[Federal Register Volume 65, Number 193 (Wednesday, October 4, 2000)]
[Notices]
[Pages 59214-59215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25421]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA # 207P]


Controlled Substances: Proposed Aggregate Production Quotas for 
2001

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed year 2001 aggregate production quotas.

-----------------------------------------------------------------------

SUMMARY: This notice proposes initial year 2001 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 November 3, 
2000.

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 
quotes 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 2001 aggregate production quotas represent those 
quantities of controlled substances that may be produced in the United 
States in 2001 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 2001 aggregate production quotas, 
the Deputy Administrator considered the following factors: total actual 
1999 and estimated 2000 and 2001 net disposals of each substance by all 
manufacturers; estimates of 2000 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 form 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.
    Pursuant to Section 1303 of Title 21 of the Code of Federal 
Regulations, the Deputy Administrator of the DEA will, in early 2001, 
adjust aggregate production quotas and individual manufacturing quotas 
allocated for the year based upon 2000 year-end inventory and actual 
2000 disposition data supplied by quota recipients for each basic class 
of Schedules 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, and the Deputy Administrator hereby proposes that the year 
2001 aggregate production quotas for the following controlled 
substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                           Proposed year
                       Basic class                          2001 quotas
------------------------------------------------------------------------
Schedule I:
  2,5-Dimethoxyamphetamine..............................      15,501,000
  2,5-Dimethoxy-4-ethylamphetamine (DOET)...............               2
  3-Methylfentanyl......................................              14
  3-Methylthiofentanyl..................................               2
  3,4-Methylenedioxyamphetamine (MDA)...................              25
  3,4-Methylenedioxy-N-ethylamphetamine (MDEA)..........              30
  3,4-Methylenedioxymethamphetamine (MDMA)..............              10
  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......................................               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.........................................               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.............................................           9,000
  Dihydromorphine.......................................         634,000
  Dimethyltryptamine....................................               2
  Gamma-hydroxybutyric acid.............................      15,000,000
  Heroin................................................               2
  Hydroxypethidine......................................               2
  Lysergic acid diethylamide (LSD)......................              37
  Marihuana.............................................         350,000
  Mescaline.............................................               7
  Methaqualone..........................................              19
  Methcathinone.........................................              11
  Morphine-N-oxide......................................               2
  N,N-Dimethylamphetamine...............................               7
  N-Ethyl-l-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
  Porpiram..............................................         415,000
  Psilocybin............................................               2
  Psilocyn..............................................               2
  Tetrahydrocannabinols.................................         131,000
  Thiofentanyl..........................................               2

[[Page 59215]]

 
  Trimeperidine.........................................               2
Schedule II:
  1-Phenylcyclohexylamine...............................              12
  1-Piperidinocyclohexanecarbonitrile (PCC).............              10
  Alfentanil............................................           3,000
  Alphaprodine..........................................               2
  Amobarbital...........................................              12
  Amphetamine...........................................      10,958,000
  Cocaine...............................................         251,000
  Codeine (for sale)....................................      43,248,000
  Codeine (for conversion)..............................      59,051,000
  Dextropropoxyphene....................................     134,401,000
  Dihydrocodeine........................................         272,000
  Diphenoxylate.........................................         401,000
  Ecgonine..............................................          51,000
  Ethylmorphine.........................................              12
  Fentanyl..............................................         440,000
  Glutethimide..........................................               2
  Hydrocodone (for sale)................................      21,417,000
  Hydrocodone (for conversion)..........................      26,540,000
  Hydromorphone.........................................       1,409,000
  Isomethadone..........................................              12
  Levo-alphacetylmethadol (LAAM)........................          41,000
  Levomethorphan........................................               2
  Levorphanol...........................................          15,000
  Meperidine............................................      10,168,000
  Methadone (for sale)..................................       8,347,000
  Methadone (for conversion)............................          60,000
  Methadone Intermediate................................       9,503,000
  Methamphetamine.......................................       2,226,000
    850,000 grams of levo-desoxyephedrine for use in a
     non-controlled, non-prescription product; 1,325,000
     grams for methamphetamine for conversion to a
     Schedule III product; and 51,000 grams for
     methamphetamine (for sale).........................
  Methylphenidate.......................................      14,957,000
  Morphine (for sale)...................................      14,706,000
  Morphine (for conversion).............................     117,675,000
  Nabilone..............................................               2
  Noroxymorphone (for sale).............................          25,000
  Noroxymorphone (for conversion).......................       3,180,000
  Opium.................................................         570,000
  Oxycodone (for sale)..................................      46,680,000
  Oxycodone (for conversion)............................         449,000
  Oxymorphone...........................................         264,000
  Pentobarbital.........................................      22,037,000
  Phencyclidine.........................................              40
  Phenmetrazine.........................................               2
  Phenylacetone.........................................              10
  Secobarbital..........................................              12
  Sufentanil............................................           1,000
  Thebaine..............................................      65,596,000
------------------------------------------------------------------------

    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 or 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 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. 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 27, 2000.
Julio F. Mercado,
Deputy Administrator.
[FR Doc. 00-25421 Filed 10-3-00; 8:45 am]
BILLING CODE 4410-09-M