Quotas - 1998
[Federal Register Volume 63, Number 246 (Wednesday, December 23, 1998)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-33888]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA # 179I]
Controlled Substances: Established Initial Aggregate Production Quotas for 1999
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of aggregate production quotas for 1999.
SUMMARY: This notice establishes initial 1999 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).
EFFECTIVE DATE: December 23, 1998.
FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug & 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, pursuant to Section 0.104 of Title 28 of the Code of Federal Regulations.
The 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 (21 U.S.C. 826(a) and 21 CFR 1303.11). These quotas do not include imports of controlled substances for use in industrial processes.
On October 16, 1998, a notice of the proposed initial 1999 aggregate production quotas for certain controlled substances in Schedules I and II was published in the Federal Register (63 FR 55640). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before November 16, 1998.
Nine companies commented on a total of 28 Schedules I and II controlled substances. The companies commented that the proposed aggregate production quotas for 2,5-dimethoxyamphetamine, 4- methoxyamphetamine, alfentanil, amphetamine, codeine (for sale), codeine (for conversion), dextropropoxyphene, dihydrocodeine, fentanyl, hydrocodone (for sale), hydrocodone (for conversion), hydromorphone, levorphanol, meperidine, methadone (for sale), methadone (for conversion), methadone intermediate, methylphenidate, morphine (for sale), morphine (for conversion), oxycodone (for sale), oxycodone (for conversion), pentobarbital, propiram, secobarbital, sufentanil 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. In addition, one company commented that the initial
aggregate production quota for diphenoxylate should be decreased.
After a review of 1998 manufacturing quotas, current 1998 sales and inventories, 1999 export requirements and research and product development requirements, the DEA agrees that changes are necessary for 2,5-dimethoxyamphetamine, 4-methoxyamphetamine, alfentanil, amphetamine, codeine (for sale), diphenoxylate, fentanyl, hydrocodone (for conversion), morphine (for conversion), oxycodone (for sale), oxycodone (for conversion), pentobarbital, sufentanil and thebaine.
In addition, one company requested a hearing to address the aggregate production quota for oxycodone (for sale) if the aggregate production quota was not increased sufficiently. The DEA has increased the aggregate production quota for oxycodone (for sale) and has determined that a hearing is not necessary.
The DEA also reviewed comments received concerning the aggregate production quotas for codeine (for conversion), dextropropoxyphene, dihydrocodeine, hydrocodone (for sale), hydromorphone, levorphanol, meperidine, methadone (for sale), methadone (for conversion), methadone intermediate, methylphenidate, morphine (for sale), propiram and secobarbital. In addition, 1998 manufacturing quotas, current 1998 sales and inventories, 1999 export requirements and research and product development requirements were reviewed, as well as other available data. Based on a review of the comments and this data, the DEA has determined that the proposed initial 1999 aggregate production quotas for these substances are sufficient to meet the current 1999 estimated medical, scientific, research and industrial needs of the United States.
Pursuant to Section 1303 of Title 21 of the Code of Federal Regulations, the 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 quota recipients for each basic class of Schedule I or II controlled substance.
Therefore, under the authority vested in the Attorney General by Section 306 of the Controlled Substances Act 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 Deputy Administrator hereby orders that the 1999 initial aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:
|2, 5-Dimethoxy-4-ethylampetamine (DOET)||2|
|3, 4-Methylenedioxyampheta- mine (MDA)||20|
|3, 4-Methylenedioxy-N-ethylamphetamine (MDEA)||30|
|3, 4-Methylendioxyme- thamphetamine (MDMA)||20|
|3, 4,5-Trimethoxyam- phetamine||2|
|4-Bromo-2, 5-Dimethoxy- amphetamine (DOB)||2|
|4-Bromo- 2,5-Dimethoxyphenethylamine (2-CB)||2|
|4-Methyl-2, 5-Dimethoxyamphetamine (DOM)||2|
|Lysergic acid diethylamide (LSD)||57|
|N-Ethyl-1-Phenylcy- clohexylamine (PCE)||5|
|N-Hydroxy-3, 4-Methylene- dioxyamphetamine||4|
|Codeine (for sale)||67,332,000|
|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)||6,000,000|
|Methadone (for sale)||4,992,000|
|Methadone (for conversion)||267,000|
|Methamphetamine (for conversion)||723,000|
|Methamphetamine (for conversion)||723,000|
|Morphine (for sale)||12,445,000|
|Morphine (for conversion)||82,300,000|
|Noroxymorphone (for sale)||25,000|
|Noroxymorphone (for conversion)||2,067,000|
|Oxycodone (for sale)||15,120,000|
|Oxycodone (for conversion)||106,000|
The 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 be established 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 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: December 15, 1998.
Donnie R. Marshall,
[FR Doc. 98-33888 Filed 12-23-98; 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).