[Federal Register Volume 60, Number 224 (Tuesday, November 21, 1995)]
[Notices]
[Pages 57808-57810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28550]



 ========================================================================
 Notices
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
 appearing in this section.
 
 ========================================================================
 

  Federal Register / Vol. 60, No. 224 / Tuesday, November 21, 1995 / 
Notices  

[[Page 57808]]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA No. 134F]


Controlled Substances: Established Initial 1996 Aggregate 
Production Quotas

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 1996.

-----------------------------------------------------------------------

SUMMARY: This notice establishes initial 1996 aggregate production 
quotas for some controlled substances in Schedules I and II of the 
Controlled Substances Act (CSA).

EFFECTIVE DATE: This order is effective upon November 21, 1995.

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 CSA (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 Section 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 Section 0.104 of 
Title 28 of the Code of Federal Regulations.
    On July 27, 1995, a notice of the proposed initial 1996 aggregate 
production quotas for certain controlled substances in Schedules I and 
II was published in the Federal Register (60 FR 38576). All interested 
persons were invited to comment on or object to the proposed aggregate 
production quotas on or before August 28, 1995. The following comments 
were received.
    A company commented that the proposed initial 1996 aggregate 
production quotas for dihydrocodeine, hydrocone and noroxymorphone (for 
conversion), are insufficient to provide for the estimated medical 
needs of the United States, estimated export requirements and for the 
establishment and maintenance of reserve stocks. The company's comments 
are based on their actual 1995 and projected 1996 domestic sales and 
1995 manufacturing quotas. After reviewing the company's current 1995 
and forecasted 1996 sales and inventory levels, the DEA determined that 
the initial 1996 aggregate production quotas for dihydrocodeine, 
hydrocodone and noroxymorphone (for conversion) must be increased to 
meet the 1996 medical needs of the United States, and are adjusted 
accordingly.
    Several companies commented that the proposed initial 1996 
aggregate production quota for amphetamine is insufficient to provide 
for the estimated medical, scientific, research and industrial needs of 
the United States, estimated export requirements and for the 
establishment and maintenance of reserve stocks. The company comments 
are based on their actual 1995 sales, projected 1996 sales and exports, 
projected 1995 and 1996 inventories and 1996 research requirements.
    Based on 1995 manufacturing quotas, the 1996 Food and Drug 
Administration estimate for amphetamine and projected 1996 inventories, 
the DEA increased the initial 1996 aggregate production quota for 
amphetamine. The DEA received no comments regarding the proposed 
aggregate production quotas for any other substances in schedule I or 
II.
    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 hereby certifies that this action has no 
significant 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 Schedules I 
and II controlled substances is mandated by law and by international 
treaty obligations. While aggregate production quotas are of primary 
importance to large manufactures, their impact upon small entities is 
neither negative nor beneficial. Accordingly, the Deputy Administrator 
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, pursuant to Section 0.104 of Title 28 of the Code of 
Federal Regulations, the Deputy Administrator hereby orders that the 
1996 initial aggregate production quotas, expressed in grams of 
anhydrous base, be established as follows.

------------------------------------------------------------------------
                                                            Established 
                       Basic class                         initial 1996 
                                                              quotas    
------------------------------------------------------------------------
Schedule I:                                                             
    Acetylmethadol......................................               7
    Alphacetylmethadol..................................               7
    Aminorex............................................               7
    Cathinone...........................................               9
    Difenoxin...........................................          14,000
    Dihydromorphine.....................................               7

[[Page 57809]]
                                                                        
    2,5-Dimethoxyamphetamine............................      10,650,000
    N,N-Dimethylamphetamine.............................               7
    Ethylamine Analog of Phencyclidine..................               5
    N-Ethylamphetamine..................................               7
    Lysergic Acid Diethylamide..........................              58
    Mescaline...........................................               7
    Methaqualone........................................              17
    Methacathinone......................................               9
    4-Methoxyamphetamine................................              17
    4-Methylaminorex....................................               2
    3-Methylfentanyl....................................              14
    3,4-Methylenedioxyamphetamine.......................              17
    3,4-Methylenedioxy-N-ethylamphetamine...............              27
    3,4-Methylenedioxymethamphetamine...................              42
    Normethadone........................................               7
    Normorphine.........................................               7
    Psilocybin..........................................               2
    Psilocyn............................................               2
    Tetrahydrocannabinols...............................          55,100
Schedule II:                                                            
    Alfentanil..........................................           8,500
    Amobarbital.........................................              15
    Amphetamine (includes the d,1-, d- and 1- forms of                  
     amphetamine........................................       1,863,200
    Cocaine.............................................         550,040
    Codeine (for sale)..................................      58,395,000
    Codeine (for conversion)............................      16,632,000
    Desoxyephedrine (1,000,000 grams of levo-                           
     desoxyephedrine for use in a non-controlled, non-                  
     prescription product and 44,000 grams for                          
     methamphetamine)...................................       1,044,000
    Dextropropoxyphene..................................     118,066,000
    Dihydrocodeine......................................         116,000
    Diphenoxylate.......................................       1,063,000
    Ecgonine (for conversion)...........................         650,100
    Ethylmorphine.......................................              12
    Fentanyl............................................         120,100
    Hydrocodone (for sale)..............................      10,575,000
    Hydrocodone (for conversion)........................       2,800,000
    Hydromorphone.......................................         448,000
    Isomethadone........................................              12
    Levo-alpha-acetylmethadol...........................         200,000
    Levorphanol.........................................          14,300
    Meperidine..........................................      10,822,000
    Methadone (for sale)................................       4,551,000
    Methadone (for conversion)..........................         364,000
    Methadone Intermediate (for conversion).............       5,534,000
    Methamphetamine (for conversion)....................         723,000
    Methylphenidate.....................................      10,291,000
    Morphine (for sale).................................       12,450,00
    Morphine (for conversion)...........................      76,735,000
    Noroxymorphone (for sale)...........................           2,000
    Noroxymorphone (for conversion).....................       3,400,000
    Opium...............................................       1,226,000
    Oxycodone (for sale)................................       5,571,000
    Oxycodone (for conversion)..........................          37,300
    Oxymorphone.........................................          11,200
    Pentobarbital.......................................      15,100,000
    Phencyclidine.......................................              40
    Phenylacetone.......................................       5,280,000
    1-Phenylcyclohexylamine.............................              10
    1-Piperidinocyclohexanecarbonitrile.................              12
    Secobarbital........................................         400,000
    Sufentanil..........................................           1,000
    Thebaine............................................       9,217,000
------------------------------------------------------------------------



[[Page 57810]]


    Dated: November 16, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-28550 Filed 11-20-95; 8:45 am]
BILLING CODE 4410-09-M