Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2011: Proposed, 55605-55610 [2010-22688]
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Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices
Scope of Investigation: Having
considered the complaint, the U.S.
International Trade Commission, on
September 7, 2010, ordered that—
(1) Pursuant to subsection (b) of
section 337 of the Tariff Act of 1930, as
amended, an investigation be instituted
to determine whether there is a
violation of subsection (a)(1)(B) of
section 337 in the importation into the
United States, the sale for importation,
or the sale within the United States after
importation of certain flash memory
chips and products containing the same
that infringe one or more of claims 1–
7 of the ‘922 patent; claims 1–10 of the
‘124 patent; claims 1–14 of the ‘625
patent; and claims 1–4 of the ‘416
patent, and whether an industry in the
United States exists as required by
subsection (a)(2) of section 337;
(2) For the purpose of the
investigation so instituted, the following
are hereby named as parties upon which
this notice of investigation shall be
served:
(a) The complainant is: Spansion LLC,
915 DeGuigne Drive, P.O. Box 3453,
Sunnyvale, CA 94088.
(b) The respondents are the following
entities alleged to be in violation of
section 337, and are the parties upon
which the complaint is to be served:
Samsung Electronics Co., Ltd., 250,
Taepyeongno 2-ga, Jung-gu, Seoul
100–742, South Korea.
Samsung Electronics America, Inc., 105
Challenger Road, Ridgefield Park, NJ
07660.
Samsung International, Inc., 10220
Sorrento Valley Road, San Diego, CA
92121.
Samsung Semiconductor, Inc., 3655
North First Street, San Jose, CA
95134.
Samsung Telecommunications America,
LLC, 1301 E. Lookout Drive,
Richardson, TX 75082.
Apple, Inc., 1 Infinite Loop, Cupertino,
CA 95014.
Nokia Corp., Keilalahdentie 4, FIN 0045
Espoo, Finland.
Nokia Inc., 6000 Connection Drive,
Irving, TX 75039.
PNY Technologies, Inc., 299 Webro
Road, Parsippany, NJ 07054.
Research In Motion Ltd., 295 Phillip
Street, Waterloo, Ontario, Canada N2L
3W8.
Research In Motion Corporation, 122 W.
John Carpenter Parkway, Suite 430,
Irving, TX 75039.
Transcend Information Inc., No. 70,
XingZhong Rd., NeiHu District,
Taipei, Taiwan.
Transcend Information, Inc. (US), 1645
North Brian Street, Orange, CA 92867.
Transcend Information Inc. (Shanghai
Factory), 4F, Kaixuan City Industrial
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Park, No. 1010, Kaixuan Road,
Shanghai, China 200052.
(c) The Commission investigative
attorney, party to this investigation, is
Stephen R. Smith, Esq., Office of Unfair
Import Investigations, U.S. International
Trade Commission, 500 E Street, SW.,
Suite 401, Washington, DC 20436; and
(3) For the investigation so instituted,
the Honorable Paul J. Luckern, Chief
Administrative Law Judge, U.S.
International Trade Commission, shall
designate the presiding Administrative
Law Judge.
Responses to the complaint and the
notice of investigation must be
submitted by the named respondents in
accordance with section 210.13 of the
Commission’s Rules of Practice and
Procedure, 19 CFR 210.13. Pursuant to
19 CFR 201.16(d)–(e) and 210.13(a),
such responses will be considered by
the Commission if received not later
than 20 days after the date of service by
the Commission of the complaint and
the notice of investigation. Extensions of
time for submitting responses to the
complaint and the notice of
investigation will not be granted unless
good cause therefor is shown.
Failure of a respondent to file a timely
response to each allegation in the
complaint and in this notice may be
deemed to constitute a waiver of the
right to appear and contest the
allegations of the complaint and this
notice, and to authorize the
administrative law judge and the
Commission, without further notice to
the respondent, to find the facts to be as
alleged in the complaint and this notice
and to enter an initial determination
and a final determination containing
such findings, and may result in the
issuance of an exclusion order or a cease
and desist order or both directed against
the respondent.
By order of the Commission.
Marilyn R. Abbott,
Secretary to the Commission.
[FR Doc. 2010–22667 Filed 9–10–10; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–350P]
Assessment of Annual Needs for the
List I Chemicals Ephedrine,
Pseudoephedrine, and
Phenylpropanolamine for 2011:
Proposed
Drug Enforcement
Administration (DEA), Justice.
AGENCY:
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55605
Notice of proposed annual
assessment of needs for 2011.
ACTION:
This notice proposes the
initial year 2011 Assessment of Annual
Needs for certain List I chemicals in
accordance with the Combat
Methamphetamine Epidemic Act
(CMEA) of 2005. The CMEA requires
DEA to establish production quotas and
import quotas for ephedrine,
pseudoephedrine, and
phenylpropanolamine. The CMEA
places additional regulatory controls
upon the manufacture, distribution,
importation, and exportation of the
three List I chemicals.
DATES: Written comments must be
postmarked, and electronic comments
must be sent, on or before October 13,
2010.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–350P’’ on all written and
electronic correspondence. Written
comments being sent via regular mail
should be sent to the Deputy Assistant
Administrator, Office of Diversion
Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152, Attention:
DEA Federal Register Representative/
ODL. Written comments sent via
express mail should be sent to DEA
Headquarters, Attention: DEA Federal
Register Representative/ODL, 8701
Morrissette Drive, Springfield, Virginia
22152. Comments may be directly sent
to DEA electronically by sending an
electronic message to 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
Morrissette Drive, Springfield, Virginia
22152, Telephone: (202) 307–7183.
SUPPLEMENTARY INFORMATION: Section
713 of the CMEA of 2005 (Title VII of
Pub. L. 109–177) (CMEA) amended
§ 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
SUMMARY:
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substance in schedules I and II and for
ephedrine, pseudoephedrine, and
phenylpropanolamine to be
manufactured each calendar year to
provide for the estimated medical,
scientific, research, and industrial needs
of the United States, for lawful export
requirements, and for the establishment
and maintenance of reserve stocks.’’
Further, § 715 of CMEA amended 21
U.S.C. 952 ‘‘Importation of controlled
substances’’ by adding the same List I
chemicals to the existing language in
paragraph (a), and by adding a new
paragraph (d) to read as follows:
(a) Controlled substances in schedule
I or II and narcotic drugs in schedules
III, IV, or V; exceptions:
It shall be unlawful to import into the
customs territory of the United States from
any place outside thereof (but within the
United States), or to import into the United
States from any place outside thereof, any
controlled substance in schedule I or II of
subchapter I of this chapter, or any narcotic
drug in schedule III, IV, or V of subchapter
I of this chapter, or ephedrine,
pseudoephedrine, and
phenylpropanolamine, except that—
(1) such amounts of crude opium, poppy
straw, concentrate of poppy straw, and coca
leaves, and of ephedrine, pseudoephedrine,
and phenylpropanolamine, as the Attorney
General finds to be necessary to provide for
medical, scientific, or other legitimate
purposes * * *
may be so imported under such regulations
as the Attorney General shall prescribe.
*
*
*
*
*
(d)(1) With respect to a registrant under
section 958 who is authorized under
subsection (a)(1) to import ephedrine,
pseudoephedrine, or phenylpropanolamine,
at any time during the year the registrant may
apply for an increase in the amount of such
chemical that the registrant is authorized to
import, and the Attorney General may
approve the application if the Attorney
General determines that the approval is
necessary to provide for medical, scientific,
or other legitimate purposes regarding the
chemical.
Editor’s Note: This excerpt of the
amendment is published for the convenience
of the reader. The official text is published
at 21 U.S.C. 952(a) and (d)(1).
The proposed 2011 Assessment of
Annual Needs represents those
quantities of ephedrine,
pseudoephedrine, and
phenylpropanolamine which may be
manufactured domestically and/or
imported into the United States to
provide adequate supplies of each
substance to meet the estimated
medical, scientific, research, and
industrial needs of the United States;
lawful export requirements; and the
establishment and maintenance of
reserve stocks.
As of June 25, 2010, the DEA has
received a total of 99 applications for
2011 import, procurement and
manufacturing quotas for ephedrine,
pseudoephedrine, and
phenylpropanolamine. As a
comparison, for the 2010 quota year,
DEA has received 204 applications for
import, procurement, and
manufacturing quotas. DEA calculated
the 2011 Assessment of Annual Needs
for the List I chemicals using the
calculation methodology described in
both the 2009 and 2010 Assessment of
Annual Needs (74 FR 32954 and 74 FR
60294, respectively). These calculations
take into account the criteria that DEA
is required to consider in accordance
with 21 U.S.C. 826 and its
implementing regulations (21 CFR
1315.11).
In finalizing the assessments for these
List I chemicals, DEA will consider the
information contained in additional
applications for 2011 import,
manufacturing and procurement quotas
from DEA registered manufacturers and
importers that DEA receives after the
date of drafting this notice, June 25,
2010, as well as the comments that DEA
receives in response to this proposal.
DEA registered manufacturers and
importers are reminded that pursuant to
21 CFR 1315.22, 1315.32(e) and
1315.34(d) applications for import and
procurement quotas are due by April 1
and that applications for manufacturing
quotas are due by May 1 of the year
preceding the year for which the quota
is to be applied. DEA encourages
registrants to submit their quota
applications by the regulatory due dates
to ensure their requirements are
considered.
Underlying Data and DEA’s Analysis
In determining the proposed 2011
assessments, DEA has considered the
total net disposals (i.e. sales) of the List
I chemicals for the current and
preceding two years, actual and
estimated inventories, projected
demand (2011), industrial use, and
export requirements from data provided
by DEA registered manufacturers and
importers in procurement quota
applications (DEA 250), from
manufacturing quota applications (DEA
189), and from import quota
applications (DEA 488).1
DEA further considered trends as
derived from information provided in
applications for import, manufacturing,
and procurement quotas and in import
and in export declarations. DEA notes
that the inventory, acquisitions
(purchases) and disposition (sales) data
provided by DEA registered
manufacturers and importers reflects the
most current information available.
Ephedrine Data
EPHEDRINE (FOR SALE) DATA FOR 2011 ASSESSMENT OF ANNUAL NEEDS
[Kilograms]
Ephedrine
2008
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Sales* (DEA 250) ............................................................................................................................
Imports** (DEA 488) ........................................................................................................................
Export Declarations (DEA 486) .......................................................................................................
Inventory* (DEA 250) .......................................................................................................................
IMS*** (NSP) ...................................................................................................................................
2009
2,159
49
18
723
1,460
2,136
0
64
497
1,401
2010
2,416
87
52
315
n/a
2011
request
2,867
104
n/a
n/a
n/a
* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250).
** Reported imports from applications for 2011 import quotas (DEA 488).
*** IMS Health, IMS National Sales PerspectivesTM, January 2008 to December 2009, Retail and Non-Retail Channels, Data Extracted June
25, 2010.
1 Applications and instructions for procurement,
import and manufacturing quotas can be found at
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Ephedrine Analysis
DEA calculated the proposed 2011
Assessment of Annual Needs for
ephedrine using the calculation
developed to determine the 2009
Assessment of Annual Needs. This
calculation considers the criteria
defined in 21 U.S.C. 826: estimated
medical, scientific, research, and
industrial needs of the United States;
lawful export requirements; and the
establishment and maintenance of
reserve stocks.
As of June 25, 2010, DEA registered
manufacturers of dosage form products
containing ephedrine requested the
authority to purchase a total of 2,867 kg
ephedrine (for sale) in 2011. DEA
registered manufacturers of ephedrine
reported sales totaling approximately
2,136 kg in 2009 and 2,416 kg in 2010;
this represents a 12 percent increase in
sales reported by these firms from 2009
to 2010. Additionally, exports of
ephedrine products from the United
States as reported on export declarations
(DEA 486) totaled 64 kg in 2009 and 52
kg in 2010; this represents a 19 percent
decrease from levels observed in 2009.
The average of the 2009 and 2010
exports of ephedrine products is
approximately 58 kg. DEA also
considered information on trends in the
national rate of net disposals from sales
data provided by IMS Health’s NSP
database. IMS NSP data reported the
average sales volume of ephedrine for
the calendar years 2008 and 2009 to be
approximately 1,431 kg. DEA notes that
the 2010 sales figure reported by
manufacturers (2,416 kg) is higher than
the average sales reported by IMS for the
previous two years (1,431 kg). This is
expected because a manufacturer’s
reported sales include quantities which
are necessary to provide reserve stocks
for distributors and retailers. In
considering the manufacturer’s reported
sales, DEA thus believes that 2,416 kg
fairly represents the U.S. sales of
ephedrine for 2011 and that 58 kg fairly
represents the export requirements of
ephedrine.
For the establishment and
maintenance of reserve stocks, DEA
notes that 21 CFR 1315.24 allows for an
inventory allowance (reserve stock) of
50 percent of a manufacturer’s estimated
sales. DEA also considered the
estimated 2010 year end inventory as
reported by DEA registrants in
determining the inventory allowance.
DEA calculated the ephedrine (for
sale) assessment by the following
methodology:
2010 sales + reserve stock + export
requirement ¥ existing inventory = AAN
2,416 + (50%*2,416) + 58 ¥ 315 = 3,367 kg
ephedrine (for sale) for 2011.
This calculation suggests that DEA’s
Assessment of Annual Needs for
ephedrine should be proposed to be
3,400 kg. Accordingly, DEA is proposing
the 2011 Assessment of Annual Needs
for ephedrine (for sale) at 3,400 kg.
Phenylpropanolamine (for Sale) Data
PHENYLPROPANOLAMINE (FOR SALE) DATA FOR 2011 ASSESSMENT OF ANNUAL NEEDS
[Kilograms]
Phenylpropanolamine (for sale)
2008
Sales* (DEA 250) ............................................................................................................................
Imports** (DEA 488) ........................................................................................................................
Export Declarations (DEA 486) .......................................................................................................
Inventory* (DEA 250) .......................................................................................................................
2009
4,252
105
0
2,054
2011
request
2010
4,350
1,503
3
2,318
4,374
1,582
0
1,951
5,638
1,596
n/a
n/a
* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) received as of June 25, 2010.
** Reported imports from applications for 2011 import quotas (DEA 488) received as of June 25, 2010.
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Phenylpropanolamine (for Sale)
Analysis
DEA utilized the same general
methodology and calculation to
establish the assessment for
phenylpropanolamine (for sale) as was
described for the assessment of
ephedrine (for sale), above.
As of June 25, 2010, DEA registered
manufacturers of dosage form products
containing phenylpropanolamine
requested the authority to purchase
5,638 kg phenylpropanolamine (for sale)
in 2011. DEA registered manufacturers
of phenylpropanolamine reported sales
totaling approximately 4,350 kg in 2009
and 4,374 kg in 2010; this represents a
0.5 percent increase in sales reported by
these firms from 2009 to 2010.
Additionally, exports of
phenylpropanolamine products from
the U.S. as reported on export
declarations (DEA 486) totaled 3 kg in
2009 and 0 kg in 2010; this represents
a 3 kg decrease from levels observed in
2009. The average of the 2009 and 2010
exports of phenylpropanolamine
products is approximately 2 kg. DEA
thus believes that 4,374 kg fairly
represents the U.S. sales of
phenylpropanolamine for 2011 and that
2 kg fairly represents the export
requirements of phenylpropanolamine.
DEA notes that phenylpropanolamine is
sold primarily as a veterinary product
for the treatment for canine
incontinence and is not approved for
human consumption. IMS Health’s NSP
Data does not capture sales of
phenylpropanolamine to these channels
and is therefore not included.
DEA calculated the
phenylpropanolamine (for sale)
assessment by the following
methodology:
2010 sales + reserve stock + export
requirement ¥ existing inventory = AAN
4,374 + (50%*4,374) + 2 ¥ 1,951 = 4,612 kg
phenylpropanolamine (for sale) for 2011.
This calculation suggests that DEA’s
2011 Assessment of Annual Needs for
phenylpropanolamine (for sale) should
be proposed at 4,700 kg. Accordingly,
DEA is proposing the 2011 Assessment
of Annual Needs for
phenylpropanolamine (for sale) at
4,700 kg.
Pseudoephedrine (for Sale) Data
PSEUDOEPHEDRINE (FOR SALE) DATA FOR 2011 ASSESSMENT OF ANNUAL NEEDS
[Kilograms]
Pseudoephedrine (for sale)
2008
Sales * (DEA 250) ............................................................................................................
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2009
2010
169,992
145,853
148,934
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PSEUDOEPHEDRINE (FOR SALE) DATA FOR 2011 ASSESSMENT OF ANNUAL NEEDS—Continued
[Kilograms]
Pseudoephedrine (for sale)
2008
Sales * (DEA 189) ............................................................................................................
Imports ** (DEA 488) .......................................................................................................
Export Declarations (DEA 486) .......................................................................................
Inventory * (DEA 250) ......................................................................................................
IMS *** (NSP) ...................................................................................................................
2009
64,781
10,872
47,199
97,026
149,232
2010
7,321
39,168
35,264
72,070
140,784
5,550
44,030
8,480
55,323
n/a
2011
request
0
74,012
n/a
n/a
n/a
* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250).
** Reported imports from applications for 2011 import quotas (DEA 488).
*** IMS Health, IMS National Sales PerspectivesTM, January 2008 to December 2009, Retail. and Non-Retail Channels, Data Extracted June
25, 2010.
Pseudoephedrine (for Sale) Analysis
DEA utilized the same general
methodology and calculations to
establish the assessment for
pseudoephedrine (for sale) as were
described for the assessment of
ephedrine (for sale), above.
As of June 25, 2010, DEA registered
manufacturers of dosage form products
containing pseudoephedrine requested
the authority to purchase 181,219 kg
pseudoephedrine. DEA registered
manufacturers of pseudoephedrine
reported sales totaling approximately
145,853 kg in 2009 and 148,934 kg in
2010; this represents a 2 percent
increase in sales reported by these firms
from 2009 to 2010. During the same
period exports of pseudoephedrine
DEA calculated the pseudoephedrine
(for sale) assessment by the following
methodology:
products from the U.S. as reported on
export declarations (DEA 486) totaled
35,264 kg in 2009 and 8,480 kg in 2010;
this represents a 76 percent decrease
from levels observed in 2009. The
average of the 2009 and 2010 exports is
21,872 kg. Additionally, DEA
considered information on trends in the
national rate of net disposals from sales
data provided by IMS Health. IMS NSP
data reported the average retail sales
volume of pseudoephedrine for the
calendar years 2008 and 2009 to be
approximately 145,008 kg. DEA thus
believes that 148,934 kg of sales
reported by manufacturers fairly
represents the U.S. sales of
pseudoephedrine for 2011 and that
21,872 kg fairly represents the export
requirements of pseudoephedrine.
2010 sales + reserve stock + export
requirement ¥ existing inventory = AAN
148,934 + (50%*148,934) + 21,872 ¥ 55,323
= 189,950 kg pseudoephedrine (for sale)
for 2011
This calculation suggests that DEA’s
2011 Assessment of Annual Needs for
pseudoephedrine (for sale) should be
proposed at 190,000 kg. Accordingly,
DEA is proposing the 2011 Assessment
of Annual Needs for pseudoephedrine
(for sale) at 190,000 kg.
Phenylpropanolamine (for Conversion)
Data
PHENYLPROPANOLAMINE (FOR CONVERSION) DATA FOR 2011 ASSESSMENT OF ANNUAL NEEDS
[Kilograms]
Phenylpropanolamine
(for conversion)
2008
Sales * (DEA 250) ............................................................................................................
Imports ** (DEA 488) .......................................................................................................
Export Declarations (DEA 486) .......................................................................................
Inventory * (DEA 250) ......................................................................................................
2009
3,120
105
0
875
2010
4,415
1,503
0
503
5,855
1,582
0
713
2011
request
12,200
1,500
n/a
n/a
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* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) received as of June 25, 2010.
** Reported imports from applications for 2011 import quotas (DEA 488) received as of June 25, 2010.
Phenylpropanolamine (for Conversion)
Analysis
As of June 25, 2010, DEA registered
manufacturers of phenylpropanolamine
(for conversion) requested the authority
to purchase a total of 12,200 kg
phenylpropanolamine for the
manufacture of amphetamine. DEA
registered manufacturers of
phenylpropanolamine reported sales of
phenylpropanolamine totaling
approximately 4,415 kg in 2009 and
5,855 kg in 2010; this represents a 26
percent increase in sales reported by
these firms from 2009 to 2010. There
were no reported exports of
phenylpropanolamine (for conversion).
DEA has not received any requests to
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synthesize phenylpropanolamine in
2011. DEA has concluded that the 2010
sales of phenylpropanolamine (for
conversion), 5,855 kg, fairly represents
U.S. requirements for 2011 and zero kg
fairly represents the export
requirements of phenylpropanolamine
(for conversion).
DEA believes that the data provided
in procurement, manufacturing, and
import quota applications best
represents the legitimate need for
phenylpropanolamine (for conversion).
Phenylpropanolamine (for conversion)
is used for the manufacture of legitimate
amphetamine products, but DEA notes
that most legitimate amphetamine is
manufactured by converting
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phenylacetone rather than
phenylpropanolamine, to amphetamine.
Basing the phenylpropanolamine (for
conversion) calculation on the total
Aggregate Production Quota (APQ) for
amphetamine therefore would
inaccurately inflate the
phenylpropanolamine (for conversion)
assessment.
DEA calculated the
phenylpropanolamine (for conversion)
assessment for the manufacture of
amphetamine as follows:
(2010 sales) + reserve stock + export
requirement ¥ inventory = AAN (5,855)
+ (50%*5,855) + 0 ¥ 713 = 8,070 kg PPA
(for conversion) for 2011
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This calculation suggests that DEA’s
2011 Assessment of Annual Needs for
phenylpropanolamine (for conversion)
should be proposed at 8,100 kg.
Accordingly, DEA is proposing the 2011
Assessment of Annual Needs for
phenylpropanolamine (for conversion)
at 8,100 kg.
Ephedrine (for Conversion) Data
EPHEDRINE (FOR CONVERSION) DATA FOR 2011 ASSESSMENT OF ANNUAL NEEDS
[Kilograms]
Ephedrine
(for conversion)
2008
Sales * (DEA 250) ............................................................................................................
Imports ** (DEA 488) .......................................................................................................
Inventory * (DEA 250) ......................................................................................................
APQ Methamphetamine *** ..............................................................................................
2009
64,665
0
233
3,130
9,316
0
99
3,130
2011
request
2010
6,057
0
152
3,130
287
0
n/a
n/a
* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of
June 25, 2010.
** Reported imports from applications for 2011 import quotas (DEA 488) received as of June 25, 2010.
*** Methamphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.
mstockstill on DSKB9S0YB1PROD with NOTICES
Ephedrine (for Conversion) Analysis
As of June 25, 2010, DEA registered
manufacturers of ephedrine (for
conversion) requested the authority to
purchase a total of 287 kg ephedrine (for
conversion) for the manufacture of two
substances: Methamphetamine and
pseudoephedrine.
DEA considered the ephedrine (for
conversion) requirements for the
manufacture of methamphetamine and
pseudoephedrine. DEA has determined
that the established assessments for the
manufacture of these two substances are
the best indicators of the need for
ephedrine (for conversion). The
assessment of need for
methamphetamine was determined by
DEA as the Aggregate Production Quota
(APQ) for methamphetamine. DEA
determined that the estimated sale of
pseudoephedrine, as referenced in the
proposed Assessment of Annual Needs
(AAN) for pseudoephedrine, represents
the need for pseudoephedrine. Reported
sales of ephedrine (for conversion) are
included as reference to DEA’s
methodology.
DEA further considered the reported
conversion yields of these substances.
DEA registered manufacturers reported
a conversion yield of 39 percent for the
synthesis of methamphetamine from
ephedrine. DEA cannot disclose the
conversion yield for the synthesis of
pseudoephedrine because this
information is proprietary to the one
manufacturer involved in this type of
manufacturing.
DEA calculated the ephedrine (for
conversion) assessment by the following
methodology:
methamphetamine requirement +
pseudoephedrine requirement = AAN
DEA calculated the ephedrine (for
conversion) requirement for the
manufacture of methamphetamine as
follows:
VerDate Mar<15>2010
17:21 Sep 10, 2010
Jkt 220001
(2010 APQ methamphetamine/39 percent
yield) + reserve stock ¥ inventory =
ephedrine (for manufacture of
methamphetamine)
(3,130/39 percent yield) + 50 percent*(3,130/
39 percent yield) ¥ 152 = 11,887 kg
The calculation for the ephedrine (for
conversion) requirement for the manufacture
of pseudoephedrine leads to a result of 6,703
kg. DEA cannot provide the details of the
calculation because this would reveal the
conversion yield for the synthesis of
pseudoephedrine, which is proprietary to the
one manufacturer involved in this type of
manufacturing. Therefore, the assessment for
ephedrine was determined by the sum total
of the ephedrine (for conversion)
requirements as described by the following
methodology:
Therefore, under the authority vested
in the Attorney General by Section 306
of the CSA (21 U.S.C. 826), and
delegated to the Administrator of the
DEA by 28 CFR 0.100, and redelegated
to the Deputy Administrator pursuant to
28 CFR 0.104, the Deputy Administrator
hereby proposes the following 2011
Assessment of Annual Needs for the List
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine for 2011,
expressed in kilograms of anhydrous
base:
methamphetamine requirement +
pseudoephedrine requirement =
AAN 11,887 + 6,703 = 18,590 kg
ephedrine (for conversion) for 2011
Ephedrine (for sale) ..............
Phenylpropanolamine (for
sale) ..................................
Pseudoephedrine (for sale) ..
Phenylpropanolamine (for
conversion) ........................
Ephedrine (for conversion) ...
This calculation suggests that DEA’s
2011 Assessment of Annual Needs for
ephedrine (for conversion) should be
proposed at 18,600 kg. Accordingly,
DEA is proposing the 2011 Assessment
of Annual Needs for ephedrine (for
conversion) at 18,600 kg.
Conclusion
In finalizing the 2011 assessments for
these List I chemicals, DEA will use the
methodology and calculations presented
above. The numbers used in the
calculations may be adjusted upwards
or downwards based on the additional
applications for 2011 import,
manufacturing and procurement quotas
received after June 25, 2010. DEA urges
registered importers and manufacturers
to submit applications for 2011 import,
manufacturing and procurement quota
so that DEA may include information
from those applications when finalizing
these assessments in accordance with 21
CFR 1315.
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
List I chemicals
Proposed year
2011 assessment of annual
needs (kg)
3,400
4,700
190,000
8,100
18,600
Ephedrine (for conversion) refers to
the industrial use of ephedrine, i.e., that
which will be converted to another
basic drug class such as
pseudoephedrine or methamphetamine
used for the manufacture of prescription
weight loss drug. Phenylpropanolamine
(for conversion) refers to the industrial
use of phenylpropanolamine, i.e., that
which will be converted to another
basic drug class such as amphetamine
for the manufacture of drug products.
The ‘‘for sale’’ assessments refer to the
amount of ephedrine, pseudoephedrine,
and phenylpropanolamine intended for
ultimate use in products containing
these List I chemicals.
All interested persons are invited to
submit their comments in writing or
electronically regarding this proposal
following the procedures in the
ADDRESSES section of this document. A
person may object to or comment on the
E:\FR\FM\13SEN1.SGM
13SEN1
55610
Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices
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
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.
mstockstill on DSKB9S0YB1PROD with NOTICES
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.
VerDate Mar<15>2010
17:21 Sep 10, 2010
Jkt 220001
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: August 27, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010–22688 Filed 9–10–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
[Docket No. OSHA–2010–0028]
Advisory Committee on Construction
Safety and Health (ACCSH)
Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Request for nominations of
members to serve on ACCSH.
AGENCY:
The Assistant Secretary of
Labor for Occupational Safety and
Health (OSHA) invites interested parties
to submit nominations for membership
on ACCSH.
DATES: Nominations for ACCSH must be
submitted (postmarked, sent,
transmitted, or received) by November
12, 2010.
ADDRESSES: You may submit
nominations and supporting materials
by any one of the following methods:
Electronically: Nominations,
including attachments, may be
submitted electronically at https://
www.regulations.gov, the Federal eRulemaking Portal. Follow the online
instructions for submitting nominations;
SUMMARY:
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Facsimile: If your nomination and
supporting materials, including
attachments, do not exceed 10 pages,
you may fax them to the OSHA Docket
Office at (202) 693–1648;
Mail, express delivery, hand delivery,
and messenger or courier service:
Submit your nominations and
supporting materials to the OSHA
Docket Office, Docket No. OSHA–2010–
0028, Room N–2625, U.S. Department of
Labor, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone (202)
693–2350 TTY number (877) 889–5627.
Deliveries by hand, express mail,
messenger, and courier service are
accepted during the OSHA Docket
Office’s normal business hours, 8:15
a.m.–4:45 p.m., e.t.
Instructions: All nominations and
supporting materials must include the
agency name and docket number for this
Federal Register notice (Docket No.
OSHA–2010–0028). Because of securityrelated procedures, submitting
nominations by regular mail may result
in a significant delay in their receipt.
Please contact the OSHA Docket Office
for information about security
procedures for submitting nominations
by hand delivery, express delivery, and
messenger or courier service. For
additional information on submitting
nominations, see the ‘‘Public
Participation’’ heading in the
SUPPLEMENTARY INFORMATION section
below.
All submissions in response to this
Federal Register notice, including
personal information provided, are
posted without change at https://
www.regulations.gov. Therefore, OSHA
cautions interested parties about
submitting personal information such as
Social Security numbers and birthdates.
Docket: To read or download
submissions in response to this Federal
Register notice, go to Docket No.
OSHA–2010–0028 at https://
www.regulations.gov. All documents in
the docket are listed in the https://
www.regulations.gov index; however,
some documents (e.g., copyrighted
material) are not publicly available to
read or download through that webpage.
All submissions, including copyrighted
material, are available for inspection
and copying at the OSHA Docket Office.
FOR ADDITIONAL INFORMATION:
For press inquiries: Ms. MaryAnn
Garrahan, Acting Director, OSHA, Office
of Communications, Room N–3647, U.S.
Department of Labor, 200 Constitution
Avenue, NW., Washington, DC 20210;
telephone (202) 693–1999.
For general information: Mr. Francis
Dougherty, OSHA, Office of
Construction Services, Directorate of
E:\FR\FM\13SEN1.SGM
13SEN1
]]>Agencies
[Federal Register Volume 75, Number 176 (Monday, September 13, 2010)]
[Notices]
[Pages 55605-55610]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22688]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-350P]
Assessment of Annual Needs for the List I Chemicals Ephedrine,
Pseudoephedrine, and Phenylpropanolamine for 2011: Proposed
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed annual assessment of needs for 2011.
-----------------------------------------------------------------------
SUMMARY: This notice proposes the initial year 2011 Assessment of
Annual Needs for certain List I chemicals in accordance with the Combat
Methamphetamine Epidemic Act (CMEA) of 2005. The CMEA requires DEA to
establish production quotas and import quotas for ephedrine,
pseudoephedrine, and phenylpropanolamine. The CMEA places additional
regulatory controls upon the manufacture, distribution, importation,
and exportation of the three List I chemicals.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before October 13, 2010.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-350P'' on all written and electronic correspondence.
Written comments being sent via regular mail should be sent to the
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration, 8701 Morrissette Drive, Springfield,
Virginia 22152, Attention: DEA Federal Register Representative/ODL.
Written comments sent via express mail should be sent to DEA
Headquarters, Attention: DEA Federal Register Representative/ODL, 8701
Morrissette Drive, Springfield, Virginia 22152. Comments may be
directly sent to DEA electronically by sending an electronic message to
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 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202)
307-7183.
SUPPLEMENTARY INFORMATION: Section 713 of the CMEA of 2005 (Title VII
of Pub. L. 109-177) (CMEA) amended Sec. 306 of the Controlled
Substances Act (CSA) (21 U.S.C. 826) by adding ephedrine,
pseudoephedrine, and phenylpropanolamine to existing language to read
as follows: ``The Attorney General shall determine the total quantity
and establish production quotas for each basic class of controlled
[[Page 55606]]
substance in schedules I and II and for ephedrine, pseudoephedrine, and
phenylpropanolamine to be manufactured each calendar year to provide
for the estimated medical, scientific, research, and industrial needs
of the United States, for lawful export requirements, and for the
establishment and maintenance of reserve stocks.'' Further, Sec. 715
of CMEA amended 21 U.S.C. 952 ``Importation of controlled substances''
by adding the same List I chemicals to the existing language in
paragraph (a), and by adding a new paragraph (d) to read as follows:
(a) Controlled substances in schedule I or II and narcotic drugs in
schedules III, IV, or V; exceptions:
It shall be unlawful to import into the customs territory of the
United States from any place outside thereof (but within the United
States), or to import into the United States from any place outside
thereof, any controlled substance in schedule I or II of subchapter
I of this chapter, or any narcotic drug in schedule III, IV, or V of
subchapter I of this chapter, or ephedrine, pseudoephedrine, and
phenylpropanolamine, except that--
(1) such amounts of crude opium, poppy straw, concentrate of
poppy straw, and coca leaves, and of ephedrine, pseudoephedrine, and
phenylpropanolamine, as the Attorney General finds to be necessary
to provide for medical, scientific, or other legitimate purposes * *
*
may be so imported under such regulations as the Attorney
General shall prescribe.
* * * * *
(d)(1) With respect to a registrant under section 958 who is
authorized under subsection (a)(1) to import ephedrine,
pseudoephedrine, or phenylpropanolamine, at any time during the year
the registrant may apply for an increase in the amount of such
chemical that the registrant is authorized to import, and the
Attorney General may approve the application if the Attorney General
determines that the approval is necessary to provide for medical,
scientific, or other legitimate purposes regarding the chemical.
Editor's Note: This excerpt of the amendment is published for
the convenience of the reader. The official text is published at 21
U.S.C. 952(a) and (d)(1).
The proposed 2011 Assessment of Annual Needs represents those
quantities of ephedrine, pseudoephedrine, and phenylpropanolamine which
may be manufactured domestically and/or imported into the United States
to provide adequate supplies of each substance to meet the estimated
medical, scientific, research, and industrial needs of the United
States; lawful export requirements; and the establishment and
maintenance of reserve stocks.
As of June 25, 2010, the DEA has received a total of 99
applications for 2011 import, procurement and manufacturing quotas for
ephedrine, pseudoephedrine, and phenylpropanolamine. As a comparison,
for the 2010 quota year, DEA has received 204 applications for import,
procurement, and manufacturing quotas. DEA calculated the 2011
Assessment of Annual Needs for the List I chemicals using the
calculation methodology described in both the 2009 and 2010 Assessment
of Annual Needs (74 FR 32954 and 74 FR 60294, respectively). These
calculations take into account the criteria that DEA is required to
consider in accordance with 21 U.S.C. 826 and its implementing
regulations (21 CFR 1315.11).
In finalizing the assessments for these List I chemicals, DEA will
consider the information contained in additional applications for 2011
import, manufacturing and procurement quotas from DEA registered
manufacturers and importers that DEA receives after the date of
drafting this notice, June 25, 2010, as well as the comments that DEA
receives in response to this proposal. DEA registered manufacturers and
importers are reminded that pursuant to 21 CFR 1315.22, 1315.32(e) and
1315.34(d) applications for import and procurement quotas are due by
April 1 and that applications for manufacturing quotas are due by May 1
of the year preceding the year for which the quota is to be applied.
DEA encourages registrants to submit their quota applications by the
regulatory due dates to ensure their requirements are considered.
Underlying Data and DEA's Analysis
In determining the proposed 2011 assessments, DEA has considered
the total net disposals (i.e. sales) of the List I chemicals for the
current and preceding two years, actual and estimated inventories,
projected demand (2011), industrial use, and export requirements from
data provided by DEA registered manufacturers and importers in
procurement quota applications (DEA 250), from manufacturing quota
applications (DEA 189), and from import quota applications (DEA
488).\1\
---------------------------------------------------------------------------
\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 in export declarations. DEA notes that the inventory,
acquisitions (purchases) and disposition (sales) data provided by DEA
registered manufacturers and importers reflects the most current
information available.
Ephedrine Data
Ephedrine (for Sale) Data for 2011 Assessment of Annual Needs
[Kilograms]
------------------------------------------------------------------------
2011
Ephedrine 2008 2009 2010 request
------------------------------------------------------------------------
Sales* (DEA 250)............ 2,159 2,136 2,416 2,867
Imports** (DEA 488)......... 49 0 87 104
Export Declarations (DEA 18 64 52 n/a
486).......................
Inventory* (DEA 250)........ 723 497 315 n/a
IMS*** (NSP)................ 1,460 1,401 n/a n/a
------------------------------------------------------------------------
* Reported sales and inventory from applications for 2011 procurement
quotas (DEA 250).
** Reported imports from applications for 2011 import quotas (DEA 488).
*** IMS Health, IMS National Sales PerspectivesTM, January 2008 to
December 2009, Retail and Non-Retail Channels, Data Extracted June 25,
2010.
[[Page 55607]]
Ephedrine Analysis
DEA calculated the proposed 2011 Assessment of Annual Needs for
ephedrine using the calculation developed to determine the 2009
Assessment of Annual Needs. This calculation considers the criteria
defined in 21 U.S.C. 826: estimated medical, scientific, research, and
industrial needs of the United States; lawful export requirements; and
the establishment and maintenance of reserve stocks.
As of June 25, 2010, DEA registered manufacturers of dosage form
products containing ephedrine requested the authority to purchase a
total of 2,867 kg ephedrine (for sale) in 2011. DEA registered
manufacturers of ephedrine reported sales totaling approximately 2,136
kg in 2009 and 2,416 kg in 2010; this represents a 12 percent increase
in sales reported by these firms from 2009 to 2010. Additionally,
exports of ephedrine products from the United States as reported on
export declarations (DEA 486) totaled 64 kg in 2009 and 52 kg in 2010;
this represents a 19 percent decrease from levels observed in 2009. The
average of the 2009 and 2010 exports of ephedrine products is
approximately 58 kg. DEA also considered information on trends in the
national rate of net disposals from sales data provided by IMS Health's
NSP database. IMS NSP data reported the average sales volume of
ephedrine for the calendar years 2008 and 2009 to be approximately
1,431 kg. DEA notes that the 2010 sales figure reported by
manufacturers (2,416 kg) is higher than the average sales reported by
IMS for the previous two years (1,431 kg). This is expected because a
manufacturer's reported sales include quantities which are necessary to
provide reserve stocks for distributors and retailers. In considering
the manufacturer's reported sales, DEA thus believes that 2,416 kg
fairly represents the U.S. sales of ephedrine for 2011 and that 58 kg
fairly represents the export requirements of ephedrine.
For the establishment and maintenance of reserve stocks, DEA notes
that 21 CFR 1315.24 allows for an inventory allowance (reserve stock)
of 50 percent of a manufacturer's estimated sales. DEA also considered
the estimated 2010 year end inventory as reported by DEA registrants in
determining the inventory allowance.
DEA calculated the ephedrine (for sale) assessment by the following
methodology:
2010 sales + reserve stock + export requirement - existing inventory
= AAN 2,416 + (50%*2,416) + 58 - 315 = 3,367 kg ephedrine (for sale)
for 2011.
This calculation suggests that DEA's Assessment of Annual Needs for
ephedrine should be proposed to be 3,400 kg. Accordingly, DEA is
proposing the 2011 Assessment of Annual Needs for ephedrine (for sale)
at 3,400 kg.
Phenylpropanolamine (for Sale) Data
Phenylpropanolamine (for Sale) Data for 2011 Assessment of Annual Needs
[Kilograms]
------------------------------------------------------------------------
Phenylpropanolamine (for 2011
sale) 2008 2009 2010 request
------------------------------------------------------------------------
Sales* (DEA 250)............ 4,252 4,350 4,374 5,638
Imports** (DEA 488)......... 105 1,503 1,582 1,596
Export Declarations (DEA 0 3 0 n/a
486).......................
Inventory* (DEA 250)........ 2,054 2,318 1,951 n/a
------------------------------------------------------------------------
* Reported sales and inventory from applications for 2011 procurement
quotas (DEA 250) received as of June 25, 2010.
** Reported imports from applications for 2011 import quotas (DEA 488)
received as of June 25, 2010.
Phenylpropanolamine (for Sale) Analysis
DEA utilized the same general methodology and calculation to
establish the assessment for phenylpropanolamine (for sale) as was
described for the assessment of ephedrine (for sale), above.
As of June 25, 2010, DEA registered manufacturers of dosage form
products containing phenylpropanolamine requested the authority to
purchase 5,638 kg phenylpropanolamine (for sale) in 2011. DEA
registered manufacturers of phenylpropanolamine reported sales totaling
approximately 4,350 kg in 2009 and 4,374 kg in 2010; this represents a
0.5 percent increase in sales reported by these firms from 2009 to
2010. Additionally, exports of phenylpropanolamine products from the
U.S. as reported on export declarations (DEA 486) totaled 3 kg in 2009
and 0 kg in 2010; this represents a 3 kg decrease from levels observed
in 2009. The average of the 2009 and 2010 exports of
phenylpropanolamine products is approximately 2 kg. DEA thus believes
that 4,374 kg fairly represents the U.S. sales of phenylpropanolamine
for 2011 and that 2 kg fairly represents the export requirements of
phenylpropanolamine. DEA notes that phenylpropanolamine is sold
primarily as a veterinary product for the treatment for canine
incontinence and is not approved for human consumption. IMS Health's
NSP Data does not capture sales of phenylpropanolamine to these
channels and is therefore not included.
DEA calculated the phenylpropanolamine (for sale) assessment by the
following methodology:
2010 sales + reserve stock + export requirement - existing inventory
= AAN
4,374 + (50%*4,374) + 2 - 1,951 = 4,612 kg phenylpropanolamine (for
sale) for 2011.
This calculation suggests that DEA's 2011 Assessment of Annual
Needs for phenylpropanolamine (for sale) should be proposed at 4,700
kg. Accordingly, DEA is proposing the 2011 Assessment of Annual Needs
for phenylpropanolamine (for sale) at 4,700 kg.
Pseudoephedrine (for Sale) Data
Pseudoephedrine (for Sale) Data for 2011 Assessment of Annual Needs
[Kilograms]
----------------------------------------------------------------------------------------------------------------
2011
Pseudoephedrine (for sale) 2008 2009 2010 request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)........................................... 169,992 145,853 148,934 181,219
[[Page 55608]]
Sales * (DEA 189)........................................... 64,781 7,321 5,550 0
Imports ** (DEA 488)........................................ 10,872 39,168 44,030 74,012
Export Declarations (DEA 486)............................... 47,199 35,264 8,480 n/a
Inventory * (DEA 250)....................................... 97,026 72,070 55,323 n/a
IMS *** (NSP)............................................... 149,232 140,784 n/a n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250).
** Reported imports from applications for 2011 import quotas (DEA 488).
*** IMS Health, IMS National Sales PerspectivesTM, January 2008 to December 2009, Retail. and Non-Retail
Channels, Data Extracted June 25, 2010.
Pseudoephedrine (for Sale) Analysis
DEA utilized the same general methodology and calculations to
establish the assessment for pseudoephedrine (for sale) as were
described for the assessment of ephedrine (for sale), above.
As of June 25, 2010, DEA registered manufacturers of dosage form
products containing pseudoephedrine requested the authority to purchase
181,219 kg pseudoephedrine. DEA registered manufacturers of
pseudoephedrine reported sales totaling approximately 145,853 kg in
2009 and 148,934 kg in 2010; this represents a 2 percent increase in
sales reported by these firms from 2009 to 2010. During the same period
exports of pseudoephedrine products from the U.S. as reported on export
declarations (DEA 486) totaled 35,264 kg in 2009 and 8,480 kg in 2010;
this represents a 76 percent decrease from levels observed in 2009. The
average of the 2009 and 2010 exports is 21,872 kg. Additionally, DEA
considered information on trends in the national rate of net disposals
from sales data provided by IMS Health. IMS NSP data reported the
average retail sales volume of pseudoephedrine for the calendar years
2008 and 2009 to be approximately 145,008 kg. DEA thus believes that
148,934 kg of sales reported by manufacturers fairly represents the
U.S. sales of pseudoephedrine for 2011 and that 21,872 kg fairly
represents the export requirements of pseudoephedrine.
DEA calculated the pseudoephedrine (for sale) assessment by the
following methodology:
2010 sales + reserve stock + export requirement - existing inventory
= AAN
148,934 + (50%*148,934) + 21,872 - 55,323 = 189,950 kg
pseudoephedrine (for sale) for 2011
This calculation suggests that DEA's 2011 Assessment of Annual
Needs for pseudoephedrine (for sale) should be proposed at 190,000 kg.
Accordingly, DEA is proposing the 2011 Assessment of Annual Needs for
pseudoephedrine (for sale) at 190,000 kg.
Phenylpropanolamine (for Conversion) Data
Phenylpropanolamine (for Conversion) Data for 2011 Assessment of Annual Needs
[Kilograms]
----------------------------------------------------------------------------------------------------------------
2011
Phenylpropanolamine (for conversion) 2008 2009 2010 request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)........................................... 3,120 4,415 5,855 12,200
Imports ** (DEA 488)........................................ 105 1,503 1,582 1,500
Export Declarations (DEA 486)............................... 0 0 0 n/a
Inventory * (DEA 250)....................................... 875 503 713 n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) received as of June 25,
2010.
** Reported imports from applications for 2011 import quotas (DEA 488) received as of June 25, 2010.
Phenylpropanolamine (for Conversion) Analysis
As of June 25, 2010, DEA registered manufacturers of
phenylpropanolamine (for conversion) requested the authority to
purchase a total of 12,200 kg phenylpropanolamine for the manufacture
of amphetamine. DEA registered manufacturers of phenylpropanolamine
reported sales of phenylpropanolamine totaling approximately 4,415 kg
in 2009 and 5,855 kg in 2010; this represents a 26 percent increase in
sales reported by these firms from 2009 to 2010. There were no reported
exports of phenylpropanolamine (for conversion). DEA has not received
any requests to synthesize phenylpropanolamine in 2011. DEA has
concluded that the 2010 sales of phenylpropanolamine (for conversion),
5,855 kg, fairly represents U.S. requirements for 2011 and zero kg
fairly represents the export requirements of phenylpropanolamine (for
conversion).
DEA believes that the data provided in procurement, manufacturing,
and import quota applications best represents the legitimate need for
phenylpropanolamine (for conversion). Phenylpropanolamine (for
conversion) is used for the manufacture of legitimate amphetamine
products, but DEA notes that most legitimate amphetamine is
manufactured by converting phenylacetone rather than
phenylpropanolamine, to amphetamine. Basing the phenylpropanolamine
(for conversion) calculation on the total Aggregate Production Quota
(APQ) for amphetamine therefore would inaccurately inflate the
phenylpropanolamine (for conversion) assessment.
DEA calculated the phenylpropanolamine (for conversion) assessment
for the manufacture of amphetamine as follows:
(2010 sales) + reserve stock + export requirement - inventory = AAN
(5,855) + (50%*5,855) + 0 - 713 = 8,070 kg PPA (for conversion) for
2011
[[Page 55609]]
This calculation suggests that DEA's 2011 Assessment of Annual
Needs for phenylpropanolamine (for conversion) should be proposed at
8,100 kg. Accordingly, DEA is proposing the 2011 Assessment of Annual
Needs for phenylpropanolamine (for conversion) at 8,100 kg.
Ephedrine (for Conversion) Data
Ephedrine (for Conversion) Data for 2011 Assessment of Annual Needs
[Kilograms]
----------------------------------------------------------------------------------------------------------------
2011
Ephedrine (for conversion) 2008 2009 2010 request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)........................................... 64,665 9,316 6,057 287
Imports ** (DEA 488)........................................ 0 0 0 0
Inventory * (DEA 250)....................................... 233 99 152 n/a
APQ Methamphetamine ***..................................... 3,130 3,130 3,130 n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) and manufacturing quotas
(DEA 189) received as of June 25, 2010.
** Reported imports from applications for 2011 import quotas (DEA 488) received as of June 25, 2010.
*** Methamphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.
Ephedrine (for Conversion) Analysis
As of June 25, 2010, DEA registered manufacturers of ephedrine (for
conversion) requested the authority to purchase a total of 287 kg
ephedrine (for conversion) for the manufacture of two substances:
Methamphetamine and pseudoephedrine.
DEA considered the ephedrine (for conversion) requirements for the
manufacture of methamphetamine and pseudoephedrine. DEA has determined
that the established assessments for the manufacture of these two
substances are the best indicators of the need for ephedrine (for
conversion). The assessment of need for methamphetamine was determined
by DEA as the Aggregate Production Quota (APQ) for methamphetamine. DEA
determined that the estimated sale of pseudoephedrine, as referenced in
the proposed Assessment of Annual Needs (AAN) for pseudoephedrine,
represents the need for pseudoephedrine. Reported sales of ephedrine
(for conversion) are included as reference to DEA's methodology.
DEA further considered the reported conversion yields of these
substances. DEA registered manufacturers reported a conversion yield of
39 percent for the synthesis of methamphetamine from ephedrine. DEA
cannot disclose the conversion yield for the synthesis of
pseudoephedrine because this information is proprietary to the one
manufacturer involved in this type of manufacturing.
DEA calculated the ephedrine (for conversion) assessment by the
following methodology:
methamphetamine requirement + pseudoephedrine requirement = AAN
DEA calculated the ephedrine (for conversion) requirement for the
manufacture of methamphetamine as follows:
(2010 APQ methamphetamine/39 percent yield) + reserve stock -
inventory = ephedrine (for manufacture of methamphetamine)
(3,130/39 percent yield) + 50 percent*(3,130/39 percent yield) - 152
= 11,887 kg
The calculation for the ephedrine (for conversion) requirement
for the manufacture of pseudoephedrine leads to a result of 6,703
kg. DEA cannot provide the details of the calculation because this
would reveal the conversion yield for the synthesis of
pseudoephedrine, which is proprietary to the one manufacturer
involved in this type of manufacturing. Therefore, the assessment
for ephedrine was determined by the sum total of the ephedrine (for
conversion) requirements as described by the following methodology:
methamphetamine requirement + pseudoephedrine requirement = AAN 11,887
+ 6,703 = 18,590 kg ephedrine (for conversion) for 2011
This calculation suggests that DEA's 2011 Assessment of Annual
Needs for ephedrine (for conversion) should be proposed at 18,600 kg.
Accordingly, DEA is proposing the 2011 Assessment of Annual Needs for
ephedrine (for conversion) at 18,600 kg.
Conclusion
In finalizing the 2011 assessments for these List I chemicals, DEA
will use the methodology and calculations presented above. The numbers
used in the calculations may be adjusted upwards or downwards based on
the additional applications for 2011 import, manufacturing and
procurement quotas received after June 25, 2010. DEA urges registered
importers and manufacturers to submit applications for 2011 import,
manufacturing and procurement quota so that DEA may include information
from those applications when finalizing these assessments in accordance
with 21 CFR 1315.
Therefore, under the authority vested in the Attorney General by
Section 306 of the CSA (21 U.S.C. 826), and delegated to the
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby
proposes the following 2011 Assessment of Annual Needs for the List I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine for 2011,
expressed in kilograms of anhydrous base:
------------------------------------------------------------------------
Proposed year
2011
List I chemicals assessment of
annual needs
(kg)
------------------------------------------------------------------------
Ephedrine (for sale).................................... 3,400
Phenylpropanolamine (for sale).......................... 4,700
Pseudoephedrine (for sale).............................. 190,000
Phenylpropanolamine (for conversion).................... 8,100
Ephedrine (for conversion).............................. 18,600
------------------------------------------------------------------------
Ephedrine (for conversion) refers to the industrial use of
ephedrine, i.e., that which will be converted to another basic drug
class such as pseudoephedrine or methamphetamine used for the
manufacture of prescription weight loss drug. Phenylpropanolamine (for
conversion) refers to the industrial use of phenylpropanolamine, i.e.,
that which will be converted to another basic drug class such as
amphetamine for the manufacture of drug products. The ``for sale''
assessments refer to the amount of ephedrine, pseudoephedrine, and
phenylpropanolamine intended for ultimate use in products containing
these List I chemicals.
All interested persons are invited to submit their comments in
writing or electronically regarding this proposal following the
procedures in the ADDRESSES section of this document. A person may
object to or comment on the
[[Page 55610]]
proposal relating to any of the above-mentioned substances without
filing comments or objections regarding the others. If a person
believes that one or more of these issues warrant a hearing, the
individual should so state and summarize the reasons for this belief.
Persons wishing to request a hearing should note that such requests
must be written and manually signed; requests for a hearing will not be
accepted via electronic means. In the event that comments or objections
to this proposal raise one or more issues which the Deputy
Administrator finds warrant a hearing, the Deputy Administrator shall
order a public hearing by notice in the Federal Register, summarizing
the issues to be heard and setting the time for the hearing as per 21
CFR 1315.13(e).
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this action will not
have a significant economic impact upon small entities whose interests
must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601-
612. The establishment of the Assessment of Annual Needs for ephedrine,
pseudoephedrine and phenylpropanolamine is mandated by law. The
assessments are necessary to provide for the estimated medical,
scientific, research and industrial needs of the United States, for
lawful export requirements, and the establishment and maintenance of
reserve stocks. Accordingly, the Deputy Administrator has determined
that this action does not require a regulatory flexibility analysis.
Executive Order 12866
The Office of Management and Budget has determined that notices of
Assessment of Annual Needs are not subject to centralized review under
Executive Order 12866.
Executive Order 13132
This action does not preempt or modify any provision of state law;
nor does it impose enforcement responsibilities on any state; nor does
it diminish the power of any state to enforce its own laws.
Accordingly, this action does not have federalism implications
warranting the application of Executive Order 13132.
Executive Order 12988
This action meets the applicable standards set forth in Sections
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
Unfunded Mandates Reform Act of 1995
This action will not result in the expenditure by state, local, and
tribal governments, in the aggregate, or by the private sector, of
$120,000,000 or more in any one year, and will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under the provisions of the Unfunded Mandates Reform Act of
1995.
Congressional Review Act
This action is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. This action
will not result in an annual effect on the economy of $100,000,000 or
more; a major increase in costs or prices; or significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of United States-based companies to
compete with foreign-based companies in domestic and export markets.
Dated: August 27, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-22688 Filed 9-10-10; 8:45 am]
BILLING CODE 4410-09-P
