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AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Notice of aggregate production quotas for 2000.

SUMMARY:

This notice establishes initial 2000 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA). This notice replaces and supersedes the final order dated December 21, 1999 and published in the Federal Register (64 FR 72686). Since the aggregate production quotas listed herein are the same as those published in 64 FR 72686, except as noted below, this will not effect individual manufacturing quotas or procurement quotas previously issued by DEA. Further, this notice corrects two errors in the notice published in 64 FR 72686 as follows: the aggregate production quota of 2 grams for the Schedule I substance codeine-N-oxide was inadvertantly deleted from the notice; and, the aggregate production quotas for hydrocodone (for conversion) and hydromorphone were inadvertantly listed twice. These two corrections are incorporated into the list of aggregate production quotas below.

EFFECTIVE DATE:

February 10, 2000.

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FOR FURTHER INFORMATION CONTACT:

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

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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 § 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 § 0.104 of Title 28 of the Code of Federal Regulations.

The 2000 aggregate production quotas represent those quantities of controlled substances that may be produced in the United States in 2000 to provide adequate supplies of each substance for: The estimated medical, scientific, research and industrial needs of the United States; lawful export requirements; and the establishment and maintenance of reserve stocks (21 U.S.C. 826(a) and 21 CFR 1303.11). These quotas do not include imports of controlled substances for use in industrial processes.

On October 21, 1999, a notice of the proposed initial 2000 aggregate production quotas for certain controlled substances in Schedules I and II was published in the Federal Register (64 FR 56809). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before November 22, 1999.

Six companies commented on a total of 16 Schedules I and II controlled substances within the published comment period. The companies commented that the proposed aggregate production quotas for alfentanial, amphetamine, diphenoxylate, fentanyl, hydromorphone, levorphanol, meperidine, levo-desoxyephedrine, methamphetamine (for sale), methamphetamine (for conversion), methylphenidate, noroxymorphone (for conversion), oxycodone (for sale), oxycodone (for conversion), sufentanil and thebaine 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.

In addition, one comment was received after the published comment Start Printed Page 6636period had ended. This comment requested that the aggregate production quota for dihydromorphone be increased to provide for an intermediate in a current manufacturing process. This comment was taken into consideration in determining the established initial 2000 aggregate production quota for dihydromorphine.

DEA has taken into consideration the above comments along with the relevant 1999 manufacturing quotas, current 1999 sales and inventories, 2000 export requirements and research and product development requirements. Based on this information, the DEA has adjusted the initial aggregate production quotas for alfentanil, dihydromorphine, diphenoxylate, fentanyl, hydromorphone, levorphanol, meperidine, levo-desoxyephedrine, methaphetamine (for conversion), noroxymorphone (for conversion), osycodone (for sale), sufentanil and thebaine to meet the legitimate needs of the United States. Significant portions of the increases for alfentanil, diphenoxylate, fentanyl, hydromorphone, levorphanol, noroxymorphone (for conversion) and sufentanil are due to a change in the manner in which manufacturing losses are accounted for by a bulk manufacturer.

In addition, one company requested a hearing to address the aggregate production quota for oxycodone (for sale) or hydromorphone if the aggregate production quotas were not increased sufficiently. The DEA, based on the data provided, has increased the aggregate production quotas for both oxycodone (for sale) and hydromorphone and has determined that a hearing is not necessary.

Regarding amphetamine, methamphetamine (for sale), methylphenidate and oxycodone (for conversion), the DEA has determined that the proposed initial 2000 aggregate production quotas are sufficient to meet the current 2000 estimated medical, scientific, research and industrial needs of the United States.

Pursuant to Section 1303 of Title 21 of the Code of Federal Regulations, the Deputy Administrator of the DEA will, in early 2000, adjust aggregate production quotas and individual manufacturing quotas allocated for the year based upon 1999 year-end inventory and actual 1999 disposition data supplied by quota recipients for each basic class of Schedules I or II controlled substance.

Therefore, under the authority vested in the Attorney General by Section 306 of the Controlled Substances Act of 1970 (21 U.S.C. 826), delegated to the Administrator of the DEA by § 0.100 of Title 28 of the Code of Federal Regulations, and redelegated to the Deputy Administrator pursuant to § 0.104 of Title 28 of the Code of Federal Regulations, the Deputy Administrator hereby orders that the 2000 initial 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 §§ 1308.11 and 1308.12 of Title 21 of the Code of Federal Regulations be established 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 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 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.

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