Quotas - 1998
[Federal Register Volume 63, Number 200 (Friday, October 16, 1998)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-27740]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled Substances: Proposed Aggregate Production Quotas for 1999
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed 1999 aggregate production quotas.
SUMMARY: This notice proposes initial 1999 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).
DATES: Comments or objections must be received on or before November 16, 1998.
ADDRESSES: Send comments or objections to the Acting 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. 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.
The proposed 1999 aggregate production quotas represent those quantities of controlled substances that may be produced in the United States in 1999 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. These quotas do not include imports of controlled substances for use in industrial processes.
In determining the proposed 1999 aggregate production quotas, the Acting Deputy Administrator considered the following factors: total actual 1997 and estimated 1998 and 1999 net disposals of each substance by all manufacturers; estimates of 1998 year-end inventories of each substance and of any substance manufactured from it and trends in accumulation of such inventories; product development requirements of both bulk and finished dosage form manufacturers; projected demand as indicated by procurement quota applications filed pursuant to Section 1303.12 of Title 21 of the Code of Federal Regulations; and other pertinent information.
Pursuant to Section 1303 of Title 21 of the Code of Federal Regulations, the Acting Deputy Administrator of the DEA will, in early 1999, adjust aggregate production quotas and individual manufacturing quotas allocated for the year based upon 1998 year-end inventory and actual 1998 disposition data supplied by quotas recipients for each basic class of Scheudle I or II controlled substance.
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 Acting Deputy Administrator hereby proposes that the 1999 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:
|Lysergic acid diethylamide (LSD)||57|
|Codeine (for sale)||60,641,000|
|Codeine (for conversion)||22,950,000|
|Desoxyephedrine--662,000 grams of levodesoxyephedrine for use in a
non-controlled, non-prescription product and 35,000 grams for methamphetamine
|Hydrocodone (for sale)||16,314,000|
|Hydrocodone (for conversion)||1,300,000|
|Methadone (for sale)||4,992,000|
|Methadone (for conversion)||267,000|
|Methamphetamine (for conversion)||723,000|
|Morphine (for sale)||12,445,000|
|Morphine (for conversion)||76,300,000|
|Noroxymorphone (for sale)||25,000|
|Noroxymorphone (for conversion)||2,067,000|
|Oxycodone (for sale)||12,118,000|
|Oxycodone (for conversion)||51,000|
The Acting Deputy Administrator further proposes 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 be established at zero.
All interested persons are invited to submit their comments and objections in writing regarding this proposal. A person may object to or comment on the proposal relating to any of the above-mentioned substances without filing comments or objections regarding the others. If a person believes that one or more of these issues warrant a hearing, the individual should so state and summarize the reasons for this belief.
In the event that comments or objections to this proposal raise one or more issues which the Acting Deputy Administrator finds warrant a hearing, the Acting Deputy Administrator shall order a public hearing by notice in the Federal Register, summarizing the issues to be heard and setting the time for the hearing.
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 substance 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: October 8, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-27740 Filed 10-15-98; 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 Publishing Office (GPO).