00-18148. Controlled Substances: Proposed Revised Aggregate Production Quotas for 2000

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Notice of proposed revised 2000 aggregate production quotas.

SUMMARY:

This notice proposes revised 2000 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).

DATES:

Comments or objections must be received on or before August 18, 2000.

ADDRESSES:

Send comments or objectives to the Deputy Administrator, Drug Enforcement Administration, Washington, D.C. 20537, Attn.: DEA Federal Register Representative (CCR).

FOR FURTHER INFORMATION CONTACT:

Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, D.C. 20537, Telephone: [phone].

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.

On February 10, 2000, DEA published a notice of established initial 2000 aggregate production quotas for certain controlled substances in Schedules I and II (65 FR 6635). This notice stipulated that the Deputy Administrator of the DEA would adjust the quotas in early 2000 as provided for in Section 1303 of Title 21 of the Code of Federal Regulations.

The proposed revised 2000 aggregate production quotes represent those quantities of controlled substances in Schedules I and II 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. These quotas do not include imports of controlled substances for use in industrial processes.

The proposed revisions are based on a review of 1999 year-end inventories, 1999 disposition data submitted by quota applicants, estimates of the medical needs of the United States, and other information available to the DEA.

In addition, in a final rule published in the Federal Register on March 13, 2000 (65 FR 13235) gamma-hydroxybutyric acid (GHB) and its salts, isomers, and salts of isomers was placed into Schedule I of the CSA. Applications for quota for this substance were submitted and the aggregate production quota for gamma-hydroxybutyric acid is proposed as listed below.

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 redelegated to the Deputy Administrator pursuant to Section 0.104 of Title 28 of the Code of Federal Regulations, the Administrator hereby proposes the following revised 2000 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base:

Basic class	Previously established initial 2000 quotas	Proposed revised 2000 quotas
SCHEDULE I
2,5-Dimethoxyamphetamine	10,001,000	10,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET)	2	2
3-Methylfentanyl	14	14
3-Methylthiofentanyl	2	2
3,4-Methylenedioxyamphetamine (MDA)	20	20
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)	30	30
3,4-Methylenedioxymethamphetamine (MDMA)	20	20
3,4, 5-Trimethoxyamphetamine	2	2
4-Bromo-2,5-Dimethoxyamphetamine (DOB)	2	2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)	2	2
4-Methoxyamphetamine	201,000	201,000
4-Methylaminorex	3	3
4-Methyl-2,5-Dimethoxyamphetamine (DOM)	2	2
5-Methoxy-3,4-Methylenedioxyamphetamine	2	2
Acetyl-alpha-methylfentanyl	2	2
Acetyldihydrocodeine	2	2
Acetylmethadol	7	7
Allylprodine	2	2
Alphacetylmethadol	7	7
Alpha-ethyltryptamine	2	2
Alphameprodine	2	2
Alphamethadol	2	2
Alpha-methylfentanyl	2	2
Alpha-methylthiofentanyl	2	2
Aminorex	7	7
Benzylmorphine	2	2
Betacetylmethadol	2	2
Beta-hydroxy-3-methylfentanyl	2	2
Beta-hydroxyfentanyl	2	2
Betameprodine	2	2
Betamethadol	2	2
Betaprodine	2	2
Bufotenine	2	2
Cathinone	9	9
Codeine-N-oxide	2	2
Diethyltryptamine	2	2
Difenoxin	10,000	10,000
Dihydromorphine	508,000	508,000
Dimethyltryptamine	3	3
Gamma-hydroxybutyric acid		15,000,000
Heroin	2	2
Hydroxypethidine	2	2
Lysergic acid diethylamide (LSD)	38	63
Mescaline	7	7
Methaqualone	17	17
Methcathinone	9	9
Morphine-N-oxide	2	2
N,N-Dimethylamphetamine	7	7
N-Ethyl-1-Phenylcyclohexylamine (PCE)	5	5
N-Ethylamphetamine	7	7
N-Hydroxy-3,4-Methylenedioxyamphetamine	2	2
Noracymethadol	2	2
Norlevorphanol	2	2
Normethadone	7	7
Normorphine	7	7
Para-fluorofentanyl	2	2
Pholcodine	2	2
Propiram	415,000	415,000
Psilocybin	2	2
Psilocyn	2	2
Tetrahydrocannabinols	101,000	115,000
Thiofentanyl	2	2
Trimeperidine	2	2
SCHEDULE II
1-Phenylcyclohexylamine	12	12
1-Piperidiocyclohexanecarbonitrile (PCC)	10	10
Alfentanil	8,000	8,000
Alphaprodine	2	2
Amobarbital	12	12
Amphetamine	9,007,000	6,491,000
Cocaine	251,000	251,000
Codeine (for sale)	54,504,000	43,248,000
Codeine (for conversion)	52,384,000	52,384,000
Dextropropoxyphene	114,078,000	121,017,000
Dihydrocodeine	268,000	133,000
Diphenoxylate	931,000	931,000
Ecgonine	36,000	36,000
Ethylmorphine	12	12
Fentanyl	300,000	300,000
Glutethimide	2	2
Hydrocodone (for sale)	20,208,000	21,417,000
Hydrocodone (for conversion)	20,700,000	20,700,000
Hydromorphone	1,239,000	1,239,000
Isomethadone	12	12
Levo-alphacetylmethadol (LAAM)	201,000	12
Levomethorphan	2	2
Levorphanol	27,000	27,000
Meperidine	11,335,000	9,870,000
Metazocine	1	1
Methadone (for sale)	8,347,000	8,347,000
Methadone (for conversion)	600,000	0
Methadone Intermediate	9,503,000	9,503,000
Methamphetamine	2,049,000	1,984,000
[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 9,000 grams for methamphetamine (for sale)]
Methylphenidate	14,957,000	14,957,000
Morphine (for sale)	14,706,000	14,706,000
Morphine (for conversion)	97,160,000	97,410,000
Nabilone	2	2
Noroxymorphone (for sale)	25,000	25,000
Noroxymorphone (for conversion)	3,813,000	3,813,000
Opium	720,000	720,000
Oxycodone (for sale)	29,826,000	32,575,000
Oxycodone (for conversion)	271,000	1,389,000
Oxymorphone	166,000	477,000
Pentobarbital	22,037,000	22,037,000
Phencyclidine	41	41
Phenmetrazine	2	2
Phenylacetone	10	10
Secobarbital	22	22
Sufentanil	1,700	1,700
Thebaine	41,300,000	45,444,000

The Administrator further proposes 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.

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 as per 21 CFR 1303.13(c) and 1303.32.

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 13132, and it has been determined that this matter does not have sufficient federalism implications to 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 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 Administrator has determined that this action does not require a regulatory flexibility analysis.

Dated: July 12, 2000.

Donnie R. Marshall,

Administrator.