Quotas - 1999
[Federal Register: October 19, 1999 (Volume 64, Number 201)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA # 179F]
Controlled Substances: 1999 Aggregate Production Quotas
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of final 1999 aggregate production quotas.
SUMMARY: This notice establishes final 1999 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA). The DEA has taken into consideration comments received in response to a notice of the proposed revised aggregate production quotas for 1999 published August 20, 1999 (64 FR 45566). No comments were received in response to an interim notice establishing revised 1999 aggregate production quotas published August 27, 1999 (64 FR 46955). The interim notice is adopted with one change, as described below.
EFFECTIVE DATES: October 19, 1999.
FOR FURTHER INFORMATION CONTACT:
Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, D.C. 20537, Telephone: (202) 307-7183.
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 Sec. 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 Sec. 0.104 of Title 28 of the Code of Federal Regulations.
On August 20, 1999, a notice of the proposed revised 1999 aggregate production quotas for certain controlled substances in Schedules I and II was published in the Federal Register (64 FR 45566). All interested parties were invited to comment on or object to these proposed aggregate production quotas on or before September 20, 1999.
Several companies commented that the revised aggregate production quotas for amphetamine, dextropropoxyphene, dihydrocodeine, hydromorphone, meperidine, methadone (for sale), methadone intermediate, methylphenidate, and opium 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. Two companies included information concerning potential increases in sales due to Y2K concerns.
DEA has taken into consideration the above comments along with the relevant 1998 year-end inventories, initial 1999 manufacturing quotas, 1999 export requirements, and actual and projected 1999 sales. Based on this information, the DEA has adjusted the final 1999 aggregate production quotas for amphetamine, desoxyephedrine, dextropropoxyphene, dihydrocodeine, hydromorphone, methadone (for sale), methadone intermediate and opium to meet the legitimate needs of the United States.
Regarding meperidine and methylphenidate, the DEA has determined that no adjustments of the aggregate production quotas are necessary to meet the 1999 estimated medical, scientific, research and industrial needs of the United States.
In addition, on August 27, 1999, an interim notice establishing revised 1999 aggregate production quotas for amphetamine, codeine (for conversion), hydrocodone (for sale), hydrocodone (for conversion), morphine (for conversion), oxycodone (for sale) and thebaine was published in the Federal Register (64 FR 46955). All interested parties were invited to comment on or before September 27, 1999. No comments or objections were received regarding this interim notice. The aggregate production quota for amphetamine has been revised in response to comments received on 64 FR 45566. The remainder of the aggregate production quotas established in the interim notice are adopted without change.
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 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 orders that the final 1999 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:
|Basic class||Established final 1999 quotas|
|Lysergic acid diethylamide (LSD)||57|
|Codeine (for sale)||58,248,000|
|Codeine (for conversion)||45,780,000|
|Desoxyephedrine (942,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product and 166,000 grams for methamphetamine)||1,108,000|
|Hydrocodone (for sale)||20,208,000|
|Hydrocodone (for conversion)||12,100,000|
|Methadone (for sale)||8,753,000|
|Methadone (for conversion)||267,000|
|Methamphetamine (for conversion)||1,522,000|
|Morphine (for sale)||12,445,000|
|Morphine (for conversion)||94,900,000|
|Noroxymorphone (for sale)||25,000|
|Noroxymorphone (for conversion)||2,067,000|
|Oxycodone (for sale)||18,517,000|
|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 Secs. 1308.11 and 1308.12 of Title 21 of the Code of Federal Regulations remain 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 section 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; October 12, 1999.
Donnie R. Marshall,
[FR Doc. 99-27291 Filed 10-18-99 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).