36684 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices

(40 FR 43745–46), all applicants for Any such comments or objections Any such written comments or registration to import a basic class of should be addressed, in quintuplicate, objections should be addressed, in any controlled substance in schedule I to the Drug Enforcement quintuplicate, to the Drug Enforcement or II are, and will continue to be, Administration, Office of Diversion Administration, Office of Diversion required to demonstrate to the Deputy Control, Federal Register Representative Control, Federal Register Representative Assistant Administrator, Office of (ODL), 8701 Morrissette Drive, (ODL), 8701 Morrissette Drive, Diversion Control, Drug Enforcement Springfield, Virginia 22152; and must be Springfield, Virginia 22152; and must be Administration, that the requirements filed no later than July 28, 2010. filed no later than August 27, 2010. This procedure is to be conducted for such registration pursuant to 21 Dated: June 17, 2010. U.S.C. 958(a); 21 U.S.C. 823(a); and 21 simultaneously with, and independent Joseph T. Rannazzisi, CFR 1301.34(b), (c), (d), (e) and (f) are of, the procedures described in 21 CFR satisfied. 1301.34(b), (c), (d), (e), and (f). As noted Deputy Assistant Administrator, Office of in a previous notice published in the Diversion Control, Drug Enforcement Dated: June 17, 2010. Administration. Federal Register on September 23, 1975, Joseph T. Rannazzisi, (40 FR 43745–46), all applicants for [FR Doc. 2010–15526 Filed 6–25–10; 8:45 am] Deputy Assistant Administrator, Office of registration to import a basic class of BILLING CODE 4410–09–P Diversion Control, Drug Enforcement Administration. any controlled substance listed in schedule I or II are, and will continue [FR Doc. 2010–15528 Filed 6–25–10; 8:45 am] DEPARTMENT OF JUSTICE to be, required to demonstrate to the BILLING CODE 4410–09–P Deputy Assistant Administrator, Office Drug Enforcement Administration of Diversion Control, Drug Enforcement [Docket No. DEA–326R] DEPARTMENT OF JUSTICE Administration, that the requirements for such registration pursuant to 21 Proposed Revised Assessment of Drug Enforcement Administration U.S.C. 958(a); 21 U.S.C. 823(a); and 21 Annual Needs for the List I Chemicals CFR 1301.34(b), (c), (d), (e), and (f) are Ephedrine, Pseudoephedrine, and Importer of Controlled Substances; satisfied. Notice of Application Phenylpropanolamine for 2010 Joseph T. Rannazzisi, AGENCY: Drug Enforcement Pursuant to 21 U.S.C. 958(i), the Deputy Assistant Administrator, Office of Attorney General shall, prior to issuing Diversion Control, Drug Enforcement Administration (DEA), Justice. a registration under this Section to a Administration. ACTION: Notice of proposed revised 2010 bulk manufacturer of a controlled [FR Doc. 2010–15523 Filed 6–25–10; 8:45 am] assessment of annual needs for the List substance in schedule I or II, and prior BILLING CODE 4410–09–P I chemicals ephedrine, to issuing a regulation under 21 U.S.C. pseudoephedrine, and 952(a)(2) authorizing the importation of phenylpropanolamine. such a substance, provide DEPARTMENT OF JUSTICE manufacturers holding registrations for SUMMARY: This notice proposes revised the bulk manufacture of the substance Drug Enforcement Administration 2010 assessment of annual needs for the an opportunity for a hearing. List I chemicals ephedrine, Therefore, in accordance with 21 CFR Manufacturer of Controlled pseudoephedrine, and 1301.34(a), this is notice that on March Substances; Notice of Application phenylpropanolamine. 22, 2010, Cerilliant Corporation, 811 Pursuant to § 1301.33(a) of Title 21 of DATES: Written comments must be Paloma Drive, Suite A, Round Rock, the Code of Federal Regulations (CFR), postmarked, and electronic comments Texas 78665–2402, made application by this is notice that on April 27, 2010, must be sent, on or before July 28, 2010. letter to the Drug Enforcement Varian, Inc., 25200 Commercentre ADDRESSES: To ensure proper handling Administration (DEA) to be registered as Drive, Lake Forest, California 92630– of comments, please reference ‘‘Docket an importer of the basic classes of 8810, made application by renewal to No. DEA–326R’’ on all written and controlled substances listed in schedule the Drug Enforcement Administration electronic correspondence. Written I: (DEA) as a bulk manufacturer of the comments being sent via regular mail basic classes of controlled substances should be sent to the Deputy Assistant Drug Schedule listed in schedule II: Administrator, Office of Diversion Racemoramide (9645) ...... I Control, Drug Enforcement Tilidine (9750) ...... I Drug Schedule Administration, Washington, DC 20537, Attention: DEA Federal Register Phencyclidine (7471) ...... II Representative/ODL. Written comments The company plans to import small 1- II quantities of the listed controlled piperidinocyclohexanecarbonitri- sent via express mail should be sent to substances for the manufacture of le (8603). DEA Headquarters, Attention: DEA analytical reference standards. Benzoylecgonine (9180) ...... II Federal Register Representative/ODL, Any bulk manufacturer who is 8701 Morrissette Drive, Springfield, presently, or is applying to be, The company plans to manufacture Virginia 22152. Comments may be registered with DEA to manufacture small quantities of the listed controlled directly sent to DEA electronically by such basic classes of controlled substances for use in diagnostic sending an electronic message to substances may file comments or products. [email protected]. objections to the issuance of the Any other such applicant, and any However, persons wishing to request a proposed registration and may, at the person who is presently registered with hearing should note that such requests same time, file a written request for a DEA to manufacture such substances, must be written and manually signed; hearing on such application pursuant to may file comments or objections to the requests for a hearing will not be 21 CFR 1301.43, and in such form as issuance of the proposed registration accepted via electronic means. DEA will prescribed by 21 CFR 1316.47. pursuant to 21 CFR 1301.33(a). accept attachments to electronic

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comments in Microsoft Word, I of this chapter, or ephedrine, DEA now proposes to revise the WordPerfect, Adobe PDF, or Excel file pseudoephedrine, and established assessments of annual needs formats only. DEA will not accept any phenylpropanolamine, except that— for 2010 for these List 1 chemicals. In file format other than those specifically (1) Such amounts of crude opium, poppy developing the proposed revisions, DEA straw, concentrate of poppy straw, and coca listed here. leaves, and of ephedrine, pseudoephedrine, has used the calculation methodology FOR FURTHER INFORMATION CONTACT: and phenylpropanolamine, as the Attorney described in both the 2009 and 2010 Christine A. Sannerud, PhD, Chief, Drug General finds to be necessary to provide for AAN (74 FR 32954 and 74 FR 60294, and Chemical Evaluation Section, Drug medical, scientific, or other legitimate respectively). These calculations take Enforcement Administration, 8701 purposes * * * may be so imported under into account the criteria that DEA is Morrissette Drive, Springfield, Virginia such regulations as the Attorney General required to consider in accordance with shall prescribe. 22152, Telephone: (202) 307–7183. 21 U.S.C. 826 and its implementing * * * * * regulations (21 CFR 1315.11). SUPPLEMENTARY INFORMATION: Section (d)(1) With respect to a registrant under 713 of the Combat Methamphetamine In finalizing the revised assessments section 958 who is authorized under for these List I chemicals, DEA will Epidemic Act of 2005 (CMEA) (Title VII subsection (a)(1) to import ephedrine, of Pub. L. 109–177) amended Section pseudoephedrine, or phenylpropanolamine, consider the information contained in 306 of the Controlled Substances Act at any time during the year the registrant may additional applications for 2010 import, (CSA) (21 U.S.C. 826) by adding apply for an increase in the amount of such manufacturing and procurement quotas ephedrine, pseudoephedrine, and chemical that the registrant is authorized to from DEA registered manufacturers and phenylpropanolamine to existing import, and the Attorney General may importers that DEA receives after the approve the application if the Attorney date of drafting this notice, March 10, language to read as follows: ‘‘The General determines that the approval is Attorney General shall determine the 2010, as well as the comments that DEA necessary to provide for medical, scientific, receives in response to this proposal. total quantity and establish production or other legitimate purposes regarding the quotas for each basic class of controlled chemical. Underlying Data and DEA’s Analysis substance in schedules I and II and for Editor’s Note: This excerpt of the ephedrine, pseudoephedrine, and In determining the proposed revisions amendment is published for the convenience to the 2010 assessments, DEA has phenylpropanolamine to be of the reader. The official text is published manufactured each calendar year to at 21 U.S.C. 952(a) and (d)(1). considered the total net disposals (i.e., sales) of the List I chemicals for the provide for the estimated medical, The 2010 Assessment of Annual scientific, research, and industrial needs current and preceding two years, actual Needs (AAN) represents those quantities and estimated inventories, projected of the United States, for lawful export of ephedrine, pseudoephedrine, and requirements, and for the establishment demand (2010), industrial use, and phenylpropanolamine which may be export requirements from data provided and maintenance of reserve stocks.’’ manufactured domestically and/or Further, section 715 of the CMEA by DEA registered manufacturers and imported into the United States to importers in procurement quota amended 21 U.S.C. 952 ‘‘Importation of provide adequate supplies of each controlled substances’’ by adding the applications (DEA 250), from substance to meet the estimated manufacturing quota applications (DEA same List I chemicals to the existing medical, scientific, research, and language in paragraph (a), and by 189), and from import quota industrial needs of the United States; applications (DEA 488).1 adding a new paragraph (d) to read as lawful export requirements; and the follows: DEA further considered trends as establishment and maintenance of derived from information provided in (a) Controlled substances in schedule I or reserve stocks. applications for import, manufacturing, II and narcotic drugs in schedule III, IV, or On November 20, 2009, DEA and procurement quotas and in import V; exceptions established the AAN for 2010 for the and export declarations. DEA notes that It shall be unlawful to import into the List I chemicals ephedrine, the inventory, acquisitions (purchases) customs territory of the United States from pseudoephedrine, and any place outside thereof (but within the and disposition (sales) data provided by phenylpropanolamine (74 FR 60294). United States), or to import into the United DEA registered manufacturers and That Notice indicated that the Deputy States from any place outside thereof, any importers reflects the most current Administrator of the DEA would adjust controlled substance in schedule I or II of information available. subchapter I of this chapter, or any narcotic the AAN at a later date if necessary, as drug in schedule III, IV, or V of subchapter permitted by 21 CFR 1315.13. Ephedrine (for Sale) Data

EPHEDRINE (FOR SALE) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS (KILOGRAMS)

2010 Ephedrine 2007 2008 2009 request

Sales * (DEA 250) ...... 2,838 2,662 2,801 3,430 Imports ** (DEA 488) ...... 9,595 1,690 2,165 2,268 Export Declarations (DEA 486) ...... 168 18 64 n/a Inventory * (DEA 250) ...... 1,428 626 191 n/a IMS *** (NSP) ...... 1,235 1,460 1,401 n/a * Reported sales and inventory from applications for 2010 procurement quotas (DEA 250). ** Reported imports from applications for 2010 import quotas (DEA 488). *** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail Channels, Data Extracted March 10, 2010.

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

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Ephedrine (for Sale) Analysis increase from levels observed in 2008. For the establishment and DEA previously has established the The average of the 2008 and 2009 maintenance of reserve stocks, DEA 2010 AAN for ephedrine (for sale) at exports of ephedrine products is notes that 21 CFR 1315.24 allows for an 3,600 kg (74 FR 60298). approximately 41 kg. DEA also inventory allowance (reserve stock) of As noted above, DEA developed the considered information on trends in the 50 percent of a manufacturer’s estimated proposed revisions to the 2010 AAN for national rate of net disposals from sales sales. DEA also considered the ephedrine (for sale) using the same data provided by IMS Health’s NSP estimated 2009 year end inventory as calculation and methodology that DEA database. IMS NSP data reported the reported by DEA registrants in used to determine the 2009 and 2010 average sales volume of ephedrine for determining the inventory allowance. AAN. the calendar years 2008 and 2009 to be DEA calculated the proposed revised As of March 10, 2010, DEA registered approximately 1,431 kg. DEA notes that ephedrine (for sale) assessment as manufacturers of dosage form products the 2009 sales figure reported by follows: containing ephedrine requested the manufacturers (2,801 kg) is higher than authority to purchase a total of 3,430 kg the average sales reported by IMS for the 2009 sales + reserve stock + export ¥ ephedrine (for sale) in 2010. DEA previous two years (1,431 kg). This is requirement existing inventory = registered manufacturers of ephedrine expected because a manufacturer’s AAN reported sales totaling approximately reported sales include quantities which 2,801 + (50%*2,801) + 41 ¥ 191 = 4,052 2,662 kg in 2008 and 2,801 kg in 2009; are necessary to provide reserve stocks kg ephedrine (for sale) for 2010 this represents a 5 percent increase in for distributors and retailers. DEA, in This calculation suggests that DEA’s sales reported by these firms from 2008 considering the manufacturer’s reported AAN for ephedrine should be 4,100 kg. to 2009. Additionally, exports of sales, thus believes that 2,801 kg fairly Accordingly, DEA is proposing to ephedrine products from the United represents the United States sales of increase the 2010 AAN for ephedrine States as reported on export declarations ephedrine for 2010 and that 41 kg fairly (for sale) from 3,600 kg to 4,100 kg. (DEA 486) totaled 18 kg in 2008 and 64 represents the export requirements of kg in 2009; this represents a 72 percent ephedrine. Phenylpropanolamine (for Sale) data

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 6,799 Imports ** (DEA 488) ...... 5,787 3,425 6,626 7,266 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 March 10, 2010. ** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.

Phenylpropanolamine (for Sale) 15.5% increase in sales reported by phenylpropanolamine to veterinary Analysis these firms from 2008 to 2009. channels and is therefore not included. Additionally, exports of DEA previously has established the DEA calculated the proposed revised phenylpropanolamine products from phenylpropanolamine (for sale) 2010 AAN for phenylpropanolamine the United States as reported on export (for sale) at 6,400 kg (74 FR 60298). assessment by the following declarations (DEA 486) totaled 0 kg in methodology: As noted above, DEA utilized the 2008 and 3 kg in 2009; this represents same general methodology and a 3 kg increase from levels observed in 2009 sales + reserve stock + export ¥ calculation to develop the proposed 2008. The average of the 2008 and 2009 requirement existing inventory = revised assessment for exports of phenylpropanolamine AAN phenylpropanolamine (for sale) that products is approximately 2 kg. DEA 5,355+ (50%*5,355) + 2 ¥ 645 = 7,390 DEA used to determine the 2009 and thus believes that 5,355 kg fairly kg phenylpropanolamine (for sale) 2010 AAN. represents the United States sales of for 2010 As of March 10, 2010, DEA registered phenylpropanolamine for 2010 and that This calculation suggests that DEA’s manufacturers of dosage form products 2 kg fairly represents the export 2010 Assessment of Annual Needs for containing phenylpropanolamine requirements of phenylpropanolamine. phenylpropanolamine (for sale) should requested the authority to purchase DEA notes that phenylpropanolamine is be 7,400 kg. Accordingly, DEA is 6,799 kg phenylpropanolamine (for sale) sold primarily as a veterinary product proposing to increase the 2010 AAN for in 2010. DEA registered manufacturers for the treatment for canine phenylpropanolamine (for sale) from of phenylpropanolamine reported sales incontinence and is not approved for 6,400 kg to 7,400 kg. totaling approximately 4,528 kg in 2008 human consumption. IMS Health’s NSP and 5,355 kg in 2009; this represents a Data does not capture sales of Pseudoephedrine (for Sale) Data

PSEUDOEPHEDRINE (FOR SALE) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS (KILOGRAMS)

2010 Pseudoephedrine (for sale) 2007 2008 2009 request

Sales * (DEA 250) ...... 239,121 223,813 287,756 239,646 Sales * (DEA 189) ...... 100,300 64,781 33,600 32,760 Imports ** (DEA 488) ...... 231,683 170,614 274,492 261,528

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PSEUDOEPHEDRINE (FOR SALE) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS (KILOGRAMS)—Continued

2010 Pseudoephedrine (for sale) 2007 2008 2009 request

Export Declarations (DEA 486) ...... 42,132 47,199 35,264 n/a Inventory * (DEA 250) ...... 135,727 120,869 54,173 n/a IMS *** (NSP) ...... 180,221 149,227 140,269 n/a * Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of March 10, 2010. ** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010. *** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail Channels, Data Extracted March 10, 2010.

Pseudoephedrine (for Sale) Analysis export declarations (DEA 486) totaled This is expected because a DEA previously has established the 47,199 kg in 2008 and 35,264 kg in manufacturer’s reported sales include 2010 AAN for pseudoephedrine (for 2009; this represents a 25 percent quantities which are necessary to sale) at 404,000 kg (74 FR 60298). decrease from levels observed in 2008. provide reserve stocks for distributors As noted above, DEA utilized the The average of the 2008 and 2009 and retailers. same general methodology and exports is 41,232 kg. Additionally, DEA DEA calculated the revised calculation to develop the proposed considered information on trends in the pseudoephedrine (for sale) assessment revised assessment for pseudoephedrine national rate of net disposals from sales by the following methodology: (for sale) that DEA used to determine data provided by IMS Health. IMS NSP 2009 sales + reserve stock + export the 2009 and 2010 AAN. data reported the average retail sales requirement ¥ existing inventory = As of March 10, 2010, DEA registered volume of pseudoephedrine for the AAN manufacturers of dosage form products calendar years 2008 and 2009 to be 287,756 + (50%*287,756) + 41,232 ¥ containing pseudoephedrine requested approximately 144,748 kg. DEA thus 54,173 = 418,693 kg the authority to purchase 239,646 kg believes that 287,756 kg of sales pseudoephedrine (for sale) for 2010. pseudoephedrine. DEA registered reported by manufacturers fairly This calculation suggests that DEA’s manufacturers of pseudoephedrine represents the U.S. sales of 2010 AAN for pseudoephedrine (for reported sales totaling approximately pseudoephedrine for 2010 and that sale) should be 419,000 kg. Accordingly, 223,813 kg in 2008 and 287,756 kg in 41,232 kg fairly represents the export DEA is proposing to increase the 2010 2009; this represents a 22 percent requirements of pseudoephedrine. DEA AAN for pseudoephedrine (for sale) increase in sales reported by these firms notes that manufacturer reported sales from 404,000 kg to 419,000 kg. from 2008 to 2009. During the same for 2009 (287,756 kg) are higher than the period exports of pseudoephedrine average retail sales reported by IMS for Phenylpropanolamine (for Conversion) products from the U.S. as reported on the previous two years (144,748 kg). Data

PHENYLPROPANOLAMINE (FOR CONVERSION) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS (KILOGRAMS)

2010 Phenylpropanolamine (for sale) 2007 2008 2009 request

Sales * (DEA 250) ...... 3,621 10,837 14,585 19,142 Imports ** (DEA 488) ...... 8,250 12,019 11,373 33,698 Export Declarations (DEA 486) ...... 0 0 0 n/a Inventory * (DEA 250) ...... 3,581 5,537 3,693 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 March 10, 2010. ** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010. *** Amphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.

Phenylpropanolamine (for Conversion) manufacture of amphetamine. DEA fairly represents the export Analysis registered manufacturers of requirements of phenylpropanolamine phenylpropanolamine reported sales of (for conversion). DEA previously has established the phenylpropanolamine totaling 2010 AAN for phenylpropanolamine Phenylpropanolamine (for (for conversion) at 16,500 kg (74 FR approximately 10,837 kg in 2008 and conversion) is used for the manufacture 60298). As noted above, DEA developed 14,585 kg in 2009; this represent a 26 of legitimate amphetamine products. the proposed revisions to the 2010 AAN percent increase in sales reported by DEA notes, most legitimate for phenylpropanolamine (for these firms from 2008 to 2009. There amphetamine is manufactured by the conversion) using the same calculation were no reported exports of conversion of the schedule II controlled and methodology that DEA used to phenylpropanolamine (for conversion). substance phenylacetone to determine the 2009 and 2010 AAN. DEA has not received any requests to amphetamine, rather than the As of March 10, 2010, DEA registered synthesize phenylpropanolamine in conversion of phenylpropanolamine. manufacturers of phenylpropanolamine 2010. DEA has concluded that the 2009 DEA believes that the data provided in (for conversion) requested the authority sales of phenylpropanolamine (for procurement, manufacturing, and to purchase a total of 19,142 kg conversion), 14,585 kg fairly represents import quota applications best phenylpropanolamine for the U.S. requirements for 2010 and zero kg represents the legitimate need for

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phenylpropanolamine (for conversion) (2009 sales) + reserve stock + export (for conversion) should be 18,200 kg. rather than total Aggregate Production requirement ¥ inventory = AAN Accordingly, DEA is proposing to Quota (APQ) for amphetamine. (14,585) + 50%*(14,585) + 0 ¥ 3,693 = increase the 2010 AAN for DEA calculated the 18,185 kg PPA (for conversion) for phenylpropanolamine (for conversion) phenylpropanolamine (for conversion) 2010 from 16,500 kg to 18,200 kg. needed for the manufacture of This calculation suggests that DEA’s amphetamine as follows: 2010 AAN for phenylpropanolamine Ephedrine (for Conversion) Data

EPHEDRINE (FOR CONVERSION) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS (KILOGRAMS)

2010 Ephedrine (for conversion) 2007 2008 2009 request

Sales * (DEA 250) ...... 99,622 64,522 40,403 40,600 Imports ** (DEA 488) ...... 99,594 64,128 39,897 40,000 Inventory * (DEA 250) ...... 13 160 254 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 March 10, 2010. ** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010. *** Methamphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.

Ephedrine (for Conversion) Analysis DEA further considered the reported methamphetamine requirement + conversion yields of these substances. pseudoephedrine requirement = DEA previously has established the DEA registered manufacturers reported AAN 2010 AAN for ephedrine (for a conversion yield of 39 percent for the conversion) at 75,000 kg (74 FR 60298). 11,785 + 63,157 = 74,942 kg ephedrine synthesis of methamphetamine from (for conversion) for 2010 As noted above, DEA developed the ephedrine. DEA cannot disclose the proposed revisions to the 2010 AAN for conversion yield for the synthesis of This calculation suggests that DEA’s ephedrine (for conversion) using the pseudoephedrine because this 2010 AAN for ephedrine (for same calculation and methodology that information is proprietary to the one conversion) should be 75,000 kg. DEA used to determine the 2009 and manufacturer involved in this type of Accordingly, DEA is proposing that the 2010 AAN. manufacturing. 2010 AAN for ephedrine (for As of March 10, 2010, DEA registered Thus, DEA calculated the ephedrine conversion) remain unchanged at 75,000 manufacturers of ephedrine (for (for conversion) requirement for the kg. conversion) requested the authority to manufacture of methamphetamine as Conclusion purchase a total of 40,600 kg ephedrine follows: (for conversion) for the manufacture of (2009 APQ methamphetamine/39% In finalizing the revised 2010 two substances: Methamphetamine and yield) + reserve stock ¥ inventory assessments for these List I chemicals, pseudoephedrine. = ephedrine (for manufacture of DEA will use the methodology and DEA considered the ephedrine (for methamphetamine) calculations presented above. The conversion) requirements for the (3,130/39% yield) + 50%*(3,130/39% numbers used in the calculations may manufacture of methamphetamine and yield) ¥ 254 = 11,785 kg be adjusted upwards or downwards pseudoephedrine. DEA has determined The calculation for the ephedrine (for based on the additional applications for that the established assessments for the conversion) requirement for the 2010 import, manufacturing and manufacture of these two substances are manufacture of pseudoephedrine leads procurement quotas received after the best indicators of the need for to a result of 63,157 kg. DEA cannot March 10, 2010, in accordance with 21 ephedrine (for conversion). The provide the details of the calculation CFR part 1315. assessment of need for because this would reveal the Therefore, under the authority vested methamphetamine was determined by conversion yield for the synthesis of in the Attorney General by Section 306 DEA as the Aggregate Production Quota pseudoephedrine, which is proprietary of the CSA (21 U.S.C. 826), and (APQ) for methamphetamine. DEA to the one manufacturer involved in this delegated to the Administrator of the determined that the estimated sales of type of manufacturing. DEA by 28 CFR 0.100, and redelegated pseudoephedrine, as referenced in the Therefore, DEA determined the to the Deputy Administrator pursuant to AAN for pseudoephedrine, represents proposed revised assessment for 28 CFR 0.104, the Deputy Administrator the need for pseudoephedrine. Reported ephedrine (for conversion) by summing hereby proposes the following revised sales of ephedrine (for conversion) are the amounts required for the 2010 AAN for the List I chemicals included as reference to DEA’s manufacture of methamphetamine and ephedrine, pseudoephedrine, and methodology. pseudoephedrine: phenylpropanolamine:

Previously List I chemicals established initial Proposed revised 2010 assessment 2010 assessment

Ephedrine (for sale) ...... 3,600 kg 4,100 kg Phenylpropanolamine (for sale) ...... 6,400 kg 7,400 kg Pseudoephedrine (for sale) ...... 404,000 kg 419,000 kg Phenylpropanolamine (for conversion) ...... 16,500 kg 18,200 kg Ephedrine (for conversion) ...... 75,000 kg No Change

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All interested persons are invited to 3(b)(2) of Executive Order 12988 Civil NW., Washington, DC 20001. Copies of submit their comments in writing or Justice Reform. any of these materials may be obtained electronically regarding this proposal upon request and payment of a copying Unfunded Mandates Reform Act of 1995 following the procedures in the fee. ADDRESSES section of this document. A This action will not result in the J. Robert Kramer II, person may object to or comment on the expenditure by state, local, and tribal proposal relating to any of the above- governments in the aggregate, or by the Director of Operations and Civil Enforcement. mentioned substances without filing private sector, of $120,000,000 or more United States District Court for the comments or objections regarding the in any one year, and will not District of Columbia significantly or uniquely affect small others. If a person believes that one or United States of America, et al., more of these issues warrant a hearing, governments. Therefore, no actions were deemed necessary under the provisions Plaintiffs, v. Election Systems and the individual should so state and Software, Inc., Defendant. summarize the reasons for this belief. of the Unfunded Mandates Reform Act of 1995. Case No.: 1:10-cv-00380 Persons wishing to request a hearing Judge: Bates, John D. should note that such requests must be Congressional Review Act Deck Type: Antitrust written and manually signed; requests This action is not a major rule as Date Stamp: for a hearing will not be accepted via Response of Plaintiff United States to defined by Section 804 of the Small electronic means. In the event that Public Comments on the Proposed Business Regulatory Enforcement comments or objections to this proposal Final Judgment raise one or more issues which the Fairness Act of 1996. This action will not result in an annual effect on the Pursuant to the requirements of the Deputy Administrator finds warrant a Antitrust Procedures and Penalties Act, hearing, the Deputy Administrator shall economy of $100,000,000 or more; a major increase in costs or prices; or 15 U.S.C. § 16(b)–(h) (‘‘APPA’’ or order a public hearing by notice in the ‘‘Tunney Act’’), the United States hereby Federal Register, summarizing the significant adverse effects on competition, employment, investment, responds to the public comments issues to be heard and setting the time received regarding the proposed Final for the hearing as per 21 CFR 1315.13(e). productivity, innovation, or on the ability of United States-based Judgment in this case. After careful Regulatory Certifications companies to compete with foreign- consideration of the comments, the United States continues to believe that Regulatory Flexibility Act based companies in domestic and export markets. the proposed Final Judgment will The Deputy Administrator hereby provide an effective and appropriate Dated: June 19, 2010. certifies that this action will not have a remedy for the antitrust violations significant economic impact upon small Michele M. Leonhart, alleged in the Complaint. The United entities whose interests must be Deputy Administrator. States will move the Court for entry of considered under the Regulatory [FR Doc. 2010–15525 Filed 6–25–10; 8:45 am] the proposed Final Judgment after the Flexibility Act, 5 U.S.C. 601–612. The BILLING CODE 4410–09–P public comments and this response establishment of the AAN for ephedrine, have been published in the Federal pseudoephedrine and Register, pursuant to 15 U.S.C. § 16(d). phenylpropanolamine is mandated by DEPARTMENT OF JUSTICE The United States and the States of law. The assessments are necessary to Arizona, Colorado, Florida, Maine, Antitrust Division provide for the estimated medical, Maryland, New Mexico, Tennessee, and Washington, and the Commonwealth of scientific, research and industrial needs United States, et al. v. Election Massachusetts (the ‘‘Plaintiff States’’), of the United States, for lawful export Systems & Software, Inc.; Public filed a civil antitrust Complaint on requirements, and the establishment Comments and Response on Proposed March 8, 2010, seeking injunctive and and maintenance of reserve stocks. Final Judgment Accordingly, the Deputy Administrator other relief to remedy the likely has determined that this action does not Pursuant to the Antitrust Procedures anticompetitive effects arising from the require a regulatory flexibility analysis. and Penalties Act, 15 U.S.C. 16(b)–(h), acquisition of Premier Election the United States hereby publishes Solutions, Inc. and PES Holdings, Inc. Executive Order 12866 below the comments received on the (collectively, ‘‘Premier’’), by Defendant The Office of Management and Budget proposed Final Judgment in United Election Systems and Software, Inc. has determined that notices of AAN are States, et al. v. Election Systems & (‘‘ES&S’’). The Complaint alleged that not subject to centralized review under Software Inc., Case No. 1:10–00380– ES&S’s acquisition of Premier likely Executive Order 12866. JDB, which were filed in the United would result in higher prices, a States District Court for the District of reduction in quality, and less Executive Order 13132 Columbia on June 17, 2010, together innovation in the U.S. voting equipment This action does not preempt or with the response of the United States systems market, in violation of Section modify any provision of state law; nor to the comments. 7 of the Clayton Act, 15 U.S.C. § 18. does it impose enforcement Copies of the comments and the Simultaneously with the filing of the responsibilities on any state; nor does it response are available for inspection at Complaint, the United States filed a diminish the power of any state to the Department of Justice Antitrust proposed Final Judgment and an Asset enforce its own laws. Accordingly, this Division, 450 Fifth Street, NW., Suite Preservation Stipulation and Order action does not have federalism 1010, Washington, DC 20530 (‘‘APSO’’) signed by the plaintiffs and implications warranting the application (telephone: 202–514–2481), on the the defendant, consenting to the entry of of Executive Order 13132. Department of Justice’s Web site at the proposed Final Judgment after http://www.usdoj.gov/atr, and at the compliance with the requirements of the Executive Order 12988 Office of the Clerk of the United States Tunney Act, 15 U.S.C. § 16. Pursuant to This action meets the applicable District Court for the District of those requirements, the United States standards set forth in Sections 3(a) and Columbia, 333 Constitution Avenue, filed its Competitive Impact Statement

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