Controlled Substances: Established Initial Aggregate Production Quotas for 2009, 79514-79518 [E8-30807]

Download as PDF dwashington3 on PROD1PC60 with NOTICES 79514 Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Notices together, §§ 826 and 952 require that DEA issue individual import and manufacturing quotas to registrants registered to import or manufacture ephedrine, pseudoephedrine, and phenylpropanolamine who apply for, and are granted, such individual quotas. As section 826 indicates, the Assessment of Annual Needs is established for each calendar year (21 U.S.C. 826(a)). The Attorney General, DEA by delegation, is required ‘‘to limit or reduce individual production quotas to the extent necessary to prevent the aggregate of individual quotas from exceeding the amount determined necessary each year by the Attorney General,’’ i.e., the Assessment of Annual Needs (21 U.S.C. 826(b)). Thus, individual manufacturing and import quotas for ephedrine, pseudoephedrine, and phenylpropanolamine cannot be calculated without the establishment of the Assessment of Annual Needs. If DEA were not to establish the initial Assessment of Annual Needs, while seeking additional comment, DEA would be unable to issue individual quotas to importers and manufacturers who had applied for, and were to be granted, such quotas. If DEA cannot issue such individual quotas prior to January 1, 2009, importers and manufacturers will have no means by which to acquire the List I chemicals ephedrine, pseudoephedrine, or phenylpropanolamine necessary for them to conduct business. DEA believes that it is in the public interest to ensure that importers and manufacturers of products containing ephedrine, pseudoephedrine, and phenylpropanolamine be able to obtain these List I chemicals on and after January 1, 2009. DEA wishes to ensure that products containing these List I chemicals remain available to the public while interested parties are provided with further opportunity to comment on DEA’s Assessment of Annual Needs. To ensure availability of these products, and to ensure continued legitimate commerce, including the importation and manufacture of products containing these List I chemicals, DEA finds good cause to publish this Assessment of Annual Needs on an interim basis while seeking additional comment. In so doing, DEA recognizes that exceptions to the APA’s notice and comment procedures are to be ‘‘narrowly construed and only reluctantly countenanced.’’ Am. Fed’n of Gov’t Employees v. Block, 655 F2d 1153, 1156 (D.C. Cir. 1981) (quoting New Jersey Dep’t of Envtl. Prot. v. EPA, 626 F.2d 1038, 1045 (D.C. Cir. 1980)). Under 5 U.S.C. 553(d), DEA must generally provide a 30-day delayed VerDate Aug<31>2005 13:19 Dec 24, 2008 Jkt 217001 effective date for final rules. DEA may dispense with the 30-day delayed effective date requirement ‘‘for good cause found and published with the rule.’’ DEA believes that good cause exists to make this Interim Assessment of Annual Needs with Request for Comment effective January 1, 2009. As DEA noted previously, the 2009 Assessment of Annual Needs must be established, and individual quotas issued, on January 1, 2009, so as not to impede legitimate commerce in these List I chemicals during the calendar year. DEA believes that good cause exists not to delay the effective date of this notice by 30 days to ensure that the Assessment of Annual Needs may be established, and individual import and manufacturing quotas issued, by January 1, 2009. Finally, DEA notes that the CSA and its implementing regulations allow registrants who have applied for or received a manufacturing quota to apply for an increase in that quota to meet the registrant’s estimated disposal, inventory, or other requirements during the remainder of the year (21 U.S.C. 826(e), 21 CFR 1315.25(a), 1315.32(g)). Further, the CSA and its implementing regulations allow registrants who are authorized to import ephedrine, pseudoephedrine, or phenylpropanolamine to apply for an increase in the amount of the chemical the registrant is authorized to import (21 U.S.C. 952(d), 21 CFR 1315.36(b)). DEA notes that registrants may use these provisions to request increases in individual manufacturing and import quotas, respectively, pending any revisions of this Interim Assessment. Regulatory Flexibility Act The Deputy Administrator hereby certifies that this action will not have a significant economic impact on a substantial number of small entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601–612. The establishment of the assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine is mandated by law. The assessments are necessary to provide for the estimated medical, scientific, research, and industrial needs of the U.S., for lawful export requirements, and the establishment and maintenance of reserve stocks. Accordingly, the Deputy Administrator has determined that this action does not require a regulatory flexibility analysis. Executive Order 12866 The Office of Management and Budget has determined that notices of assessment of annual needs are not PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 subject to centralized review under Executive Order 12866. Executive Order 13132 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. Executive Order 12988 This action meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform. Unfunded Mandates Reform Act of 1995 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 (adjusted for inflation) 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. Congressional Review Act 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 U.S.-based companies to compete with foreign-based companies in domestic and export markets. Dated: December 19, 2008. Michele M. Leonhart, Deputy Administrator. [FR Doc. E8–30808 Filed 12–24–08; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [DEA # 317E] Controlled Substances: Established Initial Aggregate Production Quotas for 2009 AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of aggregate production quotas for 2009. SUMMARY: This notice establishes initial 2009 aggregate production quotas for E:\FR\FM\29DEN1.SGM 29DEN1 Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Notices controlled substances in schedules I and II of the Controlled Substances Act (CSA). DATES: Effective Date: December 29, 2008. FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, Drug & 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 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 1piperdinocyclohexanecarbonitrile, difenoxin, gamma hydroxybutyric acid, meperidine intermediate A, meperidine intermediate B, meperidine intermediate C, nabilone, Nbenzylpiperazine 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: Established 2009 quotas dwashington3 on PROD1PC60 with NOTICES Basic class—Schedule I 2,5–Dimethoxyamphetamine ........................................................................................................................................................... 2,5–Dimethoxy-4-ethylamphetamine (DOET) .................................................................................................................................. 3–Methylfentanyl .............................................................................................................................................................................. 3–Methylthiofentanyl ........................................................................................................................................................................ 3,4–Methylenedioxyamphetamine (MDA) ........................................................................................................................................ 3,4–Methylenedioxy-N-ethylamphetamine (MDEA) ......................................................................................................................... 3,4–Methylenedioxymethamphetamine (MDMA) ............................................................................................................................. 3,4,5–Trimethoxyamphetamine ....................................................................................................................................................... 4–Bromo-2,5-dimethoxyamphetamine (DOB) ................................................................................................................................. 4–Bromo-2,5-dimethoxyphenethylamine (2–CB) ............................................................................................................................. 4–Methoxyamphetamine .................................................................................................................................................................. 4–Methylaminorex ............................................................................................................................................................................ 4–Methyl-2,5-dimethoxyamphetamine (DOM) ................................................................................................................................. VerDate Aug<31>2005 13:19 Dec 24, 2008 Jkt 217001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 79515 E:\FR\FM\29DEN1.SGM 29DEN1 2 2 2 2 25 10 20 2 2 2 27 2 2 g g g g g g g g g g g g g 79516 Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Notices Established 2009 quotas Basic class—Schedule I 5–Methoxy-3,4-methylenedioxyamphetamine ................................................................................................................................. 5–Methoxy-N,N-diisopropyltryptamine ............................................................................................................................................. Acetyl-alpha-methylfentanyl ............................................................................................................................................................. Acetyldihydrocodeine ....................................................................................................................................................................... Acetylmethadol ................................................................................................................................................................................ Allylprodine ...................................................................................................................................................................................... Alphacetylmethadol .......................................................................................................................................................................... Alpha-ethyltryptamine ...................................................................................................................................................................... Alphameprodine ............................................................................................................................................................................... Alphamethadol ................................................................................................................................................................................. Alpha-methylfentanyl ....................................................................................................................................................................... Alpha-methylthiofentanyl .................................................................................................................................................................. Aminorex .......................................................................................................................................................................................... Benzylmorphine ............................................................................................................................................................................... Betacetylmethadol ........................................................................................................................................................................... Beta-hydroxy-3-methylfentanyl ........................................................................................................................................................ Beta-hydroxyfentanyl ....................................................................................................................................................................... Betameprodine ................................................................................................................................................................................. Betamethadol ................................................................................................................................................................................... Betaprodine ...................................................................................................................................................................................... Bufotenine ........................................................................................................................................................................................ Cathinone ......................................................................................................................................................................................... Codeine-N-oxide .............................................................................................................................................................................. Diethyltryptamine ............................................................................................................................................................................. Difenoxin .......................................................................................................................................................................................... Dihydromorphine .............................................................................................................................................................................. Dimethyltryptamine .......................................................................................................................................................................... Gamma-hydroxybutyric acid ............................................................................................................................................................ Heroin .............................................................................................................................................................................................. Hydromorphinol ................................................................................................................................................................................ Hydroxypethidine ............................................................................................................................................................................. Ibogaine ........................................................................................................................................................................................... Lysergic acid diethylamide (LSD) .................................................................................................................................................... Marihuana ........................................................................................................................................................................................ Mescaline ......................................................................................................................................................................................... Methaqualone .................................................................................................................................................................................. Methcathinone ................................................................................................................................................................................. Methyldihydromorphine .................................................................................................................................................................... Morphine-N-oxide ............................................................................................................................................................................ N-Benzylpiperazine .......................................................................................................................................................................... N,N-Dimethylamphetamine .............................................................................................................................................................. N-Ethylamphetamine ....................................................................................................................................................................... N-Hydroxy-3,4-methylenedioxyamphetamine .................................................................................................................................. Noracymethadol ............................................................................................................................................................................... Norlevorphanol ................................................................................................................................................................................. Normethadone ................................................................................................................................................................................. Normorphine .................................................................................................................................................................................... Para-fluorofentanyl ........................................................................................................................................................................... Phenomorphan ................................................................................................................................................................................ Pholcodine ....................................................................................................................................................................................... Psilocybin ......................................................................................................................................................................................... Psilocyn ............................................................................................................................................................................................ Tetrahydrocannabinols .................................................................................................................................................................... Thiofentanyl ..................................................................................................................................................................................... Trimeperidine ................................................................................................................................................................................... 2 5 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 602 2 3,000 2,549,000 3 24,200,000 20 2 2 1 10 4,500,000 7 5 4 2 605 2 7 2 2 2 52 2 16 2 2 2 7 7 312,500 2 2 g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g dwashington3 on PROD1PC60 with NOTICES Basic class—Schedule II Established 2009 quotas 1–Phenylcyclohexylamine ................................................................................................................................................................ 1–piperdinocyclohexanecarbonitrile ................................................................................................................................................. Alfentanil .......................................................................................................................................................................................... Alphaprodine .................................................................................................................................................................................... Amobarbital ...................................................................................................................................................................................... Amphetamine (for sale) ................................................................................................................................................................... Amphetamine (for conversion) ........................................................................................................................................................ Cocaine ............................................................................................................................................................................................ Codeine (for sale) ............................................................................................................................................................................ Codeine (for conversion) ................................................................................................................................................................. Dextropropoxyphene ........................................................................................................................................................................ Dihydrocodeine ................................................................................................................................................................................ Diphenoxylate .................................................................................................................................................................................. Ecgonine .......................................................................................................................................................................................... 2 2 8,000 2 3 17,000,000 5,000,000 247,000 39,605,000 65,000,000 106,000,000 1,200,000 947,000 83,000 VerDate Aug<31>2005 13:19 Dec 24, 2008 Jkt 217001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1 g g g g g g g g g g g g g g Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Notices 79517 Established 2009 quotas Basic class—Schedule II dwashington3 on PROD1PC60 with NOTICES Ethylmorphine .................................................................................................................................................................................. 2g Fentanyl ........................................................................................................................................................................................... 1,428,000 g Glutethimide ..................................................................................................................................................................................... 2g Hydrocodone (for sale) .................................................................................................................................................................... 55,000,000 g Hydromorphone ............................................................................................................................................................................... 3,300,000 g Isomethadone .................................................................................................................................................................................. 2g Levo-alphacetylmethadol (LAAM) .................................................................................................................................................... 3g Levomethorphan .............................................................................................................................................................................. 5g Levorphanol ..................................................................................................................................................................................... 10,000 g Lisdexamfetamine ............................................................................................................................................................................ 6,200,000 g Meperidine ....................................................................................................................................................................................... 8,600,000 g Meperidine Intermediate-A .............................................................................................................................................................. 3g Meperidine Intermediate-B .............................................................................................................................................................. 7g Meperidine Intermediate-C .............................................................................................................................................................. 3g Metazocine ....................................................................................................................................................................................... 1g Methadone (for sale) ....................................................................................................................................................................... 25,000,000 g Methadone Intermediate .................................................................................................................................................................. 26,000,000 g Methamphetamine ........................................................................................................................................................................... 3,130,000 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)] Methylphenidate ............................................................................................................................................................................... 50,000,000 g Morphine (for sale) .......................................................................................................................................................................... 35,000,000 g Morphine (for conversion) ................................................................................................................................................................ 100,000,000 g Nabilone ........................................................................................................................................................................................... 9,002 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 Oripavine .......................................................................................................................................................................................... 15,000,000 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 Pentobarbital .................................................................................................................................................................................... 28,000,000 g Phenazocine .................................................................................................................................................................................... 1g Phencyclidine ................................................................................................................................................................................... 20 g Phenmetrazine ................................................................................................................................................................................. 2g Phenylacetone ................................................................................................................................................................................. 1g Racemethorphan ............................................................................................................................................................................. 2g Remifentanil ..................................................................................................................................................................................... 500 g Secobarbital ..................................................................................................................................................................................... 67,000 g Sufentanil ......................................................................................................................................................................................... 10,300 g Thebaine .......................................................................................................................................................................................... 126,000,000 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 VerDate Aug<31>2005 13:19 Dec 24, 2008 Jkt 217001 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. PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 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 foreignbased companies in domestic and export markets. E:\FR\FM\29DEN1.SGM 29DEN1 79518 Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Notices Dated: December 19, 2008. Michele M. Leonhart, Deputy Administrator. [FR Doc. E8–30807 Filed 12–24–08; 8:45 am] BILLING CODE 4410–09–P NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (08–099)] Notice of Information Collection AGENCY: National Aeronautics and Space Administration. ACTION: Notice of information collection cancellation. SUMMARY: We are cancelling FR Notice 08–093, Information Collection Title: TITLE IX Survey, published at 73 FR 70678, November 21, 2008, because we determined the need to implement compliance programs under three additional grant-related civil rights laws for which NASA has regulations, i.e., Title VI of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, and the Age Discrimination Act of 1975. In FY 2009, NASA will stand-up compliance programs involving at least one onsite compliance review pursuant to each of these laws. We also need to issue a notice of information collection that can support our compliance activities under all four laws, reflecting the differing coverage under each of the laws. FOR FURTHER INFORMATION CONTACT: Dr. Walter Kit, NASA Clearance Officer, NASA Headquarters, 300 E Street SW., JF0000, Washington, DC 20546, (202) 358–1350, Walter.Kit-1@nasa.gov. Walter Kit, NASA Clearance Officer. [FR Doc. E8–30732 Filed 12–24–08; 8:45 am] BILLING CODE 7510–13–M NUCLEAR REGULATORY COMMISSION [Docket No. 72–25] dwashington3 on PROD1PC60 with NOTICES Foster Wheeler Environmental Corporation; Idaho Spent Fuel Facility; Notice of Consideration of Approval of Application Regarding Proposed Corporate Restructuring and Opportunity for a Hearing AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of indirect license transfer application and opportunity to request a hearing. FOR FURTHER INFORMATION, CONTACT: Shana Helton, Senior Project Manager, VerDate Aug<31>2005 13:19 Dec 24, 2008 Jkt 217001 Licensing Branch, Division of Spent Fuel Storage and Transportation, Office of Nuclear Material Safety and Safeguards (NMSS), U.S. Nuclear Regulatory Commission (NRC), Rockville, MD 20852. Telephone: (301) 492–3284; fax number: (301) 492–3348; e-mail: shana.helton@nrc.gov. SUPPLEMENTARY INFORMATION: The U.S. Nuclear Regulatory Commission (the Commission) is considering the issuance of an order under 10 CFR 72.50 approving the indirect transfer of Special Nuclear Materials (SNM) License No. 2512 for the Idaho Spent Fuel (ISF) Facility independent spent fuel storage installation (ISFSI) currently held by Foster Wheeler Environmental Corporation (FWENC). According to an application for approval filed by FWENC, the indirect transfer of control of FWENC’s license would result from a planned corporate restructuring whereby Foster Wheeler AG will become the new corporate parent holding company, replacing FWENC’s current parent holding company, Foster Wheeler Ltd. Foster Wheeler Ltd. is a corporation duly organized under the laws of Bermuda, with shares that are widely held and publicly traded in the United States on the NASDAQ Global Select Market. The proposed new parent holding company, Foster Wheeler AG, is a corporation duly organized under the laws of Switzerland. No physical changes to the ISF facility or operational changes are being proposed in the application. Additionally, according to the application, the proposed restructuring will not impact the operations of FWENC, nor will it impact any of the terms and conditions under which it holds SNM–2512. Pursuant to 10 CFR 72.50, no license or any part included in a license issued under 10 CFR Part 72 for an ISFSI shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, unless the Commission shall give its consent in writing. The Commission will approve an application for the indirect transfer of a license, if the Commission determines that the proposed restructuring will not affect the qualifications of the licensee to hold the license, and that the transfer is consistent with applicable provisions of law and the regulations and orders issued by the Commission. The filing of requests for hearing and petitions for leave to intervene, and written comments with regard to the license transfer application, are discussed below. PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 Within 20 days from the date of publication of this notice, any person(s) whose interest may be affected by the Commission’s action on the application may request a hearing and intervention via electronic submission through the NRC E-filing system. Requests for a hearing and petitions for leave to intervene should be filed in accordance with the Commission’s rules of practice set forth in Subpart C ‘‘Rules of General Applicability: Hearing Requests, Petitions to Intervene, Availability of Documents, Selection of Specific Hearing Procedures, Presiding Officer Powers, and General Hearing Management for NRC Adjudicatory Hearings,’’ of 10 CFR Part 2. In particular, such requests and petitions must comply with the requirements set forth in 10 CFR 2.309. Untimely requests and petitions may be denied, as provided in 10 CFR 2.309(c)(1), unless good cause for failure to file on time is established. In addition, an untimely request or petition should address the factors that the Commission will also consider, in reviewing untimely requests or petitions, set forth in 10 CFR 2.309(c)(1)(i)–(viii). A request for hearing or a petition for leave to intervene must be filed in accordance with the NRC E-Filing rule, which the NRC promulgated on August 28, 2007 (72 FR 49139). The E-Filing process requires participants to submit and serve documents over the internet or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek a waiver in accordance with the procedures described below. To comply with the procedural requirements of E-Filing, at least ten (10) days prior to the filing deadline, the petitioner/requestor must contact the Office of the Secretary by e-mail at hearing.docket@nrc.gov, or by calling (301) 415–1677, to request (1) a digital ID certificate, which allows the participant (or its counsel or representative) to digitally sign documents and access the E-Submittal server for any proceeding in which it is participating; and/or (2) creation of an electronic docket for the proceeding (even in instances in which the petitioner/requestor (or its counsel or representative) already holds an NRCissued digital ID certificate). Each petitioner/requestor will need to download the Workplace Forms ViewerTM to access the Electronic Information Exchange (EIE), a component of the E-Filing system. The Workplace Forms ViewerTM is free and is available at http://www.nrc.gov/sitehelp/e-submittals/install-viewer.html. E:\FR\FM\29DEN1.SGM 29DEN1

Agencies

[Federal Register Volume 73, Number 249 (Monday, December 29, 2008)]
[Notices]
[Pages 79514-79518]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30807]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA  317E]


Controlled Substances: Established Initial Aggregate Production 
Quotas for 2009

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 2009.

-----------------------------------------------------------------------

SUMMARY: This notice establishes initial 2009 aggregate production 
quotas for

[[Page 79515]]

controlled substances in schedules I and II of the Controlled 
Substances Act (CSA).

DATES: Effective Date: December 29, 2008.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, 
Drug & 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 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:

------------------------------------------------------------------------
                                                        Established 2009
                Basic class--Schedule I                      quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine..............................               2 g
2,5-Dimethoxy-4-ethylamphetamine (DOET)...............               2 g
3-Methylfentanyl......................................               2 g
3-Methylthiofentanyl..................................               2 g
3,4-Methylenedioxyamphetamine (MDA)...................              25 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)..........              10 g
3,4-Methylenedioxymethamphetamine (MDMA)..............              20 g
3,4,5-Trimethoxyamphetamine...........................               2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB)................               2 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)............               2 g
4-Methoxyamphetamine..................................              27 g
4-Methylaminorex......................................               2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM)...............               2 g

[[Page 79516]]

 
5-Methoxy-3,4-methylenedioxyamphetamine...............               2 g
5-Methoxy-N,N-diisopropyltryptamine...................               5 g
Acetyl-alpha-methylfentanyl...........................               2 g
Acetyldihydrocodeine..................................               2 g
Acetylmethadol........................................               2 g
Allylprodine..........................................               2 g
Alphacetylmethadol....................................               2 g
Alpha-ethyltryptamine.................................               2 g
Alphameprodine........................................               2 g
Alphamethadol.........................................               2 g
Alpha-methylfentanyl..................................               2 g
Alpha-methylthiofentanyl..............................               2 g
Aminorex..............................................               2 g
Benzylmorphine........................................               2 g
Betacetylmethadol.....................................               2 g
Beta-hydroxy-3-methylfentanyl.........................               2 g
Beta-hydroxyfentanyl..................................               2 g
Betameprodine.........................................               2 g
Betamethadol..........................................               2 g
Betaprodine...........................................               2 g
Bufotenine............................................               3 g
Cathinone.............................................               3 g
Codeine-N-oxide.......................................             602 g
Diethyltryptamine.....................................               2 g
Difenoxin.............................................           3,000 g
Dihydromorphine.......................................       2,549,000 g
Dimethyltryptamine....................................               3 g
Gamma-hydroxybutyric acid.............................      24,200,000 g
Heroin................................................              20 g
Hydromorphinol........................................               2 g
Hydroxypethidine......................................               2 g
Ibogaine..............................................               1 g
Lysergic acid diethylamide (LSD)......................              10 g
Marihuana.............................................       4,500,000 g
Mescaline.............................................               7 g
Methaqualone..........................................               5 g
Methcathinone.........................................               4 g
Methyldihydromorphine.................................               2 g
Morphine-N-oxide......................................             605 g
N-Benzylpiperazine....................................               2 g
N,N-Dimethylamphetamine...............................               7 g
N-Ethylamphetamine....................................               2 g
N-Hydroxy-3,4-methylenedioxyamphetamine...............               2 g
Noracymethadol........................................               2 g
Norlevorphanol........................................              52 g
Normethadone..........................................               2 g
Normorphine...........................................              16 g
Para-fluorofentanyl...................................               2 g
Phenomorphan..........................................               2 g
Pholcodine............................................               2 g
Psilocybin............................................               7 g
Psilocyn..............................................               7 g
Tetrahydrocannabinols.................................         312,500 g
Thiofentanyl..........................................               2 g
Trimeperidine.........................................               2 g
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                        Established 2009
               Basic class--Schedule II                      quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine...............................               2 g
1-piperdinocyclohexanecarbonitrile....................               2 g
Alfentanil............................................           8,000 g
Alphaprodine..........................................               2 g
Amobarbital...........................................               3 g
Amphetamine (for sale)................................      17,000,000 g
Amphetamine (for conversion)..........................       5,000,000 g
Cocaine...............................................         247,000 g
Codeine (for sale)....................................      39,605,000 g
Codeine (for conversion)..............................      65,000,000 g
Dextropropoxyphene....................................     106,000,000 g
Dihydrocodeine........................................       1,200,000 g
Diphenoxylate.........................................         947,000 g
Ecgonine..............................................          83,000 g

[[Page 79517]]

 
Ethylmorphine.........................................               2 g
Fentanyl..............................................       1,428,000 g
Glutethimide..........................................               2 g
Hydrocodone (for sale)................................      55,000,000 g
Hydromorphone.........................................       3,300,000 g
Isomethadone..........................................               2 g
Levo-alphacetylmethadol (LAAM)........................               3 g
Levomethorphan........................................               5 g
Levorphanol...........................................          10,000 g
Lisdexamfetamine......................................       6,200,000 g
Meperidine............................................       8,600,000 g
Meperidine Intermediate-A.............................               3 g
Meperidine Intermediate-B.............................               7 g
Meperidine Intermediate-C.............................               3 g
Metazocine............................................               1 g
Methadone (for sale)..................................      25,000,000 g
Methadone Intermediate................................      26,000,000 g
Methamphetamine.......................................      3,130,000 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)] ...........................................
Methylphenidate.......................................      50,000,000 g
Morphine (for sale)...................................      35,000,000 g
Morphine (for conversion).............................     100,000,000 g
Nabilone..............................................           9,002 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
Oripavine.............................................      15,000,000 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
Pentobarbital.........................................      28,000,000 g
Phenazocine...........................................               1 g
Phencyclidine.........................................              20 g
Phenmetrazine.........................................               2 g
Phenylacetone.........................................               1 g
Racemethorphan........................................               2 g
Remifentanil..........................................             500 g
Secobarbital..........................................          67,000 g
Sufentanil............................................          10,300 g
Thebaine..............................................     126,000,000 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.


[[Page 79518]]


    Dated: December 19, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-30807 Filed 12-24-08; 8:45 am]
BILLING CODE 4410-09-P