[Federal Register Volume 65, Number 186 (Monday, September 25, 2000)]
[Notices]
[Pages 57624-57626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24554]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA #186F]


Controlled Substances: 2000 Aggregate Production Quotas

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION:  Notice of final 2000 aggregate production quotas.

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SUMMARY: This notice establishes final 2000 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 2000 published July 19, 2000 (65 FR 44836).

EFFECTIVE DATE: September 25, 2000.

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 of the DEA pursuant to Section 0.104 of 
Title 28 of the Code of Federal Regulations.
    On July 19, 2000, a notice of the proposed revised 2000 aggregate 
production quotas for certain controlled substances in Schedules I and 
II was published in the Federal Register (65 FR 44836). All interested 
parties were invited to comment on or object to these proposed 
aggregate production quotas on or before August 18, 2000.
    Several companies and one individual commented that the revised 
aggregate production quotas for amphetamine, codeine (for sale), 
dextropropoxyphene, dihydrocodeine, hydrocodone (for sale), 
hydromorphone, meperidine, methadone intermediate, methylphenidate, 
opium, oxycodone (for sale), oxycodone (for conversion), oxymorphone, 
pentobarbital, phenylacetone, and tetrahydrocannabinols 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 1999 year-end inventories, initial 2000 manufacturing quotas, 
2000 export requirements, and actual and projected 2000 sales. Based on 
this information, the DEA has adjusted the final 2000 aggregate 
production quotas for 4-methoyxamphetamine, amphetamine, 
dihydrocodeine, hydromorphone, meperidine, methamphetamine, oxycodone 
(for sale), oxycodone (for conversion), oxymorphone and pentobarbital 
to meet the legitimate needs of the United States.
    Regarding codeine (for sale), dextropropoxyphene, hydrocodone (for 
sale), methadone intermediate, opium, methylphenidate, phenylacetone 
and tetrahydrocannabinols, the DEA has determined that no adjustments 
of the aggregate production quotas are necessary to meet the 2000 
estimated medical, scientific, research and industrial needs of the 
United States.
    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 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 final 2000 
aggregate production quotas for the following controlled substances, 
expressed in grams of anhydrous acid or base, be established as 
follows:

------------------------------------------------------------------------
                                                            Established
                       Basic class                          final 2000
                                                              quotas
------------------------------------------------------------------------
Schedule I:
    2,5-Dimethoxyamphetamine............................      10,501,000
    2,5-Dimethoxy-4-ethylamphetamine (DOET).............               2
    3-Methylfentanyl....................................              14
    3-Methylthiofentanyl................................               2
    3,4-Methylenedioxyamphetamine (MDA).................              20
    3,4-Methylenedioxy-N-ethylamphetamine (MDEA)........              30
    3,4-Methylenedioxymethamphetamine (MDMA)............              20
    3,4,5-Trimethoxyamphetamine.........................               2
    4-Bromo-2,5-Dimethoxyamphetamine (DOB)..............               2
    4-Bromo-2,5-Dimethoxyphenethylamine (2 CB)..........               2
    4-Methoxyamphetamine................................         251,000
    4-Methylaminorex....................................               3
    4-Methyl-2,5-Dimethoxyamphetamine (DOM).............               2
    5-Methoxy-3,4-Methylenedioxyamphetamine.............               2
    Acetyl-alpha-methylfentanyl.........................               2
    Acetyldihydrocodeine................................               2
    Acetylmethadol......................................               7
    Allylprodine........................................               2
    Alphacetylmethadol..................................               7
    Alpha-ethyltryptamine...............................               2

[[Page 57625]]

 
    Alphameprodine......................................               2
    Alphamethadol.......................................               2
    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.....................................               2
    Diethyltryptamine...................................               2
    Difenoxin...........................................          10,000
    Dihydromorphine.....................................         508,000
    Dimethyltryptamine..................................               3
    Gamma-hydroxybutyric acid...........................      15,000,000
    Heroin..............................................               2
    Hydroxypethidine....................................               2
    Lysergic acid diethylamide (LSD)....................              63
    Mescaline...........................................               7
    Methaqualone........................................              17
    Methcathinone.......................................               9
    Morphine-N-oxide....................................               2
    N,N-Dimethylamphetamine.............................               7
    N-Ethyl-1-Phenylcyclohexylamine (PCE)...............               5
    N-Ethylamphetamine..................................               7
    N-Hydroxy-3,4-Methylenedioxyamphetamine.............               2
    Noracymethadol......................................               2
    Norlevorphanol......................................               2
    Normethadone........................................               7
    Normorphine.........................................               7
    Para-fluorofentanyl.................................               2
    Pholcodine..........................................               2
    Propiram............................................         415,000
    Psilocybin..........................................               2
    Psilocyn............................................               2
    Tetrahydrocannabinols...............................         115,000
    Thiofentanyl........................................               2
    Trimeperidine.......................................               2
Schedule II:
    1-Phenylcyclohexylamine.............................              12
    1-Piperidinocyclohexanecarbonitrile (PCC)...........              10
    Alfentanil..........................................           8,000
    Alphaprodine........................................               2
    Amobarbital.........................................              12
    Amphetamine.........................................      10,958,000
    Cocaine.............................................         251,000
    Codeine (for sale)..................................      43,248,000
    Codeine (for conversion)............................      52,384,000
    Dextropropoxyphene..................................     121,017,000
    Dihydrocodeine......................................         244,000
    Diphenoxylate.......................................         931,000
    Ecgonine............................................          36,000
    Ethylmorphine.......................................              12
    Fentanyl............................................         300,000
    Glutethimide........................................               2
    Hydrocodone (for sale)..............................      21,417,000
    Hydrocodone (for conversion)........................      20,700,000
    Hydromorphone.......................................       1,409,000
    Isomethadone........................................              12
    Levo-alphacetylmethadol (LAAM)......................              12
    Levomethorphan......................................               2
    Levorphanol.........................................          27,000
    Meperidine..........................................      10,168,000
    Metazocine..........................................               1
    Methadone (for sale)................................       8,347,000
    Methadone (for conversion)..........................               0
    Methadone Intermediate..............................       9,503,000

[[Page 57626]]

 
    Methamphetamine.....................................      2,104,000
  850,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 1,225,000 grams for methamphetamine for conversion
to a Schedule III product; and, 29,000 grams for methamphetamine (for
sale)
    Methylphenidate.....................................      14,957,000
    Morphine (for sale).................................      14,706,000
    Morphine (for conversion)...........................      97,410,000
    Nabilone............................................               2
    Noroxymorphone (for sale)...........................          25,000
    Noroxymorphone (for conversion).....................       3,813,000
    Opium...............................................         720,000
    Oxycodone (for sale)................................      35,850,000
    Oxycodone (for conversion)..........................         602,000
    Oxymorphone.........................................         353,000
    Pentobarbital.......................................      24,037,000
    Phencyclidine.......................................              41
    Phenmetrazine.......................................               2
    Phenylacetone.......................................              10
    Secobarbital........................................              22
    Sufentanil..........................................           1,700
    Thebaine............................................      45,444,000
------------------------------------------------------------------------

    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 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 has been analyzed in accordance with 
the principles and criteria contained in Executive Order 13132, and it 
has been determined that this matter does not have sufficient 
federalism implications to warrant the preparation of a Federalism 
Assessment.
    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. Aggregate production quotas apply to approximately 200 DEA 
registered bulk and dosage form manufacturers of Schedules I and II 
controlled substances. 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.

    Dated: September 15, 2000.
Julio F. Mercado,
Deputy Administrator.
[FR Doc. 00-24554 Filed 9-22-00; 8:45 am]
BILLING CODE 4410-09-M