Date="10/20/94" Citation="59 FR 52991" Group="legal" Type="NOTICE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE" Subject="Controlled Substances: Established Initial 1995 Aggregate Production Q uotas"

DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled Substances: Established Initial 1995 Aggregate Production Quotas AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of aggregate production quotas for 1995.

DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled Substances: Established Initial 1995 Aggregate Production Quotas AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of aggregate production quotas for 1995. + ------------------------------------------------------------ SUMMARY: This notice establishes initial 1995 aggregate production quotas for some controlled substances in Schedules I and II of the Controlled Substances Act (CSA). EFFECTIVE DATE: This order is effective upon October 20, 1994. FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug & Chemical Evaluation Section, Drug Enforcement Administration, Drug Enforcement Administration, Washington, D.C. 20537, Telephone: (202) 307-7183. SUPPLEMENTARY INFORMATION: Section 306 of the Controlled Substances Act (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas for controlled substances in Schedules I and II each year. This responsibility has been delegated to the Administrator of the DEA pursuant to sec 0.100 of title 28 of the Code of Federal Regulations. The Administrator, in turn, has redelegated this function to the Deputy Administrtor pursuant to 59 FR 23637 (May 6, 1994). On August 4, 1994, a notice of the proposed initial 1995 aggregate production quotas for certain controlled substances in Schedules I and II was published in the Federal Register (59 FR 39790). All interested persons were invited to comment on or before September 6, 1994. The following comments were received. Two companies commented that the proposed 1995 initial aggregate production quota for amphetamine is insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States, for export requirements and the maintenance of reserve stocks. Based on current 1994 manufacturing quotas, the 1995 FDA estimate of medical need, and export requirements, the DEA increased the 1995 initial aggregate production quota for amphetamine. A company commented that the proposed initial 1995 aggregate production quota for levo-desoxyephedrine is insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States, for export requirements and the maintenance of reserve stocks. After a review of the 1994 manufacturing quota, the 1995 FDA estimate of medical need and other data, the DEA has determined that no adjustment is necessary at this time. Two companies commented that the proposed 1995 initial aggregate production quota for methylphenidate is insufficient to meet the estimated medical, scientific, research and industrial needs of the United States and for the maintenance of reserve stocks. Based on 1994 manufacturing quotas, 1993 year-end inventories, the 1995 FDA estimate of medical need and research and development requirements, the DEA adjusted the initial 1995 aggregate production quota for methylphenidate accordingly. Pertaining to Sufentanil, one company commented that the proposed 1995 initial aggregate production quota is insufficient to meet the estimated medical, scientific, research and industrial needs of the United States. The DEA reviewed all available information and adjusted the initial 1995 aggregate production quota for Sufentanil. Another company commented that the proposed initial 1995 aggregate production quotas for hydromorphone, oxymorphone and oxycodone (for conversion) are insufficient to meet the estimated medical, scientific, research and industrial needs of the United States. After a review of 1994 manufacturing quotas and research and product development requirements, the DEA has determined that increases are necessary to meet medical, scientific, research and industrial needs of the United States. 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 12612, and it has been determined that this matter does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. The Deputy Administrator hereby certifies that this action will have no significant impact upon small entities whose interest must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The establishment of annual aggregate production quotas for Schedules I and II controlled substances is mandated by law and by international treaty obligations. While aggregate production quotas are of primary importance to large manufacturers, their impact upon small entities is neither negative nor beneficial. Accordingly, the Deputy Administrator has determined that this actions does not require a regulatory flexibility analysis. Therefore, under the authority vested in the Attorney General by Section 306 of the Controlled Substances Act of 1970 (21 U.S.C. 826), delegated to the Administrator of the DEA by sec 0.100 of title 28 of the Code of Federal Regulations, and redelegated to the Deputy Administrator, pursuant to 59 FR 23637 (May 6, 1994), the Deputy Administrator hereby orders that the 1995 initial aggregate production quotas, expressed in grams of anhydrous acid or base, be established as follows. ------------------------------------------------------------+----------------- | Established Basic class | initial 1995 | quotas (in | grams) ------------------------------------------------------------+----------------- | Schedule I: | Acetylmethadol ........................................... | 2 Aminorex ................................................. | 2 Bufotenine ............................................... | 10 Cathinone ................................................ | 4 Difenoxin ................................................ | 14,000 2,5- | Dimethoxy-amphetamine ................................... | 15,650,000 Dimethylamphetamine ...................................... | 2 N-Ethylamphetamine ....................................... | 4 Lysergic acid diethylamide ............................... | 41 Mescaline ................................................ | 2 Methaqualone ............................................. | 2 Methcathinone ............................................ | 9 4-Methoxyamphetamine ..................................... | 12 4-Methylaminorex ......................................... | 2 3-Methylfentanyl ......................................... | 12 3,4- | Methylenediox-yamphetamine .............................. | 12 3,4-Methylenedioxy-N-ethylamphetamine .................... | 2 3,4-...................................................... | Methylenedioxy-methamphetamine .......................... | 12 Normorphine .............................................. | 2 Tetrahydrocannabinols .................................... | 35,000 Thiophene Analog of Phencyclidine ........................ | 10 Schedule II: | Alfentanil ............................................... | 7,000 Amobarbital .............................................. | 5 Amphetamine .............................................. | 1,026,100 Cocaine .................................................. | 550,000 Codeine (for sale) ....................................... | 67,312,000 Codeine (for conversion) ................................. | 16,181,000 Desoxyephedrine .......................................... | {1} 900,020 Dextropropoxyphene ....................................... | 124,012,000 Dihydrocodeine ........................................... | 202,000 Diphenoxylate ............................................ | 688,000 Ecgonine (for conversion) ................................ | 650,000 Fentanyl ................................................. | 76,000 Hydrocodone .............................................. | 8,474,000 Hydromorphone ............................................ | 404,000 Levo-alpha-acetylmethadol ................................ | 200,000 Levorphanol .............................................. | 8,000 Meperidine ............................................... | 8,637,000 Methadone ................................................ | 3,779,000 Methadone (for conversion) ............................... | 364,000 Methadone Intermediate (for sale) ........................ | 300,000 Methadone Intermediate (for conversion) .................. | 4,393,000 Methylphenidate .......................................... | 8,886,000 Morphine (for sale) ...................................... | 7,612,000 Morphine (for conversion) ................................ | 78,105,000 Noroxymorphone (for sale) ................................ | 21,000 Noroxymorphone (for conversion) .......................... | 3,500,000 Opium .................................................... | 1,118,000 Oxycodone (for sale) ..................................... | 3,613,000 Oxycodone (for conversion) ............................... | 23,000 Oxymorphone .............................................. | 9,200 Pentobarbital ............................................ | 15,706,000 Phencyclidine ............................................ | 52 Phenylacetone (for conversion) ........................... | 3,528,000 Secobarbital ............................................. | 480,000 Sufentanil ............................................... | 1,600 Thebaine ................................................. | 9,383,000 ------------------------------------------------------------+----------------- {1} 900,000 grams of levo-desoxyephedrine for use in a non-controlled, non -prescription product and 20 grams for methamphetamine. Dated: October 12, 1994. Stephen H. Greene, Deputy Administrator. [FR Doc. 94-25947 Filed 10-19-94; 8:45 am] BILLING CODE 4410-09-M ------------------------------------------------------ The Contents entry for this article reads as follows: Schedules of controlled substances; production quotas: Schedules I and II- 1995 aggregate, 52991