[Federal Register Volume 63, Number 200 (Friday, October 16, 1998)]
[Notices]
[Pages 55640-55642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27740]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA #179P]


Controlled Substances: Proposed Aggregate Production Quotas for 
1999

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed 1999 aggregate production quotas.

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SUMMARY: This notice proposes initial 1999 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 
16, 1998.

ADDRESSES: Send comments or objections to the Acting 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 1999 aggregate production quotas represent those 
quantities of controlled substances that may be produced in the United 
States in 1999 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 1999 aggregate production quotas, the 
Acting Deputy Administrator considered the following factors: total 
actual 1997 and estimated 1998 and 1999 net disposals of each substance 
by all manufacturers; estimates of 1998 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 Acting Deputy Administrator of the DEA will, in early 
1999, adjust aggregate production quotas and individual manufacturing 
quotas allocated for the year based upon 1998 year-end inventory and 
actual 1998 disposition data supplied by quotas recipients for each 
basic class of Scheudle 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 Acting Deputy Administrator hereby proposes that the 
1999 aggregate production quotas for the following controlled 
substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                           Proposed 1999
                       Basic class                            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................................              17
    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
    Alpha-acetylmethadol................................               7

[[Page 55641]]

    Alpha-ethyltryptamine...............................               2
    Alphameprodine......................................               2
    Alpha-methadol......................................               2
    Alpha-methylfentanyl................................               2
    Alpha-methylthiofentanyl............................               2
    Alphaprodine........................................               2
    Aminorex............................................               7
    Benzylmorphine......................................               2
    Beta-acetylmethadol.................................               2
    Beta-hydroxy-3-methylfentanyl.......................               2
    Beta-hydroxyfentanyl................................               2
    Betameprodine.......................................               2
    Beta-methadol.......................................               2
    Betaprodine.........................................               2
    Bufotenine..........................................               2
    Cathinone...........................................               9
    Codeine-N-oxide.....................................               2
    Diethyltryptamine...................................               3
    Difenoxin...........................................           9,000
    Dihydromorphine.....................................               7
    Dimethyltryptamine..................................               3
    Heroin..............................................               2
    Hydroxypethidine....................................               2
    Lysergic acid diethylamide (LSD)....................              57
    Mescaline...........................................               8
    Methaqualone........................................              17
    Methcathinone.......................................              11
    Morphine-N-oxide....................................               2
    N,N-Diemethylamphetamine............................               7
    N-Ethyl-1-Phenylcyclohexylamine (PCE)...............               5
    N-Ethylamphetamine..................................               7
    N-Hydroxy-3,4-Methylenedioxyamphetamine.............               4
    Noracymethadol......................................               2
    Norlevorphanol......................................               2
    Normethadone........................................               7
    Normorphine.........................................               7
    Para-fluorofentanyl.................................               2
    Pholcodine..........................................               2
    Propiram............................................         415,000
    Psilocin............................................               2
    Psilocybin..........................................               2
    Tetrahydrocannabinols...............................          52,000
    Thiofentanyl........................................               2
    Trimeperidine.......................................               2
Schedule II:
    1-Phenylcyclohexylamine.............................              12
    1-Piperidinocyclohexanecarbonitrile (PCC)...........              12
    Alfentanil..........................................               2
    Amobarbital.........................................              12
    Amphetamine.........................................       5,554,000
    Cocaine.............................................         251,000
    Codeine (for sale)..................................      60,641,000
    Codeine (for conversion)............................      22,950,000
    Desoxyephedrine--662,000 grams of
     levodesoxyephedrine for use in a non-controlled,
     non-prescription product and 35,000 grams for
     methamphetamine....................................         697,000
    Dextropropoxyphene..................................     109,500,000
    Dihydrocodeine......................................         121,000
    Diphenoxylate.......................................       1,240,000
    Ecgonine............................................         151,000
    Ethylmorphine.......................................              13
    Fentanyl............................................         228,000
    Glutethimide........................................               2
    Hydrocodone (for sale)..............................      16,314,000
    Hydrocodone (for conversion)........................       1,300,000
    Hydromorphone.......................................         856,000
    Isomethadone........................................              12
    Levo-alpha-acetylmethadol (LAAM)....................         201,000
    Levomethorphan......................................               2
    Levorphanol.........................................          15,000
    Meperidine..........................................      10,294,000
    Methadone (for sale)................................       4,992,000
    Methadone (for conversion)..........................         267,000
    Methadone Intermediate..............................       7,223,000

[[Page 55642]]

    Methamphetamine (for conversion)....................         723,000
    Methylphenidate.....................................      14,442,000
    Morphine (for sale).................................      12,445,000
    Morphine (for conversion)...........................      76,300,000
    Nabilone............................................               2
    Noroxymorphone (for sale)...........................          25,000
    Noroxymorphone (for conversion).....................       2,067,000
    Opium...............................................         640,000
    Oxycodone (for sale)................................      12,118,000
    Oxycodone (for conversion)..........................          51,000
    Oxymorphone.........................................         166,000
    Pentobarbital.......................................      17,356,000
    Phencyclidine.......................................              40
    Phenmetrazine.......................................               2
    Phenylacetone.......................................              10
    Secobarbital........................................              25
    Sufentanil..........................................             752
    Thebaine............................................      17,695,000
------------------------------------------------------------------------

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

    Dated: October 8, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-27740 Filed 10-15-98; 8:45 am]
BILLING CODE 4410-09-M