[Federal Register Volume 65, Number 139 (Wednesday, July 19, 2000)]
[Notices]
[Pages 44836-44838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18148]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA #186R]


Controlled Substances: Proposed Revised Aggregate Production 
Quotas for 2000

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed revised 2000 aggregate production quotas.

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SUMMARY: This notice proposes revised 2000 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 18, 
2000.

ADDRESSES: Send comments or objectives to the Deputy Administrator, 
Drug Enforcement Administration, Washington, D.C. 20537, Attn.: DEA 
Federal Register Representative (CCR).

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, D.C. 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 February 10, 2000, DEA published a notice of established initial 
2000 aggregate production quotas for certain controlled substances in 
Schedules I and II (65 FR 6635). This notice stipulated that the Deputy 
Administrator of the DEA would adjust the quotas in early 2000 as 
provided for in Section 1303 of Title 21 of the Code of Federal 
Regulations.
    The proposed revised 2000 aggregate production quotes represent 
those quantities of controlled substances in Schedules I and II that 
may be produced in the United States in 2000 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 1999 year-end 
inventories, 1999 disposition data submitted by quota applicants, 
estimates of the medical needs of the United States, and other 
information available to the DEA.
    In addition, in a final rule published in the Federal Register on 
March 13, 2000 (65 FR 13235) gamma-hydroxybutyric acid (GHB) and its 
salts, isomers, and salts of isomers was placed into Schedule I of the 
CSA. Applications for quota for this substance were submitted and the 
aggregate production quota for gamma-hydroxybutyric acid is proposed as 
listed below.
    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 Administrator hereby proposes the following revised 
2000 aggregate production quotas for the following controlled 
substances, expressed in grams of anhydrous acid or base:

------------------------------------------------------------------------
                                            Previously
                                            established      Proposed
               Basic class                 initial 2000    revised 2000
                                              quotas          quotas
------------------------------------------------------------------------
                               SCHEDULE I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................      10,001,000      10,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET).               2               2
3-Methylfentanyl........................              14              14
3-Methylthiofentanyl....................               2               2
3,4-Methylenedioxyamphetamine (MDA).....              20              20
3,4-Methylenedioxy-N-ethylamphetamine                 30              30
 (MDEA).................................
3,4-Methylenedioxymethamphetamine (MDMA)              20              20
3,4, 5-Trimethoxyamphetamine............               2               2
4-Bromo-2,5-Dimethoxyamphetamine (DOB)..               2               2
4-Bromo-2,5-Dimethoxyphenethylamine (2-                2               2
 CB)....................................
4-Methoxyamphetamine....................         201,000         201,000
4-Methylaminorex........................               3               3
4-Methyl-2,5-Dimethoxyamphetamine (DOM).               2               2
5-Methoxy-3,4-Methylenedioxyamphetamine.               2               2
Acetyl-alpha-methylfentanyl.............               2               2
Acetyldihydrocodeine....................               2               2
Acetylmethadol..........................               7               7
Allylprodine............................               2               2
Alphacetylmethadol......................               7               7
Alpha-ethyltryptamine...................               2               2
Alphameprodine..........................               2               2
Alphamethadol...........................               2               2
Alpha-methylfentanyl....................               2               2
Alpha-methylthiofentanyl................               2               2
Aminorex................................               7               7
Benzylmorphine..........................               2               2
Betacetylmethadol.......................               2               2
Beta-hydroxy-3-methylfentanyl...........               2               2

[[Page 44837]]

 
Beta-hydroxyfentanyl....................               2               2
Betameprodine...........................               2               2
Betamethadol............................               2               2
Betaprodine.............................               2               2
Bufotenine..............................               2               2
Cathinone...............................               9               9
Codeine-N-oxide.........................               2               2
Diethyltryptamine.......................               2               2
Difenoxin...............................          10,000          10,000
Dihydromorphine.........................         508,000         508,000
Dimethyltryptamine......................               3               3
Gamma-hydroxybutyric acid...............  ..............      15,000,000
Heroin..................................               2               2
Hydroxypethidine........................               2               2
Lysergic acid diethylamide (LSD)........              38              63
Mescaline...............................               7               7
Methaqualone............................              17              17
Methcathinone...........................               9               9
Morphine-N-oxide........................               2               2
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..........................               2               2
Normethadone............................               7               7
Normorphine.............................               7               7
Para-fluorofentanyl.....................               2               2
Pholcodine..............................               2               2
Propiram................................         415,000         415,000
Psilocybin..............................               2               2
Psilocyn................................               2               2
Tetrahydrocannabinols...................         101,000         115,000
Thiofentanyl............................               2               2
Trimeperidine...........................               2               2
------------------------------------------------------------------------
                               SCHEDULE II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................              12              12
1-Piperidiocyclohexanecarbonitrile (PCC)              10              10
Alfentanil..............................           8,000           8,000
Alphaprodine............................               2               2
Amobarbital.............................              12              12
Amphetamine.............................       9,007,000       6,491,000
Cocaine.................................         251,000         251,000
Codeine (for sale)......................      54,504,000      43,248,000
Codeine (for conversion)................      52,384,000      52,384,000
Dextropropoxyphene......................     114,078,000     121,017,000
Dihydrocodeine..........................         268,000         133,000
Diphenoxylate...........................         931,000         931,000
Ecgonine................................          36,000          36,000
Ethylmorphine...........................              12              12
Fentanyl................................         300,000         300,000
Glutethimide............................               2               2
Hydrocodone (for sale)..................      20,208,000      21,417,000
Hydrocodone (for conversion)............      20,700,000      20,700,000
Hydromorphone...........................       1,239,000       1,239,000
Isomethadone............................              12              12
Levo-alphacetylmethadol (LAAM)..........         201,000              12
Levomethorphan..........................               2               2
Levorphanol.............................          27,000          27,000
Meperidine..............................      11,335,000       9,870,000
Metazocine..............................               1               1
Methadone (for sale)....................       8,347,000       8,347,000
Methadone (for conversion)..............         600,000               0
Methadone Intermediate..................       9,503,000       9,503,000
Methamphetamine.........................       2,049,000       1,984,000
    [750,000 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 9,000
     grams for methamphetamine (for
     sale)]
Methylphenidate.........................      14,957,000      14,957,000
Morphine (for sale).....................      14,706,000      14,706,000

[[Page 44838]]

 
Morphine (for conversion)...............      97,160,000      97,410,000
Nabilone................................               2               2
Noroxymorphone (for sale)...............          25,000          25,000
Noroxymorphone (for conversion).........       3,813,000       3,813,000
Opium...................................         720,000         720,000
Oxycodone (for sale)....................      29,826,000      32,575,000
Oxycodone (for conversion)..............         271,000       1,389,000
Oxymorphone.............................         166,000         477,000
Pentobarbital...........................      22,037,000      22,037,000
Phencyclidine...........................              41              41
Phenmetrazine...........................               2               2
Phenylacetone...........................              10              10
Secobarbital............................              22              22
Sufentanil..............................           1,700           1,700
Thebaine................................      41,300,000      45,444,000
------------------------------------------------------------------------

    The Administrator further proposes 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.
    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 Administrator finds warrant a hearing, the 
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 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 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 
Administrator has determined that this action does not require a 
regulatory flexibility analysis.

    Dated: July 12, 2000.
Donnie R. Marshall,
Administrator.
[FR Doc. 00-18148 Filed 7-18-00; 8:45 am]
BILLING CODE 4410-09-M