projected demand as indicated by procurement quota applications filed pursuant to Section 1303.12 of Title 21 of the Code of Federal Regulations; and other pertinent information. Pursuant to Section 1303 of Title 21 of the Code of Federal Regulations, the Deputy Administrator of the DEA will, in early 2005, adjust aggregate production quotas and individual manufacturing quotas allocated for the year based upon 2004 year-end inventory and actual 2004 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 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 proposes that the year 2005 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows: Basic class—Schedule I
Proposed year 2005 quotas2,5-Dimethoxyamphetamine
2,801,000 g2,5-Dimethoxy-4-ethylamphetamine (DOET)
2 g2,5-Dimethoxy-4-(n)-propylthiophenethylamine
10 g3-Methylfentanyl
2 g3-Methylthiofentanyl
2 g3,4-Methylenedioxyamphetamine(MDA)
15 g3,4-Methylenedioxy-N-ethylamphetamine (MDEA)
5 g3,4-Methylenedioxymethamphetamine (MDMA)
15 g3,4,5-Trimethoxyamphetamine
2 g4-Bromo-2,5-dimethoxyamphetamine (DOB)
2 g4-Bromo-2,5-dimethoxyphenethylamine (2-CB)
2 g4-Methoxyamphetamine
2 g4-Methylaminorex
2 g4-Methyl-2,5-dimethoxyamphetamine (DOM)
2 g5-Methoxy-3,4-methylenedioxyamphetamine
2 g5-Methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT)
10 gAcetyl-alpha-methylfentanyl
2 gAcetyldihydrocodeine
2 gAcetylmethadol
2 gAllylprodine
2 gAlphacetylmethadol
2 gAlpha-ethyltryptamine
2 gAlphameprodine
2 gAlphamethadol
3 gAlpha-methyltryptamine (AMT)
10 gAlpha-methylfentanyl
2 gAlpha-methylthiofentanyl
2 gAminorex
2 gBenzylmorphine
2 gBetacetylmethadol
2 gBeta-hydroxy-3-methylfentanyl
2 gBeta-hydroxyfentanyl
2 gBetameprodine
2 gBetamethadol
2 gBetaprodine
2 gBufotenine
2 gCathinone
2 gCodeine-N-oxide
252 gDiethyltryptamine
2 gDifenoxin
5,000 gDihydromorphine
1,551,000 gDimethyltryptamine
3 gGamma-hydroxybutyric acid
8,000,000 gHeroin
2 gHydromorphinol
2 gHydroxypethidine
2 gLysergic acid diethylamide (LSD)
60 gMarihuana
840,020 gMescaline
2 gMethaqualone
5 gMethcathinone
4 gMethyldihydromorphine
2 gMorphine-N-oxide
252 gN,N-Dimethylamphetamine
2 gN-Ethylamphetamine
2 gN-Hydroxy-3,4-methylenedioxyamphetamine
2 gNoracymethadol
2 gNorlevorphanol
52 gNormethadone
2 g( print page 70286)Normorphine
12 gPara-fluorofentanyl
2 gPhenomorphan
2 gPholcodine
2 gPropiram
50,000 gPsilocybin
2 gPsilocyn
7 gTetrahydrocannabinols
211,000 gThiofentanyl
2 gTrimeperidine
2 g
 Basic class—Schedule II
Proposed year 2005 quotas1-Phenylcyclohexylamine
2 gAlfentanil
2,500 gAlphaprodine
2 gAmobarbital
2 gAmphetamine
12,700,000 gCocaine
228,000 gCodeine (for sale)
39,605,000 gCodeine (for conversion)
55,000,000 gDextropropoxyphene
167,365,000 gDihydrocodeine
748,000 gDiphenoxylate
571,000 gEcgonine
53,000 gEthylmorphine
2 gFentanyl
1,428,000 gGlutethimide
2 gHydrocodone (for sale)
37,604,000 gHydrocodone (for conversion)
g 1,500,000Hydromorphone
1,951,000 gIsomethadone
2 gLevo-alphacetylmethadol (LAAM)
2 gLevomethorphan
2 gLevorphanol
5,000 gMeperidine
9,753,000 gMetazocine
1 gMethadone (for sale)
13,900,000 gMethadone Intermediate
18,000,000 gMethamphetamine
2,782,000 g[680,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,050,000 grams for methamphetamine mostly for conversion to a Schedule III product; and 52,000 grams for methamphetamine (for sale)]Methylphenidate
30,817,000 gMorphine (for sale)
35,000,000 gMorphine (for conversion)
110,774,000 gNabilone
2 gNoroxymorphone (for sale)
1,002 gNoroxymorphone (for conversion)
4,000,000 gOpium
1,180,000 gOxycodone (for sale)
49,200,000 gOxycodone (for conversion)
920,000 gOxymorphone
534,000 gPentobarbital
18,251,000 gPhencyclidine
2,006 gPhenmetrazine
2 gRacemethorphan
2 gSecobarbital
2 gSufentanil
4,000 gThebaine
72,453,000 g
 The Deputy Administrator further proposes 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. All interested persons are invited to submit their comments in writing or electronically regarding this proposal following the procedures in the “addresses” section of this document. A person may object to or comment on the proposal relating to any of the above-mentioned substances without filing comments or objections regarding the others. If a person believes that one or more of these issues warrant a hearing, the individual should so state and summarize the reasons for this belief. In the event that comments or objections to this proposal raise one or more issues which the Deputy 
                    ( print page 70287)
                    Administrator finds warrant a hearing, the Deputy Administrator shall order a public hearing by notice in the 
                    **Federal Register**
                    , summarizing the issues to be heard and setting the time for the hearing. 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 companies to compete with foreign-based companies in domestic and export markets. Dated: November 30, 2004. Michele M. Leonhart, Deputy Administrator.


[FR Doc. 04-26689 Filed 12-2-04; 8:45 am] BILLING CODE 4410-09-P