02-31898. Controlled Substances: Established Initial Aggregate Production Quotas for 2003  

  • Start Preamble

    AGENCY:

    Drug Enforcement Administration (DEA), Justice.

    ACTION:

    Notice of aggregate production quotas for 2003.

    SUMMARY:

    This notice establishes initial 2003 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).

    EFFECTIVE DATE:

    December 19, 2002.

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    Frank L. Sapienza, Chief, Drug & Chemical Evaluation Section, Drug Enforcement Administration, Washington, D.C. 20537, Telephone: (202) 307-7183.

    End Further Info End Preamble Start Supplemental Information

    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 2003 aggregate production quotas represent those quantities of controlled substances that may be produced in the United States in 2003 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 1, 2002, a notice of the proposed initial 2003 aggregate production quotas for certain controlled substances in Schedules I and II was published in the Federal Register (67 FR 66663). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before November 22, 2002.

    Ten companies commented on a total of twenty Schedules I and II controlled substances within the published comment period. The companies commented that the proposed aggregate production quotas for amobarbital, amphetamine, codeine (for sale), codeine (for conversion), dextropropoxyphene, dihydrocodeine, fentanyl, glutethimide, hydrocodone (for sale), hydromorphone, methadone (for sale), methadone intermediate, methamphetamine (for conversion), methamphetamine (for sale), morphine (for conversion), noroxymorphone (for sale), opium, oxycodone (for sale), sufentanil 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. One company commented that the proposed aggregate production quota for methamphetamine (for sale) was adequate to provide for the estimated medical needs of the United States.

    DEA has taken into consideration the above comments along with the relevant 2002 manufacturing quotas, current 2002 sales and inventories, 2003 export requirements and research and product development requirements, and Start Printed Page 77810additional and revised applications for 2003 manufacturing quotas. Based on this information, the DEA has adjusted the initial aggregate production quotas for amobarbital, codeine (for conversion), codeine-N-oxide, glutethimide, methadone (for sale), methadone intermediate, levo-desoxyephedrine, methamphetamine (for conversion), morphine-N-oxide, opium, and sufentanil to meet the legitimate needs of the United States.

    Regarding amphetamine, codeine (for sale), dextropropoxyphene, dihydrocodeine, fentanyl, hydrocodone (for sale), hydromorphone, morphine (for conversion), noroxymorphone (for sale), oxycodone (for sale), and thebaine, the DEA has determined that the proposed initial 2003 aggregate production quotas are sufficient to meet the current 2003 estimated medical, scientific, research and industrial needs of the United States.

    Pursuant to Section 1303 of Title 21 of the Code of Federal Regulations, the Deputy Administrator of the DEA will, in early 2003, adjust aggregate production quotas and individual manufacturing quotas allocated for the year based upon 2002 year-end inventory and actual 2002 disposition data supplied by quota recipients for each basic class of Schedules I and 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 Deputy Administrator hereby orders that the 2003 initial aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:

    Basic classEstablished initial 2003 quotas
    Schedule I:
    2,5-Dimethoxyamphetamine9,501,000
    2,5-Dimethoxy-4-ethylamphetamine (DOET)2
    3-Methylfentanyl4
    3-Methylthiofentanyl2
    3,4-Methylenedioxyamphetamine (MDA)15
    3,4-Methylenedioxy-N-ethylamphetamine (MDEA)10
    3,4-Methylenedioxymethamphetamine (MDMA)19
    3,4,5-Trimethoxyamphetamine2
    4-Bromo-2,5-Dimethoxyamphetamine (DOB)2
    4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)2
    4-Methoxyamphetamine7
    4-Methylaminorex2
    4-Methyl-2,5-Dimethoxyamphetamine (DOM)2
    5-Methoxy-3,4-Methylenedioxyamphetamine2
    Acetyl-alpha-methylfentanyl2
    Acetyldihydrocodeine2
    Acetylmethadol2
    Allylprodine2
    Alphacetylmethadol7
    Alpha-ethyltryptamine2
    Alphameprodine2
    Alphamethadol2
    Alpha-methylfentanyl2
    Alpha-methylthiofentanyl2
    Aminorex17
    Benzylmorphine2
    Betacetylmethadol2
    Beta-hydroxy-3-methylfentanyl2
    Beta-hydroxyfentanyl2
    Betameprodine2
    Betamethadol2
    Betaprodine2
    Bufotenine2
    Cathinone12
    Codeine-N-oxide202
    Diethyltryptamine2
    Difenoxin9,000
    Dihydromorphine1,101,000
    Dimethyltryptamine3
    Gamma-hydroxybutyric acid45,566,000
    Heroin5
    Hydromorphinol2
    Hydroxypethidine2
    Lysergic acid diethylamide (LSD)61
    Marihuana840,000
    Mescaline7
    Methaqualone9
    Methcathinone9
    Methyldihydromorphine2
    Morphine-N-oxide202
    N,N-Dimethylamphetamine7
    N-Ethyl-1-Phenylcyclohexylamine (PCE)5
    Start Printed Page 77811
    N-Ethylamphetamine7
    N-Hydroxy-3,4-Methylenedioxyamphetamine2
    Noracymethadol2
    Norlevorphanol52
    Normethadone7
    Normorphine57
    Para-fluorofentanyl2
    Phenomorphan2
    Pholcodine2
    Propiram415,000
    Psilocybin2
    Psilocyn2
    Tetrahydrocannabinols131,000
    Thiofentanyl2
    Trimeperidine2
    Schedule II:
    1-Phenylcyclohexylamine12
    1-Piperidinocyclohexanecarbonitrile (PCC)10
    Alfentanil700
    Alphaprodine2
    Amobarbital451,000
    Amphetamine10,987,000
    Cocaine171,000
    Codeine (for sale)43,494,000
    Codeine (for conversion)43,559,000
    Dextropropoxyphene167,365,000
    Dihydrocodeine741,000
    Diphenoxylate501,000
    Ecgonine31,000
    Ethylmorphine12
    Fentanyl733,000
    Glutethimide1,002
    Hydrocodone (for sale)29,243,000
    Hydrocodone (for conversion)3,800,000
    Hydromorphone1,409,000
    Isomethadone12
    Levo-alphacetylmethadol (LAAM)12
    Levomethorphan2
    Levorphanol8,600
    Meperidine9,649,000
    Metazocine1
    Methadone (for sale)14,057,000
    Methadone Intermediate17,393,000
    Methamphetamine2,325,000
    804,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 1,520,000 grams for methamphetamine for conversion to a Schedule III product; and 1,000 grams for methamphetamine (for sale)
    Methylphenidate20,967,000
    Morphine (for sale)18,218,000
    Morphine (for conversion)110,774,000
    Nabilone2
    Noroxymorphone (for sale)40,000
    Noroxymorphone (for conversion)4,400,000
    Opium1,000,000
    Oxycodone (for sale)34,482,000
    Oxycodone (for conversion)700,000
    Oxymorphone454,000
    Pentobarbital27,728,000
    Phencyclidine16
    Phenmetrazine2
    Phenylacetone21,975,000
    Secobarbital1,100
    Sufentanil3,000
    Thebaine43,292,000

    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 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 Start Printed Page 77812diminish 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 $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 Frank L. Sapienza, Chief, Drug & Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183.

    Start Signature

    Dated: December 13, 2002.

    John B. Brown, III,

    Deputy Administrator.

    End Signature End Supplemental Information

    [FR Doc. 02-31898 Filed 12-18-02; 8:45 am]

    BILLING CODE 4410-09-P

Document Information

Effective Date:
12/19/2002
Published:
12/19/2002
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Notice of aggregate production quotas for 2003.
Document Number:
02-31898
Dates:
December 19, 2002.
Pages:
77809-77812 (4 pages)
Docket Numbers:
DEA # 237E
PDF File:
02-31898.pdf