Drug Enforcement Administration (DEA), Justice.
Notice of final aggregate production quotas for 2009.
This notice establishes final 2009 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 2009 published July 23, 2009 (74 FR 36511).
Effective Date: October 21, 2009.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D, 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 2009 aggregate production quotas represent those quantities of controlled substances in schedules I and II that may be produced in the United States in 2009 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, 2009, a notice of the proposed revised 2009 aggregate production quotas for certain controlled substances in schedules I and II was published in the Federal Register (74 FR 36511). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before August 24, 2009.
Seven companies commented on a total of 18 schedules I and II controlled substances within the published comment period. Seven companies proposed that the aggregate production quotas for amphetamine (for sale), codeine (for conversion), dihydromorphine, fentanyl, hydrocodone (for sale), hydromorphone, lisdexamfetamine, methadone, methadone intermediate, methamphetamine (for sale), methylphenidate, nabilone, opium (tincture), oxycodone (for sale), oxycodone (for conversion), oxymorphone (for sale), phenylacetone, 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 2008 year-end inventories, initial 2009 manufacturing quotas, 2009 export requirements, actual and projected 2009 sales, research, product development requirements, and additional applications received. Based on this information, the DEA has adjusted the final 2009 aggregate production quotas for amphetamine (for conversion), dihydromorphine, hydrocodone (for sale), hydromorphone, lisdexamfetamine, morphine (for sale), opium (tincture), oxycodone (for sale), oxycodone (for conversion), oxymorphone (for sale), and phenylacetone to meet the legitimate needs of the United States.
Regarding amphetamine (for sale), codeine (for conversion), fentanyl, methadone, methadone intermediate, methamphetamine (for sale), methylphenidate, nabilone, and thebaine, the DEA has determined that the proposed revised 2009 aggregate production quotas are sufficient to meet the current 2009 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 2009 final aggregate production quotas for the following controlled substances, Start Printed Page 54078expressed in grams of anhydrous acid or base, be established as follows:
|Basic class—Schedule I||Final revised 2009 quotas|
|2,5-Dimethoxy-4-ethylamphetamine (DOET)||2 g|
|3,4-Methylenedioxyamphetamine (MDA)||25 g|
|3,4-Methylenedioxy-N-ethylamphetamine (MDEA)||10 g|
|3,4-Methylenedioxymethamphetamine (MDMA)||20 g|
|4-Bromo-2,5-dimethoxyamphetamine (DOB)||2 g|
|4-Bromo-2,5-dimethoxyphenethylamine (2-CB)||2 g|
|4-Methyl-2,5-dimethoxyamphetamine (DOM)||2 g|
|Gamma-hydroxybutyric acid||24,200,00 g|
|Lysergic acid diethylamide (LSD)||10 g|
|Basic class—Schedule II||Final revised 2009 quotas|
|Amphetamine (for sale)||17,000,000 g|
|Amphetamine (for conversion)||7,500,000 g|
|Codeine (for sale)||39,605,000 g|
|Codeine (for conversion)||65,000,000 g|
|Hydrocodone (for sale)||55,500,000 g|
|Levo-alphacetylmethadol (LAAM)||3 g|
|Meperidine Intermediate-A||3 g|
|Meperidine Intermediate-B||7 g|
|Meperidine Intermediate-C||3 g|
|Methadone (for sale)||25,000,000 g|
|Methadone Intermediate||26,000,000 g|
|Morphine (for sale)||36,300,000 g|
|Morphine (for conversion)||100,000,000 g|
|Noroxymorphone (for sale)||10,000 g|
|Noroxymorphone (for conversion)||9,000,000 g|
|Opium (powder)||230,000 g|
|Opium (tincture)||1,250,000 g|
|Oxycodone (for sale)||94,000,000 g|
|Oxycodone (for conversion)||4,500,000 g|
|Oxymorphone (for sale)||2,570,000 g|
|Oxymorphone (for conversion)||12,000,000 g|
DEA proposed the aggregate production quota for tapentadol at 519,000 g in the 2009 proposed revised aggregate production quota notice published on July 23, 2009, in the Federal Register (74 FR 36511). Tapentadol is no longer listed because the material will be imported into the United States and not manufactured domestically.
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 Start Printed Page 54080necessary 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 $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 13, 2009.
Michele M. Leonhart,
[FR Doc. E9-25274 Filed 10-20-09; 8:45 am]
BILLING CODE 4410-09-P