CONTROLLED SUBSTANCES/ REVISED AGGREGATE PRODUCTION QUOTAS FOR 1998

DEPARTMENT OF JUSTICE Drug Enforcement Administration [DEA #167F]
Controlled Substances: Revised Aggregate Production Quotas for 1998 AGENCY:
Drug Enforcement Administration
(DEA), Justice.

ACTION: Notice of final revised 1998 aggregate production
quotas.

SUMMARY: This notice establishes revised 1998 aggregate production
quotas for controlled substances in Schedules I and II of the
Controlled Substances Act (CSA).

EFFECTIVE DATE: September 15, 1998.

On July 17, 1998, a notice of the proposed revised 1998 aggregate
production quotas for certain controlled substances in Schedules I and
II was published in the Federal Register (63 FR 38671). All interested
parties were invited to comment on or object to these proposed
aggregate production quotas on or before August 17, 1998.

Several companies commented that the revised aggregate production
quotas for amphetamine, codeine (for conversion), desoxyephedrine
(methamphetamine), dihydrocodeine, fentanyl, hydrocodone (for sale),
meperidine, methadone (for sale), methadone intermediate,
methylphenidate, morphine (for sale), morphine (for conversion),
oxycodone (for sale), oxymorphone, pentobarbital, propiram,
secobarbital, sufentanil, tetrahydrocannabinols, 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.

DEA has reviewed the involved companies' 1997 year-end inventories,
their initial 1998 manufacturing quotas, 1998 export requirements and
their actual and projected 1998 sales. Based on this data, the DEA has
adjusted the revised 1998 aggregate production quotas for amphetamine,
desoxyephedrine (methamphetamine), dihydrocodeine, fentanyl,
meperidine, methadone (for sale), methadone intermediate, morphine
(for sale), morphine (for conversion), oxycodone (for sale),
oxymorphone, pentobarbital, propiram, tetrahydrocannabinols and
thebaine to meet the estimated medical, scientific, research and
industrial needs of the United States.

Regarding codeine (for conversion), hydrocodone (for sale),
methylphenidate, secobarbital and sufentanil, the DEA has determined
that no adjustments of the aggregate production quotas are necessary
to meet the 1998 estimated medical, scientific, research and
industrial needs of the United States.

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 of the DEA by Section 0.100 of Title 28 of the Code of
Federal Regulations, and redelgated to the 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 1998 aggregate production quotas for the following controlled
substances, expressed in grams of anhydrous acid or base, be
established as follows:

Basic class Established revised 1998 quotas SCHEDULE I
2,5-Dimethoxyamphetamine 20,000,100 2,5-Dimethoxy-4-ethylamphetamine
(DOET) 2 3-Methylfentanyl 14 3-Methylthiofentanyl 2
3,4-Methylenedioxyamphetamine (MDA) 25 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
100,100 4-Methylaminorex 2 4-Methyl-2,5-Dimethoxyamphetamine (DOM) 2
5-Methoxy-3,4-Methylenedioxyamphetamine 2 Acetyl-alpha-methylfentanyl
2 Acetylmethadol 7 Allylprodine 2 Alpha-acetylmethadol 7
Alpha-ethyltryptamine 2 Alphameprodine 2 Alpha-methadol 2
Alpha-methylfentanyl 2 Alphaprodine 2 Alpha-methylthiofentanyl 2
Aminorex 7 Beta-acetylmethadol 2 Beta-hydroxyfentanyl 2
Beta-hydroxy-3-metthylfentanyl 2 Beta-methadol 2 Betaprodine 2
Bufotenine 2 Cathinone 9 Codeine-N-oxide 2 Diethyltryptamine 2
Difenoxin 16,000 Dihydromorphine 7 Dimethyltryptamine 2 Ethylamine
Analog of PCP 5 Heroin 2 Hydroxypethidine 2 Lysergic acid diethylamide
(LSD) 57 Mescaline 7 Methaqualone 17 Methcathinone 11 Morphine-N-oxide
2 N-Ethylamphetamine 7 N-Hydroxy-3,4-Methylenedioxyamphetamine 4
N,N-Dimethylamphetamine 7 Noracymethadol 2 Norlevorphanol 2
Normethadone 7 Normorphine 7 Para-fluorofentanyl 2 Pholcodine 2
Propiram 412,800 Psilocin 2 Psilocybin 2 Tetrahydrocannabinols 51,000
Thiofentanyl 2 Trimeperidine 2 SCHEDULE II 1-Phenylcyclohexylamine 15
1-Piperidinocyclohexanecarbonitrile (PCC) 12 Alfentanil 8,100
Amobarbital 12 Amphetamine 5,554,000 Cocaine 550,100 Codeine (for
sale) 62,020,000 Codeine (for conversion) 23,906,000 Desoxyephedrine
1,184,000 controlled, non-prescription product and 33,000 grams for
methamphetamine.

Dextropropoxyphene 109,500,000 Dihydrocodeine 141,000 Diphenoxylate
1,600,000 Ecgonine 651,000 Ethylmorphine 12 Fentanyl 228,000
Glutethimide 2 Hydrocodone (for sale) 16,314,000 Hydrocodone (for
conversion) 3,000,000 Hydromorphone 766,000 Isomethadone 12
Levo-alpha-acetylmethadol (LAAM) 356,000 Levomethorphan 2 Levorphanol
15,000 Meperidine 10,111,000 Methadone (for sale) 5,975,000 Methadone
(for conversion) 585,000 Methadone Intermediate 8,939,000
Methamphetamine (for conversion) 723,000 Methylphenidate 14,442,000
Morphine (for sale) 12,445,000 Morphine (for conversion) 77,975,000
Nabilone 2 Noroxymorphone (for sale) 25,000 Noroxymorphone (for
conversion) 2,117,000 Opium 615,000 Oxycodone (for sale) 12,118,000
Oxymorphone 198,000 Pentobarbital 19,501,000 Phencyclidine 60
Phenmetrazine 2 Phenylacetone 10 Secobarbital 397,000 Sufentanil 1,800
Thebaine 17,695,000 The Acting Deputy Administrator further orders
that aggregate production quotas for all other Schedules I and II
controlled substances included in Sections 1308.11 and 1308.12 of
Title 21 of the Code of Federal Regulations remain 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 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 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: September 3, 1998.

Donnie R. Marshall, Acting Deputy Administrator.

[FR Doc. 98-24621 Filed 9-14-98; 8:45 am] BILLING CODE
4410-09-M

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 Section 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 pursuant to Section
0.104 of Title 28 of the Code of Federal Regulations.

Checked-by: Patrick Henry