[Federal Register Volume 62, Number 209 (Wednesday, October 29, 1997)]
[Notices]
[Page 56200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28557]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA #171I]


Controlled Substances: 1997 Aggregate Production Quota

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Interim notice establishing a 1997 aggregate production quota 
and request for comments.

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SUMMARY: This interim notice establishes a revised 1997 aggregate 
production quota for codeine (for sale), a Schedule II controlled 
substance, as required under the Controlled Substances Act of 1970.

DATES: This is effective on October 29, 1997. Comments must be received 
on or before November 28, 1997.

ADDRESSES: Send comments or objections to the Acting Deputy 
Administrator, Drug Enforcement Administration, Washington, D.C. 20537, 
Attn.: DEA Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT:
Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Drug 
Enforcement Administration, Washington, D.C. 20537, (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 Acting Deputy Administrator of the DEA pursuant to Section 0.014 
of Title 28 of the Code of Federal Regulations.
    The DEA established revised 1997 aggregate production quotas for 
controlled substances in Schedules I and II, including codeine (for 
sale), in a Federal Register notice published on August 15, 1997 (62 FR 
43750). Since publication of the revised 1997 aggregate production 
quotas, DEA has received information which necessitates an immediate 
increase in the revised 1997 aggregate production quota for codeine 
(for sale). The increase for codeine (for sale) is necessary to meet 
additional and unforeseen domestic manufacturing needs and export 
requirements. For these reasons, an interim notice is being published.
    Therefore, 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 of the DEA by Section 0.100 of Title 28 
of the Code of Federal Regulations, and redelegated to the Acting 
Deputy Administrator, pursuant to Section 0.104 of Title 28 of the Code 
of Federal Regulations, the Acting Deputy Administrator hereby orders 
that the revised aggregate production quota for the following 
controlled substance, expressed in grams of anhydrous base, be 
established as follows:

------------------------------------------------------------------------
                                                            Established 
                       Basic class                         revised  1997
                                                               quota    
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Codeine (for sale)......................................      58,140,000
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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 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 Acting 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 
Schedule I and II controlled substances is mandated by law and by 
international treaty obligations. Aggregate production quotas apply to 
approximately 200 DEA registered bulk and dosage from manufacturers of 
Schedule I and II controlled substances. 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 Deputy Administrator has determined that this 
action does not require a regulatory flexibility analysis.

    Dated: October 22, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-28557 Filed 10-28-97; 8:45 am]
BILLING CODE 4410-09-M