32954 Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Notices 

Dated: July 1, 2009. 

John K. Rabiej, 

Chief, Rules Committee Support Office. 

[FR Doc. E9–16018 Filed 7–8–09; 8:45 am] 

BILLING CODE 2210–55–M 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Application 

Pursuant to 21 U.S.C. 958(i), the 

Attorney General shall, prior to issuing 

a registration under this section to a 

bulk manufacturer of a controlled 

substance in schedule I or II, and prior 

to issuing a regulation under 21 U.S.C. 

952(a)(2), authorizing the importation of 

such a substance, provide 

manufacturers holding registrations for 

the bulk manufacture of the substance 

an opportunity for a hearing. 

Therefore, in accordance with Title 21 

Code of Federal Regulations (CFR), 

1301.34(a), this is notice that on 

February 13, 2009, Rhodes 

Technologies, 498 Washington Street, 

Coventry, Rhode Island 02816, made 

application by renewal to the Drug 

Enforcement Administration (DEA) to 

be registered as an importer of the basic 

classes of controlled substances listed in 

schedule II: 

Drug Schedule 

Raw Opium (9600) ....................... II 

Concentrate of Poppy Straw 

(9670) ........................................ II 

The company plans to import narcotic 

raw materials to be used in ancillary 

activities including product 

development and analytical studies. 

No comments, objections, or requests 

for any hearings will be accepted on any 

application for registration or reregistration to import raw opium and 

concentrate of poppy straw. As 

explained in the Correction to Notice of 

Application pertaining to Rhodes 

Technologies, 72 FR 3417 (2007), 

comments and requests for hearings on 

applications to import narcotic raw 

material are not appropriate. 

Any bulk manufacturer who is 

presently, or is applying to be, 

registered with DEA to manufacture 

such basic classes of controlled 

substances may file comments or 

objections to the issuance of the 

proposed registration and may, at the 

same time, file a written request for a 

hearing on such application pursuant to 

21 CFR 1301.43, and in such form as 

prescribed by 21 CFR 1316.47. 

Any such comments or objections 

should be addressed, in quintuplicate, 

to the Drug Enforcement 

Administration, Office of Diversion 

Control, Federal Register Representative 

(ODL), 8701 Morrissette Drive, 

Springfield, Virginia 22152; and must be 

filed no later than August 10, 2009. 

This procedure is to be conducted 

simultaneously with, and independent 

of, the procedures described in 21 CFR 

1301.34(b), (c), (d), (e), and (f). As noted 

in a previous notice published in the 

Federal Register on September 23, 1975, 

(40 FR 43745–46), all applicants for 

registration to import a basic class of 

any controlled substance in schedule I 

or II are, and will continue to be, 

required to demonstrate to the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, that the requirements 

for such registration pursuant to 21 

U.S.C. 958(a); 21 U.S.C. 823(a); and 21 

CFR 1301.34(b), (c), (d), (e), and (f) are 

satisfied. 

Dated: June 24, 2009. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. E9–16296 Filed 7–8–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–314E] 

Established Assessment of Annual 

Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2009 

AGENCY: Drug Enforcement 

Administration (DEA), Justice. 

ACTION: Notice of Assessment of Annual 

Needs for 2009. 

SUMMARY: This notice establishes the 

initial 2009 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: August 10, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, Ph.D., 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 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). 

Background and Legal Authority 

Section 713 of the Combat 

Methamphetamine Epidemic Act of 

2005 (CMEA) (Title VII of Pub. L. 109– 

177) amended section 306 of the 

Controlled Substances Act (CSA) (21 


rmajette on DSK29S0YB1 with NOTICES
Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Notices 32955 

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 2009 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 2009 

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 

Section 0.100. The Administrator, in 

turn, has redelegated this function to the 

Deputy Administrator, pursuant to 28 

CFR Section 0.104. 

On December 29, 2008, a notice 

entitled, ‘‘Assessment of Annual Needs 

for the List I Chemicals Ephedrine, 

Pseudoephedrine, and 

Phenylpropanolamine for 2009’’ was 

published in the Federal Register (73 

FR 79508). This notice established, on 

an interim basis, the 2009 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 interim 

assessments on or before January 28, 

2009. 

Comments Received 

DEA received a total of four 

comments, one regarding the assessment 

for ephedrine (for sale) and the other 

three regarding the assessment for 

phenylpropanolamine (for sale). The 

first commenter was from a law firm 

representing an industry group 

comprised of distributors and retailers 

of over-the-counter (OTC) medications. 

This commenter believes that quota 

requests for ephedrine (for sale) are not 

comparable to the products sold and 

recommended that the 2009 ephedrine 

assessment be the same as the 2008 

assessment (i.e. 11,500 kg). 

The second comment was from a DEA 

registered chemical manufacturer of 

phenylpropanolamine who requested 

that DEA ‘‘consider revising the 

calculation methodology for 

establishing (individual) quotas’’ and 

also encouraged ‘‘the establishment of a 

safety reserve’’ for the list I chemicals. 

The third and fourth comments were 

received from two distributors of 

veterinary prescription products 

containing phenylpropanolamine. These 

commenters encouraged DEA to 

consider in its evaluation the medical 

needs of the companion animal 

population and for DEA to include in its 

phenylpropanolamine (for sale) 

assessment a safety reserve to ensure an 

uninterrupted supply of the substance. 

All comments received during the 

comment period are discussed further 

below. 

DEA did not receive any comments on 

its Interim Final Assessment of Annual 

Needs for ephedrine (for conversion), 

phenylpropanolamine (for conversion), 

and pseudoephedrine (for sale). DEA is 

adjusting the interim established 

assessment for these chemicals based on 

additional information provided by DEA 

registered importers and manufacturers 

whose quota applications were received 

as of April 1, 2009 (i.e. one year after the 

April 1, 2008, application due date). 

DEA also is providing the underlying 

data used in establishing these 

assessments. 

Comment Regarding DEA’s Interim 

Final Assessment for Ephedrine (For 

Sale) 

DEA received one comment on its 

Interim Final assessment for ephedrine 

(for sale) from a law firm representing 

an industry group comprised of 

distributors and retailers of over-thecounter (OTC) medications. The 

comment stated that ‘‘DEA’s projection 

of decreased demand is inaccurate’’ and 

recommended that the 2009 ephedrine 

assessment be the same as the 2008 (for 

sale) assessment (i.e. 11,500 kg). The 

commenter made the following 

statements: (1) ‘‘On an annualized basis, 

the level of 941 [sic] kg requested as of 

July 2008 (134 kg per month) may well 

grow to 1,608 kg for all of 2009;’’ (2) 

‘‘Comparing requests for raw materials 

to actual sales of finished product does 

not provide an accurate basis to measure 

consumer demand or medical need;’’ (3) 

‘‘DEA’s projection of decreased demand 

is not based on the medical needs of 

consumers, but on the effects of 

increased regulation and decreased 

supply;’’ and (4) the commenter stated 

its concern with the DEA’s reliance on 

data provided by IMS Health’s (IMS) 

National Sales PerspectiveTM (NSP) 

database. 

DEA Response 

In response to the first comment that 

‘‘On an annualized basis, the level of 

941 [sic] kg requested as of July 2008 

(134 kg per month) may well grow to 

1,608 kg for all of 2009,’’ DEA believes 

that the commenter misinterpreted its 

original statement. DEA stated the 

following in its interim assessment: 

At the time DEA drafted the 2009 proposed 

assessment (i.e., July 15, 2008), DEA 

considered applications for procurement 

quotas from DEA registered manufacturers of 

ephedrine. These applications were due on 

or before April 1, 2008. These firms 

requested authority to purchase a total of 921 

kg of ephedrine (for sale) in 2009. (73 FR 

79510) 

The commenter interpreted the 

statement above to mean that the 

manufacturers’ request to purchase 921 

kg represented purchase requirements 

for the first 7 months of the calendar 

year, or 134 kg/month (134.4 kg × 7 = 

941 kg [sic]). By this logic, the 

commenter believed the annual 

requirement for ephedrine could be as 

much as 1,608 kg (134 kg × 12 months 

= 1,608 kg). This is an incorrect 

interpretation. DEA registered 

manufacturers of ephedrine that had 

submitted applications on or before July 

15, 2008, requested the authority to 

purchase a total of 921 kg of ephedrine 

for the entire calendar year of 2009. This 

means that the total annual requirement 

of ephedrine (for sale) for 2009 for the 

United States was 921 kg, as reported by 

DEA registered manufacturers. 

In response to the commenter’s 

second comment that ‘‘comparing 

requests for raw materials to actual sales 

of finished product does not provide an 

accurate basis to measure consumer 

demand or medical need,’’ DEA notes 

that the regulations require DEA to 

consider the ‘‘projected demand for 

each chemical [ephedrine] as indicated 

by procurement and import quotas 

requested pursuant to section 1315.32.’’ 

(see 21 CFR 1315.11(b)(4)). DEA also 

notes that requests for raw material 

consider not only the raw material 

necessary to meet medical needs, but 

also the raw material needed for other 

uses. For instance, raw material requests 

include the additional quantities 

necessary to bring a finished product to 

market, to cover production losses 

occurring during manufacturing and 

packaging operations, to allow for 

quality assurance/control testing, and to 

provide additional quantities for the 

reserve stocks of distributors and 

retailers. 

The commenter’s third comment is 

that the DEA’s projection of decreased 

demand is not based on the medical 

needs of consumers, but on the effects 

of increased regulation and decreased 

supply. In response to this comment, 

DEA notes that the regulation at 21 CFR 

1315.11(b) clearly articulates those 


rmajette on DSK29S0YB1 with NOTICES
32956 Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Notices 

1 2008 data represents estimated sales, imports, 

and inventories as reported on applications for 

quotas. 

2Applications and instructions for procurement, 

import and manufacturing quotas can be found at 

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

quota_apps.htm. 

factors that DEA is to consider when 

making its determination, which 

include: 

1. Total net disposal of the chemical 

by all manufacturers and importers 

during the current and preceding two 

years; 

2. Trends in the national rate of net 

disposal of each chemical; 

3. Total actual (or estimated) 

inventories of the chemical and of all 

substances manufactured from the 

chemical, and trends in inventory 

accumulation; 

4. Projected demand for each 

chemical as indicated by procurement 

and import quotas requested pursuant to 

section 1315.32, and 

5. Other factors * * * as the 

Administrator finds relevant. 

Medical need could impact one or 

several of these factors. For instance, 

increased medical need could result in 

an increased number of quota 

applications, decreased inventories, and 

changes upward in the national rate of 

disposals. Thus, it is not necessary to 

consider medical need separately from 

the factors mandated by the regulation. 

Finally, in response to the fourth 

comment, in which the commenter 

noted its ‘‘concern over the DEA’s 

reliance on data provided by IMS in 

proposing the 2009 assessment,’’ DEA 

notes that data provided by IMS Health 

provides national estimates of sales at 

the retail level which are used to 

consider trends in the rate of net 

disposals (i.e., sales) as mandated by 

regulation. The most recent IMS data 

available reports retail level sales 

totaling 1,267 kg in 2007 and 1,489 kg 

in 2008; this represents an 18 percent 

increase in retail sales from 2007 to 

2008. During the same period registered 

manufacturers of ephedrine reported 

sales totaling approximately 5,409 kg in 

2007 and 2,465 kg in 2008; this 

represents a 54 percent decrease in sales 

reported by these firms from 2007 to 

2008. The retail sales reported by IMS 

Health are expected to be lower than the 

sales to distributors and retailers 

reported by manufacturers because a 

manufacturer’s sales include quantities 

which are necessary to provide reserve 

stocks for distributors and retailers. DEA 

also believes that manufacturers’ sales 

in 2007 may have been artificially 

inflated as manufacturers, distributors, 

and retailers built unusually large 

reserve stocks due to concerns over 

newly codified regulations that were 

thought to limit or restrict the 

availability of substances. DEA thus 

believes that the manufacturers’ 

reported sales of 2,465 kg fairly 

represent the net disposals of ephedrine 

products. DEA notes that IMS data is 

one of several considerations that DEA 

uses to evaluate trends and projected 

demand of ephedrine-based products. 

As the calculations and methodology 

demonstrate, the assessment of annual 

needs for ephedrine is based primarily 

on the information provided by DEA 

registered manufacturers and importers 

of ephedrine products. 

DEA has received additional quota 

applications from DEA registered 

manufacturers and importers for the 

2009 assessment year. Based on an 

analysis of the underlying data from 

quota applications received through 

April 1, 2009, DEA is establishing the 

2009 assessment of annual needs for 

ephedrine (for sale) at 3,400 kg. 

Ephedrine Data 

EPHEDRINE (FOR SALE) DATA FOR 2009 ASSESSMENT OF ANNUAL NEEDS

[Kilograms] 

Ephedrine 2006 2007 20081 2009 Request 

Sales * (DEA 250) ............................................................................................ 5,435 5,409 2,465 3,088 

Imports ** (DEA 488) ....................................................................................... 3,886 10,480 2,104 2,678 

Export Declarations (DEA 486) ....................................................................... 313 168 91 n/a 

Inventory * (DEA 250) ...................................................................................... 1,245 1,457 423 n/a 

IMS *** (NSP) ................................................................................................... 1,256 1,267 1,489 n/a 

* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) received as of April 1, 2009. 

** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009. 

*** IMS Health, IMS National Sales PerspectivesTM, January 2006 to December 2008, Retail and Non-Retail Channels, Data Extracted April 1, 

2009. 

Underlying Data and DEA’s Analysis 

The DEA considered total net 

disposals (i.e. sales) of ephedrine for the 

current and preceding two years, actual 

and estimated inventories, projected 

demand (2009), 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).2

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 provided by manufacturers 

and importers. This information 

includes applications which have been 

newly submitted, amended or 

withdrawn as of April 1, 2009, for the 

2009 quota year. 

Ephedrine Calculation 

DEA calculated the 2009 Assessment 

of Annual Needs for ephedrine as 

follows. DEA developed a calculation 

that 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 April 1, 2009, DEA registered 

manufacturers of dosage form products 

containing ephedrine reported sales 

totaling approximately 5,409 kg in 2007 

and 2,465 kg in 2008; this represents a 

54 percent decrease in sales reported by 

these firms from 2007 to 2008. 

Additionally, exports of ephedrine 

products from the United States as 

reported on export declarations (DEA 

486), totaled 168 kg in 2007 and 91 kg 

in 2008; this represents a 46 percent 

decrease from levels observed in 2007. 

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 1,378 kg. 


rmajette on DSK29S0YB1 with NOTICES
Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Notices 32957 

3 2008 data represents estimated sales, imports, 

and inventories as reported on applications for 

quotas. 

DEA notes that the 2008 sales figure 

reported by manufacturers (2,465 kg) is 

higher than the sales reported by IMS 

(1,378 kg). As previously explained, 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 2,465 kg fairly 

represents the U.S. sales of ephedrine 

for 2009 and that 91 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 2008 year end inventory as 

reported by DEA registrants in 

determining the inventory allowance. 

DEA calculated the ephedrine (for 

sale) assessment by the following 

methodology: 

2008 sales + reserve stock + export 

requirement ¥ existing inventory = 

AAN 

2,465 + (50 percent * 2,465) + 91 ¥ 423 

= 3,366 kg ephedrine (for sale) for 

2009 

This calculation suggests that DEA’s 

Assessment of Annual Needs for 

ephedrine can be revised to 3,400 kg 

rather than the 1,500 kg established in 

the Interim Final Rule. DEA notes that 

this upward revision is attributed to 

DEA’s consideration of applications for 

2009 quotas received as of April 1, 2009, 

a one-year time period since the 

application due date. 

Accordingly, DEA is establishing the 

Assessment of Annual Needs for 

ephedrine (for sale) at 3,400 kg. 

Comments Regarding DEA’s Interim 

Final Assessment for 

Phenylpropanolamine (For Sale) 

The second commenter, a 

manufacturer of phenylpropanolamine 

products used by veterinary 

professionals, urged DEA ‘‘to consider 

revising the calculation methodology for 

establishing quotas’’ to consider 

whether the market need was met in the 

prior year. Additionally, the commenter 

suggested that there ‘‘should be a factor 

inserted in the calculation that would 

more accurately reflect market need and 

the changing demand.’’ The commenter 

also encouraged ‘‘the establishment of a 

safety reserve so that the DEA and 

manufacturers can be responsive to the 

ever-changing health care needs of 

companion animals.’’ 

The third and fourth comments were 

received from two distributors that sell 

phenylpropanolamine products used by 

veterinarians. These commenters stated 

that ‘‘To base quotas on last year’s sales 

and inventories and formulas does not 

allow for the increased need.’’ The 

commenters encouraged DEA ‘‘to 

consider increasing the quotas based on 

the aging of the companion animal 

population.’’ Additionally, the 

commenter encouraged DEA ‘‘to work 

with individual manufacturers of PPA 

in order to assure the uninterrupted 

supply of PPA.’’ 

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. 

With regard to the establishment of 

the assessment of annual needs for 

phenylpropanolamine (for sale), DEA 

believes that the sales information 

provided in requests for quotas for the 

manufacture of phenylpropanolamine 

products fairly represents the legitimate 

medical needs of the companion animal 

population. Additionally, DEA notes 

that the requirements of the two 

distributors and one manufacturer of 

phenylpropanolamine were considered 

as part of the assessment for 

phenylpropanolamine. DEA notes that 

there was a 3 percent increase in 

reported sales of phenylpropanolamine 

from 2007 to 2008. For the 2009 

assessment, DEA has determined that 

the higher 2008 sales fairly represent the 

manufacturing requirements of 

phenylpropanolamine. In calculating 

the assessment, DEA provides for 

quantities to support sales of 

phenylpropanolamine and also for a 

reserve stock of 50 percent. This is not 

only consistent with the 50 percent 

inventory allowance permitted under 21 

CFR 1315.24, but also provides 

manufacturers with sufficient material 

to account for slight increases in 

demand that may occur in 2009. 

Additionally, DEA notes that 

pursuant to 21 CFR 1315.32, DEA 

registered manufacturers and importers 

may request adjustments to their 

individual quotas at any time. This 

option allows the DEA and DEA 

registrants to respond to the changing 

needs of the companion animal 

population. 

Considering that 2008 was the first 

year of implementation of quotas for the 

List I chemicals, DEA is revising the 

2009 assessments to consider 

applications received as of April 1, 2009 

(i.e. one year after the April 1, 2008, 

application due date). This ensures that 

DEA considered the most recent 

information provided by DEA registered 

manufacturers and importers for 2009. 

A summary of the underlying data from 

quota applications and other sources, as 

well as DEA’s analysis of that data, are 

provided below. 

Phenylpropanolamine (For Sale) Data 

PHENYLPROPANOLAMINE (FOR SALE) DATA FOR 2009 ASSESSMENT OF ANNUAL NEEDS

[Kilograms] 

Phenylpropanolamine (for sale) 2006 2007 2008 3 2009 Request 

Sales * (DEA 250) ............................................................................................ 4,179 4,224 4,362 5,462 

Imports ** (DEA 488) ....................................................................................... 1,119 9,381 3,032 5,295 

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

Inventory * (DEA 250) ...................................................................................... 3,555 3,976 1,696 n/a

* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of 

April 1, 2009. 

** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009. 


rmajette on DSK29S0YB1 with NOTICES
32958 Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Notices 

4 2008 data represents estimated sales, imports, 

and inventories as reported on applications for 

quotas. 

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 April 1, 2009, DEA registered 

manufacturers of dosage form products 

containing phenylpropanolamine 

reported sales totaling approximately 

4,224 kg in 2007 and 4,362 kg in 2008; 

this represents a 3 percent increase in 

sales reported by these firms from 2007 

to 2008. 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: 

2008 sales + reserve stock + export 

requirement ¥ existing inventory = 

AAN 

4,362 + (50 percent * 4,362) + 0 

¥ 1,696 = 4,847 kg 

phenylpropanolamine (for sale) for 

2009 

This calculation suggests that DEA’s 

Assessment of Annual Needs for 

phenylpropanolamine (for sale) can be 

revised to be 4,900 kg rather than the 

4,500 kg established in the Interim Final 

Rule. 

DEA is establishing the Assessment of 

Annual Needs for phenylpropanolamine 

(for sale) at 4,900 kg. 

Pseudoephedrine, Ephedrine (for 

Conversion), and Phenylpropanolamine 

(for Conversion) 

DEA did not receive any comments on 

its interim Assessment of Annual Needs 

for pseudoephedrine, ephedrine (for 

conversion), and phenylpropanolamine 

(for conversion). However, DEA is 

providing the underlying data, analysis, 

methodology and calculation for the 

establishment of the assessments for 

these List I chemicals. These 

assessments reflect new information 

received from applications for quota 

received as of April 1, 2009 (i.e. one 

year after the April 1, 2008 application 

due date). 

Pseudoephedrine (for Sale) Data 

PSEUDOEPHEDRINE (FOR SALE) DATA FOR 2009 ASSESSMENT OF ANNUAL NEEDS

[Kilograms] 

Pseudoephedrine (for sale) 2006 2007 2008 4 2009 Request 

Sales * (DEA 250) ............................................................................................ 232,721 215,877 262,159 273,659 

Sales * (DEA 189) ............................................................................................ 56,563 100,300 111,292 105,967 

Imports ** (DEA 488) ....................................................................................... 133,802 225,973 165,708 205,783 

Export Declarations (DEA 486) ....................................................................... 37,069 42,142 85,756 n/a 

Inventory * (DEA 250) ...................................................................................... 83,104 115,307 89,921 n/a 

IMS *** (NSP) ................................................................................................... 207,509 183,382 151,013 n/a 

* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of 

April 1, 2009. 

** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009. 

*** IMS Health, IMS National Sales PerspectivesTM, January 2006 to December 2008, Retail and Non-Retail Channels, Data Extracted April 1, 

2009. 

Pseudoephedrine (for Sale) Analysis 

DEA utilized the same general 

methodology and calculations to 

establish the assessment for 

pseudoephedrine (for sale) as was 

described for the assessment of 

ephedrine (for sale), above. 

As of April 1, 2009, DEA registered 

manufacturers of dosage form products 

containing pseudoephedrine reported 

sales totaling approximately 215,877 kg 

in 2007 and 262,159 kg in 2008; this 

represents a 21 percent increase in sales 

reported by these firms from 2007 to 

2008. During the same period exports of 

pseudoephedrine products from the 

United States as reported on export 

declarations (DEA 486) totaled 42,142 

kg in 2007 and 85,756 kg in 2008; this 

represents a 103 percent increase from 

levels observed in 2007. 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 167,171 kg. DEA thus 

believes that 262,159 kg of sales 

reported by manufacturers fairly 

represents the U.S. sales of 

pseudoephedrine for 2009 and that 

85,756 kg fairly represents the export 

requirements of pseudoephedrine. DEA 

notes that manufacturer reported sales 

(262,159 kg) are higher than the retail 

sales reported by IMS (167,171 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: 

2008 sales + reserve stock + export 

requirement ¥ existing inventory = 

AAN 

262,159 + (50 percent * 262,159) + 

85,756 ¥ 89,921 = 389,074 kg 

pseudoephedrine (for sale) for 2009 

This calculation suggests that based 

on quota applications received as of 

April 1, 2009, DEA’s Assessment of 

Annual Needs for pseudoephedrine (for 

sale) should be established at 390,000 kg 

rather than the 380,000 kg established in 

the December 29, 2008 Interim Final 

Rule. DEA is establishing the 

Assessment of Annual Needs for 

pseudoephedrine (for sale) at 390,000 

kg. 

Phenylpropanolamine (for Conversion) 

Data 


rmajette on DSK29S0YB1 with NOTICES
Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Notices 32959 

5 2008 data represents estimated sales, imports, 

and inventories as reported on applications for 

quotas. 

6 2008 data represents estimated sales, imports, 

and inventories as reported on applications for 

quotas. 

PHENYLPROPANOLAMINE (FOR CONVERSION) DATA FOR 2009 ASSESSMENT OF ANNUAL NEEDS

[Kilograms] 

Phenylpropanolamine (for conversion) 2006 2007 2008 5 2009 Request 

Sales * (DEA 250) ............................................................................................ 8,004 9,991 15,498 13,606 

Imports ** (DEA 488) ....................................................................................... 14,476 9,370 15,776 14,175 

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

Inventory * (DEA 250) ...................................................................................... 4,863 3,742 4,566 n/a

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

* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) received as of April 1, 2009. 

** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009. 

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

Phenylpropanolamine (for Conversion) 

Analysis 

As of April 1, 2009, DEA registered 

manufacturers of phenylpropanolamine 

(for conversion) requested the authority 

to purchase a total of 13,606 kg 

phenylpropanolamine (for conversion). 

Additionally, DEA registered importers 

of phenylpropanolamine (for 

conversion) requested the authority to 

import a total of 14,175 kg of 

phenylpropanolamine (for conversion). 

DEA had not received any requests to 

synthesize phenylpropanolamine in 

2009. 

DEA has determined that 13,606 kg of 

phenylpropanolamine (for conversion) 

would be insufficient to meet the 

requirements for phenylpropanolamine 

for the production of amphetamine as 

established by DEA as the Aggregate 

Production Quota (APQ) for 

amphetamine (i.e., 22,000 kg for 2008). 

13,606 kg would be sufficient to 

manufacture only 30 percent of the APQ 

of amphetamine. DEA further 

considered manufacturer’s conversion 

yields of phenylpropanolamine to 

amphetamine of 50 percent in its 

calculation of the phenylpropanolamine 

assessment. DEA calculated the 

phenylpropanolamine (for conversion) 

assessment by the following 

methodology: 

(2008 APQ/50 percent yield) + reserve 

stock ¥ inventory = AAN 

(22,000/50 percent yield) + 50 percent * 

(22,000/50 percent yield) ¥ 4,566 = 

61,434 kg PPA (for conversion) for 

2009 

This calculation suggests that DEA’s 

Assessment of Annual Needs for 

phenylpropanolamine (for conversion) 

should be established as 62,000 kg, as 

established in the Interim Final Rule. 

DEA is establishing the Assessment of 

Annual Needs for phenylpropanolamine 

(for conversion) at 62,000 kg. 

Ephedrine (for Conversion) Data 

EPHEDRINE (FOR CONVERSION) DATA FOR 2009 ASSESSMENT OF ANNUAL NEEDS

[Kilograms] 

Ephedrine (for conversion) 2006 2007 2008 6 2009 Request 

Sales * (DEA 250) ............................................................................................ 49,973 100,093 133,209 112,277 

Imports ** (DEA 488) ....................................................................................... 43,612 107,230 122,683 111,365 

Inventory * (DEA 250) ...................................................................................... 77 28 10 n/a 

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

* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of 

April 1, 2009. 

** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009. 

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

Ephedrine (for Conversion) Analysis 

For ephedrine (for conversion), DEA 

utilized the same general methodology 

and calculation as was described for the 

assessment of phenylpropanolamine (for 

conversion), above. 

As of April 1, 2009, DEA registered 

manufacturers of ephedrine (for 

conversion) requested the authority to 

purchase a total of 112,277 kg ephedrine 

(for conversion) for the manufacture of 

two substances: methamphetamine and 

pseudoephedrine. 

DEA in its methodology considered 

the ephedrine (for conversion) 

requirements for the manufacture of 

these two substances: 

methamphetamine and 

pseudoephedrine. DEA has determined 

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. The 

assessment of need for pseudoephedrine 

was determined by DEA as the 

estimated sales of pseudoephedrine as 

referenced in the 2008 Annual 

Assessment of Need (AAN) 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. 

These firms reported a conversion yield 

of 39 percent for the synthesis of 

methamphetamine. 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 

The calculation for the ephedrine (for 

conversion) requirement for the 


rmajette on DSK29S0YB1 with NOTICES
32960 Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Notices 

manufacture of methamphetamine is as 

follows: 

(2008 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) ¥ 35 = 

12,003 kg 

The calculation for the ephedrine (for 

conversion) requirement for the 

manufacture of pseudoephedrine leads 

to a result of 106,424 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 

12,003 + 106,424 = 118,427 kg 

ephedrine (for conversion) for 2009 

This calculation suggests that based 

on applications received as of April 1, 

2009, DEA’s Assessment of Annual 

Needs for ephedrine (for conversion) 

should be established as 120,000 kg 

rather than the 110,000 kg established 

on an interim basis in the December 29, 

2008, notice. Under this rulemaking, 

DEA is establishing the Assessment of 

Annual Needs for ephedrine (for 

conversion) as 120,000 kg. 

Conclusion 

DEA has carefully considered the 

comments received in connection with 

the 2009 Assessment of Annual Needs. 

Based on information provided in the 

comments, along with information 

provided by DEA-registered 

manufacturers and importers of these 

List I chemicals on applications for 

individual import, manufacturing, and 

procurement quotas pursuant to DEA 

regulations, DEA has fully addressed the 

relevant issues set forth in the 

comments. 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 Section 0.100, 

and redelegated to the Deputy 

Administrator pursuant to 28 CFR 

Section 0.104, the Deputy Administrator 

hereby orders that the 2009 Assessment 

of Annual Needs for ephedrine, 

pseudoephedrine, and 

phenylpropanolamine, expressed in 

kilograms of anhydrous acid or base, be 

established as follows: 

List I chemical 

Established 

2009 

Assessment of 

Annual Needs 

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

Ephedrine (for conversion) ... 120,000 

Pseudoephedrine (for sale) .. 390,000 

Phenylpropanolamine (for 

sale) .................................. 4,900 

Phenylpropanolamine (for 

conversion) ........................ 62,000 

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: June 26, 2009. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E9–16152 Filed 7–8–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Registration 

By Notice dated June 7, 2007, and 

published in the Federal Register on 

June 20, 2007, 72 FR 34040, Cambrex 

Charles City, Inc., 1205 11th Street, 

Charles City, Iowa 50616–3466, made 

application by letter to the Drug 

Enforcement Administration (DEA) to 

be registered as an importer of the basic 

classes of controlled substances listed in 

schedule II: 

Drug Schedule 

Opium, raw (9600) ........................ II 

Poppy Straw Concentrate (9670) II 

The company plans to import the 

basic classes of controlled substances 

for manufacture of active 

pharmaceutical ingredients for sale to 

its customers. 

No comments or objections have been 

received. DEA has considered the 

factors in 21 U.S.C. 823(a) and 952(a) 

and determined that the registration of 

Cambrex Charles City, Inc. to import the 

basic classes of controlled substances is 

consistent with the public interest and 

with United States obligations under 

international treaties, conventions, or 

protocols in effect on May 1, 1971, at 

this time. DEA has investigated 

Cambrex Charles City, Inc. to ensure 

that the company’s registration is 

consistent with the public interest. The 

investigation has included inspection 

and testing of the company’s physical 

security systems, verification of the 

company’s compliance with state and 

local laws, and a review of the 

company’s background and history. 

Therefore, pursuant to 21 U.S.C. 952(a) 

and 958(a), and in accordance with 21 

CFR 1301.34, the above named company 

is granted registration as an importer of 

the basic classes of controlled 

substances listed. 


rmajette on DSK29S0YB1 with NOTICES