[Federal Register Volume 61, Number 243 (Tuesday, December 17, 1996)] [Notices] [Pages 66311-66314] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-31889] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE [DEA #153F] Controlled Substances: Established Initial 1997 Aggregate Production Quotas AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of aggregate production quotas for 1997. ----------------------------------------------------------------------- SUMMARY: This notice establishes initial 1997 aggregate production quotas for controlled substances in Schedule I and II of the Controlled Substances Act (CSA). EFFECTIVE DATE: This order is effective upon December 17, 1996. FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug & Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 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 each basic class of controlled substance listed in Schedule I and II. 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 pursuant to Section 0.104 of Title 28 of the Code of Federal Regulations. On October 17, 1996, a notice of the proposed initial 1997 aggregate production quotas for certain controlled substances in Schedule I and II was published in the Federal Register (61 FR 54222). All interested person were invited to comment on or before November 18, 1996. The following comments were received. A company commented that the proposed 1997 initial aggregate production quota for fentanyl 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 1996 sales and inventories, and 1997 export requirements, the DEA increased the 1997 initial aggregate production quota for fentanyl. A company commented that the proposed initial 1997 aggregate production quota for methylphenidate is insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States and for the establishment of reserve stocks. After a review of current 1996 manufacturing quotas and 1997 customer requirements, the DEA has determined that no adjustment is necessary at this time. One company commented that the proposed 1997 initial aggregate production quota for oxymorphone is insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States. Based on a review of 1997 product development requirements, the DEA adjusted the initial 1997 aggregate [[Page 66312]] production quota for oxymorphone accordingly. Another company commented that the proposed initial 1997 aggregate production quotas for alfentanil, diphenoxylate, noroxymorphone, and oxycodone (for sale) are insufficient to meet the estimated medical, scientific, research and industrial needs of the United States. After a review of 1996 manufacturing quotas, current 1996 sales and inventories, 1997 export requirements and research and product development requirements, the DEA agrees that increases are necessary for diphenoxylate, noroxymorphone and oxycodone. Regarding alfentanil, DEA determined that the proposed initial 1997 aggregate production quota is sufficient to meet 1997 requirements. The DEA received updated information from a manufacturer regarding levo-alpha-acetylmethadol and methadone intermediate (for conversion) and from two manufacturers concerning methadone (for sale), which necessitates adjustments of the initial 1997 aggregate production quotas for these substances. The adjustments are increases which will provide for the estimated medical, scientific, research and industrial needs of the United States and for the establishment and maintenance of reserve stocks. Therefore, DEA adjusted the 1997 initial aggregate production quotas for levo-alpha-acetylmethadol, methadone (for sale) and methadone intermediate (for conversion) accordingly. Concerning lysergic acid diethylamide and N,N-dimethylamphetamine, the DEA increased the 1997 initial aggregate production quotas for these substances since applications made by several companies for these substances were not taken into consideration in the proposal. A company commented that the proposed initial 1997 aggregate production quota for N-ethylamphetamine is insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States, and for export requirements. Since the commenter is not registered with DEA to manufacture this substance, DEA will consider this request at a later time when the proper registration is obtained. 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 meter 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 economic 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 Schedule I and II controlled substances is mandated by law and by international treaty obligations. Aggregate production quotas apply to approximately 200 DEA registered bulk and dosage from manufacturers of Schedule I and II controlled substances. 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 Deputy Administrator has determined that this action 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 Section 0.100 of Title 28 of the Code of Federal Regulations, and redelegated to the Deputy Administrator, by Section 0.104 of Title 28 of the Code of Federal Regulations, the Deputy Administrator hereby orders that the 1997 initial aggregate production quotas, expressed in grams of anhydrous acid or base, be established as follows: 2,5-Dimethoxy-4-ethylamphetamine (DOET)................. 2 3-Methylfentanyl........................................ 14 3-Methylthiofentanyl.................................... 2 3,4-Methylenedioxyamphetamine (MDA)..................... 22 3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............ 27 3,4-Methylenedioxymethamphetamine (MDMA)................ 7 3,4,5-Trimethoxyamphetamine............................. 2 4-Bromo-2,5-Dimethoxyamphetamine........................ 2 4-Bromo-2,5-Dimethoxyphenethylamine (2-CB).............. 2 4-Methoxyamphetamine.................................... 17 4-Methylaminorex........................................ 2 4-Methyl-2,5-Dimethoxyamphetamine (DOM)................. 2 5-Methoxy-3,4-Methylenedioxyamphetamine................. 2 Acetyl-alpha-methylfentanyl............................. 2 Acetylmethadol.......................................... 7 Alpha-acetylmethadol.................................... 7 Alpha-ethyltryptamine................................... 2 Alpha-methadol.......................................... 2 Alpha-methylfentanyl.................................... 2 Alpha-methylthiofentanyl................................ 2 Aminorex................................................ 7 Beta-acetylmethadol..................................... 2 Beta-hydroxyfentanyl.................................... 2 Beta-hydroxy-3-methylfentanyl........................... 2 Beta-methadol........................................... 2 Bufotenine.............................................. 2 Cathinone............................................... 9 Codeine-N-oxide......................................... 2 Difenoxin............................................... 14,000 Dihydromorphine......................................... 7 Ethylamine Analog of PCP................................ 5 Heroin.................................................. 2 Lysergic acid diethylamide (LSD)........................ 32 [[Page 66313]] Mescaline............................................... 7 Methaqualone............................................ 17 Methcathinone........................................... 11 Morphine-N-oxide........................................ 2 N-Ethylamphetamine...................................... 7 N-Hydroxy-3,4-Methylenedioxyamphetamine................. 2 N,N-Dimethylamphetamine................................. 7 N,N-Dimethyltryptamine.................................. 7 Norlevorphanol.......................................... 2 Normethadone............................................ 7 Normorphine............................................. 7 Para-fluorofentanyl..................................... 2 Pholcodine.............................................. 2 Psilocin................................................ 2 Psilocybin.............................................. 2 Tetrahydrocannibinols................................... 25,100 Thiofentanyl............................................ 2 Thiophene Analog of Phencyclidine....................... 5 Psilocin................................................ 2 Psilocybin.............................................. 2 Tetrahydrocannibinols................................... 25,100 Thiofentanyl............................................ 2 Thiophene Analog of Phencyclidine....................... 5 Schedule II 1-Phenylcyclohexylamine................................. 10 1-Piperidinocyclohexanecarbonitrile (PCC)............... 12 Alfentanil.............................................. 9,300 Amobarbital............................................. 15 Amphetamine............................................. 2,968,000 Carfentanil............................................. 500 Cocaine................................................. 550,100 Codeine (for sale)...................................... 49,103,000 Codeine (for conversion)................................ 19,679,000 Desoxyephedrine......................................... 1,422,000 1,361,000 grams of levodesoxyephedrine for use in a noncontrolled, nonprescription product and 61,000 grams for methamphetamine. Dextropropoxyphene...................................... 116,469,000 Dihydrocodeine.......................................... 255,100 Diphenoxylate........................................... 1,572,000 Ecgonine (for conversion)............................... 651,000 Ethylmorphine........................................... 12 Fentanyl................................................ 193,000 Glutethimide............................................ 2 Hydrocodone (for sale).................................. 13,891,000 Hydrocodone (for conversion)............................ 1,769,000 Hydromorphone........................................... 563,000 Isomethadone............................................ 12 Levo-alpha-acetylmethadol (LAAM)........................ 356,000 Levomethorphan.......................................... 2 Levorphanol............................................. 16,400 Meperidine.............................................. 9,843,000 Methadone (for sale).................................... 3,977,000 Methadone (for conversion).............................. 364,000 Methadone Intermediate (for conversion)................. 5,275,000 Methamphetamine (for conversion)........................ 723,000 Methylphenidate......................................... 13,824,000 Morphine (for sale)..................................... 11,126,000 Morphine (for conversion)............................... 68,165,000 Noroxymorphone (for sale)............................... 30,000 Noroxymorphone (for conversion)......................... 2,000,000 Opium................................................... 937,000 Oxycodone (for sale).................................... 6,634,000 Oxycodone (for conversion).............................. 1,200 Oxymorphone............................................. 56,000 [[Page 66314]] Dated: December 10, 1996. James S. Milford, Acting Deputy Administrator. [FR Doc. 96-31889 Filed 12-16-96; 8:45 am] BILLING CODE 4410-09-M