Established Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2010, 60294-60298 [E9-27890]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 74, Number 223 (Friday, November 20, 2009)]
[Notices]
[Pages 60294-60298]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27890]



[[Page 60294]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-326F]


Established Assessment of Annual Needs for the List I Chemicals 
Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2010

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of Assessment of Annual Needs for 2010.

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SUMMARY: This notice establishes the initial 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: November 20, 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 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 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 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.
    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 14, 2009, a notice entitled, ``Assessment of Annual 
Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and 
Phenylpropanolamine for 2010'' was published in the Federal Register 
(74 FR 47021). That notice proposed the 2010 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 14, 2009.

Comments Received

    DEA did not receive any comments to the Assessment of Annual Needs 
for ephedrine (for sale), ephedrine (for conversion), pseudoephedrine 
(for sale), phenylpropanolamine (for sale) and phenylpropanolamine (for 
conversion). DEA is finalizing the assessments for these List I 
chemicals based on information contained in additional applications for 
2010 import, manufacturing and procurement quotas provided by DEA 
registered importers and manufacturers whose quota applications were 
received as of October 21, 2009. 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.

Underlying Data and DEA's Analysis

    In determining the final 2010 assessments, DEA has considered the 
total net disposals (i.e., sales) of the List I chemicals for the 
current and preceding two years, actual and estimated inventories, 
projected demand (2010), industrial use, and export requirements from 
data provided by DEA registered manufacturers and importers in 
procurement quota applications (DEA 250), from manufacturing quota 
applications (DEA 189), and from import quota applications (DEA 488). 
\1\
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    \1\ Applications and instructions for procurement, import and 
manufacturing quotas can be found at https://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 export declarations. DEA notes that the inventory, 
acquisitions (purchases) and disposition (sales) data provided by DEA 
registered manufacturers and importers reflects the most current 
information available.

Ephedrine Data

[[Page 60295]]



                          Ephedrine (for Sale) Data for 2010 Assessment of Annual Needs
                                                   [Kilograms]
----------------------------------------------------------------------------------------------------------------
                                                                                                         2010
                            Ephedrine                                2007        2008        2009       Request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)...............................................       2,743       2,508       2,431       2,861
Imports ** (DEA 488)............................................       9,595       1,686       2,160       1,552
Export Declarations (DEA 486)...................................         168          91          10         n/a
Inventory * (DEA 250)...........................................       1,332         592         181         n/a
IMS *** (NSP)...................................................       1,235       1,460         n/a         n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250).
** Reported imports from applications for 2010 import quotas (DEA 488).
*** IMS Health, IMS National Sales Perspectives\TM\, January 2007 to December 2008, Retail and Non-Retail
  Channels, Data Extracted October 21, 2009.

Ephedrine Analysis

    DEA calculated the established 2010 Assessment of Annual Needs for 
ephedrine using the calculation developed to determine the 2009 
Assessment of Annual Needs. This calculation considers the criteria 
defined in 21 U.S.C. 826: estimated medical, scientific, research, and 
industrial needs of the United States; lawful export requirements; and 
the establishment and maintenance of reserve stocks.
    As of October 21, 2009, DEA registered manufacturers of dosage form 
products containing ephedrine requested the authority to purchase a 
total of 2,861 kg ephedrine (for sale) in 2010. DEA registered 
manufacturers of ephedrine reported sales totaling approximately 2,508 
kg in 2008 and 2,431 kg in 2009; this represents a 3% decrease in sales 
reported by these firms from 2008 to 2009. Additionally, exports of 
ephedrine products from the United States as reported on export 
declarations (DEA 486) totaled 91 kg in 2008 and 10 kg in 2009; this 
represents a 90% decrease from levels observed in 2008. The average of 
the 2008 and 2009 exports of ephedrine products is approximately 51 kg. 
DEA also considered information on trends in the national rate of net 
disposals from sales data provided by IMS Health's National Sales 
Perspective\TM\ (NSP) database. IMS NSP data reported the average sales 
volume of ephedrine for the calendar years 2007 and 2008 to be 
approximately 1,348 kg. DEA notes that the 2009 sales figure reported 
by manufacturers (2,431 kg) is higher than the average sales reported 
by IMS for the previous two years (1,348 kg). This is expected because 
a manufacturer's reported sales include quantities which are necessary 
to provide reserve stocks for distributors and retailers. DEA, in 
considering the manufacturer's reported sales, thus believes that 2,431 
kg fairly represents the U.S. sales of ephedrine for 2010 and that 51 
kg fairly represents the export requirements of ephedrine.
    For the establishment and maintenance of reserve stocks, DEA notes 
that 21 CFR 1315.24 allows for an inventory allowance (reserve stock) 
of 50% of a manufacturer's estimated sales. DEA also considered the 
estimated 2009 year end inventory as reported by DEA registrants in 
determining the inventory allowance.
    DEA calculated the ephedrine (for sale) assessment by the following 
methodology:

2009 sales + reserve stock + export requirement - existing inventory = 
AAN
2,431 + (50%*2,431) + 51 - 181 = 3,517 kg ephedrine (for sale) for 2010

    This calculation suggests that DEA's Assessment of Annual Needs for 
ephedrine should be established as 3,600 kg. Accordingly, DEA is 
establishing the 2010 Assessment of Annual Needs for ephedrine (for 
sale) at 3,600 kg.

Phenylpropanolamine (for Sale) Data

                     Phenylpropanolamine (for Sale) Data for 2010 Assessment of Annual Needs
                                                   [Kilograms]
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                                                                                                         2010
                 Phenylpropanolamine (for sale)                      2007        2008        2009       Request
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Sales * (DEA 250)...............................................       3,770       4,274       4,638       6,288
Imports ** (DEA 488)............................................          73          79         134         263
Export Declarations (DEA 486)...................................       1,002           0           3         n/a
Inventory * (DEA 250)...........................................       3,597       2,093         596         n/a
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of October
  21, 2009.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of October 21, 2009.

Phenylpropanolamine (for Sale) Analysis

    DEA utilized the same general methodology and calculation to 
establish the assessment for phenylpropanolamine (for sale) as was 
described for the assessment of ephedrine (for sale), above.
    As of October 21, 2009, DEA registered manufacturers of dosage form 
products containing phenylpropanolamine requested the authority to 
purchase 6,288 kg phenylpropanolamine (for sale) in 2010. DEA 
registered manufacturers of phenylpropanolamine reported sales totaling 
approximately 4,274 kg in 2008 and 4,638 kg in 2009; this represents an 
8% increase in sales reported by these firms from 2008 to 2009. 
Additionally, exports of phenylpropanolamine products from the U.S. as 
reported on export declarations (DEA 486) totaled 0 kg in 2008 and 3 kg 
in 2009; this represents a 3 kg increase from levels observed in 2008. 
The average of the 2008 and 2009 exports of phenylpropanolamine 
products is approximately 2 kg. DEA thus believes that 4,638 kg fairly 
represents the U.S. sales of phenylpropanolamine for 2010 and that 2 kg 
fairly represents the export requirements of phenylpropanolamine.

[[Page 60296]]

DEA notes that phenylpropanolamine is sold primarily as a veterinary 
product for the treatment for canine incontinence and is not approved 
for human consumption. IMS Health's NSP Data does not capture sales of 
phenylpropanolamine to these channels and is therefore not included.
    DEA calculated the phenylpropanolamine (for sale) assessment by the 
following methodology:

2009 sales + reserve stock + export requirement - existing inventory = 
AAN
4,638 + (50%*4,638) + 2 - 596 = 6,363 kg phenylpropanolamine (for sale) 
for 2010

    This calculation suggests that DEA's 2010 Assessment of Annual 
Needs for phenylpropanolamine (for sale) should be established as 6,400 
kg. Accordingly, DEA is establishing the 2010 Assessment of Annual 
Needs for phenylpropanolamine (for sale) at 6,400 kg.

Pseudoephedrine (for Sale) Data

                       Pseudoephedrine (for Sale) Data for 2010 Assessment of Annual Needs
                                                   [Kilograms]
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                                                                                                         2010
                   Pseudoephedrine (for sale)                        2007        2008        2009       Request
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Sales * (DEA 250)...............................................     238,608     223,196     286,516     225,116
Sales * (DEA 189)...............................................     100,300      64,781      33,600      32,760
Imports ** (DEA 488)............................................     232,822     170,995     267,808     233,569
Export Declarations (DEA 486)...................................      42,132      47,194      25,526         n/a
Inventory * (DEA 250)...........................................     135,097     119,515      62,748         n/a
IMS *** (NSP)...................................................     180,204     149,159         n/a         n/a
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas
  (DEA 189) received as of October 21, 2009.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of October 21, 2009.
*** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2008, Retail and Non-Retail
  Channels, Data Extracted October 21, 2009.

Pseudoephedrine (for Sale) Analysis

    DEA utilized the same general methodology and calculations to 
establish the assessment for pseudoephedrine (for sale) as were 
described for the assessment of ephedrine (for sale), above.
    As of October 21, 2009, DEA registered manufacturers of dosage form 
products containing pseudoephedrine requested the authority to purchase 
225,116 kg pseudoephedrine. DEA registered manufacturers of 
pseudoephedrine reported sales totaling approximately 223,196 kg in 
2008 and 286,516 kg in 2009; this represents a 22% increase in sales 
reported by these firms from 2008 to 2009. During the same period 
exports of pseudoephedrine products from the U.S. as reported on export 
declarations (DEA 486) totaled 47,194 kg in 2008 and 25,526 kg in 2009; 
this represents a 54% decrease from levels observed in 2008. The 
average of the 2008 and 2009 exports is 36,360 kg. Additionally, DEA 
considered information on trends in the national rate of net disposals 
from sales data provided by IMS Health. IMS NSP data reported the 
average retail sales volume of pseudoephedrine for the calendar years 
2007 and 2008 to be approximately 164,682 kg. DEA thus believes that 
286,516 kg of sales reported by manufacturers fairly represents the 
U.S. sales of pseudoephedrine for 2010 and that 36,360 kg fairly 
represents the export requirements of pseudoephedrine. DEA notes that 
manufacturer reported sales for 2009 (286,516 kg) are higher than the 
average retail sales reported by IMS for the previous two years 
(164,682 kg). This is expected because a manufacturer's reported sales 
include quantities which are necessary to provide reserve stocks for 
distributors and retailers.
    DEA calculated the pseudoephedrine (for sale) assessment by the 
following methodology:

2009 sales + reserve stock + export requirement - existing inventory = 
AAN
286,516 + (50%*286,516) + 36,360 - 62,748 = 403,386 kg pseudoephedrine 
(for sale) for 2010.

    This calculation suggests that DEA's 2010 Assessment of Annual 
Needs for pseudoephedrine (for sale) should be established at 404,000 
kg. Accordingly, DEA is establishing the 2010 Assessment of Annual 
Needs for pseudoephedrine (for sale) at 404,000 kg.

Phenylpropanolamine (for Conversion) Data

                  Phenylpropanolamine (for Conversion) Data for 2010 Assessment of Annual Needs
                                                   [Kilograms]
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                                                                                                         2010
              Phenylpropanolamine (for conversion)                   2007        2008        2009       Request
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Sales * (DEA 250)...............................................       3,621      10,834      13,582      14,900
Imports ** (DEA 488)............................................       1,000       3,225       6,514       7,108
Export Declarations (DEA 486)...................................           0           0           0         n/a
Inventory * (DEA 250)...........................................       3,581       5,533       4,103         n/a
APQ Amphetamine ***.............................................      17,000      22,000      22,000         n/a
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of October
  21, 2009.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of October 21, 2009.
*** Amphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.htm.


[[Page 60297]]

Phenylpropanolamine (for Conversion) Analysis

    As of October 21, 2009, DEA registered manufacturers of 
phenylpropanolamine (for conversion) requested the authority to 
purchase a total of 14,900 kg phenylpropanolamine for the manufacture 
of amphetamine. DEA registered manufacturers of phenylpropanolamine 
reported sales of phenylpropanolamine totaling approximately 10,834 kg 
in 2008 and 13,582 kg in 2009; this represent a 20% increase in sales 
reported by these firms from 2008 to 2009. There were no reported 
exports of phenylpropanolamine (for conversion). DEA has not received 
any requests to synthesize phenylpropanolamine in 2010. DEA has 
concluded that the 2009 sales of phenylpropanolamine (for conversion), 
13,582 kg, fairly represents U.S. requirements for 2010 and zero kg 
fairly represents the export requirements of phenylpropanolamine (for 
conversion).
    Phenylpropanolamine is used in the production of legitimate 
amphetamine products. DEA has established an Aggregate Production Quota 
(APQ) for amphetamine of 22,000 kg for 2009. DEA notes amphetamine is 
primarily manufactured by the conversion of the schedule II controlled 
substance phenylacetone to amphetamine. DEA did not consider this 
alternative synthesis route in the 2009 Assessment of Annual Needs for 
phenylpropanolamine (for conversion).
    DEA calculated the phenylpropanolamine (for conversion) for the 
manufacture of amphetamine as follows:

(2009 sales) + reserve stock + export requirement - inventory = AAN
(13,582) + 50%*(13,582) + 0 - 4,103 = 16,270 kg PPA (for conversion) 
for 2010

    This calculation suggests that DEA's 2010 Assessment of Annual 
Needs for phenylpropanolamine (for conversion) should be established at 
16,500 kg. Accordingly, DEA is establishing the 2010 Assessment of 
Annual Needs for phenylpropanolamine (for conversion) at 16,500 kg.

Ephedrine (for Conversion) Data

                       Ephedrine (for Conversion) Data for 2010 Assessment of Annual Needs
                                                   [Kilograms]
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                                                                                                         2010
                   Ephedrine (for conversion)                        2007        2008        2009       Request
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Sales * (DEA 250)...............................................      99,622      64,522      40,403      40,646
Imports ** (DEA 488)............................................      99,594      64,128      39,897      40,000
Inventory * (DEA 250)...........................................          13         160         254         n/a
APQ Methamphetamine ***.........................................       3,130       3,130       3,130         n/a
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas
  (DEA 189) received as of October 21, 2009.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of October 21, 2009.
*** Methamphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.htm.

Ephedrine (for Conversion) Analysis

    As of October 21, 2009, DEA registered manufacturers of ephedrine 
(for conversion) requested the authority to purchase a total of 40,646 
kg ephedrine (for conversion) for the manufacture of two substances: 
methamphetamine and pseudoephedrine.
    DEA considered the ephedrine (for conversion) requirements for the 
manufacture of methamphetamine and pseudoephedrine. DEA has determined 
that the established assessments for the manufacture of these two 
substances are the best indicators of the need for ephedrine (for 
conversion). The assessment of need for methamphetamine was determined 
by DEA as the Aggregate Production Quota (APQ) for methamphetamine. DEA 
determined that the estimated sales of pseudoephedrine, as referenced 
in the Assessment of Annual Needs (AAN) for pseudoephedrine, represents 
the need for pseudoephedrine. Reported sales of ephedrine (for 
conversion) are included as reference to DEA's methodology.
    DEA further considered the reported conversion yields of these 
substances. DEA registered manufacturers reported a conversion yield of 
39% for the synthesis of methamphetamine from ephedrine. DEA cannot 
disclose the conversion yield for the synthesis of pseudoephedrine 
because this information is proprietary to the one manufacturer 
involved in this type of manufacturing.
    DEA calculated the ephedrine (for conversion) assessment by the 
following methodology:

methamphetamine requirement + pseudoephedrine requirement = AAN

    DEA calculated the ephedrine (for conversion) requirement for the 
manufacture of methamphetamine as follows:

(2009 APQ methamphetamine/39% yield) + reserve stock - inventory = 
ephedrine (for manufacture of methamphetamine)
(3,130/39% yield) + 50%*(3,130/39% yield) - 46 = 11,993 kg

    The calculation for the ephedrine (for conversion) requirement for 
the manufacture of pseudoephedrine leads to a result of 63,157 kg. DEA 
cannot provide the details of the calculation because this would reveal 
the conversion yield for the synthesis of pseudoephedrine, which is 
proprietary to the one manufacturer involved in this type of 
manufacturing. Therefore, the assessment for ephedrine was determined 
by the sum total of the ephedrine (for conversion) requirements as 
described by the following methodology:

methamphetamine requirement + pseudoephedrine requirement = AAN
11,993 + 63,157 = 75,150 kg ephedrine (for conversion) for 2010

    This calculation suggests that DEA's 2010 Assessment of Annual 
Needs for ephedrine (for conversion) should be established at 75,000 
kg. Accordingly, DEA is establishing the 2010 Assessment of Annual 
Needs for ephedrine (for conversion) at 75,000 kg.

Conclusion

    DEA did not receive any comments on its Assessment of Annual Needs 
for ephedrine (for sale), ephedrine (for conversion), pseudoephedrine 
(for sale), phenylpropanolamine (for sale) and phenylpropanolamine (for 
conversion). DEA is finalizing the assessments for these List I 
chemicals based on information contained in additional applications for 
2010 import, manufacturing and procurement quotas provided by DEA 
registered importers

[[Page 60298]]

and manufacturers whose quota applications were received as of October 
21, 2009.
    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 2010 Assessment of Annual Needs for ephedrine, 
pseudoephedrine, and phenylpropanolamine, expressed in kilograms of 
anhydrous acid or base, be established as follows:

------------------------------------------------------------------------
                                                       Established 2010
                   List I chemical                       assessment of
                                                         annual needs
------------------------------------------------------------------------
Ephedrine (for sale)................................               3,600
Phenylpropanolamine (for sale)......................               6,400
Pseudoephedrine (for sale)..........................             404,000
Phenylpropanolamine (for conversion)................              16,500
Ephedrine (for conversion)..........................              75,000
------------------------------------------------------------------------

    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 foreign-based companies 
in domestic and export markets.

    Dated: November 11, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-27890 Filed 11-19-09; 8:45 am]
BILLING CODE 4410-09-P