Skip to Content

Notice

Controlled Substances: Final Revised Aggregate Production Quotas for 2001

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Notice of final aggregate production quotas for 2001.

SUMMARY:

This notice establishes final 2001 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA). The DEA has taken into consideration comments received in response to a notice of the proposed revised aggregate production quotas for 2001 published August 6, 2001 (66 FR 41049). No comments were received in response to an interim notice establishing revised 2001 aggregate production quotas published August 14, 2001 (66 FR 42680). The interim notice is adopted as published.

EFFECTIVE DATE:

October 15, 2001.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183.

End Further Info End Preamble Start Supplemental Information

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 § 0.100 of Title 28 of the Code of Federal Regulations.

The 2001 aggregate production quotas represent those quantities of controlled substances in Schedules I and II that may be produced in the United States in 2001 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.

On August 6, 2001, a notice of the proposed revised 2001 aggregate production quotas for certain controlled substances in Schedules I and II was published in the Federal Register (66 FR 41049). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before September 5, 2001.

Six companies and one individual commented on a total of thirteen Schedules I and II controlled substances within the published comment period. The companies commented that the proposed aggregate production quotas for 4-methoxyamphetamine, amphetamine, hydrocodone (for sale), marihuana, methamphetamine (for sale), methylphenidate, morphine (for sale), noroxymorphone (for conversion), oxycodone (for sale), pentobarbital, phenylacetone 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. The individual's comment questioned the increase in the aggregate production quota for secobarbital and raised other issues, including how to obtain additional information concerning this quota.

DEA has taken into consideration the above comments along with the relevant 2000 year-end inventories, initial 2001 manufacturing quotas, 2001 export requirements, actual and projected 2001 sales and use, and research and product development requirements. Based on this information, the DEA has adjusted the final 2001 aggregate production quotas for marihuana, methylphenidate, morphine (for sale), pentobarbital and phenylacetone to meet the legitimate needs of the United States.

Regarding 4-methoxyamphetamine, amphetamine, hydrocodone (for sale), Start Printed Page 52454methamphetamine (for sale), noroxymorphone (for conversion), oxycodone (for sale) and thebaine, the DEA has determined that the proposed revised 2001 aggregate production quotas are sufficient to meet the current 2001 estimated medical, scientific, research and industrial needs of the United States. The proposed increase in the aggregate production quota for secobarbital was also determined to be necessary to meet the legitimate needs of the United States.

In addition, on August 14, 2001, an interim notice establishing revised 2001 aggregate production quotas for methadone and methadone intermediate was published in the Federal Register (66 FR 42680). All interested parties were invited to comment on or before September 14, 2001. No comments or objections were received regarding this interim notice. The aggregate production quotas established in the interim notice are adopted without change.

Therefore, under the authority vested in the Attorney General by Section 306 of the Controlled Substances Act of 1970 (21 U.S.C. 826), and delegated to the Administrator of the DEA by § 0.100 of Title 28 of the Code of Federal Regulations, the Administrator hereby orders that the 2001 final aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:

Basic ClassEstablished final 2001 quotas
Schedule I
2,5-Dimethoxyamphetamine15,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET)2
3-Methylfentanyl14
3-Methylthiofentanyl2
3,4-Methylenedioxyamphetamine (MDA)30
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)30
3,4-Methylenedioxymethamphetamine (MDMA)15
3,4,5-Trimethoxyamphetamine2
4-Bromo-2,5-Dimethoxyamphetamine (DOB)2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)2
4-Methoxyamphetamine201,000
4-Methylaminorex2
4-Methyl-2,5-Dimethoxyamphetamine (DOM)2
5-Methoxy-3,4-Methylenedioxyamphetamine2
Acetyl-alpha-methylfentanyl2
Acetyldihydrocodeine2
Acetylmethadol2
Allylprodine2
Alphacetylmethadol7
Alpha-ethyltryptamine2
Alphameprodine2
Alphamethadol2
Alpha-methylfentanyl2
Alpha-methylthiofentanyl2
Aminorex7
Benzylmorphine2
Betacetylmethadol2
Beta-hydroxy-3-methylfentanyl2
Beta-hydroxyfentanyl2
Betameprodine2
Betamethadol2
Betaprodine2
Bufotenine2
Cathinone9
Codeine-N-oxide2
Diethyltryptamine2
Difenoxin9,000
Dihydromorphine771,000
Dimethyltryptamine3
Gamma-hydroxybutyric acid7
Heroin2
Hydroxypethidine2
Lysergic acid diethylamide (LSD)63
Marihuana500,000
Mescaline7
Methaqualone19
Methcathinone11
Morphine-N-oxide2
N,N-Dimethylamphetamine7
N-Ethyl-1-Phenylcyclohexylamine (PCE)5
N-Ethylamphetamine7
N-Hydroxy-3,4-Methylenedioxyamphetamine2
Noracymethadol2
Norlevorphanol2
Normethadone7
Start Printed Page 52455
Normorphine7
Para-fluorofentanyl2
Pholcodine2
Propiram415,000
Psilocybin2
Psilocyn2
Tetrahydrocannabinols131,000
Thiofentanyl2
Trimeperidine2
Schedule II
1-Phenylcyclohexylamine12
1-Piperidinocyclohexanecarbonitrile (PCC)10
Alfentanil3,500
Alphaprodine2
Amobarbital12
Amphetamine13,964,000
Cocaine251,000
Codeine (for sale)43,248,000
Codeine (for conversion)59,051,000
Dextropropoxyphene153,380,000
Dihydrocodeine334,000
Diphenoxylate401,000
Ecgonine51,000
Ethylmorphine12
Fentanyl440,000
Glutethimide2
Hydrocodone (for sale)23,825,000
Hydrocodone (for conversion)18,000,000
Hydromorphone1,409,000
Isomethadone12
Levo-alphacetylmethadol (LAAM)41,000
Levomethorphan2
Levorphanol23,000
Meperidine10,168,000
Metazocine1
Methadone (for sale)12,705,000
Methadone (for conversion)60,000
Methadone Intermediate18,004,000
Methamphetamine*3,211,000
Methylphenidate17,618,000
Morphine (for sale)15,615,000
Morphine (for conversion)110,774,000
Nabilone2
Noroxymorphone (for sale)25,000
Noroxymorphone (for conversion)4,500,000
Opium630,000
Oxycodone (for sale)46,680,000
Oxycodone (for conversion)449,000
Oxymorphone264,000
Pentobarbital27,728,000
Phencyclidine40
Phenmetrazine2
Phenylacetone801,000
Secobarbital1,946,000
Sufentanil1,700
Thebaine67,446,000
* 850,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,286,000 grams for methamphetamine for conversion to a Schedule III product; and 75,000 grams for methamphetamine (for sale).

The Administrator further orders that aggregate production quotas for all other Schedules I and II controlled substances included in §§ 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 does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this action does not have federalism implications warranting the application of Executive Order 13132.

The Administrator hereby certifies that this action will have no significant impact upon small entities whose interests must be considered under the Start Printed Page 52456Regulatory 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. 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.

This action meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.

This action will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This action is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This action will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

The DEA makes every effort to write clearly. If you have suggestions as to how to improve the clarity of this regulation, call or write Frank L. Sapienza, Chief, Drug & Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183.

Start Signature

Dated: October 4, 2001.

Asa Hutchinson,

Administrator.

End Signature End Supplemental Information

[FR Doc. 01-25761 Filed 10-12-01; 8:45 am]

BILLING CODE 4410-09-P