[Federal Register Volume 67, Number 183 (Friday, September 20, 2002)]
[Notices]
[Pages 59313-59316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23876]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA  223F]


Controlled Substances: Final Revised Aggregate Production Quotas 
for 2002

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of final aggregate production quotas for 2002.

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SUMMARY: This notice establishes final 2002 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 2002 published July 23, 2002 (67 FR 48207).

EFFECTIVE DATE: September 20, 2002.

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 Sec.  0.104 of Title 28 of the 
Code of Federal Regulations.
    The 2002 aggregate production quotas represent those quantities of 
controlled substances in Schedules I and II that may be produced in the 
United States in 2002 to provide adequate supplies of

[[Page 59314]]

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 July 23, 2002, a notice of the proposed revised 2002 aggregate 
production quotas for certain controlled substances in Schedules I and 
II was published in the Federal Register (67 FR 48207). All interested 
persons were invited to comment on or object to these proposed 
aggregate production quotas on or before August 22, 2002.
    Ten companies commented on a total of eleven Schedules I and II 
controlled substances within the published comment period. The 
companies commented that the proposed aggregate production quotas for 
gamma-hydroxybutyric acid, dextropropoxyphene, dihydrocodeine, 
fentanyl, hydrocodone (for sale), hydromorphone, methylphenidate, 
morphine (for sale), noroxymorphone (for sale), oxycodone (for sale) 
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 2001 year-end inventories, initial 2002 manufacturing quotas, 
2002 export requirements, actual and projected 2002 sales and use, and 
research and product development requirements. Based on this 
information, the DEA has adjusted the final 2002 aggregate production 
quotas for alphamethadol, gamma-hydroxybutyric acid, 
dextropropoxyphene, dihydrocodeine, fentanyl, hydrocodone (for 
conversion), morphine (for sale), noroxymorphone (for sale), oxycodone 
(for sale) and thebaine to meet the legitimate needs of the United 
States.
    Regarding hydrocodone (for sale), hydromorphone and 
methylphenidate, the DEA has determined that the proposed revised 2002 
aggregate production quotas are sufficient to meet the current 2002 
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 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 Deputy Administrator hereby orders that the 
2002 final aggregate production quotas for the following controlled 
substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                           Established
                      Basic class                           final 2002
                                                              quotas
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine...............................       12,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET)................                2
3-Methylfentanyl.......................................                4
3-Methylthiofentanyl...................................                2
3,4-Methylenedioxyamphetamine (MDA)....................               15
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)...........               15
3,4-Methylenedioxymethamphetamine (MDMA)...............               15
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..........................................                3
Alpha-methylfentanyl...................................                2
Alpha-methylthiofentanyl...............................                2
Aminorex...............................................                7
Benzylmorphine.........................................                2
Betacetylmethadol......................................                2
Beta-hydroxy-3-methylfentanyl..........................                2
Beta-hydroxyfentanyl...................................                2
Betameprodine..........................................                2
Betamethadol...........................................                2
Betaprodine............................................                2
Bufotenine.............................................                2
Cathinone..............................................                9
Codeine-N-oxide........................................               95
Diethyltryptamine......................................                2
Difenoxin..............................................            9,000
Dihydromorphine........................................        1,101,000
Dimethyltryptamine.....................................                3
Gamma-hydroxybutyric acid..............................        8,220,000
Heroin.................................................                9

[[Page 59315]]

 
Hydromorphinol.........................................                2
Hydroxypethidine.......................................                2
Lysergic acid diethylamide (LSD).......................               46
Marihuana..............................................          840,000
Mescaline..............................................                7
Methaqualone...........................................                9
Methcathinone..........................................                9
Methyldihydromorphine..................................                2
Morphine-N-oxide.......................................              201
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..................................          131,000
Thiofentanyl...........................................                2
Trimeperidine..........................................                2
--------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................................               12
1-Piperidinocyclohexanecarbonitrile (PCC)..............               10
Alfentanil.............................................              902
Alphaprodine...........................................                2
Amobarbital............................................          451,000
Amphetamine............................................       13,964,000
Carfentanil............................................              120
Cocaine................................................          251,000
Codeine (for sale).....................................       43,494,000
Codeine (for conversion)...............................       59,051,000
Dextropropoxyphene.....................................      167,365,000
Dihydrocodeine.........................................          741,000
Diphenoxylate..........................................          708,000
Ecgonine...............................................           51,000
Ethylmorphine..........................................               12
Fentanyl...............................................          733,000
Glutethimide...........................................                2
Hydrocodone (for sale).................................       25,702,000
Hydrocodone (for conversion)...........................        2,500,000
Hydromorphone..........................................        1,409,000
Isomethadone...........................................               12
Levo-alphacetylmethadol (LAAM).........................               12
Levomethorphan.........................................                2
Levorphanol............................................           37,000
Meperidine.............................................        9,583,000
Metazocine.............................................                1
Methadone (for sale)...................................       12,705,000
Methadone Intermediate.................................       19,081,000
Methamphetamine........................................        2,244,000
--------------------------------------------------------
[275,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
 prescription product; 1,950,000 grams for methamphetamine for
 conversion to a Schedule III product; and 19,000 grams for
 methamphetamine (for sale)]
Methylphenidate........................................       20,967,000
Morphine (for sale)....................................       18,046,000
Morphine (for conversion)..............................      110,774,000
Nabilone...............................................                2
Noroxymorphone (for sale)..............................           40,000
Noroxymorphone (for conversion)........................        6,000,000
Opium..................................................          700,000
Oxycodone (for sale)...................................       34,482,000
Oxycodone (for conversion).............................        1,100,000
Oxymorphone............................................          454,000
Pentobarbital..........................................       27,728,000

[[Page 59316]]

 
Phencyclidine..........................................               21
Phenmetrazine..........................................                2
Phenylacetone..........................................       10,218,000
Secobarbital...........................................            1,002
Sufentanil.............................................            2,100
Thebaine...............................................       43,292,000
------------------------------------------------------------------------

    The Deputy Administrator further orders 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.
    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 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 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 13, 2002.
John B. Brown III,
Deputy Administrator.
[FR Doc. 02-23876 Filed 9-19-02; 8:45 am]
BILLING CODE 4410-09-P