[Federal Register Volume 75, Number 176 (Monday, September 13, 2010)]
[Notices]
[Pages 55605-55610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22688]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-350P]


Assessment of Annual Needs for the List I Chemicals Ephedrine, 
Pseudoephedrine, and Phenylpropanolamine for 2011: Proposed

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed annual assessment of needs for 2011.

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SUMMARY: This notice proposes the initial year 2011 Assessment of 
Annual Needs for certain List I chemicals in accordance with the Combat 
Methamphetamine Epidemic Act (CMEA) of 2005. 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 13, 2010.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-350P'' 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 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 
307-7183.

SUPPLEMENTARY INFORMATION: Section 713 of the CMEA of 2005 (Title VII 
of Pub. L. 109-177) (CMEA) amended Sec.  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

[[Page 55606]]

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, Sec.  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 
schedules 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 proposed 2011 Assessment of Annual Needs represents those 
quantities of ephedrine, pseudoephedrine, and phenylpropanolamine which 
may be manufactured domestically and/or imported into the United States 
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 June 25, 2010, the DEA has received a total of 99 
applications for 2011 import, procurement and manufacturing quotas for 
ephedrine, pseudoephedrine, and phenylpropanolamine. As a comparison, 
for the 2010 quota year, DEA has received 204 applications for import, 
procurement, and manufacturing quotas. DEA calculated the 2011 
Assessment of Annual Needs for the List I chemicals using the 
calculation methodology described in both the 2009 and 2010 Assessment 
of Annual Needs (74 FR 32954 and 74 FR 60294, respectively). 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 2011 
import, manufacturing and procurement quotas from DEA registered 
manufacturers and importers that DEA receives after the date of 
drafting this notice, June 25, 2010, as well as the comments that DEA 
receives in response to this proposal. DEA registered manufacturers and 
importers are reminded that pursuant to 21 CFR 1315.22, 1315.32(e) and 
1315.34(d) applications for import and procurement quotas are due by 
April 1 and that applications for manufacturing quotas are due by May 1 
of the year preceding the year for which the quota is to be applied. 
DEA encourages registrants to submit their quota applications by the 
regulatory due dates to ensure their requirements are considered.

Underlying Data and DEA's Analysis

    In determining the proposed 2011 assessments, DEA has considered 
the total net disposals (i.e. sales) of the List I chemicals for the 
current and preceding two years, actual and estimated inventories, 
projected demand (2011), industrial use, and export requirements from 
data provided by DEA registered manufacturers and importers in 
procurement quota applications (DEA 250), from manufacturing quota 
applications (DEA 189), and from import quota applications (DEA 
488).\1\
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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 in export declarations. DEA notes that the inventory, 
acquisitions (purchases) and disposition (sales) data provided by DEA 
registered manufacturers and importers reflects the most current 
information available.

Ephedrine Data

      Ephedrine (for Sale) Data for 2011 Assessment of Annual Needs
                               [Kilograms]
------------------------------------------------------------------------
                                                                  2011
          Ephedrine              2008       2009       2010     request
------------------------------------------------------------------------
Sales* (DEA 250)............      2,159      2,136      2,416      2,867
Imports** (DEA 488).........         49          0         87        104
Export Declarations (DEA             18         64         52        n/a
 486).......................
Inventory* (DEA 250)........        723        497        315        n/a
IMS*** (NSP)................      1,460      1,401        n/a        n/a
------------------------------------------------------------------------
* Reported sales and inventory from applications for 2011 procurement
  quotas (DEA 250).
** Reported imports from applications for 2011 import quotas (DEA 488).
*** IMS Health, IMS National Sales PerspectivesTM, January 2008 to
  December 2009, Retail and Non-Retail Channels, Data Extracted June 25,
  2010.


[[Page 55607]]

Ephedrine Analysis

    DEA calculated the proposed 2011 Assessment of Annual Needs for 
ephedrine using the calculation developed to determine the 2009 
Assessment of Annual Needs. This calculation considers the criteria 
defined in 21 U.S.C. 826: estimated medical, scientific, research, and 
industrial needs of the United States; lawful export requirements; and 
the establishment and maintenance of reserve stocks.
    As of June 25, 2010, DEA registered manufacturers of dosage form 
products containing ephedrine requested the authority to purchase a 
total of 2,867 kg ephedrine (for sale) in 2011. DEA registered 
manufacturers of ephedrine reported sales totaling approximately 2,136 
kg in 2009 and 2,416 kg in 2010; this represents a 12 percent increase 
in sales reported by these firms from 2009 to 2010. Additionally, 
exports of ephedrine products from the United States as reported on 
export declarations (DEA 486) totaled 64 kg in 2009 and 52 kg in 2010; 
this represents a 19 percent decrease from levels observed in 2009. The 
average of the 2009 and 2010 exports of ephedrine products is 
approximately 58 kg. DEA also considered information on trends in the 
national rate of net disposals from sales data provided by IMS Health's 
NSP database. IMS NSP data reported the average sales volume of 
ephedrine for the calendar years 2008 and 2009 to be approximately 
1,431 kg. DEA notes that the 2010 sales figure reported by 
manufacturers (2,416 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. In considering 
the manufacturer's reported sales, DEA thus believes that 2,416 kg 
fairly represents the U.S. sales of ephedrine for 2011 and that 58 kg 
fairly represents the export requirements of ephedrine.
    For the establishment and maintenance of reserve stocks, DEA notes 
that 21 CFR 1315.24 allows for an inventory allowance (reserve stock) 
of 50 percent of a manufacturer's estimated sales. DEA also considered 
the estimated 2010 year end inventory as reported by DEA registrants in 
determining the inventory allowance.
    DEA calculated the ephedrine (for sale) assessment by the following 
methodology:

2010 sales + reserve stock + export requirement - existing inventory 
= AAN 2,416 + (50%*2,416) + 58 - 315 = 3,367 kg ephedrine (for sale) 
for 2011.

    This calculation suggests that DEA's Assessment of Annual Needs for 
ephedrine should be proposed to be 3,400 kg. Accordingly, DEA is 
proposing the 2011 Assessment of Annual Needs for ephedrine (for sale) 
at 3,400 kg.

Phenylpropanolamine (for Sale) Data

 Phenylpropanolamine (for Sale) Data for 2011 Assessment of Annual Needs
                               [Kilograms]
------------------------------------------------------------------------
  Phenylpropanolamine (for                                        2011
            sale)                2008       2009       2010     request
------------------------------------------------------------------------
Sales* (DEA 250)............      4,252      4,350      4,374      5,638
Imports** (DEA 488).........        105      1,503      1,582      1,596
Export Declarations (DEA              0          3          0        n/a
 486).......................
Inventory* (DEA 250)........      2,054      2,318      1,951        n/a
------------------------------------------------------------------------
* Reported sales and inventory from applications for 2011 procurement
  quotas (DEA 250) received as of June 25, 2010.
** Reported imports from applications for 2011 import quotas (DEA 488)
  received as of June 25, 2010.

Phenylpropanolamine (for Sale) Analysis

    DEA utilized the same general methodology and calculation to 
establish the assessment for phenylpropanolamine (for sale) as was 
described for the assessment of ephedrine (for sale), above.
    As of June 25, 2010, DEA registered manufacturers of dosage form 
products containing phenylpropanolamine requested the authority to 
purchase 5,638 kg phenylpropanolamine (for sale) in 2011. DEA 
registered manufacturers of phenylpropanolamine reported sales totaling 
approximately 4,350 kg in 2009 and 4,374 kg in 2010; this represents a 
0.5 percent increase in sales reported by these firms from 2009 to 
2010. Additionally, exports of phenylpropanolamine products from the 
U.S. as reported on export declarations (DEA 486) totaled 3 kg in 2009 
and 0 kg in 2010; this represents a 3 kg decrease from levels observed 
in 2009. The average of the 2009 and 2010 exports of 
phenylpropanolamine products is approximately 2 kg. DEA thus believes 
that 4,374 kg fairly represents the U.S. sales of phenylpropanolamine 
for 2011 and that 2 kg fairly represents the export requirements of 
phenylpropanolamine. DEA notes that phenylpropanolamine is sold 
primarily as a veterinary product for the treatment for canine 
incontinence and is not approved for human consumption. IMS Health's 
NSP Data does not capture sales of phenylpropanolamine to these 
channels and is therefore not included.
    DEA calculated the phenylpropanolamine (for sale) assessment by the 
following methodology:

2010 sales + reserve stock + export requirement - existing inventory 
= AAN

4,374 + (50%*4,374) + 2 - 1,951 = 4,612 kg phenylpropanolamine (for 
sale) for 2011.

    This calculation suggests that DEA's 2011 Assessment of Annual 
Needs for phenylpropanolamine (for sale) should be proposed at 4,700 
kg. Accordingly, DEA is proposing the 2011 Assessment of Annual Needs 
for phenylpropanolamine (for sale) at 4,700 kg.

Pseudoephedrine (for Sale) Data

                       Pseudoephedrine (for Sale) Data for 2011 Assessment of Annual Needs
                                                   [Kilograms]
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                                                                                                         2011
                 Pseudoephedrine (for sale)                       2008         2009         2010       request
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Sales * (DEA 250)...........................................      169,992      145,853      148,934      181,219

[[Page 55608]]

 
Sales * (DEA 189)...........................................       64,781        7,321        5,550            0
Imports ** (DEA 488)........................................       10,872       39,168       44,030       74,012
Export Declarations (DEA 486)...............................       47,199       35,264        8,480          n/a
Inventory * (DEA 250).......................................       97,026       72,070       55,323          n/a
IMS *** (NSP)...............................................      149,232      140,784          n/a          n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250).
** Reported imports from applications for 2011 import quotas (DEA 488).
*** IMS Health, IMS National Sales PerspectivesTM, January 2008 to December 2009, Retail. and Non-Retail
  Channels, Data Extracted June 25, 2010.

Pseudoephedrine (for Sale) Analysis

    DEA utilized the same general methodology and calculations to 
establish the assessment for pseudoephedrine (for sale) as were 
described for the assessment of ephedrine (for sale), above.
    As of June 25, 2010, DEA registered manufacturers of dosage form 
products containing pseudoephedrine requested the authority to purchase 
181,219 kg pseudoephedrine. DEA registered manufacturers of 
pseudoephedrine reported sales totaling approximately 145,853 kg in 
2009 and 148,934 kg in 2010; this represents a 2 percent increase in 
sales reported by these firms from 2009 to 2010. During the same period 
exports of pseudoephedrine products from the U.S. as reported on export 
declarations (DEA 486) totaled 35,264 kg in 2009 and 8,480 kg in 2010; 
this represents a 76 percent decrease from levels observed in 2009. The 
average of the 2009 and 2010 exports is 21,872 kg. Additionally, DEA 
considered information on trends in the national rate of net disposals 
from sales data provided by IMS Health. IMS NSP data reported the 
average retail sales volume of pseudoephedrine for the calendar years 
2008 and 2009 to be approximately 145,008 kg. DEA thus believes that 
148,934 kg of sales reported by manufacturers fairly represents the 
U.S. sales of pseudoephedrine for 2011 and that 21,872 kg fairly 
represents the export requirements of pseudoephedrine.
    DEA calculated the pseudoephedrine (for sale) assessment by the 
following methodology:

2010 sales + reserve stock + export requirement - existing inventory 
= AAN
148,934 + (50%*148,934) + 21,872 - 55,323 = 189,950 kg 
pseudoephedrine (for sale) for 2011

    This calculation suggests that DEA's 2011 Assessment of Annual 
Needs for pseudoephedrine (for sale) should be proposed at 190,000 kg. 
Accordingly, DEA is proposing the 2011 Assessment of Annual Needs for 
pseudoephedrine (for sale) at 190,000 kg.

Phenylpropanolamine (for Conversion) Data

                  Phenylpropanolamine (for Conversion) Data for 2011 Assessment of Annual Needs
                                                   [Kilograms]
----------------------------------------------------------------------------------------------------------------
                                                                                                         2011
            Phenylpropanolamine (for conversion)                  2008         2009         2010       request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)...........................................        3,120        4,415        5,855       12,200
Imports ** (DEA 488)........................................          105        1,503        1,582        1,500
Export Declarations (DEA 486)...............................            0            0            0          n/a
Inventory * (DEA 250).......................................          875          503          713          n/a
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* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) received as of June 25,
  2010.
** Reported imports from applications for 2011 import quotas (DEA 488) received as of June 25, 2010.

Phenylpropanolamine (for Conversion) Analysis

    As of June 25, 2010, DEA registered manufacturers of 
phenylpropanolamine (for conversion) requested the authority to 
purchase a total of 12,200 kg phenylpropanolamine for the manufacture 
of amphetamine. DEA registered manufacturers of phenylpropanolamine 
reported sales of phenylpropanolamine totaling approximately 4,415 kg 
in 2009 and 5,855 kg in 2010; this represents a 26 percent increase in 
sales reported by these firms from 2009 to 2010. There were no reported 
exports of phenylpropanolamine (for conversion). DEA has not received 
any requests to synthesize phenylpropanolamine in 2011. DEA has 
concluded that the 2010 sales of phenylpropanolamine (for conversion), 
5,855 kg, fairly represents U.S. requirements for 2011 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) assessment 
for the manufacture of amphetamine as follows:

(2010 sales) + reserve stock + export requirement - inventory = AAN 
(5,855) + (50%*5,855) + 0 - 713 = 8,070 kg PPA (for conversion) for 
2011


[[Page 55609]]


    This calculation suggests that DEA's 2011 Assessment of Annual 
Needs for phenylpropanolamine (for conversion) should be proposed at 
8,100 kg. Accordingly, DEA is proposing the 2011 Assessment of Annual 
Needs for phenylpropanolamine (for conversion) at 8,100 kg.

Ephedrine (for Conversion) Data

                       Ephedrine (for Conversion) Data for 2011 Assessment of Annual Needs
                                                   [Kilograms]
----------------------------------------------------------------------------------------------------------------
                                                                                                         2011
                 Ephedrine (for conversion)                       2008         2009         2010       request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)...........................................       64,665        9,316        6,057          287
Imports ** (DEA 488)........................................            0            0            0            0
Inventory * (DEA 250).......................................          233           99          152          n/a
APQ Methamphetamine ***.....................................        3,130        3,130        3,130          n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) and manufacturing quotas
  (DEA 189) received as of June 25, 2010.
** Reported imports from applications for 2011 import quotas (DEA 488) received as of June 25, 2010.
*** Methamphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.

Ephedrine (for Conversion) Analysis

    As of June 25, 2010, DEA registered manufacturers of ephedrine (for 
conversion) requested the authority to purchase a total of 287 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 sale of pseudoephedrine, as referenced in 
the proposed Assessment of Annual Needs (AAN) for pseudoephedrine, 
represents the need for pseudoephedrine. Reported sales of ephedrine 
(for conversion) are included as reference to DEA's methodology.
    DEA further considered the reported conversion yields of these 
substances. DEA registered manufacturers reported a conversion yield of 
39 percent for the synthesis of methamphetamine from ephedrine. DEA 
cannot disclose the conversion yield for the synthesis of 
pseudoephedrine because this information is proprietary to the one 
manufacturer involved in this type of manufacturing.
    DEA calculated the ephedrine (for conversion) assessment by the 
following methodology:

methamphetamine requirement + pseudoephedrine requirement = AAN

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

(2010 APQ methamphetamine/39 percent yield) + reserve stock - 
inventory = ephedrine (for manufacture of methamphetamine)

(3,130/39 percent yield) + 50 percent*(3,130/39 percent yield) - 152 
= 11,887 kg

    The calculation for the ephedrine (for conversion) requirement 
for the manufacture of pseudoephedrine leads to a result of 6,703 
kg. DEA cannot provide the details of the calculation because this 
would reveal the conversion yield for the synthesis of 
pseudoephedrine, which is proprietary to the one manufacturer 
involved in this type of manufacturing. Therefore, the assessment 
for ephedrine was determined by the sum total of the ephedrine (for 
conversion) requirements as described by the following methodology:


methamphetamine requirement + pseudoephedrine requirement = AAN 11,887 
+ 6,703 = 18,590 kg ephedrine (for conversion) for 2011

    This calculation suggests that DEA's 2011 Assessment of Annual 
Needs for ephedrine (for conversion) should be proposed at 18,600 kg. 
Accordingly, DEA is proposing the 2011 Assessment of Annual Needs for 
ephedrine (for conversion) at 18,600 kg.

Conclusion

    In finalizing the 2011 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 2011 import, manufacturing and 
procurement quotas received after June 25, 2010. DEA urges registered 
importers and manufacturers to submit applications for 2011 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 2011 Assessment of Annual Needs for the List I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine for 2011, 
expressed in kilograms of anhydrous base:

------------------------------------------------------------------------
                                                           Proposed year
                                                               2011
                    List I chemicals                       assessment of
                                                           annual needs
                                                               (kg)
------------------------------------------------------------------------
Ephedrine (for sale)....................................           3,400
Phenylpropanolamine (for sale)..........................           4,700
Pseudoephedrine (for sale)..............................         190,000
Phenylpropanolamine (for conversion)....................           8,100
Ephedrine (for conversion)..............................          18,600
------------------------------------------------------------------------

    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

[[Page 55610]]

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 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: August 27, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-22688 Filed 9-10-10; 8:45 am]
BILLING CODE 4410-09-P