Drug Enforcement Administration (DEA), Justice.
Notice of proposed year 2001 aggregate production quotas.
This notice proposes initial year 2001 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).
Comments or objections must be received on or before November 3, 2000.
Send comments or objections to the Deputy Administrator, Drug Enforcement Administration, Washington, D.C. 20537, Attn.: DEA Federal Register Representative (CCR).Start Further Info
FOR FURTHER INFORMATION CONTACT:
Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, D.C. 20537, Telephone: (202) 307-7183.End Further Info End Preamble Start Supplemental Information
Section 306 of the CSA (21 U.S.C. 826) requires that the Attorney General establish aggregate production quotes 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 year 2001 aggregate production quotas represent those quantities of controlled substances that may be produced in the United States in 2001 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 year 2001 aggregate production quotas, the Deputy Administrator considered the following factors: total actual 1999 and estimated 2000 and 2001 net disposals of each substance by all manufacturers; estimates of 2000 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 Deputy Administrator of the DEA will, in early 2001, adjust aggregate production quotas and individual manufacturing quotas allocated for the year based upon 2000 year-end inventory and actual 2000 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 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, and the Deputy Administrator hereby proposes that the year 2001 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:
|Basic class||Proposed year 2001 quotas|
|Lysergic acid diethylamide (LSD)||37|
|Start Printed Page 59215|
|Codeine (for sale)||43,248,000|
|Codeine (for conversion)||59,051,000|
|Hydrocodone (for sale)||21,417,000|
|Hydrocodone (for conversion)||26,540,000|
|Methadone (for sale)||8,347,000|
|Methadone (for conversion)||60,000|
|850,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 1,325,000 grams for methamphetamine for conversion to a Schedule III product; and 51,000 grams for methamphetamine (for sale)|
|Morphine (for sale)||14,706,000|
|Morphine (for conversion)||117,675,000|
|Noroxymorphone (for sale)||25,000|
|Noroxymorphone (for conversion)||3,180,000|
|Oxycodone (for sale)||46,680,000|
|Oxycodone (for conversion)||449,000|
The 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 or 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 Deputy Administrator finds warrant a hearing, the 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 13132, 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. 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.Start Signature
Dated: September 27, 2000.
Julio F. Mercado,
[FR Doc. 00-25421 Filed 10-3-00; 8:45 am]
BILLING CODE 4410-09-M