[Federal Register Volume 66, Number 157 (Tuesday, August 14, 2001)]
[Notices]
[Pages 42680-42681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20306]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA #207I]
Controlled Substances: 2001 Aggregate Production Quotas
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Interim notice establishing revised 2001 aggregate production
quotas and request for comments.
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SUMMARY: This interim notice establishes revised 2001 aggregate
production quotas for methadone (for sale) and methadone intermediate,
both Schedule II controlled substances in the Controlled Substances Act
(CSA).
DATES: This is effective on August 14, 2001. Comments or objections
must be received on or before (30 days from date of publication).
ADDRESSES: Send comments or objections to the Acting Administrator,
Drug Enforcement Administration, Washington, DC 20537, Attn.: DEA
Federal Register Representative (CCR).
FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and
Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: Section 306 of the CSA (21 U.S.C. 826)
requires that the Attorney General establish aggregate production
quotas for each basic class of controlled substance listed in Schedules
I and II each year. This responsibility has been delegated to the
Administrator of the DEA by Section 0.100 of Title 28 of the Code of
Federal Regulations.
On December 19, 2000, DEA published a notice of established initial
2001 aggregate production quotas for certain controlled substances in
Schedules I and II (65 FR 79428). This notice stipulated that the
Deputy Administrator of the DEA would adjust the quotas in early 2001
as provided for in Section 1303 of Title 21 of the Code of Federal
Reglations.
In a recently published Federal Register notice, the DEA has
proposed revised aggregate production quotas for controlled substances
in Schedules I and II, including methadone (for sale) and methadone
intermediate. However, based on recently obtained information, the
quotas for methadone (for sale) and methadone intermediate, which is
used to manufacture methadone, must be increased immediately in order
to provide a continuous and uninterrupted supply of methadone products
to the public. The additional quantities proposed in the recently
published Federal Register notice will not be available to the bulk
manufacturers until completion of that rulemaking. In order to provide
adequate and timely supplies of methadone product, an interim notice is
being published under the good cause exception to the Administrative
Procedure Act, 5 U.S.C. 553. This interim notice will establish revised
201 aggregate production quotas for methadone (for sale) and methadone
intermediate effective immediately. DEA will also publish a final
notice after considering any comments or objections to this interim
notice.
Therefore, under the authority vested in the Attorney General by
Section 306 of the CSA (21 U.S.C. 826), and delegated to the
Administrator of the DEA by Section 0.100 of Title 28 of the Code of
Federal Regulations, the Acting Administrator hereby establishes the
following revised 2001 aggregate production quotas for the listed
controlled substances, expressed in grams of anhydrous base:
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Revised 2001
Basic class quota
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Methadone (for sale).................................... 12,705,000
Methadone Intermediate.................................. 18,004,000
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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 does not preempt or modify any provision of state law;
nor does it impose enforcement responsibilities on any state; nor does
it diminish the power of any state to enforce its own laws.
Accordingly, this action does not have federalism implications
warranting the application of Executive Order 13132.
The Acting 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 aggregate production quotas for Schedules I and II
controlled substances is mandated by law and by international treaty
obligations. The quotas are necessary to provide for the estimated
medical, scientific, research and industrial needs of the United
States, for export requirements and the establishment and maintenance
of reserve stocks. While aggregate production quotas are of primary
importance to large manufacturers, their impact upon small entities is
neither negative nor beneficial. Accordingly, the Acting Administrator
has determined that this action does not require a regulatory
flexibility analysis.
This action meets the applicable standards set forth in Sections
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
This action will not result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more in any one year, and will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under the provisions of the Unfunded Mandates Reform Act of
1995.
This action is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. This action
will not result in an annual effect on the economy of $100,000,000 or
more; a
[[Page 42681]]
major increase in costs or prices; or significant adverse effects on
competition, employment, investment, productivity, innovation, or on
the ability of United States-based companies to compete with foreign-
based companies in domestic and export markets.
The Drug Enforcement Administration makes every effort to write
clearly. If you have suggestions as to how to improve the clarity of
this regulation, call or write Frank L. Sapienza, Chief, Drug &
Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537, telephone (202) 307-
7183.
Dated: August 6, 2001.
William B. Simpkins,
Acting Administrator.
[FR Doc. 01-20306 Filed 8-13-01; 8:45 am]
BILLING CODE 4410-09-M