Quotas - 1999
[Federal Register: August 20, 1999 (Volume 64, Number 161)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled Substances: Proposed Revised Aggregate Production Quotas for 1999
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed revised 1999 aggregate production quotas.
SUMMARY: This notice proposes revised 1999 aggregate production quotas for controlled substances in Schedule I and II of the Controlled Substances Act (CSA).
DATES: Comments or objections must be received on or before September 20, 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.
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 Schedule 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.
On December 23, 1998 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.
The proposed revised 1999 aggregate production quotas represent those quantities of controlled substances in Schedules I and II 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.
The proposed revisions are based on a review of 1998 year-end inventories, 1998 disposition data submitted by quota applicants, estimates of the medical needs of the United States, and other information available to the DEA. In light of potential Y2K concerns, the DEA has included 50 percent inventories for each basic class of controlled substance manufactured for legitimate medical use. Therefore, the aggregate production quotas proposed in this notice may be significantly higher than usual.
Proposed Aggregate Production Quotas
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 Section 0.104 of Title 28 of the Code of Federal Regulations, the Deputy Administrator hereby proposes the following revised 1999 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base:
|Basic class||Previously established initial 1999 quotas||Proposed revised 1999 quotas|
|Lysergic acid diethylamide (LSD)||57||57|
|Codeine (for sale)||67,332,000||58,248,000|
|Codeine (for conversion)||22,950,000||45,780,000|
|Desoxyephedrine--942,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product and 113,000 grams for methamphetamine||697,000||1,055,000|
|Hydrocodone (for sale)||16,314,000||20,208,000|
|Hydrocodone (for conversion)||6,000,000||12,100,000|
|Methadone (for sale)||4,992,000||8,347,000|
|Methadone (for conversion)||267,000||267,000|
|Methamphetamine (for conversion)||723,000||1,522,000|
|Morphine (for sale)||12,445,000||12,445,000|
|Morphine (for conversion)||82,300,000||94,900,000|
|Noroxymorphone (for sale)||25,000||25,000|
|Noroxymorphone (for conversion)||2,067,000||2,067,000|
|Oxycodone (for sale)||15,120,000||18,517,000|
|Oxycodone (for conversion)||106,000||106,000|
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 remain at zero.
Comments and Y2K Issues
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.
The DEA is aware of concerns regarding a potential increase in sales due to customer stockpiling for Y2K. In response to this issue, the DEA has adjusted the aggregate production quotas to include the allowable maximum of 50 percent inventory for those controlled substances manufactured for medical use. Additional Y2K concerns should be included when commenting or objecting to this proposal.
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 the 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 Federal Assessment.
The Deputy Administrator hereby certifies that this action will have no significant impact upon small entities whose interests must by 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 11, 1999.
Donnie R. Marshall,
[FR Doc. 99-21583 Filed 8-19-99; 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).