Final Revised Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2010, 79412-79417 [2010-31848]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Notices]
[Pages 79412-79417]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31848]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-326F]


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

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of Final Assessment of Annual Needs for 2010.

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SUMMARY: This notice establishes the Final Revised 2010 Assessment of 
Annual Needs for certain List I chemicals in accordance with the Combat 
Methamphetamine Epidemic Act of 2005 (CMEA), enacted on March 9, 2006.

DATES: Effective Date: December 20, 2010.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, 
Drug & Chemical Evaluation Section, Drug Enforcement Administration 
(DEA), Springfield, Virginia 22152, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION: Section 713 of the Combat Methamphetamine 
Epidemic Act of 2005 (Title VII of Pub. L. 109-177) (CMEA) amended 
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) by 
adding ephedrine, pseudoephedrine, and phenylpropanolamine to existing 
language to read as follows: ``The Attorney General shall determine the 
total quantity and establish production quotas for each basic class of 
controlled substance in schedules I and II and for ephedrine, 
pseudoephedrine, and phenylpropanolamine to be manufactured each 
calendar year to provide for the estimated medical, scientific, 
research, and industrial needs of the United States, for lawful export 
requirements, and for the establishment and maintenance of reserve 
stocks.'' Further, 715 of CMEA amended 21 U.S.C. 952 ``Importation of 
controlled substances'' by adding the same List I chemicals to the 
existing language in paragraph (a), and by adding a new paragraph (d) 
to read as follows:

    (a) Controlled substances in schedule I or II and narcotic drugs 
in schedule III, IV, or V; exceptions
    It shall be unlawful to import into the customs territory of the 
United States from any place outside thereof (but within the United 
States), or to import into the United States from any place outside 
thereof, any controlled substance in schedule I or II of subchapter 
I of this chapter, or any narcotic drug in schedule III, IV, or V of 
subchapter I of this chapter, or ephedrine, pseudoephedrine, and 
phenylpropanolamine, except that--
    (1) such amounts of crude opium, poppy straw, concentrate of 
poppy straw, and coca leaves, and of ephedrine, pseudoephedrine, and 
phenylpropanolamine, as the Attorney General finds to be necessary 
to provide for medical, scientific, or other legitimate purposes
    * * * may be so imported under such regulations as the Attorney 
General shall prescribe.
* * * * *
    (d)(1) With respect to a registrant under section 958 who is 
authorized under subsection (a)(1) to import ephedrine, 
pseudoephedrine, or phenylpropanolamine, at any time during the year 
the registrant may apply for an increase in the amount of such 
chemical that the registrant is authorized to import, and the 
Attorney General may approve the application if the Attorney General 
determines that the approval is necessary to provide for medical, 
scientific, or other legitimate purposes regarding the chemical.


    Editor's Note:  This excerpt of the amendment is published for 
the convenience of the reader. The official text is published at 21 
U.S.C. 952(a) and (d)(1).

    The 2010 Assessment of Annual Needs represents those quantities of 
ephedrine, pseudoephedrine, and phenylpropanolamine which may be 
manufactured domestically and/or imported into the United States in 
2010 to provide adequate supplies of each chemical for: The estimated 
medical, scientific, research, and industrial needs of the United 
States; lawful export requirements; and the establishment and 
maintenance of reserve stocks.
    On June 28, 2010, a notice entitled, ``Proposed Revised Assessment 
of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, 
and Phenylpropanolamine for 2010'' was published in the Federal 
Register (75 FR 36684). This notice proposed the revised 2010 
Assessment of Annual Needs for ephedrine (for sale), ephedrine (for 
conversion), pseudoephedrine (for sale), phenylpropanolamine (for sale) 
and phenylpropanolamine (for conversion).

[[Page 79413]]

All interested persons were invited to comment on or object to the 
proposed assessments on or before July 28, 2010.

Comments Received

    DEA did not receive any comments to the Assessment of Annual Needs 
for ephedrine (for sale), ephedrine (for conversion), pseudoephedrine 
(for sale), phenylpropanolamine (for sale) and phenylpropanolamine (for 
conversion). DEA is finalizing the assessments for these List I 
chemicals based on information contained in applications for 2010 
import, manufacturing and procurement quotas provided by DEA registered 
importers and manufacturers, including those quota applications that 
DEA received between the drafting of the June 28th notice and the 
drafting of this notice on August 10, 2010. DEA is providing the data 
used in developing the established assessments for each of the listed 
chemicals.

Underlying Data and DEA's Analysis

    In determining the 2010 assessments, DEA has considered the total 
net disposals (i.e. sales) of the List I chemicals for the current and 
preceding two years, actual and estimated inventories, projected demand 
(2010), industrial use, and export requirements from data provided by 
DEA registered manufacturers and importers in procurement quota 
applications (DEA 250), from manufacturing quota applications (DEA 
189), and from import quota applications (DEA 488).\1\
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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 (for Sale) Data

                          Ephedrine (for Sale) Data for 2010 Assessment of Annual Needs
                                                   [Kilograms]
----------------------------------------------------------------------------------------------------------------
                                                                                                         2010
                          Ephedrine                               2007         2008         2009       Request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)...........................................        2,698        2,507        2,650        3,289
Imports ** (DEA 488)........................................        9,595        1,690        2,139        2,431
Export Declarations (DEA 486)...............................          168           18           64          n/a
Inventory * (DEA 250).......................................        1,373          626          191          n/a
IMS *** (NSP)...............................................        1,236        1,460        1,401          n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 10,
  2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010.
*** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail
  Channels, Data Extracted August 10, 2010.

Ephedrine (for Sale) Analysis

    DEA previously has established the 2010 assessment of annual needs 
for ephedrine (for sale) at 3,600 kg (74 FR 60298).
    As noted above, DEA developed the revisions to the 2010 assessment 
of annual needs for ephedrine (for sale) using the same calculation and 
methodology that DEA used to determine the 2009 and 2010 assessment of 
annual needs.
    As of August 10, 2010, DEA registered manufacturers of dosage form 
products containing ephedrine requested the authority to purchase a 
total of 3,289 kg ephedrine (for sale) in 2010. DEA registered 
manufacturers of ephedrine reported sales totaling approximately 2,507 
kg in 2008 and 2,650 kg in 2009; this represents a 5 percent increase 
in sales reported by these firms from 2008 to 2009. Additionally, 
exports of ephedrine products from the United States as reported on 
export declarations (DEA 486) totaled 18 kg in 2008 and 64 kg in 2009; 
this represents a 72 percent increase from levels observed in 2008. The 
average of the 2008 and 2009 exports of ephedrine products is 
approximately 41 kg. DEA also considered information on trends in the 
national rate of net disposals from sales data provided by IMS Health's 
NSP database. IMS NSP data reported the average sales volume of 
ephedrine for the calendar years 2008 and 2009 to be approximately 
1,431 kg. DEA notes that the 2009 sales figure reported by 
manufacturers (2,650 kg) is higher than the average sales reported by 
IMS for the previous two years (1,431 kg). This is expected because a 
manufacturer's reported sales include quantities which are necessary to 
provide reserve stocks for distributors and retailers. DEA, in 
considering the manufacturer's reported sales, thus believes that 2,650 
kg fairly represents the United States sales of ephedrine for 2010 and 
that 41 kg fairly represents the export requirements of ephedrine.
    For the establishment and maintenance of reserve stocks, DEA notes 
that 21 CFR 1315.24 allows for an inventory allowance (reserve stock) 
of 50 percent of a manufacturer's estimated sales. DEA also considered 
the estimated 2009 year end inventory as reported by DEA registrants in 
determining the inventory allowance.
    DEA calculated the proposed revised ephedrine (for sale) assessment 
as follows:
    2009 sales + reserve stock + export requirement-existing inventory 
= AAN
    2,650 + (50%*2,650) + 41-191 = 3,825 kg ephedrine (for sale) for 
2010
    This calculation suggests that DEA's assessment of annual needs for 
ephedrine should be 3,900 kg. DEA notes that its June 28, 2010, notice 
proposed to increase the ephedrine assessment to 4,100 kg. That 
proposal was based on information received as of March 10, 2010. Since 
that time DEA has received revised manufacture production data, i.e., 
sales and inventory information decreasing the reported sales of 
ephedrine for 2009. After calculating the ephedrine (for sale) 
assessment using the most current data--that reported by DEA registered 
manufactures as of August 10, 2010--DEA concludes that the proposed 
revised assessment of 4,100 kg would have been unnecessarily high. 
Accordingly, DEA is increasing the 2010 assessment of annual needs for 
ephedrine (for sale) from 3,600 kg to 3,900 kg.

Phenylpropanolamine (for Sale) data

[[Page 79414]]



                     Phenylpropanolamine (for Sale) Data for 2010 Assessment of Annual Needs
                                                   [Kilograms]
----------------------------------------------------------------------------------------------------------------
                                                                                                         2010
               Phenylpropanolamine (for sale)                     2007         2008         2009       Request
----------------------------------------------------------------------------------------------------------------
Sales* (DEA 250)............................................        4,158        4,528        5,355        7,480
Imports** (DEA 488).........................................        5,787        3,425        6,626        7,271
Export Declarations (DEA 486)...............................        1,002            0            3          n/a
Inventory* (DEA 250)........................................        3,642        2,470          645          n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 10,
  2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010.

Phenylpropanolamine (for Sale) Analysis

    DEA previously has established the 2010 assessment of annual needs 
for phenylpropanolamine (for sale) at 6,400 kg (74 FR 60298).
    As noted above, DEA utilized the same general methodology and 
calculation to develop the proposed revised assessment for 
phenylpropanolamine (for sale) that DEA used to determine the 2009 and 
2010 assessment of annual needs.
    As of August 10, 2010, DEA registered manufacturers of dosage form 
products containing phenylpropanolamine requested the authority to 
purchase 7,480 kg phenylpropanolamine (for sale) in 2010. DEA 
registered manufacturers of phenylpropanolamine reported sales totaling 
approximately 4,528 kg in 2008 and 5,355 kg in 2009; this represents a 
15.5% increase in sales reported by these firms from 2008 to 2009. 
Additionally, exports of phenylpropanolamine products from the United 
States as reported on export declarations (DEA 486) totaled 0 kg in 
2008 and 3 kg in 2009; this represents a 3 kg increase from levels 
observed in 2008. The average of the 2008 and 2009 exports of 
phenylpropanolamine products is approximately 2 kg. DEA thus believes 
that 5,355 kg fairly represents the United States sales of 
phenylpropanolamine for 2010 and that 2 kg fairly represents the export 
requirements of phenylpropanolamine. DEA notes that phenylpropanolamine 
is sold primarily as a veterinary product for the treatment for canine 
incontinence and is not approved for human consumption. IMS Health's 
NSP data does not capture sales of phenylpropanolamine to veterinary 
channels and is, therefore, not included.
    DEA calculated the proposed revised phenylpropanolamine (for sale) 
assessment by the following methodology:
    2009 sales + reserve stock + export requirement - existing 
inventory = AAN
    5,355 + (50%*5,355) + 2 - 645 = 7,390 kg phenylpropanolamine (for 
sale) for 2010
    This calculation suggests that DEA's 2010 Assessment of Annual 
Needs for phenylpropanolamine (for sale) should be 7,400 kg. 
Accordingly, DEA is increasing the 2010 assessment of annual needs for 
phenylpropanolamine (for sale) from 6,400 kg to 7,400 kg.

Pseudoephedrine (for Sale) Data

                       Pseudoephedrine (for Sale) Data for 2010 Assessment of Annual Needs
                                                   [Kilograms]
----------------------------------------------------------------------------------------------------------------
                                                                                                         2010
                 Pseudoephedrine (for sale)                       2007         2008         2009       Request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)...........................................      239,314      224,480      286,607      254,286
Sales * (DEA 189)...........................................      100,300       64,781       33,600       32,760
Imports ** (DEA 488)........................................      231,683      170,614      274,492      261,528
Export Declarations (DEA 486)...............................       42,132       47,199       35,264          n/a
Inventory * (DEA 250).......................................      136,039      121,374       68,100          n/a
IMS *** (NSP)...............................................      180,221      149,232      140,784          n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas
  (DEA 189) received as of August 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010.
*** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail
  Channels, Data Extracted August 10, 2010.

Pseudoephedrine (for Sale) Analysis

    DEA previously has established the 2010 assessment of annual needs 
for pseudoephedrine (for sale) at 404,000 kg (74 FR 60298).
    As noted above, DEA utilized the same general methodology and 
calculation to develop the proposed revised assessment for 
pseudoephedrine (for sale) that DEA used to determine the 2009 and 2010 
assessment of annual needs.
    As of August 10, 2010, DEA registered manufacturers of dosage form 
products containing pseudoephedrine requested the authority to purchase 
254,286 kg pseudoephedrine. DEA registered manufacturers of 
pseudoephedrine reported sales totaling approximately 224,480 kg in 
2008 and 286,607 kg in 2009; this represents a 22 percent increase in 
sales reported by these firms from 2008 to 2009. During the same period 
exports of pseudoephedrine products from the United States as reported 
on export declarations (DEA 486) totaled 47,199 kg in 2008 and 35,264 
kg in 2009; this represents a 25 percent decrease from levels observed 
in 2008. The average of the 2008 and 2009 exports is 41,232 kg. 
Additionally, DEA considered information on trends in the national rate 
of net disposals from sales data provided by IMS Health. IMS NSP data 
reported the average retail sales volume of pseudoephedrine for the 
calendar years 2008 and 2009 to be approximately 145,006 kg. DEA thus 
believes that 286,607 kg of sales reported by manufacturers fairly 
represents the United States sales of pseudoephedrine for 2010 and that

[[Page 79415]]

41,232 kg fairly represents the export requirements of pseudoephedrine. 
DEA notes that manufacturer reported sales for 2009 (286,607 kg) are 
higher than the average retail sales reported by IMS for the previous 
two years (145,006 kg). This is expected because a manufacturer's 
reported sales include quantities which are necessary to provide 
reserve stocks for distributors and retailers.
    DEA calculated the revised pseudoephedrine (for sale) assessment by 
the following methodology:
    2009 sales + reserve stock + export requirement - existing 
inventory = AAN
    286,607 + (50%*286,607) + 41,232 - 68,100 = 403,043 kg 
pseudoephedrine (for sale) for 2010.
    This calculation suggests that DEA's 2010 assessment of annual 
needs for pseudoephedrine (for sale) should be 404,000 kg. DEA notes 
that its June 28, 2010, notice proposed to increase the pseudoephedrine 
assessment to 419,000 kg. That proposal was based on information 
received as of March 10, 2010. Since that time DEA has received 
additional request for quotas, revised manufacture production data, 
i.e., sales and inventory information, requests for withdrawal of 
quota, and request for adjustments to individual procurement quotas. As 
a result of this additional information, the 2009 reported sales of 
pseudoephedrine decreased from 287,756 kg to 286,607 kg and the 
reported inventory increased from 54,173 kg to 68,001 kg. After 
calculating the pseudoephedrine (for sale) assessment using the most 
current data--that was reported by DEA registered manufactures as of 
August 10, 2010--DEA concludes that the proposed revised assessment of 
419,000 kg would have been unnecessarily high. Accordingly, DEA has 
determined that the established 2010 AAN for pseudoephedrine of 404,000 
kg is appropriate and requires no change.

Phenylpropanolamine (for Conversion) Data

                  Phenylpropanolamine (for Conversion) Data for 2010 Assessment of Annual Needs
                                                   [Kilograms]
----------------------------------------------------------------------------------------------------------------
                                                                                                         2010
            Phenylpropanolamine (for conversion)                  2007         2008         2009       Request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)...........................................        3,621       10,837       14,585       14,910
Imports ** (DEA 488)........................................        8,250       12,019       11,373       28,408
Export Declarations (DEA 486)...............................            0            0            0          n/a
Inventory* (DEA 250)........................................        3,581        5,537        4,104          n/a
APQ Amphetamine ***.........................................       22,000       22,000       24,500       23,500
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 10,
  2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010.
*** Amphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.

Phenylpropanolamine (for Conversion) Analysis

    DEA previously had established the 2010 assessment of annual needs 
for phenylpropanolamine (for conversion) at 16,500 kg (74 FR 60298). As 
noted above, DEA developed the proposed revisions to the 2010 
assessment of annual needs for phenylpropanolamine (for conversion) 
using the same calculation and methodology that DEA used to determine 
the 2009 and 2010 assessment of annual needs.
    As of August 10, 2010, DEA registered manufacturers of 
phenylpropanolamine (for conversion) requested the authority to 
purchase a total of 14,910 kg phenylpropanolamine for the manufacture 
of amphetamine. DEA registered manufacturers of phenylpropanolamine 
reported sales of phenylpropanolamine totaling approximately 10,837 kg 
in 2008 and 14,585 kg in 2009; this represents a 26 percent increase in 
sales reported by these firms from 2008 to 2009. There were no reported 
exports of phenylpropanolamine (for conversion). DEA has not received 
any requests to synthesize phenylpropanolamine in 2010. DEA has 
concluded that the 2009 sales of phenylpropanolamine (for conversion), 
14,585 kg fairly represents United States requirements for 2010 and 
zero kg fairly represents the export requirements of 
phenylpropanolamine (for conversion).
    DEA believes that the data provided in procurement, manufacturing, 
and import quota applications best represents the legitimate need for 
phenylpropanolamine (for conversion). Phenylpropanolamine (for 
conversion) is used for the manufacture of legitimate amphetamine 
products, but DEA notes that most legitimate amphetamine is 
manufactured by converting phenylacetone rather than 
phenylpropanolamine, to amphetamine. Basing the phenylpropanolamine 
(for conversion) calculation on the total Aggregate Production Quota 
(APQ) for amphetamine, therefore, would inaccurately inflate the 
phenylpropanolamine (for conversion) assessment.
    DEA calculated the phenylpropanolamine (for conversion) needed for 
the manufacture of amphetamine as follows:
    (2009 sales) + reserve stock + export requirement - inventory = AAN
    (14,585) + 50%*(14,585) + 0 - 4,104 = 17,774 kg PPA (for 
conversion) for 2010
    This calculation suggests that DEA's 2010 assessment of annual 
needs for phenylpropanolamine (for conversion) should be 17,800 kg. DEA 
notes that its June 28, 2010, notice proposed to increase the 
phenylpropanolamine (for conversion) assessment to 18,200 kg. That 
proposal was based on information received as of March 10, 2010. Since 
that time DEA has received additional request for quotas, revised 
manufacture production data, i.e., sales and inventory information, and 
request for adjustments to individual procurement quotas. As a result 
the 2009 reported inventory of phenylpropanolamine increased from 3,693 
kg to 4,104 kg. After calculating the phenylpropanolamine (for 
conversion) assessment using the most current data--that reported by 
DEA registered manufactures as of August 10, 2010--DEA concludes that 
the proposed revised assessment of 18,200 kg would have been 
unnecessarily high. Accordingly, DEA is increasing the 2010 assessment 
of annual needs for phenylpropanolamine (for conversion) from 16,500 kg 
to 17,800 kg.

Ephedrine (for Conversion) Data

[[Page 79416]]



                       Ephedrine (for Conversion) Data for 2010 Assessment of Annual Needs
                                                   [Kilograms]
----------------------------------------------------------------------------------------------------------------
                                                                                                         2010
                 Ephedrine (for conversion)                       2007         2008         2009       Request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)...........................................       99,594       64,522       40,387       40,600
Imports ** (DEA 488)........................................       99,594       64,128       39,897       40,204
Inventory * (DEA 250).......................................            0           99          208          n/a
APQ Methamphetamine ***.....................................        3,130        3,130        3,130        3,130
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas
  (DEA 189) received as of August 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010.
*** Methamphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.

Ephedrine (for Conversion) Analysis

    DEA previously has established the 2010 assessment of annual needs 
for ephedrine (for conversion) at 75,000 kg (74 FR 60298). As noted 
above, DEA developed the proposed revisions to the 2010 assessment of 
annual needs for ephedrine (for conversion) using the same calculation 
and methodology that DEA used to determine the 2009 and 2010 assessment 
of annual needs.
    As of August 10, 2010, DEA registered manufacturers of ephedrine 
(for conversion) requested the authority to purchase a total of 40,600 
kg ephedrine (for conversion) for the manufacture of two substances: 
methamphetamine and pseudoephedrine.
    DEA considered the ephedrine (for conversion) requirements for the 
manufacture of methamphetamine and pseudoephedrine. DEA has determined 
that the established assessments for the manufacture of these two 
substances are the best indicators of the need for ephedrine (for 
conversion). The assessment of need for methamphetamine was determined 
by DEA as the APQ for methamphetamine. DEA determined that the 
estimated sales of pseudoephedrine by manufacturers, as referenced in 
the assessment of annual needs for pseudoephedrine, represents the need 
for pseudoephedrine. Reported sales of ephedrine (for conversion) are 
included as reference to DEA's methodology.
    DEA further considered the reported conversion yields of these 
substances. DEA registered manufacturers reported a conversion yield of 
39 percent for the synthesis of methamphetamine from ephedrine. DEA 
cannot disclose the conversion yield for the synthesis of 
pseudoephedrine because this information is proprietary to the one 
manufacturer involved in this type of manufacturing.
    Thus, DEA calculated the ephedrine (for conversion) requirement for 
the manufacture of methamphetamine as follows:
    (2009 APQ methamphetamine/39% yield) + reserve stock - inventory = 
ephedrine (for manufacture of methamphetamine) (3,130/39% yield) + 
50%*(3,130/39% yield) - 208 = 11,830 kg
    The calculation for the ephedrine (for conversion) requirement for 
the manufacture of pseudoephedrine leads to a result of 63,157 kg. DEA 
cannot provide the details of the calculation because this would reveal 
the conversion yield for the synthesis of pseudoephedrine, which is 
proprietary to the one manufacturer involved in this type of 
manufacturing.
    Therefore, DEA determined the proposed revised assessment for 
ephedrine (for conversion) by summing the amounts required for the 
manufacture of methamphetamine and pseudoephedrine:
    methamphetamine requirement + pseudoephedrine requirement = AAN 
11,830 + 63,157 = 74,987 kg ephedrine (for conversion) for 2010
    This calculation suggests that DEA's 2010 assessment of annual 
needs for ephedrine (for conversion) should be 75,000 kg. Accordingly, 
DEA is leaving the 2010 assessment of annual needs for ephedrine (for 
conversion) unchanged at 75,000 kg.
    DEA did not receive any comments on its Assessment of Annual Needs 
for ephedrine (for sale), ephedrine (for conversion), pseudoephedrine 
(for sale), phenylpropanolamine (for sale) and phenylpropanolamine (for 
conversion). DEA is finalizing the assessments for these List I 
chemicals based on information contained in additional applications for 
2010 import, manufacturing and procurement quotas provided by DEA 
registered importers and manufacturers whose quota applications were 
received as of August 10, 2010.
    Therefore, under the authority vested in the Attorney General by 
section 306 of the CSA (21 U.S.C. 826), and delegated to the 
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy 
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby 
orders that the Revised 2010 Assessment of Annual Needs for ephedrine, 
pseudoephedrine, and phenylpropanolamine, expressed in kilograms of 
anhydrous acid or base, be established as follows:

------------------------------------------------------------------------
                                              Final 2010 assessment of
              List I chemical                       annual needs
------------------------------------------------------------------------
Ephedrine (for sale)......................  3,900 kg
Phenylpropanolamine (for sale)............  7,400 kg
Pseudoephedrine (for sale)................  404,000 kg
Phenylpropanolamine (for conversion)......  17,800 kg
Ephedrine (for conversion)................  75,000 kg
------------------------------------------------------------------------

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Administrator hereby certifies that this action will not 
have a significant economic impact upon small entities whose interests 
must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601-
612. The establishment of the assessment of annual needs for ephedrine, 
pseudoephedrine, and phenylpropanolamine is mandated by law. The 
assessments are necessary to provide for the estimated medical, 
scientific, research and industrial needs of the United States, for 
lawful export requirements, and the establishment and maintenance of 
reserve stocks. Accordingly, the Deputy Administrator has determined 
that this action does not require a regulatory flexibility analysis.

Executive Order 12866

    The Office of Management and Budget has determined that notices of 
assessment of annual needs are not subject to centralized review under 
Executive Order 12866.

Executive Order 13132

    This action does not preempt or modify any provision of State law; 
nor does it impose enforcement

[[Page 79417]]

responsibilities on any State; nor does it diminish the power of any 
State to enforce its own laws. Accordingly, this action does not have 
federalism implications warranting the application of Executive Order 
13132.

Executive Order 12988

    This action meets the applicable standards set forth in Sections 
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.

Unfunded Mandates Reform Act of 1995

    This action will not result in the expenditure by State, local, and 
Tribal governments, in the aggregate, or by the private sector, of 
$120,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.

Congressional Review Act

    This action is not a major rule as defined by Section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This action 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

    Dated: December 13, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-31848 Filed 12-17-10; 8:45 am]
BILLING CODE 4410-09-P