00-23901. Controlled Substances: 2000 Aggregate Production Quota

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Notice of a proposed revision to the 2000 aggregate production quota for marihuana.

SUMMARY:

This notice proposes a revised 2000 aggregate production quota for marihuana, a Schedule I controlled substance in the Controlled Substances Act (CSA).

DATES:

Comments or objections should be received on or before October 3, 2000.

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: [phone].

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 substances listed in Schedules I and II each year. 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.

Until recently, there have been no DEA registrants with status as a bulk manufacturer of marihuana plant material. Therefore, the DEA had not previously established an aggregate production quota for marihuana greater than zero. However, on November 4, 1999, DEA granted a bulk manufacturing registration to an applicant who will cultivate marihuana for scientific, research, and development purposes. The nature of the cultivation process necessitates the sowing of seeds immediately in order to manufacture the controlled substance in calendar year 2000.

Therefore, under the authority vested in the Attorney General by Section 306 of the CSA (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 proposes the following revision to the 2000 aggregate production quota for the listed controlled substance, expressed in grams of manicured material (i.e. leaves, flowering tops, and seeds):

Basic class	Proposed revised 2000 aggregate production quota
Marihuana	350,000

All interested persons are invited to submit their comments and objections in writing regarding this proposal. If a person believes this issue warrants 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 in accordance with Section 1303.32 of 21 CFR, 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. 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. Furthermore, this action involves only one basic class of controlled substance. Accordingly, the Deputy Administrator has determined that this action does not require a regulatory flexibility analysis.

Dated: September 6, 2000.

Julio F. Mercado,

Deputy Administrator.