[Federal Register Volume 59, Number 186 (Tuesday, September 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23788]
[[Page Unknown]]
[Federal Register: September 27, 1994]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled Substances: Established Revised 1994 Aggregate
Production Quotas
AGENCY: Drug Enforcement Administration (DEA).
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 methylphenidate, a Schedule II controlled
substance, as required under the Controlled Substances Act of 1970.
DATES: This is effective on September 27, 1994. Comments must be
submitted on or before October 27, 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 & Chemical Evaluation Section, Drug
Enforcement Administration, Washington, DC 20537, Telephone: (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 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).
The DEA established initial 1994 aggregate production quotas for
controlled substances in Schedules I and II, including methylphenidate,
in a Federal Register notice published on October 8, 1993 (58 FR
52508). DEA revised some of the aggregate production quotas, including
that for methylphenidate, on June 22, 1994 (59 FR 32223) in accordance
with 21 CFR 1303.13.
Since publication of the revised 1994 aggregate production quotas,
DEA has received information which necessitates an increase in
methylphenidate's 1994 aggregate production quota. Because this
increase is immediately required to meet the 1994 year-end medical
needs of the United States, an interim rule is being established.
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 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 establishes
the following revised 1994 aggregate production quota for
methylphenidate, expressed in grams of anhydrous base:
Basic Class--Established Revised
Schedule II--1994 Quotas
Methylphenidate--8,189,000
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 his action does not require a regulatory
flexibility analysis.
Dated: September 20, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-23788 Filed 9-26-94; 8:45 am]
BILLING CODE 4410-09-M
