[Federal Register Volume 61, Number 243 (Tuesday, December 17, 1996)]
[Notices]
[Pages 66311-66314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31889]


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DEPARTMENT OF JUSTICE
[DEA #153F]


Controlled Substances: Established Initial 1997 Aggregate 
Production Quotas

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 1997.

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SUMMARY: This notice establishes initial 1997 aggregate production 
quotas for controlled substances in Schedule I and II of the Controlled 
Substances Act (CSA).

EFFECTIVE DATE: This order is effective upon December 17, 1996.

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 the Attorney General to establish aggregate 
production quotas for each basic class of controlled substance listed 
in Schedule I and II. This responsibility has been delegated to the 
Administrator of the DEA pursuant to 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 October 17, 1996, a notice of the proposed initial 1997 
aggregate production quotas for certain controlled substances in 
Schedule I and II was published in the Federal Register (61 FR 54222). 
All interested person were invited to comment on or before November 18, 
1996. The following comments were received.
    A company commented that the proposed 1997 initial aggregate 
production quota for fentanyl is insufficient to provide for the 
estimated medical, scientific, research and industrial needs of the 
United States, for export requirements and the maintenance of reserve 
stocks. Based on current 1996 sales and inventories, and 1997 export 
requirements, the DEA increased the 1997 initial aggregate production 
quota for fentanyl.
    A company commented that the proposed initial 1997 aggregate 
production quota for methylphenidate is insufficient to provide for the 
estimated medical, scientific, research and industrial needs of the 
United States and for the establishment of reserve stocks. After a 
review of current 1996 manufacturing quotas and 1997 customer 
requirements, the DEA has determined that no adjustment is necessary at 
this time.
    One company commented that the proposed 1997 initial aggregate 
production quota for oxymorphone is insufficient to provide for the 
estimated medical, scientific, research and industrial needs of the 
United States. Based on a review of 1997 product development 
requirements, the DEA adjusted the initial 1997 aggregate

[[Page 66312]]

production quota for oxymorphone accordingly.
    Another company commented that the proposed initial 1997 aggregate 
production quotas for alfentanil, diphenoxylate, noroxymorphone, and 
oxycodone (for sale) are insufficient to meet the estimated medical, 
scientific, research and industrial needs of the United States. After a 
review of 1996 manufacturing quotas, current 1996 sales and 
inventories, 1997 export requirements and research and product 
development requirements, the DEA agrees that increases are necessary 
for diphenoxylate, noroxymorphone and oxycodone. Regarding alfentanil, 
DEA determined that the proposed initial 1997 aggregate production 
quota is sufficient to meet 1997 requirements.
    The DEA received updated information from a manufacturer regarding 
levo-alpha-acetylmethadol and methadone intermediate (for conversion) 
and from two manufacturers concerning methadone (for sale), which 
necessitates adjustments of the initial 1997 aggregate production 
quotas for these substances. The adjustments are increases which will 
provide for the estimated medical, scientific, research and industrial 
needs of the United States and for the establishment and maintenance of 
reserve stocks. Therefore, DEA adjusted the 1997 initial aggregate 
production quotas for levo-alpha-acetylmethadol, methadone (for sale) 
and methadone intermediate (for conversion) accordingly.
    Concerning lysergic acid diethylamide and N,N-dimethylamphetamine, 
the DEA increased the 1997 initial aggregate production quotas for 
these substances since applications made by several companies for these 
substances were not taken into consideration in the proposal.
    A company commented that the proposed initial 1997 aggregate 
production quota for N-ethylamphetamine is insufficient to provide for 
the estimated medical, scientific, research and industrial needs of the 
United States, and for export requirements. Since the commenter is not 
registered with DEA to manufacture this substance, DEA will consider 
this request at a later time when the proper registration is obtained.
    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 meter 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 economic impact upon small entities whose interest 
must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601, 
et seq. The establishment of annual 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 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, by Section 0.104 of Title 28 of the Code of Federal 
Regulations, the Deputy Administrator hereby orders that the 1997 
initial aggregate production quotas, expressed in grams of anhydrous 
acid or base, be established as follows:

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...............................................          14,000
Dihydromorphine.........................................               7
Ethylamine Analog of PCP................................               5
Heroin..................................................               2
Lysergic acid diethylamide (LSD)........................              32

[[Page 66313]]

                                                                        
Mescaline...............................................               7
Methaqualone............................................              17
Methcathinone...........................................              11
Morphine-N-oxide........................................               2
N-Ethylamphetamine......................................               7
N-Hydroxy-3,4-Methylenedioxyamphetamine.................               2
N,N-Dimethylamphetamine.................................               7
N,N-Dimethyltryptamine..................................               7
Norlevorphanol..........................................               2
Normethadone............................................               7
Normorphine.............................................               7
Para-fluorofentanyl.....................................               2
Pholcodine..............................................               2
Psilocin................................................               2
Psilocybin..............................................               2
Tetrahydrocannibinols...................................          25,100
Thiofentanyl............................................               2
Thiophene Analog of Phencyclidine.......................               5
Psilocin................................................               2
Psilocybin..............................................               2
Tetrahydrocannibinols...................................          25,100
Thiofentanyl............................................               2
Thiophene Analog of Phencyclidine.......................               5
                                                                        
                               Schedule II                              
                                                                        
1-Phenylcyclohexylamine.................................              10
1-Piperidinocyclohexanecarbonitrile (PCC)...............              12
Alfentanil..............................................           9,300
Amobarbital.............................................              15
Amphetamine.............................................       2,968,000
Carfentanil.............................................             500
Cocaine.................................................         550,100
Codeine (for sale)......................................      49,103,000
Codeine (for conversion)................................      19,679,000
Desoxyephedrine.........................................       1,422,000
    1,361,000 grams of levodesoxyephedrine for use in a                 
     noncontrolled, nonprescription product and 61,000                  
     grams for methamphetamine.                                         
Dextropropoxyphene......................................     116,469,000
Dihydrocodeine..........................................         255,100
Diphenoxylate...........................................       1,572,000
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...........................................         563,000
Isomethadone............................................              12
Levo-alpha-acetylmethadol (LAAM)........................         356,000
Levomethorphan..........................................               2
Levorphanol.............................................          16,400
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...................................................         937,000
Oxycodone (for sale)....................................       6,634,000
Oxycodone (for conversion)..............................           1,200
Oxymorphone.............................................          56,000
                                                                        


[[Page 66314]]

    Dated: December 10, 1996.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 96-31889 Filed 12-16-96; 8:45 am]
BILLING CODE 4410-09-M