Controlled Substances: Established Initial Aggregate Production Quotas for 2000

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA No. 1861]

Controlled Substances: Established Initial Aggregate Production

Quotas for 2000

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 2000.

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SUMMARY: This notice establishes initial 2000 aggregate production

quotas for controlled substances in Schedules I and II of the

Controlled Substances Act (CSA).

EFFECTIVE DATE: December 28, 1999.

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and

Chemical Evaluation Section, Drug Enforcement Administration,

Washington, DC 20537, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION: Section 306 of the CSA (21 U.S.C. 826)

requires that the Attorney General establish aggregate production

quotas for each basic class of controlled substance 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. The Administrator, in turn, has redelegated this function

to the Deputy Administrator, pursuant to Sec. 0.104 of Title 28 of the

Code of Federal Regulations.

The 2000 aggregate production quotas represent those quantities of

controlled substances that may be produced in the United States in 2000

to provide adequate supplies of each substance for: the estimated

medical, scientific, research and industrial needs of the United

States; lawful export requirements; and the establishment and

maintenance of reserve stocks (21 U.S.C. 826(a) and 21 CFR 1303.11).

These quotas do not include imports of controlled substances for use in

industrial processes.

On October 21, 1999, a notice of the proposed initial 2000

aggregate production quotas for certain controlled substances in

Schedules I and II was published in the Federal Register (64 FR 56809).

All interested persons were invited to comment on or object to these

proposed aggregate production quotas on or before November 22, 1999.

Six companies commented on a total of 16 Schedules I and II

controlled substances within the published comment period. The

companies commented that the proposed aggregate

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production quotas for alfentanil, amphetamine, diphenoxylate, fentanyl,

hydromorphone, levorphanol, meperidine, levo-desoxyephedrine,

methamphetamine (for sale), methamphetamine (for conversion),

methylphenidate, noroxymorphone (for conversion), oxycodone (for sale),

oxycodone (for conversion), sufentanil and thebaine were insufficient

to provide for the estimated medical, scientific, research and

industrial needs of the United States, for export requirements and for

the establishment and maintenance of reserve stocks.

In addition, one comment was received after the published comment

period had ended. This comment requested that the aggregate production

quota for dihydromorphine be increased to provide for an intermediate

in a current manufacturing process. This comment was taken into

consideration in determining the established initial 2000 aggregate

production quota for dihydromorphine.

DEA has taken into consideration the above comments along with the

relevant 1999 manufacdturing quotas, current 1999 sales and

inventories, 2000 export requirements and research and product

development requirements. Based on this information, the DEA has

adjusted the initial aggregate production quotas for alfentanil,

dihydromorphine, diphenoxylate, fentanyl, hydromorphone, levorphanol,

meperidine, levo-desoxyephedrine, methamphetamine (for conversion),

noroxymorphone (for conversion), oxycodone (for sale), sufentanil and

thebaine to meet the legitimate needs of the United States. Significant

portions of the increases for alfentanil, diphenoxylate,, fentanyl,

hydromorphone, levorphanol, noroxymorphone (for conversion) and

sufentanil are due to a change in the manner in which manufacturing

losses are accounted for by a bulk manufacturer.

In addition, one company requested a hearing to address the

aggregate production quota for oxycodone (for sale) or hydromorphone if

the aggregate production quotas were not increased sufficiently. The

DA, based on the date provided, has increased the aggregate production

quotas for both oxycodone (for sale) and hydromorphone and has

determined that a hearing is not necessary.

Regarding amphetamine, methamphetamine (for sale), methylphenidate

and oxycodone (for conversion), the DEA has determined that the

proposed initial 2000 aggregate production quotas are sufficient to

meet the current 2000 estimated medical, scientific, research and

industrial needs of the United States.

Pursuant to section 1303 of Title 21 of the Code of Federal

Regulations, the Deputy Administrator of the DEA will, in early 2000,

adjust aggregate production quotas and individual manufacturing quotas

allocated for the year based upon 1999 year-end inventory and actual

1999 disposition data supplied by quota recipients for each basic class

of Schedule I or II controlled substance.

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 Sec. 0.100 of Title 28 of

the Code of Federal Regulations, and redelegated to the Deputy

Administrator pursuant to Sec. 0.104 of Title 28 of the Code of Federal

Regulations, the Acting Deputy Administrator hereby orders that the

2000 initial aggregate production quotas for the following controlled

substances, expressed in grams of anhydrous acid or base, be

established as follows:

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Established

Basic class initial 2000

quotas

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Schedule I:

2,5-Dimethoxyamphetamine......................... 10,001,000

2,5-Dimethoxy-4-ethylamphetamine (DOET).......... 2

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

3-Methylthiofentanyl............................. 2

3,4-Methylenedioxyamphetamine (MDA).............. 20

3,4-Methylenedioxy-N-ethylamphetamine (MDEA)..... 30

3,4-Methylenedioxymethamphetamine (MDMA)......... 20

3,4,5-Trimethoxyamphetamine...................... 2

4-Bromo-2,5-Dimethoxyamphetamine (DOB)........... 2

4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)....... 2

4-Methoxyamphetamine............................. 201,000

4-Methylaminoex.................................. 3

4-Methyl-2,5-Dimethoxyamphetamine (DOM).......... 2

5-Methoxy-3,4-Methylenedioxyamphetamine.......... 2

Acetyl-alpha-Methylfentanyl...................... 2

Acetyldihydrocodeine............................. 2

Acetylmethadol................................... 7

Allylprodine..................................... 2

Alphacetylmethadol............................... 7

Alpha-ethyltryptamine............................ 2

Alphameprodine................................... 2

Alphamethadol.................................... 2

Alpha-methylfentanyl............................. 2

Alpha-methylthiofentanyl......................... 2

Aminorex......................................... 7

Benzylmorphine................................... 2

Betacetylmethadol................................ 2

Beta-hydroxy-3-methylfentanyl.................... 2

Beta-hydroxyfentanyl............................. 2

Betameprodine.................................... 2

Betamethadol..................................... 2

Betaprodine...................................... 2

Bufotenine....................................... 2

Cathinone........................................ 9

Diethyltryptamine................................ 2

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Difenoxin........................................ 10,000

Dihydromorphine.................................. 508,000

Dimethyltryptamine............................... 3

Heroin........................................... 2

Hydroxypethidine................................. 2

Lysergic acid diethylamide (LDS)................. 38

Mescaline........................................ 7

Methaqualone..................................... 17

Methcathinone.................................... 9

Morphine-N-oxide................................. 2

N,N-Dimethylamphetamine.......................... 7

N-Ethyl-1-Phenylcyclohexylamine (PCE)............ 5

N-Ethylamphetamine............................... 7

N-Hydroxy-3,4-Methylenedioxyamphetamine.......... 2

Noracymethadol................................... 2

Norlevorphanol................................... 2

Normethadone..................................... 7

Normorphine...................................... 7

Para-fluorofentanyl.............................. 2

Pholcodine....................................... 2

Propiram......................................... 415,000

Psilocybin....................................... 2

Psilocyn......................................... 2

Tetrahydrocannabinols............................ 101,000

Thiofentanyl..................................... 2

Trimeperidine.................................... 2

Schedule II:

1-Phenylcyclohexylamine.......................... 12

1-Piperidinocyclohexanecarbonitrile (PCC)........ 10

Alfentanil....................................... 8,000

Alphaprodine..................................... 2

Amobarbital...................................... 12

Amphetamine...................................... 9,007,000

Cocaine.......................................... 251,000

Codeine (for sale)............................... 54,504,000

Codeine (for conversion)......................... 52,384,000

Dextropropoxyphene............................... 114,078,000

Dihydrocodeine................................... 268,000

Diphenoxylate.................................... 931,000

Ecgonine......................................... 36,000

Ethylmorphine.................................... 12

Fentanyl......................................... 300,000

Glutethimide..................................... 2

Hydrocodone (for sale)........................... 20,208,000

Hydrocodone (for conversion)..................... 20,700,000

Hydromorphone.................................... 1,239,000

Hydrocodone (For conversion)..................... 20,700,000

Hydromorphone.................................... 1,239,000

Isomethadone..................................... 12

Levo-alphacetylmethadol (LAAM)................... 201,000

Levomethorphan................................... 2

Levorphanol...................................... 27,000

Meperidine....................................... 11,335,000

Metazocine....................................... 1

Methadone (for sale)............................. 8,347,000

Methadone (for conversion)....................... 600,000

Methadone Intermediate........................... 9,503,000

Methamphetamine.................................. 2,049,000

750,000 grams of levo-desoxyephedrine for use in a non-

controlled, non-prescription product; 1,225,000 grams for

methamphetamine for conversion to a Schedule III product; and

74,000 grams for methamphetamine (for sale)....................

Methylphenidate.................................. 14,957,000

Morphine (for sale).............................. 14,706,000

Morphine (for conversion)........................ 97,160,000

Nabilone......................................... 2

Noroxymorphone (for sale)........................ 25,000

Noroxymorphone (for conversion).................. 3,813,000

Opium............................................ 720,000

Oxycodone (for sale)............................. 29,826,000

Oxycodone (for conversion)....................... 271,000

Oxymorphone...................................... 166,000

Pentobarbital.................................... 22,037,000

Phencyclidine.................................... 41

Phenmetrazine.................................... 2

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Phenylacetone.................................... 10

Secobarbital..................................... 22

Sufentanil....................................... 1,700

Thebaine......................................... 41,300,000

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The Acting Deputy Administrator further orders that aggregate

production quotas for all other Schedules I and II controlled

substances included in Secs. 1308.11 and 1308.12 of Title 21 of the

Code of Federal Regulations be established at zero.

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 his 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 aggregate production quotas for Schedules

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 form manufacturers of Schedules 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: December 21, 1999.

Julio F. Mercado,

Acting Deputy Administrator.

[FR Doc. 99-33550 Filed 12-27-99; 8:45 am]

BILLING CODE 4410-09-M