Date="09/27/94" Citation="59 FR 49256" Group="legal" Type="NOTICE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA)" Subject="Controlled Substances: Established Revised 1994 Aggregate Production Q uotas"

DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled Substances: Established Revised 1994 Aggregate Production Quotas AGENCY: Drug Enforcement Administration (DEA). ACTION: Interim notice establishing a 1994 aggregate production quota and request for comments.

DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled Substances: Established Revised 1994 Aggregate Production Quotas AGENCY: Drug Enforcement Administration (DEA). ACTION: Interim notice establishing a 1994 aggregate production quota and request for comments. + ------------------------------------------------------------ SUMMARY: This interim notice establishes a revised 1994 aggregate production quota for methylphenidate, a Schedule II controlled substance, as required under the Controlled Substances Act of 1970. DATES: This is effective on September 27, 1994. Comments must be submitted on or before October 27, 1994. 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 (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 pursuant to 59 FR 23637 (May 6, 1994). The DEA established initial 1994 aggregate production quotas for controlled substances in Schedules I and II, including methylphenidate, in a Federal Register notice published on October 8, 1993 (58 FR 52508). DEA revised some of the aggregate production quotas, including that for methylphenidate, on June 22, 1994 (59 FR 32223) in accordance with 21 CFR 1303.13. Since publication of the revised 1994 aggregate production quotas, DEA has received information which necessitates an increase in methylphenidate's 1994 aggregate production quota. Because this increase is immediately required to meet the 1994 year- end medical needs of the United States, an interim rule is being established. Based on a review of 1993 year-end inventories, 1994 manufacturing quotas, 1994 sales, export requirements and other information available to the DEA, the Deputy Administrator of the DEA, 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 section 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), hereby establishes the following revised 1994 aggregate production quota for methylphenidate, expressed in grams of anhydrous base: Basic Class-Established Revised Schedule II-1994 Quotas Methylphenidate-8,189,000 All interested persons are invited to submit their comments in writing regarding this interim notice. 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 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 his action does not require a regulatory flexibility analysis. Dated: September 20, 1994. Stephen H. Greene, Deputy Administrator. [FR Doc. 94-23788 Filed 9-26-94; 8:45 am] BILLING CODE 4410-09-M ------------------------------------------------------ The Contents entry for this article reads as follows: Schedules of controlled substances: Methylphenidate, 49256