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Notice

Controlled Substances: Proposed Revised Aggregate Production Quotas for 2001

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AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Notice of proposed revised 2001 aggregate production quotas.

SUMMARY:

This notice proposes revised 2001 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 September 5, 2001.

ADDRESSES:

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

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FOR FURTHER INFORMATION CONTACT:

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

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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.

On December 19, 2000, DEA published a notice of established initial 2001 aggregate production quotas for certain controlled substances in Schedules I and II (65 FR 79428). This notice stipulated that the Deputy Administrator of the DEA would adjust the quotas in early 2001 as provided for in Section 1303 of Title 21 of the Code of Federal Regulations.

The proposed revised 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. These quotas do not include imports of controlled substances for use in industrial processes.

The proposed revisions are based on a review of 2000 year-end inventories, 2000 disposition data submitted by quota applicants, estimates of the medical needs of the United States, 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) and delegated to the Administrator of the DEA by Section 0.100 of Title 28 of the Code of Federal Regulations, the Acting Administrator hereby proposes the following revised 2001 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base:

Basic classPrevously established initial 2001 quotasProposed revised 2001 quotas
Schedule I
2,5-Dimethroxyamphetamine15,501,00015,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET)22
3-Methylfentanyl1414
3-Methylthiofentanyl22
3,4-Methylendedioxyamphetamine (MDA)2530
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)3030
3,4-Methylenedioxymethamphetamine (MDMA)1015
3,4,5-Trimethoxyamphetamine22
4-Bromo-2,5-Dimethoxyamphetamine (DOB)22
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)22
4-Methoxyamphetamine201,000201,000
4-Methylaminorex22
4-Methyl-2,5-Dimethoxyamphetamine (DOM)22
5-Methoxy-3,4-Methylenedioxyamphetamine22
Acetyl-alpha-methylfentanyl22
Acetyldihydrocodeine22
Acethylmethadol22
Allylprodine22
Alphacetylmethadol77
Alpha-ethyltryptamine22
Alphameprodine22
Alphamethadol22
Alpha-methylfentanyl22
Alpha-methylthiofentanyl22
Aminorex77
Benzylmorphine22
Betacetylmethadol22
Beta-hydroxy-3-methylfentanyl22
Beta-hydroxyfentanyl22
Betameprodine22
Betamethadol22
Betaprodine22
Bufotenine22
Cathinone99
Codeine-N-oxide22
Diethyltryptamine22
Difenoxin9,0009,000
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Dihydromorphine771,000771,000
Dimethyltryptamine23
Gamma-hydroxybutyric acid15,000,0007
Heroin22
Hydroxypethidine22
Lysergic acid diethylamide (LSD)3763
Marihuana350,000350,000
Mescaline77
Methaqualone1919
Methcathinone1111
Morphine-N-oxide22
N,N-Dimethylamphetamine77
N-Ethyl-1-Phenylcyclohexylamine (PCE)55
N-Ethylamphetamine77
N-Hydroxy-3,4-Methylenedioxyamphetamine22
Noracymethadol22
Norlevorphanol22
Normethadone77
Normorphine77
Para-fluorofenthanyl22
Pholcodine22
Propiram415,000415,000
Psilocybin22
Psilocyn22
Tetrahydrocannabinols131,000131,000
Thiofentanyl22
Trimeperidine22
Schedule II
1-Phenylcyclohexylamine1212
1-Piperidinocyclonhexanecarbonitrile (PCC)1010
Alfentanil3,5003,500
Alphaprodine22
Amobarabital1212
Amphetamine10,958,00013,964,000
Cocaine251,000251,000
Codeine (for sale)43,248,00043,248,000
Codeine (for conversion)59,051,00059,051,000
Dextropropoxyphene134,401,000153,380,000
Dihydrocodeine474,000334,000
Diphenoxylate401,000401,000
Ecogonine51,00051,000
Ethylmorphine1212
Fentanyl440,000440,000
Glutethimide22
Hydrocodone (for sale)22,325,00023,825,000
Hydrocodone (for conversion)18,000,00018,000,000
Hydromorphone1,409,0001,409,000
Isomethadone1212
Levo-alphacetylmethadol (LAAM)41,00041,000
Levomethorphan22
Levorphanol23,00023,000
Meperidine10,168,00010,168,000
Metazocine01
Methadone (for sale)8,347,00012,705,000
Methadone (for conversion)60,00060,000
Methadone Intermediate9,503,00018,004,000
Methamphetamine3,187,0003,211,000
[850,000 grams of levo-desoxy-ephedrine for use in a non-controlled, non-prescription product; 2,286,000 grams for meth-amphet-amine for conversion to a Schedule III product; and 75,000 grams for meth-amphet-amine (for sale)]
Methylphenidate14,957,00015,946,000
Morphine (for sale)14,706,00015,202,000
Morphine (for conversion)117,675,000110,774,000
Nabilone22
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Noroxymorphone (for sale)25,00025,000
Noroxymorphone (for conversion)4,000,0004,500,000
Opium630,000630,000
Oxycodone (for sale)46,680,00046,680,000
Oxycodone (for conversion)449,000449,000
Oxymorphone264,000264,000
Pentobarbital22,037,00025,025,000
Phencyclidine4040
Phenmetrazine22
Phenylacetone1010
Secobarbital121,946,000
Sufentanil1,7001,700
Thebaine65,596,00067,446,000

The Acting Administrator further proposes 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.

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 Acting Administrator finds warrant a hearing, the Acting 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 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 Acting 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. 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 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.

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Dated: July 31, 2001.

William B. Simpkins,

Acting Administrator.

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[FR Doc. 01-19513 Filed 8-3-01; 8:45 am]

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