[Federal Register Volume 59, Number 71 (Wednesday, April 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8784]
[[Page Unknown]]
[Federal Register: April 13, 1994]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled Substances: Notice of Proposed 1994 Aggregate
Production Quotas
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of proposed revised aggregate production quotas for
1994.
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SUMMARY: This notice proposes revised 1994 aggregate production quotas
for controlled substances in Schedules I and II, as required under the
Controlled Substances Act of 1970.
DATES: Comments or objections should be received on or before (30 days
after date of publication).
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
(CSA) (21 U.S.C. 826) requires that the Attorney General establish
aggregate production quotas for all controlled substances listed in
Schedules I and II. This responsibility has been delegated to the
Administrator of the DEA by Sec. 0.100 of title 28 of the Code of
Federal Regulations.
On October 8, 1993, a notice of the 1994 established aggregate
production quotas was published in the Federal Register (58 FR 52508).
The notice stipulated that the Administrator of the DEA would adjust
the quotas in early 1994 as provided for in title 21, Code of Federal
Regulations, Sec. 1303.23(c). These aggregate production quotas
represent those amounts of controlled substances that may be produced
in the United States in 1994 and do not include amounts which may be
imported for use in industrial processes.
The proposed revisions are based on a review of 1993 year-end
inventories, 1993 disposition data submitted by quota applicants,
estimates of the medical needs of the United States submitted to the
DEA by the Food and Drug Administration and other information available
to the DEA.
Therefore, under the authority vested in the Attorney General by
section 306 of the CSA of 1970 (21 U.S.C. 826) and delegated to the
Administrator by section 0.100 of Title 28 of the Code of Federal
Regulations, the Administrator of the DEA hereby proposes the following
changes in the 1994 aggregate production quotas for the listed
controlled substances, expressed in grams of anhydrous acid or base.
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Previously
established 1994 Proposed revised
Basic class aggregate 1994 aggregate
production quotas production quotas
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Schedule I:
2,5-Dimethoxyamphetamine...... 15,400,000 15,510,000
Schedule II:
Alfentanil.................... 7,110 8,000
Amphetamine................... 359,000 469,000
Codeine (for sale)............ 64,235,000 58,127,000
Desoxyephedrine............... 22,100 11,000
Diphenoxylate................. 1,023,000 638,000
Levorphanol................... 6,400 7,400
Methylphenidate............... 5,300,000 6,924,000
Opium......................... 1,242,000 688,000
Oxycodone (for sale).......... 4,312,000 2,995,000
Oxycodone (for conversion).... 3,400 5,400
Oxymorphone................... 1,400 2,420
Pentobarbital................. 14,430,000 15,000,000
Phencyclidine................. 32 52
Secobarbital.................. 550,000 338,000
Sufentanil.................... 620 870
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All interested persons are invited to submit their comments and
objections in writing regarding this proposal. A person may object to
or comment on the proposal relating to any of the above mentioned
substances without filing comments or objections regarding the others.
If a person believes that one or more of these issues warrant a
hearing, the individual should so state and summarize the reasons for
this belief.
In the event that comments or objections to this proposal raise one
or more issues which the Administrator finds warrant a hearing, the
Administrator shall order a public hearing by notice in the Federal
Register, summarizing the issues to be heard and setting the time for
the hearing.
The Office of Management and Budget has determined that notice of
aggregate production quotas are not subject to centralized review under
Executive Order 12866.
Rules establishing aggregate production quotas for controlled
substances in Schedules I and II are required by statute, fulfill
United States obligations under the Single Convention on Narcotic
Drugs, 1961, and other international treaties, and are essential to a
criminal law enforcement function of the United States. Without the
periodic establishment and adjustment of aggregate production quotas,
pharmaceutical manufacturers in the United States could not lawfully
produce a wide variety of medically necessary pharmaceutical drugs.
These actions have been analyzed in accordance with the principles
and criteria contained in Executive Order 12612 and it has been
determined that this matter raises no Federalism implications which
would warrant the preparation of a Federalism Assessment.
The 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 and revision of annual production quotas for
Schedules I and II controlled substances is mandated by law and by the
international obligations of the United States. Such quotas impact
predominantly upon major manufacturers of the affected controlled
substances.
Dated: April 5, 1994.
Thomas A. Constantine,
Administrator.
[FR Doc. 94-8784 Filed 4-12-94; 8:45 am]
BILLING CODE 4410-09-M
