Date="07/05/95" Citation="60 FR 35050" Group="legal" Type="NOTICE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE" Subject="1995 Revised Aggregate Production Quotas for Controlled Substances in Schedules I and II"

DEPARTMENT OF JUSTICE Drug Enforcement Administration [DEA No. 132F] 1995 Revised Aggregate Production Quotas for Controlled Substances in Schedules I and II AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of final revised aggregate production quotas for 1995.

DEPARTMENT OF JUSTICE Drug Enforcement Administration [DEA No. 132F] 1995 Revised Aggregate Production Quotas for Controlled Substances in Schedules I and II AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of final revised aggregate production quotas for 1995. + ------------------------------------------------------------ SUMMARY: This notice establishes revised 1995 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA). DATES: This order is effective on July 5, 1995. FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, D.C. 20537, Telephone: (202) 307-7183. SUPPLEMENTARY INFORMATION: Section 306 of the CSA (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 Section 0.100 of Title 28 of the Code of Federal Regulations. The Administrator, in turn, has redelegated this function to the Deputy Administrator of the DEA pursuant to Section 0.104 of Title 28 of the Code of Federal Regulations. On May 9, 1995, a notice of the proposed revised 1995 aggregate production quotas for controlled substances in Schedules I and II was published in the Federal Register (60 FR 24649). All interested parties were invited to comment on or object to these proposed aggregate production quotas on or before June 9, 1995. Several companies commented that the revised 1995 aggregate production quotas for amphetamine, diphenoxylate, fentanyl, hydrocodone, hydromorphone, methadone, methadone intermediate (for conversion), methylphenidate, morphine and oxycodone (for sale), 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 DEA has reviewed the involved companies' 1994 year-end inventories, their initial 1995 manufacturing quotas, 1995 export requirements and their actual and projected 1995 sales. Based on this data, the DEA has adjusted the revised 1995 aggregate production quotas for amphetamine, diphenoxylate, fentanyl, hydromorphone, methadone, methadone intermediate (for conversion), morphine and oxycodone (for sale) to meet the estimated medical, scientific, research and industrial needs of the United States. Regarding hydrocodone and methylphenidate, the DEA has decided that no adjustments are necessary to meet the 1995 estimated 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 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. While aggregate production quotas are of primary importance to large manufacturers, their ---- page 35051 ---- impact upon small entities is neither negative nor beneficial. Accordingly, the Deputy Administrator has determined that this action does not required 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 by Section 0.100 of Title 28 of the Code of Federal Regulations, and redelegated to the Deputy Administrator of the DEA by Section 0.104 of Title 28 of the Code of Federal Regulations, the Deputy Administrator hereby orders that the 1995 revised aggregate production quotas, expressed in grams of anhydrous acid or base, be established as follows: -------------------------------------------------------------+------------------- | Established Basic class | revised 1995 | quotas -------------------------------------------------------------+------------------- | Schedule I: | Acetylmethadol ........................................... | 7 Alphacetylmethadol ....................................... | 5 Aminorex ................................................. | 7 Bufotenine ............................................... | 10 Cathinone ................................................ | 9 Difenoxin ................................................ | 14,000 Dihydromorphine .......................................... | 5 2,5-Dimethoxyamphetamine ................................. | 15,650,000 Dimethoxyamphetamine ..................................... | 7 Ethylamine analog of Phencyclidine ....................... | 5 N-Ethylamphetamine ....................................... | 9 Lysergic acid diethylamide ............................... | 56 Mescaline ................................................ | 7 Methaqualone ............................................. | 7 Methcathinone ............................................ | 14 4-Methoxyamphetamine ..................................... | 17 4-Methylaminorex ......................................... | 2 3,4-Methylenedioxyamphetamine ............................ | 17 3,4-Methylenedioxy-N-ethylamphetamine .................... | 27 3,4-Methylenedioxymethamphetamine ........................ | 17 3-Methylfentanyl ......................................... | 14 Normethadone ............................................. | 5 Normorphine .............................................. | 7 Tetrahydrocannabinols .................................... | 35,000 Thiophene Analog of Phencyclidine ........................ | 10 Schedule II: | Alfentanil ............................................... | 7,000 Amobarbital .............................................. | 15 Amphetamine .............................................. | 1,226,000 Cocaine .................................................. | 550,000 Codeine (for sale) ...................................... | 67,312,000 Codeine (for conversion) ................................. | 16,181,000 Desoxyephedrine .......................................... | 1,154,000 -------------------------------------------------------------+------------------- (1,138,000 grams of levo-desoxyephedrine for use in a non-controlled, non- prescription product and 16,000 grams for methamphetamine) -------------------------------------------------------------+------------------- Dextropropoxyphene ....................................... | 124,012,000 Dihydrocodeine ........................................... | 100,000 Diphenoxylate ............................................ | 965,000 Ecogonine (for conversion) ............................... | 650,000 Ethylmorphine ............................................ | 10 Fentanyl ................................................. | 114,200 Hydrocodone .............................................. | 8,474,000 Hydromorphone ............................................ | 435,500 Isomethadone ............................................. | 10 Levo-alpha-acetylmethadol ................................ | 200,000 Levorphanol .............................................. | 8,000 Meperidine ............................................... | 9,521,000 Methadone ................................................ | 4,388,000 Methadone (for conv) ..................................... | 364,000 Methadone Intermediate (for sale) ........................ | 0 Methadone Int. (for conv) ................................ | 5,533,000 Methylphenidate .......................................... | 10,410,000 Morphine (for sale) ...................................... | 11,145,000 Morphine (for conv) ...................................... | 78,105,000 Noroxymorphone (for sale) ................................ | 21,000 Noroxymorphone (for conv) ................................ | 3,500,000 Opium .................................................... | 1,304,000 Oxycodone (for sale) ..................................... | 4,794,000 Oxycodone (for conv) ..................................... | 25,500 Oxymorphone .............................................. | 10,200 Pentobarbital ............................................ | 15,706,000 ---- page 35052 ---- Phencyclidine ............................................ | 72 Phenylacetone (for conv) ................................. | 3,528,000 1-Phenylcyclohexylamine .................................. | 10 1-Piperidinocyclohexanecarbonitrile ...................... | 10 Secobarbital ............................................. | 322,000 Sufentanil ............................................... | 1,600 Thebaine ................................................. | 9,383,000 -------------------------------------------------------------+------------------- Dated: June 26, 1995. Stephen H. Greene, Deputy Administrator. [FR Doc. 95-16321 Filed 7-3-95; 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, 35050