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[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Notices]
[Pages 79407-79412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31853]

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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.

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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

[[Page 79408]]

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\
---------------------------------------------------------------------------

    \1\ Applications and instructions for procurement, import and 
manufacturing quotas can be found at http://www.deadiversion.usdoj.gov/quotas/quota_apps.htm.
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    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

[[Page 79409]]

      Ephedrine (for Sale) Data for 2011 Assessment of Annual Needs
                               (Kilograms)
------------------------------------------------------------------------
                                                                  2011
          Ephedrine              2008       2009       2010     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             18         64         52        n/a
 486).......................
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 
Sec.  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                                        2011
            sale)                2008       2009       2010     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              0          3          0        n/a
 486).......................
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

[[Page 79410]]

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)
----------------------------------------------------------------------------------------------------------------
                                                                                                         2011
                 Pseudoephedrine (for sale)                       2008         2009         2010       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                                        2011
         conversion)             2008       2009       2010     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              0          0          0        n/a
 486).......................
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).

[[Page 79411]]

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)
------------------------------------------------------------------------
                                                                  2011
 Ephedrine (for conversion)      2008       2009       2010     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,

[[Page 79412]]

pseudoephedrine, and phenylpropanolamine, expressed in kilograms of 
anhydrous acid or base, be established as follows:

------------------------------------------------------------------------
                                                            Established
                                                               2011
                     List I chemical                       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 foreign-based 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
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