[Federal Register Volume 61, Number 101 (Thursday, May 23, 1996)]
[Notices]
[Pages 25895-25897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12899]



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DEPARTMENT OF JUSTICE
[DEA No. 150P]


Controlled Substances: Notice of Proposed 1996 Aggregate 
Production Quotas

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of proposed revised aggregate production quotas for 
1996.

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SUMMARY: This notice proposes revised 1996 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 24, 
1996.

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

FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug & 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, D.C. 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 section 0.104 
of Title 28 of the Code of Federal Regulations.
    On November 21, 1995, a notice of the 1996 established aggregate 
production quotas was published in the Federal Register (60 FR 57808). 
The notice stipulated that the Deputy Administrator of the DEA would 
adjust the quotas in early 1996 as provided for in Title 21, Code of 
Federal Regulations, Section 1303.23(c). Subsequently, the DEA revised 
1996 aggregate production quotas for amobarbital, heroin and 
hydromorphone as published in the Federal Register (61 FR 19090 and 61 
FR 14336). Those revised figures are included with the proposed 1996 
revised aggregate production quotas below. These proposed aggregate 
production quotas represent those amounts of controlled substances that 
may be produced in the United States in 1996 and do not include amounts 
which may be imported for use in industrial processes.
    The proposed revisions are based on a review of 1995 year-end 
inventories, 1995 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.

[[Page 25896]]

    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 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 of the DEA hereby proposes the following 1996 aggregate 
production quotas for the listed controlled substances, expressed in 
grams of anhydrous acid or base.

----------------------------------------------------------------------------------------------------------------
                                                        Previously established 1996     Proposed revised 1996   
                      Basic class                       aggregate production quotas  aggregate production quotas
----------------------------------------------------------------------------------------------------------------
Schedule I:                                                                                                     
    Acetylmethadol....................................                            7                            7
    Alphacetylmethadol................................                            7                            7
    Aminorex..........................................                            7                            7
    Cathinone.........................................                            9                            9
    Difenoxin.........................................                       14,000                       14,000
    Dihydromorphine...................................                            7                            7
    2, 5-Dimethoxyamphetamine.........................                   10,650,000                   10,650,000
    Dimethylamphetamine...............................                            7                            7
    Ethylamine analog of Phencyclidine................                            5                            5
    N-Ethylamphetamine................................                            7                            7
    Heroin............................................                            5                            5
    Lysergic acid diethylamide........................                           58                           58
    Mescaline.........................................                            7                            7
    Methaqualone......................................                           17                           17
    Methcathinone.....................................                            9                            9
    4-Methoxyamphetamine..............................                           17                           17
    4-Methylaminorex..................................                            2                            2
    3,4-Methylenedioxyamphetamine.....................                           17                           17
    3,4-Methylenedioxy-N-ethylamphetamine.............                           27                           27
    3,4-Methylenedioxymethamphetamine.................                           42                           42
    3-Methylfentanyl..................................                           14                           14
    Normethadone......................................                            7                            7
    Normorphine.......................................                            7                            7
    Psilocybin........................................                            2                            2
    Psilocyn..........................................                            2                            2
    Tetrahydrocannabinols.............................                       55,100                       55,100
                                                                                                                
Schedule II:                                                                                                    
    Alfentanil........................................                        8,500                        8,500
    Amobarbital.......................................                      301,000                      301,000
    Amphetamine.......................................                    1,863,200                    2,280,000
    Cocaine...........................................                      550,040                      550,040
    Codeine (for sale)................................                   58,395,000                   47,000,000
    Codeine (for conversion)..........................                   16,632,000                   17,519,000
    Desoxyephedrine...................................                    1,044,000                    1,044,000
                                                                                                                
 (1,000,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product and 44,000 grams
                                              for methamphetamine)                                              
                                                                                                                
    Dextropropoxyphene................................                  118,066,000                  118,066,000
    Dihydrocodeine....................................                      116,000                      214,000
    Diphenoxylate.....................................                    1,063,000                    1,002,000
    Ecgonine (for conversion).........................                      650,100                      650,100
    Ethylmorphine.....................................                           12                           12
    Fentanyl..........................................                      120,100                      143,000
    Hydrocodone (for sale)............................                   10,575,000                   12,145,000
    Hydrocodone (for conversion)......................                    2,800,000                    2,800,000
    Hydromorphone.....................................                      718,000                      718,000
    Isomethadone......................................                           12                           12
    Levo-alpha-acetylmethadol.........................                      200,000                      200,000
    Levorphanol.......................................                       14,300                       14,300
    Meperidine........................................                   10,822,000                   10,822,000
    Methadone.........................................                    4,551,000                    4,551,000
    Methadone (for conv)..............................                      364,000                      364,000
    Methadone Int. (for conv).........................                    5,534,000                    5,534,000
    Methamphetamine (for conv)........................                      723,000                      723,000
    Methylphenidate...................................                   10,291,000                   11,090,000
    Morphine (for sale)...............................                   12,450,000                   12,450,000
    Morphine (for conv)...............................                   76,735,000                   76,735,000
    Noroxymorphone (for sale).........................                        2,000                        2,000
    Noroxymorphone (for conv).........................                    3,400,000                    3,400,000
    Opium.............................................                    1,226,000                      714,000
    Oxycodone (for sale)..............................                    5,571,000                    5,571,000
    Oxycodone (for conv)..............................                       37,300                       37,300
    Oxymorphone.......................................                       11,200                       11,200
    Pentobarbital.....................................                   15,100,000                   15,100,000
    Phencyclidine.....................................                           40                           40
    Phenylacetone (for conv)..........................                    5,280,000                           10
    1-Phenylcyclohexylamine...........................                           10                           10

[[Page 25897]]

                                                                                                                
    1-Piperidinocyclohexanecarbonitrile...............                           12                           12
    Secobarbital......................................                      400,000                      400,000
    Sufentanil........................................                        1,000                        1,000
    Thebaine..........................................                    9,217,000                    9,387,000
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    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 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 15, 1996.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 96-12899 Filed 5-22-96; 8:45 am]
BILLING CODE 4410-09-M