[Federal Register Volume 59, Number 71 (Wednesday, April 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8784]


[[Page Unknown]]

[Federal Register: April 13, 1994]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

 

Controlled Substances: Notice of Proposed 1994 Aggregate 
Production Quotas

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of proposed revised aggregate production quotas for 
1994.

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SUMMARY: This notice proposes revised 1994 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 (30 days 
after date of publication).

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 by Sec. 0.100 of title 28 of the Code of 
Federal Regulations.
    On October 8, 1993, a notice of the 1994 established aggregate 
production quotas was published in the Federal Register (58 FR 52508). 
The notice stipulated that the Administrator of the DEA would adjust 
the quotas in early 1994 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 1994 and do not include amounts which may be 
imported for use in industrial processes.
    The proposed revisions are based on a review of 1993 year-end 
inventories, 1993 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) and delegated to the 
Administrator by section 0.100 of Title 28 of the Code of Federal 
Regulations, the Administrator of the DEA hereby proposes the following 
changes in the 1994 aggregate production quotas for the listed 
controlled substances, expressed in grams of anhydrous acid or base.

------------------------------------------------------------------------
                                        Previously                      
                                     established 1994   Proposed revised
           Basic class                  aggregate        1994 aggregate 
                                    production quotas  production quotas
                                                                        
------------------------------------------------------------------------
Schedule I:                                                             
    2,5-Dimethoxyamphetamine......         15,400,000         15,510,000
Schedule II:                                                            
    Alfentanil....................              7,110              8,000
    Amphetamine...................            359,000            469,000
    Codeine (for sale)............         64,235,000         58,127,000
    Desoxyephedrine...............             22,100             11,000
    Diphenoxylate.................          1,023,000            638,000
    Levorphanol...................              6,400              7,400
    Methylphenidate...............          5,300,000          6,924,000
    Opium.........................          1,242,000            688,000
    Oxycodone (for sale)..........          4,312,000          2,995,000
    Oxycodone (for conversion)....              3,400              5,400
    Oxymorphone...................              1,400              2,420
    Pentobarbital.................         14,430,000         15,000,000
    Phencyclidine.................                 32                 52
    Secobarbital..................            550,000            338,000
    Sufentanil....................                620                870
------------------------------------------------------------------------

    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 Administrator finds warrant a hearing, the 
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 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: April 5, 1994.
Thomas A. Constantine,
Administrator.
[FR Doc. 94-8784 Filed 4-12-94; 8:45 am]
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