[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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