[Federal Register Volume 75, Number 123 (Monday, June 28, 2010)]
[Notices]
[Pages 36684-36689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15525]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-326R]


Proposed 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 proposed revised 2010 assessment of annual needs for 
the List I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

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SUMMARY: This notice proposes revised 2010 assessment of annual needs 
for the List I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: Written comments must be postmarked, and electronic comments 
must be sent, on or before July 28, 2010.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-326R'' 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, Washington, DC 20537, 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

[[Page 36685]]

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

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

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

    The 2010 Assessment of Annual Needs (AAN) 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.
    On November 20, 2009, DEA established the AAN for 2010 for the List 
I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine (74 FR 
60294). That Notice indicated that the Deputy Administrator of the DEA 
would adjust the AAN at a later date if necessary, as permitted by 21 
CFR 1315.13.
    DEA now proposes to revise the established assessments of annual 
needs for 2010 for these List 1 chemicals. In developing the proposed 
revisions, DEA has used the calculation methodology described in both 
the 2009 and 2010 AAN (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 revised 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 the date 
of drafting this notice, March 10, 2010, as well as the comments that 
DEA receives in response to this proposal.

Underlying Data and DEA's Analysis

    In determining the proposed revisions to 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 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 (for Sale) Data

                    Ephedrine (for Sale) Data for 2010 Assessment of Annual Needs (Kilograms)
----------------------------------------------------------------------------------------------------------------
                                                                                                         2010
                          Ephedrine                               2007         2008         2009       request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)...........................................        2,838        2,662        2,801        3,430
Imports ** (DEA 488)........................................        9,595        1,690        2,165        2,268
Export Declarations (DEA 486)...............................          168           18           64          n/a
Inventory * (DEA 250).......................................        1,428          626          191          n/a
IMS *** (NSP)...............................................        1,235        1,460        1,401          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 2009, Retail and Non-Retail
  Channels, Data Extracted March 10, 2010.


[[Page 36686]]

Ephedrine (for Sale) Analysis

    DEA previously has established the 2010 AAN for ephedrine (for 
sale) at 3,600 kg (74 FR 60298).
    As noted above, DEA developed the proposed revisions to the 2010 
AAN for ephedrine (for sale) using the same calculation and methodology 
that DEA used to determine the 2009 and 2010 AAN.
    As of March 10, 2010, DEA registered manufacturers of dosage form 
products containing ephedrine requested the authority to purchase a 
total of 3,430 kg ephedrine (for sale) in 2010. DEA registered 
manufacturers of ephedrine reported sales totaling approximately 2,662 
kg in 2008 and 2,801 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 (2,801 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 2,801 
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
2,801 + (50%*2,801) + 41 - 191 = 4,052 kg ephedrine (for sale) for 2010

    This calculation suggests that DEA's AAN for ephedrine should be 
4,100 kg. Accordingly, DEA is proposing to increase the 2010 AAN for 
ephedrine (for sale) from 3,600 kg to 4,100 kg.

Phenylpropanolamine (for Sale) data

               Phenylpropanolamine (for Sale) Data for 2010 Assessment of Annual Needs (Kilograms)
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                                                                                                         2010
               Phenylpropanolamine  (for sale)                    2007         2008         2009       request
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Sales * (DEA 250)...........................................        4,158        4,528        5,355        6,799
Imports ** (DEA 488)........................................        5,787        3,425        6,626        7,266
Export Declarations (DEA 486)...............................        1,002            0            3          n/a
Inventory * (DEA 250).......................................        3,642        2,470          645          n/a
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of March 10,
  2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.

Phenylpropanolamine (for Sale) Analysis

    DEA previously has established the 2010 AAN 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 AAN.
    As of March 10, 2010, DEA registered manufacturers of dosage form 
products containing phenylpropanolamine requested the authority to 
purchase 6,799 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 proposing to increase the 2010 AAN 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)
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                                                                                                         2010
                 Pseudoephedrine (for sale)                       2007         2008         2009       request
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Sales * (DEA 250)...........................................      239,121      223,813      287,756      239,646
Sales * (DEA 189)...........................................      100,300       64,781       33,600       32,760
Imports ** (DEA 488)........................................      231,683      170,614      274,492      261,528

[[Page 36687]]

 
Export Declarations (DEA 486)...............................       42,132       47,199       35,264          n/a
Inventory * (DEA 250).......................................      135,727      120,869       54,173          n/a
IMS *** (NSP)...............................................      180,221      149,227      140,269          n/a
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas
  (DEA 189) received as of March 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
*** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail
  Channels, Data Extracted March 10, 2010.

Pseudoephedrine (for Sale) Analysis

    DEA previously has established the 2010 AAN 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 
AAN.
    As of March 10, 2010, DEA registered manufacturers of dosage form 
products containing pseudoephedrine requested the authority to purchase 
239,646 kg pseudoephedrine. DEA registered manufacturers of 
pseudoephedrine reported sales totaling approximately 223,813 kg in 
2008 and 287,756 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 U.S. 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 144,748 kg. DEA thus believes that 
287,756 kg of sales reported by manufacturers fairly represents the 
U.S. sales of pseudoephedrine for 2010 and that 41,232 kg fairly 
represents the export requirements of pseudoephedrine. DEA notes that 
manufacturer reported sales for 2009 (287,756 kg) are higher than the 
average retail sales reported by IMS for the previous two years 
(144,748 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
287,756 + (50%*287,756) + 41,232 - 54,173 = 418,693 kg pseudoephedrine 
(for sale) for 2010.

    This calculation suggests that DEA's 2010 AAN for pseudoephedrine 
(for sale) should be 419,000 kg. Accordingly, DEA is proposing to 
increase the 2010 AAN for pseudoephedrine (for sale) from 404,000 kg to 
419,000 kg.

Phenylpropanolamine (for Conversion) Data

            Phenylpropanolamine (for conversion) Data for 2010 Assessment of Annual Needs (Kilograms)
----------------------------------------------------------------------------------------------------------------
                                                                                                         2010
               Phenylpropanolamine (for sale)                     2007         2008         2009       request
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Sales * (DEA 250)...........................................        3,621       10,837       14,585       19,142
Imports ** (DEA 488)........................................        8,250       12,019       11,373       33,698
Export Declarations (DEA 486)...............................            0            0            0          n/a
Inventory * (DEA 250).......................................        3,581        5,537        3,693          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 March 10,
  2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
*** Amphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.

Phenylpropanolamine (for Conversion) Analysis

    DEA previously has established the 2010 AAN for phenylpropanolamine 
(for conversion) at 16,500 kg (74 FR 60298). As noted above, DEA 
developed the proposed revisions to the 2010 AAN for 
phenylpropanolamine (for conversion) using the same calculation and 
methodology that DEA used to determine the 2009 and 2010 AAN.
    As of March 10, 2010, DEA registered manufacturers of 
phenylpropanolamine (for conversion) requested the authority to 
purchase a total of 19,142 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 represent 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 U.S. requirements for 2010 and zero kg 
fairly represents the export requirements of phenylpropanolamine (for 
conversion).
    Phenylpropanolamine (for conversion) is used for the manufacture of 
legitimate amphetamine products. DEA notes, most legitimate amphetamine 
is manufactured by the conversion of the schedule II controlled 
substance phenylacetone to amphetamine, rather than the conversion of 
phenylpropanolamine. DEA believes that the data provided in 
procurement, manufacturing, and import quota applications best 
represents the legitimate need for

[[Page 36688]]

phenylpropanolamine (for conversion) rather than total Aggregate 
Production Quota (APQ) for amphetamine.
    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 - 3,693 = 18,185 kg PPA (for conversion) 
for 2010

    This calculation suggests that DEA's 2010 AAN for 
phenylpropanolamine (for conversion) should be 18,200 kg. Accordingly, 
DEA is proposing to increase the 2010 AAN for phenylpropanolamine (for 
conversion) from 16,500 kg to 18,200 kg.

Ephedrine (for Conversion) Data

                 Ephedrine (for Conversion) Data for 2010 Assessment of Annual Needs (Kilograms)
----------------------------------------------------------------------------------------------------------------
                                                                                                         2010
                 Ephedrine (for conversion)                       2007         2008         2009       request
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Sales * (DEA 250)...........................................       99,622       64,522       40,403       40,600
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        3,130
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas
  (DEA 189) received as of March 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
*** Methamphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.

Ephedrine (for Conversion) Analysis

    DEA previously has established the 2010 AAN for ephedrine (for 
conversion) at 75,000 kg (74 FR 60298). As noted above, DEA developed 
the proposed revisions to the 2010 AAN for ephedrine (for conversion) 
using the same calculation and methodology that DEA used to determine 
the 2009 and 2010 AAN.
    As of March 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 Aggregate Production Quota (APQ) for methamphetamine. DEA 
determined that the estimated sales of pseudoephedrine, as referenced 
in the 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.
    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) - 254 = 11,785 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
11,785 + 63,157 = 74,942 kg ephedrine (for conversion) for 2010

    This calculation suggests that DEA's 2010 AAN for ephedrine (for 
conversion) should be 75,000 kg. Accordingly, DEA is proposing that the 
2010 AAN for ephedrine (for conversion) remain unchanged at 75,000 kg.

Conclusion

    In finalizing the revised 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 March 10, 2010, in 
accordance with 21 CFR part 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 revised 2010 AAN for the List I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine:

----------------------------------------------------------------------------------------------------------------
                                                                Previously  established
                       List I chemicals                              initial  2010        Proposed revised 2010
                                                                       assessment               assessment
----------------------------------------------------------------------------------------------------------------
Ephedrine (for sale)..........................................                 3,600 kg                 4,100 kg
Phenylpropanolamine (for sale)................................                 6,400 kg                 7,400 kg
Pseudoephedrine (for sale)....................................               404,000 kg               419,000 kg
Phenylpropanolamine (for conversion)..........................                16,500 kg                18,200 kg
Ephedrine (for conversion)....................................                75,000 kg                No Change
----------------------------------------------------------------------------------------------------------------


[[Page 36689]]

    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 AAN 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 
AAN 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: June 19, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-15525 Filed 6-25-10; 8:45 am]
BILLING CODE 4410-09-P