[Federal Register Volume 62, Number 158 (Friday, August 15, 1997)]
[Notices]
[Pages 43750-43752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21587]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA #153F]


Controlled Substances: Revised Aggregate Production Quotas for 
1997

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of final revised aggregate production quotas for 1997.

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SUMMARY: This notice establishes revised 1997 aggregate production 
quotas for controlled substances in Schedules I and II of the 
Controlled Substances Act.

EFFECTIVE DATE: August 15, 1997.

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 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 Sec. 0.100 of Title 28 of the Code of 
Federal Regulations. The Administrator, in turn, has redelegated this 
function to the Acting Deputy Administrator pursuant to Sec. 0.104 of 
Title 28 of the Code of Federal Regulations.
    On June 5, 1997, a notice of the proposed revised 1997 aggregate 
production quotas for controlled substances in Schedules I and II was 
published in the Federal Register (62 FR 30883). All interested parties 
were invited to comment on or object to these proposed aggregate 
production quotas on or before July 7, 1997.
    Several companies commented that the revised 1997 aggregate 
production quotas for amphetamine, difenoxin, diphenoxylate, methadone 
intermediate, N-ethylamphetamine, noracymethadol, oxycodone, 
oxymorphone and pentobarbital were 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.
    DEA has reviewed the involved companies' 1996 year-end inventories, 
their initial 1997 manufacturing quotas, 1997 export requirements and 
their actual and projected 1997 sales. Based on this data, the DEA has 
adjusted the revised 1997 aggregate production quotas for difenoxin, 
diphenoxylate, N-ethylamphetamine, noracymethadol, oxycodone, 
oxymorphone and pentobarbital to meet the estimated medical, 
scientific, research and industrial needs of the United States.
    Regarding amphetamine and methadone intermediate, the DEA has 
determined that no adjustments of the aggregate production quotas are 
necessary to meet the 1997 estimated medical, scientific, research and 
industrial needs of the United States.
    Based on recent data submitted by two companies, DEA has adjusted 
the revised 1997 aggregate production quotas for hydromorphone and 
lysergic acid diethylamide (LSD) to meet the 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 Schedule 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 Schedule 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.
    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 Sec. 0.100 of Title 28 of 
the Code of Federal Regulations, and redelegated to the Acting Deputy 
Administrator pursuant to Sec. 0.104 of Title 28 of the Code of

[[Page 43751]]

Federal Regulations, the Acting Deputy Administrator hereby orders that 
the revised aggregate production quotas for 1997 for the following 
controlled substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                            Established 
                       Basic class                         revised 1997 
                                                              quotas    
------------------------------------------------------------------------
                       Schedule I                                       
                                                                        
2,5-Dimethoxyamphetamine................................      15,200,100
2,5-Dimethoxy-4-ethylamphetamine (DOET).................               2
3-Methylfentanyl........................................              14
3-Methylthiofentanyl....................................               2
3,4-Methylenedioxyamphetamine (MDA).....................              22
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............              27
3,4-Methylenedioxymethamphetamine (MDMA)................               7
3,4,5-Trimethoxyamphetamine.............................               2
4-Bromo-2,5-Dimethoxyamphetamine........................               2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)..............               2
4-Methoxyamphetamine....................................              17
4-Methylaminorex........................................               2
4-Methyl-2,5-Dimethoxyamphetamine (DOM).................               2
5-Methoxy-3,4-Methylenedioxyamphetamine.................               2
Acetyl-alpha-methylfentanyl.............................               2
Acetylmethadol..........................................               7
Alpha-acetylmethadol....................................               7
Alpha-ethyltryptamine...................................               2
Alpha-methadol..........................................               2
Alpha-methylfentanyl....................................               2
Alpha-methylthiofentanyl................................               2
Aminorex................................................               7
Beta-acetylmethadol.....................................               2
Beta-hydroxyfentanyl....................................               2
Beta-hydroxy-3-methylfentanyl...........................               2
Beta-methadol...........................................               2
Bufotenine..............................................               2
Cathinone...............................................               9
Codeine-N-oxide.........................................               2
Difenoxin...............................................          21,000
Dihydromorphine.........................................               7
Ethylamine Analog of PCP................................               5
Heroin..................................................               2
Lysergic acid diethylamide (LSD)........................              57
Mescaline...............................................               7
Methaqualone............................................              17
Methcathinone...........................................              11
Morphine-N-oxide........................................               2
N-Ethylamphetamine......................................         251,000
N-Hydroxy-3,4-Methylenedioxyamphetamine.................               2
N,N-Dimethyltryptamine..................................               7
Noracymethadol..........................................               2
Norlevorphanol..........................................               2
Normethadone............................................               7
Normorphine.............................................               7
Para-fluorofentanyl.....................................               2
Pholcodine..............................................               2
Psilocin................................................               2
Psilocybin..............................................               2
Tetrahydrocannabinols...................................          25,100
Thiofentanyl............................................               2
Thiophene Analog of Phencyclidine.......................               5
                                                                        
                       Schedule II                                      
                                                                        
1-Phenylcyclohexylamine.................................              10
1-Piperidinocyclohexanecarbonitrile (PCC)...............              12
Alfentanil..............................................           9,300
Amobarbital.............................................              15
Amphetamine.............................................       3,137,000
Carfentanil.............................................             500
Cocaine.................................................         550,100
Codeine (for sale)......................................      53,140,000
Codeine (for conversion)................................      19,679,000
Desoxyephedrine.........................................       1,393,000
                                                                        
  1,361,000 grams of levodesoxyephedrine for use in a non-controlled,   
non-prescription product and 32,000 grams for methamphetamine.          
                                                                        
Dextropropoxyphene......................................     116,469,000

[[Page 43752]]

                                                                        
Dihydrocodeine..........................................         188,000
Diphenoxylate...........................................       2,247,000
Ecgonine (for conversion)...............................         651,000
Ethylmorphine...........................................              12
Fentanyl................................................         193,000
Glutethimide............................................               2
Hydrocodone (for sale)..................................      13,891,000
Hydrocodone (for conversion)............................       1,769,000
Hydromorphone...........................................         743,000
Isomethadone............................................              12
Levo-alpha-acetylmethadol (LAAM)........................         356,000
Levomethorphan..........................................               2
Levorphanol.............................................          12,000
Meperidine..............................................       9,843,000
Methadone (for sale)....................................       3,977,000
Methadone (for conversion)..............................         364,000
Methadone Intermediate (for conversion).................       5,275,000
Methamphetamine (for conversion)........................         723,000
Methylphenidate.........................................      13,824,000
Morphine (for sale).....................................      11,126,000
Morphine (for conversion)...............................      68,165,000
Noroxymorphone (for sale)...............................          30,000
Noroxymorphone (for conversion).........................       2,000,000
Opium...................................................         575,000
Oxycodone (for sale)....................................       8,323,000
Oxycodone (for conversion)..............................           1,200
Oxymorphone.............................................          66,000
Pentobarbital...........................................      19,201,000
Phencyclidine...........................................              60
Phenmetrazine...........................................               2
Phenylacetone...........................................              10
Secobarbital............................................         491,000
Sufentanil..............................................           1,000
Thebaine................................................       9,325,000
------------------------------------------------------------------------

    Dated: August 11, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-21587 Filed 8-14-97; 8:45 am]
BILLING CODE 4410-09-M