79412 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 

pseudoephedrine, and 

phenylpropanolamine, expressed in 

kilograms of anhydrous acid or base, be 

established as follows: 

List I chemical 

Established 

2011 assessment of annual 

needs (kg) 

Ephedrine (for sale) .............. 4,200 

Phenylpropanolamine (for 

sale) .................................. 5,300 

Pseudoephedrine (for sale) .. 280,000 

Phenylpropanolamine (for 

conversion) ........................ 21,800 

Ephedrine (for conversion) ... 18,600 

The Office of Management and Budget 

has determined that notices of quotas 

are not subject to centralized review 

under Executive Order 12866. 

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 any federalism 

implications warranting the application 

of Executive Order 13132. 

The Deputy Administrator hereby 

certifies that this action will not have a 

significant economic impact upon a 

substantial number of small entities 

whose interests must be considered 

under the Regulatory Flexibility Act, 5 

U.S.C. 601–612. The establishment of 

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. 

This action meets the applicable 

standards set forth in Sections 3(a) and 

3(b)(2) of Executive Order 12988 Civil 

Justice Reform. 

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 

(adjusted for inflation) 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. 

This action is not a major rule as 

defined by Section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act). 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: December 10, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–31853 Filed 12–17–10; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–326F] 

Final Revised Assessment of Annual 

Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2010 

AGENCY: Drug Enforcement 

Administration (DEA), Justice. 

ACTION: Notice of Final Assessment of 

Annual Needs for 2010. 

SUMMARY: This notice establishes the 

Final Revised 2010 Assessment of 

Annual Needs for certain List I 

chemicals in accordance with the 

Combat Methamphetamine Epidemic 

Act of 2005 (CMEA), enacted on March 

9, 2006. 

DATES: Effective Date: December 20, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, PhD, Chief, Drug 

& Chemical Evaluation Section, Drug 

Enforcement Administration (DEA), 

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, 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, 

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 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 in 2010 

to provide adequate supplies of each 

chemical for: The estimated medical, 

scientific, research, and industrial needs 

of the United States; lawful export 

requirements; and the establishment 

and maintenance of reserve stocks. 

On June 28, 2010, a notice entitled, 

‘‘Proposed Revised Assessment of 

Annual Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2010’’ was 

published in the Federal Register (75 

FR 36684). This notice proposed the 

revised 2010 Assessment of Annual 

Needs for ephedrine (for sale), 

ephedrine (for conversion), 

pseudoephedrine (for sale), 

phenylpropanolamine (for sale) and 

phenylpropanolamine (for conversion). 


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1Applications and instructions for procurement, 

import and manufacturing quotas can be found at 

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

apps.htm. 

All interested persons were invited to 

comment on or object to the proposed 

assessments on or before July 28, 2010. 

Comments Received 

DEA did not receive any comments to 

the Assessment of Annual Needs for 

ephedrine (for sale), ephedrine (for 

conversion), pseudoephedrine (for sale), 

phenylpropanolamine (for sale) and 

phenylpropanolamine (for conversion). 

DEA is finalizing the assessments for 

these List I chemicals based on 

information contained in applications 

for 2010 import, manufacturing and 

procurement quotas provided by DEA 

registered importers and manufacturers, 

including those quota applications that 

DEA received between the drafting of 

the June 28th notice and the drafting of 

this notice on August 10, 2010. DEA is 

providing the data used in developing 

the established assessments for each of 

the listed chemicals. 

Underlying Data and DEA’s Analysis 

In determining the 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 (for Sale) Data 

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

[Kilograms] 

Ephedrine 2007 2008 2009 2010 

Request 

Sales * (DEA 250) ............................................................................................................ 2,698 2,507 2,650 3,289 

Imports ** (DEA 488) ....................................................................................................... 9,595 1,690 2,139 2,431 

Export Declarations (DEA 486) ....................................................................................... 168 18 64 n/a 

Inventory * (DEA 250) ...................................................................................................... 1,373 626 191 n/a 

IMS *** (NSP) ................................................................................................................... 1,236 1,460 1,401 n/a 

* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 10, 2010. 

** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010. 

*** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail Channels, Data Extracted August 

10, 2010. 

Ephedrine (for Sale) Analysis 

DEA previously has established the 

2010 assessment of annual needs for 

ephedrine (for sale) at 3,600 kg (74 FR 

60298). 

As noted above, DEA developed the 

revisions to the 2010 assessment of 

annual needs for ephedrine (for sale) 

using the same calculation and 

methodology that DEA used to 

determine the 2009 and 2010 

assessment of annual needs. 

As of August 10, 2010, DEA registered 

manufacturers of dosage form products 

containing ephedrine requested the 

authority to purchase a total of 3,289 kg 

ephedrine (for sale) in 2010. DEA 

registered manufacturers of ephedrine 

reported sales totaling approximately 

2,507 kg in 2008 and 2,650 kg in 2009; 

this represents a 5 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 18 kg in 2008 and 64 

kg in 2009; this represents a 72 percent 

increase from levels observed in 2008. 

The average of the 2008 and 2009 

exports of ephedrine products is 

approximately 41 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 2009 sales figure reported by 

manufacturers (2,650 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. DEA, in 

considering the manufacturer’s reported 

sales, thus believes that 2,650 kg fairly 

represents the United States sales of 

ephedrine for 2010 and that 41 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 2009 year end inventory as 

reported by DEA registrants in 

determining the inventory allowance. 

DEA calculated the proposed revised 

ephedrine (for sale) assessment as 

follows: 

2009 sales + reserve stock + export 

requirement¥existing inventory = AAN 

2,650 + (50%*2,650) + 41¥191 = 

3,825 kg ephedrine (for sale) for 2010 

This calculation suggests that DEA’s 

assessment of annual needs for 

ephedrine should be 3,900 kg. DEA 

notes that its June 28, 2010, notice 

proposed to increase the ephedrine 

assessment to 4,100 kg. That proposal 

was based on information received as of 

March 10, 2010. Since that time DEA 

has received revised manufacture 

production data, i.e., sales and 

inventory information decreasing the 

reported sales of ephedrine for 2009. 

After calculating the ephedrine (for sale) 

assessment using the most current 

data—that reported by DEA registered 

manufactures as of August 10, 2010— 

DEA concludes that the proposed 

revised assessment of 4,100 kg would 

have been unnecessarily high. 

Accordingly, DEA is increasing the 2010 

assessment of annual needs for 

ephedrine (for sale) from 3,600 kg to 

3,900 kg. 

Phenylpropanolamine (for Sale) data 


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79414 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 

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

[Kilograms] 

Phenylpropanolamine 

(for sale) 2007 2008 2009 2010 Request 

Sales* (DEA 250) ............................................................................................................ 4,158 4,528 5,355 7,480 

Imports** (DEA 488) ........................................................................................................ 5,787 3,425 6,626 7,271 

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

Inventory* (DEA 250) ....................................................................................................... 3,642 2,470 645 n/a 

* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 10, 2010. 

** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010. 

Phenylpropanolamine (for Sale) 

Analysis 

DEA previously has established the 

2010 assessment of annual needs for 

phenylpropanolamine (for sale) at 6,400 

kg (74 FR 60298). 

As noted above, DEA utilized the 

same general methodology and 

calculation to develop the proposed 

revised assessment for 

phenylpropanolamine (for sale) that 

DEA used to determine the 2009 and 

2010 assessment of annual needs. 

As of August 10, 2010, DEA registered 

manufacturers of dosage form products 

containing phenylpropanolamine 

requested the authority to purchase 

7,480 kg phenylpropanolamine (for sale) 

in 2010. DEA registered manufacturers 

of phenylpropanolamine reported sales 

totaling approximately 4,528 kg in 2008 

and 5,355 kg in 2009; this represents a 

15.5% increase in sales reported by 

these firms from 2008 to 2009. 

Additionally, exports of 

phenylpropanolamine products from 

the United States 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 5,355 kg fairly 

represents the United States 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 veterinary 

channels and is, therefore, not included. 

DEA calculated the proposed revised 

phenylpropanolamine (for sale) 

assessment by the following 

methodology: 

2009 sales + reserve stock + export 

requirement ¥ existing inventory = 

AAN 

5,355 + (50%*5,355) + 2 ¥ 645 = 

7,390 kg phenylpropanolamine (for sale) 

for 2010 

This calculation suggests that DEA’s 

2010 Assessment of Annual Needs for 

phenylpropanolamine (for sale) should 

be 7,400 kg. Accordingly, DEA is 

increasing the 2010 assessment of 

annual needs for phenylpropanolamine 

(for sale) from 6,400 kg to 7,400 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) ............................................................................................................ 239,314 224,480 286,607 254,286 

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

Imports ** (DEA 488) ....................................................................................................... 231,683 170,614 274,492 261,528 

Export Declarations (DEA 486) ....................................................................................... 42,132 47,199 35,264 n/a 

Inventory * (DEA 250) ...................................................................................................... 136,039 121,374 68,100 n/a 

IMS *** (NSP) ................................................................................................................... 180,221 149,232 140,784 n/a 

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

August 10, 2010. 

** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010. 

*** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail Channels, Data Extracted August 

10, 2010. 

Pseudoephedrine (for Sale) Analysis 

DEA previously has established the 

2010 assessment of annual needs for 

pseudoephedrine (for sale) at 404,000 kg 

(74 FR 60298). 

As noted above, DEA utilized the 

same general methodology and 

calculation to develop the proposed 

revised assessment for pseudoephedrine 

(for sale) that DEA used to determine 

the 2009 and 2010 assessment of annual 

needs. 

As of August 10, 2010, DEA registered 

manufacturers of dosage form products 

containing pseudoephedrine requested 

the authority to purchase 254,286 kg 

pseudoephedrine. DEA registered 

manufacturers of pseudoephedrine 

reported sales totaling approximately 

224,480 kg in 2008 and 286,607 kg in 

2009; this represents a 22 percent 

increase in sales reported by these firms 

from 2008 to 2009. During the same 

period exports of pseudoephedrine 

products from the United States as 

reported on export declarations (DEA 

486) totaled 47,199 kg in 2008 and 

35,264 kg in 2009; this represents a 25 

percent decrease from levels observed in 

2008. The average of the 2008 and 2009 

exports is 41,232 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 145,006 kg. DEA thus 

believes that 286,607 kg of sales 

reported by manufacturers fairly 

represents the United States sales of 

pseudoephedrine for 2010 and that 


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41,232 kg fairly represents the export 

requirements of pseudoephedrine. DEA 

notes that manufacturer reported sales 

for 2009 (286,607 kg) are higher than the 

average retail sales reported by IMS for 

the previous two years (145,006 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 revised 

pseudoephedrine (for sale) assessment 

by the following methodology: 

2009 sales + reserve stock + export 

requirement ¥ existing inventory = 

AAN 

286,607 + (50%*286,607) + 41,232 ¥ 

68,100 = 403,043 kg pseudoephedrine 

(for sale) for 2010. 

This calculation suggests that DEA’s 

2010 assessment of annual needs for 

pseudoephedrine (for sale) should be 

404,000 kg. DEA notes that its June 28, 

2010, notice proposed to increase the 

pseudoephedrine assessment to 419,000 

kg. That proposal was based on 

information received as of March 10, 

2010. Since that time DEA has received 

additional request for quotas, revised 

manufacture production data, i.e., sales 

and inventory information, requests for 

withdrawal of quota, and request for 

adjustments to individual procurement 

quotas. As a result of this additional 

information, the 2009 reported sales of 

pseudoephedrine decreased from 

287,756 kg to 286,607 kg and the 

reported inventory increased from 

54,173 kg to 68,001 kg. After calculating 

the pseudoephedrine (for sale) 

assessment using the most current 

data—that was reported by DEA 

registered manufactures as of August 10, 

2010—DEA concludes that the proposed 

revised assessment of 419,000 kg would 

have been unnecessarily high. 

Accordingly, DEA has determined that 

the established 2010 AAN for 

pseudoephedrine of 404,000 kg is 

appropriate and requires no change. 

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 10,837 14,585 14,910 

Imports ** (DEA 488) ....................................................................................................... 8,250 12,019 11,373 28,408 

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

Inventory* (DEA 250) ....................................................................................................... 3,581 5,537 4,104 n/a 

APQ Amphetamine *** ..................................................................................................... 22,000 22,000 24,500 23,500 

* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 10, 2010. 

** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010. 

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

Phenylpropanolamine (for Conversion) 

Analysis 

DEA previously had established the 

2010 assessment of annual needs for 

phenylpropanolamine (for conversion) 

at 16,500 kg (74 FR 60298). As noted 

above, DEA developed the proposed 

revisions to the 2010 assessment of 

annual needs for phenylpropanolamine 

(for conversion) using the same 

calculation and methodology that DEA 

used to determine the 2009 and 2010 

assessment of annual needs. 

As of August 10, 2010, DEA registered 

manufacturers of phenylpropanolamine 

(for conversion) requested the authority 

to purchase a total of 14,910 kg 

phenylpropanolamine for the 

manufacture of amphetamine. DEA 

registered manufacturers of 

phenylpropanolamine reported sales of 

phenylpropanolamine totaling 

approximately 10,837 kg in 2008 and 

14,585 kg in 2009; this represents a 26 

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), 14,585 kg fairly represents 

United States requirements for 2010 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) 

needed for the manufacture of 

amphetamine as follows: 

(2009 sales) + reserve stock + export 

requirement ¥ inventory = AAN 

(14,585) + 50%*(14,585) + 0 ¥ 4,104 

= 17,774 kg PPA (for conversion) for 

2010 

This calculation suggests that DEA’s 

2010 assessment of annual needs for 

phenylpropanolamine (for conversion) 

should be 17,800 kg. DEA notes that its 

June 28, 2010, notice proposed to 

increase the phenylpropanolamine (for 

conversion) assessment to 18,200 kg. 

That proposal was based on information 

received as of March 10, 2010. Since 

that time DEA has received additional 

request for quotas, revised manufacture 

production data, i.e., sales and 

inventory information, and request for 

adjustments to individual procurement 

quotas. As a result the 2009 reported 

inventory of phenylpropanolamine 

increased from 3,693 kg to 4,104 kg. 

After calculating the 

phenylpropanolamine (for conversion) 

assessment using the most current 

data—that reported by DEA registered 

manufactures as of August 10, 2010— 

DEA concludes that the proposed 

revised assessment of 18,200 kg would 

have been unnecessarily high. 

Accordingly, DEA is increasing the 2010 

assessment of annual needs for 

phenylpropanolamine (for conversion) 

from 16,500 kg to 17,800 kg. 

Ephedrine (for Conversion) Data 


jlentini on DSKJ8SOYB1PROD with NOTICES
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EPHEDRINE (FOR CONVERSION) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS

[Kilograms] 

Ephedrine 

(for conversion) 2007 2008 2009 2010 Request 

Sales * (DEA 250) ............................................................................................................ 99,594 64,522 40,387 40,600 

Imports ** (DEA 488) ....................................................................................................... 99,594 64,128 39,897 40,204 

Inventory * (DEA 250) ...................................................................................................... 0 99 208 n/a 

APQ Methamphetamine *** .............................................................................................. 3,130 3,130 3,130 3,130 

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

August 10, 2010. 

** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010. 

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

Ephedrine (for Conversion) Analysis 

DEA previously has established the 

2010 assessment of annual needs for 

ephedrine (for conversion) at 75,000 kg 

(74 FR 60298). As noted above, DEA 

developed the proposed revisions to the 

2010 assessment of annual needs for 

ephedrine (for conversion) using the 

same calculation and methodology that 

DEA used to determine the 2009 and 

2010 assessment of annual needs. 

As of August 10, 2010, DEA registered 

manufacturers of ephedrine (for 

conversion) requested the authority to 

purchase a total of 40,600 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 APQ for methamphetamine. 

DEA determined that the estimated sales 

of pseudoephedrine by manufacturers, 

as referenced in the assessment of 

annual needs 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. 

Thus, 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) ¥ 208 = 11,830 

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, DEA determined the 

proposed revised assessment for 

ephedrine (for conversion) by summing 

the amounts required for the 

manufacture of methamphetamine and 

pseudoephedrine: 

methamphetamine requirement + 

pseudoephedrine requirement = AAN 

11,830 + 63,157 = 74,987 kg ephedrine 

(for conversion) for 2010 

This calculation suggests that DEA’s 

2010 assessment of annual needs for 

ephedrine (for conversion) should be 

75,000 kg. Accordingly, DEA is leaving 

the 2010 assessment of annual needs for 

ephedrine (for conversion) unchanged at 

75,000 kg. 

DEA did not receive any comments on 

its Assessment of Annual Needs for 

ephedrine (for sale), ephedrine (for 

conversion), pseudoephedrine (for sale), 

phenylpropanolamine (for sale) and 

phenylpropanolamine (for conversion). 

DEA is finalizing the assessments for 

these List I chemicals based on 

information contained in additional 

applications for 2010 import, 

manufacturing and procurement quotas 

provided by DEA registered importers 

and manufacturers whose quota 

applications were received as of August 

10, 2010. 

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 orders that the Revised 2010 

Assessment of Annual Needs for 

ephedrine, pseudoephedrine, and 

phenylpropanolamine, expressed in 

kilograms of anhydrous acid or base, be 

established as follows: 

List I chemical Final 2010 assessment of annual needs 

Ephedrine (for sale) .. 3,900 kg 

Phenylpropanolamine 

(for sale).

7,400 kg 

Pseudoephedrine (for 

sale).

404,000 kg 

Phenylpropanolamine 

(for conversion).

17,800 kg 

Ephedrine (for conversion).75,000 kg 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 79417 

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: December 13, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–31848 Filed 12–17–10; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

United States Parole Commission 

[Public Law 94–409; 5 U.S.C. Sec. 552b] 

Record of Vote of Meeting Closure 

I, Isaac Fulwood, of the United States 

Parole Commission, was present at a 

meeting of said Commission, which 

started at approximately 12 p.m., on 

Tuesday, December 7, 2010, at the U.S. 

Parole Commission, 5550 Friendship 

Boulevard, 4th Floor, Chevy Chase, 

Maryland 20815. The purpose of the 

meeting was to decide two petitions for 

reconsideration pursuant to 28 CFR 

Section 2.27. Four Commissioners were 

present, constituting a quorum when the 

vote to close the meeting was submitted. 

Public announcement further 

describing the subject matter of the 

meeting and certifications of General 

Counsel that this meeting may be closed 

by vote of the Commissioners present 

were submitted to the Commissioners 

prior to the conduct of any other 

business. Upon motion duly made, 

seconded, and carried, the following 

Commissioners voted that the meeting 

be closed: Isaac Fulwood, Cranston J. 

Mitchell and Patricia K. Cushwa, J. 

Patricia Wilson Smoot. 

In witness whereof, I make this official 

record of the vote taken to close this 

meeting and authorize this record to be 

made available to the public. 

Dated: December 8, 2010. 

Isaac Fulwood, 

Chairman, U.S. Parole Commission. 

[FR Doc. 2010–31860 Filed 12–17–10; 8:45 am] 

BILLING CODE 4410–01–M 

DEPARTMENT OF LABOR 

Office of the Secretary 

Agency Information Collection 

Activities; Submission for OMB 

Review; Comment Request; Diesel 

Particulate Matter Exposure of 

Underground Coal Miners 

ACTION: Notice. 

SUMMARY: The Department of Labor 

(DOL) hereby announces the submission 

of the Mine Safety and Health 

Administration (MSHA) sponsored 

information collection request (ICR) 

titled, ‘‘Diesel Particulate Matter 

Exposure of Underground Coal Miners,’’ 

to the Office of Management and Budget 

(OMB) for review and approval for 

continued use in accordance with the 

Paperwork Reduction Act of 1995 (Pub. 

L. 104–13, 44 U.S.C. chapter 35). 

DATES: Submit comments on or before 

January 19, 2011. 

ADDRESSES: A copy of this ICR, with 

applicable supporting documentation; 

including a description of the likely 

respondents, proposed frequency of 

response, and estimated total burden 

may be obtained from the RegInfo.gov 

Web site, http://www.reginfo.gov/ 

public/do/PRAMain or by contacting 

Michel Smyth by telephone at 202–693– 

4129 (this is not a toll-free number) or 

sending an e-mail to 

DOL_PRA_PUBLIC@dol.gov. 

Submit comments about this request 

to the Office of Information and 

Regulatory Affairs, Attn: OMB Desk 

Officer for the Department of Labor, 

Mine Safety and Health Administration 

(MSHA), Office of Management and 

Budget, Room 10235, Washington, DC 

20503, Telephone: 202–395–4816/Fax: 

202–395–6881 (these are not toll-free 

numbers), e-mail: 

OIRA_submission@omb.eop.gov. 

FOR FURTHER INFORMATION CONTACT: 

Contact Michel Smyth by telephone at 

202–693–4129 (this is not a toll-free 

number) or by e-mail at 

DOL_PRA_PUBLIC@dol.gov. 

SUPPLEMENTARY INFORMATION: Federal 

Mine Safety and Health Act of 1977 

(Mine Act) section 101(a) provides that 

the Secretary of Labor shall develop, 

promulgate, and revise, as may be 

appropriate, improved mandatory 

health or safety standards for the 

protection of life and prevention of 

injuries in coal or other mines. In 

addition, Mine Act section 103(h) 

mandates that mine operators keep any 

records and make any reports that are 

reasonably necessary for the MSHA to 

perform its duties under the Mine Act. 

The MSHA established standards and 

regulations for diesel-powered 

equipment in underground coal mines 

that provide additional important 

protection for coal miners who work on 

and around diesel-powered equipment. 

The standards were designed to reduce 

the risks to underground coal miners of 

serious health hazards that are 

associated with exposure to high 

concentrations of diesel particulate 

matter. The standards contain 

information collection requirements for 

underground coal mine operators in 30 

CFR 72.503 (d), 72.510, 72.520, and 

75.1915. As a result of 39 CFR 72.500, 

manufacturers of diesel equipment are 

affected under 30 CFR parts 7 or 36. 

This information collection is subject 

to the PRA. A Federal agency generally 

cannot conduct or sponsor a collection 

of information, and the public is 

generally not required to respond to an 

information collection, unless it is 

currently approved by the OMB under 

the PRA and displays a currently valid 

OMB Control Number. In addition, 

notwithstanding any other provisions of 

law, no person shall generally be subject 

to penalty for failing to comply with a 

collection of information if the 

collection of information does not 

display a currently valid OMB control 

number. See 5 CFR 1320.5(a) and 

1320.6. The DOL obtains OMB approval 

for this information collection under 

OMB Control Number 1219–0124. The 

current OMB approval is scheduled to 

expire on December 31, 2010; however, 

it should be noted that information 

collections submitted to the OMB 

receive a month-to-month extension 

while they undergo review. For 

additional information, see the related 

notice published in the Federal Register 

on September 16, 2010, (75 FR 56560). 


jlentini on DSKJ8SOYB1PROD with NOTICES