[Federal Register Volume 74, Number 176 (Monday, September 14, 2009)]
[Notices]
[Pages 47021-47026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22043]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-326P]


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

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed annual assessment of needs for 2010.

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SUMMARY: This notice proposes the initial year 2010 Assessment of 
Annual Needs for certain List I chemicals in accordance with the Combat 
Methamphetamine Epidemic Act (CMEA) of 2005, enacted on March 9, 2006. 
The CMEA requires DEA to establish production quotas and import quotas 
for ephedrine, pseudoephedrine, and phenylpropanolamine. The CMEA 
places additional regulatory controls upon the manufacture, 
distribution, importation, and exportation of the three List I 
chemicals.

DATES: Written comments must be postmarked, and electronic comments 
must be sent, on or before October 14, 2009.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-326P'' on all written and electronic correspondence. 
Written comments being sent via regular mail should be sent to the 
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration, 8701 Morrissette Drive, Springfield, 
Virginia 22152, attention: DEA Federal Register Representative/ODL. 
Written comments sent via express mail should be sent to DEA 
Headquarters, Attention: DEA Federal Register Representative/ODL, 8701 
Morrissette Drive, Springfield, Virginia 22152. Comments may be 
directly sent to DEA electronically by sending an electronic message to 
[email protected]. However, persons wishing to request a 
hearing should note that such requests must be written and manually 
signed; requests for a hearing will not be accepted via electronic 
means. DEA will accept attachments to electronic comments in Microsoft 
Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not 
accept any file format other than those specifically listed here.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, 
Drug and Chemical Evaluation Section, Drug Enforcement Administration, 
8701 Morrisette Drive, Springfield, Virginia 22152, Telephone: (202) 
307-7183.

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

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

[[Page 47022]]

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 proposed 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 
to provide adequate supplies of each substance to meet the estimated 
medical, scientific, research, and industrial needs of the United 
States; lawful export requirements; and the establishment and 
maintenance of reserve stocks.
    As of August 4, 2009, the DEA had received a total of 134 
applications for 2010 import, procurement and manufacturing quotas for 
ephedrine, pseudoephedrine and phenylpropanolamine. As a comparison, 
for the 2009 quota year DEA has received 201 applications for import, 
procurement and manufacturing quotas. DEA calculated the 2010 
Assessment of Annual Needs for the List I chemicals using the 
calculation methodology described in both the interim and final 2009 
Assessment of Annual Needs (73 FR 79508 and 74 FR 32954, respectively). 
The phenylpropanolamine (for conversion) calculation has been modified 
to account for additional information. These calculations take into 
account the criteria that DEA is required to consider in accordance 
with 21 U.S.C. 826 and its implementing regulations (21 CFR 1315.11).
    In finalizing the assessments for these List I chemicals, DEA will 
consider the information contained in additional applications for 2010 
import, manufacturing and procurement quotas from DEA registered 
manufacturers and importers that DEA receives after August 4, 2009, as 
well as the comments that DEA receives in response to this proposal.

Underlying Data and DEA's Analysis

    In determining the proposed 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 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 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

      Ephedrine (for Sale) Data for 2010 Assessment of Annual Needs
                               (Kilograms)
------------------------------------------------------------------------
                                                                  2010
          Ephedrine              2007       2008       2009     Request
------------------------------------------------------------------------
Sales* (DEA 250)............      1,509      1,988      2,107      2,486
Imports** (DEA 488).........          1          3         42         17
Export Declarations (DEA            168         91         10        n/a
 486).......................
Inventory* (DEA 250)........        714        421        176        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 PerspectivesTM, January 2007 to
  December 2008, Retail and Non-Retail Channels, Data Extracted August
  4, 2009.

Ephedrine Analysis

    DEA calculated the proposed 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 August 4, 2009, DEA registered manufacturers of dosage form 
products containing ephedrine requested the authority to purchase a 
total of 2,486 kg ephedrine (for sale) in 2010. DEA registered 
manufacturers of ephedrine reported sales totaling approximately 1,988 
kg in 2008 and 2,107 kg in 2009; this represents a 6 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 91 kg in 2008 and 10 kg in 2009; 
this represents a 90 percent 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 
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 (2,107 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 2,107 
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 percent of a manufacturer's estimated

[[Page 47023]]

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
2,107 + (50%*2,107) + 51-176 = 3,036 kg ephedrine (for sale) for 2010

    This calculation suggests that DEA's Assessment of Annual Needs for 
ephedrine should be proposed to be 3,100 kg. Accordingly, DEA is 
proposing the 2010 Assessment of Annual Needs for ephedrine (for sale) 
at 3,100 kg.

Phenylpropanolamine (for Sale) Data

 Phenylpropanolamine (for Sale) Data for 2010 Assessment of Annual Needs
                               [Kilograms]
------------------------------------------------------------------------
  Phenylpropanolamine (for                                        2010
            sale)                2007       2008       2009     Request
------------------------------------------------------------------------
Sales * (DEA 250)...........      3,674      4,119      4,452      5,680
Imports ** (DEA 488)........         73         79        134        263
Export Declarations (DEA          1,002          0          3        n/a
 486).......................
Inventory * (DEA 250).......      3,498      2,045        573        n/a
------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement
  quotas (DEA 250) received as of August 4, 2009.
** Reported imports from applications for 2010 import quotas (DEA 488)
  received as of August 4, 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 August 4, 2009, DEA registered manufacturers of dosage form 
products containing phenylpropanolamine requested the authority to 
purchase 5,680 kg phenylpropanolamine (for sale) in 2010. DEA 
registered manufacturers of phenylpropanolamine reported sales totaling 
approximately 4,119 kg in 2008 and 4,452 kg in 2009; this represents a 
7.5% 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 4,452 kg fairly 
represents the U.S. 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 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
4,452 + (50%*4,452) + 2 - 573 = 6,107 kg phenylpropanolamine (for sale) 
for 2010

    This calculation suggests that DEA's 2010 Assessment of Annual 
Needs for phenylpropanolamine (for sale) should be proposed at 6,100 
kg. Accordingly, DEA is proposing the 2010 Assessment of Annual Needs 
for phenylpropanolamine (for sale) at 6,100 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)...........................................      204,028      179,566      236,650      196,912
Sales * (DEA 189)...........................................      100,300       64,781       33,600       32,760
Imports ** (DEA 488)........................................       44,499       60,300      147,002       78,884
Export Declarations (DEA 486)...............................       42,142       85,757       18,974          n/a
Inventory * (DEA 250).......................................      132,838      114,795       61,613          n/a
IMS *** (NSP)...............................................      180,172      149,110          n/a          n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas
  (DEA 189) received as of August 4, 2009.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 4, 2009.
*** IMS Health, IMS National Sales Perspectives TM, January 2007 to December 2008, Retail and Non-Retail
  Channels, Data Extracted August 4, 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 August 4, 2009, DEA registered manufacturers of dosage form 
products containing pseudoephedrine requested the authority to purchase 
196,912 kg pseudoephedrine. DEA registered manufacturers of 
pseudoephedrine reported sales totaling approximately 179,566 kg in 
2008 and 236,650 kg in 2009; this represents a 24 percent 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 85,757 kg in 2008 and 18,974 kg in 2009; 
this represents a 78 percent

[[Page 47024]]

decrease from levels observed in 2008. The average of the 2008 and 2009 
exports is 52,366 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 164,641 kg. DEA thus believes that 236,650 kg of sales 
reported by manufacturers fairly represents the U.S. sales of 
pseudoephedrine for 2010 and that 52,366 kg fairly represents the 
export requirements of pseudoephedrine. DEA notes that manufacturer 
reported sales for 2009 (236,650 kg) are higher than the average retail 
sales reported by IMS for the previous two years (164,641 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
236,650 + (50%*236,650) + 52,366 - 61,613 = 345,728 kg pseudoephedrine 
(for sale) for 2010.

    This calculation suggests that DEA's 2010 Assessment of Annual 
Needs for pseudoephedrine (for sale) should be proposed at 346,000 kg. 
Accordingly, DEA is proposing the 2010 Assessment of Annual Needs for 
pseudoephedrine (for sale) at 346,000 kg.

Phenylpropanolamine (for Conversion) Data

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

Phenylpropanolamine (for Conversion) Analysis

    As of August 4, 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 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), 
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 2009

    This calculation suggests that DEA's 2009 Assessment of Annual 
Needs for phenylpropanolamine (for conversion) should be proposed at 
16,500 kg. Accordingly, DEA is proposing 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]
------------------------------------------------------------------------
                                                                  2010
 Ephedrine  (for conversion)     2007       2008       2009     Request
------------------------------------------------------------------------
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
------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement
  quotas (DEA 250) and manufacturing quotas (DEA 189) received as of
  August 4, 2009.
** Reported imports from applications for 2010 import quotas (DEA 488)
  received as of August 4, 2009.
*** Methamphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.htm.


[[Page 47025]]

Ephedrine (for Conversion) Analysis

    As of August 4, 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 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:

(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 proposed at 75,000 kg. 
Accordingly, DEA is proposing the 2010 Assessment of Annual Needs for 
ephedrine (for conversion) at 75,000 kg.

Conclusion

    In finalizing the 2010 assessments for these list I chemicals, DEA 
will use the methodology and calculations presented above. The numbers 
used in the calculations may be adjusted upwards or downwards based on 
the additional applications for 2010 import, manufacturing and 
procurement quotas received after August 4, 2009. DEA urges registered 
importers and manufacturers to submit applications for 2010 import, 
manufacturing and procurement quota so that DEA may include information 
from those applications when finalizing these assessments in accordance 
with 21 CFR 1315.
    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 
proposes the following 2010 Assessment of Annual Needs for the List I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine for 2010, 
expressed in kilograms of anhydrous base:

 
------------------------------------------------------------------------
                                                 Proposed Year 2010
             List I Chemicals                Assessment of Annual Needs
------------------------------------------------------------------------
Ephedrine (for sale)......................  3,100 kg.
Phenylpropanolamine (for sale)............  6,100 kg.
Pseudoephedrine (for sale)................  346,000 kg.
Phenylpropanolamine (for conversion)......  16,500 kg.
Ephedrine (for conversion)................  75,000 kg.
------------------------------------------------------------------------

    Ephedrine (for conversion) refers to the industrial use of 
ephedrine, i.e., that which will be converted to another basic drug 
class such as pseudoephedrine or methamphetamine used for the 
manufacture of prescription weight loss drug. Phenylpropanolamine (for 
conversion) refers to the industrial use of phenylpropanolamine, i.e., 
that which will be converted to another basic drug class such as 
amphetamine for the manufacture of drug products. The ``for sale'' 
assessments refer to the amount of ephedrine, pseudoephedrine, and 
phenylpropanolamine intended for ultimate use in products containing 
these List I chemicals.
    All interested persons are invited to submit their comments in 
writing or electronically regarding this proposal following the 
procedures in the ADDRESSES section of this document. A person may 
object to or comment on the proposal relating to any of the above-
mentioned substances without filing comments or objections regarding 
the others. If a person believes that one or more of these issues 
warrant a hearing, the individual should so state and summarize the 
reasons for this belief. Persons wishing to request a hearing should 
note that such requests must be written and manually signed; requests 
for a hearing will not be accepted via electronic means. In the event 
that comments or objections to this proposal raise one or more issues 
which the Deputy Administrator finds warrant a hearing, the Deputy 
Administrator shall order a public hearing by notice in the Federal 
Register, summarizing the issues to be heard and setting the time for 
the hearing as per 21 CFR 1315.13(e).

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 47026]]

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: September 2, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-22043 Filed 9-11-09; 8:45 am]
BILLING CODE 4410-09-P