Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2010: Proposed, 47021-47026 [E9-22043]
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—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
—Evaluate the accuracy of the agencies’
estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
—Enhance the quality, utility, and
clarity of the information to be
collected; and
—Minimize the burden of the collection
of information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms
of information technology, e.g.,
permitting electronic submission of
responses.
Overview of This Information
Collection
(1) Type of Information Collection:
Extension of a currently approved
collection.
(2) Title of the Form/Collection:
Notification of Change of Mailing or
Premise Address.
(3) Agency form number, if any, and
the applicable component of the
Department of Justice sponsoring the
collection: Form Number: None. Bureau
of Alcohol, Tobacco, Firearms and
Explosives.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Not-for-profit
institutions. Other: Business or other
for-profit. Licensees and permittees
whose mailing address will change must
notify the Chief, Federal Explosives
Licensing Center, at least 10 days before
the change. The information is used by
ATF to identify correct locations of
storage of explosives licensees/
permittees and location of storage of
explosives materials for purposes of
inspection as well as to notify permitee/
licensees of any change in regulations or
laws that may affect their business
activities.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: It is estimated that 1,000
respondents will take 10 minutes to
respond via letter to the Federal
Explosives Licensing Center.
(6) An estimate of the total public
burden (in hours) associated with the
collection: There are an estimated 170
annual total burden hours associated
with this collection.
If additional information is required
contact: Lynn Bryant, Department
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Clearance Officer, Policy and Planning
Staff, Justice Management Division,
Department of Justice, Patrick Henry
Building, Suite 1600, 601 D Street, NW.,
Washington, DC 20530.
Dated: September 9, 2009.
Lynn Bryant,
Department Clearance Officer, PRA, U.S.
Department of Justice.
[FR Doc. E9–22042 Filed 9–11–09; 8:45 am]
BILLING CODE 4410–FY–P
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.
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
dea.diversion.policy@usdoj.gov.
However, persons wishing to request a
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47021
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,
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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
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)
Ephedrine
2007
Sales* (DEA 250) ............................................................................................................................
Imports** (DEA 488) ........................................................................................................................
Export Declarations (DEA 486) .......................................................................................................
Inventory* (DEA 250) .......................................................................................................................
IMS*** (NSP) ...................................................................................................................................
2008
1,509
1
168
714
1,235
1,988
3
91
421
1,460
2009
2,107
42
10
176
n/a
2010
Request
2,486
17
n/a
n/a
n/a
*Reported
sales and inventory from applications for 2010 procurement quotas (DEA 250)
imports from applications for 2010 import quotas (DEA 488)
Health, IMS National Sales PerspectivesTM, January 2007 to December 2008, Retail and Non-Retail Channels, Data Extracted August
**Reported
***IMS
4, 2009.
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
1 Applications and instructions for procurement,
import and manufacturing quotas can be found at
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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
https://www.deadiversion.usdoj.gov/quotas/
quota_apps.htm.
Ephedrine Analysis
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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 sale)
2007
Sales * (DEA 250) ............................................................................................................................
Imports ** (DEA 488) .......................................................................................................................
Export Declarations (DEA 486) .......................................................................................................
Inventory * (DEA 250) ......................................................................................................................
2008
3,674
73
1,002
3,498
2009
4,119
79
0
2,045
2010
Request
4,452
134
3
573
5,680
263
n/a
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]
Pseudoephedrine
(for sale)
2007
Sales * (DEA 250) ............................................................................................................
Sales * (DEA 189) ............................................................................................................
Imports ** (DEA 488) .......................................................................................................
Export Declarations (DEA 486) .......................................................................................
Inventory * (DEA 250) ......................................................................................................
IMS *** (NSP) ...................................................................................................................
2008
2009
204,028
100,300
44,499
42,142
132,838
180,172
179,566
64,781
60,300
85,757
114,795
149,110
236,650
33,600
147,002
18,974
61,613
n/a
2010
Request
196,912
32,760
78,884
n/a
n/a
n/a
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of
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.
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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
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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
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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 conversion)
2007
Sales * (DEA 250) ............................................................................................................................
Imports ** (DEA 488) .......................................................................................................................
Export Declarations (DEA 486) .......................................................................................................
Inventory * (DEA 250) ......................................................................................................................
APQ Amphetamine *** .....................................................................................................................
2008
2009
3,621
1,000
0
3,581
17,000
10,834
3,225
0
5,533
22,000
2010 Request
13,582
6,514
0
4,103
22,000
14,900
6,108
n/a
n/a
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 https://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]
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Ephedrine
(for conversion)
2007
Sales * (DEA 250) ............................................................................................................................
Imports ** (DEA 488) .......................................................................................................................
Inventory * (DEA 250) ......................................................................................................................
APQ Methamphetamine *** ..............................................................................................................
2008
2009
99,622
99,594
13
3,130
64,522
64,128
160
3,130
40,403
39,897
254
3,130
2010 Request
40,646
40,000
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.
*** Methamphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.htm.
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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:
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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:
List I Chemicals
Ephedrine (for sale) ..
Phenylpropanolamine
(for sale).
Pseudoephedrine (for
sale).
Phenylpropanolamine
(for conversion).
Ephedrine (for conversion).
Proposed Year 2010
Assessment of Annual Needs
3,100 kg.
6,100 kg.
346,000 kg.
16,500 kg.
75,000 kg.
Frm 00059
Fmt 4703
Sfmt 4703
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 abovementioned 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
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
PO 00000
47025
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
E:\FR\FM\14SEN1.SGM
14SEN1
47026
Federal Register / Vol. 74, No. 176 / Monday, September 14, 2009 / Notices
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 foreignbased 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
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
cprice-sewell on DSK2BSOYB1PROD with NOTICES
148th Meeting of the Advisory Council
on Employee Welfare and Pension
Benefit Plans; Notice of Meeting
11:30 a.m. to approximately 5:30 p.m.
The purpose of the open meeting is to
discuss reports/recommendations for
the Secretary of Labor on the issues of
(1) Stable Value Funds and Retirement
Security in the Current Economic
Conditions, (2) Promoting Retirement
Literacy and Security by Streamlining
Disclosures to Participants and
Beneficiaries, and (3) Approaches for
Retirement Security in the United
States. Descriptions of these topics are
available on the Advisory Council page
of the EBSA Web site at https://
www.dol.gov/ebsa/aboutebsa/
erisa_advisory_council.html.
Organizations or members of the
public wishing to submit a written
statement pertaining to the topic may do
so by submitting 30 copies on or before
September 22, 2009 to Larry Good,
Executive Secretary, ERISA Advisory
Council, U.S. Department of Labor,
Suite N–5623, 200 Constitution Avenue
NW., Washington, DC 20210.
Statements also may be submitted as email attachments in text or pdf format
transmitted to good.larry@dol.gov. It is
requested that statements not be
included in the body of the e-mail.
Statements received on or before
September 22, 2009 will be included in
the record of the meeting. Individuals or
representatives of organizations wishing
to address the Advisory Council should
forward their requests to the Executive
Secretary or telephone (202) 693–8668.
Oral presentations will be limited to 10
minutes, time permitting, but an
extended statement may be submitted
for the record. Individuals with
disabilities who need special
accommodations should contact Larry
Good by September 22 at the address
indicated.
Signed at Washington, DC, this 10th day of
September, 2009.
Michael L. Davis,
Deputy Assistant Secretary, Employee
Benefits Security Administration.
[FR Doc. E9–22108 Filed 9–11–09; 8:45 am]
BILLING CODE 4510–29–P
Pursuant to the authority contained in
Section 512 of the Employee Retirement
Income Security Act of 1974 (ERISA), 29
U.S.C. 1142, the Advisory Council on
Employee Welfare and Pension Benefit
Plans will hold a public teleconference
meeting on September 29, 2009.
The meeting will take place in Room
N3437 A–B, U.S. Department of Labor,
200 Constitution Avenue, NW.,
Washington, DC 20210. Public access is
available only in this room (i.e. not by
telephone). The meeting will run from
VerDate Nov<24>2008
15:23 Sep 11, 2009
Jkt 217001
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
[Docket Nos. OSHA–2005–022, OSHA–
2006–0028, OSHA–2006–0029, OSHA–2006–
0040, OSHA–2006–0042, OSHA–2007–0039,
OSHA–2007–0041, OSHA–2007–0042,
OSHA–2009–0025, OSHA–2009–0026,
OSHA–2009–0027]
Modifications to the Scope of NRTL
Recognition
AGENCY: Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Notice.
SUMMARY: This notice modifies the
scopes of recognition of several
Nationally Recognized Testing
Laboratories resulting from the
withdrawal of test standards by
standards-developing organizations.
DATES: Effective Date: The effective date
of this notice is September 14, 2009.
FOR FURTHER INFORMATION CONTACT:
MaryAnn Garrahan, Director, Office of
Technical Programs and Coordination
Activities, NRTL Program, Occupational
Safety and Health Administration, U.S.
Department of Labor, 200 Constitution
Avenue, NW., Room N–3655,
Washington, DC 20210; phone: (202)
693–2110.
SUPPLEMENTARY INFORMATION:
I. Notice of Modifications
In this notice, the Occupational Safety
and Health Administration (OSHA) is
modifying the scopes of recognition of
several Nationally Recognized Testing
Laboratories (NRTLs). Specifically, one
or more of the test standards that OSHA
currently includes in the scopes of
recognition of these NRTLs are no
longer ‘‘appropriate test standards’’
under 29 CFR 1910.07(c) because the
standards-developing organizations that
wrote and published the standards
withdrew the standards. Consequently,
OSHA is deleting the test standards
from the scope of recognition of each
affected NRTL. Section IV of this notice
(‘‘Modifications to Each NRTL’s Scope
of Recognition’’) identifies the affected
NRTLs.
To substitute other test standards for
the standards being removed, OSHA’s
policy permits NRTLs to request, or
OSHA to provide, recognition for
comparable test standards, i.e., other
appropriate test standards covering
comparable product testing. The table in
Section III (‘‘Withdrawn Test Standards
and Replacement Test Standards’’)
identifies the test standards removed
from the scopes of recognition of the
affected NRTL, under the heading
E:\FR\FM\14SEN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 176 (Monday, September 14, 2009)]
[Notices]
[Pages 47021-47026]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22043]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
dea.diversion.policy@usdoj.gov. 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\
---------------------------------------------------------------------------
\1\ Applications and instructions for procurement, import and
manufacturing quotas can be found at https://www.deadiversion.usdoj.gov/quotas/quota_apps.htm.
---------------------------------------------------------------------------
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 https://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 https://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
