Drug Enforcement Administration (DEA), Justice.
Notice of aggregate production quotas for 2009.
This notice establishes initial 2009 aggregate production quotas for Start Printed Page 79515controlled substances in schedules I and II of the Controlled Substances Act (CSA).
Effective Date: December 29, 2008.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D., Chief, Drug & Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, 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 to 28 CFR 0.104.
The 2009 aggregate production quotas represent those quantities of controlled substances 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 for use in industrial processes.
On November 7, 2008, a notice of the proposed initial 2009 aggregate production quotas for certain controlled substances in schedules I and II was published in the Federal Register (73 FR 66256). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before December 8, 2008.
Six responses were received within the published comment period, offering comments on a total of 20 schedule I and II controlled substances. The commenters stated that the proposed aggregate production quotas for 1-piperdinocyclohexanecarbonitrile, codeine (for sale), difenoxin, dihydromorphine, gamma hydroxybutyric acid, hydromorphone, meperidine, merperidine intermediate A, meperidine intermediate B, meperidine intermediate C, methadone, methadone intermediate, methamphetamine (for conversion), methylphenidate, morphine (for sale), nabilone, N-benzylpiperazine, oxycodone (for sale), 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.
One of the commenters also stated that publication of the proposed aggregate production quotas in November leaves insufficient time to consider comments and further commented that DEA has not complied with the requirement of 21 U.S.C. 826(c) to establish manufacturing quota for individual companies by October 1 for the entire calendar year.
DEA is unable to issue individual manufacturing quotas until the initial aggregate production quotas have been established. DEA strives to publish all Federal Register notices pertaining to the aggregate production quotas as early as possible, but is limited by the timeliness and availability of information utilized by the agency in establishing the aggregate production quotas. The publication of the aggregate production quotas was delayed, in part, due to incomplete and late submissions of manufacturer year-end inventories and untimely procurement and manufacturing quota applications. In addition, DEA had to give priority to the current manufacturing and procurement quota requests to ensure the maintenance of an uninterrupted supply in 2008.
In arriving at the aggregate production quotas, DEA has taken into consideration the above comments along with the factors set forth at 21 CFR 1303.11(b) and other relevant 2008 factors, including 2008 manufacturing quotas, current 2008 sales and inventories, 2009 export requirements, additional applications received, and research and product development requirements. Based on this information, DEA has adjusted the initial aggregate production quotas for 1-piperdinocyclohexanecarbonitrile, difenoxin, gamma hydroxybutyric acid, meperidine intermediate A, meperidine intermediate B, meperidine intermediate C, nabilone, N-benzylpiperazine and oxycodone (for sale) to meet the legitimate needs of the United States.
Regarding codeine (for sale), dihydromorphine, hydromorphone, methadone, methadone intermediate, methamphetamine (for conversion), morphine (for sale), tetrahydrocannabinols, and thebaine, DEA has determined that the proposed initial 2009 aggregate production quotas are sufficient to meet the current 2009 estimated medical, scientific, research and industrial needs of the United States.
Pursuant to 21 CFR 1303, the Deputy Administrator of DEA will, in 2009, adjust aggregate production quotas and individual manufacturing quotas allocated for the year based upon 2008 year-end inventory and actual 2008 disposition data supplied by quota recipients for each basic class of schedule I or II controlled substance.
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 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 initial aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows:
|Basic class—Schedule I||Established 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|
|Start Printed Page 79516|
|Gamma-hydroxybutyric acid||24,200,000 g|
|Lysergic acid diethylamide (LSD)||10 g|
|Basic class—Schedule II||Established 2009 quotas|
|Amphetamine (for sale)||17,000,000 g|
|Amphetamine (for conversion)||5,000,000 g|
|Codeine (for sale)||39,605,000 g|
|Codeine (for conversion)||65,000,000 g|
|Start Printed Page 79517|
|Hydrocodone (for sale)||55,000,000 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|
|[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 g|
|Morphine (for conversion)||100,000,000 g|
|Noroxymorphone (for sale)||10,000 g|
|Noroxymorphone (for conversion)||9,000,000 g|
|Opium (powder)||1,050,000 g|
|Opium (tincture)||230,000 g|
|Oxycodone (for sale)||77,560,000 g|
|Oxycodone (for conversion)||3,400,000 g|
|Oxymorphone (for sale)||2,000,000 g|
|Oxymorphone (for conversion)||12,000,000 g|
The Deputy Administrator further orders that aggregate production quotas for all other schedules I and II controlled substances included in 21 CFR 1308.11 and 1308.12 be established 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 $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: December 19, 2008.
Michele M. Leonhart,
[FR Doc. E8-30807 Filed 12-24-08; 8:45 am]
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