[Federal Register Volume 62, Number 108 (Thursday, June 5, 1997)]
[Notices]
[Pages 30883-30885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14698]



[[Page 30883]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA # 153R]


Controlled Substances: Notice of Proposed Revised 1997 Aggregate 
Production Quotas

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed revised 1997 aggregate production quotas and 
request for comments.

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SUMMARY: This notice proposes revised 1997 aggregate production quotas 
for controlled substances in Schedules I and II, as required under the 
Controlled Substances Act of 1970.

DATES: Comments or objections should be received on or before July 7, 
1997.

ADDRESSES: Send comments or objections to the Administrator, Drug 
Enforcement Administration, Washington, DC. 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, (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 controlled substances in Schedules I 
and II each year. This responsibility has been delegated to the 
Administrator of the DEA pursuant to Sec. 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 
Sec. 0.104 of Title 28 of the Code of Federal Regulations.
    On December 17, 1996, a notice of the established initial 1997 
aggregate production quotas was published in the Federal Register (61 
FR 66311). The notice stipulated that the Deputy Administrator of the 
DEA would adjust the quotas in early 1997 as provided for in Title 21, 
Code of Federal Regulations, Sec. 1303.13(c). The proposed revised 1997 
aggregate production quotas represent those quantities of controlled 
substances that may be produced in the United States in 1997, and do 
not include imports of controlled substances for use in industrial 
processes.
    The proposed revisions are based on a review of 1996 year-end 
inventories, 1996 disposition data submitted by quota applicants, 
estimates of the medical needs of the United States submitted to the 
DEA by the Food and Drug Administration, and other information 
available to the DEA.
    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 Deputy 
Administrator, pursuant to Sec. 0.104 of Title 28 of the Code of 
Federal Regulations, the Deputy Administrator hereby proposes the 
following revised 1997 aggregate production quotas for the listed 
controlled substances, expressed in grams of anhydrous acid or base:

------------------------------------------------------------------------
                                            Previously       Proposed   
                                            established    revised 1997 
               Basic class                1997 aggregate     aggregate  
                                            production      production  
                                              quotas          quotas    
------------------------------------------------------------------------
               Schedule I                                               
                                                                        
2,5-Dimethoxyamphetamine................      15,200,100      15,200,100
2,5-Dimethoxy-4-ethylamphetamine........               2               2
3-Methylfentanyl........................              14              14
3-Methylthiofentanyl....................               2               2
3,4-Methylenedioxyamphetamine...........              22              22
3,4-Methylenedioxy-N-ethylamphetamine...              27              27
3,4-Methylenedioxymethamphetamine.......               7               7
3,4,5-Trimethoxyamphetamine.............               2               2
4-Bromo-2,5-Dimethoxyamphetamine........               2               2
4-Bromo-2,5-Dimethoxyphenethylamine.....               2               2
4-Methoxyamphetamine....................              17              17
4-Methylaminorex........................               2               2
4-Methyl-2,5-Dimethoxyamphetamine.......               2               2
5-Methoxy-3,4-Methylenedioxyamphetamine.               2               2
Acetyl-alpha-methylfentanyl.............               2               2
Acetylmethadol..........................               7               7
Alpha-acetylmethadol....................               7               7
Alpha-ethyltryptamine...................               2               2
Alpha-methadol..........................               2               2
Alpha-methylfentanyl....................               2               2
Alpha-methylthiofentanyl................               2               2
Aminorex................................               7               7
Beta-acetylmethadol.....................               2               2
Beta-hydroxyfentanyl....................               2               2
Beta-hydroxy-3-methylfentanyl...........               2               2
Beta-methadol...........................               2               2
Bufotenine..............................               2               2
Cathinone...............................               9               9
Codeine-N-oxide.........................               2               2
Difenoxin...............................          14,000          14,000
Dihydromorphine.........................               7               7
Ethylamine Analog of PCP................               5               5
Heroin..................................               2               2
Lysergic acid diethylamide..............              32              32
Mescaline...............................               7               7
Methaqualone............................              17              17
Methcathinone...........................              11              11

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Morphine-N-oxide........................               2               2
N-Ethylamphetamine......................               7               7
N-Hydroxy-3,4-Methylenedioxyamphetamine.               2               2
N,N-Dimethyltryptamine..................               7               7
Norlevorphanol..........................               2               2
Normethadone............................               7               7
Normorphine.............................               7               7
Para-fluorofentanyl.....................               2               2
Pholcodine..............................               2               2
Psilocin................................               2               2
Psilocybin..............................               2               2
Tetrahydrocannibinols...................          25,100          25,100
Thiofentanyl............................               2               2
Thiophene Analog of Phencyclidine.......               5               5
                                                                        
               Schedule II                                              
                                                                        
1-Phenylcyclohexylamine.................              10              10
1-Piperidinocyclohexanecarbonitrile.....              12              12
Alfentanil..............................           9,300           9,300
Amobarbital.............................              15              15
Amphetamine.............................       2,968,000       3,137,000
Carfentanil.............................             500             500
Cocaine.................................         550,100         550,100
Codeine (for sale)......................      49,103,000      53,140,000
Codeine (for conv)......................      19,679,000      19,679,000
Desoxyephedrine.........................       1,422,000       1,393,000
                                                                        
  1,361,000 grams of levodesoxyephedrine for use in a noncontrolled,    
nonprescription product and 32,00 grams for methamphetamine.            
                                                                        
Dextroproproxyphene.....................     116,469,000     116,469,000
Dihydrocodeine..........................         255,100         188,000
Diphenoxylate...........................       1,572,000       1,572,000
Ecgonine (for conv).....................         651,000         651,000
Ethylmorphine...........................              12              12
Fentanyl................................         193,000         193,000
Glutethimide............................               2               2
Hydrocodone (for sale)..................      13,891,000      13,891,000
Hydrocodone (for conv)..................       1,769,000       1,769,000
Hydromorphone...........................         563,000         563,000
Isomethadone............................              12              12
Levo-alpha-acetylmethadol...............         356,000         356,000
Levomethorphan..........................               2               2
Levorphanol.............................          16,400          12,000
Meperidine..............................       9,843,000       9,843,000
Methadone (for sale)....................       3,977,000       3,977,000
Methadone (for conv)....................         364,000         364,000
Methadone Intermediate (for conv).......       5,275,000       5,275,000
Methamphetamine (for conv)..............         723,000         723,000
Methylphenidate.........................      13,824,000      13,824,000
Morphine (for sale).....................      11,126,000      11,126,000
Morphine (for conv).....................      68,165,000      68,165,000
Noroxymorphone (for sale)...............          30,000          30,000
Noroxymorphone (for conv)...............       2,000,000       2,000,000
Opium...................................         937,000         575,000
Oxycodone (for sale)....................       6,634,000       6,634,000
Oxycodone (for conv)....................           1,200           1,200
Oxymorphone.............................          56,000          56,000
Pentobarbital...........................      16,772,000      16,772,000
Phencyclidine...........................              60              60
Phenmetrazine...........................               2               2
Phenylacetone...........................              10              10
Secobarbital............................         491,000         491,000
Sufentanil..............................           1,000           1,000
Thebaine................................       9,325,000       9,325,000
------------------------------------------------------------------------

    All interested persons are invited to submit their comments 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

[[Page 30885]]

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 thereby 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 annual 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 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.

    Dated: May 28, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-14698 Filed 6-4-97; 8:45 am]
BILLING CODE 4410-09-M