[Federal Register Volume 59, Number 202 (Thursday, October 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25947]


[[Page Unknown]]

[Federal Register: October 20, 1994]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

 

Controlled Substances: Established Initial 1995 Aggregate 
Production Quotas

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 1995.

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SUMMARY: This notice establishes initial 1995 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 October 20, 1994.

FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug & 
Chemical Evaluation Section, Drug Enforcement Administration, Drug 
Enforcement Administration, Washington, D.C. 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 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 Administrtor pursuant to 59 FR 23637 (May 6, 1994).
    On August 4, 1994, a notice of the proposed initial 1995 aggregate 
production quotas for certain controlled substances in Schedules I and 
II was published in the Federal Register (59 FR 39790). All interested 
persons were invited to comment on or before September 6, 1994. The 
following comments were received.
    Two companies commented that the proposed 1995 initial aggregate 
production quota for amphetamine 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 1994 manufacturing quotas, the 1995 FDA 
estimate of medical need, and export requirements, the DEA increased 
the 1995 initial aggregate production quota for amphetamine.
    A company commented that the proposed initial 1995 aggregate 
production quota for levo-desoxyephedrine 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. After a review of the 1994 manufacturing quota, the 
1995 FDA estimate of medical need and other data, the DEA has 
determined that no adjustment is necessary at this time.
    Two companies commented that the proposed 1995 initial aggregate 
production quota for methylphenidate is insufficient to meet the 
estimated medical, scientific, research and industrial needs of the 
United States and for the maintenance of reserve stocks. Based on 1994 
manufacturing quotas, 1993 year-end inventories, the 1995 FDA estimate 
of medical need and research and development requirements, the DEA 
adjusted the initial 1995 aggregate production quota for 
methylphenidate accordingly.
    Pertaining to Sufentanil, one company commented that the proposed 
1995 initial aggregate production quota is insufficient to meet the 
estimated medical, scientific, research and industrial needs of the 
United States. The DEA reviewed all available information and adjusted 
the initial 1995 aggregate production quota for Sufentanil.
    Another company commented that the proposed initial 1995 aggregate 
production quotas for hydromorphone, oxymorphone and oxycodone (for 
conversion) are insufficient to meet the estimated medical, scientific, 
research and industrial needs of the United States. After a review of 
1994 manufacturing quotas and research and product development 
requirements, the DEA has determined that increases are necessary to 
meet medical, scientific, research and industrial needs of the United 
States.
    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 will 
have 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 manufacturers, their impact upon small entities is 
neither negative nor beneficial. Accordingly, the Deputy Administrator 
has determined that this actions 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 Sec. 0.100 of title 28 of 
the Code of Federal Regulations, and redelegated to the Deputy 
Administrator, pursuant to 59 FR 23637 (May 6, 1994), the Deputy 
Administrator hereby orders that the 1995 initial aggregate production 
quotas, expressed in grams of anhydrous acid or base, be established as 
follows.

------------------------------------------------------------------------
                                                            Established 
                                                           initial 1995 
                       Basic class                          quotas (in  
                                                              grams)    
------------------------------------------------------------------------
Schedule I:                                                             
  Acetylmethadol........................................               2
  Aminorex..............................................               2
  Bufotenine............................................              10
  Cathinone.............................................               4
  Difenoxin.............................................          14,000
  2,5-                                                                  
    Dimethoxy-amphetamine...............................      15,650,000
  Dimethylamphetamine...................................               2
  N-Ethylamphetamine....................................               4
  Lysergic acid diethylamide............................              41
  Mescaline.............................................               2
  Methaqualone..........................................               2
  Methcathinone.........................................               9
  4-Methoxyamphetamine..................................              12
  4-Methylaminorex......................................               2
  3-Methylfentanyl......................................              12
  3,4-                                                                  
    Methylenediox-yamphetamine..........................              12
  3,4-Methylenedioxy-N-ethylamphetamine.................               2
  3,4-..................................................                
    Methylenedioxy-methamphetamine......................              12
  Normorphine...........................................               2
  Tetrahydrocannabinols.................................          35,000
  Thiophene Analog of Phencyclidine.....................              10
Schedule II:                                                            
  Alfentanil............................................           7,000
  Amobarbital...........................................               5
  Amphetamine...........................................       1,026,100
  Cocaine...............................................         550,000
  Codeine (for sale)....................................      67,312,000
  Codeine (for conversion)..............................      16,181,000
  Desoxyephedrine.......................................      \1\900,020
  Dextropropoxyphene....................................     124,012,000
  Dihydrocodeine........................................         202,000
  Diphenoxylate.........................................         688,000
  Ecgonine (for conversion).............................         650,000
  Fentanyl..............................................          76,000
  Hydrocodone...........................................       8,474,000
  Hydromorphone.........................................         404,000
  Levo-alpha-acetylmethadol.............................         200,000
  Levorphanol...........................................           8,000
  Meperidine............................................       8,637,000
  Methadone.............................................       3,779,000
  Methadone (for conversion)............................         364,000
  Methadone Intermediate (for sale).....................         300,000
  Methadone Intermediate (for conversion)...............       4,393,000
  Methylphenidate.......................................       8,886,000
  Morphine (for sale)...................................       7,612,000
  Morphine (for conversion).............................      78,105,000
  Noroxymorphone (for sale).............................          21,000
  Noroxymorphone (for conversion).......................       3,500,000
  Opium.................................................       1,118,000
  Oxycodone (for sale)..................................       3,613,000
  Oxycodone (for conversion)............................          23,000
  Oxymorphone...........................................           9,200
  Pentobarbital.........................................      15,706,000
  Phencyclidine.........................................              52
  Phenylacetone (for conversion)........................       3,528,000
  Secobarbital..........................................         480,000
  Sufentanil............................................           1,600
  Thebaine..............................................       9,383,000
------------------------------------------------------------------------
\1\900,000 grams of levo-desoxyephedrine for use in a non-controlled,   
  non-prescription product and 20 grams for methamphetamine.            

    Dated: October 12, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-25947 Filed 10-19-94; 8:45 am]
BILLING CODE 4410-09-M