[Federal Register Volume 67, Number 244 (Thursday, December 19, 2002)]
[Notices]
[Pages 77809-77812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31898]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA  237E]


Controlled Substances: Established Initial Aggregate Production 
Quotas for 2003

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 2003.

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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.

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug & 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, D.C. 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 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

[[Page 77810]]

additional 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:

------------------------------------------------------------------------
                                                          Established
                     Basic class                         initial 2003
                                                            quotas
------------------------------------------------------------------------
Schedule I:
    2,5-Dimethoxyamphetamine........................           9,501,000
    2,5-Dimethoxy-4-ethylamphetamine (DOET).........                   2
    3-Methylfentanyl................................                   4
    3-Methylthiofentanyl............................                   2
    3,4-Methylenedioxyamphetamine (MDA).............                  15
    3,4-Methylenedioxy-N-ethylamphetamine (MDEA)....                  10
    3,4-Methylenedioxymethamphetamine (MDMA)........                  19
    3,4,5-Trimethoxyamphetamine.....................                   2
    4-Bromo-2,5-Dimethoxyamphetamine (DOB)..........                   2
    4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)......                   2
    4-Methoxyamphetamine............................                   7
    4-Methylaminorex................................                   2
    4-Methyl-2,5-Dimethoxyamphetamine (DOM).........                   2
    5-Methoxy-3,4-Methylenedioxyamphetamine.........                   2
    Acetyl-alpha-methylfentanyl.....................                   2
    Acetyldihydrocodeine............................                   2
    Acetylmethadol..................................                   2
    Allylprodine....................................                   2
    Alphacetylmethadol..............................                   7
    Alpha-ethyltryptamine...........................                   2
    Alphameprodine..................................                   2
    Alphamethadol...................................                   2
    Alpha-methylfentanyl............................                   2
    Alpha-methylthiofentanyl........................                   2
    Aminorex........................................                  17
    Benzylmorphine..................................                   2
    Betacetylmethadol...............................                   2
    Beta-hydroxy-3-methylfentanyl...................                   2
    Beta-hydroxyfentanyl............................                   2
    Betameprodine...................................                   2
    Betamethadol....................................                   2
    Betaprodine.....................................                   2
    Bufotenine......................................                   2
    Cathinone.......................................                  12
    Codeine-N-oxide.................................                 202
    Diethyltryptamine...............................                   2
    Difenoxin.......................................               9,000
    Dihydromorphine.................................           1,101,000
    Dimethyltryptamine..............................                   3
    Gamma-hydroxybutyric acid.......................          45,566,000
    Heroin..........................................                   5
    Hydromorphinol..................................                   2
    Hydroxypethidine................................                   2
    Lysergic acid diethylamide (LSD)................                  61
    Marihuana.......................................             840,000
    Mescaline.......................................                   7
    Methaqualone....................................                   9
    Methcathinone...................................                   9
    Methyldihydromorphine...........................                   2
    Morphine-N-oxide................................                 202
    N,N-Dimethylamphetamine.........................                   7
    N-Ethyl-1-Phenylcyclohexylamine (PCE)...........                   5

[[Page 77811]]

 
    N-Ethylamphetamine..............................                   7
    N-Hydroxy-3,4-Methylenedioxyamphetamine.........                   2
    Noracymethadol..................................                   2
    Norlevorphanol..................................                  52
    Normethadone....................................                   7
    Normorphine.....................................                  57
    Para-fluorofentanyl.............................                   2
    Phenomorphan....................................                   2
    Pholcodine......................................                   2
    Propiram........................................             415,000
    Psilocybin......................................                   2
    Psilocyn........................................                   2
    Tetrahydrocannabinols...........................             131,000
    Thiofentanyl....................................                   2
    Trimeperidine...................................                   2
Schedule II:
    1-Phenylcyclohexylamine.........................                  12
    1-Piperidinocyclohexanecarbonitrile (PCC).......                  10
    Alfentanil......................................                 700
    Alphaprodine....................................                   2
    Amobarbital.....................................             451,000
    Amphetamine.....................................          10,987,000
    Cocaine.........................................             171,000
    Codeine (for sale)..............................          43,494,000
    Codeine (for conversion)........................          43,559,000
    Dextropropoxyphene..............................         167,365,000
    Dihydrocodeine..................................             741,000
    Diphenoxylate...................................             501,000
    Ecgonine........................................              31,000
    Ethylmorphine...................................                  12
    Fentanyl........................................             733,000
    Glutethimide....................................               1,002
    Hydrocodone (for sale)..........................          29,243,000
    Hydrocodone (for conversion)....................           3,800,000
    Hydromorphone...................................           1,409,000
    Isomethadone....................................                  12
    Levo-alphacetylmethadol (LAAM)..................                  12
    Levomethorphan..................................                   2
    Levorphanol.....................................               8,600
    Meperidine......................................           9,649,000
    Metazocine......................................                   1
    Methadone (for sale)............................          14,057,000
    Methadone Intermediate..........................          17,393,000
    Methamphetamine.................................          2,325,000
        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) ....................
    Methylphenidate.................................          20,967,000
    Morphine (for sale).............................          18,218,000
    Morphine (for conversion).......................         110,774,000
    Nabilone........................................                   2
    Noroxymorphone (for sale).......................              40,000
    Noroxymorphone (for conversion).................           4,400,000
    Opium...........................................           1,000,000
    Oxycodone (for sale)............................          34,482,000
    Oxycodone (for conversion)......................             700,000
    Oxymorphone.....................................             454,000
    Pentobarbital...................................          27,728,000
    Phencyclidine...................................                  16
    Phenmetrazine...................................                   2
    Phenylacetone...................................          21,975,000
    Secobarbital....................................               1,100
    Sufentanil......................................               3,000
    Thebaine........................................          43,292,000
------------------------------------------------------------------------

    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

[[Page 77812]]

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 
$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.

    Dated: December 13, 2002.
John B. Brown, III,
Deputy Administrator.
[FR Doc. 02-31898 Filed 12-18-02; 8:45 am]
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