[Federal Register: November 4, 2003 (Volume 68, Number 213)]
[Notices]               
[Page 62474-62477]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no03-86]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA 249]

 
Controlled Substances: Proposed Aggregate Production Quotas for 
2004

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed year 2004 aggregate production quotas.

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SUMMARY: This notice proposes initial year 2004 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 November 
25, 2003.

ADDRESSES: Send comments or objections to the Acting Deputy 
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. The Administrator, in turn, has redelegated this function 
to the Deputy Administrator, pursuant to Sec.  0.104 of title 28 of the 
Code of Federal Regulations.
    The proposed year 2004 aggregate production quotas represent those 
quantities of controlled substances 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. These quotas do not include imports of 
controlled substances for use in industrial processes.
    In determining the proposed year 2004 aggregate production quotas, 
the Acting Deputy Administrator considered the following factors: Total 
actual 2002 and estimated 2003 and 2004 net disposals of each substance 
by all manufacturers; estimates of 2003 year-end inventories of each 
substance and of any substance manufactured from it and trends in 
accumulation of such inventories; product development requirements of 
both bulk and finished dosage form manufacturers; projected demand as 
indicated by procurement quota applications filed pursuant to Sec.  
1303.12 of title 21 of the Code of Federal Regulations; and other 
pertinent information.
    Pursuant to part 1303 of title 21 of the Code of Federal 
Regulations, the Acting

[[Page 62475]]

Deputy Administrator of the DEA will, in early 2004, adjust aggregate 
production quotas and individual manufacturing quotas allocated for the 
year based upon 2003 year-end inventory and actual 2003 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 
Sec.  306 of the CSA of 1970 (21 U.S.C. 826), and delegated to the 
Administrator of the DEA by Sec.  0.100 of title 28 of the Code of 
Federal Regulations, and redelegated to the Deputy Administrator 
pursuant to Sec.  0.104 of title 28 of the Code of Federal Regulations, 
the Acting Deputy Administrator hereby proposes that the year 2004 
aggregate production quotas for the following controlled substances, 
expressed in grams of anhydrous acid or base, be established as 
follows:

------------------------------------------------------------------------
                                                         Proposed year
                     Basic class                          2004 quotas
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine.............................          3,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET)..............                  2
3-Methylfentanyl.....................................                  2
3-Methylthiofentanyl.................................                  2
3,4-Methylenedioxyamphetamine (MDA)..................                 11
3,4-Methylenedioxy-N-ethylamphetamine (MDEA).........                  5
3,4-Methylenedioxymethamphetamine (MDMA).............                 16
3,4,5-Trimethoxyamphetamine..........................                  2
4-Bromo-2,5-Dimethoxyamphetamine (DOB)...............                  2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)...........                  2
4-Methoxyamphetamine.................................                  2
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.........................................                  4
Alphacetylmethadol...................................                  2
Alpha-ethyltryptamine................................                  2
Alphameprodine.......................................                  2
Alphamethadol........................................                  3
Alpha-methylfentanyl.................................                  2
Alpha-methylthiofentanyl.............................                  2
Aminorex.............................................                  2
Benzylmorphine.......................................                  2
Betacetylmethadol....................................                  2
Beta-hydroxy-3-methylfentanyl........................                  2
Beta-hydroxyfentanyl.................................                  2
Betameprodine........................................                  2
Betamethadol.........................................                  2
Betaprodine..........................................                  2
Bufotenine...........................................                  2
Cathinone............................................                  2
Codeine-N-oxide......................................                352
Diethyltryptamine....................................                  2
Difenoxin............................................              9,000
Dihydromorphine......................................          1,101,000
Dimethyltryptamine...................................                  3
Gamma-hydroxybutyric acid............................         10,000,000
Heroin...............................................                  5
Hydromorphinol.......................................                  2
Hydroxypethidine.....................................                  2
Lysergic acid diethylamide (LSD).....................                 61
Marihuana............................................            840,000
Mescaline............................................                  2
Methaqualone.........................................                  5
Methcathinone........................................                  4
Methyldihydromorphine................................                  2
Morphine-N-oxide.....................................                352
N,N-Dimethylamphetamine..............................                  2
N-Ethyl-1-Phenylcyclohexylamine (PCE)................                  5
N-Ethylamphetamine...................................                  7
N-Hydroxy-3,4-Methylenedioxyamphetamine..............                  2
Noracymethadol.......................................                  2
Norlevorphanol.......................................                 52
Normethadone.........................................                  2
Normorphine..........................................                 12
Para-fluorofentanyl..................................                  2
Phenomorphan.........................................                  2
Pholcodine...........................................                  2

[[Page 62476]]


Propiram.............................................            210,000
Psilocybin...........................................                  2
Psilocyn.............................................                  2
Tetrahydrocannabinols................................            176,000
Thiofentanyl.........................................                  2
Trimeperidine........................................                  2
------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                  2
1-Piperidinocyclohexanecarbonitrile (PCC)............                 10
Alfentanil...........................................                200
Alphaprodine.........................................                  2
Amobarbital..........................................                  3
Amphetamine..........................................         10,987,000
Cocaine..............................................            186,000
Codeine (for sale)...................................         41,341,000
Codeine (for conversion).............................         42,136,000
Dextropropoxyphene...................................        167,365,000
Dihydrocodeine.......................................            681,000
Diphenoxylate........................................            716,000
Ecgonine.............................................             38,000
Ethylmorphine........................................                  2
Fentanyl.............................................            970,000
Glutethimide.........................................                  2
Hydrocodone (for sale)...............................         30,622,000
Hydrocodone (for conversion).........................          1,500,000
Hydromorphone........................................          1,651,000
Isomethadone.........................................                  2
Levo-alphacetylmethadol (LAAM).......................                  2
Levomethorphan.......................................                  0
Levorphanol..........................................             15,000
Meperidine...........................................          9,753,000
Metazocine...........................................                  1
Methadone (for sale).................................         14,057,000
Methadone Intermediate...............................         17,393,000
Methamphetamine......................................         2,275,000
    825,000 grams of levo-desoxyephedrine for use in a non-controlled,
     non-prescription product; 1,420,000 grams for methamphetamine
     mostly for conversion to a schedule III product; and 30,000 grams
     for methamphetamine (for sale)
Methylphenidate......................................         23,726,000
Morphine (for sale)..................................         20,762,000
Morphine (for conversion)............................        110,774,000
Nabilone.............................................                  2
Noroxymorphone (for sale)............................             99,000
Noroxymorphone (for conversion)......................          2,900,000
Opium................................................          1,000,000
Oxycodone (for sale).................................         41,182,000
Oxycodone (for conversion)...........................            700,000
Oxymorphone..........................................            466,000
Pentobarbital........................................         18,251,000
Phencyclidine........................................                 60
Phenmetrazine........................................                  2
Phenylacetone........................................                  0
Secobarbital.........................................              1,000
Sufentanil...........................................              3,000
Thebaine.............................................         58,832,000
------------------------------------------------------------------------

    The Acting Deputy 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 be established 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 Deputy Administrator finds warrant a 
hearing, the Acting 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

[[Page 62477]]

enforce its own laws. Accordingly, this action does not have federalism 
implications warranting the application of Executive Order 13132.
    The Acting 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 Acting 
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 and 
Chemical Evaluation Section, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-
7183.

    Dated: October 27, 2003.
Michele M. Leonhart,
Acting Deputy Administrator.
[FR Doc. 03-27636 Filed 11-3-03; 8:45 am]

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