[Federal Register Volume 62, Number 225 (Friday, November 21, 1997)]
[Notices]
[Pages 62349-62351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30651]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA #167F]


Controlled Substances: Established Initial Aggregate Production 
Quotas for 1998

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 1998.

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SUMMARY: This notice establishes initial 1998 aggregate production 
quotas for controlled substances in Schedules I and II of the 
Controlled Substances Act.

EFFECTIVE DATE: November 21, 1997.

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug & 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 20537, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION: Section 306 of the Controlled Substances Act 
(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 pursuant to Section 0.104 of Title 
28 of the Code of Federal Regulations.
    On September 2, 1997, a notice of the proposed initial 1998 
aggregate production quotas for certain controlled substances in 
Schedules I and II was published in the Federal Register (62 FR 46373). 
All interested persons were invited to comment on or object to these 
proposed aggregate production quotas on or before October 2, 1997.
    One company commented that the initial 1998 aggregate production 
quota for amphetamine is insufficient to provide for the estimated 
medical, scientific, research and industrial needs of the United 
States, for export requirements and for the establishment and 
maintenance of reserve stocks.
    Another company commented that the initial 1998 aggregate 
production quotas for codeine (for sale), diphenoxylate, morphine (for 
sale), opium, and oxycodone (for sale) are insufficient to provide for 
the estimated medical, scientific, research and industrial needs of the 
United States, for export requirements and for the establishment and 
maintenance of reserve stocks.
    After a review of 1997 manufacturing quotas, current 1997 sales and 
inventories, 1998 export requirements and research and product 
development requirements, the DEA agrees that increases are necessary 
for amphetamine, codeine (for sale), morphine (for sale) and oxycodone 
(for sale). Regarding diphenoxylate and opium, the DEA has determined 
that the proposed initial 1998 aggregate production quotas are 
sufficient to meet the 1998 estimated medical, scientific, research and 
industrial needs of the United States.
    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 substances is mandated by law and by international 
treaty obligations. Aggregate production quotas apply to approximately 
200 DEA registered bulk and dosage from manufacturers of Schedules I 
and II controlled

[[Page 62350]]

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.
    Therefore, under the authority vested in the Attorney General by 
Section 306 of the Controlled Substances Act 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 orders that 
the 1998 initial aggregate production quotas for the following 
controlled substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                             Established
                        Basic class                            initial  
                                                             1998 quotas
------------------------------------------------------------------------
Schedule I:                                                             
    2,5-Dimethoxyamphetamine...............................   15,000,100
    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)...............           20
    3,4,5-Trimethoxyamphetamine............................            2
    4-Bromo-2,5,-Dimeththoxyamphetamine....................            2
    4-Bromo-2,5-Dimeththoxyphenethylamine (2-CB)...........            2
    4-Methoxyamphetamine...................................      100,100
    4-Methylaminorex.......................................            2
    4-Methyl-2,5-Dimethoxyamphetamine (DOM)................            2
    5-Methoxy-3,4-Methylenedioxyamphetamine................            2
    Acetyl-alpha-methylfentanyl............................            2
    Acetylmethadol.........................................            7
    Allylprodine...........................................            2
    Alpha-acetylmethadol...................................            7
    Alpha-ethyltryptamine..................................            2
    Alphameprodine.........................................            2
    Alpha-methadol.........................................            2
    Alpha-methylfentanyl...................................            2
    Alphaprodine...........................................            2
    Alpha-methylthiofentanyl...............................            2
    Aminorex...............................................            7
    Beta-acetylmethadol....................................            2
    Beta-hydroxyfentanyl...................................            2
    Beta-hydroxy-3-methylfentanyl..........................            2
    Beta-methadol..........................................            2
    Betaprodine............................................            2
    Bufotenine.............................................            2
    Cathinone..............................................            9
    Codeine-N-oxide........................................            2
    Diethyltryptamine......................................            2
    Difenoxin..............................................       16,000
    Dihydromorphine........................................            7
    Dimethyltryptamine.....................................            2
    Ethylamine Analog of PCP...............................            5
    Heroin.................................................            2
    Hydroxypethidine.......................................            2
    Lysergic acid diethylamide (LSD).......................           57
    Mescaline..............................................            7
    Methaqualone...........................................           17
    Methcathinone..........................................           11
    Morphine-N-oxide.......................................            2
    N-Ethylamphetamine.....................................            7
    N-Hydroxy-3,4-Methylenedioxyamphetamine................            4
    N,N-Dimethylamphetamine................................            7
    Noracymethadol.........................................            2
    Norlevorphanol.........................................            2
    Normethadone...........................................            7
    Normorphine............................................            7
    Para-fluorofentanyl....................................            2
    Pholcodine.............................................            2
    Psilocin...............................................            2
    Psilocybin.............................................            2
    Tetrahydrocannabinols..................................       26,000
    Thiofentanyl...........................................            2
    Trimeperidine..........................................            2

[[Page 62351]]

                                                                        
Schedule II:                                                            
    1-Phenylcyclohexylamine................................           15
    1-Piperidinocyclohexanecarbonitrile (PCC)..............           12
    Alfentanil.............................................        8,100
    Amobarbital............................................           12
    Amphetamine............................................    4,037,000
    Cocaine................................................      550,100
    Codeine (for sale).....................................   62,020,000
    Codeine (for conversion)...............................   18,460,000
    Desoxyephedrine........................................    1,332,000
        1,300,000 grams of levodesoxyephedrine for use in a             
         non-controlled, non-prescription product and                   
         32,000 grams for methamphetamine.                              
    Dextropropoxyphene.....................................  109,500,000
    Dihydrocodeine.........................................      189,000
    Diphenoxylate..........................................    1,600,000
    Ecgonine...............................................      651,000
    Ethylmorphine..........................................           12
    Fentanyl...............................................      202,000
    Glutethimide...........................................            2
    Hydrocodone (for sale).................................   13,908,000
    Hydrocodone (for conversion)...........................    3,000,000
    Hydromorphone..........................................      766,000
    Isomethadone...........................................           12
    Levo-alpha-acetylmethadol (LAAM).......................      356,000
    Levomethorphan.........................................            2
    Levorphanol............................................       15,000
    Meperidine.............................................    9,311,000
    Methadone (for sale)...................................    3,790,000
    Methadone (for conversion).............................    1,169,000
    Methadone Intermediate.................................    6,777,000
    Methamphetamine (for conversion).......................      723,000
    Methylphenidate........................................   14,442,000
    Morphine (for sale)....................................   11,535,000
    Morphine (for conversion)..............................   75,918,000
    Nabilone...............................................            2
    Noroxymorphone (for sale)..............................       25,000
    Noroxymorphone (for conversion)........................    2,117,000
    Opium..................................................      615,000
    Oxycodone (for sale)...................................    9,032,000
    Oxymorphone............................................      120,000
    Pentobarbital..........................................   16,562,000
    Phencyclidine..........................................           60
    Phenmetrazine..........................................            2
    Phenylacetone..........................................           10
    Secobarbital...........................................      301,000
    Sufentanil.............................................          700
    Thebaine...............................................    9,580,000
------------------------------------------------------------------------

    Dated: November 17, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-30651 Filed 11-20-97; 8:45 am]
BILLING CODE 4410-09-M