01-20306. Controlled Substances: 2001 Aggregate Production Quotas

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Interim notice establishing revised 2001 aggregate production quotas and request for comments.

SUMMARY:

This interim notice establishes revised 2001 aggregate production quotas for methadone (for sale) and methadone intermediate, both Schedule II controlled substances in the Controlled Substances Act (CSA).

DATES:

This is effective on August 14, 2001. Comments or objections must be received on or before (30 days from date of publication).

ADDRESSES:

Send comments or objections to the Acting Administrator, Drug Enforcement Administration, Washington, DC 20537, Attn.: DEA Federal Register Representative (CCR).

FOR FURTHER INFORMATION CONTACT:

Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 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 substance 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.

On December 19, 2000, DEA published a notice of established initial 2001 aggregate production quotas for certain controlled substances in Schedules I and II (65 FR 79428). This notice stipulated that the Deputy Administrator of the DEA would adjust the quotas in early 2001 as provided for in Section 1303 of Title 21 of the Code of Federal Reglations.

In a recently published Federal Register notice, the DEA has proposed revised aggregate production quotas for controlled substances in Schedules I and II, including methadone (for sale) and methadone intermediate. However, based on recently obtained information, the quotas for methadone (for sale) and methadone intermediate, which is used to manufacture methadone, must be increased immediately in order to provide a continuous and uninterrupted supply of methadone products to the public. The additional quantities proposed in the recently published Federal Register notice will not be available to the bulk manufacturers until completion of that rulemaking. In order to provide adequate and timely supplies of methadone product, an interim notice is being published under the good cause exception to the Administrative Procedure Act, 5 U.S.C. 553. This interim notice will establish revised 201 aggregate production quotas for methadone (for sale) and methadone intermediate effective immediately. DEA will also publish a final notice after considering any comments or objections to this interim notice.

Therefore, under the authority vested in the Attorney General by Section 306 of the CSA (21 U.S.C. 826), and delegated to the Administrator of the DEA by Section 0.100 of Title 28 of the Code of Federal Regulations, the Acting Administrator hereby establishes the following revised 2001 aggregate production quotas for the listed controlled substances, expressed in grams of anhydrous base:

Basic class	Revised 2001 quota
Methadone (for sale)	12,705,000
Methadone Intermediate	18,004,000

All interested persons are invited to submit their comments in writing regarding this interim notice.

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 does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this action does not have federalism implications warranting the application of Executive Order 13132.

The Acting 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 Acting Administrator has determined that this action does not require a regulatory flexibility analysis.

This action meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.

This action will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This action is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This action will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

The Drug Enforcement Administration makes every effort to write clearly. If you have suggestions as to how to improve the clarity of this regulation, call or write Frank L. Sapienza, Chief, Drug & Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, telephone [phone].

Dated: August 6, 2001.

William B. Simpkins,

Acting Administrator.