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Federal Register/Vol. 75, No. 243/Monday, December 20, 2010

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Federal Register/Vol. 75, No. 243/Monday, December 20, 2010 79412 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices pseudoephedrine, and $100,000,000 or more; a major increase substances’’ by adding the same List I phenylpropanolamine, expressed in in costs or prices; or significant adverse chemicals to the existing language in kilograms of anhydrous acid or base, be effects on competition, employment, paragraph (a), and by adding a new established as follows: investment, productivity, innovation, or paragraph (d) to read as follows: on the ability of United States-based (a) Controlled substances in schedule I or Established companies to compete with foreign- II and narcotic drugs in schedule III, IV, or 2011 assess- based companies in domestic and List I chemical ment of annual V; exceptions needs (kg) export markets. It shall be unlawful to import into the Dated: December 10, 2010. customs territory of the United States from any place outside thereof (but within the Ephedrine (for sale) .............. 4,200 Michele M. Leonhart, Phenylpropanolamine (for United States), or to import into the United Deputy Administrator. sale) .................................. 5,300 States from any place outside thereof, any Pseudoephedrine (for sale) .. 280,000 [FR Doc. 2010–31853 Filed 12–17–10; 8:45 am] controlled substance in schedule I or II of Phenylpropanolamine (for BILLING CODE 4410–09–P subchapter I of this chapter, or any narcotic conversion) ........................ 21,800 drug in schedule III, IV, or V of subchapter Ephedrine (for conversion) ... 18,600 I of this chapter, or ephedrine, DEPARTMENT OF JUSTICE pseudoephedrine, and phenylpropanolamine, except that— The Office of Management and Budget Drug Enforcement Administration (1) such amounts of crude opium, poppy has determined that notices of quotas straw, concentrate of poppy straw, and coca are not subject to centralized review [Docket No. DEA–326F] leaves, and of ephedrine, pseudoephedrine, under Executive Order 12866. and phenylpropanolamine, as the Attorney This action does not preempt or Final Revised Assessment of Annual General finds to be necessary to provide for modify any provision of State law; nor Needs for the List I Chemicals medical, scientific, or other legitimate does it impose enforcement Ephedrine, Pseudoephedrine, and purposes responsibilities on any State; nor does it Phenylpropanolamine for 2010 * * * may be so imported under such diminish the power of any State to regulations as the Attorney General shall AGENCY: prescribe. enforce its own laws. Accordingly, this Drug Enforcement action does not have any federalism Administration (DEA), Justice. * * * * * implications warranting the application ACTION: Notice of Final Assessment of (d)(1) With respect to a registrant under Annual Needs for 2010. section 958 who is authorized under of Executive Order 13132. subsection (a)(1) to import ephedrine, The Deputy Administrator hereby SUMMARY: This notice establishes the pseudoephedrine, or phenylpropanolamine, certifies that this action will not have a Final Revised 2010 Assessment of at any time during the year the registrant may significant economic impact upon a Annual Needs for certain List I apply for an increase in the amount of such substantial number of small entities chemicals in accordance with the chemical that the registrant is authorized to whose interests must be considered import, and the Attorney General may Combat Methamphetamine Epidemic approve the application if the Attorney under the Regulatory Flexibility Act, 5 Act of 2005 (CMEA), enacted on March U.S.C. 601–612. The establishment of General determines that the approval is 9, 2006. necessary to provide for medical, scientific, Assessment of Annual Needs for DATES: Effective Date: December 20, or other legitimate purposes regarding the ephedrine, pseudoephedrine, and 2010. chemical. phenylpropanolamine is mandated by law. The assessments are necessary to FOR FURTHER INFORMATION CONTACT: Editor’s Note: This excerpt of the provide for the estimated medical, Christine A. Sannerud, PhD, Chief, Drug amendment is published for the convenience scientific, research and industrial needs & Chemical Evaluation Section, Drug of the reader. The official text is published of the United States; for lawful export Enforcement Administration (DEA), at 21 U.S.C. 952(a) and (d)(1). requirements; and the establishment Springfield, Virginia 22152, Telephone: The 2010 Assessment of Annual and maintenance of reserve stocks. (202) 307–7183. Needs represents those quantities of Accordingly, the Deputy Administrator SUPPLEMENTARY INFORMATION: Section ephedrine, pseudoephedrine, and has determined that this action does not 713 of the Combat Methamphetamine phenylpropanolamine which may be require a regulatory flexibility analysis. Epidemic Act of 2005 (Title VII of Pub. manufactured domestically and/or This action meets the applicable L. 109–177) (CMEA) amended Section imported into the United States in 2010 standards set forth in Sections 3(a) and 306 of the Controlled Substances Act to provide adequate supplies of each 3(b)(2) of Executive Order 12988 Civil (CSA) (21 U.S.C. 826) by adding chemical for: The estimated medical, Justice Reform. ephedrine, pseudoephedrine, and scientific, research, and industrial needs This action will not result in the phenylpropanolamine to existing of the United States; lawful export expenditure by State, local, and Tribal language to read as follows: ‘‘The requirements; and the establishment governments, in the aggregate, or by the Attorney General shall determine the and maintenance of reserve stocks. private sector, of $120,000,000 or more total quantity and establish production On June 28, 2010, a notice entitled, (adjusted for inflation) in any one year, quotas for each basic class of controlled ‘‘Proposed Revised Assessment of and will not significantly or uniquely substance in schedules I and II and for Annual Needs for the List I Chemicals affect small governments. Therefore, no ephedrine, pseudoephedrine, and Ephedrine, Pseudoephedrine, and actions were deemed necessary under phenylpropanolamine to be Phenylpropanolamine for 2010’’ was the provisions of the Unfunded manufactured each calendar year to published in the Federal Register (75 Mandates Reform Act of 1995. provide for the estimated medical, FR 36684). This notice proposed the This action is not a major rule as scientific, research, and industrial needs revised 2010 Assessment of Annual defined by Section 804 of the Small of the United States, for lawful export Needs for ephedrine (for sale), Business Regulatory Enforcement requirements, and for the establishment ephedrine (for conversion), Fairness Act of 1996 (Congressional and maintenance of reserve stocks.’’ pseudoephedrine (for sale), Review Act). This action will not result Further, 715 of CMEA amended 21 phenylpropanolamine (for sale) and in an annual effect on the economy of U.S.C. 952 ‘‘Importation of controlled phenylpropanolamine (for conversion). VerDate Mar<15>2010 17:18 Dec 17, 2010 Jkt 223001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\20DEN1.SGM 20DEN1 jlentini on DSKJ8SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 79413 All interested persons were invited to including those quota applications that manufacturers and importers in comment on or object to the proposed DEA received between the drafting of procurement quota applications (DEA assessments on or before July 28, 2010. the June 28th notice and the drafting of 250), from manufacturing quota this notice on August 10, 2010. DEA is applications (DEA 189), and from Comments Received providing the data used in developing import quota applications (DEA 488).1 DEA did not receive any comments to the established assessments for each of DEA further considered trends as the Assessment of Annual Needs for the listed chemicals. derived from information provided in ephedrine (for sale), ephedrine (for applications for import, manufacturing, conversion), pseudoephedrine (for sale), Underlying Data and DEA’s Analysis and procurement quotas and in import phenylpropanolamine (for sale) and In determining the 2010 assessments, and export declarations. DEA notes that phenylpropanolamine (for conversion). DEA has considered the total net the inventory, acquisitions (purchases) DEA is finalizing the assessments for disposals (i.e. sales) of the List I and disposition (sales) data provided by these List I chemicals based on chemicals for the current and preceding DEA registered manufacturers and information contained in applications two years, actual and estimated importers reflects the most current for 2010 import, manufacturing and inventories, projected demand (2010), information available. procurement quotas provided by DEA industrial use, and export requirements registered importers and manufacturers, from data provided by DEA registered Ephedrine (for Sale) Data EPHEDRINE (FOR SALE) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS [Kilograms] 2010 Ephedrine 2007 2008 2009 Request Sales * (DEA 250) ............................................................................................................ 2,698 2,507 2,650 3,289 Imports ** (DEA 488) ....................................................................................................... 9,595 1,690 2,139 2,431 Export Declarations (DEA 486) ....................................................................................... 168 18 64 n/a Inventory * (DEA 250) .....................................................................................................
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