01-25761. Controlled Substances: Final Revised Aggregate Production Quotas for 2001

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.

FOR FURTHER INFORMATION CONTACT:

Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 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 § 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), methamphetamine (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 Class	Established final 2001 quotas
Schedule I
2,5-Dimethoxyamphetamine	15,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET)	2
3-Methylfentanyl	14
3-Methylthiofentanyl	2
3,4-Methylenedioxyamphetamine (MDA)	30
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)	30
3,4-Methylenedioxymethamphetamine (MDMA)	15
3,4,5-Trimethoxyamphetamine	2
4-Bromo-2,5-Dimethoxyamphetamine (DOB)	2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)	2
4-Methoxyamphetamine	201,000
4-Methylaminorex	2
4-Methyl-2,5-Dimethoxyamphetamine (DOM)	2
5-Methoxy-3,4-Methylenedioxyamphetamine	2
Acetyl-alpha-methylfentanyl	2
Acetyldihydrocodeine	2
Acetylmethadol	2
Allylprodine	2
Alphacetylmethadol	7
Alpha-ethyltryptamine	2
Alphameprodine	2
Alphamethadol	2
Alpha-methylfentanyl	2
Alpha-methylthiofentanyl	2
Aminorex	7
Benzylmorphine	2
Betacetylmethadol	2
Beta-hydroxy-3-methylfentanyl	2
Beta-hydroxyfentanyl	2
Betameprodine	2
Betamethadol	2
Betaprodine	2
Bufotenine	2
Cathinone	9
Codeine-N-oxide	2
Diethyltryptamine	2
Difenoxin	9,000
Dihydromorphine	771,000
Dimethyltryptamine	3
Gamma-hydroxybutyric acid	7
Heroin	2
Hydroxypethidine	2
Lysergic acid diethylamide (LSD)	63
Marihuana	500,000
Mescaline	7
Methaqualone	19
Methcathinone	11
Morphine-N-oxide	2
N,N-Dimethylamphetamine	7
N-Ethyl-1-Phenylcyclohexylamine (PCE)	5
N-Ethylamphetamine	7
N-Hydroxy-3,4-Methylenedioxyamphetamine	2
Noracymethadol	2
Norlevorphanol	2
Normethadone	7
Normorphine	7
Para-fluorofentanyl	2
Pholcodine	2
Propiram	415,000
Psilocybin	2
Psilocyn	2
Tetrahydrocannabinols	131,000
Thiofentanyl	2
Trimeperidine	2
Schedule II
1-Phenylcyclohexylamine	12
1-Piperidinocyclohexanecarbonitrile (PCC)	10
Alfentanil	3,500
Alphaprodine	2
Amobarbital	12
Amphetamine	13,964,000
Cocaine	251,000
Codeine (for sale)	43,248,000
Codeine (for conversion)	59,051,000
Dextropropoxyphene	153,380,000
Dihydrocodeine	334,000
Diphenoxylate	401,000
Ecgonine	51,000
Ethylmorphine	12
Fentanyl	440,000
Glutethimide	2
Hydrocodone (for sale)	23,825,000
Hydrocodone (for conversion)	18,000,000
Hydromorphone	1,409,000
Isomethadone	12
Levo-alphacetylmethadol (LAAM)	41,000
Levomethorphan	2
Levorphanol	23,000
Meperidine	10,168,000
Metazocine	1
Methadone (for sale)	12,705,000
Methadone (for conversion)	60,000
Methadone Intermediate	18,004,000
Methamphetamine	*3,211,000
Methylphenidate	17,618,000
Morphine (for sale)	15,615,000
Morphine (for conversion)	110,774,000
Nabilone	2
Noroxymorphone (for sale)	25,000
Noroxymorphone (for conversion)	4,500,000
Opium	630,000
Oxycodone (for sale)	46,680,000
Oxycodone (for conversion)	449,000
Oxymorphone	264,000
Pentobarbital	27,728,000
Phencyclidine	40
Phenmetrazine	2
Phenylacetone	801,000
Secobarbital	1,946,000
Sufentanil	1,700
Thebaine	67,446,000
* 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 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 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: [phone].

Dated: October 4, 2001.

Asa Hutchinson,

Administrator.