Date="04/19/95" Citation="60 FR 19608" Group="legal" Type="NOTICE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE" Subject="Established 1995 Aggregate Production Quota for a Schedule II Controlled Substance"

DEPARTMENT OF JUSTICE Drug Enforcement Administration [DEA No. 129F] Established 1995 Aggregate Production Quota for a Schedule II Controlled Substance AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of an established 1995 aggregate production quota.

DEPARTMENT OF JUSTICE Drug Enforcement Administration [DEA No. 129F] Established 1995 Aggregate Production Quota for a Schedule II Controlled Substance AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of an established 1995 aggregate production quota. + ------------------------------------------------------------ SUMMARY: This notice establishes a 1995 aggregate production quota for hydrocodone (for conversion), a controlled substance in Schedule II of the Controlled Substances Act (CSA). DATES: This order is effective on April 19, 1995. FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug & Chemical Evaluation Section, Drug Enforcement Administration, Washington, D.C. 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 controlled substances in Schedule I and II each year. This responsibility has been redelegated to the Deputy Administrator of the DEA pursuant to sec 0.104 of Title 28 of the Code of Federal Regulations. On February 13, 1995, a notice of the proposed 1995 aggregate production quota for hydrocodone (for conversion), a Schedule II controlled substance, was published in the Federal Register (60 FR 8251). All interested persons were invited to comment on or object to this proposed aggregate production quota on or before March 15, 1995. Comments were received from and a hearing on this matter was requested by one pharmaceutical company. The company maintains that the establishment of this aggregate production quota could have an impact on the United States and international narcotic raw material supply, since hydrocodone is derived from narcotic raw materials. Pursuant to the Code of Federal Regulations, Title 21, sec 1303.11(c), the Deputy Administrator may at his discretion hold a hearing on any issue relevant to the determination of an aggregate production quota. After review of all pertinent information, the Deputy Administrator has determined that no issue was found which warrants a hearing on this matter. Moreover, the proposed 2,200 kg of hydrocodone will not threaten the balance and supply of narcotic raw materials. Therefore the proposal for the 1995 aggregate production quota for hydrocodone (for conversion) is adopted without change. 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 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 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) 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 orders that the 1995 ---- page 19609 ---- aggregate production quota for the following controlled substance, expressed in grams of anhydrous base, be established as follows: --------------------------------------------------------------+--------------- | Established Basic class | 1995 quota | (in grams) --------------------------------------------------------------+--------------- | Hydrocodone (for conversion) ................................ | 2,200,000 --------------------------------------------------------------+--------------- Dated: April 11, 1995. Stephen H. Greene, Deputy Administrator. [FR Doc. 95-9588 Filed 4-18-95; 8:45 am] BILLING CODE 4410-09-M ------------------------------------------------------ The Contents entry for this article reads as follows: Schedules of controlled substances; production quotas: Schedule II- 1995 aggregate, 19608