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 28 CFR 0.100. The Administrator, in turn, has redelegated this function to the Deputy Administrator, pursuant 28 CFR 0.104.

The 2010 aggregate production quotas represent those quantities of controlled substances in schedules I and II that may be produced in the United States in 2010 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 June 23, 2010, a notice of the proposed revised 2010 aggregate production quotas for certain controlled substances in schedules I and II was published in the Federal Register (75 FR 35838). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before July 23, 2010.

Fourteen companies, thirteen DEA registered manufacturers and one non-registrant, commented on a total of 28 schedules I and II controlled substances within the published comment period. Comments received proposed that the aggregate production quotas for alfentanil, amphetamine (for conversion), amphetamine (for sale), codeine (for conversion), codeine (for sale), dextropropoxyphene, dihydromorphine, diphenoxylate, gamma hydroxybutyric acid, hydrocodone, hydromorphone, lisdexamfetamine, meperidine, methadone, methylphenidate, morphine (for conversion), morphine (for sale), nabilone, opium (tincture), oxycodone (for conversion), oxycodone (for sale), oxymorphone (for sale), remifentanil, sufentanil, tapentadol, tetrahydrocannabinols, thebaine and tilidine 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 2009 year-end inventories, initial 2010 manufacturing quotas, 2010 export requirements, actual and projected 2010 sales, research, product development requirements and additional applications received. Based on this information, the DEA has adjusted the final 2010 aggregate production quotas for alfentanil, amphetamine (for conversion), amphetamine (for sale), carfentanil, dihydromorphine, diphenoxylate, marihuana, morphine (for sale), noroxymorphone (for sale), opium (tincture), oxycodone (for conversion), oxycodone (for sale), oxymorphone (for conversion), oxymorphone (for sale), tapentadol, tetrahydrocannabinols, and tilidine.

4-anilino-N-phenethyl-4-piperidine (ANPP) pursuant to DEA's final rule published in the Federal Register on June 29, 2010 (75 FR 37295) will be controlled as a schedule II controlled substance on August 30, 2010. As such, DEA has established an aggregate production quota for ANPP to meet the estimated medical, scientific, research, and industrial needs of the United States; lawful export requirements; and the establishment and maintenance of reserve stocks.

Regarding codeine (for conversion), codeine (for sale), dextropropoxyphene, gamma hydroxybutyric acid, hydrocodone, hydromorphone, lisdexamfetamine, meperidine, methadone, methylphenidate, morphine (for conversion), nabilone, remifentanil, sufentanil, and thebaine, DEA has determined that the proposed revised 2010 aggregate production quotas are sufficient to meet the current 2010 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 CSA (21 U.S.C. 826), and delegated to the Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy Administrator, pursuant to 28 CFR 0.104, the Deputy ( printed page 55829) Administrator hereby orders that the 2010 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 the aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 shall be zero.

The Office of Management and Budget has determined that notices of aggregate production quotas are not subject to ( printed page 55831) 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 $126,400,000 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.