[Federal Register Volume 60, Number 89 (Tuesday, May 9, 1995)]
[Notices]
[Pages 24649-24651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11370]



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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA No. 132P]


Controlled Substances: Proposed 1995 Aggregate Production Quotas

AGENCY: Drug Enforcement Administration.

ACTION: Notice of proposed revised aggregate production quotas for 
1995.

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SUMMARY: This notice proposes revised 1995 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 June 8, 
1995.

ADDRESSES: Send comments or objections to the Administrator, Drug 
Enforcement Administration, Washington, DC 20537, Attn: DEA Federal 
Register Representative/CCR.

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

SUPPLEMENTARY INFORMATION: Section 306 of the Controlled Substances Act 
(CSA) (21 U.S.C. 826) requires that the Attorney General establish 
aggregate production quotas for all controlled substances listed in 
Schedules I and II. 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 by Sec. 0.104 of Title 28 of the Code 
of Federal Regulations.
    On October 20, 1994, a notice of the 1995 established aggregate 
production quotas was published in the Federal Register (59 FR 52991). 
The notice stipulated that the Deputy Administrator of the DEA would 
adjust the quotas in early 1995 as provided for in Title 21, Code of 
Federal Regulations, Sec. 1303.23(c). These aggregate production quotas 
represent those amounts of controlled substances that may be produced 
in the United States in 1995 and do not include amounts which may be 
imported for use in industrial processes.
    The proposed revisions are based on a review of 1994 year-end 
inventories, 1994 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 CSA of 1970 (21 U.S.C. 826), delegated to the 
Administrator by Sec. 0.100 of Title 28 of the Code of Federal 
Regulations, and redelegated to the Deputy Administrator by Sec. 0.104 
of Title 28 of the Code of Federal Regulations, the Deputy 
Administrator of the DEA hereby proposes the following changes in the 
1995 aggregate production quotas for the listed controlled substances, 
expressed in grams of anhydrous acid or base.

------------------------------------------------------------------------
                                            Previously       Proposed   
                                            established    revised 1995 
               Basic class                1995 aggregate     aggregate  
                                            production      production  
                                              quotas          quotas    
------------------------------------------------------------------------
Schedule I:.............................                                
    Acetylmethadol......................               2               7
    Alphacetymethadol...................               0               5
    Aminorex............................               2               7
    Bufotenine..........................              10              10
    Cathinone...........................               4               9
    Difenoxin...........................          14,000          14,000
[[Page 24650]]
                                                                        
    Dihydromorphine.....................               0               5
    2,5-Dimethylamphetamine.............      15,650,000      15,650,000
    Dimethylamphetamine.................               2               7
    Ethylamine analog of Phencyclidine..               0               5
    N-Ethylamphetamine..................               4               9
    Lysergic acid diethylamide..........              41              56
    Mescaline...........................               2               7
    Methaqualone........................               2               7
    Methcathinone.......................               9              14
    4-Methoxyamphetamine................              12              17
    4-Methylaminorex....................               2               2
    3,4-Methylenedioxyamphetamine.......              12              17
    3,4-Methylenedioxy-N-                                               
     ethylamphetamine...................               2              27
    3,4-Methylenedioxymethamphetamine...              12              17
    3-Methylfentanyl....................              12              14
    Normethadone........................               0               5
    Normorphine.........................               2               7
    Tetrahydrocannabinols...............          35,000          35,000
    Thiophene Analog of Phencyclidine...              10              10
Schedule II:............................                                
    Alfentanil..........................           7,000           7,000
    Amobarbital.........................               5              15
    Amphetamine.........................       1,026,100       1,026,100
    Cocaine.............................         550,000         550,000
    Codeine (for sale)..................      67,312,000      67,312,000
    Codeine (for conversion)............      16,181,000      16,181,000
    Desoxyephedrine.....................         900,000       1,154,000
                                                                        
(1,138,000 grams of levo-desoxyephedrine for use in a non-controlled,   
 non-prescription product and 16,000 grams for methamphetamine).........
                                                                        
Dextropropoxyphene......................     124,012,000     124,012,000
Dihydrocodeine..........................         202,000         100,000
Diphenoxylate...........................         688,000         346,000
Ecgonine (for conversion)...............         650,000         650,000
Ethylmorphine...........................               0              10
Fentanyl................................          76,000          52,000
Hydrocodone.............................       8,474,000       8,474,000
Hydromorphone...........................         404,000         404,000
Isomethadone............................               0              10
Levo-alpha-acetylmethadol...............         200,000         200,000
Levorphanol.............................           8,000           8,000
Meperidine..............................       8,637,000       9,521,000
Methadone...............................       3,779,000       3,779,000
Methadone (for conv)....................         364,000         364,000
Methadone Intermediate (for sale).......         300,000               0
Methadone Int. (for conv)...............       4,393,000       4,393,000
Methylphenidate.........................       8,886,000      10,410,000
Morphine (for sale).....................       7,612,000       7,612,000
Morphine (for conv).....................      78,105,000      78,105,000
Noroxymorphone (for sale)...............          21,000          21,000
Noroxymorphone (for conv)...............       3,500,000       3,500,000
Opium...................................       1,118,000       1,304,000
Oxycodone (for sale)....................        3,613,00       4,254,000
Oxycodone (for conv)....................          23,000          25,500
Oxymorphone.............................           9,200          10,200
Pentobarbital...........................      15,706,000      15,706,000
Phencyclidine...........................              52              72
Phenylacetone (for conv)................       3,528,000       3,528,000
1-Phenylcyclohexylamine.................               0              10
1-Piperidinocyclohexanecarbonitrile.....               0              10
Secobarbital............................         480,000         322,000
Sufentanil..............................           1,600           1,600
Thebaine................................       9,383,000       9,383,000
------------------------------------------------------------------------

  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 Deputy Administrator finds warrant a hearing, 
the Deputy Administrator shall order a public hearing by notice in the 
Federal [[Page 24651]] Register, summarizing the issues to be heard and 
setting the time for the hearing.
    The Office of Management and budget has determined that notice of 
aggregate production quotas are not subject to centralized review under 
Executive Order 12866.
    Rules establishing aggregate production quotas for controlled 
substances in Schedules I and II are required by statute, fulfill 
United States obligations under the Single Convention on Narcotic 
Drugs, 1961, and other international treaties, and are essential to a 
criminal law enforcement function of the United States. Without the 
periodic establishment and adjustment of aggregate production quotas, 
pharmaceutical manufacturers in the United States could not lawfully 
produce a wide variety of medically necessary pharmaceutical drugs.
    These actions have been analyzed in accordance with the principles 
and criteria contained in Executive Order 12612 and it has been 
determined that this matter raises no Federalism implications which 
would warrant the preparation of a Federalism Assessment.
    The 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 and revision of annual production quotas for 
Schedules I and II controlled substances is mandated by law and by the 
international obligations of the United States. Such quotas impact 
predominantly upon major manufacturers of the affected controlled 
substances.

    Dated: May 3, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-11370 Filed 5-8-95; 8:45 am]
BILLING CODE 4410-09-M