Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices 55605 

Scope of Investigation: Having 

considered the complaint, the U.S. 

International Trade Commission, on 

September 7, 2010, ordered that— 

(1) Pursuant to subsection (b) of 

section 337 of the Tariff Act of 1930, as 

amended, an investigation be instituted 

to determine whether there is a 

violation of subsection (a)(1)(B) of 

section 337 in the importation into the 

United States, the sale for importation, 

or the sale within the United States after 

importation of certain flash memory 

chips and products containing the same 

that infringe one or more of claims 1– 

7 of the ‘922 patent; claims 1–10 of the 

‘124 patent; claims 1–14 of the ‘625 

patent; and claims 1–4 of the ‘416 

patent, and whether an industry in the 

United States exists as required by 

subsection (a)(2) of section 337; 

(2) For the purpose of the 

investigation so instituted, the following 

are hereby named as parties upon which 

this notice of investigation shall be 

served: 

(a) The complainant is: Spansion LLC, 

915 DeGuigne Drive, P.O. Box 3453, 

Sunnyvale, CA 94088. 

(b) The respondents are the following 

entities alleged to be in violation of 

section 337, and are the parties upon 

which the complaint is to be served: 

Samsung Electronics Co., Ltd., 250, 

Taepyeongno 2-ga, Jung-gu, Seoul 

100–742, South Korea. 

Samsung Electronics America, Inc., 105 

Challenger Road, Ridgefield Park, NJ 

07660. 

Samsung International, Inc., 10220 

Sorrento Valley Road, San Diego, CA 

92121. 

Samsung Semiconductor, Inc., 3655 

North First Street, San Jose, CA 

95134. 

Samsung Telecommunications America, 

LLC, 1301 E. Lookout Drive, 

Richardson, TX 75082. 

Apple, Inc., 1 Infinite Loop, Cupertino, 

CA 95014. 

Nokia Corp., Keilalahdentie 4, FIN 0045 

Espoo, Finland. 

Nokia Inc., 6000 Connection Drive, 

Irving, TX 75039. 

PNY Technologies, Inc., 299 Webro 

Road, Parsippany, NJ 07054. 

Research In Motion Ltd., 295 Phillip 

Street, Waterloo, Ontario, Canada N2L 

3W8. 

Research In Motion Corporation, 122 W. 

John Carpenter Parkway, Suite 430, 

Irving, TX 75039. 

Transcend Information Inc., No. 70, 

XingZhong Rd., NeiHu District, 

Taipei, Taiwan. 

Transcend Information, Inc. (US), 1645 

North Brian Street, Orange, CA 92867. 

Transcend Information Inc. (Shanghai 

Factory), 4F, Kaixuan City Industrial 

Park, No. 1010, Kaixuan Road, 

Shanghai, China 200052. 

(c) The Commission investigative 

attorney, party to this investigation, is 

Stephen R. Smith, Esq., Office of Unfair 

Import Investigations, U.S. International 

Trade Commission, 500 E Street, SW., 

Suite 401, Washington, DC 20436; and 

(3) For the investigation so instituted, 

the Honorable Paul J. Luckern, Chief 

Administrative Law Judge, U.S. 

International Trade Commission, shall 

designate the presiding Administrative 

Law Judge. 

Responses to the complaint and the 

notice of investigation must be 

submitted by the named respondents in 

accordance with section 210.13 of the 

Commission’s Rules of Practice and 

Procedure, 19 CFR 210.13. Pursuant to 

19 CFR 201.16(d)–(e) and 210.13(a), 

such responses will be considered by 

the Commission if received not later 

than 20 days after the date of service by 

the Commission of the complaint and 

the notice of investigation. Extensions of 

time for submitting responses to the 

complaint and the notice of 

investigation will not be granted unless 

good cause therefor is shown. 

Failure of a respondent to file a timely 

response to each allegation in the 

complaint and in this notice may be 

deemed to constitute a waiver of the 

right to appear and contest the 

allegations of the complaint and this 

notice, and to authorize the 

administrative law judge and the 

Commission, without further notice to 

the respondent, to find the facts to be as 

alleged in the complaint and this notice 

and to enter an initial determination 

and a final determination containing 

such findings, and may result in the 

issuance of an exclusion order or a cease 

and desist order or both directed against 

the respondent. 

By order of the Commission. 

Marilyn R. Abbott, 

Secretary to the Commission. 

[FR Doc. 2010–22667 Filed 9–10–10; 8:45 am] 

BILLING CODE 7020–02–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–350P] 

Assessment of Annual Needs for the 

List I Chemicals Ephedrine, 

Pseudoephedrine, and 

Phenylpropanolamine for 2011: 

Proposed 

AGENCY: Drug Enforcement 

Administration (DEA), Justice. 

ACTION: Notice of proposed annual 

assessment of needs for 2011. 

SUMMARY: This notice proposes the 

initial year 2011 Assessment of Annual 

Needs for certain List I chemicals in 

accordance with the Combat 

Methamphetamine Epidemic Act 

(CMEA) of 2005. The CMEA requires 

DEA to establish production quotas and 

import quotas for ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. The CMEA 

places additional regulatory controls 

upon the manufacture, distribution, 

importation, and exportation of the 

three List I chemicals. 

DATES: Written comments must be 

postmarked, and electronic comments 

must be sent, on or before October 13, 

2010. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–350P’’ on all written and 

electronic correspondence. Written 

comments being sent via regular mail 

should be sent to the Deputy Assistant 

Administrator, Office of Diversion 

Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, Virginia 22152, Attention: 

DEA Federal Register Representative/ 

ODL. Written comments sent via 

express mail should be sent to DEA 

Headquarters, Attention: DEA Federal 

Register Representative/ODL, 8701 

Morrissette Drive, Springfield, Virginia 

22152. Comments may be directly sent 

to DEA electronically by sending an 

electronic message to dea.diversion.

policy@usdoj.gov. However, persons 

wishing to request a hearing should note 

that such requests must be written and 

manually signed; requests for a hearing 

will not be accepted via electronic 

means. DEA will accept attachments to 

electronic comments in Microsoft Word, 

WordPerfect, Adobe PDF, or Excel file 

formats only. DEA will not accept any 

file format other than those specifically 

listed here. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, PhD, Chief, Drug 

and Chemical Evaluation Section, Drug 

Enforcement Administration, 8701 

Morrissette Drive, Springfield, Virginia 

22152, Telephone: (202) 307–7183. 

SUPPLEMENTARY INFORMATION: Section 

713 of the CMEA of 2005 (Title VII of 

Pub. L. 109–177) (CMEA) amended 

§ 306 of the Controlled Substances Act 

(CSA) (21 U.S.C. 826) by adding 

ephedrine, pseudoephedrine, and 

phenylpropanolamine to existing 

language to read as follows: ‘‘The 

Attorney General shall determine the 

total quantity and establish production 

quotas for each basic class of controlled 

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55606 Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices 

1Applications and instructions for procurement, 

import and manufacturing quotas can be found at 

http://www.deadiversion.usdoj.gov/quotas/quota_

apps.htm. 

substance in schedules I and II and for 

ephedrine, pseudoephedrine, and 

phenylpropanolamine to be 

manufactured each calendar year to 

provide for the estimated medical, 

scientific, research, and industrial needs 

of the United States, for lawful export 

requirements, and for the establishment 

and maintenance of reserve stocks.’’ 

Further, § 715 of CMEA amended 21 

U.S.C. 952 ‘‘Importation of controlled 

substances’’ by adding the same List I 

chemicals to the existing language in 

paragraph (a), and by adding a new 

paragraph (d) to read as follows: 

(a) Controlled substances in schedule 

I or II and narcotic drugs in schedules 

III, IV, or V; exceptions: 

It shall be unlawful to import into the 

customs territory of the United States from 

any place outside thereof (but within the 

United States), or to import into the United 

States from any place outside thereof, any 

controlled substance in schedule I or II of 

subchapter I of this chapter, or any narcotic 

drug in schedule III, IV, or V of subchapter 

I of this chapter, or ephedrine, 

pseudoephedrine, and 

phenylpropanolamine, except that— 

(1) such amounts of crude opium, poppy 

straw, concentrate of poppy straw, and coca 

leaves, and of ephedrine, pseudoephedrine, 

and phenylpropanolamine, as the Attorney 

General finds to be necessary to provide for 

medical, scientific, or other legitimate 

purposes * * * 

may be so imported under such regulations 

as the Attorney General shall prescribe. 

* * * * * 

(d)(1) With respect to a registrant under 

section 958 who is authorized under 

subsection (a)(1) to import ephedrine, 

pseudoephedrine, or phenylpropanolamine, 

at any time during the year the registrant may 

apply for an increase in the amount of such 

chemical that the registrant is authorized to 

import, and the Attorney General may 

approve the application if the Attorney 

General determines that the approval is 

necessary to provide for medical, scientific, 

or other legitimate purposes regarding the 

chemical. 

Editor’s Note: This excerpt of the 

amendment is published for the convenience 

of the reader. The official text is published 

at 21 U.S.C. 952(a) and (d)(1). 

The proposed 2011 Assessment of 

Annual Needs represents those 

quantities of ephedrine, 

pseudoephedrine, and 

phenylpropanolamine which may be 

manufactured domestically and/or 

imported into the United States to 

provide adequate supplies of each 

substance to meet the estimated 

medical, scientific, research, and 

industrial needs of the United States; 

lawful export requirements; and the 

establishment and maintenance of 

reserve stocks. 

As of June 25, 2010, the DEA has 

received a total of 99 applications for 

2011 import, procurement and 

manufacturing quotas for ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. As a 

comparison, for the 2010 quota year, 

DEA has received 204 applications for 

import, procurement, and 

manufacturing quotas. DEA calculated 

the 2011 Assessment of Annual Needs 

for the List I chemicals using the 

calculation methodology described in 

both the 2009 and 2010 Assessment of 

Annual Needs (74 FR 32954 and 74 FR 

60294, respectively). These calculations 

take into account the criteria that DEA 

is required to consider in accordance 

with 21 U.S.C. 826 and its 

implementing regulations (21 CFR 

1315.11). 

In finalizing the assessments for these 

List I chemicals, DEA will consider the 

information contained in additional 

applications for 2011 import, 

manufacturing and procurement quotas 

from DEA registered manufacturers and 

importers that DEA receives after the 

date of drafting this notice, June 25, 

2010, as well as the comments that DEA 

receives in response to this proposal. 

DEA registered manufacturers and 

importers are reminded that pursuant to 

21 CFR 1315.22, 1315.32(e) and 

1315.34(d) applications for import and 

procurement quotas are due by April 1 

and that applications for manufacturing 

quotas are due by May 1 of the year 

preceding the year for which the quota 

is to be applied. DEA encourages 

registrants to submit their quota 

applications by the regulatory due dates 

to ensure their requirements are 

considered. 

Underlying Data and DEA’s Analysis 

In determining the proposed 2011 

assessments, DEA has considered the 

total net disposals (i.e. sales) of the List 

I chemicals for the current and 

preceding two years, actual and 

estimated inventories, projected 

demand (2011), industrial use, and 

export requirements from data provided 

by DEA registered manufacturers and 

importers in procurement quota 

applications (DEA 250), from 

manufacturing quota applications (DEA 

189), and from import quota 

applications (DEA 488).1

DEA further considered trends as 

derived from information provided in 

applications for import, manufacturing, 

and procurement quotas and in import 

and in export declarations. DEA notes 

that the inventory, acquisitions 

(purchases) and disposition (sales) data 

provided by DEA registered 

manufacturers and importers reflects the 

most current information available. 

Ephedrine Data 

EPHEDRINE (FOR SALE) DATA FOR 2011 ASSESSMENT OF ANNUAL NEEDS

[Kilograms] 

Ephedrine 2008 2009 2010 2011 

request 

Sales* (DEA 250) ............................................................................................................................ 2,159 2,136 2,416 2,867 

Imports** (DEA 488) ........................................................................................................................ 49 0 87 104 

Export Declarations (DEA 486) ....................................................................................................... 18 64 52 n/a 

Inventory* (DEA 250) ....................................................................................................................... 723 497 315 n/a 

IMS*** (NSP) ................................................................................................................................... 1,460 1,401 n/a n/a 

* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250). 

** Reported imports from applications for 2011 import quotas (DEA 488). 

*** IMS Health, IMS National Sales PerspectivesTM, January 2008 to December 2009, Retail and Non-Retail Channels, Data Extracted June 

25, 2010. 

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Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices 55607 

Ephedrine Analysis 

DEA calculated the proposed 2011 

Assessment of Annual Needs for 

ephedrine using the calculation 

developed to determine the 2009 

Assessment of Annual Needs. This 

calculation considers the criteria 

defined in 21 U.S.C. 826: estimated 

medical, scientific, research, and 

industrial needs of the United States; 

lawful export requirements; and the 

establishment and maintenance of 

reserve stocks. 

As of June 25, 2010, DEA registered 

manufacturers of dosage form products 

containing ephedrine requested the 

authority to purchase a total of 2,867 kg 

ephedrine (for sale) in 2011. DEA 

registered manufacturers of ephedrine 

reported sales totaling approximately 

2,136 kg in 2009 and 2,416 kg in 2010; 

this represents a 12 percent increase in 

sales reported by these firms from 2009 

to 2010. Additionally, exports of 

ephedrine products from the United 

States as reported on export declarations 

(DEA 486) totaled 64 kg in 2009 and 52 

kg in 2010; this represents a 19 percent 

decrease from levels observed in 2009. 

The average of the 2009 and 2010 

exports of ephedrine products is 

approximately 58 kg. DEA also 

considered information on trends in the 

national rate of net disposals from sales 

data provided by IMS Health’s NSP 

database. IMS NSP data reported the 

average sales volume of ephedrine for 

the calendar years 2008 and 2009 to be 

approximately 1,431 kg. DEA notes that 

the 2010 sales figure reported by 

manufacturers (2,416 kg) is higher than 

the average sales reported by IMS for the 

previous two years (1,431 kg). This is 

expected because a manufacturer’s 

reported sales include quantities which 

are necessary to provide reserve stocks 

for distributors and retailers. In 

considering the manufacturer’s reported 

sales, DEA thus believes that 2,416 kg 

fairly represents the U.S. sales of 

ephedrine for 2011 and that 58 kg fairly 

represents the export requirements of 

ephedrine. 

For the establishment and 

maintenance of reserve stocks, DEA 

notes that 21 CFR 1315.24 allows for an 

inventory allowance (reserve stock) of 

50 percent of a manufacturer’s estimated 

sales. DEA also considered the 

estimated 2010 year end inventory as 

reported by DEA registrants in 

determining the inventory allowance. 

DEA calculated the ephedrine (for 

sale) assessment by the following 

methodology: 

2010 sales + reserve stock + export 

requirement ¥ existing inventory = AAN 

2,416 + (50%*2,416) + 58 ¥ 315 = 3,367 kg 

ephedrine (for sale) for 2011. 

This calculation suggests that DEA’s 

Assessment of Annual Needs for 

ephedrine should be proposed to be 

3,400 kg. Accordingly, DEA is proposing 

the 2011 Assessment of Annual Needs 

for ephedrine (for sale) at 3,400 kg. 

Phenylpropanolamine (for Sale) Data 

PHENYLPROPANOLAMINE (FOR SALE) DATA FOR 2011 ASSESSMENT OF ANNUAL NEEDS

[Kilograms] 

Phenylpropanolamine (for sale) 2008 2009 2010 2011 

request 

Sales* (DEA 250) ............................................................................................................................ 4,252 4,350 4,374 5,638 

Imports** (DEA 488) ........................................................................................................................ 105 1,503 1,582 1,596 

Export Declarations (DEA 486) ....................................................................................................... 0 3 0 n/a 

Inventory* (DEA 250) ....................................................................................................................... 2,054 2,318 1,951 n/a 

* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) received as of June 25, 2010. 

** Reported imports from applications for 2011 import quotas (DEA 488) received as of June 25, 2010. 

Phenylpropanolamine (for Sale) 

Analysis 

DEA utilized the same general 

methodology and calculation to 

establish the assessment for 

phenylpropanolamine (for sale) as was 

described for the assessment of 

ephedrine (for sale), above. 

As of June 25, 2010, DEA registered 

manufacturers of dosage form products 

containing phenylpropanolamine 

requested the authority to purchase 

5,638 kg phenylpropanolamine (for sale) 

in 2011. DEA registered manufacturers 

of phenylpropanolamine reported sales 

totaling approximately 4,350 kg in 2009 

and 4,374 kg in 2010; this represents a 

0.5 percent increase in sales reported by 

these firms from 2009 to 2010. 

Additionally, exports of 

phenylpropanolamine products from 

the U.S. as reported on export 

declarations (DEA 486) totaled 3 kg in 

2009 and 0 kg in 2010; this represents 

a 3 kg decrease from levels observed in 

2009. The average of the 2009 and 2010 

exports of phenylpropanolamine 

products is approximately 2 kg. DEA 

thus believes that 4,374 kg fairly 

represents the U.S. sales of 

phenylpropanolamine for 2011 and that 

2 kg fairly represents the export 

requirements of phenylpropanolamine. 

DEA notes that phenylpropanolamine is 

sold primarily as a veterinary product 

for the treatment for canine 

incontinence and is not approved for 

human consumption. IMS Health’s NSP 

Data does not capture sales of 

phenylpropanolamine to these channels 

and is therefore not included. 

DEA calculated the 

phenylpropanolamine (for sale) 

assessment by the following 

methodology: 

2010 sales + reserve stock + export 

requirement ¥ existing inventory = AAN 

4,374 + (50%*4,374) + 2 ¥ 1,951 = 4,612 kg 

phenylpropanolamine (for sale) for 2011. 

This calculation suggests that DEA’s 

2011 Assessment of Annual Needs for 

phenylpropanolamine (for sale) should 

be proposed at 4,700 kg. Accordingly, 

DEA is proposing the 2011 Assessment 

of Annual Needs for 

phenylpropanolamine (for sale) at 

4,700 kg. 

Pseudoephedrine (for Sale) Data 

PSEUDOEPHEDRINE (FOR SALE) DATA FOR 2011 ASSESSMENT OF ANNUAL NEEDS

[Kilograms] 

Pseudoephedrine (for sale) 2008 2009 2010 2011 

request 

Sales * (DEA 250) ............................................................................................................ 169,992 145,853 148,934 181,219 

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55608 Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices 

PSEUDOEPHEDRINE (FOR SALE) DATA FOR 2011 ASSESSMENT OF ANNUAL NEEDS—Continued 

[Kilograms] 

Pseudoephedrine (for sale) 2008 2009 2010 2011 

request 

Sales * (DEA 189) ............................................................................................................ 64,781 7,321 5,550 0 

Imports ** (DEA 488) ....................................................................................................... 10,872 39,168 44,030 74,012 

Export Declarations (DEA 486) ....................................................................................... 47,199 35,264 8,480 n/a 

Inventory * (DEA 250) ...................................................................................................... 97,026 72,070 55,323 n/a 

IMS *** (NSP) ................................................................................................................... 149,232 140,784 n/a n/a 

* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250). 

** Reported imports from applications for 2011 import quotas (DEA 488). 

*** IMS Health, IMS National Sales PerspectivesTM, January 2008 to December 2009, Retail. and Non-Retail Channels, Data Extracted June 

25, 2010. 

Pseudoephedrine (for Sale) Analysis 

DEA utilized the same general 

methodology and calculations to 

establish the assessment for 

pseudoephedrine (for sale) as were 

described for the assessment of 

ephedrine (for sale), above. 

As of June 25, 2010, DEA registered 

manufacturers of dosage form products 

containing pseudoephedrine requested 

the authority to purchase 181,219 kg 

pseudoephedrine. DEA registered 

manufacturers of pseudoephedrine 

reported sales totaling approximately 

145,853 kg in 2009 and 148,934 kg in 

2010; this represents a 2 percent 

increase in sales reported by these firms 

from 2009 to 2010. During the same 

period exports of pseudoephedrine 

products from the U.S. as reported on 

export declarations (DEA 486) totaled 

35,264 kg in 2009 and 8,480 kg in 2010; 

this represents a 76 percent decrease 

from levels observed in 2009. The 

average of the 2009 and 2010 exports is 

21,872 kg. Additionally, DEA 

considered information on trends in the 

national rate of net disposals from sales 

data provided by IMS Health. IMS NSP 

data reported the average retail sales 

volume of pseudoephedrine for the 

calendar years 2008 and 2009 to be 

approximately 145,008 kg. DEA thus 

believes that 148,934 kg of sales 

reported by manufacturers fairly 

represents the U.S. sales of 

pseudoephedrine for 2011 and that 

21,872 kg fairly represents the export 

requirements of pseudoephedrine. 

DEA calculated the pseudoephedrine 

(for sale) assessment by the following 

methodology: 

2010 sales + reserve stock + export 

requirement ¥ existing inventory = AAN 

148,934 + (50%*148,934) + 21,872 ¥ 55,323 

= 189,950 kg pseudoephedrine (for sale) 

for 2011 

This calculation suggests that DEA’s 

2011 Assessment of Annual Needs for 

pseudoephedrine (for sale) should be 

proposed at 190,000 kg. Accordingly, 

DEA is proposing the 2011 Assessment 

of Annual Needs for pseudoephedrine 

(for sale) at 190,000 kg. 

Phenylpropanolamine (for Conversion) 

Data 

PHENYLPROPANOLAMINE (FOR CONVERSION) DATA FOR 2011 ASSESSMENT OF ANNUAL NEEDS

[Kilograms] 

Phenylpropanolamine 

(for conversion) 2008 2009 2010 2011 request 

Sales * (DEA 250) ............................................................................................................ 3,120 4,415 5,855 12,200 

Imports ** (DEA 488) ....................................................................................................... 105 1,503 1,582 1,500 

Export Declarations (DEA 486) ....................................................................................... 0 0 0 n/a 

Inventory * (DEA 250) ...................................................................................................... 875 503 713 n/a 

* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) received as of June 25, 2010. 

** Reported imports from applications for 2011 import quotas (DEA 488) received as of June 25, 2010. 

Phenylpropanolamine (for Conversion) 

Analysis 

As of June 25, 2010, DEA registered 

manufacturers of phenylpropanolamine 

(for conversion) requested the authority 

to purchase a total of 12,200 kg 

phenylpropanolamine for the 

manufacture of amphetamine. DEA 

registered manufacturers of 

phenylpropanolamine reported sales of 

phenylpropanolamine totaling 

approximately 4,415 kg in 2009 and 

5,855 kg in 2010; this represents a 26 

percent increase in sales reported by 

these firms from 2009 to 2010. There 

were no reported exports of 

phenylpropanolamine (for conversion). 

DEA has not received any requests to 

synthesize phenylpropanolamine in 

2011. DEA has concluded that the 2010 

sales of phenylpropanolamine (for 

conversion), 5,855 kg, fairly represents 

U.S. requirements for 2011 and zero kg 

fairly represents the export 

requirements of phenylpropanolamine 

(for conversion). 

DEA believes that the data provided 

in procurement, manufacturing, and 

import quota applications best 

represents the legitimate need for 

phenylpropanolamine (for conversion). 

Phenylpropanolamine (for conversion) 

is used for the manufacture of legitimate 

amphetamine products, but DEA notes 

that most legitimate amphetamine is 

manufactured by converting 

phenylacetone rather than 

phenylpropanolamine, to amphetamine. 

Basing the phenylpropanolamine (for 

conversion) calculation on the total 

Aggregate Production Quota (APQ) for 

amphetamine therefore would 

inaccurately inflate the 

phenylpropanolamine (for conversion) 

assessment. 

DEA calculated the 

phenylpropanolamine (for conversion) 

assessment for the manufacture of 

amphetamine as follows: 

(2010 sales) + reserve stock + export 

requirement ¥ inventory = AAN (5,855) 

+ (50%*5,855) + 0 ¥ 713 = 8,070 kg PPA 

(for conversion) for 2011 

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Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices 55609 

This calculation suggests that DEA’s 

2011 Assessment of Annual Needs for 

phenylpropanolamine (for conversion) 

should be proposed at 8,100 kg. 

Accordingly, DEA is proposing the 2011 

Assessment of Annual Needs for 

phenylpropanolamine (for conversion) 

at 8,100 kg. 

Ephedrine (for Conversion) Data 

EPHEDRINE (FOR CONVERSION) DATA FOR 2011 ASSESSMENT OF ANNUAL NEEDS

[Kilograms] 

Ephedrine 

(for conversion) 2008 2009 2010 2011 request 

Sales * (DEA 250) ............................................................................................................ 64,665 9,316 6,057 287 

Imports ** (DEA 488) ....................................................................................................... 0 0 0 0 

Inventory * (DEA 250) ...................................................................................................... 233 99 152 n/a 

APQ Methamphetamine *** .............................................................................................. 3,130 3,130 3,130 n/a 

* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of 

June 25, 2010. 

** Reported imports from applications for 2011 import quotas (DEA 488) received as of June 25, 2010. 

*** Methamphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf. 

Ephedrine (for Conversion) Analysis 

As of June 25, 2010, DEA registered 

manufacturers of ephedrine (for 

conversion) requested the authority to 

purchase a total of 287 kg ephedrine (for 

conversion) for the manufacture of two 

substances: Methamphetamine and 

pseudoephedrine. 

DEA considered the ephedrine (for 

conversion) requirements for the 

manufacture of methamphetamine and 

pseudoephedrine. DEA has determined 

that the established assessments for the 

manufacture of these two substances are 

the best indicators of the need for 

ephedrine (for conversion). The 

assessment of need for 

methamphetamine was determined by 

DEA as the Aggregate Production Quota 

(APQ) for methamphetamine. DEA 

determined that the estimated sale of 

pseudoephedrine, as referenced in the 

proposed Assessment of Annual Needs 

(AAN) for pseudoephedrine, represents 

the need for pseudoephedrine. Reported 

sales of ephedrine (for conversion) are 

included as reference to DEA’s 

methodology. 

DEA further considered the reported 

conversion yields of these substances. 

DEA registered manufacturers reported 

a conversion yield of 39 percent for the 

synthesis of methamphetamine from 

ephedrine. DEA cannot disclose the 

conversion yield for the synthesis of 

pseudoephedrine because this 

information is proprietary to the one 

manufacturer involved in this type of 

manufacturing. 

DEA calculated the ephedrine (for 

conversion) assessment by the following 

methodology: 

methamphetamine requirement + 

pseudoephedrine requirement = AAN 

DEA calculated the ephedrine (for 

conversion) requirement for the 

manufacture of methamphetamine as 

follows: 

(2010 APQ methamphetamine/39 percent 

yield) + reserve stock ¥ inventory = 

ephedrine (for manufacture of 

methamphetamine) 

(3,130/39 percent yield) + 50 percent*(3,130/ 

39 percent yield) ¥ 152 = 11,887 kg 

The calculation for the ephedrine (for 

conversion) requirement for the manufacture 

of pseudoephedrine leads to a result of 6,703 

kg. DEA cannot provide the details of the 

calculation because this would reveal the 

conversion yield for the synthesis of 

pseudoephedrine, which is proprietary to the 

one manufacturer involved in this type of 

manufacturing. Therefore, the assessment for 

ephedrine was determined by the sum total 

of the ephedrine (for conversion) 

requirements as described by the following 

methodology: 

methamphetamine requirement + 

pseudoephedrine requirement = 

AAN 11,887 + 6,703 = 18,590 kg 

ephedrine (for conversion) for 2011 

This calculation suggests that DEA’s 

2011 Assessment of Annual Needs for 

ephedrine (for conversion) should be 

proposed at 18,600 kg. Accordingly, 

DEA is proposing the 2011 Assessment 

of Annual Needs for ephedrine (for 

conversion) at 18,600 kg. 

Conclusion 

In finalizing the 2011 assessments for 

these List I chemicals, DEA will use the 

methodology and calculations presented 

above. The numbers used in the 

calculations may be adjusted upwards 

or downwards based on the additional 

applications for 2011 import, 

manufacturing and procurement quotas 

received after June 25, 2010. DEA urges 

registered importers and manufacturers 

to submit applications for 2011 import, 

manufacturing and procurement quota 

so that DEA may include information 

from those applications when finalizing 

these assessments in accordance with 21 

CFR 1315. 

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 the 

DEA by 28 CFR 0.100, and redelegated 

to the Deputy Administrator pursuant to 

28 CFR 0.104, the Deputy Administrator 

hereby proposes the following 2011 

Assessment of Annual Needs for the List 

I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine for 2011, 

expressed in kilograms of anhydrous 

base: 

List I chemicals 

Proposed year 

2011 assessment of annual 

needs (kg) 

Ephedrine (for sale) .............. 3,400 

Phenylpropanolamine (for 

sale) .................................. 4,700 

Pseudoephedrine (for sale) .. 190,000 

Phenylpropanolamine (for 

conversion) ........................ 8,100 

Ephedrine (for conversion) ... 18,600 

Ephedrine (for conversion) refers to 

the industrial use of ephedrine, i.e., that 

which will be converted to another 

basic drug class such as 

pseudoephedrine or methamphetamine 

used for the manufacture of prescription 

weight loss drug. Phenylpropanolamine 

(for conversion) refers to the industrial 

use of phenylpropanolamine, i.e., that 

which will be converted to another 

basic drug class such as amphetamine 

for the manufacture of drug products. 

The ‘‘for sale’’ assessments refer to the 

amount of ephedrine, pseudoephedrine, 

and phenylpropanolamine intended for 

ultimate use in products containing 

these List I chemicals. 

All interested persons are invited to 

submit their comments in writing or 

electronically regarding this proposal 

following the procedures in the 

ADDRESSES section of this document. A 

person may object to or comment on the 

mstockstill on DSKB9S0YB1PROD with NOTICES

55610 Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices 

proposal relating to any of the abovementioned substances without filing 

comments or objections regarding the 

others. If a person believes that one or 

more of these issues warrant a hearing, 

the individual should so state and 

summarize the reasons for this belief. 

Persons wishing to request a hearing 

should note that such requests must be 

written and manually signed; requests 

for a hearing will not be accepted via 

electronic means. In the event that 

comments or objections to this proposal 

raise one or more issues which the 

Deputy Administrator finds warrant a 

hearing, the Deputy Administrator shall 

order a public hearing by notice in the 

Federal Register, summarizing the 

issues to be heard and setting the time 

for the hearing as per 21 CFR 1315.13(e). 

Regulatory Certifications 

Regulatory Flexibility Act 

The Deputy Administrator hereby 

certifies that this action will not have a 

significant economic impact upon 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 United States, 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 

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 

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 United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

Dated: August 27, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–22688 Filed 9–10–10; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Occupational Safety and Health 

Administration 

[Docket No. OSHA–2010–0028] 

Advisory Committee on Construction 

Safety and Health (ACCSH) 

AGENCY: Occupational Safety and Health 

Administration (OSHA), Labor. 

ACTION: Request for nominations of 

members to serve on ACCSH. 

SUMMARY: The Assistant Secretary of 

Labor for Occupational Safety and 

Health (OSHA) invites interested parties 

to submit nominations for membership 

on ACCSH. 

DATES: Nominations for ACCSH must be 

submitted (postmarked, sent, 

transmitted, or received) by November 

12, 2010. 

ADDRESSES: You may submit 

nominations and supporting materials 

by any one of the following methods: 

Electronically: Nominations, 

including attachments, may be 

submitted electronically at http:// 

www.regulations.gov, the Federal eRulemaking Portal. Follow the online 

instructions for submitting nominations; 

Facsimile: If your nomination and 

supporting materials, including 

attachments, do not exceed 10 pages, 

you may fax them to the OSHA Docket 

Office at (202) 693–1648; 

Mail, express delivery, hand delivery, 

and messenger or courier service: 

Submit your nominations and 

supporting materials to the OSHA 

Docket Office, Docket No. OSHA–2010– 

0028, Room N–2625, U.S. Department of 

Labor, 200 Constitution Avenue, NW., 

Washington, DC 20210; telephone (202) 

693–2350 TTY number (877) 889–5627. 

Deliveries by hand, express mail, 

messenger, and courier service are 

accepted during the OSHA Docket 

Office’s normal business hours, 8:15 

a.m.–4:45 p.m., e.t. 

Instructions: All nominations and 

supporting materials must include the 

agency name and docket number for this 

Federal Register notice (Docket No. 

OSHA–2010–0028). Because of securityrelated procedures, submitting 

nominations by regular mail may result 

in a significant delay in their receipt. 

Please contact the OSHA Docket Office 

for information about security 

procedures for submitting nominations 

by hand delivery, express delivery, and 

messenger or courier service. For 

additional information on submitting 

nominations, see the ‘‘Public 

Participation’’ heading in the 

SUPPLEMENTARY INFORMATION section 

below. 

All submissions in response to this 

Federal Register notice, including 

personal information provided, are 

posted without change at http:// 

www.regulations.gov. Therefore, OSHA 

cautions interested parties about 

submitting personal information such as 

Social Security numbers and birthdates. 

Docket: To read or download 

submissions in response to this Federal 

Register notice, go to Docket No. 

OSHA–2010–0028 at http:// 

www.regulations.gov. All documents in 

the docket are listed in the http:// 

www.regulations.gov index; however, 

some documents (e.g., copyrighted 

material) are not publicly available to 

read or download through that webpage. 

All submissions, including copyrighted 

material, are available for inspection 

and copying at the OSHA Docket Office. 

FOR ADDITIONAL INFORMATION: 

For press inquiries: Ms. MaryAnn 

Garrahan, Acting Director, OSHA, Office 

of Communications, Room N–3647, U.S. 

Department of Labor, 200 Constitution 

Avenue, NW., Washington, DC 20210; 

telephone (202) 693–1999. 

For general information: Mr. Francis 

Dougherty, OSHA, Office of 

Construction Services, Directorate of 

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