[Federal Register Volume 60, Number 75 (Wednesday, April 19, 1995)]
[Notices]
[Pages 19608-19609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9588]



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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA No. 129F]


Established 1995 Aggregate Production Quota for a Schedule II 
Controlled Substance

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of an established 1995 aggregate production quota.

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SUMMARY: This notice establishes a 1995 aggregate production quota for 
hydrocodone (for conversion), a controlled substance in Schedule II of 
the Controlled Substances Act (CSA).

DATES: This order is effective on April 19, 1995.

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 controlled substances in Schedule I and 
II each year. This responsibility has been redelegated to the Deputy 
Administrator of the DEA pursuant to Sec. 0.104 of Title 28 of the Code 
of Federal Regulations.
    On February 13, 1995, a notice of the proposed 1995 aggregate 
production quota for hydrocodone (for conversion), a Schedule II 
controlled substance, was published in the Federal Register (60 FR 
8251). All interested persons were invited to comment on or object to 
this proposed aggregate production quota on or before March 15, 1995. 
Comments were received from and a hearing on this matter was requested 
by one pharmaceutical company. The company maintains that the 
establishment of this aggregate production quota could have an impact 
on the United States and international narcotic raw material supply, 
since hydrocodone is derived from narcotic raw materials.
    Pursuant to the Code of Federal Regulations, Title 21, 
Sec. 1303.11(c), the Deputy Administrator may at his discretion hold a 
hearing on any issue relevant to the determination of an aggregate 
production quota. After review of all pertinent information, the Deputy 
Administrator has determined that no issue was found which warrants a 
hearing on this matter. Moreover, the proposed 2,200 kg of hydrocodone 
will not threaten the balance and supply of narcotic raw materials. 
Therefore the proposal for the 1995 aggregate production quota for 
hydrocodone (for conversion) is adopted without change.
    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 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.
    Therefore, under the authority vested in the Attorney General by 
Section 306 of the Controlled Substances Act of 1970 (21 U.S.C. 826) 
and redelegated to the Deputy Administrator by Sec. 0.104 of Title 28 
of the Code of Federal Regulations, the Deputy Administrator of the DEA 
hereby orders that the 1995 [[Page 19609]] aggregate production quota 
for the following controlled substance, expressed in grams of anhydrous 
base, be established as follows:

------------------------------------------------------------------------
                                                             Established
                        Basic class                           1995 quota
                                                              (in grams)
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Hydrocodone (for conversion)...............................    2,200,000
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    Dated: April 11, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-9588 Filed 4-18-95; 8:45 am]
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