Controlled Substances: Final Revised Aggregate Production Quotas for 2002

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Notice of final aggregate production quotas for 2002.

SUMMARY:

This notice establishes final 2002 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 2002 published July 23, 2002 (67 FR 48207).

EFFECTIVE DATE:

September 20, 2002.

FOR FURTHER INFORMATION CONTACT:

Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 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 § 0.104 of Title 28 of the Code of Federal Regulations.

The 2002 aggregate production quotas represent those quantities of controlled substances in Schedules I and II that may be produced in the United States in 2002 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.

On July 23, 2002, a notice of the proposed revised 2002 aggregate production quotas for certain controlled substances in Schedules I and II was published in the Federal Register (67 FR 48207). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before August 22, 2002.

Ten companies commented on a total of eleven Schedules I and II controlled substances within the published comment period. The companies commented that the proposed aggregate production quotas for gamma-hydroxybutyric acid, dextropropoxyphene, dihydrocodeine, fentanyl, hydrocodone (for sale), hydromorphone, methylphenidate, morphine (for sale), noroxymorphone (for sale), oxycodone (for sale) 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.

DEA has taken into consideration the above comments along with the relevant 2001 year-end inventories, initial 2002 manufacturing quotas, 2002 export requirements, actual and projected 2002 sales and use, and research and product development requirements. Based on this information, the DEA has adjusted the final 2002 aggregate production quotas for alphamethadol, gamma-hydroxybutyric acid, dextropropoxyphene, dihydrocodeine, fentanyl, hydrocodone (for conversion), morphine (for sale), noroxymorphone (for sale), oxycodone (for sale) and thebaine to meet the legitimate needs of the United States.

Regarding hydrocodone (for sale), hydromorphone and methylphenidate, the DEA has determined that the proposed revised 2002 aggregate production quotas are sufficient to meet the current 2002 estimated medical, scientific, research and industrial needs of the United States and to provide for adequate inventories.

Therefore, under the authority vested in the Attorney General by Section 306 of the Controlled Substances Act of 1970 (21 U.S.C. 826), and delegated to the Administrator of the DEA by § 0.100 of Title 28 of the Code of Federal Regulations, and redelegated to the Deputy Administrator pursuant to § 0.104 of Title 28 of the Code of Federal Regulations, the Deputy Administrator hereby orders that the 2002 final aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:

The Deputy Administrator further orders that aggregate production quotas for all other Schedules I and II controlled substances included in §§ 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 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 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. 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.

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 DEA 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: (202) 307-7183.