[Federal Register Volume 64, Number 203 (Thursday, October 21, 1999)]
[Notices]
[Pages 56809-56811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27428]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA 186P]


Controlled Substances: Proposed Aggregate Production Quotas for 
2000

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed year 2000 aggregate production quotas.

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SUMMARY: This notice proposes initial year 2000 aggregate production 
quotas for controlled substances in Schedules I and II of the 
Controlled Substances Act (CSA).

DATES: Comments or objections should be received on or before November 
22, 1999.

ADDRESSES: Send comments or objections 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.
    The proposed year 2000 aggregate production quotas represent those 
quantities of controlled substances 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.
    In determining the proposed year 2000 aggregate production quotas, 
the Deputy Administrator considered the following factors: total actual 
1998 and estimated 1999 and 2000 net disposals of each substance by all 
manufacturers; estimates of 1999 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 from manufacturers; projected demand as indicated by 
procurement quota applications filed pursuant to Section 1303.12 of 
Title 21 of the Code of Federal Regulations; and other pertinent 
information.
    In the past, the basic class methamphetamine has been listed as 
desoxyephedrine for aggregate production quota purposes. For 
clarification, the desoxyephedrine aggregate production quota was 
divided into a methamphetamine for sale quota and a levo-
desoxyephedrine quote. The aggregate production quota for 
methamphetamine for conversion was listed separately. In order to more 
accurately reflect the nomenclature used in Section 1308.12(d) of Title 
21 of the Code of Federal Regulations, levo-desoxyephedrine, 
methamphetamine (for sale) and methamphetamine (for conversion) are now 
listed under the basic class of methamphetamine.
    Pursuant to Section 1303 of Title 21 of the Code of Federal 
Regulations, the Deputy Administrator of the DEA will, in early 2000, 
adjust aggregate production quotas and individual manufacturing quotas 
allocated for the year based upon 1999 year-end inventory and actual 
1999 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 
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 proposes that the year 
2000 aggregate production quotas for the following controlled 
substances, expressed in grams of anhydrous acid or base, by 
established as follows:

[[Page 56810]]



------------------------------------------------------------------------
                                                           Proposed year
                       Basic class                          2000 quotas
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................................      10,001,000
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....................................         201,000
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
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.........................................               8
Dimethyltryptamine......................................               3
Heroin..................................................               2
Hydroxypethidine........................................               2
Lysergic acid diethylamine (LSD)........................              38
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...................................         101,000
Thiofentanyl............................................               2
Trimeperidine...........................................               2
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................              12
1-Piperidinocyclohexanecarbonitrile (PCC)...............              10
Alfentanil..............................................           3,800
Alphaprodine............................................               2
Amobarbital.............................................              12
Amphetamine.............................................       9,007,000

[[Page 56811]]

 
Cocaine.................................................         251,000
Codeine (for sale)......................................      54,504,000
Codeine (for conversion)................................      52,384,000
Dextropropoxyphene......................................     114,078,000
Dihydrocodeine..........................................         268,000
Diphenoxylate...........................................         615,000
Ecgonine................................................          36,000
Ethylmorphine...........................................              12
Fentanyl................................................         269,000
Glutethimide............................................               2
Hydrocodone (for sale)..................................      20,208,000
Hydrocodone (for conversion)............................      20,700,000
Hydromorphone...........................................         856,000
Isomethadone............................................              12
Levo-alphacetylmethadol (LAAM)..........................         201,000
Levomethorphan..........................................               2
Levorphanol.............................................          16,000
Meperidine..............................................      10,731,000
Metazocine..............................................               1
Methadone (for sale)....................................       8,347,000
Methadone (for conversion)..............................         600,000
Methadone Intermediate..................................       9,503,000
Methamphetamine.........................................       1,419,000
        595,000 grams of devo-desxyephedine for use in a
         non-controlled, non-prescription product;
         750,000 grams for methamphetamine for
         conversion to a Schedule III product; and
         74,000 grams for methamphetamine (for sale)
Methylphenidate.........................................      14,957,000
Morphine (for sale).....................................      14,706,000
Morphine (for conversion)...............................      97,160,000
Nabilone................................................               2
Noroxymorphone (for sale)...............................          25,000
Noroxymorphone (for conversion).........................       2,067,000
Opium...................................................         720,000
Oxycodone (for sale)....................................      22,020,000
Oxycodone (for conversion)..............................         271,000
Oxymorphone.............................................         166,000
Pentobarbital...........................................      22,037,000
Phencyclidine...........................................              41
Phenmetrazine...........................................               2
Phenylacetone...........................................              10
Secobarbital............................................              22
Sufentanil..............................................             852
Thebaine................................................      35,102,000
------------------------------------------------------------------------

    The Deputy 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 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 Deputy Administrator finds warrant a hearing, 
the 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 has been analyzed in accordance with 
the principles and criteria contained in Executive Order 12612, 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. 6501 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 re 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: October 12, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-27428 Filed 10-20-99; 8:45 am]
BILLING CODE 4410-09-M