Date="04/13/94" Citation="59 FR 17568" Group="" Type="NOTICE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE" Subject="Controlled Substances: Notice of Proposed 1994 Aggregate Production Qu otas"

DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled Substances: Notice of Proposed 1994 Aggregate Production Quotas AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of proposed revised aggregate production quotas for 1994.

DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled Substances: Notice of Proposed 1994 Aggregate Production Quotas AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of proposed revised aggregate production quotas for 1994. + ------------------------------------------------------------ SUMMARY: This notice proposes revised 1994 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 (30 days after date of publication). 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 by sec 0.100 of title 28 of the Code of Federal Regulations. On October 8, 1993, a notice of the 1994 established aggregate production quotas was published in the Federal Register (58 FR 52508). The notice stipulated that the Administrator of the DEA would adjust the quotas in early 1994 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 1994 and do not include amounts which may be imported for use in industrial processes. The proposed revisions are based on a review of 1993 year- end inventories, 1993 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) and delegated to the Administrator by section 0.100 of Title 28 of the Code of Federal Regulations, the Administrator of the DEA hereby proposes the following changes in the 1994 aggregate production quotas for the listed controlled substances, expressed in grams of anhydrous acid or base. --------------------------------------+------------------+-------------------- | Previously | Proposed revised | established 1994 | 1994 aggregate Basic class | aggregate | production | production | quotas | quotas | --------------------------------------+------------------+-------------------- | | Schedule I: | | 2,5-Dimethoxyamphetamine .......... | 15,400,000 | 15,510,000 Schedule II: | | Alfentanil ........................ | 7,110 | 8,000 Amphetamine ....................... | 359,000 | 469,000 Codeine (for sale) ................ | 64,235,000 | 58,127,000 Desoxyephedrine ................... | 22,100 | 11,000 Diphenoxylate ..................... | 1,023,000 | 638,000 Levorphanol ....................... | 6,400 | 7,400 Methylphenidate ................... | 5,300,000 | 6,924,000 Opium ............................. | 1,242,000 | 688,000 Oxycodone (for sale) .............. | 4,312,000 | 2,995,000 Oxycodone (for conversion) ........ | 3,400 | 5,400 Oxymorphone ....................... | 1,400 | 2,420 Pentobarbital ..................... | 14,430,000 | 15,000,000 Phencyclidine ..................... | 32 | 52 Secobarbital ...................... | 550,000 | 338,000 Sufentanil ........................ | 620 | 870 --------------------------------------+------------------+-------------------- 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 Administrator finds warrant a hearing, the Administrator shall order a public hearing by notice in the Federal 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 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: April 5, 1994. Thomas A. Constantine, Administrator. [FR Doc. 94-8784 Filed 4-12-94; 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- 1994 proposed aggregate, 17568