Controlled Substances: Proposed 1995 Aggregate Production Quotas

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA No. 132P]

Controlled Substances: Proposed 1995 Aggregate Production Quotas

AGENCY: Drug Enforcement Administration.

ACTION: Notice of proposed revised aggregate production quotas for

1995.

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SUMMARY: This notice proposes revised 1995 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 June 8,

1995.

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 pursuant to Sec. 0.100 of Title 28 of the Code

of Federal Regulations.

The Administrator, in turn, has redelegated this function to the

Deputy Administrator of the DEA by Sec. 0.104 of Title 28 of the Code

of Federal Regulations.

On October 20, 1994, a notice of the 1995 established aggregate

production quotas was published in the Federal Register (59 FR 52991).

The notice stipulated that the Deputy Administrator of the DEA would

adjust the quotas in early 1995 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 1995 and do not include amounts which may be

imported for use in industrial processes.

The proposed revisions are based on a review of 1994 year-end

inventories, 1994 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), delegated to the

Administrator by Sec. 0.100 of Title 28 of the Code of Federal

Regulations, and redelegated to the Deputy Administrator by Sec. 0.104

of Title 28 of the Code of Federal Regulations, the Deputy

Administrator of the DEA hereby proposes the following changes in the

1995 aggregate production quotas for the listed controlled substances,

expressed in grams of anhydrous acid or base.

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Previously Proposed

established revised 1995

Basic class 1995 aggregate aggregate

production production

quotas quotas

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Schedule I:.............................

Acetylmethadol...................... 2 7

Alphacetymethadol................... 0 5

Aminorex............................ 2 7

Bufotenine.......................... 10 10

Cathinone........................... 4 9

Difenoxin........................... 14,000 14,000

[[Page 24650]]

Dihydromorphine..................... 0 5

2,5-Dimethylamphetamine............. 15,650,000 15,650,000

Dimethylamphetamine................. 2 7

Ethylamine analog of Phencyclidine.. 0 5

N-Ethylamphetamine.................. 4 9

Lysergic acid diethylamide.......... 41 56

Mescaline........................... 2 7

Methaqualone........................ 2 7

Methcathinone....................... 9 14

4-Methoxyamphetamine................ 12 17

4-Methylaminorex.................... 2 2

3,4-Methylenedioxyamphetamine....... 12 17

3,4-Methylenedioxy-N-

ethylamphetamine................... 2 27

3,4-Methylenedioxymethamphetamine... 12 17

3-Methylfentanyl.................... 12 14

Normethadone........................ 0 5

Normorphine......................... 2 7

Tetrahydrocannabinols............... 35,000 35,000

Thiophene Analog of Phencyclidine... 10 10

Schedule II:............................

Alfentanil.......................... 7,000 7,000

Amobarbital......................... 5 15

Amphetamine......................... 1,026,100 1,026,100

Cocaine............................. 550,000 550,000

Codeine (for sale).................. 67,312,000 67,312,000

Codeine (for conversion)............ 16,181,000 16,181,000

Desoxyephedrine..................... 900,000 1,154,000

(1,138,000 grams of levo-desoxyephedrine for use in a non-controlled,

non-prescription product and 16,000 grams for methamphetamine).........

Dextropropoxyphene...................... 124,012,000 124,012,000

Dihydrocodeine.......................... 202,000 100,000

Diphenoxylate........................... 688,000 346,000

Ecgonine (for conversion)............... 650,000 650,000

Ethylmorphine........................... 0 10

Fentanyl................................ 76,000 52,000

Hydrocodone............................. 8,474,000 8,474,000

Hydromorphone........................... 404,000 404,000

Isomethadone............................ 0 10

Levo-alpha-acetylmethadol............... 200,000 200,000

Levorphanol............................. 8,000 8,000

Meperidine.............................. 8,637,000 9,521,000

Methadone............................... 3,779,000 3,779,000

Methadone (for conv).................... 364,000 364,000

Methadone Intermediate (for sale)....... 300,000 0

Methadone Int. (for conv)............... 4,393,000 4,393,000

Methylphenidate......................... 8,886,000 10,410,000

Morphine (for sale)..................... 7,612,000 7,612,000

Morphine (for conv)..................... 78,105,000 78,105,000

Noroxymorphone (for sale)............... 21,000 21,000

Noroxymorphone (for conv)............... 3,500,000 3,500,000

Opium................................... 1,118,000 1,304,000

Oxycodone (for sale).................... 3,613,00 4,254,000

Oxycodone (for conv).................... 23,000 25,500

Oxymorphone............................. 9,200 10,200

Pentobarbital........................... 15,706,000 15,706,000

Phencyclidine........................... 52 72

Phenylacetone (for conv)................ 3,528,000 3,528,000

1-Phenylcyclohexylamine................. 0 10

1-Piperidinocyclohexanecarbonitrile..... 0 10

Secobarbital............................ 480,000 322,000

Sufentanil.............................. 1,600 1,600

Thebaine................................ 9,383,000 9,383,000

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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 Deputy Administrator finds warrant a hearing,

the Deputy Administrator shall order a public hearing by notice in the

Federal [[Page 24651]] 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 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 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: May 3, 1995.

Stephen H. Greene,

Deputy Administrator.

[FR Doc. 95-11370 Filed 5-8-95; 8:45 am]

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