Date="05/09/95" Citation="60 FR 24649" Group="legal" Type="NOTICE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION" Subject="Controlled Substances: Proposed 1995 Aggregate Production Quotas"

DEPARTMENT OF JUSTICE Drug Enforcement Administration [DEA No. 132P] Controlled Substances: Proposed 1995 Aggregate Production Quotas AGENCY: Drug Enforcement Administration. ACTION: Notice of proposed revised aggregate production quotas for 1995.

DEPARTMENT OF JUSTICE Drug Enforcement Administration [DEA No. 132P] Controlled Substances: Proposed 1995 Aggregate Production Quotas AGENCY: Drug Enforcement Administration. ACTION: Notice of proposed revised aggregate production quotas for 1995. + ------------------------------------------------------------ SUMMARY: This notice proposes revised 1995 aggregate production quotas for controlled substances in Schedules I and II, as required under the Controlled Substances Act of 1970. DATES: Comments or objections should be received on or before June 8, 1995. ADDRESSES: Send comments or objections to the Administrator, Drug Enforcement Administration, Washington, DC 20537, Attn: DEA Federal Register Representative/CCR. FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug & Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183. SUPPLEMENTARY INFORMATION: Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for all controlled substances listed in Schedules I and II. 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 Administrator of the DEA by sec 0.104 of Title 28 of the Code of Federal Regulations. On October 20, 1994, a notice of the 1995 established aggregate production quotas was published in the Federal Register (59 FR 52991). The notice stipulated that the Deputy Administrator of the DEA would adjust the quotas in early 1995 as provided for in Title 21, Code of Federal Regulations, sec 1303.23(c). These aggregate production quotas represent those amounts of controlled substances that may be produced in the United States in 1995 and do not include amounts which may be imported for use in industrial processes. The proposed revisions are based on a review of 1994 year- end inventories, 1994 disposition data submitted by quota applicants, estimates of the medical needs of the United States submitted to the DEA by the Food and Drug Administration 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 by sec 0.100 of Title 28 of the Code of Federal Regulations, and redelegated to the Deputy Administrator by sec 0.104 of Title 28 of the Code of Federal Regulations, the Deputy Administrator of the DEA hereby proposes the following changes in the 1995 aggregate production quotas for the listed controlled substances, expressed in grams of anhydrous acid or base. ----------------------------------------------------+---------------+----------------- | Previously | Proposed | established | revised 1995 Basic class | 1995 | aggregate | aggregate | production | production | quotas | quotas | ----------------------------------------------------+---------------+----------------- | | Schedule I: | | Acetylmethadol .................................. | 2 | 7 Alphacetymethadol ............................... | 0 | 5 Aminorex ........................................ | 2 | 7 Bufotenine ...................................... | 10 | 10 Cathinone ....................................... | 4 | 9 Difenoxin ....................................... | 14,000 | 14,00 ---- page 24650 ---- Dihydromorphine ................................. | 0 | 5 2,5-Dimethylamphetamine ......................... | 15,650,000 | 15,650,000 Dimethylamphetamine ............................. | 2 | 7 Ethylamine analog of Phencyclidine .............. | 0 | 5 N-Ethylamphetamine .............................. | 4 | 9 Lysergic acid diethylamide ...................... | 41 | 56 Mescaline ....................................... | 2 | 7 Methaqualone .................................... | 2 | 7 Methcathinone ................................... | 9 | 14 4-Methoxyamphetamine ............................ | 12 | 17 4-Methylaminorex ................................ | 2 | 2 3,4-Methylenedioxyamphetamine ................... | 12 | 17 3,4-Methylenedioxy-N-ethylamphetamine ........... | 2 | 27 3,4-Methylenedioxymethamphetamine ............... | 12 | 17 3-Methylfentanyl ................................ | 12 | 14 Normethadone .................................... | 0 | 5 Normorphine ..................................... | 2 | 7 Tetrahydrocannabinols ........................... | 35,000 | 35,000 Thiophene Analog of Phencyclidine ............... | 10 | 10 Schedule II: | | Alfentanil ...................................... | 7,000 | 7,000 Amobarbital ..................................... | 5 | 15 Amphetamine ..................................... | 1,026,100 | 1,026,100 Cocaine ......................................... | 550,000 | 550,000 Codeine (for sale) .............................. | 67,312,000 | 67,312,000 Codeine (for conversion) ........................ | 16,181,000 | 16,181,000 Desoxyephedrine ................................. | 900,000 | 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 | 124,012,000 Dihydrocodeine .................................... | 202,000 | 100,000 Diphenoxylate ..................................... | 688,000 | 346,000 Ecgonine (for conversion) ......................... | 650,000 | 650,000 Ethylmorphine ..................................... | 0 | 10 Fentanyl .......................................... | 76,000 | 52,000 Hydrocodone ....................................... | 8,474,000 | 8,474,000 Hydromorphone ..................................... | 404,000 | 404,000 Isomethadone ...................................... | 0 | 10 Levo-alpha-acetylmethadol ......................... | 200,000 | 200,000 Levorphanol ....................................... | 8,000 | 8,000 Meperidine ........................................ | 8,637,000 | 9,521,000 Methadone ......................................... | 3,779,000 | 3,779,000 Methadone (for conv)............................... | 364,000 | 364,000 Methadone Intermediate (for sale) ................. | 300,000 | 0 Methadone Int. (for conv) ......................... | 4,393,000 | 4,393,000 Methylphenidate ................................... | 8,886,000 | 10,410,000 Morphine (for sale) ............................... | 7,612,000 | 7,612,000 Morphine (for conv) ............................... | 78,105,000 | 78,105,000 Noroxymorphone (for sale) ......................... | 21,000 | 21,000 Noroxymorphone (for conv) ......................... | 3,500,000 | 3,500,000 Opium ............................................. | 1,118,000 | 1,304,000 Oxycodone (for sale) .............................. | 3,613,00 | 4,254,000 Oxycodone (for conv) .............................. | 23,000 | 25,500 Oxymorphone ....................................... | 9,200 | 10,200 Pentobarbital ..................................... | 15,706,000 | 15,706,000 Phencyclidine ..................................... | 52 | 72 Phenylacetone (for conv) .......................... | 3,528,000 | 3,528,000 1-Phenylcyclohexylamine ........................... | 0 | 10 1-Piperidinocyclohexanecarbonitrile ............... | 0 | 10 Secobarbital ...................................... | 480,000 | 322,000 Sufentanil ........................................ | 1,600 | 1,600 Thebaine .......................................... | 9,383,000 | 9,383,000 ----------------------------------------------------+---------------+----------------- 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 Deputy Administrator finds warrant a hearing, the Deputy Administrator shall order a public hearing by notice in the Federal ---- page 24651 ---- Register, summarizing the issues to be heard and setting the time for the hearing. The Office of Management and budget has determined that notice of aggregate production quotas are not subject to centralized review under Executive Order 12866. Rules establishing aggregate production quotas for controlled substances in Schedules I and II are required by statute, fulfill United States obligations under the Single Convention on Narcotic Drugs, 1961, and other international treaties, and are essential to a criminal law enforcement function of the United States. Without the periodic establishment and adjustment of aggregate production quotas, pharmaceutical manufacturers in the United States could not lawfully produce a wide variety of medically necessary pharmaceutical drugs. These actions have been analyzed in accordance with the principles and criteria contained in Executive Order 12612 and it has been determined that this matter raises no Federalism implications which would 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 and revision of annual production quotas for Schedules I and II controlled substances is mandated by law and by the international obligations of the United States. Such quotas impact predominantly upon major manufacturers of the affected controlled substances. Dated: May 3, 1995. Stephen H. Greene, Deputy Administrator. [FR Doc. 95-11370 Filed 5-8-95; 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 proposed aggregate, 24649