Quotas - 1999
[Federal Register: June 1, 1999 (Volume 64, Number 104)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled Substances: 1999 Aggregate Production Quota
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Interim notice establishing a revised 1999 aggregate production quota and request for comments.
SUMMARY: This interim notice establishes a revised 1999 aggregate production quota for secobarbital, a Schedule II controlled substance in the Controlled Substances Act (CSA).
DATES: This is effective on June 1, 1999. Comments or objections must be received on or before July 1, 1999.
ADDRESSES: Send comments or objections to the Deputy Administrator, Drug Enforcement Administration, Washington, D.C. 20537, Attn: DEA Federal Register Representative (CCR).
FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, D.C. 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 basis class of controlled substance listed in Schedules I and II each year. This responsibility has been delegated to the Administrator of the DEA by Section 0.100 of Title 28 of Code of Federal Regulations. The Administrator, in turn, has redelegated this function to the Deputy Administrator of the DEA pursuant to Sec. 0.104 of Title 28 of the Code of Federal Regulations.
The DEA established initial 1999 aggregate production quotas for controlled substances in Schedules I and II, including secobarbital, in a Federal Register notice published on December 23, 1998 (63 FR 71160). A consideration of the information available at that time resulted in the establishment of an aggregate production quota of 25 grams for secobarbital. Since publication of the initial 1999 aggregate production quotas, the DEA has received information which necessitates an immediate increase in the 1999 aggregate production quota for secobarbital. The increase in the quota for secobarbital is necessary in order for the sole U.S. manufacturer to meet unforeseen domestic requirements. For this reason, an interim notice is being published. Therefore, under the authority vested in the Attorney General by Section 306 of the CSA (21 U.S.C. 826), delegated to the Administrator of the DEA by Sec. 0.100 of Title 28 of the Code of Federal
Regulations, and redelegated to the Deputy Administrator, pursuant to Sec. 0.104 of Title 28 of the Code of Federal Regulations, the Deputy Administrator hereby establishes the following revised 1999 aggregate production quota for the listed controlled substance, expressed in grams of anhydrous acid:
|Basic class||Revised 1999 quota|
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 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 from 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 Unites 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. Furthermore, this action involves only one basic class of controlled substance. Accordingly, the Deputy Administrator has determined that this action does not require a regulatory flexibility analysis.
Dated: May 13, 1999.
Donnie R. Marshall,
[FR Doc. 99-13829 Filed 5-28-99; 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 Publishing Office (GPO).