[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:
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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
