[Federal Register Volume 60, Number 29 (Monday, February 13, 1995)]
[Notices]
[Page 8251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3456]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA No. 129P]
Proposed 1995 Aggregate Production Quota for a Schedule II
Controlled Substance
AGENCY: Drug Enforcement Administration.
ACTION: Notice of a proposed 1995 aggregate production quota.
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SUMMARY: This notice proposes a 1995 aggregate production quota for
hydrocodone (for conversion), a controlled substance in Schedule II of
the Controlled Substances Act (CSA).
DATES: Comments or objections must be received on or before March 15,
1995.
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 controlled substances in Schedules I
and II each year. This responsibility has been delegated to the
Administrator of the DEA pursuant to Section 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).
A company submitted an application for a manufacturing quota for
hydrocodone (for conversion) a Schedule II controlled substance. Based
on the review of this application 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 Controlled
Substances Act of 1970 (21 U.S.C. 826), delegated to the Administrator
by Section 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 proposes that the 1995 aggregate production quota for the
following controlled substance, expressed in grams of anhydrous base,
be established as follows:
------------------------------------------------------------------------
Proposed
1995
aggregate
Basic class production
quota
(grams)
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Hydrocodone (for conversion)............................... 2,200,000
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All interested persons are invited to submit comments or
objections, in writing, regarding this proposal. 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 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 the 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 within the meaning of
and intent of 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: February 6, 1995.
Stephen H. Green,
Deputy Administrator.
[FR Doc. 95-3456 Filed 2-10-95; 8:45 am]
BILLING CODE 4410-09-M
