[Federal Register Volume 59, Number 210 (Tuesday, November 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27049]


[[Page Unknown]]

[Federal Register: November 1, 1994]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

 

Controlled Substances: Established Revised 1994 Aggregate 
Production Quotas

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Interim notice establishing a 1994 aggregate production quota 
and request for comments.

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SUMMARY: This interim notice establishes a revised 1994 aggregate 
production quota for morphine, a Schedule II controlled substance, as 
required under the Controlled Substances Act of 1970.

DATES: This is effective on November 1, 1994. Comments must be 
submitted on or before December 1, 1994.

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 and Chemical Evaluation Section, Drug 
Enforcement Administration, Washington, DC 20537, (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 Drug Enforcement Administration 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 pursuant to 59 FR 23637 (May 6, 1994).
    The DEA established initial 1994 aggregate production quotas for 
controlled substances in Schedules I and II, including morphine, in a 
Federal Register notice published on October 8, 1993 (58 FR 52508). DEA 
revised some of the aggregate production quotas on June 22, 1994 (59 FR 
32223) in accordance with 21 CFR 1303.13. At that time, there were no 
comments on the aggregate production quota for morphine and therefore 
it was not revised.
    Since publication of the revised 1994 aggregate production quotas, 
DEA has received information which necessitates an increase in 
morphine's 1994 aggregate production quota. Because this increase is 
immediately required to meet the 1994 year-end medical needs of the 
United States and for reserve stocks, an interim notice is being 
published.
    Based on a review of 1993 year-end inventories, 1994 manufacturing 
quotas, 1994 sales, export requirements and other information available 
to the DEA, the Deputy Administrator of the DEA, 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 pursuant to 59 FR 23637 (May 6, 1994), hereby establishes 
the following revised 1994 aggregate production quota for the listed 
controlled substance, expressed in grams of anhydrous base: 

------------------------------------------------------------------------
                                                             Established
                        Basic class                            revised  
                                                              1994 quota
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Morphine...................................................    7,800,000
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    All interested persons are invited to submit their comments in 
writing regarding this interim notice.
    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 interests 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 action does not require a regulatory 
flexibility analysis.

    Dated: October 25, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-27049 Filed 10-31-94; 8:45 am]
BILLING CODE 4410-09-M