[Federal Register Volume 68, Number 151 (Wednesday, August 6, 2003)]
[Notices]
[Pages 46664-46666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19954]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA  237R]


Controlled Substances: Proposed Revised Aggregate Production 
Quotas for 2003

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed revised 2003 aggregate production quotas.

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SUMMARY: This notice proposes revised 2003 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 August 27, 
2003.

ADDRESSES: Send comments or objections to the Acting Administrator, 
Drug Enforcement Administration, Washington, DC 20537, Attn.: DEA 
Federal Register Representative (CCR).

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, 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 Sec.  0.100 of Title 28 of the Code of Federal 
Regulations.
    On December 19, 2002, DEA published a notice of established initial 
2003 aggregate production quotas for certain controlled substances in 
Schedules I and II (67 FR 77809). This notice stipulated that the DEA 
would adjust the quotas in early 2003 as provided for in part 1303 of 
Title 21 of the Code of Federal Regulations.
    The proposed revised 2003 aggregate production quotas represent 
those quantities of controlled substances in Schedules I and II 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. 
These quotas do not include imports of controlled substances for use in 
industrial processes.
    The proposed revisions are based on a review of 2002 year-end 
inventories, 2002 disposition data submitted by quota applicants, 
estimates of the medical needs of the United States, product 
development, and other information available to the DEA.
    Therefore, under the authority vested in the Attorney General by 
section 306 of the CSA of 1970 (21 U.S.C. 826), delegated to the 
Administrator of the DEA by Sec.  0.100 of Title 28 of the Code of 
Federal Regulations, the Acting Administrator hereby proposes the 
following revised 2003 aggregate production quotas for the following 
controlled substances, expressed in grams of anhydrous acid or base:

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                                                                                Previously
                                                                               established      Proposed revised
                                Basic class                                    initial 2003       2003 quotas
                                                                                  quotas
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                                Schedule I
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2,5-Dimethoxyamphetamine..................................................          9,501,000          9,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET)...................................                  2                  2
3-Methylfentanyl..........................................................                  4                  4
3-Methylthiofentanyl......................................................                  2                  2
3,4-Methylenedioxyamphetamine (MDA).......................................                 15                 15
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)..............................                 10                 10
3,4-Methylenedioxymethamphetamine (MDMA)..................................                 19                 19
3,4,5-Trimethoxyamphetamine...............................................                  2                  2
4-Bromo-2,5-Dimethoxyamphetamine (DOB)....................................                  2                  2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)................................                  2                  2
4-Methoxyamphetamine......................................................
4-Methylaminorex..........................................................                  7                  7
4-Methyl-2,5-Dimethoxyamphetamine (DOM)...................................                  2                  2
5-Methoxy-3,4-Methylenedioxyamphetamine...................................                  2                  2
Acetyl-alpha-methylfentanyl...............................................                  2                  2
Acetyldihydrocodeine......................................................                  2                  2
Acetylmethadol............................................................                  2                  3
Allylprodine..............................................................                  2                  2
Alphacetylmethadol........................................................                  7                  7
Alpha-ethyltryptamine.....................................................                  2                  2
Alphameprodine............................................................                  2                  2
Alphamethadol.............................................................                  2                  2

[[Page 46665]]

 
Alpha-methylfentanyl......................................................                  2                  2
Alpha-methylthiofentanyl..................................................                  2                  2
Aminorex..................................................................                 17                 17
Benzylmorphine............................................................                  2                  2
Betacetylmethadol.........................................................                  2                  2
Beta-hydroxy-3-methylfentanyl.............................................                  2                  2
Beta-hydroxyfentanyl......................................................                  2                  2
Betameprodine.............................................................                  2                  2
Betamethadol..............................................................                  2                  2
Betaprodine...............................................................                  2                  2
Bufotenine................................................................                  2                  2
Cathinone.................................................................                 12                 12
Codeine-N-oxide...........................................................                202                352
Diethyltryptamine.........................................................                  2                  2
Difenoxin.................................................................              9,000              9,000
Dihydromorphine...........................................................          1,101,000          1,101,000
Dimethyltryptamine........................................................                  3                  3
Gamma-hydroxybutyric acid.................................................         45,566,000         20,000,000
Heroin....................................................................                  5                  5
Hydromorphinol............................................................                  2                  2
Hydroxypethidine..........................................................                  2                  2
Lysergic acid diethylamide (LSD)..........................................                 61                 61
Marihuana.................................................................            840,000            840,000
Mescaline.................................................................                  7                  7
Methaqualone..............................................................                  9                  9
Methcathinone.............................................................                  9                  9
Methyldihydromorphine.....................................................                  2                  2
Morphine-N-oxide..........................................................                202                352
N,N-Dimethylamphetamine...................................................                  7                  7
N-Ethyl-1-Phenylcyclohexylamine (PCE).....................................                  5                  5
N-Ethylamphetamine........................................................                  7                  7
N-Hydroxy-3,4-Methylenedioxyamphetamine...................................                  2                  2
Noracymethadol............................................................                  2                  2
Norlevorphanol............................................................                 52                 52
Normethadone..............................................................                  7                  7
Normorphine...............................................................                 57                 57
Para-fluorofentanyl.......................................................                  2                  2
Phenomorphan..............................................................                  2                  2
Pholcodine................................................................                  2                  2
Propiram..................................................................            415,000            415,000
Psilocybin................................................................                  2                  2
Psilocyn..................................................................                  2                  2
Tetrahydrocannabinols.....................................................            131,000            131,000
Thiofentanyl..............................................................                  2                  2
Trimeperidine.............................................................                  2                  2
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                                Schedule II
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1-Phenylcyclohexylamine...................................................                 12                 12
1-Piperidinocyclohexanecarbonitrile (PCC).................................                 10                 10
Alfentanil................................................................                700                700
Alphaprodine..............................................................                  2                  2
Amobarbital...............................................................            451,000                  0
Amphetamine...............................................................         10,987,000         10,987,000
Cocaine...................................................................            171,000            175,000
Codeine (for sale)........................................................         43,494,000         43,494,000
Codeine (for conversion)..................................................         43,559,000         43,559,000
Dextropropoxyphene........................................................        167,365,000        167,365,000
Dihydrocodeine............................................................            741,000            741,000
Diphenoxylate.............................................................            501,000            546,000
Ecgonine..................................................................             31,000             33,000
Ethylmorphine.............................................................                 12                 12
Fentanyl..................................................................            733,000            804,000
Glutethimide..............................................................              1,002              1,002
Hydrocodone (for sale)....................................................         29,243,000         29,543,000
Hydrocodone (for conversion)..............................................          3,800,000          3,800,000
Hydromorphone.............................................................          1,409,000          1,620,000
Isomethadone..............................................................                 12                 12
Levo-alphacetylmethadol (LAAM)............................................                 12                 12
Levomethorphan............................................................                  2                  2
Levorphanol...............................................................              8,600              8,600
Meperidine................................................................          9,649,000          9,753,000

[[Page 46666]]

 
Metazocine................................................................                  1                  1
Methadone (for sale)......................................................         14,057,000         14,057,000
Methadone Intermediate....................................................         17,393,000         17,393,000
Methamphetamine [704,000 grams of levo-desoxyephedrine for use in a non-            2,325,000          2,125,000
 controlled, non-prescription product; 1,420,000 grams for methamphetamine
 mostly for conversion to a Schedule III product; and 1,000 grams for
 methamphetamine (for sale)]..............................................
Methylphenidate...........................................................         20,967,000         23,726,000
Morphine (for sale).......................................................         18,218,000         20,252,000
Morphine (for conversion).................................................        110,774,000        110,774,000
Nabilone..................................................................                  2                  2
Noroxymorphone (for sale).................................................             40,000             80,000
Noroxymorphone (for conversion)...........................................          4,400,000          4,400,000
Opium.....................................................................          1,000,000          1,000,000
Oxycodone (for sale)......................................................         34,482,000         39,090,000
Oxycodone (for conversion)................................................            700,000            700,000
Oxymorphone...............................................................            454,000            454,000
Pentobarbital.............................................................         27,728,000         27,728,000
Phencyclidine.............................................................                 16                 16
Phenmetrazine.............................................................                  2                  2
Phenylacetone.............................................................         21,975,000         21,975,000
Secobarbital..............................................................              1,100              1,100
Sufentanil................................................................              3,000              3,000
Thebaine..................................................................         43,292,000         56,652,000
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    The Acting Administrator further proposes that aggregate production 
quotas for all other Schedules I and II controlled substances included 
in Sec. Sec.  1308.11 and 1308.12 of Title 21 of the Code of Federal 
Regulations remain at zero.
    All interested persons are invited to submit their comments and 
objections in writing regarding this proposal. 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 Acting Administrator finds warrant a hearing, 
the Acting 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 as per 21 CFR 1303.13(c) and 1303.32.
    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 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 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 DEA 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: July 31, 2003.
William B. Simpkins,
Acting Administrator.
[FR Doc. 03-19954 Filed 8-5-03; 8:45 am]
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