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).

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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) ...... 1,373 626 191 n/a IMS *** (NSP) ...... 1,236 1,460 1,401 n/a * Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 10, 2010. ** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010. *** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail Channels, Data Extracted August 10, 2010.

Ephedrine (for Sale) Analysis considered information on trends in the DEA calculated the proposed revised DEA previously has established the national rate of net disposals from sales ephedrine (for sale) assessment as 2010 assessment of annual needs for data provided by IMS Health’s NSP follows: database. IMS NSP data reported the 2009 sales + reserve stock + export ephedrine (for sale) at 3,600 kg (74 FR ¥ 60298). average sales volume of ephedrine for requirement existing inventory = AAN 2,650 + (50%*2,650) + 41¥191 = As noted above, DEA developed the the calendar years 2008 and 2009 to be 3,825 kg ephedrine (for sale) for 2010 revisions to the 2010 assessment of approximately 1,431 kg. DEA notes that This calculation suggests that DEA’s annual needs for ephedrine (for sale) the 2009 sales figure reported by assessment of annual needs for using the same calculation and manufacturers (2,650 kg) is higher than ephedrine should be 3,900 kg. DEA methodology that DEA used to the average sales reported by IMS for the notes that its June 28, 2010, notice determine the 2009 and 2010 previous two years (1,431 kg). This is proposed to increase the ephedrine assessment of annual needs. expected because a manufacturer’s assessment to 4,100 kg. That proposal As of August 10, 2010, DEA registered reported sales include quantities which was based on information received as of manufacturers of dosage form products are necessary to provide reserve stocks March 10, 2010. Since that time DEA containing ephedrine requested the for distributors and retailers. DEA, in has received revised manufacture authority to purchase a total of 3,289 kg considering the manufacturer’s reported production data, i.e., sales and ephedrine (for sale) in 2010. DEA sales, thus believes that 2,650 kg fairly inventory information decreasing the registered manufacturers of ephedrine represents the United States sales of reported sales of ephedrine for 2009. reported sales totaling approximately ephedrine for 2010 and that 41 kg fairly After calculating the ephedrine (for sale) 2,507 kg in 2008 and 2,650 kg in 2009; represents the export requirements of assessment using the most current this represents a 5 percent increase in ephedrine. data—that reported by DEA registered sales reported by these firms from 2008 manufactures as of August 10, 2010— to 2009. Additionally, exports of For the establishment and DEA concludes that the proposed ephedrine products from the United maintenance of reserve stocks, DEA revised assessment of 4,100 kg would States as reported on export declarations notes that 21 CFR 1315.24 allows for an have been unnecessarily high. (DEA 486) totaled 18 kg in 2008 and 64 inventory allowance (reserve stock) of Accordingly, DEA is increasing the 2010 kg in 2009; this represents a 72 percent 50 percent of a manufacturer’s estimated assessment of annual needs for increase from levels observed in 2008. sales. DEA also considered the ephedrine (for sale) from 3,600 kg to The average of the 2008 and 2009 estimated 2009 year end inventory as 3,900 kg. exports of ephedrine products is reported by DEA registrants in approximately 41 kg. DEA also determining the inventory allowance. Phenylpropanolamine (for Sale) data

1 Applications and instructions for procurement, http://www.deadiversion.usdoj.gov/quotas/quota_ import and manufacturing quotas can be found at apps.htm.

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PHENYLPROPANOLAMINE (FOR SALE) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS [Kilograms]

Phenylpropanolamine 2010 (for sale) 2007 2008 2009 Request

Sales* (DEA 250) ...... 4,158 4,528 5,355 7,480 Imports** (DEA 488) ...... 5,787 3,425 6,626 7,271 Export Declarations (DEA 486) ...... 1,002 0 3 n/a Inventory* (DEA 250) ...... 3,642 2,470 645 n/a * Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 10, 2010. ** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010.

Phenylpropanolamine (for Sale) and 5,355 kg in 2009; this represents a data does not capture sales of Analysis 15.5% increase in sales reported by phenylpropanolamine to veterinary these firms from 2008 to 2009. channels and is, therefore, not included. DEA previously has established the Additionally, exports of DEA calculated the proposed revised 2010 assessment of annual needs for phenylpropanolamine products from phenylpropanolamine (for sale) phenylpropanolamine (for sale) at 6,400 the United States as reported on export assessment by the following kg (74 FR 60298). declarations (DEA 486) totaled 0 kg in methodology: As noted above, DEA utilized the 2008 and 3 kg in 2009; this represents 2009 sales + reserve stock + export same general methodology and a 3 kg increase from levels observed in requirement ¥ existing inventory = calculation to develop the proposed 2008. The average of the 2008 and 2009 AAN revised assessment for exports of phenylpropanolamine 5,355 + (50%*5,355) + 2 ¥ 645 = phenylpropanolamine (for sale) that products is approximately 2 kg. DEA DEA used to determine the 2009 and 7,390 kg phenylpropanolamine (for sale) thus believes that 5,355 kg fairly for 2010 2010 assessment of annual needs. represents the United States sales of This calculation suggests that DEA’s As of August 10, 2010, DEA registered phenylpropanolamine for 2010 and that 2010 Assessment of Annual Needs for manufacturers of dosage form products 2 kg fairly represents the export phenylpropanolamine (for sale) should containing phenylpropanolamine requirements of phenylpropanolamine. be 7,400 kg. Accordingly, DEA is requested the authority to purchase DEA notes that phenylpropanolamine is increasing the 2010 assessment of 7,480 kg phenylpropanolamine (for sale) sold primarily as a veterinary product annual needs for phenylpropanolamine in 2010. DEA registered manufacturers for the treatment for canine (for sale) from 6,400 kg to 7,400 kg. of phenylpropanolamine reported sales incontinence and is not approved for totaling approximately 4,528 kg in 2008 human consumption. IMS Health’s NSP Pseudoephedrine (for Sale) Data

PSEUDOEPHEDRINE (FOR SALE) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS [Kilograms]

Pseudoephedrine 2010 (for sale) 2007 2008 2009 Request

Sales * (DEA 250) ...... 239,314 224,480 286,607 254,286 Sales * (DEA 189) ...... 100,300 64,781 33,600 32,760 Imports ** (DEA 488) ...... 231,683 170,614 274,492 261,528 Export Declarations (DEA 486) ...... 42,132 47,199 35,264 n/a Inventory * (DEA 250) ...... 136,039 121,374 68,100 n/a IMS *** (NSP) ...... 180,221 149,232 140,784 n/a * Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of August 10, 2010. ** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010. *** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail Channels, Data Extracted August 10, 2010.

Pseudoephedrine (for Sale) Analysis containing pseudoephedrine requested percent decrease from levels observed in DEA previously has established the the authority to purchase 254,286 kg 2008. The average of the 2008 and 2009 2010 assessment of annual needs for pseudoephedrine. DEA registered exports is 41,232 kg. Additionally, DEA pseudoephedrine (for sale) at 404,000 kg manufacturers of pseudoephedrine considered information on trends in the (74 FR 60298). reported sales totaling approximately national rate of net disposals from sales As noted above, DEA utilized the 224,480 kg in 2008 and 286,607 kg in data provided by IMS Health. IMS NSP same general methodology and 2009; this represents a 22 percent data reported the average retail sales calculation to develop the proposed increase in sales reported by these firms volume of pseudoephedrine for the revised assessment for pseudoephedrine from 2008 to 2009. During the same calendar years 2008 and 2009 to be (for sale) that DEA used to determine period exports of pseudoephedrine approximately 145,006 kg. DEA thus the 2009 and 2010 assessment of annual products from the United States as believes that 286,607 kg of sales needs. reported on export declarations (DEA reported by manufacturers fairly As of August 10, 2010, DEA registered 486) totaled 47,199 kg in 2008 and represents the United States sales of manufacturers of dosage form products 35,264 kg in 2009; this represents a 25 pseudoephedrine for 2010 and that

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41,232 kg fairly represents the export 286,607 + (50%*286,607) + 41,232 ¥ information, the 2009 reported sales of requirements of pseudoephedrine. DEA 68,100 = 403,043 kg pseudoephedrine pseudoephedrine decreased from notes that manufacturer reported sales (for sale) for 2010. 287,756 kg to 286,607 kg and the for 2009 (286,607 kg) are higher than the This calculation suggests that DEA’s reported inventory increased from average retail sales reported by IMS for 2010 assessment of annual needs for 54,173 kg to 68,001 kg. After calculating the previous two years (145,006 kg). pseudoephedrine (for sale) should be the pseudoephedrine (for sale) This is expected because a 404,000 kg. DEA notes that its June 28, assessment using the most current manufacturer’s reported sales include 2010, notice proposed to increase the data—that was reported by DEA quantities which are necessary to pseudoephedrine assessment to 419,000 registered manufactures as of August 10, provide reserve stocks for distributors kg. That proposal was based on 2010—DEA concludes that the proposed and retailers. information received as of March 10, revised assessment of 419,000 kg would 2010. Since that time DEA has received have been unnecessarily high. DEA calculated the revised Accordingly, DEA has determined that additional request for quotas, revised pseudoephedrine (for sale) assessment the established 2010 AAN for manufacture production data, i.e., sales by the following methodology: pseudoephedrine of 404,000 kg is and inventory information, requests for appropriate and requires no change. 2009 sales + reserve stock + export withdrawal of quota, and request for ¥ requirement existing inventory = adjustments to individual procurement Phenylpropanolamine (for Conversion) AAN quotas. As a result of this additional Data

PHENYLPROPANOLAMINE (FOR CONVERSION) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS [Kilograms]

Phenylpropanolamine 2010 (for conversion) 2007 2008 2009 Request

Sales * (DEA 250) ...... 3,621 10,837 14,585 14,910 Imports ** (DEA 488) ...... 8,250 12,019 11,373 28,408 Export Declarations (DEA 486) ...... 0 0 0 n/a Inventory* (DEA 250) ...... 3,581 5,537 4,104 n/a APQ Amphetamine *** ...... 22,000 22,000 24,500 23,500 * Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 10, 2010. ** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010. *** Amphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.

Phenylpropanolamine (for Conversion) conversion), 14,585 kg fairly represents This calculation suggests that DEA’s Analysis United States requirements for 2010 and 2010 assessment of annual needs for zero kg fairly represents the export DEA previously had established the phenylpropanolamine (for conversion) requirements of phenylpropanolamine 2010 assessment of annual needs for should be 17,800 kg. DEA notes that its (for conversion). phenylpropanolamine (for conversion) June 28, 2010, notice proposed to DEA believes that the data provided increase the phenylpropanolamine (for at 16,500 kg (74 FR 60298). As noted in procurement, manufacturing, and above, DEA developed the proposed conversion) assessment to 18,200 kg. import quota applications best That proposal was based on information revisions to the 2010 assessment of represents the legitimate need for received as of March 10, 2010. Since annual needs for phenylpropanolamine phenylpropanolamine (for conversion). that time DEA has received additional (for conversion) using the same Phenylpropanolamine (for conversion) calculation and methodology that DEA is used for the manufacture of legitimate request for quotas, revised manufacture used to determine the 2009 and 2010 amphetamine products, but DEA notes production data, i.e., sales and assessment of annual needs. that most legitimate amphetamine is inventory information, and request for As of August 10, 2010, DEA registered manufactured by converting adjustments to individual procurement manufacturers of phenylpropanolamine phenylacetone rather than quotas. As a result the 2009 reported (for conversion) requested the authority phenylpropanolamine, to amphetamine. inventory of phenylpropanolamine to purchase a total of 14,910 kg Basing the phenylpropanolamine (for increased from 3,693 kg to 4,104 kg. phenylpropanolamine for the conversion) calculation on the total After calculating the manufacture of amphetamine. DEA Aggregate Production Quota (APQ) for phenylpropanolamine (for conversion) registered manufacturers of amphetamine, therefore, would assessment using the most current phenylpropanolamine reported sales of inaccurately inflate the data—that reported by DEA registered phenylpropanolamine totaling phenylpropanolamine (for conversion) manufactures as of August 10, 2010— approximately 10,837 kg in 2008 and assessment. DEA concludes that the proposed 14,585 kg in 2009; this represents a 26 DEA calculated the revised assessment of 18,200 kg would percent increase in sales reported by phenylpropanolamine (for conversion) have been unnecessarily high. these firms from 2008 to 2009. There needed for the manufacture of Accordingly, DEA is increasing the 2010 were no reported exports of amphetamine as follows: assessment of annual needs for phenylpropanolamine (for conversion). (2009 sales) + reserve stock + export DEA has not received any requests to requirement ¥ inventory = AAN phenylpropanolamine (for conversion) synthesize phenylpropanolamine in (14,585) + 50%*(14,585) + 0 ¥ 4,104 from 16,500 kg to 17,800 kg. 2010. DEA has concluded that the 2009 = 17,774 kg PPA (for conversion) for Ephedrine (for Conversion) Data sales of phenylpropanolamine (for 2010

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EPHEDRINE (FOR CONVERSION) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS [Kilograms]

Ephedrine 2010 (for conversion) 2007 2008 2009 Request

Sales * (DEA 250) ...... 99,594 64,522 40,387 40,600 Imports ** (DEA 488) ...... 99,594 64,128 39,897 40,204 Inventory * (DEA 250) ...... 0 99 208 n/a APQ Methamphetamine *** ...... 3,130 3,130 3,130 3,130 * Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of August 10, 2010. ** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010. *** Methamphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.

Ephedrine (for Conversion) Analysis (2009 APQ methamphetamine/39% 28 CFR 0.104, the Deputy Administrator yield) + reserve stock ¥ inventory = hereby orders that the Revised 2010 DEA previously has established the ephedrine (for manufacture of Assessment of Annual Needs for 2010 assessment of annual needs for methamphetamine) (3,130/39% yield) + ephedrine, pseudoephedrine, and ephedrine (for conversion) at 75,000 kg 50%*(3,130/39% yield) ¥ 208 = 11,830 phenylpropanolamine, expressed in (74 FR 60298). As noted above, DEA kg kilograms of anhydrous acid or base, be developed the proposed revisions to the The calculation for the ephedrine (for established as follows: 2010 assessment of annual needs for conversion) requirement for the ephedrine (for conversion) using the manufacture of pseudoephedrine leads List I chemical Final 2010 assess- same calculation and methodology that to a result of 63,157 kg. DEA cannot ment of annual needs DEA used to determine the 2009 and provide the details of the calculation 2010 assessment of annual needs. because this would reveal the Ephedrine (for sale) .. 3,900 kg As of August 10, 2010, DEA registered Phenylpropanolamine 7,400 kg conversion yield for the synthesis of (for sale). manufacturers of ephedrine (for pseudoephedrine, which is proprietary Pseudoephedrine (for 404,000 kg conversion) requested the authority to to the one manufacturer involved in this sale). purchase a total of 40,600 kg ephedrine type of manufacturing. Phenylpropanolamine 17,800 kg (for conversion) for the manufacture of Therefore, DEA determined the (for conversion). two substances: methamphetamine and proposed revised assessment for Ephedrine (for con- 75,000 kg pseudoephedrine. ephedrine (for conversion) by summing version). DEA considered the ephedrine (for the amounts required for the conversion) requirements for the manufacture of methamphetamine and Regulatory Certifications pseudoephedrine: manufacture of methamphetamine and Regulatory Flexibility Act pseudoephedrine. DEA has determined methamphetamine requirement + that the established assessments for the pseudoephedrine requirement = AAN The Deputy Administrator hereby manufacture of these two substances are 11,830 + 63,157 = 74,987 kg ephedrine certifies that this action will not have a the best indicators of the need for (for conversion) for 2010 significant economic impact upon small ephedrine (for conversion). The This calculation suggests that DEA’s entities whose interests must be assessment of need for 2010 assessment of annual needs for considered under the Regulatory methamphetamine was determined by ephedrine (for conversion) should be Flexibility Act, 5 U.S.C. 601–612. The DEA as the APQ for methamphetamine. 75,000 kg. Accordingly, DEA is leaving establishment of the assessment of DEA determined that the estimated sales the 2010 assessment of annual needs for annual needs for ephedrine, ephedrine (for conversion) unchanged at of pseudoephedrine by manufacturers, pseudoephedrine, and 75,000 kg. as referenced in the assessment of phenylpropanolamine is mandated by DEA did not receive any comments on annual needs for pseudoephedrine, law. The assessments are necessary to its Assessment of Annual Needs for provide for the estimated medical, represents the need for ephedrine (for sale), ephedrine (for pseudoephedrine. Reported sales of scientific, research and industrial needs conversion), pseudoephedrine (for sale), of the United States, for lawful export ephedrine (for conversion) are included phenylpropanolamine (for sale) and as reference to DEA’s methodology. requirements, and the establishment phenylpropanolamine (for conversion). and maintenance of reserve stocks. DEA further considered the reported DEA is finalizing the assessments for Accordingly, the Deputy Administrator conversion yields of these substances. these List I chemicals based on has determined that this action does not DEA registered manufacturers reported information contained in additional require a regulatory flexibility analysis. a conversion yield of 39 percent for the applications for 2010 import, synthesis of methamphetamine from manufacturing and procurement quotas Executive Order 12866 ephedrine. DEA cannot disclose the provided by DEA registered importers The Office of Management and Budget conversion yield for the synthesis of and manufacturers whose quota has determined that notices of pseudoephedrine because this applications were received as of August assessment of annual needs are not information is proprietary to the one 10, 2010. subject to centralized review under manufacturer involved in this type of Therefore, under the authority vested Executive Order 12866. manufacturing. in the Attorney General by section 306 Thus, DEA calculated the ephedrine of the CSA (21 U.S.C. 826), and Executive Order 13132 (for conversion) requirement for the delegated to the Administrator of the This action does not preempt or manufacture of methamphetamine as DEA by 28 CFR 0.100, and redelegated modify any provision of State law; nor follows: to the Deputy Administrator pursuant to does it impose enforcement

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responsibilities on any State; nor does it meeting and certifications of General 202–395–6881 (these are not toll-free diminish the power of any State to Counsel that this meeting may be closed numbers), e-mail: enforce its own laws. Accordingly, this by vote of the Commissioners present [email protected]. action does not have federalism were submitted to the Commissioners FOR FURTHER INFORMATION CONTACT: implications warranting the application prior to the conduct of any other Contact Michel Smyth by telephone at of Executive Order 13132. business. Upon motion duly made, 202–693–4129 (this is not a toll-free Executive Order 12988 seconded, and carried, the following number) or by e-mail at Commissioners voted that the meeting [email protected]. This action meets the applicable be closed: Isaac Fulwood, Cranston J. SUPPLEMENTARY INFORMATION: standards set forth in Sections 3(a) and Mitchell and Patricia K. Cushwa, J. Federal 3(b)(2) of Executive Order 12988 Civil Patricia Wilson Smoot. Mine Safety and Health Act of 1977 Justice Reform. In witness whereof, I make this official (Mine Act) section 101(a) provides that the Secretary of Labor shall develop, Unfunded Mandates Reform Act of 1995 record of the vote taken to close this meeting and authorize this record to be promulgate, and revise, as may be This action will not result in the made available to the public. appropriate, improved mandatory expenditure by State, local, and Tribal health or safety standards for the governments, in the aggregate, or by the Dated: December 8, 2010. protection of life and prevention of private sector, of $120,000,000 or more Isaac Fulwood, injuries in coal or other mines. In in any one year, and will not Chairman, U.S. Parole Commission. addition, Mine Act section 103(h) significantly or uniquely affect small [FR Doc. 2010–31860 Filed 12–17–10; 8:45 am] mandates that mine operators keep any governments. Therefore, no actions were BILLING CODE 4410–01–M records and make any reports that are deemed necessary under the provisions reasonably necessary for the MSHA to of the Unfunded Mandates Reform Act perform its duties under the Mine Act. of 1995. DEPARTMENT OF LABOR The MSHA established standards and regulations for diesel-powered Congressional Review Act Office of the Secretary equipment in underground coal mines This action is not a major rule as that provide additional important defined by Section 804 of the Small Agency Information Collection protection for coal miners who work on Business Regulatory Enforcement Activities; Submission for OMB and around diesel-powered equipment. Fairness Act of 1996. This action will Review; Comment Request; Diesel The standards were designed to reduce not result in an annual effect on the Particulate Matter Exposure of the risks to underground coal miners of economy of $100,000,000 or more; a Underground Coal Miners serious health hazards that are major increase in costs or prices; or associated with exposure to high significant adverse effects on ACTION: Notice. concentrations of diesel particulate competition, employment, investment, matter. The standards contain SUMMARY: The Department of Labor productivity, innovation, or on the information collection requirements for (DOL) hereby announces the submission ability of United States-based underground coal mine operators in 30 of the Mine Safety and Health companies to compete with foreign- CFR 72.503 (d), 72.510, 72.520, and Administration (MSHA) sponsored based companies in domestic and 75.1915. As a result of 39 CFR 72.500, information collection request (ICR) export markets. manufacturers of diesel equipment are titled, ‘‘Diesel Particulate Matter Dated: December 13, 2010. affected under 30 CFR parts 7 or 36. Exposure of Underground Coal Miners,’’ This information collection is subject Michele M. Leonhart, to the Office of Management and Budget to the PRA. A Federal agency generally Deputy Administrator. (OMB) for review and approval for cannot conduct or sponsor a collection [FR Doc. 2010–31848 Filed 12–17–10; 8:45 am] continued use in accordance with the of information, and the public is BILLING CODE 4410–09–P Paperwork Reduction Act of 1995 (Pub. generally not required to respond to an L. 104–13, 44 U.S.C. chapter 35). information collection, unless it is DATES: Submit comments on or before currently approved by the OMB under DEPARTMENT OF JUSTICE January 19, 2011. the PRA and displays a currently valid United States Parole Commission ADDRESSES: A copy of this ICR, with OMB Control Number. In addition, applicable supporting documentation; notwithstanding any other provisions of [Public Law 94–409; 5 U.S.C. Sec. 552b] including a description of the likely law, no person shall generally be subject respondents, proposed frequency of to penalty for failing to comply with a Record of Vote of Meeting Closure response, and estimated total burden collection of information if the I, Isaac Fulwood, of the United States may be obtained from the RegInfo.gov collection of information does not Parole Commission, was present at a Web site, http://www.reginfo.gov/ display a currently valid OMB control meeting of said Commission, which public/do/PRAMain or by contacting number. See 5 CFR 1320.5(a) and started at approximately 12 p.m., on Michel Smyth by telephone at 202–693– 1320.6. The DOL obtains OMB approval Tuesday, December 7, 2010, at the U.S. 4129 (this is not a toll-free number) or for this information collection under Parole Commission, 5550 Friendship sending an e-mail to OMB Control Number 1219–0124. The Boulevard, 4th Floor, Chevy Chase, [email protected]. current OMB approval is scheduled to Maryland 20815. The purpose of the Submit comments about this request expire on December 31, 2010; however, meeting was to decide two petitions for to the Office of Information and it should be noted that information reconsideration pursuant to 28 CFR Regulatory Affairs, Attn: OMB Desk collections submitted to the OMB Section 2.27. Four Commissioners were Officer for the Department of Labor, receive a month-to-month extension present, constituting a quorum when the Mine Safety and Health Administration while they undergo review. For vote to close the meeting was submitted. (MSHA), Office of Management and additional information, see the related Public announcement further Budget, Room 10235, Washington, DC notice published in the Federal Register describing the subject matter of the 20503, Telephone: 202–395–4816/Fax: on September 16, 2010, (75 FR 56560).

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