[Federal Register Volume 68, Number 189 (Tuesday, September 30, 2003)]
[Notices]
[Pages 56322-56324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24653]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA  237F]


Controlled Substances: Final Revised Aggregate Production Quotas 
for 2003

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of final aggregate production quotas for 2003.

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SUMMARY: This notice establishes final 2003 aggregate production quotas 
for controlled substances in Schedules I and II of the Controlled 
Substances Act (CSA). The DEA has taken into consideration comments 
received in response to a notice of the proposed revised aggregate 
production quotas for 2003 published August 6, 2003 (68 FR 46664) and 
August 19, 2003 (68 FR 49843) [Corrections].

EFFECTIVE DATE: September 30, 2003.

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 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 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 (21 U.S.C. 826(a) and 21 CFR 
1303.11). These quotas do not include imports of controlled substances.
    On August 6, 2003, a notice of the proposed revised 2003 aggregate 
production quotas for certain controlled substances in Schedules I and 
II was published in the Federal Register (68 FR 46664) and (68 FR 
49843) [Corrections]. All interested persons were invited to comment on 
or object to these proposed aggregate production quotas on or before 
August 27, 2003.
    Seven companies commented on a total of 18 Schedules I and II 
controlled substances within the published comment period. The 
companies commented that the proposed aggregate production quotas for 
tetrahydrocannabinols, codeine (for conversion), dextropropoxyphene, 
diphenoxylate, fentanyl, hydrocodone (for sale), hydromorphone, 
meperidine, levo-desoxyephedrine (levo-methamphetamine), 
methamphetamine (for sale), methylphenidate, morphine (for sale), 
morphine (for conversion), noroxymorphone (for sale), oxycodone (for 
sale), pentobarbital, 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.
    DEA has taken into consideration the above comments along with the 
relevant 2002 year-end inventories, initial 2003 manufacturing quotas, 
2003 export requirements, actual and projected 2003 sales and use, and 
research and product development requirements. Based on this 
information, the DEA has adjusted the final 2003 aggregate production 
quotas for tetrahydrocannabinols, amobarbital, diphenoxylate, fentanyl, 
hydrocodone (for sale), hydrocodone (for conversion), hydromorphone, 
levo-desoxyephedrine (l-methamphetamine), methamphetamine (for sale), 
morphine (for sale), noroxymorphone (for sale), oxycodone (for sale) 
and thebaine to meet the legitimate needs of the United States.
    Regarding codeine (for conversion), dextropropoxyphene, meperidine, 
methylphenidate, morphine (for conversion), pentobarbital, and 
sufentanil, the DEA has determined that the proposed revised 2003 
aggregate production quotas are sufficient to meet the current 2003 
estimated medical, scientific, research, and industrial needs of the 
United States and to provide for adequate inventories.
    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 Acting Deputy Administrator hereby orders that 
the 2003 final aggregate production quotas for the following controlled 
substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                       Established final
                     Basic class                          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.......................................                  3
Allylprodine.........................................                  2

[[Page 56323]]

 
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......................................                352
Diethyltryptamine....................................                  2
Difenoxin............................................              9,000
Dihydromorphine......................................          1,101,000
Dimethyltryptamine...................................                  3
Gamma-hydroxybutyric acid............................         20,000,000
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.....................................                352
N,N-Dimethylamphetamine..............................                  7
N-Ethyl-1-Phenylcyclohexylamine (PCE)................                  5
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................................            135,000
Thiofentanyl.........................................                  2
Trimeperidine........................................                  2
------------------------------------------------------
Schedule II
------------------------------------------------------
1-Phenylcyclohexylamine..............................                 12
1-Piperidinocyclohexanecarbonitrile (PCC)............                 10
Alfentanil...........................................                700
Alphaprodine.........................................                  2
Amobarbital..........................................              1,000
Amphetamine..........................................         10,987,000
Cocaine..............................................            175,000
Codeine (for sale)...................................         43,494,000
Codeine (for conversion).............................         43,559,000
Dextropropoxyphene...................................        167,365,000
Dihydrocodeine.......................................            741,000
Diphenoxylate........................................            641,000
Ecgonine.............................................             33,000
Ethylmorphine........................................                 12
Fentanyl.............................................            858,000
Glutethimide.........................................              1,002
Hydrocodone (for sale)...............................         30,622,000
Hydrocodone (for conversion).........................          1,500,000
Hydromorphone........................................          1,651,000
Isomethadone.........................................                 12
Levo-alphacetylmethadol (LAAM).......................                 12

[[Page 56324]]

 
Levomethorphan.......................................                  2
Levorphanol..........................................              8,600
Meperidine...........................................          9,753,000
Metazocine...........................................                  1
Methadone (for sale).................................         14,057,000
Methadone Intermediate...............................         17,393,000
Methamphetamine......................................          2,263,000
[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 18,000 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)......................          4,400,000
Opium................................................          1,000,000
Oxycodone (for sale).................................         41,182,000
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.............................................         58,832,000
------------------------------------------------------------------------

    The Acting 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 remain 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 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 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 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: September 24, 2003.
Michele M. Leonhart,
Acting Deputy Administrator.
[FR Doc. 03-24653 Filed 9-29-03; 8:45 am]
BILLING CODE 4410-09-P