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RESOURCES > Federal Register Notices > Quotas - 2003 > Controlled Substances: Proposed Revised Aggregate Production Quotas for 2003

Quotas - 2003

FR Doc 03-19954 [Federal Register: August 6, 2003 (Volume 68, Number 151)] [Notices] [Page 46664-46666] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr06au03-121]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA 237R]

Controlled Substances: Proposed Revised Aggregate Production Quotas for 2003

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed revised 2003 aggregate production quotas.


SUMMARY: This notice proposes revised 2003 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 27, 2003.

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

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

On December 19, 2002, DEA published a notice of established initial 2003 aggregate production quotas for certain controlled substances in Schedules I and II (67 FR 77809). This notice stipulated that the DEA would adjust the quotas in early 2003 as provided for in part 1303 of Title 21 of the Code of Federal Regulations.

The proposed revised 2003 aggregate production quotas represent those quantities of controlled substances in Schedules I and II that may be produced in the United States in 2003 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 2002 year-end inventories, 2002 disposition data submitted by quota applicants, estimates of the medical needs of the United States, product development, 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), delegated to the Administrator of the DEA by § 0.100 of Title 28 of the Code of Federal Regulations, the Acting Administrator hereby proposes the following revised 2003 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base:

Basic class Previously established initial 2003 quotas Proposed revised 2003 quotas
Schedule I
2,5-Dimethoxyamphetamine 9,501,000 9,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET) 2
3-Methylfentanyl 4 4
3-Methylthiofentanyl 2 2
3,4-Methylenedioxyamphetamine (MDA) 15 15
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) 10 10
3,4-Methylenedioxymethamphetamine (MDMA) 19 19
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    
4-Methylaminorex 7 7
4-Methyl-2,5-Dimethoxyamphetamine (DOM) 2 2
5-Methoxy-3,4-Methylenedioxyamphetamine 2 2
Acetyl-alpha-methylfentanyl 2 2
Acetyldihydrocodeine 2 2
Acetylmethadol 2 3
Allylprodine 2 2
Alphacetylmethadol 7 7
Alpha-ethyltryptamine 2 2
Alphameprodine 2 2
Alphamethadol 2 2
[[Page 46665]]
Alpha-methylfentanyl 2 2
Alpha-methylthiofentanyl 2 2
Aminorex 17 17
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 12 12
Codeine-N-oxide 202  352
Diethyltryptamine 2 2
Difenoxin 9,000 9,000
Dihydromorphine 1,101,000 1,101,000
Dimethyltryptamine 3 3
Gamma-hydroxybutyric acid 45,566,000 20,000,000
Heroin 5 5
Hydromorphinol 2 2
Hydroxypethidine 2 2
Lysergic acid diethylamide (LSD) 61 61
Marihuana 840,000 840,000
Mescaline 7 7
Methaqualone 9 9
Methcathinone 9 9
Methyldihydromorphine 2 2
Morphine-N-oxide 202 352
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 52 52
Normethadone 7 7
Normorphine 57 57
Para-fluorofentanyl 2 2
Phenomorphan 2 2
Pholcodine 2 2
Propiram 415,000 415,000
Psilocybin 2 2
Psilocyn 2 2
Tetrahydrocannabinols 131,000 131,000
Thiofentanyl 2 2
Trimeperidine 2 2
Schedule II
1-Phenylcyclohexylamine 12  12
1-Piperidinocyclohexanecarbonitrile (PCC) 10  10
Alfentanil 700  700
Alphaprodine 2 2
Amobarbital 451,000 0
Amphetamine 10,987,000 10,987,000
Cocaine 171,000 175,000
Codeine (for sale) 43,494,000 43,494,000
Codeine (for conversion) 43,559,000 43,559,000
Dextropropoxyphene 167,365,000 167,365,000
Dihydrocodeine 741,000 741,000
Diphenoxylate 501,000 546,000
Ecgonine 31,000 33,000
Ethylmorphine 12  12
Fentanyl 733,000 804,000
Glutethimide 1,002 1,002
Hydrocodone (for sale) 29,243,000 29,543,000
Hydrocodone (for conversion) 3,800,000 3,800,000
Hydromorphone 1,409,000 1,620,000
Isomethadone 12  12
Levo-alphacetylmethadol (LAAM) 12 12
Levomethorphan 2 2
Levorphanol 8,600 8,600
Meperidine 9,649,000 9,753,000
[[Page 46666]]
Metazocine 1 1
Methadone (for sale) 14,057,000 14,057,000
Methadone Intermediate 17,393,000 17,393,000
Methamphetamine [704,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 1,420,000 grams for methamphetamine mostly for conversion to a Schedule III product; and 1,000 grams for methamphetamine (for sale)] 2,325,000 2,125,000
Methylphenidate 20,967,000 23,726,000
Morphine (for sale) 18,218,000 20,252,000
Morphine (for conversion) 110,774,000 110,774,000
Nabilone 2 2
Noroxymorphone (for sale) 40,000 80,000
Noroxymorphone (for conversion) 4,400,000 4,400,000
Opium 1,000,000 1,000,000
Oxycodone (for sale) 34,482,000 39,090,000
Oxycodone (for conversion) 700,000 700,000
Oxymorphone 454,000 454,000
Pentobarbital 27,728,000 27,728,000
Phencyclidine 16  16
Phenmetrazine 2 2
Phenylacetone 21,975,000 21,975,000
Secobarbital 1,100 1,100
Sufentanil 3,000 3,000
Thebaine 43,292,000 56,652,000

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.

Dated: July 31, 2003.

William B. Simpkins,
Acting Administrator.

[FR Doc. 03-19954 Filed 8-5-03; 8:45 am]

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