Proposed Revised Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2010, 36684-36689 [2010-15525]
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36684
Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices
(40 FR 43745–46), all applicants for
registration to import a basic class of
any controlled substance in schedule I
or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e) and (f) are
satisfied.
Dated: June 17, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2010–15528 Filed 6–25–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Pursuant to 21 U.S.C. 958(i), the
Attorney General shall, prior to issuing
a registration under this Section to a
bulk manufacturer of a controlled
substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
952(a)(2) authorizing the importation of
such a substance, provide
manufacturers holding registrations for
the bulk manufacture of the substance
an opportunity for a hearing.
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on March
22, 2010, Cerilliant Corporation, 811
Paloma Drive, Suite A, Round Rock,
Texas 78665–2402, made application by
letter to the Drug Enforcement
Administration (DEA) to be registered as
an importer of the basic classes of
controlled substances listed in schedule
I:
Drug
Schedule
jlentini on DSKJ8SOYB1PROD with NOTICES
Racemoramide (9645) ..................
Tilidine (9750) ...............................
21:02 Jun 25, 2010
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2010–15523 Filed 6–25–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application
Pursuant to § 1301.33(a) of Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on April 27, 2010,
Varian, Inc., 25200 Commercentre
Drive, Lake Forest, California 92630–
8810, made application by renewal to
the Drug Enforcement Administration
(DEA) as a bulk manufacturer of the
basic classes of controlled substances
listed in schedule II:
I
I
Drug
The company plans to import small
quantities of the listed controlled
substances for the manufacture of
analytical reference standards.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances may file comments or
objections to the issuance of the
proposed registration and may, at the
same time, file a written request for a
hearing on such application pursuant to
21 CFR 1301.43, and in such form as
prescribed by 21 CFR 1316.47.
VerDate Mar<15>2010
Any such comments or objections
should be addressed, in quintuplicate,
to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than July 28, 2010.
This procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
1301.34(b), (c), (d), (e), and (f). As noted
in a previous notice published in the
Federal Register on September 23, 1975,
(40 FR 43745–46), all applicants for
registration to import a basic class of
any controlled substance listed in
schedule I or II are, and will continue
to be, required to demonstrate to the
Deputy Assistant Administrator, Office
of Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Jkt 220001
Schedule
Phencyclidine (7471) ....................
1piperidinocyclohexanecarbonitrile (8603).
Benzoylecgonine (9180) ...............
II
II
II
The company plans to manufacture
small quantities of the listed controlled
substances for use in diagnostic
products.
Any other such applicant, and any
person who is presently registered with
DEA to manufacture such substances,
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
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Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than August 27, 2010.
Dated: June 17, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2010–15526 Filed 6–25–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–326R]
Proposed Revised Assessment of
Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2010
AGENCY: Drug Enforcement
Administration (DEA), Justice.
ACTION: Notice of proposed revised 2010
assessment of annual needs for the List
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine.
SUMMARY: This notice proposes revised
2010 assessment of annual needs for the
List I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine.
DATES: Written comments must be
postmarked, and electronic comments
must be sent, on or before July 28, 2010.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–326R’’ on all written and
electronic correspondence. Written
comments being sent via regular mail
should be sent to the Deputy Assistant
Administrator, Office of Diversion
Control, Drug Enforcement
Administration, Washington, DC 20537,
Attention: DEA Federal Register
Representative/ODL. Written comments
sent via express mail should be sent to
DEA Headquarters, Attention: DEA
Federal Register Representative/ODL,
8701 Morrissette Drive, Springfield,
Virginia 22152. Comments may be
directly sent to DEA electronically by
sending an electronic message to
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
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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices
comments in Microsoft Word,
WordPerfect, Adobe PDF, or Excel file
formats only. DEA will not accept any
file format other than those specifically
listed here.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD, Chief, Drug
and Chemical Evaluation Section, Drug
Enforcement Administration, 8701
Morrissette Drive, Springfield, Virginia
22152, Telephone: (202) 307–7183.
SUPPLEMENTARY INFORMATION: Section
713 of the Combat Methamphetamine
Epidemic Act of 2005 (CMEA) (Title VII
of Pub. L. 109–177) amended Section
306 of the Controlled Substances Act
(CSA) (21 U.S.C. 826) by adding
ephedrine, pseudoephedrine, and
phenylpropanolamine to existing
language to read as follows: ‘‘The
Attorney General shall determine the
total quantity and establish production
quotas for each basic class of controlled
substance in schedules I and II and for
ephedrine, pseudoephedrine, and
phenylpropanolamine to be
manufactured each calendar year to
provide for the estimated medical,
scientific, research, and industrial needs
of the United States, for lawful export
requirements, and for the establishment
and maintenance of reserve stocks.’’
Further, section 715 of the CMEA
amended 21 U.S.C. 952 ‘‘Importation of
controlled substances’’ by adding the
same List I chemicals to the existing
language in paragraph (a), and by
adding a new paragraph (d) to read as
follows:
(a) Controlled substances in schedule I or
II and narcotic drugs in schedule III, IV, or
V; exceptions
It shall be unlawful to import into the
customs territory of the United States from
any place outside thereof (but within the
United States), or to import into the United
States from any place outside thereof, any
controlled substance in schedule I or II of
subchapter I of this chapter, or any narcotic
drug in schedule III, IV, or V of subchapter
I of this chapter, or ephedrine,
pseudoephedrine, and
phenylpropanolamine, except that—
(1) Such amounts of crude opium, poppy
straw, concentrate of poppy straw, and coca
leaves, and of ephedrine, pseudoephedrine,
and phenylpropanolamine, as the Attorney
General finds to be necessary to provide for
medical, scientific, or other legitimate
purposes * * * may be so imported under
such regulations as the Attorney General
shall prescribe.
*
*
*
*
*
(d)(1) With respect to a registrant under
section 958 who is authorized under
subsection (a)(1) to import ephedrine,
pseudoephedrine, or phenylpropanolamine,
at any time during the year the registrant may
apply for an increase in the amount of such
chemical that the registrant is authorized to
import, and the Attorney General may
approve the application if the Attorney
General determines that the approval is
necessary to provide for medical, scientific,
or other legitimate purposes regarding the
chemical.
Editor’s Note: This excerpt of the
amendment is published for the convenience
of the reader. The official text is published
at 21 U.S.C. 952(a) and (d)(1).
The 2010 Assessment of Annual
Needs (AAN) represents those quantities
of ephedrine, pseudoephedrine, and
phenylpropanolamine which may be
manufactured domestically and/or
imported into the United States to
provide adequate supplies of each
substance to meet the estimated
medical, scientific, research, and
industrial needs of the United States;
lawful export requirements; and the
establishment and maintenance of
reserve stocks.
On November 20, 2009, DEA
established the AAN for 2010 for the
List I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine (74 FR 60294).
That Notice indicated that the Deputy
Administrator of the DEA would adjust
the AAN at a later date if necessary, as
permitted by 21 CFR 1315.13.
DEA now proposes to revise the
established assessments of annual needs
for 2010 for these List 1 chemicals. In
developing the proposed revisions, DEA
has used the calculation methodology
described in both the 2009 and 2010
AAN (74 FR 32954 and 74 FR 60294,
respectively). These calculations take
into account the criteria that DEA is
required to consider in accordance with
21 U.S.C. 826 and its implementing
regulations (21 CFR 1315.11).
In finalizing the revised assessments
for these List I chemicals, DEA will
consider the information contained in
additional applications for 2010 import,
manufacturing and procurement quotas
from DEA registered manufacturers and
importers that DEA receives after the
date of drafting this notice, March 10,
2010, as well as the comments that DEA
receives in response to this proposal.
Underlying Data and DEA’s Analysis
In determining the proposed revisions
to the 2010 assessments, DEA has
considered the total net disposals (i.e.,
sales) of the List I chemicals for the
current and preceding two years, actual
and estimated inventories, projected
demand (2010), industrial use, and
export requirements from data provided
by DEA registered manufacturers and
importers in procurement quota
applications (DEA 250), from
manufacturing quota applications (DEA
189), and from import quota
applications (DEA 488).1
DEA further considered trends as
derived from information provided in
applications for import, manufacturing,
and procurement quotas and in import
and export declarations. DEA notes that
the inventory, acquisitions (purchases)
and disposition (sales) data provided by
DEA registered manufacturers and
importers reflects the most current
information available.
Ephedrine (for Sale) Data
EPHEDRINE (FOR SALE) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS (KILOGRAMS)
Ephedrine
2007
jlentini on DSKJ8SOYB1PROD with NOTICES
Sales * (DEA 250) ............................................................................................................
Imports ** (DEA 488) .......................................................................................................
Export Declarations (DEA 486) .......................................................................................
Inventory * (DEA 250) ......................................................................................................
IMS *** (NSP) ...................................................................................................................
2,838
9,595
168
1,428
1,235
2008
2,662
1,690
18
626
1,460
2009
2,801
2,165
64
191
1,401
2010
request
3,430
2,268
n/a
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 2009, Retail and Non-Retail Channels, Data Extracted March
10, 2010.
1 Applications and instructions for procurement,
import and manufacturing quotas can be found at
VerDate Mar<15>2010
21:02 Jun 25, 2010
Jkt 220001
https://www.deadiversion.usdoj.gov/quotas/
quota_apps.htm.
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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices
Ephedrine (for Sale) Analysis
DEA previously has established the
2010 AAN for ephedrine (for sale) at
3,600 kg (74 FR 60298).
As noted above, DEA developed the
proposed revisions to the 2010 AAN for
ephedrine (for sale) using the same
calculation and methodology that DEA
used to determine the 2009 and 2010
AAN.
As of March 10, 2010, DEA registered
manufacturers of dosage form products
containing ephedrine requested the
authority to purchase a total of 3,430 kg
ephedrine (for sale) in 2010. DEA
registered manufacturers of ephedrine
reported sales totaling approximately
2,662 kg in 2008 and 2,801 kg in 2009;
this represents a 5 percent increase in
sales reported by these firms from 2008
to 2009. Additionally, exports of
ephedrine products from the United
States as reported on export declarations
(DEA 486) totaled 18 kg in 2008 and 64
kg in 2009; this represents a 72 percent
increase from levels observed in 2008.
The average of the 2008 and 2009
exports of ephedrine products is
approximately 41 kg. DEA also
considered information on trends in the
national rate of net disposals from sales
data provided by IMS Health’s NSP
database. IMS NSP data reported the
average sales volume of ephedrine for
the calendar years 2008 and 2009 to be
approximately 1,431 kg. DEA notes that
the 2009 sales figure reported by
manufacturers (2,801 kg) is higher than
the average sales reported by IMS for the
previous two years (1,431 kg). This is
expected because a manufacturer’s
reported sales include quantities which
are necessary to provide reserve stocks
for distributors and retailers. DEA, in
considering the manufacturer’s reported
sales, thus believes that 2,801 kg fairly
represents the United States sales of
ephedrine for 2010 and that 41 kg fairly
represents the export requirements of
ephedrine.
For the establishment and
maintenance of reserve stocks, DEA
notes that 21 CFR 1315.24 allows for an
inventory allowance (reserve stock) of
50 percent of a manufacturer’s estimated
sales. DEA also considered the
estimated 2009 year end inventory as
reported by DEA registrants in
determining the inventory allowance.
DEA calculated the proposed revised
ephedrine (for sale) assessment as
follows:
2009 sales + reserve stock + export
requirement ¥ existing inventory =
AAN
2,801 + (50%*2,801) + 41 ¥ 191 = 4,052
kg ephedrine (for sale) for 2010
This calculation suggests that DEA’s
AAN for ephedrine should be 4,100 kg.
Accordingly, DEA is proposing to
increase the 2010 AAN for ephedrine
(for sale) from 3,600 kg to 4,100 kg.
Phenylpropanolamine (for Sale) data
PHENYLPROPANOLAMINE (FOR SALE) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS (KILOGRAMS)
Phenylpropanolamine
(for sale)
2007
Sales * (DEA 250) ............................................................................................................
Imports ** (DEA 488) .......................................................................................................
Export Declarations (DEA 486) .......................................................................................
Inventory * (DEA 250) ......................................................................................................
2008
4,158
5,787
1,002
3,642
2009
4,528
3,425
0
2,470
2010
request
5,355
6,626
3
645
6,799
7,266
n/a
n/a
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of March 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
Phenylpropanolamine (for Sale)
Analysis
jlentini on DSKJ8SOYB1PROD with NOTICES
DEA previously has established the
2010 AAN for phenylpropanolamine
(for sale) at 6,400 kg (74 FR 60298).
As noted above, DEA utilized the
same general methodology and
calculation to develop the proposed
revised assessment for
phenylpropanolamine (for sale) that
DEA used to determine the 2009 and
2010 AAN.
As of March 10, 2010, DEA registered
manufacturers of dosage form products
containing phenylpropanolamine
requested the authority to purchase
6,799 kg phenylpropanolamine (for sale)
in 2010. DEA registered manufacturers
of phenylpropanolamine reported sales
totaling approximately 4,528 kg in 2008
and 5,355 kg in 2009; this represents a
15.5% increase in sales reported by
these firms from 2008 to 2009.
Additionally, exports of
phenylpropanolamine products from
the United States as reported on export
declarations (DEA 486) totaled 0 kg in
2008 and 3 kg in 2009; this represents
a 3 kg increase from levels observed in
2008. The average of the 2008 and 2009
exports of phenylpropanolamine
products is approximately 2 kg. DEA
thus believes that 5,355 kg fairly
represents the United States sales of
phenylpropanolamine for 2010 and that
2 kg fairly represents the export
requirements of phenylpropanolamine.
DEA notes that phenylpropanolamine is
sold primarily as a veterinary product
for the treatment for canine
incontinence and is not approved for
human consumption. IMS Health’s NSP
Data does not capture sales of
phenylpropanolamine to veterinary
channels and is therefore not included.
DEA calculated the proposed revised
phenylpropanolamine (for sale)
assessment by the following
methodology:
2009 sales + reserve stock + export
requirement ¥ existing inventory =
AAN
5,355+ (50%*5,355) + 2 ¥ 645 = 7,390
kg phenylpropanolamine (for sale)
for 2010
This calculation suggests that DEA’s
2010 Assessment of Annual Needs for
phenylpropanolamine (for sale) should
be 7,400 kg. Accordingly, DEA is
proposing to increase the 2010 AAN for
phenylpropanolamine (for sale) from
6,400 kg to 7,400 kg.
Pseudoephedrine (for Sale) Data
PSEUDOEPHEDRINE (FOR SALE) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS (KILOGRAMS)
Pseudoephedrine (for sale)
2007
Sales * (DEA 250) ............................................................................................................
Sales * (DEA 189) ............................................................................................................
Imports ** (DEA 488) .......................................................................................................
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21:02 Jun 25, 2010
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2008
2009
239,121
100,300
231,683
223,813
64,781
170,614
287,756
33,600
274,492
E:\FR\FM\28JNN1.SGM
28JNN1
2010
request
239,646
32,760
261,528
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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices
PSEUDOEPHEDRINE (FOR SALE) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS (KILOGRAMS)—Continued
Pseudoephedrine (for sale)
2007
Export Declarations (DEA 486) .......................................................................................
Inventory * (DEA 250) ......................................................................................................
IMS *** (NSP) ...................................................................................................................
2008
2009
42,132
135,727
180,221
47,199
120,869
149,227
2010
request
35,264
54,173
140,269
n/a
n/a
n/a
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of
March 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
*** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail Channels, Data Extracted March
10, 2010.
Pseudoephedrine (for Sale) Analysis
DEA previously has established the
2010 AAN for pseudoephedrine (for
sale) at 404,000 kg (74 FR 60298).
As noted above, DEA utilized the
same general methodology and
calculation to develop the proposed
revised assessment for pseudoephedrine
(for sale) that DEA used to determine
the 2009 and 2010 AAN.
As of March 10, 2010, DEA registered
manufacturers of dosage form products
containing pseudoephedrine requested
the authority to purchase 239,646 kg
pseudoephedrine. DEA registered
manufacturers of pseudoephedrine
reported sales totaling approximately
223,813 kg in 2008 and 287,756 kg in
2009; this represents a 22 percent
increase in sales reported by these firms
from 2008 to 2009. During the same
period exports of pseudoephedrine
products from the U.S. as reported on
export declarations (DEA 486) totaled
47,199 kg in 2008 and 35,264 kg in
2009; this represents a 25 percent
decrease from levels observed in 2008.
The average of the 2008 and 2009
exports is 41,232 kg. Additionally, DEA
considered information on trends in the
national rate of net disposals from sales
data provided by IMS Health. IMS NSP
data reported the average retail sales
volume of pseudoephedrine for the
calendar years 2008 and 2009 to be
approximately 144,748 kg. DEA thus
believes that 287,756 kg of sales
reported by manufacturers fairly
represents the U.S. sales of
pseudoephedrine for 2010 and that
41,232 kg fairly represents the export
requirements of pseudoephedrine. DEA
notes that manufacturer reported sales
for 2009 (287,756 kg) are higher than the
average retail sales reported by IMS for
the previous two years (144,748 kg).
This is expected because a
manufacturer’s reported sales include
quantities which are necessary to
provide reserve stocks for distributors
and retailers.
DEA calculated the revised
pseudoephedrine (for sale) assessment
by the following methodology:
2009 sales + reserve stock + export
requirement ¥ existing inventory =
AAN
287,756 + (50%*287,756) + 41,232 ¥
54,173 = 418,693 kg
pseudoephedrine (for sale) for 2010.
This calculation suggests that DEA’s
2010 AAN for pseudoephedrine (for
sale) should be 419,000 kg. Accordingly,
DEA is proposing to increase the 2010
AAN for pseudoephedrine (for sale)
from 404,000 kg to 419,000 kg.
Phenylpropanolamine (for Conversion)
Data
PHENYLPROPANOLAMINE (FOR CONVERSION) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS (KILOGRAMS)
Phenylpropanolamine (for sale)
2007
Sales * (DEA 250) ............................................................................................................
Imports ** (DEA 488) .......................................................................................................
Export Declarations (DEA 486) .......................................................................................
Inventory * (DEA 250) ......................................................................................................
APQ Amphetamine *** .....................................................................................................
2008
3,621
8,250
0
3,581
22,000
2009
10,837
12,019
0
5,537
22,000
14,585
11,373
0
3,693
24,500
2010
request
19,142
33,698
n/a
n/a
23,500
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of March 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
*** Amphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.
jlentini on DSKJ8SOYB1PROD with NOTICES
Phenylpropanolamine (for Conversion)
Analysis
DEA previously has established the
2010 AAN for phenylpropanolamine
(for conversion) at 16,500 kg (74 FR
60298). As noted above, DEA developed
the proposed revisions to the 2010 AAN
for phenylpropanolamine (for
conversion) using the same calculation
and methodology that DEA used to
determine the 2009 and 2010 AAN.
As of March 10, 2010, DEA registered
manufacturers of phenylpropanolamine
(for conversion) requested the authority
to purchase a total of 19,142 kg
phenylpropanolamine for the
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21:02 Jun 25, 2010
Jkt 220001
manufacture of amphetamine. DEA
registered manufacturers of
phenylpropanolamine reported sales of
phenylpropanolamine totaling
approximately 10,837 kg in 2008 and
14,585 kg in 2009; this represent a 26
percent increase in sales reported by
these firms from 2008 to 2009. There
were no reported exports of
phenylpropanolamine (for conversion).
DEA has not received any requests to
synthesize phenylpropanolamine in
2010. DEA has concluded that the 2009
sales of phenylpropanolamine (for
conversion), 14,585 kg fairly represents
U.S. requirements for 2010 and zero kg
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fairly represents the export
requirements of phenylpropanolamine
(for conversion).
Phenylpropanolamine (for
conversion) is used for the manufacture
of legitimate amphetamine products.
DEA notes, most legitimate
amphetamine is manufactured by the
conversion of the schedule II controlled
substance phenylacetone to
amphetamine, rather than the
conversion of phenylpropanolamine.
DEA believes that the data provided in
procurement, manufacturing, and
import quota applications best
represents the legitimate need for
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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices
phenylpropanolamine (for conversion)
rather than total Aggregate Production
Quota (APQ) for amphetamine.
DEA calculated the
phenylpropanolamine (for conversion)
needed for the manufacture of
amphetamine as follows:
(for conversion) should be 18,200 kg.
Accordingly, DEA is proposing to
increase the 2010 AAN for
phenylpropanolamine (for conversion)
from 16,500 kg to 18,200 kg.
(2009 sales) + reserve stock + export
requirement ¥ inventory = AAN
(14,585) + 50%*(14,585) + 0 ¥ 3,693 =
18,185 kg PPA (for conversion) for
2010
This calculation suggests that DEA’s
2010 AAN for phenylpropanolamine
Ephedrine (for Conversion) Data
EPHEDRINE (FOR CONVERSION) DATA FOR 2010 ASSESSMENT OF ANNUAL NEEDS (KILOGRAMS)
Ephedrine (for conversion)
2007
Sales * (DEA 250) ............................................................................................................
Imports ** (DEA 488) .......................................................................................................
Inventory * (DEA 250) ......................................................................................................
APQ Methamphetamine *** ..............................................................................................
2008
99,622
99,594
13
3,130
2009
64,522
64,128
160
3,130
40,403
39,897
254
3,130
2010
request
40,600
40,000
n/a
3,130
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of
March 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
*** Methamphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.
Ephedrine (for Conversion) Analysis
DEA previously has established the
2010 AAN for ephedrine (for
conversion) at 75,000 kg (74 FR 60298).
As noted above, DEA developed the
proposed revisions to the 2010 AAN for
ephedrine (for conversion) using the
same calculation and methodology that
DEA used to determine the 2009 and
2010 AAN.
As of March 10, 2010, DEA registered
manufacturers of ephedrine (for
conversion) requested the authority to
purchase a total of 40,600 kg ephedrine
(for conversion) for the manufacture of
two substances: Methamphetamine and
pseudoephedrine.
DEA considered the ephedrine (for
conversion) requirements for the
manufacture of methamphetamine and
pseudoephedrine. DEA has determined
that the established assessments for the
manufacture of these two substances are
the best indicators of the need for
ephedrine (for conversion). The
assessment of need for
methamphetamine was determined by
DEA as the Aggregate Production Quota
(APQ) for methamphetamine. DEA
determined that the estimated sales of
pseudoephedrine, as referenced in the
AAN for pseudoephedrine, represents
the need for pseudoephedrine. Reported
sales of ephedrine (for conversion) are
included as reference to DEA’s
methodology.
DEA further considered the reported
conversion yields of these substances.
DEA registered manufacturers reported
a conversion yield of 39 percent for the
synthesis of methamphetamine from
ephedrine. DEA cannot disclose the
conversion yield for the synthesis of
pseudoephedrine because this
information is proprietary to the one
manufacturer involved in this type of
manufacturing.
Thus, DEA calculated the ephedrine
(for conversion) requirement for the
manufacture of methamphetamine as
follows:
(2009 APQ methamphetamine/39%
yield) + reserve stock ¥ inventory
= ephedrine (for manufacture of
methamphetamine)
(3,130/39% yield) + 50%*(3,130/39%
yield) ¥ 254 = 11,785 kg
The calculation for the ephedrine (for
conversion) requirement for the
manufacture of pseudoephedrine leads
to a result of 63,157 kg. DEA cannot
provide the details of the calculation
because this would reveal the
conversion yield for the synthesis of
pseudoephedrine, which is proprietary
to the one manufacturer involved in this
type of manufacturing.
Therefore, DEA determined the
proposed revised assessment for
ephedrine (for conversion) by summing
the amounts required for the
manufacture of methamphetamine and
pseudoephedrine:
Conclusion
In finalizing the revised 2010
assessments for these List I chemicals,
DEA will use the methodology and
calculations presented above. The
numbers used in the calculations may
be adjusted upwards or downwards
based on the additional applications for
2010 import, manufacturing and
procurement quotas received after
March 10, 2010, in accordance with 21
CFR part 1315.
Therefore, under the authority vested
in the Attorney General by Section 306
of the CSA (21 U.S.C. 826), and
delegated to the Administrator of the
DEA by 28 CFR 0.100, and redelegated
to the Deputy Administrator pursuant to
28 CFR 0.104, the Deputy Administrator
hereby proposes the following revised
2010 AAN for the List I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine:
Previously
established initial
2010 assessment
List I chemicals
jlentini on DSKJ8SOYB1PROD with NOTICES
methamphetamine requirement +
pseudoephedrine requirement =
AAN
11,785 + 63,157 = 74,942 kg ephedrine
(for conversion) for 2010
This calculation suggests that DEA’s
2010 AAN for ephedrine (for
conversion) should be 75,000 kg.
Accordingly, DEA is proposing that the
2010 AAN for ephedrine (for
conversion) remain unchanged at 75,000
kg.
Ephedrine (for sale) .................................................................................................................
Phenylpropanolamine (for sale) ...............................................................................................
Pseudoephedrine (for sale) .....................................................................................................
Phenylpropanolamine (for conversion) ....................................................................................
Ephedrine (for conversion) ......................................................................................................
VerDate Mar<15>2010
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E:\FR\FM\28JNN1.SGM
3,600
6,400
404,000
16,500
75,000
28JNN1
Proposed revised
2010 assessment
kg
kg
kg
kg
kg
4,100 kg
7,400 kg
419,000 kg
18,200 kg
No Change
Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices
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 AAN for ephedrine,
pseudoephedrine and
phenylpropanolamine is mandated by
law. The assessments are necessary to
provide for the estimated medical,
scientific, research and industrial needs
of the United States, for lawful export
requirements, and the establishment
and maintenance of reserve stocks.
Accordingly, the Deputy Administrator
has determined that this action does not
require a regulatory flexibility analysis.
Executive Order 12866
The Office of Management and Budget
has determined that notices of AAN are
not subject to centralized review under
Executive Order 12866.
jlentini on DSKJ8SOYB1PROD 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
VerDate Mar<15>2010
21:02 Jun 25, 2010
Jkt 220001
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: June 19, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010–15525 Filed 6–25–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Antitrust Division
United States, et al. v. Election
Systems & Software, Inc.; Public
Comments and Response on Proposed
Final Judgment
Pursuant to the Antitrust Procedures
and Penalties Act, 15 U.S.C. 16(b)–(h),
the United States hereby publishes
below the comments received on the
proposed Final Judgment in United
States, et al. v. Election Systems &
Software Inc., Case No. 1:10–00380–
JDB, which were filed in the United
States District Court for the District of
Columbia on June 17, 2010, together
with the response of the United States
to the comments.
Copies of the comments and the
response are available for inspection at
the Department of Justice Antitrust
Division, 450 Fifth Street, NW., Suite
1010, Washington, DC 20530
(telephone: 202–514–2481), on the
Department of Justice’s Web site at
https://www.usdoj.gov/atr, and at the
Office of the Clerk of the United States
District Court for the District of
Columbia, 333 Constitution Avenue,
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
36689
NW., Washington, DC 20001. Copies of
any of these materials may be obtained
upon request and payment of a copying
fee.
J. Robert Kramer II,
Director of Operations and Civil Enforcement.
United States District Court for the
District of Columbia
United States of America, et al.,
Plaintiffs, v. Election Systems and
Software, Inc., Defendant.
Case No.: 1:10-cv-00380
Judge: Bates, John D.
Deck Type: Antitrust
Date Stamp:
Response of Plaintiff United States to
Public Comments on the Proposed
Final Judgment
Pursuant to the requirements of the
Antitrust Procedures and Penalties Act,
15 U.S.C. § 16(b)–(h) (‘‘APPA’’ or
‘‘Tunney Act’’), the United States hereby
responds to the public comments
received regarding the proposed Final
Judgment in this case. After careful
consideration of the comments, the
United States continues to believe that
the proposed Final Judgment will
provide an effective and appropriate
remedy for the antitrust violations
alleged in the Complaint. The United
States will move the Court for entry of
the proposed Final Judgment after the
public comments and this response
have been published in the Federal
Register, pursuant to 15 U.S.C. § 16(d).
The United States and the States of
Arizona, Colorado, Florida, Maine,
Maryland, New Mexico, Tennessee, and
Washington, and the Commonwealth of
Massachusetts (the ‘‘Plaintiff States’’),
filed a civil antitrust Complaint on
March 8, 2010, seeking injunctive and
other relief to remedy the likely
anticompetitive effects arising from the
acquisition of Premier Election
Solutions, Inc. and PES Holdings, Inc.
(collectively, ‘‘Premier’’), by Defendant
Election Systems and Software, Inc.
(‘‘ES&S’’). The Complaint alleged that
ES&S’s acquisition of Premier likely
would result in higher prices, a
reduction in quality, and less
innovation in the U.S. voting equipment
systems market, in violation of Section
7 of the Clayton Act, 15 U.S.C. § 18.
Simultaneously with the filing of the
Complaint, the United States filed a
proposed Final Judgment and an Asset
Preservation Stipulation and Order
(‘‘APSO’’) signed by the plaintiffs and
the defendant, consenting to the entry of
the proposed Final Judgment after
compliance with the requirements of the
Tunney Act, 15 U.S.C. § 16. Pursuant to
those requirements, the United States
filed its Competitive Impact Statement
E:\FR\FM\28JNN1.SGM
28JNN1
]]>Agencies
[Federal Register Volume 75, Number 123 (Monday, June 28, 2010)]
[Notices]
[Pages 36684-36689]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15525]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-326R]
Proposed Revised Assessment of Annual Needs for the List I
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2010
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed revised 2010 assessment of annual needs for
the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
-----------------------------------------------------------------------
SUMMARY: This notice proposes revised 2010 assessment of annual needs
for the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before July 28, 2010.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-326R'' on all written and electronic correspondence.
Written comments being sent via regular mail should be sent to the
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537, Attention: DEA
Federal Register Representative/ODL. Written comments sent via express
mail should be sent to DEA Headquarters, Attention: DEA Federal
Register Representative/ODL, 8701 Morrissette Drive, Springfield,
Virginia 22152. Comments may be directly sent to DEA electronically by
sending an electronic message to 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
[[Page 36685]]
comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel file
formats only. DEA will not accept any file format other than those
specifically listed here.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Drug Enforcement Administration,
8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202)
307-7183.
SUPPLEMENTARY INFORMATION: Section 713 of the Combat Methamphetamine
Epidemic Act of 2005 (CMEA) (Title VII of Pub. L. 109-177) amended
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) by
adding ephedrine, pseudoephedrine, and phenylpropanolamine to existing
language to read as follows: ``The Attorney General shall determine the
total quantity and establish production quotas for each basic class of
controlled substance in schedules I and II and for ephedrine,
pseudoephedrine, and phenylpropanolamine to be manufactured each
calendar year to provide for the estimated medical, scientific,
research, and industrial needs of the United States, for lawful export
requirements, and for the establishment and maintenance of reserve
stocks.'' Further, section 715 of the CMEA amended 21 U.S.C. 952
``Importation of controlled substances'' by adding the same List I
chemicals to the existing language in paragraph (a), and by adding a
new paragraph (d) to read as follows:
(a) Controlled substances in schedule I or II and narcotic drugs
in schedule III, IV, or V; exceptions
It shall be unlawful to import into the customs territory of the
United States from any place outside thereof (but within the United
States), or to import into the United States from any place outside
thereof, any controlled substance in schedule I or II of subchapter
I of this chapter, or any narcotic drug in schedule III, IV, or V of
subchapter I of this chapter, or ephedrine, pseudoephedrine, and
phenylpropanolamine, except that--
(1) Such amounts of crude opium, poppy straw, concentrate of
poppy straw, and coca leaves, and of ephedrine, pseudoephedrine, and
phenylpropanolamine, as the Attorney General finds to be necessary
to provide for medical, scientific, or other legitimate purposes * *
* may be so imported under such regulations as the Attorney General
shall prescribe.
* * * * *
(d)(1) With respect to a registrant under section 958 who is
authorized under subsection (a)(1) to import ephedrine,
pseudoephedrine, or phenylpropanolamine, at any time during the year
the registrant may apply for an increase in the amount of such
chemical that the registrant is authorized to import, and the
Attorney General may approve the application if the Attorney General
determines that the approval is necessary to provide for medical,
scientific, or other legitimate purposes regarding the chemical.
Editor's Note: This excerpt of the amendment is published for
the convenience of the reader. The official text is published at 21
U.S.C. 952(a) and (d)(1).
The 2010 Assessment of Annual Needs (AAN) represents those
quantities of ephedrine, pseudoephedrine, and phenylpropanolamine which
may be manufactured domestically and/or imported into the United States
to provide adequate supplies of each substance to meet the estimated
medical, scientific, research, and industrial needs of the United
States; lawful export requirements; and the establishment and
maintenance of reserve stocks.
On November 20, 2009, DEA established the AAN for 2010 for the List
I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine (74 FR
60294). That Notice indicated that the Deputy Administrator of the DEA
would adjust the AAN at a later date if necessary, as permitted by 21
CFR 1315.13.
DEA now proposes to revise the established assessments of annual
needs for 2010 for these List 1 chemicals. In developing the proposed
revisions, DEA has used the calculation methodology described in both
the 2009 and 2010 AAN (74 FR 32954 and 74 FR 60294, respectively).
These calculations take into account the criteria that DEA is required
to consider in accordance with 21 U.S.C. 826 and its implementing
regulations (21 CFR 1315.11).
In finalizing the revised assessments for these List I chemicals,
DEA will consider the information contained in additional applications
for 2010 import, manufacturing and procurement quotas from DEA
registered manufacturers and importers that DEA receives after the date
of drafting this notice, March 10, 2010, as well as the comments that
DEA receives in response to this proposal.
Underlying Data and DEA's Analysis
In determining the proposed revisions to the 2010 assessments, DEA
has considered the total net disposals (i.e., sales) of the List I
chemicals for the current and preceding two years, actual and estimated
inventories, projected demand (2010), industrial use, and export
requirements from data provided by DEA registered manufacturers and
importers in procurement quota applications (DEA 250), from
manufacturing quota applications (DEA 189), and from import quota
applications (DEA 488).\1\
---------------------------------------------------------------------------
\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 (for Sale) Data
Ephedrine (for Sale) Data for 2010 Assessment of Annual Needs (Kilograms)
----------------------------------------------------------------------------------------------------------------
2010
Ephedrine 2007 2008 2009 request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)........................................... 2,838 2,662 2,801 3,430
Imports ** (DEA 488)........................................ 9,595 1,690 2,165 2,268
Export Declarations (DEA 486)............................... 168 18 64 n/a
Inventory * (DEA 250)....................................... 1,428 626 191 n/a
IMS *** (NSP)............................................... 1,235 1,460 1,401 n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250).
** Reported imports from applications for 2010 import quotas (DEA 488).
*** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail
Channels, Data Extracted March 10, 2010.
[[Page 36686]]
Ephedrine (for Sale) Analysis
DEA previously has established the 2010 AAN for ephedrine (for
sale) at 3,600 kg (74 FR 60298).
As noted above, DEA developed the proposed revisions to the 2010
AAN for ephedrine (for sale) using the same calculation and methodology
that DEA used to determine the 2009 and 2010 AAN.
As of March 10, 2010, DEA registered manufacturers of dosage form
products containing ephedrine requested the authority to purchase a
total of 3,430 kg ephedrine (for sale) in 2010. DEA registered
manufacturers of ephedrine reported sales totaling approximately 2,662
kg in 2008 and 2,801 kg in 2009; this represents a 5 percent increase
in sales reported by these firms from 2008 to 2009. Additionally,
exports of ephedrine products from the United States as reported on
export declarations (DEA 486) totaled 18 kg in 2008 and 64 kg in 2009;
this represents a 72 percent increase from levels observed in 2008. The
average of the 2008 and 2009 exports of ephedrine products is
approximately 41 kg. DEA also considered information on trends in the
national rate of net disposals from sales data provided by IMS Health's
NSP database. IMS NSP data reported the average sales volume of
ephedrine for the calendar years 2008 and 2009 to be approximately
1,431 kg. DEA notes that the 2009 sales figure reported by
manufacturers (2,801 kg) is higher than the average sales reported by
IMS for the previous two years (1,431 kg). This is expected because a
manufacturer's reported sales include quantities which are necessary to
provide reserve stocks for distributors and retailers. DEA, in
considering the manufacturer's reported sales, thus believes that 2,801
kg fairly represents the United States sales of ephedrine for 2010 and
that 41 kg fairly represents the export requirements of ephedrine.
For the establishment and maintenance of reserve stocks, DEA notes
that 21 CFR 1315.24 allows for an inventory allowance (reserve stock)
of 50 percent of a manufacturer's estimated sales. DEA also considered
the estimated 2009 year end inventory as reported by DEA registrants in
determining the inventory allowance.
DEA calculated the proposed revised ephedrine (for sale) assessment
as follows:
2009 sales + reserve stock + export requirement - existing inventory =
AAN
2,801 + (50%*2,801) + 41 - 191 = 4,052 kg ephedrine (for sale) for 2010
This calculation suggests that DEA's AAN for ephedrine should be
4,100 kg. Accordingly, DEA is proposing to increase the 2010 AAN for
ephedrine (for sale) from 3,600 kg to 4,100 kg.
Phenylpropanolamine (for Sale) data
Phenylpropanolamine (for Sale) Data for 2010 Assessment of Annual Needs (Kilograms)
----------------------------------------------------------------------------------------------------------------
2010
Phenylpropanolamine (for sale) 2007 2008 2009 request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)........................................... 4,158 4,528 5,355 6,799
Imports ** (DEA 488)........................................ 5,787 3,425 6,626 7,266
Export Declarations (DEA 486)............................... 1,002 0 3 n/a
Inventory * (DEA 250)....................................... 3,642 2,470 645 n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of March 10,
2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
Phenylpropanolamine (for Sale) Analysis
DEA previously has established the 2010 AAN for phenylpropanolamine
(for sale) at 6,400 kg (74 FR 60298).
As noted above, DEA utilized the same general methodology and
calculation to develop the proposed revised assessment for
phenylpropanolamine (for sale) that DEA used to determine the 2009 and
2010 AAN.
As of March 10, 2010, DEA registered manufacturers of dosage form
products containing phenylpropanolamine requested the authority to
purchase 6,799 kg phenylpropanolamine (for sale) in 2010. DEA
registered manufacturers of phenylpropanolamine reported sales totaling
approximately 4,528 kg in 2008 and 5,355 kg in 2009; this represents a
15.5% increase in sales reported by these firms from 2008 to 2009.
Additionally, exports of phenylpropanolamine products from the United
States as reported on export declarations (DEA 486) totaled 0 kg in
2008 and 3 kg in 2009; this represents a 3 kg increase from levels
observed in 2008. The average of the 2008 and 2009 exports of
phenylpropanolamine products is approximately 2 kg. DEA thus believes
that 5,355 kg fairly represents the United States sales of
phenylpropanolamine for 2010 and that 2 kg fairly represents the export
requirements of phenylpropanolamine. DEA notes that phenylpropanolamine
is sold primarily as a veterinary product for the treatment for canine
incontinence and is not approved for human consumption. IMS Health's
NSP Data does not capture sales of phenylpropanolamine to veterinary
channels and is therefore not included.
DEA calculated the proposed revised phenylpropanolamine (for sale)
assessment by the following methodology:
2009 sales + reserve stock + export requirement - existing inventory =
AAN
5,355+ (50%*5,355) + 2 - 645 = 7,390 kg phenylpropanolamine (for sale)
for 2010
This calculation suggests that DEA's 2010 Assessment of Annual
Needs for phenylpropanolamine (for sale) should be 7,400 kg.
Accordingly, DEA is proposing to increase the 2010 AAN for
phenylpropanolamine (for sale) from 6,400 kg to 7,400 kg.
Pseudoephedrine (for Sale) Data
Pseudoephedrine (for sale) Data for 2010 Assessment of Annual Needs (Kilograms)
----------------------------------------------------------------------------------------------------------------
2010
Pseudoephedrine (for sale) 2007 2008 2009 request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)........................................... 239,121 223,813 287,756 239,646
Sales * (DEA 189)........................................... 100,300 64,781 33,600 32,760
Imports ** (DEA 488)........................................ 231,683 170,614 274,492 261,528
[[Page 36687]]
Export Declarations (DEA 486)............................... 42,132 47,199 35,264 n/a
Inventory * (DEA 250)....................................... 135,727 120,869 54,173 n/a
IMS *** (NSP)............................................... 180,221 149,227 140,269 n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas
(DEA 189) received as of March 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
*** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail
Channels, Data Extracted March 10, 2010.
Pseudoephedrine (for Sale) Analysis
DEA previously has established the 2010 AAN for pseudoephedrine
(for sale) at 404,000 kg (74 FR 60298).
As noted above, DEA utilized the same general methodology and
calculation to develop the proposed revised assessment for
pseudoephedrine (for sale) that DEA used to determine the 2009 and 2010
AAN.
As of March 10, 2010, DEA registered manufacturers of dosage form
products containing pseudoephedrine requested the authority to purchase
239,646 kg pseudoephedrine. DEA registered manufacturers of
pseudoephedrine reported sales totaling approximately 223,813 kg in
2008 and 287,756 kg in 2009; this represents a 22 percent increase in
sales reported by these firms from 2008 to 2009. During the same period
exports of pseudoephedrine products from the U.S. as reported on export
declarations (DEA 486) totaled 47,199 kg in 2008 and 35,264 kg in 2009;
this represents a 25 percent decrease from levels observed in 2008. The
average of the 2008 and 2009 exports is 41,232 kg. Additionally, DEA
considered information on trends in the national rate of net disposals
from sales data provided by IMS Health. IMS NSP data reported the
average retail sales volume of pseudoephedrine for the calendar years
2008 and 2009 to be approximately 144,748 kg. DEA thus believes that
287,756 kg of sales reported by manufacturers fairly represents the
U.S. sales of pseudoephedrine for 2010 and that 41,232 kg fairly
represents the export requirements of pseudoephedrine. DEA notes that
manufacturer reported sales for 2009 (287,756 kg) are higher than the
average retail sales reported by IMS for the previous two years
(144,748 kg). This is expected because a manufacturer's reported sales
include quantities which are necessary to provide reserve stocks for
distributors and retailers.
DEA calculated the revised pseudoephedrine (for sale) assessment by
the following methodology:
2009 sales + reserve stock + export requirement - existing inventory =
AAN
287,756 + (50%*287,756) + 41,232 - 54,173 = 418,693 kg pseudoephedrine
(for sale) for 2010.
This calculation suggests that DEA's 2010 AAN for pseudoephedrine
(for sale) should be 419,000 kg. Accordingly, DEA is proposing to
increase the 2010 AAN for pseudoephedrine (for sale) from 404,000 kg to
419,000 kg.
Phenylpropanolamine (for Conversion) Data
Phenylpropanolamine (for conversion) Data for 2010 Assessment of Annual Needs (Kilograms)
----------------------------------------------------------------------------------------------------------------
2010
Phenylpropanolamine (for sale) 2007 2008 2009 request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)........................................... 3,621 10,837 14,585 19,142
Imports ** (DEA 488)........................................ 8,250 12,019 11,373 33,698
Export Declarations (DEA 486)............................... 0 0 0 n/a
Inventory * (DEA 250)....................................... 3,581 5,537 3,693 n/a
APQ Amphetamine ***......................................... 22,000 22,000 24,500 23,500
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of March 10,
2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
*** Amphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.
Phenylpropanolamine (for Conversion) Analysis
DEA previously has established the 2010 AAN for phenylpropanolamine
(for conversion) at 16,500 kg (74 FR 60298). As noted above, DEA
developed the proposed revisions to the 2010 AAN for
phenylpropanolamine (for conversion) using the same calculation and
methodology that DEA used to determine the 2009 and 2010 AAN.
As of March 10, 2010, DEA registered manufacturers of
phenylpropanolamine (for conversion) requested the authority to
purchase a total of 19,142 kg phenylpropanolamine for the manufacture
of amphetamine. DEA registered manufacturers of phenylpropanolamine
reported sales of phenylpropanolamine totaling approximately 10,837 kg
in 2008 and 14,585 kg in 2009; this represent a 26 percent increase in
sales reported by these firms from 2008 to 2009. There were no reported
exports of phenylpropanolamine (for conversion). DEA has not received
any requests to synthesize phenylpropanolamine in 2010. DEA has
concluded that the 2009 sales of phenylpropanolamine (for conversion),
14,585 kg fairly represents U.S. requirements for 2010 and zero kg
fairly represents the export requirements of phenylpropanolamine (for
conversion).
Phenylpropanolamine (for conversion) is used for the manufacture of
legitimate amphetamine products. DEA notes, most legitimate amphetamine
is manufactured by the conversion of the schedule II controlled
substance phenylacetone to amphetamine, rather than the conversion of
phenylpropanolamine. DEA believes that the data provided in
procurement, manufacturing, and import quota applications best
represents the legitimate need for
[[Page 36688]]
phenylpropanolamine (for conversion) rather than total Aggregate
Production Quota (APQ) for amphetamine.
DEA calculated the phenylpropanolamine (for conversion) needed for
the manufacture of amphetamine as follows:
(2009 sales) + reserve stock + export requirement - inventory = AAN
(14,585) + 50%*(14,585) + 0 - 3,693 = 18,185 kg PPA (for conversion)
for 2010
This calculation suggests that DEA's 2010 AAN for
phenylpropanolamine (for conversion) should be 18,200 kg. Accordingly,
DEA is proposing to increase the 2010 AAN for phenylpropanolamine (for
conversion) from 16,500 kg to 18,200 kg.
Ephedrine (for Conversion) Data
Ephedrine (for Conversion) Data for 2010 Assessment of Annual Needs (Kilograms)
----------------------------------------------------------------------------------------------------------------
2010
Ephedrine (for conversion) 2007 2008 2009 request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)........................................... 99,622 64,522 40,403 40,600
Imports ** (DEA 488)........................................ 99,594 64,128 39,897 40,000
Inventory * (DEA 250)....................................... 13 160 254 n/a
APQ Methamphetamine ***..................................... 3,130 3,130 3,130 3,130
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas
(DEA 189) received as of March 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
*** Methamphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.
Ephedrine (for Conversion) Analysis
DEA previously has established the 2010 AAN for ephedrine (for
conversion) at 75,000 kg (74 FR 60298). As noted above, DEA developed
the proposed revisions to the 2010 AAN for ephedrine (for conversion)
using the same calculation and methodology that DEA used to determine
the 2009 and 2010 AAN.
As of March 10, 2010, DEA registered manufacturers of ephedrine
(for conversion) requested the authority to purchase a total of 40,600
kg ephedrine (for conversion) for the manufacture of two substances:
Methamphetamine and pseudoephedrine.
DEA considered the ephedrine (for conversion) requirements for the
manufacture of methamphetamine and pseudoephedrine. DEA has determined
that the established assessments for the manufacture of these two
substances are the best indicators of the need for ephedrine (for
conversion). The assessment of need for methamphetamine was determined
by DEA as the Aggregate Production Quota (APQ) for methamphetamine. DEA
determined that the estimated sales of pseudoephedrine, as referenced
in the AAN for pseudoephedrine, represents the need for
pseudoephedrine. Reported sales of ephedrine (for conversion) are
included as reference to DEA's methodology.
DEA further considered the reported conversion yields of these
substances. DEA registered manufacturers reported a conversion yield of
39 percent for the synthesis of methamphetamine from ephedrine. DEA
cannot disclose the conversion yield for the synthesis of
pseudoephedrine because this information is proprietary to the one
manufacturer involved in this type of manufacturing.
Thus, DEA calculated the ephedrine (for conversion) requirement for
the manufacture of methamphetamine as follows:
(2009 APQ methamphetamine/39% yield) + reserve stock - inventory =
ephedrine (for manufacture of methamphetamine)
(3,130/39% yield) + 50%*(3,130/39% yield) - 254 = 11,785 kg
The calculation for the ephedrine (for conversion) requirement for
the manufacture of pseudoephedrine leads to a result of 63,157 kg. DEA
cannot provide the details of the calculation because this would reveal
the conversion yield for the synthesis of pseudoephedrine, which is
proprietary to the one manufacturer involved in this type of
manufacturing.
Therefore, DEA determined the proposed revised assessment for
ephedrine (for conversion) by summing the amounts required for the
manufacture of methamphetamine and pseudoephedrine:
methamphetamine requirement + pseudoephedrine requirement = AAN
11,785 + 63,157 = 74,942 kg ephedrine (for conversion) for 2010
This calculation suggests that DEA's 2010 AAN for ephedrine (for
conversion) should be 75,000 kg. Accordingly, DEA is proposing that the
2010 AAN for ephedrine (for conversion) remain unchanged at 75,000 kg.
Conclusion
In finalizing the revised 2010 assessments for these List I
chemicals, DEA will use the methodology and calculations presented
above. The numbers used in the calculations may be adjusted upwards or
downwards based on the additional applications for 2010 import,
manufacturing and procurement quotas received after March 10, 2010, in
accordance with 21 CFR part 1315.
Therefore, under the authority vested in the Attorney General by
Section 306 of the CSA (21 U.S.C. 826), and delegated to the
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby
proposes the following revised 2010 AAN for the List I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine:
----------------------------------------------------------------------------------------------------------------
Previously established
List I chemicals initial 2010 Proposed revised 2010
assessment assessment
----------------------------------------------------------------------------------------------------------------
Ephedrine (for sale).......................................... 3,600 kg 4,100 kg
Phenylpropanolamine (for sale)................................ 6,400 kg 7,400 kg
Pseudoephedrine (for sale).................................... 404,000 kg 419,000 kg
Phenylpropanolamine (for conversion).......................... 16,500 kg 18,200 kg
Ephedrine (for conversion).................................... 75,000 kg No Change
----------------------------------------------------------------------------------------------------------------
[[Page 36689]]
All interested persons are invited to submit their comments in
writing or electronically regarding this proposal following the
procedures in the Addresses section of this document. A person may
object to or comment on the proposal relating to any of the above-
mentioned substances without filing comments or objections regarding
the others. If a person believes that one or more of these issues
warrant a hearing, the individual should so state and summarize the
reasons for this belief. Persons wishing to request a hearing should
note that such requests must be written and manually signed; requests
for a hearing will not be accepted via electronic means. In the event
that comments or objections to this proposal raise one or more issues
which the Deputy Administrator finds warrant a hearing, the Deputy
Administrator shall order a public hearing by notice in the Federal
Register, summarizing the issues to be heard and setting the time for
the hearing as per 21 CFR 1315.13(e).
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this action will not
have a significant economic impact upon small entities whose interests
must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601-
612. The establishment of the AAN for ephedrine, pseudoephedrine and
phenylpropanolamine is mandated by law. The assessments are necessary
to provide for the estimated medical, scientific, research and
industrial needs of the United States, for lawful export requirements,
and the establishment and maintenance of reserve stocks. Accordingly,
the Deputy Administrator has determined that this action does not
require a regulatory flexibility analysis.
Executive Order 12866
The Office of Management and Budget has determined that notices of
AAN are not subject to centralized review under Executive Order 12866.
Executive Order 13132
This action does not preempt or modify any provision of state law;
nor does it impose enforcement responsibilities on any state; nor does
it diminish the power of any state to enforce its own laws.
Accordingly, this action does not have federalism implications
warranting the application of Executive Order 13132.
Executive Order 12988
This action meets the applicable standards set forth in Sections
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
Unfunded Mandates Reform Act of 1995
This action will not result in the expenditure by state, local, and
tribal governments in the aggregate, or by the private sector, of
$120,000,000 or more in any one year, and will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under the provisions of the Unfunded Mandates Reform Act of
1995.
Congressional Review Act
This action is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. This action
will not result in an annual effect on the economy of $100,000,000 or
more; a major increase in costs or prices; or significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of United States-based companies to
compete with foreign-based companies in domestic and export markets.
Dated: June 19, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-15525 Filed 6-25-10; 8:45 am]
BILLING CODE 4410-09-P
