Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 79407 

Basic class—Schedule II Established 2011 

quotas 

Phencyclidine ........................................................................................................................................................................... 24 g 

Phenmetrazine ......................................................................................................................................................................... 2 g 

Phenylacetone ......................................................................................................................................................................... 8,000,000 g 

Racemethorphan ..................................................................................................................................................................... 2 g 

Remifentanil ............................................................................................................................................................................. 2,500 g 

Secobarbital ............................................................................................................................................................................. 260,002 g 

Sufentanil ................................................................................................................................................................................. 7,000 g 

Tapentadol ............................................................................................................................................................................... 1,000,000 g 

Thebaine .................................................................................................................................................................................. 126,000,000 g 

The Deputy Administrator further 

orders that aggregate production quotas 

for all other schedules I and II 

controlled substances included in 21 

CFR 1308.11 and 1308.12 be established 

at zero. 

The Office of Management and Budget 

has determined that notices of aggregate 

production 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 federalism 

implications warranting the application 

of Executive Order 13132. 

The Deputy Administrator hereby 

certifies that this action will have no 

significant impact upon small entities 

whose interests must be considered 

under the Regulatory Flexibility Act, 5 

U.S.C. 601 et seq. The establishment of 

aggregate production quotas for 

schedules I and II controlled substances 

is mandated by law and by international 

treaty obligations. The quotas are 

necessary to provide for the estimated 

medical, scientific, research, and 

industrial needs of the United States, for 

export requirements and the 

establishment and maintenance of 

reserve stocks. While aggregate 

production quotas are of primary 

importance to large manufacturers, their 

impact upon small entities is neither 

negative nor beneficial. 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 $126,400,000 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. 

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 10, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–31849 Filed 12–17–10; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–350E] 

Established Assessment of Annual 

Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2011 

AGENCY: Drug Enforcement 

Administration (DEA), Justice. 

ACTION: Notice of Assessment of Annual 

Needs for 2011. 

SUMMARY: This notice establishes the 

initial 2011 Assessment of Annual 

Needs for certain List I chemicals in 

accordance with the Combat 

Methamphetamine Epidemic Act of 

2005 (CMEA). 

DATES: Effective Date: December 20, 

2010. 

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 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 the 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 


jlentini on DSKJ8SOYB1PROD with NOTICES
79408 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 

1Applications and instructions for procurement, 

import and manufacturing quotas can be found at 

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

quota_apps.htm. 

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). 

Background and Legal Authority 

Section 713 of the CMEA of 2005 

(Title VII of Pub. L. 109–177) amended 

section 306 of the CSA (21 U.S.C. 826) 

to require that the Attorney General 

establish quotas to provide for the 

annual needs for ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. Section 715 of 

the CMEA amended 21 U.S.C. 952 by 

adding ephedrine, pseudoephedrine, 

and phenylpropanolamine to the 

existing language concerning 

importation of controlled substances. 

The 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 in 2011 

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. 

The responsibility for establishing the 

assessment has been delegated to the 

Administrator of the DEA by 28 CFR 

0.100. The Administrator, in turn, has 

redelegated this function to the Deputy 

Administrator, pursuant to 28 CFR 

0.104. 

On September 13, 2010, a notice 

entitled, ‘‘Assessment of Annual Needs 

for the List I Chemicals Ephedrine, 

Pseudoephedrine, and 

Phenylpropanolamine for 2011: 

Proposed’’ was published in the Federal 

Register (75 FR 55605). That notice 

proposed the 2011 Assessment of 

Annual Needs for ephedrine (for sale), 

ephedrine (for conversion), 

pseudoephedrine (for sale), 

phenylpropanolamine (for sale) and 

phenylpropanolamine (for conversion). 

All interested persons were invited to 

comment on or object to the assessments 

on or before October 13, 2010. 

Comments Received 

DEA received one comment regarding 

the assessment for annual needs for 

phenylpropanolamine (for conversion). 

DEA discusses this comment in further 

detail below. DEA did not receive any 

comments to the Assessment of Annual 

Needs for ephedrine (for sale), 

ephedrine (for conversion), 

pseudoephedrine (for sale), and 

phenylpropanolamine (for sale). DEA is 

finalizing the assessments for these List 

I chemicals based on information 

contained in applications for 2011 

import, manufacturing and procurement 

quotas provided by DEA registered 

importers and manufacturers as of 

October 21, 2010. DEA is providing the 

data used in developing the established 

assessments for each of the listed 

chemicals. DEA also notes that the 

Assessment of Annual Needs may be 

adjusted at a later date pursuant to 21 

CFR 1315.13. 

Comment Regarding DEA’s Assessment 

for Phenylpropanolamine (For 

Conversion) 

DEA received one comment regarding 

the assessment of annual need for 

phenylpropanolamine (for conversion). 

The comment was from a DEA 

registered manufacturer of 

phenylpropanolamine (for conversion) 

who converts phenylpropanolamine to 

amphetamine. The commenter stated 

that, ‘‘the proposed quantities for the 

material mentioned below is not 

sufficient to provide for adequate 

supplies for the medical, scientific, 

research and industrial needs of the 

United States, and for the lawful export 

requirements, and that the quotas 

should be increased to cover our needs 

* * *.’’ Additionally, the commenter 

further stated, ‘‘the 

Phenylpropanolamine quota should be 

increased by 8,500,000 grams as base to 

allow for increased quantity of material 

to be purchased from our importer of 

record * * *.’’ 

DEA Response 

As a preliminary matter, this Federal 

Register notice establishes the 

assessment of annual needs for List I 

chemicals and the methodology used by 

the DEA to set that number. The 

assessment of annual needs is different 

than individual quotas and this 

rulemaking does not address the 

regulatory process for evaluating 

individual import, manufacturing and 

procurement quotas issued to DEA 

registered manufacturers and importers. 

In calculating the assessment for 

phenylpropanolamine (for conversion) 

DEA considered the commenter’s 

phenylpropanolamine requirements, as 

submitted in the commenter’s request 

for quota, along with the requirements 

of other manufacturers of 

phenylpropanolamine as stated in 

requests for 2011 quotas for the 

manufacture of phenylpropanolamine 

(for conversion) received as of October 

21, 2010. The commenter suggested that 

the phenylpropanolamine assessment be 

increased by 8,500 kg. DEA notes that 

based on the sales information provided 

in pending 2011 requests for individual 

manufacturing quotas, the DEA is 

establishing the phenylpropanolamine 

(for conversion) at 21,800 kg, which 

represents an increase of 13,700 kg from 

the original 8,100 kg proposed 

phenylpropanolamine assessment (75 

FR 55609). The full calculation is 

provided below. 

Underlying Data and DEA’s Analysis 

DEA is establishing the assessment of 

annual needs based on information 

provided by DEA registered 

manufacturers and importers as of 

October 21, 2010. A summary of the 

underlying data from quota applications 

and other sources, as well as DEA’s 

analysis of that data, are provided 

below. 

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 (for Sale) Data 


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Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 79409 

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

Ephedrine 2008 2009 2010 2011 

Request 

Sales* (DEA 250) ............................................................................................................................. 2,640 2,302 3,014 3,685 

Imports** (DEA 488) ......................................................................................................................... 1,692 4,208 3,202 3,302 

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

Inventory* (DEA 250) ....................................................................................................................... 603 432 457 n/a 

IMS*** (NSP) .................................................................................................................................... 1,460 1,406 n/a n/a 

* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) received as of October 21, 2010. 

** Reported imports from applications for 2011 import quotas (DEA 488) received as of October 21, 2010. 

*** IMS Health, IMS National Sales Perspectives TM, January 2008 to December 2009, Retail and Non-Retail Channels, Data Extracted October 

21, 2010. 

Ephedrine (for Sale) 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 October 21, 2010, DEA 

registered manufacturers of dosage form 

products containing ephedrine 

requested the authority to purchase a 

total of 3,685 kg ephedrine (for sale) in 

2011. DEA registered manufacturers of 

ephedrine reported sales totaling 

approximately 2,302 kg in 2009 and 

3,014 kg in 2010; this represents a 24 

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 1,433 kg. DEA notes that 

the 2010 sales figure reported by 

manufacturers (3,014 kg) is higher than 

the average sales reported by IMS for the 

previous two years (1,433 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 3,014 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 

3,014 + (50%* 3,014) + 58 - 457 = 4,122 

kg ephedrine (for sale) for 2011 

This calculation suggests that DEA’s 

Assessment of Annual Needs for 

ephedrine should be established as 

4,200 kg. Accordingly, DEA is 

establishing the 2011 Assessment of 

Annual Needs for ephedrine (for sale) at 

4,200 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) ............................................................................................................................. 4,300 4,825 5,005 6,110 

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

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

Inventory* (DEA 250) ....................................................................................................................... 2,455 2,483 2,261 n/a 

* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) received as of October 21, 2010. 

** Reported imports from applications for 2011 import quotas (DEA 488) received as of October 21, 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 October 21, 2010, DEA 

registered manufacturers of dosage form 

products containing 

phenylpropanolamine requested the 

authority to purchase 6,110 kg 

phenylpropanolamine (for sale) in 2011. 

DEA registered manufacturers of 

phenylpropanolamine reported sales 

totaling approximately 4,825 kg in 2009 

and 5,005 kg in 2010; this represents a 

3.6 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 5,005 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 


jlentini on DSKJ8SOYB1PROD with NOTICES
79410 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 

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 

5,005 + (50% * 5,005) + 2 - 2,261 = 5,249 

kg phenylpropanolamine (for sale) 

for 2011 

This calculation suggests that DEA’s 

2011 Assessment of Annual Needs for 

phenylpropanolamine (for sale) should 

be established as 5,300 kg. Accordingly, 

DEA is establishing the 2011 

Assessment of Annual Needs for 

phenylpropanolamine (for sale) at 5,300 

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) ............................................................................................................. 200,235 193,092 203,734 218,037. 

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

Imports** (DEA 488) ......................................................................................................... 138,602 164,906 168,618 220,926. 

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

Inventory* (DEA 250) ....................................................................................................... 109,427 76,505 48,004 n/a. 

IMS*** (NSP) .................................................................................................................... 148,456 139,908 n/a n/a. 

* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) received as of October 21, 2010. 

** Reported imports from applications for 2011 import quotas (DEA 488) received as of October 21, 2010. 

*** IMS Health, IMS National Sales Perspectives TM, January 2008 to December 2009, Retail and Non-Retail Channels, Data Extracted October 

21, 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 October 21, 2010, DEA 

registered manufacturers of dosage form 

products containing pseudoephedrine 

requested the authority to purchase 

218,037 kg pseudoephedrine. DEA 

registered manufacturers of 

pseudoephedrine reported sales totaling 

approximately 193,092 kg in 2009 and 

203,734 kg in 2010; this represents a 5 

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 144,182 kg. DEA thus 

believes that 203,734 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 for pseudoephedrine. 

DEA calculated the pseudoephedrine 

(for sale) assessment by the following 

methodology: 

2010 sales + reserve stock + export 

requirement ¥ existing inventory = 

AAN 

203,734 + (50% * 203,734) + 21,872 ¥ 

48,004 = 279,469 kg 

pseudoephedrine (for sale) for 2011. 

This calculation suggests that DEA’s 

2011 Assessment of Annual Needs for 

pseudoephedrine (for sale) should be 

established as 280,000 kg. Accordingly, 

DEA is establishing the 2011 

Assessment of Annual Needs for 

pseudoephedrine (for sale) at 

280,000 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) ............................................................................................................................. 10,834 11,486 17,086 23,700 

Imports** (DEA 488) ......................................................................................................................... 8,294 5,766 15,177 27,500 

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

Inventory* (DEA 250) ....................................................................................................................... 5,533 3,145 3,854 n/a 

* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) received as of received as of October 21, 2010. 

** Reported imports from applications for 2011 import quotas (DEA 488) received as of October 21, 2010. 

Phenylpropanolamine (for Conversion) 

Analysis 

As of October 21, 2010, DEA 

registered manufacturers of 

phenylpropanolamine (for conversion) 

requested the authority to purchase a 

total of 23,700 kg phenylpropanolamine 

for the manufacture of amphetamine. 

DEA registered manufacturers of 

phenylpropanolamine reported sales of 

phenylpropanolamine totaling 

approximately 11,486 kg in 2009 and 

17,086 kg in 2010; this represents a 33 

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), 17,086 kg, fairly represents 

U.S. requirements for 2011 and zero kg 

fairly represents the export 

requirements of phenylpropanolamine 

(for conversion). 

DEA determined that the data 

provided in procurement, 

manufacturing, and import quota 

applications best represents the 

legitimate need for 

phenylpropanolamine (for conversion). 


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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 

(17,086) + (50%*17,086) + 0 ¥ 3,854 = 

21,775 kg PPA (for conversion) for 

2011 

This calculation suggests that DEA’s 

2011 Assessment of Annual Needs for 

phenylpropanolamine (for conversion) 

should be established as 21,800 kg. 

Accordingly, DEA is establishing the 

2011 Assessment of Annual Needs for 

phenylpropanolamine (for conversion) 

at 21,800 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 9,562 6,303 653 

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 

received as of October 21, 2010. 

** Reported imports from applications for 2011 import quotas (DEA 488) received as of received as of October 21, 2010. 

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

Ephedrine (for Conversion) Analysis 

As of October 21, 2010, DEA 

registered manufacturers of ephedrine 

(for conversion) requested the authority 

to purchase a total of 653 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: 

(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 6,692 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 + 6,692 = 18,579 kg ephedrine 

(for conversion) for 2011 

This calculation suggests that DEA’s 

2011 Assessment of Annual Needs for 

ephedrine (for conversion) should be 

established as 18,600 kg. Accordingly, 

DEA is establishing the 2011 

Assessment of Annual Needs for 

ephedrine (for conversion) at 18,600 kg. 

Conclusion 

DEA received one comment regarding 

the assessment for 

phenylpropanolamine (for conversion). 

DEA has carefully considered the 

comment received in connection with 

the 2011 Assessment of Annual Needs. 

DEA calculated the assessment for 

phenylpropanolamine (for conversion) 

using the data provided in applications 

for 2011 import, manufacturing and 

procurement quotas provided by DEA 

registered importers and manufacturers 

as of October 21, 2010. This data 

included the quota request submitted by 

the commenter. The results of the 

calculation led DEA to increase the 

phenylpropanolamine (for conversion) 

assessment from the proposed 8,100 kg 

to 21,800 kg. 

DEA did not receive any comments on 

its Assessment of Annual Needs for 

ephedrine (for sale), ephedrine (for 

conversion), pseudoephedrine (for sale) 

and phenylpropanolamine (for sale). 

DEA is finalizing the assessments for 

these List I chemicals based on 

information contained in applications 

for 2011 import, manufacturing and 

procurement quotas provided by DEA 

registered importers and manufacturers 

as of October 21, 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 2011 Assessment 

of Annual Needs for ephedrine, 


jlentini on DSKJ8SOYB1PROD with NOTICES
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). 


jlentini on DSKJ8SOYB1PROD with NOTICES