Quotas - 1998

[Federal Register Volume 63, Number 178 (Tuesday, September 15, 1998)]
[Notices]
[Pages 49369-49370]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-24621]

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA #167F]

Controlled Substances: Revised Aggregate Production Quotas for 1998

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of final revised 1998 aggregate production quotas.

SUMMARY: This notice establishes revised 1998 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).

EFFECTIVE DATE: September 15, 1998.

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 17, 1998, a notice of the proposed revised 1998 aggregate production quotas for certain controlled substances in Schedules I and II was published in the Federal Register (63 FR 38671). All interested parties were invited to comment on or object to these proposed aggregate production quotas on or before August 17, 1998.

Several companies commented that the revised aggregate production quotas for amphetamine, codeine (for conversion), desoxyephedrine (methamphetamine), dihydrocodeine, fentanyl, hydrocodone (for sale), meperidine, methadone (for sale), methadone intermediate, methylphenidate, morphine (for sale), morphine (for conversion), oxycodone (for sale), oxymorphone, pentobarbital, propiram, secobarbital, sufentanil, tetrahydrocannabinols, 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.

DEA has reviewed the involved companies' 1997 year-end inventories, their initial 1998 manufacturing quotas, 1998 export requirements and their actual and projected 1998 sales. Based on this data, the DEA has adjusted the revised 1998 aggregate production quotas for amphetamine, desoxyephedrine (methamphetamine), dihydrocodeine, fentanyl, meperidine, methadone (for sale), methadone intermediate, morphine (for sale), morphine (for conversion), oxycodone (for sale), oxymorphone, pentobarbital, propiram, tetrahydrocannabinols and thebaine to meet the estimated medical, scientific, research and industrial needs of the United States.

Regarding codeine (for conversion), hydrocodone (for sale), methylphenidate, secobarbital and sufentanil, the DEA has determined that no adjustments of the aggregate production quotas are necessary to meet the 1998 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 redelgated to the Deputy Administrator pursuant to Section 0.104 of Title 28 of the Code of Federal Regulations, the Acting Deputy Administrator hereby orders that the revised 1998 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:

The Acting 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 12612, and it has been determined that this matter does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

The Acting 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 Acting Deputy Administrator has determined that this action does not require a regulatory flexibility analysis.

Dated: September 3, 1998.

Donnie R. Marshall,
Acting Deputy Administrator.

[FR Doc. 98-24621 Filed 9-14-98; 8:45 am]

BILLING CODE 4410-09-M

NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).