Quotas - 1999
[Federal Register: August 27, 1999 (Volume 64, Number 166)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled Substances: 1999 Aggregate Production Quotas
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Interim notice establishing revised 1999 aggregate production quotas and request for comments.
SUMMARY: This interim notice establishes revised 1999 aggregate production quotas for amphetamine, codeine (for conversion), hydrocodone (for sale), hydrocodone (for conversion), morphine (for conversion), oxycodone (for sale) and thebaine, all of which are Schedule II controlled substances in the Controlled Substances Act (CSA).
DATES: This is effective on August 27, 1999. Comments or objections must be received on or before September 27, 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 basic 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 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 December 23, 1998, the DEA published a notice of established initial 1999 aggregate production quotas for certain controlled substances in Schedules I and II (63 FR 71160). This notice stipulated that the Deputy Administrator of the DEA would adjust the quotas in early 1999 as provided for in Section 1303 of Title 21 of the Code of Federal Regulations.
In a recently published Federal Register Notice, the DEA has proposed revised aggregate production quotas for controlled substances in Schedules I and II, including amphetamine, codeine (for conversion), hydrocodone (for sale), hydrocodone (for conversion), morphine (for conversion), oxycodone (for sale) and thebaine. However, due to the unforeseen and dramatic increase in sales of amphetamine, oxycodone and hydrocodone, the quotas for these three substances and four of the controlled substances used in their manufacture must be increased immediately. Without this immediate increase, bulk manufacturers will not be able to produce the material needed by the dosage form manufacturers. This could, in turn, impact the supply of products to distributors and retail pharmacies. In order to avoid this situation, an interim notice is being published. This interim notice will establish revised 1999 aggregate production quotas for amphetamine, codeine (for conversion), hydrocodone (for conversion), morphine (for conversion), oxycodone (for sale) and thebaine effective immediately.
Therefore, under the authority vested in the Attorney General by Section 306 of 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 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 establishes the following revised 1999 aggregate production quotas for the listed controlled substances, expressed in grams of anhydrous base:
|Basic class||Revised 1999 quota|
|Codeine (for conversion)||45,780,000|
|Hydrocodone (for sale)||20,208,000|
|Hydrocodone (for conversion)||12,100,000|
|Morphine (for conversion)||94,900,000|
|Oxycodone (for sale)||18,517,000|
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 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.
Dated: August 19, 1999.
Donnie R. Marshall,
[FR Doc. 99-22306 Filed 8-26-99; 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).