[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:

------------------------------------------------------------------------
                                                           Revised 2001
                       Basic class                             quota
------------------------------------------------------------------------
Methadone (for sale)....................................      12,705,000
Methadone Intermediate..................................      18,004,000
------------------------------------------------------------------------

    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 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