Controlled Substances: 2000 Aggregate Production Quotas

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Notice of final 2000 aggregate production quotas.

SUMMARY:

This notice establishes final 2000 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA). The DEA has taken into consideration comments received in response to a notice of the proposed revised aggregate production quotas for 2000 published July 19, 2000 (65 FR 44836).

EFFECTIVE DATE:

September 25, 2000.

FOR FURTHER INFORMATION CONTACT:

Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION:

Section 306 of the CSA (21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for each basic class of controlled substance listed in Schedules I and II. This responsibility has been delegated to the Administrator of the DEA by Section 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 pursuant to Section 0.104 of Title 28 of the Code of Federal Regulations.

On July 19, 2000, a notice of the proposed revised 2000 aggregate production quotas for certain controlled substances in Schedules I and II was published in the Federal Register (65 FR 44836). All interested parties were invited to comment on or object to these proposed aggregate production quotas on or before August 18, 2000.

Several companies and one individual commented that the revised aggregate production quotas for amphetamine, codeine (for sale), dextropropoxyphene, dihydrocodeine, hydrocodone (for sale), hydromorphone, meperidine, methadone intermediate, methylphenidate, opium, oxycodone (for sale), oxycodone (for conversion), oxymorphone, pentobarbital, phenylacetone, and tetrahydrocannabinols were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States, for export requirements and for the establishment and maintenance of reserve stocks.

DEA has taken into consideration the above comments along with the relevant 1999 year-end inventories, initial 2000 manufacturing quotas, 2000 export requirements, and actual and projected 2000 sales. Based on this information, the DEA has adjusted the final 2000 aggregate production quotas for 4-methoyxamphetamine, amphetamine, dihydrocodeine, hydromorphone, meperidine, methamphetamine, oxycodone (for sale), oxycodone (for conversion), oxymorphone and pentobarbital to meet the legitimate needs of the United States.

Regarding codeine (for sale), dextropropoxyphene, hydrocodone (for sale), methadone intermediate, opium, methylphenidate, phenylacetone and tetrahydrocannabinols, the DEA has determined that no adjustments of the aggregate production quotas are necessary to meet the 2000 estimated medical, scientific, research and industrial needs of the United States.

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 of the DEA by Section 0.100 of Title 28 of the Code of Federal Regulations, and redelegated to the Deputy Administrator pursuant to Section 0.104 of Title 28 of the Code of Federal Regulations, the Deputy Administrator hereby orders that the final 2000 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:

The Deputy Administrator further orders that aggregate production quotas for all other Schedules I and II controlled substances included in Sections 1308.11 and 1308.12 of Title 21 of the Code of Federal Regulations remain at zero.

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 13132, 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 aggregate production quotas for Schedules 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 form manufacturers of Schedules 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.