Drug Enforcement Administration (DEA), Justice.
Notice of final aggregate production quotas for 2008.
This notice establishes final 2008 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 2008 published July 1, 2008 (73 FR 37496).
Effective Date: November 12, 2008.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 307-7183.End Further Info End Preamble Start Supplemental 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 2008 aggregate production quotas represent those quantities of controlled substances in schedules I and II that may be produced in the United States in 2008 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 1, 2008, a notice of the proposed revised 2008 aggregate production quotas for certain controlled substances in schedules I and II was published in the Federal Register (73 FR 37496). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before July 31, 2008.
Five companies commented on a total of 25 schedules I and II controlled substances within the published comment period. One additional comment was received after the comment period ended and therefore was not considered. Five companies proposed that the aggregate production quotas for amphetamine (for sale), codeine (for sale), codeine (for conversion), dextropropoxyphene, dihydromorphine, diphenoxylate, fentanyl, gamma-hydroxybutyric acid, hydrocodone (for sale), hydromorphone, methadone, methadone intermediate, morphine (for sale), morphine (for conversion), nabilone, noroxymorphone (for conversion), opium, oripavine, oxycodone (for sale), oxycodone (for conversion), oxymorphone (for sale), oxymorphone (for conversion), sufentanil, tetrahydrocannabinols, 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 2007 year-end inventories, initial 2008 manufacturing quotas, 2008 export requirements, actual and projected 2008 sales, research, product development requirements and additional applications received. Based on this information, the DEA has adjusted the final 2008 aggregate production quotas for codeine (for conversion), diphenoxylate, heroin, hydrocodone (for sale), morphine (for conversion), nabilone, noroxymorphone (for conversion), oxymorphone (for conversion), phenazocine, and phenylacetone to meet the legitimate needs of the United States.
Regarding amphetamine (for sale), codeine (for sale), dextropropoxyphene, dihydromorphine, fentanyl, gamma-hydroxybutyric acid, hydromorphone, methadone, methadone intermediate, morphine (for sale), opium, oripavine, oxycodone (for sale), oxycodone (for conversion), oxymorphone (for sale), sufentanil, tetrahydrocannabinols, and thebaine, the DEA has determined that the proposed revised 2008 aggregate production quotas are sufficient to meet the current 2008 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 Administrator hereby orders that the 2008 final aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:
|Basic class—Schedule I||Final revised 2008 quotas (grams)|
|Start Printed Page 66940|
|Lysergic acid diethylamide (LSD)||61|
|Basic class—Schedule II||Final revised 2008 quotas (grams)|
|Start Printed Page 66941|
|Amphetamine (for sale)||17,000,000|
|Amphetamine (for conversion)||5,000,000|
|Codeine (for sale)||39,605,000|
|Codeine (for conversion)||71,000,000|
|Hydrocodone (for sale)||55,000,000|
|Hydrocodone (for conversion)||1,500,000|
|Methadone (for sale)||25,000,000|
|[680,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,405,000 grams for methamphetamine mostly for conversion to a schedule III product; and 45,000 grams for methamphetamine (for sale)]|
|Morphine (for sale)||35,000,000|
|Morphine (for conversion)||110,000,000|
|Noroxymorphone (for sale)||10,000|
|Noroxymorphone (for conversion)||9,000,000|
|Oxycodone (for sale)||70,000,000|
|Oxycodone (for conversion)||4,820,000|
|Oxymorphone (for sale)||2,000,000|
|Oxymorphone (for conversion)||12,000,000|
The Deputy Administrator further orders that the aggregate production quotas for all other schedules 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 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 Start Printed Page 669423(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 $120,000,000 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.Start Signature
Dated: October 31, 2008.
Michele M. Leonhart,
[FR Doc. E8-26798 Filed 11-10-08; 8:45 am]
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