Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices 47021 

—Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

—Evaluate the accuracy of the agencies’ 

estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

—Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

—Minimize the burden of the collection 

of information on those who are to 

respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms 

of information technology, e.g., 

permitting electronic submission of 

responses. 

Overview of This Information 

Collection 

(1) Type of Information Collection: 

Extension of a currently approved 

collection. 

(2) Title of the Form/Collection: 

Notification of Change of Mailing or 

Premise Address. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Justice sponsoring the 

collection: Form Number: None. Bureau 

of Alcohol, Tobacco, Firearms and 

Explosives. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Not-for-profit 

institutions. Other: Business or other 

for-profit. Licensees and permittees 

whose mailing address will change must 

notify the Chief, Federal Explosives 

Licensing Center, at least 10 days before 

the change. The information is used by 

ATF to identify correct locations of 

storage of explosives licensees/ 

permittees and location of storage of 

explosives materials for purposes of 

inspection as well as to notify permitee/ 

licensees of any change in regulations or 

laws that may affect their business 

activities. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: It is estimated that 1,000 

respondents will take 10 minutes to 

respond via letter to the Federal 

Explosives Licensing Center. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: There are an estimated 170 

annual total burden hours associated 

with this collection. 

If additional information is required 

contact: Lynn Bryant, Department 

Clearance Officer, Policy and Planning 

Staff, Justice Management Division, 

Department of Justice, Patrick Henry 

Building, Suite 1600, 601 D Street, NW., 

Washington, DC 20530. 

Dated: September 9, 2009. 

Lynn Bryant, 

Department Clearance Officer, PRA, U.S. 

Department of Justice. 

[FR Doc. E9–22042 Filed 9–11–09; 8:45 am] 

BILLING CODE 4410–FY–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–326P] 

Assessment of Annual Needs for the 

List I Chemicals Ephedrine, 

Pseudoephedrine, and 

Phenylpropanolamine for 2010: 

Proposed 

AGENCY: Drug Enforcement 

Administration (DEA), Justice. 

ACTION: Notice of proposed annual 

assessment of needs for 2010. 

SUMMARY: This notice proposes the 

initial year 2010 Assessment of Annual 

Needs for certain List I chemicals in 

accordance with the Combat 

Methamphetamine Epidemic Act 

(CMEA) of 2005, enacted on March 9, 

2006. 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 14, 

2009. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–326P’’ 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 

Morrisette Drive, Springfield, Virginia 

22152, Telephone: (202) 307–7183. 

SUPPLEMENTARY INFORMATION: Section 

713 of the Combat Methamphetamine 

Epidemic Act of 2005 (Title VII of Pub. 

L. 109–177) (CMEA) amended Section 

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 

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, section 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 schedule 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, 


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47022 Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices 

1Applications and instructions for procurement, 

import and manufacturing quotas can be found at 

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

quota_apps.htm. 

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 2010 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 August 4, 2009, the DEA had 

received a total of 134 applications for 

2010 import, procurement and 

manufacturing quotas for ephedrine, 

pseudoephedrine and 

phenylpropanolamine. As a 

comparison, for the 2009 quota year 

DEA has received 201 applications for 

import, procurement and manufacturing 

quotas. DEA calculated the 2010 

Assessment of Annual Needs for the List 

I chemicals using the calculation 

methodology described in both the 

interim and final 2009 Assessment of 

Annual Needs (73 FR 79508 and 74 FR 

32954, respectively). The 

phenylpropanolamine (for conversion) 

calculation has been modified to 

account for additional information. 

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 2010 import, 

manufacturing and procurement quotas 

from DEA registered manufacturers and 

importers that DEA receives after 

August 4, 2009, as well as the comments 

that DEA receives in response to this 

proposal. 

Underlying Data and DEA’s Analysis 

In determining the proposed 2010 

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 (2010), 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 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 2010 ASSESSMENT OF ANNUAL NEEDS

(Kilograms) 

Ephedrine 2007 2008 2009 2010 

Request 

Sales* (DEA 250) ............................................................................................................................ 1,509 1,988 2,107 2,486 

Imports** (DEA 488) ........................................................................................................................ 1 3 42 17 

Export Declarations (DEA 486) ....................................................................................................... 168 91 10 n/a 

Inventory* (DEA 250) ....................................................................................................................... 714 421 176 n/a 

IMS*** (NSP) ................................................................................................................................... 1,235 1,460 n/a 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 2008, Retail and Non-Retail Channels, Data Extracted August 

4, 2009. 

Ephedrine Analysis 

DEA calculated the proposed 2010 

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 August 4, 2009, DEA registered 

manufacturers of dosage form products 

containing ephedrine requested the 

authority to purchase a total of 2,486 kg 

ephedrine (for sale) in 2010. DEA 

registered manufacturers of ephedrine 

reported sales totaling approximately 

1,988 kg in 2008 and 2,107 kg in 2009; 

this represents a 6 percent increase in 

sales reported by these firms from 2008 

to 2009. Additionally, exports of 

ephedrine products from the United 

States as reported on export declarations 

(DEA 486) totaled 91 kg in 2008 and 10 

kg in 2009; this represents a 90 percent 

decrease from levels observed in 2008. 

The average of the 2008 and 2009 

exports of ephedrine products is 

approximately 51 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 2007 and 2008 to be 

approximately 1,348 kg. DEA notes that 

the 2009 sales figure reported by 

manufacturers (2,107 kg) is higher than 

the average sales reported by IMS for the 

previous two years (1,348 kg). This is 

expected because a manufacturer’s 

reported sales include quantities which 

are necessary to provide reserve stocks 

for distributors and retailers. DEA, in 

considering the manufacturer’s reported 

sales, thus believes that 2,107 kg fairly 

represents the U.S. sales of ephedrine 

for 2010 and that 51 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 


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Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices 47023 

sales. DEA also considered the 

estimated 2009 year end inventory as 

reported by DEA registrants in 

determining the inventory allowance. 

DEA calculated the ephedrine (for 

sale) assessment by the following 

methodology: 

2009 sales + reserve stock + export 

requirement¥existing inventory = 

AAN 

2,107 + (50%*2,107) + 51¥176 = 3,036 

kg ephedrine (for sale) for 2010 

This calculation suggests that DEA’s 

Assessment of Annual Needs for 

ephedrine should be proposed to be 

3,100 kg. Accordingly, DEA is proposing 

the 2010 Assessment of Annual Needs 

for ephedrine (for sale) at 3,100 kg. 

Phenylpropanolamine (for Sale) Data 

PHENYLPROPANOLAMINE (FOR SALE) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS

[Kilograms] 

Phenylpropanolamine 

(for sale) 2007 2008 2009 2010 Request 

Sales * (DEA 250) ............................................................................................................................ 3,674 4,119 4,452 5,680 

Imports ** (DEA 488) ....................................................................................................................... 73 79 134 263 

Export Declarations (DEA 486) ....................................................................................................... 1,002 0 3 n/a 

Inventory * (DEA 250) ...................................................................................................................... 3,498 2,045 573 n/a 

* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 4, 2009. 

** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 4, 2009. 

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 August 4, 2009, DEA registered 

manufacturers of dosage form products 

containing phenylpropanolamine 

requested the authority to purchase 

5,680 kg phenylpropanolamine (for sale) 

in 2010. DEA registered manufacturers 

of phenylpropanolamine reported sales 

totaling approximately 4,119 kg in 2008 

and 4,452 kg in 2009; this represents a 

7.5% increase in sales reported by these 

firms from 2008 to 2009. Additionally, 

exports of phenylpropanolamine 

products from the U.S. as reported on 

export declarations (DEA 486) totaled 0 

kg in 2008 and 3 kg in 2009; this 

represents a 3 kg increase from levels 

observed in 2008. The average of the 

2008 and 2009 exports of 

phenylpropanolamine products is 

approximately 2 kg. DEA thus believes 

that 4,452 kg fairly represents the U.S. 

sales of phenylpropanolamine for 2010 

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: 

2009 sales + reserve stock + export 

requirement ¥ existing inventory = 

AAN 

4,452 + (50%*4,452) + 2 ¥ 573 = 6,107 

kg phenylpropanolamine (for sale) for 

2010 

This calculation suggests that DEA’s 

2010 Assessment of Annual Needs for 

phenylpropanolamine (for sale) should 

be proposed at 6,100 kg. Accordingly, 

DEA is proposing the 2010 Assessment 

of Annual Needs for 

phenylpropanolamine (for sale) at 6,100 

kg. 

Pseudoephedrine (for Sale) Data 

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

[Kilograms] 

Pseudoephedrine 

(for sale) 2007 2008 2009 2010 Request 

Sales * (DEA 250) ............................................................................................................ 204,028 179,566 236,650 196,912 

Sales * (DEA 189) ............................................................................................................ 100,300 64,781 33,600 32,760 

Imports ** (DEA 488) ....................................................................................................... 44,499 60,300 147,002 78,884 

Export Declarations (DEA 486) ....................................................................................... 42,142 85,757 18,974 n/a 

Inventory * (DEA 250) ...................................................................................................... 132,838 114,795 61,613 n/a 

IMS *** (NSP) ................................................................................................................... 180,172 149,110 n/a n/a 

* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of 

August 4, 2009. 

** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 4, 2009. 

*** IMS Health, IMS National Sales Perspectives TM, January 2007 to December 2008, Retail and Non-Retail Channels, Data Extracted August 

4, 2009. 

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 August 4, 2009, DEA registered 

manufacturers of dosage form products 

containing pseudoephedrine requested 

the authority to purchase 196,912 kg 

pseudoephedrine. DEA registered 

manufacturers of pseudoephedrine 

reported sales totaling approximately 

179,566 kg in 2008 and 236,650 kg in 

2009; this represents a 24 percent 

increase in sales reported by these firms 

from 2008 to 2009. During the same 

period exports of pseudoephedrine 

products from the U.S. as reported on 

export declarations (DEA 486) totaled 

85,757 kg in 2008 and 18,974 kg in 

2009; this represents a 78 percent 


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47024 Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices 

decrease from levels observed in 2008. 

The average of the 2008 and 2009 

exports is 52,366 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 2007 and 2008 to be 

approximately 164,641 kg. DEA thus 

believes that 236,650 kg of sales 

reported by manufacturers fairly 

represents the U.S. sales of 

pseudoephedrine for 2010 and that 

52,366 kg fairly represents the export 

requirements of pseudoephedrine. DEA 

notes that manufacturer reported sales 

for 2009 (236,650 kg) are higher than the 

average retail sales reported by IMS for 

the previous two years (164,641 kg). 

This is expected because a 

manufacturer’s reported sales include 

quantities which are necessary to 

provide reserve stocks for distributors 

and retailers. 

DEA calculated the pseudoephedrine 

(for sale) assessment by the following 

methodology: 

2009 sales + reserve stock + export 

requirement ¥ existing inventory = 

AAN 

236,650 + (50%*236,650) + 52,366 ¥ 

61,613 = 345,728 kg pseudoephedrine 

(for sale) for 2010. 

This calculation suggests that DEA’s 

2010 Assessment of Annual Needs for 

pseudoephedrine (for sale) should be 

proposed at 346,000 kg. Accordingly, 

DEA is proposing the 2010 Assessment 

of Annual Needs for pseudoephedrine 

(for sale) at 346,000 kg. 

Phenylpropanolamine (for Conversion) 

Data 

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

[Kilograms] 

Phenylpropanolamine 

(for conversion) 2007 2008 2009 2010 Request 

Sales * (DEA 250) ............................................................................................................................ 3,621 10,834 13,582 14,900 

Imports ** (DEA 488) ....................................................................................................................... 1,000 3,225 6,514 6,108 

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

Inventory * (DEA 250) ...................................................................................................................... 3,581 5,533 4,103 n/a 

APQ Amphetamine *** ..................................................................................................................... 17,000 22,000 22,000 n/a 

* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 4, 2009. 

** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 4, 2009. 

*** Amphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.htm. 

Phenylpropanolamine (for Conversion) 

Analysis 

As of August 4, 2009, DEA registered 

manufacturers of phenylpropanolamine 

(for conversion) requested the authority 

to purchase a total of 14,900 kg 

phenylpropanolamine for the 

manufacture of amphetamine. DEA 

registered manufacturers of 

phenylpropanolamine reported sales of 

phenylpropanolamine totaling 

approximately 10,834 kg in 2008 and 

13,582 kg in 2009; this represent a 20 

percent increase in sales reported by 

these firms from 2008 to 2009. There 

were no reported exports of 

phenylpropanolamine (for conversion). 

DEA has not received any requests to 

synthesize phenylpropanolamine in 

2010. DEA has concluded that the 2009 

sales of phenylpropanolamine (for 

conversion), 13,582 kg, fairly represents 

U.S. requirements for 2010 and zero kg 

fairly represents the export 

requirements of phenylpropanolamine 

(for conversion). 

Phenylpropanolamine is used in the 

production of legitimate amphetamine 

products. DEA has established an 

Aggregate Production Quota (APQ) for 

amphetamine of 22,000 kg for 2009. 

DEA notes amphetamine is primarily 

manufactured by the conversion of the 

schedule II controlled substance 

phenylacetone to amphetamine. DEA 

did not consider this alternative 

synthesis route in the 2009 Assessment 

of Annual Needs for 

phenylpropanolamine (for conversion). 

DEA calculated the 

phenylpropanolamine (for conversion) 

for the manufacture of amphetamine as 

follows: 

(2009 sales) + reserve stock + export 

requirement ¥ inventory = AAN 

(13,582) + 

50%*(13,582) + 0 ¥ 4,103 = 16,270 kg 

PPA (for conversion) for 2009 

This calculation suggests that DEA’s 

2009 Assessment of Annual Needs for 

phenylpropanolamine (for conversion) 

should be proposed at 16,500 kg. 

Accordingly, DEA is proposing the 2010 

Assessment of Annual Needs for 

phenylpropanolamine (for conversion) 

at 16,500 kg. 

Ephedrine (for Conversion) Data 

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

[Kilograms] 

Ephedrine 

(for conversion) 2007 2008 2009 2010 Request 

Sales * (DEA 250) ............................................................................................................................ 99,622 64,522 40,403 40,646 

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 n/a 

* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of 

August 4, 2009. 

** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 4, 2009. 

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


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Ephedrine (for Conversion) Analysis 

As of August 4, 2009, DEA registered 

manufacturers of ephedrine (for 

conversion) requested the authority to 

purchase a total of 40,646 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 sales of 

pseudoephedrine, as referenced in the 

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: 

(2009 APQ methamphetamine/39% 

yield) + reserve stock ¥ inventory = 

ephedrine 

(for manufacture of methamphetamine) 

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

yield) ¥ 46 = 11,993 kg 

The calculation for the ephedrine (for 

conversion) requirement for the 

manufacture of pseudoephedrine leads 

to a result of 63,157 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 

11,993 + 63,157 = 75,150 kg ephedrine 

(for conversion) for 2010 

This calculation suggests that DEA’s 

2010 Assessment of Annual Needs for 

ephedrine (for conversion) should be 

proposed at 75,000 kg. Accordingly, 

DEA is proposing the 2010 Assessment 

of Annual Needs for ephedrine (for 

conversion) at 75,000 kg. 

Conclusion 

In finalizing the 2010 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 2010 import, 

manufacturing and procurement quotas 

received after August 4, 2009. DEA 

urges registered importers and 

manufacturers to submit applications 

for 2010 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 2010 

Assessment of Annual Needs for the List 

I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine for 2010, 

expressed in kilograms of anhydrous 

base: 

List I Chemicals 

Proposed Year 2010 

Assessment of Annual Needs 

Ephedrine (for sale) .. 3,100 kg. 

Phenylpropanolamine 

(for sale).

6,100 kg. 

Pseudoephedrine (for 

sale).

346,000 kg. 

Phenylpropanolamine 

(for conversion).

16,500 kg. 

Ephedrine (for conversion).75,000 kg. 

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 

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 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
47026 Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices 

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: September 2, 2009. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E9–22043 Filed 9–11–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

148th Meeting of the Advisory Council 

on Employee Welfare and Pension 

Benefit Plans; Notice of Meeting 

Pursuant to the authority contained in 

Section 512 of the Employee Retirement 

Income Security Act of 1974 (ERISA), 29 

U.S.C. 1142, the Advisory Council on 

Employee Welfare and Pension Benefit 

Plans will hold a public teleconference 

meeting on September 29, 2009. 

The meeting will take place in Room 

N3437 A–B, U.S. Department of Labor, 

200 Constitution Avenue, NW., 

Washington, DC 20210. Public access is 

available only in this room (i.e. not by 

telephone). The meeting will run from 

11:30 a.m. to approximately 5:30 p.m. 

The purpose of the open meeting is to 

discuss reports/recommendations for 

the Secretary of Labor on the issues of 

(1) Stable Value Funds and Retirement 

Security in the Current Economic 

Conditions, (2) Promoting Retirement 

Literacy and Security by Streamlining 

Disclosures to Participants and 

Beneficiaries, and (3) Approaches for 

Retirement Security in the United 

States. Descriptions of these topics are 

available on the Advisory Council page 

of the EBSA Web site at http:// 

www.dol.gov/ebsa/aboutebsa/ 

erisa_advisory_council.html. 

Organizations or members of the 

public wishing to submit a written 

statement pertaining to the topic may do 

so by submitting 30 copies on or before 

September 22, 2009 to Larry Good, 

Executive Secretary, ERISA Advisory 

Council, U.S. Department of Labor, 

Suite N–5623, 200 Constitution Avenue 

NW., Washington, DC 20210. 

Statements also may be submitted as email attachments in text or pdf format 

transmitted to good.larry@dol.gov. It is 

requested that statements not be 

included in the body of the e-mail. 

Statements received on or before 

September 22, 2009 will be included in 

the record of the meeting. Individuals or 

representatives of organizations wishing 

to address the Advisory Council should 

forward their requests to the Executive 

Secretary or telephone (202) 693–8668. 

Oral presentations will be limited to 10 

minutes, time permitting, but an 

extended statement may be submitted 

for the record. Individuals with 

disabilities who need special 

accommodations should contact Larry 

Good by September 22 at the address 

indicated. 

Signed at Washington, DC, this 10th day of 

September, 2009. 

Michael L. Davis, 

Deputy Assistant Secretary, Employee 

Benefits Security Administration. 

[FR Doc. E9–22108 Filed 9–11–09; 8:45 am] 

BILLING CODE 4510–29–P 

DEPARTMENT OF LABOR 

Occupational Safety and Health 

Administration 

[Docket Nos. OSHA–2005–022, OSHA– 

2006–0028, OSHA–2006–0029, OSHA–2006– 

0040, OSHA–2006–0042, OSHA–2007–0039, 

OSHA–2007–0041, OSHA–2007–0042, 

OSHA–2009–0025, OSHA–2009–0026, 

OSHA–2009–0027] 

Modifications to the Scope of NRTL 

Recognition 

AGENCY: Occupational Safety and Health 

Administration (OSHA), Labor. 

ACTION: Notice. 

SUMMARY: This notice modifies the 

scopes of recognition of several 

Nationally Recognized Testing 

Laboratories resulting from the 

withdrawal of test standards by 

standards-developing organizations. 

DATES: Effective Date: The effective date 

of this notice is September 14, 2009. 

FOR FURTHER INFORMATION CONTACT: 

MaryAnn Garrahan, Director, Office of 

Technical Programs and Coordination 

Activities, NRTL Program, Occupational 

Safety and Health Administration, U.S. 

Department of Labor, 200 Constitution 

Avenue, NW., Room N–3655, 

Washington, DC 20210; phone: (202) 

693–2110. 

SUPPLEMENTARY INFORMATION: 

I. Notice of Modifications 

In this notice, the Occupational Safety 

and Health Administration (OSHA) is 

modifying the scopes of recognition of 

several Nationally Recognized Testing 

Laboratories (NRTLs). Specifically, one 

or more of the test standards that OSHA 

currently includes in the scopes of 

recognition of these NRTLs are no 

longer ‘‘appropriate test standards’’ 

under 29 CFR 1910.07(c) because the 

standards-developing organizations that 

wrote and published the standards 

withdrew the standards. Consequently, 

OSHA is deleting the test standards 

from the scope of recognition of each 

affected NRTL. Section IV of this notice 

(‘‘Modifications to Each NRTL’s Scope 

of Recognition’’) identifies the affected 

NRTLs. 

To substitute other test standards for 

the standards being removed, OSHA’s 

policy permits NRTLs to request, or 

OSHA to provide, recognition for 

comparable test standards, i.e., other 

appropriate test standards covering 

comparable product testing. The table in 

Section III (‘‘Withdrawn Test Standards 

and Replacement Test Standards’’) 

identifies the test standards removed 

from the scopes of recognition of the 

affected NRTL, under the heading 


cprice-sewell on DSK2BSOYB1PROD with NOTICES