[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:
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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]
BILLING CODE 4410-09-M
