Controlled Substances: Notice of Proposed 1994 Aggregate Production Quotas

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]

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