Established Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2009, 32954-32960 [E9-16152]
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32954
Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Notices
Dated: July 1, 2009.
John K. Rabiej,
Chief, Rules Committee Support Office.
[FR Doc. E9–16018 Filed 7–8–09; 8:45 am]
BILLING CODE 2210–55–M
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 Title 21
Code of Federal Regulations (CFR),
1301.34(a), this is notice that on
February 13, 2009, Rhodes
Technologies, 498 Washington Street,
Coventry, Rhode Island 02816, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the basic
classes of controlled substances listed in
schedule II:
Drug
Schedule
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Raw Opium (9600) .......................
Concentrate of Poppy Straw
(9670) ........................................
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Dated: June 24, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–16296 Filed 7–8–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
II
[Docket No. DEA–314E]
II
Established Assessment of Annual
Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2009
The company plans to import narcotic
raw materials to be used in ancillary
activities including product
development and analytical studies.
No comments, objections, or requests
for any hearings will be accepted on any
application for registration or reregistration to import raw opium and
concentrate of poppy straw. As
explained in the Correction to Notice of
Application pertaining to Rhodes
Technologies, 72 FR 3417 (2007),
comments and requests for hearings on
applications to import narcotic raw
material are not appropriate.
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.
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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 August 10, 2009.
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 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.
Drug Enforcement
Administration (DEA), Justice.
ACTION: Notice of Assessment of Annual
Needs for 2009.
AGENCY:
SUMMARY: This notice establishes the
initial 2009 Assessment of Annual
Needs for certain List I chemicals in
accordance with the Combat
Methamphetamine Epidemic Act of
2005 (CMEA), enacted on March 9,
2006.
DATES: Effective Date: August 10, 2009.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D., 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 (Title VII of Pub.
L. 109–177) (CMEA) amended Section
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306 of the Controlled Substances Act
(CSA) (21 U.S.C. 826) by adding
ephedrine, pseudoephedrine, and
phenylpropanolamine to existing
language to read as follows: ‘‘The
Attorney General shall determine the
total quantity and establish production
quotas for each basic class of controlled
substance in schedules I and II and for
ephedrine, pseudoephedrine, and
phenylpropanolamine to be
manufactured each calendar year to
provide for the estimated medical,
scientific, research, and industrial needs
of the United States, for lawful export
requirements, and for the establishment
and maintenance of reserve stocks.’’
Further, section 715 of CMEA amended
21 U.S.C. 952 ‘‘Importation of controlled
substances’’ by adding the same List I
chemicals to the existing language in
paragraph (a), and by adding a new
paragraph (d) to read as follows:
(a) Controlled substances in schedule I or
II and narcotic drugs in schedule III, IV, or
V; exceptions
It shall be unlawful to import into the
customs territory of the United States from
any place outside thereof (but within the
United States), or to import into the United
States from any place outside thereof, any
controlled substance in schedule I or II of
subchapter I of this chapter, or any narcotic
drug in schedule III, IV, or V of subchapter
I of this chapter, or ephedrine,
pseudoephedrine, and
phenylpropanolamine, except that—
(1) such amounts of crude opium, poppy
straw, concentrate of poppy straw, and coca
leaves, and of ephedrine, pseudoephedrine,
and phenylpropanolamine, as the Attorney
General finds to be necessary to provide for
medical, scientific, or other legitimate
purposes * * * may be so imported under
such regulations as the Attorney General
shall prescribe.
*
*
*
*
*
(d)(1) With respect to a registrant under
section 958 who is authorized under
subsection (a)(1) to import ephedrine,
pseudoephedrine, or phenylpropanolamine,
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).
Background and Legal Authority
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
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U.S.C. 826) to require that the Attorney
General establish quotas to provide for
the annual needs for ephedrine,
pseudoephedrine, and
phenylpropanolamine. Section 715 of
the CMEA amended 21 U.S.C. 952 by
adding ephedrine, pseudoephedrine,
and phenylpropanolamine to the
existing language concerning
importation of controlled substances.
The 2009 Assessment of Annual
Needs represents those quantities of
ephedrine, pseudoephedrine, and
phenylpropanolamine which may be
manufactured domestically and/or
imported into the United States in 2009
to provide adequate supplies of each
chemical for: The estimated medical,
scientific, research, and industrial needs
of the United States; lawful export
requirements; and the establishment
and maintenance of reserve stocks.
The responsibility for establishing the
assessment has been delegated to the
Administrator of the DEA by 28 CFR
Section 0.100. The Administrator, in
turn, has redelegated this function to the
Deputy Administrator, pursuant to 28
CFR Section 0.104.
On December 29, 2008, a notice
entitled, ‘‘Assessment of Annual Needs
for the List I Chemicals Ephedrine,
Pseudoephedrine, and
Phenylpropanolamine for 2009’’ was
published in the Federal Register (73
FR 79508). This notice established, on
an interim basis, the 2009 Assessment of
Annual Needs for ephedrine (for sale),
ephedrine (for conversion),
pseudoephedrine (for sale),
phenylpropanolamine (for sale) and
phenylpropanolamine (for conversion).
All interested persons were invited to
comment on or object to the interim
assessments on or before January 28,
2009.
Comments Received
DEA received a total of four
comments, one regarding the assessment
for ephedrine (for sale) and the other
three regarding the assessment for
phenylpropanolamine (for sale). The
first commenter was from a law firm
representing an industry group
comprised of distributors and retailers
of over-the-counter (OTC) medications.
This commenter believes that quota
requests for ephedrine (for sale) are not
comparable to the products sold and
recommended that the 2009 ephedrine
assessment be the same as the 2008
assessment (i.e. 11,500 kg).
The second comment was from a DEA
registered chemical manufacturer of
phenylpropanolamine who requested
that DEA ‘‘consider revising the
calculation methodology for
establishing (individual) quotas’’ and
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also encouraged ‘‘the establishment of a
safety reserve’’ for the list I chemicals.
The third and fourth comments were
received from two distributors of
veterinary prescription products
containing phenylpropanolamine. These
commenters encouraged DEA to
consider in its evaluation the medical
needs of the companion animal
population and for DEA to include in its
phenylpropanolamine (for sale)
assessment a safety reserve to ensure an
uninterrupted supply of the substance.
All comments received during the
comment period are discussed further
below.
DEA did not receive any comments on
its Interim Final Assessment of Annual
Needs for ephedrine (for conversion),
phenylpropanolamine (for conversion),
and pseudoephedrine (for sale). DEA is
adjusting the interim established
assessment for these chemicals based on
additional information provided by DEA
registered importers and manufacturers
whose quota applications were received
as of April 1, 2009 (i.e. one year after the
April 1, 2008, application due date).
DEA also is providing the underlying
data used in establishing these
assessments.
Comment Regarding DEA’s Interim
Final Assessment for Ephedrine (For
Sale)
DEA received one comment on its
Interim Final assessment for ephedrine
(for sale) from a law firm representing
an industry group comprised of
distributors and retailers of over-thecounter (OTC) medications. The
comment stated that ‘‘DEA’s projection
of decreased demand is inaccurate’’ and
recommended that the 2009 ephedrine
assessment be the same as the 2008 (for
sale) assessment (i.e. 11,500 kg). The
commenter made the following
statements: (1) ‘‘On an annualized basis,
the level of 941 [sic] kg requested as of
July 2008 (134 kg per month) may well
grow to 1,608 kg for all of 2009;’’ (2)
‘‘Comparing requests for raw materials
to actual sales of finished product does
not provide an accurate basis to measure
consumer demand or medical need;’’ (3)
‘‘DEA’s projection of decreased demand
is not based on the medical needs of
consumers, but on the effects of
increased regulation and decreased
supply;’’ and (4) the commenter stated
its concern with the DEA’s reliance on
data provided by IMS Health’s (IMS)
National Sales PerspectiveTM (NSP)
database.
DEA Response
In response to the first comment that
‘‘On an annualized basis, the level of
941 [sic] kg requested as of July 2008
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(134 kg per month) may well grow to
1,608 kg for all of 2009,’’ DEA believes
that the commenter misinterpreted its
original statement. DEA stated the
following in its interim assessment:
At the time DEA drafted the 2009 proposed
assessment (i.e., July 15, 2008), DEA
considered applications for procurement
quotas from DEA registered manufacturers of
ephedrine. These applications were due on
or before April 1, 2008. These firms
requested authority to purchase a total of 921
kg of ephedrine (for sale) in 2009. (73 FR
79510)
The commenter interpreted the
statement above to mean that the
manufacturers’ request to purchase 921
kg represented purchase requirements
for the first 7 months of the calendar
year, or 134 kg/month (134.4 kg × 7 =
941 kg [sic]). By this logic, the
commenter believed the annual
requirement for ephedrine could be as
much as 1,608 kg (134 kg × 12 months
= 1,608 kg). This is an incorrect
interpretation. DEA registered
manufacturers of ephedrine that had
submitted applications on or before July
15, 2008, requested the authority to
purchase a total of 921 kg of ephedrine
for the entire calendar year of 2009. This
means that the total annual requirement
of ephedrine (for sale) for 2009 for the
United States was 921 kg, as reported by
DEA registered manufacturers.
In response to the commenter’s
second comment that ‘‘comparing
requests for raw materials to actual sales
of finished product does not provide an
accurate basis to measure consumer
demand or medical need,’’ DEA notes
that the regulations require DEA to
consider the ‘‘projected demand for
each chemical [ephedrine] as indicated
by procurement and import quotas
requested pursuant to section 1315.32.’’
(see 21 CFR 1315.11(b)(4)). DEA also
notes that requests for raw material
consider not only the raw material
necessary to meet medical needs, but
also the raw material needed for other
uses. For instance, raw material requests
include the additional quantities
necessary to bring a finished product to
market, to cover production losses
occurring during manufacturing and
packaging operations, to allow for
quality assurance/control testing, and to
provide additional quantities for the
reserve stocks of distributors and
retailers.
The commenter’s third comment is
that the DEA’s projection of decreased
demand is not based on the medical
needs of consumers, but on the effects
of increased regulation and decreased
supply. In response to this comment,
DEA notes that the regulation at 21 CFR
1315.11(b) clearly articulates those
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factors that DEA is to consider when
making its determination, which
include:
1. Total net disposal of the chemical
by all manufacturers and importers
during the current and preceding two
years;
2. Trends in the national rate of net
disposal of each chemical;
3. Total actual (or estimated)
inventories of the chemical and of all
substances manufactured from the
chemical, and trends in inventory
accumulation;
4. Projected demand for each
chemical as indicated by procurement
and import quotas requested pursuant to
section 1315.32, and
5. Other factors * * * as the
Administrator finds relevant.
Medical need could impact one or
several of these factors. For instance,
increased medical need could result in
an increased number of quota
applications, decreased inventories, and
changes upward in the national rate of
disposals. Thus, it is not necessary to
consider medical need separately from
the factors mandated by the regulation.
Finally, in response to the fourth
comment, in which the commenter
noted its ‘‘concern over the DEA’s
reliance on data provided by IMS in
proposing the 2009 assessment,’’ DEA
notes that data provided by IMS Health
provides national estimates of sales at
the retail level which are used to
consider trends in the rate of net
disposals (i.e., sales) as mandated by
regulation. The most recent IMS data
available reports retail level sales
totaling 1,267 kg in 2007 and 1,489 kg
in 2008; this represents an 18 percent
increase in retail sales from 2007 to
2008. During the same period registered
manufacturers of ephedrine reported
sales totaling approximately 5,409 kg in
2007 and 2,465 kg in 2008; this
represents a 54 percent decrease in sales
reported by these firms from 2007 to
2008. The retail sales reported by IMS
Health are expected to be lower than the
sales to distributors and retailers
reported by manufacturers because a
manufacturer’s sales include quantities
which are necessary to provide reserve
stocks for distributors and retailers. DEA
also believes that manufacturers’ sales
in 2007 may have been artificially
inflated as manufacturers, distributors,
and retailers built unusually large
reserve stocks due to concerns over
newly codified regulations that were
thought to limit or restrict the
availability of substances. DEA thus
believes that the manufacturers’
reported sales of 2,465 kg fairly
represent the net disposals of ephedrine
products. DEA notes that IMS data is
one of several considerations that DEA
uses to evaluate trends and projected
demand of ephedrine-based products.
As the calculations and methodology
demonstrate, the assessment of annual
needs for ephedrine is based primarily
on the information provided by DEA
registered manufacturers and importers
of ephedrine products.
DEA has received additional quota
applications from DEA registered
manufacturers and importers for the
2009 assessment year. Based on an
analysis of the underlying data from
quota applications received through
April 1, 2009, DEA is establishing the
2009 assessment of annual needs for
ephedrine (for sale) at 3,400 kg.
Ephedrine Data
EPHEDRINE (FOR SALE) DATA FOR 2009 ASSESSMENT OF ANNUAL NEEDS
[Kilograms]
Ephedrine
2006
Sales * (DEA 250) ............................................................................................
Imports ** (DEA 488) .......................................................................................
Export Declarations (DEA 486) .......................................................................
Inventory * (DEA 250) ......................................................................................
IMS *** (NSP) ...................................................................................................
2007
5,435
3,886
313
1,245
1,256
5,409
10,480
168
1,457
1,267
20081
2,465
2,104
91
423
1,489
2009 Request
3,088
2,678
n/a
n/a
n/a
* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) received as of April 1, 2009.
** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009.
*** IMS Health, IMS National Sales PerspectivesTM, January 2006 to December 2008, Retail and Non-Retail Channels, Data Extracted April 1,
2009.
Underlying Data and DEA’s Analysis
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The DEA considered total net
disposals (i.e. sales) of ephedrine for the
current and preceding two years, actual
and estimated inventories, projected
demand (2009), 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).2
DEA further considered trends as
derived from information provided in
1 2008
data represents estimated sales, imports,
and inventories as reported on applications for
quotas.
2 Applications and instructions for procurement,
import and manufacturing quotas can be found at
https://www.deadiversion.usdoj.gov/quotas/
quota_apps.htm.
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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 provided by manufacturers
and importers. This information
includes applications which have been
newly submitted, amended or
withdrawn as of April 1, 2009, for the
2009 quota year.
Ephedrine Calculation
DEA calculated the 2009 Assessment
of Annual Needs for ephedrine as
follows. DEA developed a calculation
that considers the criteria defined in 21
U.S.C. 826: Estimated medical,
scientific, research, and industrial needs
of the United States; lawful export
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requirements; and the establishment
and maintenance of reserve stocks.
As of April 1, 2009, DEA registered
manufacturers of dosage form products
containing ephedrine reported sales
totaling approximately 5,409 kg in 2007
and 2,465 kg in 2008; this represents a
54 percent decrease in sales reported by
these firms from 2007 to 2008.
Additionally, exports of ephedrine
products from the United States as
reported on export declarations (DEA
486), totaled 168 kg in 2007 and 91 kg
in 2008; this represents a 46 percent
decrease from levels observed in 2007.
DEA also considered information on
trends in the national rate of net
disposals from sales data provided by
IMS Health’s NSP database. IMS NSP
data reported the average sales volume
of ephedrine for the calendar years 2007
and 2008 to be approximately 1,378 kg.
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DEA notes that the 2008 sales figure
reported by manufacturers (2,465 kg) is
higher than the sales reported by IMS
(1,378 kg). As previously explained, 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 2,465 kg fairly
represents the U.S. sales of ephedrine
for 2009 and that 91 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 2008 year end inventory as
reported by DEA registrants in
determining the inventory allowance.
DEA calculated the ephedrine (for
sale) assessment by the following
methodology:
2008 sales + reserve stock + export
requirement ¥ existing inventory =
AAN
2,465 + (50 percent * 2,465) + 91 ¥ 423
= 3,366 kg ephedrine (for sale) for
2009
This calculation suggests that DEA’s
Assessment of Annual Needs for
ephedrine can be revised to 3,400 kg
rather than the 1,500 kg established in
the Interim Final Rule. DEA notes that
this upward revision is attributed to
DEA’s consideration of applications for
2009 quotas received as of April 1, 2009,
a one-year time period since the
application due date.
Accordingly, DEA is establishing the
Assessment of Annual Needs for
ephedrine (for sale) at 3,400 kg.
Comments Regarding DEA’s Interim
Final Assessment for
Phenylpropanolamine (For Sale)
The second commenter, a
manufacturer of phenylpropanolamine
products used by veterinary
professionals, urged DEA ‘‘to consider
revising the calculation methodology for
establishing quotas’’ to consider
whether the market need was met in the
prior year. Additionally, the commenter
suggested that there ‘‘should be a factor
inserted in the calculation that would
more accurately reflect market need and
the changing demand.’’ The commenter
also encouraged ‘‘the establishment of a
safety reserve so that the DEA and
manufacturers can be responsive to the
ever-changing health care needs of
companion animals.’’
The third and fourth comments were
received from two distributors that sell
phenylpropanolamine products used by
veterinarians. These commenters stated
that ‘‘To base quotas on last year’s sales
and inventories and formulas does not
allow for the increased need.’’ The
commenters encouraged DEA ‘‘to
consider increasing the quotas based on
the aging of the companion animal
population.’’ Additionally, the
commenter encouraged DEA ‘‘to work
with individual manufacturers of PPA
in order to assure the uninterrupted
supply of PPA.’’
DEA Response
As a preliminary matter, this Federal
Register notice establishes the
assessment of annual needs for List I
chemicals and the methodology used by
the DEA to set that number. The
assessment of annual needs is different
than individual quotas and this
rulemaking does not address the
regulatory process for evaluating
individual import, manufacturing and
procurement quotas issued to DEA
registered manufacturers and importers.
With regard to the establishment of
the assessment of annual needs for
phenylpropanolamine (for sale), DEA
believes that the sales information
provided in requests for quotas for the
manufacture of phenylpropanolamine
products fairly represents the legitimate
medical needs of the companion animal
population. Additionally, DEA notes
that the requirements of the two
distributors and one manufacturer of
phenylpropanolamine were considered
as part of the assessment for
phenylpropanolamine. DEA notes that
there was a 3 percent increase in
reported sales of phenylpropanolamine
from 2007 to 2008. For the 2009
assessment, DEA has determined that
the higher 2008 sales fairly represent the
manufacturing requirements of
phenylpropanolamine. In calculating
the assessment, DEA provides for
quantities to support sales of
phenylpropanolamine and also for a
reserve stock of 50 percent. This is not
only consistent with the 50 percent
inventory allowance permitted under 21
CFR 1315.24, but also provides
manufacturers with sufficient material
to account for slight increases in
demand that may occur in 2009.
Additionally, DEA notes that
pursuant to 21 CFR 1315.32, DEA
registered manufacturers and importers
may request adjustments to their
individual quotas at any time. This
option allows the DEA and DEA
registrants to respond to the changing
needs of the companion animal
population.
Considering that 2008 was the first
year of implementation of quotas for the
List I chemicals, DEA is revising the
2009 assessments to consider
applications received as of April 1, 2009
(i.e. one year after the April 1, 2008,
application due date). This ensures that
DEA considered the most recent
information provided by DEA registered
manufacturers and importers for 2009.
A summary of the underlying data from
quota applications and other sources, as
well as DEA’s analysis of that data, are
provided below.
Phenylpropanolamine (For Sale) Data
PHENYLPROPANOLAMINE (FOR SALE) DATA FOR 2009 ASSESSMENT OF ANNUAL NEEDS
[Kilograms]
Phenylpropanolamine (for sale)
2006
Sales * (DEA 250) ............................................................................................
Imports ** (DEA 488) .......................................................................................
Export Declarations (DEA 486) .......................................................................
Inventory * (DEA 250) ......................................................................................
2007
4,179
1,119
0
3,555
4,224
9,381
1,002
3,976
2008 3
4,362
3,032
0
1,696
2009 Request
5,462
5,295
n/a
n/a
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* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of
April 1, 2009.
** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009.
3 2008 data represents estimated sales, imports,
and inventories as reported on applications for
quotas.
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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 April 1, 2009, DEA registered
manufacturers of dosage form products
containing phenylpropanolamine
reported sales totaling approximately
4,224 kg in 2007 and 4,362 kg in 2008;
this represents a 3 percent increase in
sales reported by these firms from 2007
to 2008. 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:
2008 sales + reserve stock + export
requirement ¥ existing inventory =
AAN
4,362 + (50 percent * 4,362) + 0
¥ 1,696 = 4,847 kg
phenylpropanolamine (for sale) for
2009
This calculation suggests that DEA’s
Assessment of Annual Needs for
phenylpropanolamine (for sale) can be
revised to be 4,900 kg rather than the
4,500 kg established in the Interim Final
Rule.
DEA is establishing the Assessment of
Annual Needs for phenylpropanolamine
(for sale) at 4,900 kg.
Pseudoephedrine, Ephedrine (for
Conversion), and Phenylpropanolamine
(for Conversion)
DEA did not receive any comments on
its interim Assessment of Annual Needs
for pseudoephedrine, ephedrine (for
conversion), and phenylpropanolamine
(for conversion). However, DEA is
providing the underlying data, analysis,
methodology and calculation for the
establishment of the assessments for
these List I chemicals. These
assessments reflect new information
received from applications for quota
received as of April 1, 2009 (i.e. one
year after the April 1, 2008 application
due date).
Pseudoephedrine (for Sale) Data
PSEUDOEPHEDRINE (FOR SALE) DATA FOR 2009 ASSESSMENT OF ANNUAL NEEDS
[Kilograms]
Pseudoephedrine (for sale)
2006
Sales * (DEA 250) ............................................................................................
Sales * (DEA 189) ............................................................................................
Imports ** (DEA 488) .......................................................................................
Export Declarations (DEA 486) .......................................................................
Inventory * (DEA 250) ......................................................................................
IMS *** (NSP) ...................................................................................................
232,721
56,563
133,802
37,069
83,104
207,509
2007
215,877
100,300
225,973
42,142
115,307
183,382
2008 4
262,159
111,292
165,708
85,756
89,921
151,013
2009 Request
273,659
105,967
205,783
n/a
n/a
n/a
* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of
April 1, 2009.
** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009.
*** IMS Health, IMS National Sales PerspectivesTM, January 2006 to December 2008, Retail and Non-Retail Channels, Data Extracted April 1,
2009.
Pseudoephedrine (for Sale) Analysis
rmajette on DSK29S0YB1 with NOTICES
DEA utilized the same general
methodology and calculations to
establish the assessment for
pseudoephedrine (for sale) as was
described for the assessment of
ephedrine (for sale), above.
As of April 1, 2009, DEA registered
manufacturers of dosage form products
containing pseudoephedrine reported
sales totaling approximately 215,877 kg
in 2007 and 262,159 kg in 2008; this
represents a 21 percent increase in sales
reported by these firms from 2007 to
2008. During the same period exports of
pseudoephedrine products from the
United States as reported on export
declarations (DEA 486) totaled 42,142
kg in 2007 and 85,756 kg in 2008; this
represents a 103 percent increase from
levels observed in 2007. Additionally,
DEA considered information on trends
in the national rate of net disposals from
sales data provided by IMS Health. IMS
NSP data reported the average retail
sales volume of pseudoephedrine for the
calendar years 2007 and 2008 to be
approximately 167,171 kg. DEA thus
believes that 262,159 kg of sales
reported by manufacturers fairly
represents the U.S. sales of
pseudoephedrine for 2009 and that
85,756 kg fairly represents the export
requirements of pseudoephedrine. DEA
notes that manufacturer reported sales
(262,159 kg) are higher than the retail
sales reported by IMS (167,171 kg). This
is expected because a manufacturer’s
reported sales include quantities which
are necessary to provide reserve stocks
for distributors and retailers. DEA
calculated the pseudoephedrine (for
sale) assessment by the following
methodology:
2008 sales + reserve stock + export
requirement ¥ existing inventory =
AAN
262,159 + (50 percent * 262,159) +
85,756 ¥ 89,921 = 389,074 kg
pseudoephedrine (for sale) for 2009
This calculation suggests that based
on quota applications received as of
April 1, 2009, DEA’s Assessment of
Annual Needs for pseudoephedrine (for
sale) should be established at 390,000 kg
rather than the 380,000 kg established in
the December 29, 2008 Interim Final
Rule. DEA is establishing the
Assessment of Annual Needs for
pseudoephedrine (for sale) at 390,000
kg.
Phenylpropanolamine (for Conversion)
Data
4 2008 data represents estimated sales, imports,
and inventories as reported on applications for
quotas.
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PHENYLPROPANOLAMINE (FOR CONVERSION) DATA FOR 2009 ASSESSMENT OF ANNUAL NEEDS
[Kilograms]
Phenylpropanolamine (for conversion)
2006
Sales * (DEA 250) ............................................................................................
Imports ** (DEA 488) .......................................................................................
Export Declarations (DEA 486) .......................................................................
Inventory * (DEA 250) ......................................................................................
APQ Amphetamine *** .....................................................................................
2007
8,004
14,476
0
4,863
17,000
2008 5
9,991
9,370
0
3,742
22,000
2009 Request
15,498
15,776
0
4,566
22,000
13,606
14,175
n/a
n/a
n/a
* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) received as of April 1, 2009.
** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009.
*** Amphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.htm.
Phenylpropanolamine (for Conversion)
Analysis
As of April 1, 2009, DEA registered
manufacturers of phenylpropanolamine
(for conversion) requested the authority
to purchase a total of 13,606 kg
phenylpropanolamine (for conversion).
Additionally, DEA registered importers
of phenylpropanolamine (for
conversion) requested the authority to
import a total of 14,175 kg of
phenylpropanolamine (for conversion).
DEA had not received any requests to
synthesize phenylpropanolamine in
2009.
DEA has determined that 13,606 kg of
phenylpropanolamine (for conversion)
would be insufficient to meet the
requirements for phenylpropanolamine
for the production of amphetamine as
established by DEA as the Aggregate
Production Quota (APQ) for
amphetamine (i.e., 22,000 kg for 2008).
13,606 kg would be sufficient to
manufacture only 30 percent of the APQ
of amphetamine. DEA further
considered manufacturer’s conversion
yields of phenylpropanolamine to
amphetamine of 50 percent in its
calculation of the phenylpropanolamine
assessment. DEA calculated the
phenylpropanolamine (for conversion)
assessment by the following
methodology:
(2008 APQ/50 percent yield) + reserve
stock ¥ inventory = AAN
(22,000/50 percent yield) + 50 percent *
(22,000/50 percent yield) ¥ 4,566 =
61,434 kg PPA (for conversion) for
2009
This calculation suggests that DEA’s
Assessment of Annual Needs for
phenylpropanolamine (for conversion)
should be established as 62,000 kg, as
established in the Interim Final Rule.
DEA is establishing the Assessment of
Annual Needs for phenylpropanolamine
(for conversion) at 62,000 kg.
Ephedrine (for Conversion) Data
EPHEDRINE (FOR CONVERSION) DATA FOR 2009 ASSESSMENT OF ANNUAL NEEDS
[Kilograms]
Ephedrine (for conversion)
2006
Sales * (DEA 250) ............................................................................................
Imports ** (DEA 488) .......................................................................................
Inventory * (DEA 250) ......................................................................................
APQ Methamphetamine *** ..............................................................................
49,973
43,612
77
3,130
2007
100,093
107,230
28
3,130
2008 6
133,209
122,683
10
3,130
2009 Request
112,277
111,365
n/a
n/a
* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) and manufacturing quotas (DEA 189) received as of
April 1, 2009.
** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009.
*** Methamphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.htm
rmajette on DSK29S0YB1 with NOTICES
Ephedrine (for Conversion) Analysis
For ephedrine (for conversion), DEA
utilized the same general methodology
and calculation as was described for the
assessment of phenylpropanolamine (for
conversion), above.
As of April 1, 2009, DEA registered
manufacturers of ephedrine (for
conversion) requested the authority to
purchase a total of 112,277 kg ephedrine
(for conversion) for the manufacture of
two substances: methamphetamine and
pseudoephedrine.
DEA in its methodology considered
the ephedrine (for conversion)
requirements for the manufacture of
these two substances:
methamphetamine and
5 2008 data represents estimated sales, imports,
and inventories as reported on applications for
quotas.
VerDate Nov<24>2008
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Jkt 217001
pseudoephedrine. DEA has determined
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. The
assessment of need for pseudoephedrine
was determined by DEA as the
estimated sales of pseudoephedrine as
referenced in the 2008 Annual
Assessment of Need (AAN) 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.
These firms reported a conversion yield
of 39 percent for the synthesis of
methamphetamine. 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
The calculation for the ephedrine (for
conversion) requirement for the
6 2008 data represents estimated sales, imports,
and inventories as reported on applications for
quotas.
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rmajette on DSK29S0YB1 with NOTICES
manufacture of methamphetamine is as
follows:
(2008 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) ¥ 35 =
12,003 kg
The calculation for the ephedrine (for
conversion) requirement for the
manufacture of pseudoephedrine leads
to a result of 106,424 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
12,003 + 106,424 = 118,427 kg
ephedrine (for conversion) for 2009
This calculation suggests that based
on applications received as of April 1,
2009, DEA’s Assessment of Annual
Needs for ephedrine (for conversion)
should be established as 120,000 kg
rather than the 110,000 kg established
on an interim basis in the December 29,
2008, notice. Under this rulemaking,
DEA is establishing the Assessment of
Annual Needs for ephedrine (for
conversion) as 120,000 kg.
Conclusion
DEA has carefully considered the
comments received in connection with
the 2009 Assessment of Annual Needs.
Based on information provided in the
comments, along with information
provided by DEA-registered
manufacturers and importers of these
List I chemicals on applications for
individual import, manufacturing, and
procurement quotas pursuant to DEA
regulations, DEA has fully addressed the
relevant issues set forth in the
comments. 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 Section 0.100,
and redelegated to the Deputy
Administrator pursuant to 28 CFR
Section 0.104, the Deputy Administrator
hereby orders that the 2009 Assessment
of Annual Needs for ephedrine,
pseudoephedrine, and
phenylpropanolamine, expressed in
kilograms of anhydrous acid or base, be
established as follows:
VerDate Nov<24>2008
15:49 Jul 08, 2009
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Established
2009
Assessment of
Annual Needs
List I chemical
Ephedrine (for sale) ..............
Ephedrine (for conversion) ...
Pseudoephedrine (for sale) ..
Phenylpropanolamine (for
sale) ..................................
Phenylpropanolamine (for
conversion) ........................
3,400
120,000
390,000
4,900
Frm 00085
Fmt 4703
Sfmt 4703
Dated: June 26, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–16152 Filed 7–8–09; 8:45 am]
BILLING CODE 4410–09–P
62,000
The Office of Management and Budget
has determined that notices of quotas
are not subject to centralized review
under Executive Order 12866.
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 any federalism
implications warranting the application
of Executive Order 13132.
The Deputy Administrator hereby
certifies that this action will not have a
significant economic impact upon a
substantial number of small entities
whose interests must be considered
under the Regulatory Flexibility Act, 5
U.S.C. 601–612. The establishment of
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.
This action meets the applicable
standards set forth in Sections 3(a) and
3(b)(2) of Executive Order 12988 Civil
Justice Reform.
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
(adjusted for inflation) 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.
This action is not a major rule as
defined by Section 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act). 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
PO 00000
companies to compete with foreignbased companies in domestic and
export markets.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated June 7, 2007, and
published in the Federal Register on
June 20, 2007, 72 FR 34040, Cambrex
Charles City, Inc., 1205 11th Street,
Charles City, Iowa 50616–3466, 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 II:
Drug
Opium, raw (9600) ........................
Poppy Straw Concentrate (9670)
Schedule
II
II
The company plans to import the
basic classes of controlled substances
for manufacture of active
pharmaceutical ingredients for sale to
its customers.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a)
and determined that the registration of
Cambrex Charles City, Inc. to import the
basic classes of controlled substances is
consistent with the public interest and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971, at
this time. DEA has investigated
Cambrex Charles City, Inc. to ensure
that the company’s registration is
consistent with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 952(a)
and 958(a), and in accordance with 21
CFR 1301.34, the above named company
is granted registration as an importer of
the basic classes of controlled
substances listed.
E:\FR\FM\09JYN1.SGM
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Agencies
[Federal Register Volume 74, Number 130 (Thursday, July 9, 2009)]
[Notices]
[Pages 32954-32960]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16152]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-314E]
Established Assessment of Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2009
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of Assessment of Annual Needs for 2009.
-----------------------------------------------------------------------
SUMMARY: This notice establishes the initial 2009 Assessment of Annual
Needs for certain List I chemicals in accordance with the Combat
Methamphetamine Epidemic Act of 2005 (CMEA), enacted on March 9, 2006.
DATES: Effective Date: August 10, 2009.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., 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 (Title VII of Pub. L. 109-177) (CMEA) amended
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) by
adding ephedrine, pseudoephedrine, and phenylpropanolamine to existing
language to read as follows: ``The Attorney General shall determine the
total quantity and establish production quotas for each basic class of
controlled substance in schedules I and II and for ephedrine,
pseudoephedrine, and phenylpropanolamine to be manufactured each
calendar year to provide for the estimated medical, scientific,
research, and industrial needs of the United States, for lawful export
requirements, and for the establishment and maintenance of reserve
stocks.'' Further, section 715 of CMEA amended 21 U.S.C. 952
``Importation of controlled substances'' by adding the same List I
chemicals to the existing language in paragraph (a), and by adding a
new paragraph (d) to read as follows:
(a) Controlled substances in schedule I or II and narcotic drugs
in schedule III, IV, or V; exceptions
It shall be unlawful to import into the customs territory of the
United States from any place outside thereof (but within the United
States), or to import into the United States from any place outside
thereof, any controlled substance in schedule I or II of subchapter
I of this chapter, or any narcotic drug in schedule III, IV, or V of
subchapter I of this chapter, or ephedrine, pseudoephedrine, and
phenylpropanolamine, except that--
(1) such amounts of crude opium, poppy straw, concentrate of
poppy straw, and coca leaves, and of ephedrine, pseudoephedrine, and
phenylpropanolamine, as the Attorney General finds to be necessary
to provide for medical, scientific, or other legitimate purposes * *
* may be so imported under such regulations as the Attorney General
shall prescribe.
* * * * *
(d)(1) With respect to a registrant under section 958 who is
authorized under subsection (a)(1) to import ephedrine,
pseudoephedrine, or phenylpropanolamine, 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).
Background and Legal Authority
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
[[Page 32955]]
U.S.C. 826) to require that the Attorney General establish quotas to
provide for the annual needs for ephedrine, pseudoephedrine, and
phenylpropanolamine. Section 715 of the CMEA amended 21 U.S.C. 952 by
adding ephedrine, pseudoephedrine, and phenylpropanolamine to the
existing language concerning importation of controlled substances.
The 2009 Assessment of Annual Needs represents those quantities of
ephedrine, pseudoephedrine, and phenylpropanolamine which may be
manufactured domestically and/or imported into the United States in
2009 to provide adequate supplies of each chemical for: The estimated
medical, scientific, research, and industrial needs of the United
States; lawful export requirements; and the establishment and
maintenance of reserve stocks.
The responsibility for establishing the assessment has been
delegated to the Administrator of the DEA by 28 CFR Section 0.100. The
Administrator, in turn, has redelegated this function to the Deputy
Administrator, pursuant to 28 CFR Section 0.104.
On December 29, 2008, a notice entitled, ``Assessment of Annual
Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2009'' was published in the Federal Register
(73 FR 79508). This notice established, on an interim basis, the 2009
Assessment of Annual Needs for ephedrine (for sale), ephedrine (for
conversion), pseudoephedrine (for sale), phenylpropanolamine (for sale)
and phenylpropanolamine (for conversion). All interested persons were
invited to comment on or object to the interim assessments on or before
January 28, 2009.
Comments Received
DEA received a total of four comments, one regarding the assessment
for ephedrine (for sale) and the other three regarding the assessment
for phenylpropanolamine (for sale). The first commenter was from a law
firm representing an industry group comprised of distributors and
retailers of over-the-counter (OTC) medications. This commenter
believes that quota requests for ephedrine (for sale) are not
comparable to the products sold and recommended that the 2009 ephedrine
assessment be the same as the 2008 assessment (i.e. 11,500 kg).
The second comment was from a DEA registered chemical manufacturer
of phenylpropanolamine who requested that DEA ``consider revising the
calculation methodology for establishing (individual) quotas'' and also
encouraged ``the establishment of a safety reserve'' for the list I
chemicals.
The third and fourth comments were received from two distributors
of veterinary prescription products containing phenylpropanolamine.
These commenters encouraged DEA to consider in its evaluation the
medical needs of the companion animal population and for DEA to include
in its phenylpropanolamine (for sale) assessment a safety reserve to
ensure an uninterrupted supply of the substance. All comments received
during the comment period are discussed further below.
DEA did not receive any comments on its Interim Final Assessment of
Annual Needs for ephedrine (for conversion), phenylpropanolamine (for
conversion), and pseudoephedrine (for sale). DEA is adjusting the
interim established assessment for these chemicals based on additional
information provided by DEA registered importers and manufacturers
whose quota applications were received as of April 1, 2009 (i.e. one
year after the April 1, 2008, application due date). DEA also is
providing the underlying data used in establishing these assessments.
Comment Regarding DEA's Interim Final Assessment for Ephedrine (For
Sale)
DEA received one comment on its Interim Final assessment for
ephedrine (for sale) from a law firm representing an industry group
comprised of distributors and retailers of over-the-counter (OTC)
medications. The comment stated that ``DEA's projection of decreased
demand is inaccurate'' and recommended that the 2009 ephedrine
assessment be the same as the 2008 (for sale) assessment (i.e. 11,500
kg). The commenter made the following statements: (1) ``On an
annualized basis, the level of 941 [sic] kg requested as of July 2008
(134 kg per month) may well grow to 1,608 kg for all of 2009;'' (2)
``Comparing requests for raw materials to actual sales of finished
product does not provide an accurate basis to measure consumer demand
or medical need;'' (3) ``DEA's projection of decreased demand is not
based on the medical needs of consumers, but on the effects of
increased regulation and decreased supply;'' and (4) the commenter
stated its concern with the DEA's reliance on data provided by IMS
Health's (IMS) National Sales PerspectiveTM (NSP) database.
DEA Response
In response to the first comment that ``On an annualized basis, the
level of 941 [sic] kg requested as of July 2008 (134 kg per month) may
well grow to 1,608 kg for all of 2009,'' DEA believes that the
commenter misinterpreted its original statement. DEA stated the
following in its interim assessment:
At the time DEA drafted the 2009 proposed assessment (i.e., July
15, 2008), DEA considered applications for procurement quotas from
DEA registered manufacturers of ephedrine. These applications were
due on or before April 1, 2008. These firms requested authority to
purchase a total of 921 kg of ephedrine (for sale) in 2009. (73 FR
79510)
The commenter interpreted the statement above to mean that the
manufacturers' request to purchase 921 kg represented purchase
requirements for the first 7 months of the calendar year, or 134 kg/
month (134.4 kg x 7 = 941 kg [sic]). By this logic, the commenter
believed the annual requirement for ephedrine could be as much as 1,608
kg (134 kg x 12 months = 1,608 kg). This is an incorrect
interpretation. DEA registered manufacturers of ephedrine that had
submitted applications on or before July 15, 2008, requested the
authority to purchase a total of 921 kg of ephedrine for the entire
calendar year of 2009. This means that the total annual requirement of
ephedrine (for sale) for 2009 for the United States was 921 kg, as
reported by DEA registered manufacturers.
In response to the commenter's second comment that ``comparing
requests for raw materials to actual sales of finished product does not
provide an accurate basis to measure consumer demand or medical need,''
DEA notes that the regulations require DEA to consider the ``projected
demand for each chemical [ephedrine] as indicated by procurement and
import quotas requested pursuant to section 1315.32.'' (see 21 CFR
1315.11(b)(4)). DEA also notes that requests for raw material consider
not only the raw material necessary to meet medical needs, but also the
raw material needed for other uses. For instance, raw material requests
include the additional quantities necessary to bring a finished product
to market, to cover production losses occurring during manufacturing
and packaging operations, to allow for quality assurance/control
testing, and to provide additional quantities for the reserve stocks of
distributors and retailers.
The commenter's third comment is that the DEA's projection of
decreased demand is not based on the medical needs of consumers, but on
the effects of increased regulation and decreased supply. In response
to this comment, DEA notes that the regulation at 21 CFR 1315.11(b)
clearly articulates those
[[Page 32956]]
factors that DEA is to consider when making its determination, which
include:
1. Total net disposal of the chemical by all manufacturers and
importers during the current and preceding two years;
2. Trends in the national rate of net disposal of each chemical;
3. Total actual (or estimated) inventories of the chemical and of
all substances manufactured from the chemical, and trends in inventory
accumulation;
4. Projected demand for each chemical as indicated by procurement
and import quotas requested pursuant to section 1315.32, and
5. Other factors * * * as the Administrator finds relevant.
Medical need could impact one or several of these factors. For
instance, increased medical need could result in an increased number of
quota applications, decreased inventories, and changes upward in the
national rate of disposals. Thus, it is not necessary to consider
medical need separately from the factors mandated by the regulation.
Finally, in response to the fourth comment, in which the commenter
noted its ``concern over the DEA's reliance on data provided by IMS in
proposing the 2009 assessment,'' DEA notes that data provided by IMS
Health provides national estimates of sales at the retail level which
are used to consider trends in the rate of net disposals (i.e., sales)
as mandated by regulation. The most recent IMS data available reports
retail level sales totaling 1,267 kg in 2007 and 1,489 kg in 2008; this
represents an 18 percent increase in retail sales from 2007 to 2008.
During the same period registered manufacturers of ephedrine reported
sales totaling approximately 5,409 kg in 2007 and 2,465 kg in 2008;
this represents a 54 percent decrease in sales reported by these firms
from 2007 to 2008. The retail sales reported by IMS Health are expected
to be lower than the sales to distributors and retailers reported by
manufacturers because a manufacturer's sales include quantities which
are necessary to provide reserve stocks for distributors and retailers.
DEA also believes that manufacturers' sales in 2007 may have been
artificially inflated as manufacturers, distributors, and retailers
built unusually large reserve stocks due to concerns over newly
codified regulations that were thought to limit or restrict the
availability of substances. DEA thus believes that the manufacturers'
reported sales of 2,465 kg fairly represent the net disposals of
ephedrine products. DEA notes that IMS data is one of several
considerations that DEA uses to evaluate trends and projected demand of
ephedrine-based products. As the calculations and methodology
demonstrate, the assessment of annual needs for ephedrine is based
primarily on the information provided by DEA registered manufacturers
and importers of ephedrine products.
DEA has received additional quota applications from DEA registered
manufacturers and importers for the 2009 assessment year. Based on an
analysis of the underlying data from quota applications received
through April 1, 2009, DEA is establishing the 2009 assessment of
annual needs for ephedrine (for sale) at 3,400 kg.
Ephedrine Data
Ephedrine (for Sale) Data for 2009 Assessment of Annual Needs
[Kilograms]
----------------------------------------------------------------------------------------------------------------
Ephedrine 2006 2007 2008\1\ 2009 Request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)............................... 5,435 5,409 2,465 3,088
Imports ** (DEA 488)............................ 3,886 10,480 2,104 2,678
Export Declarations (DEA 486)................... 313 168 91 n/a
Inventory * (DEA 250)........................... 1,245 1,457 423 n/a
IMS *** (NSP)................................... 1,256 1,267 1,489 n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) received as of April 1,
2009.
** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009.
*** IMS Health, IMS National Sales PerspectivesTM, January 2006 to December 2008, Retail and Non-Retail
Channels, Data Extracted April 1, 2009.
Underlying Data and DEA's Analysis
The DEA considered total net disposals (i.e. sales) of ephedrine
for the current and preceding two years, actual and estimated
inventories, projected demand (2009), 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).\2\
---------------------------------------------------------------------------
\1\ 2008 data represents estimated sales, imports, and
inventories as reported on applications for quotas.
\2\ 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 provided by manufacturers and importers. This information
includes applications which have been newly submitted, amended or
withdrawn as of April 1, 2009, for the 2009 quota year.
Ephedrine Calculation
DEA calculated the 2009 Assessment of Annual Needs for ephedrine as
follows. DEA developed a calculation that 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 April 1, 2009, DEA registered manufacturers of dosage form
products containing ephedrine reported sales totaling approximately
5,409 kg in 2007 and 2,465 kg in 2008; this represents a 54 percent
decrease in sales reported by these firms from 2007 to 2008.
Additionally, exports of ephedrine products from the United States as
reported on export declarations (DEA 486), totaled 168 kg in 2007 and
91 kg in 2008; this represents a 46 percent decrease from levels
observed in 2007. DEA also considered information on trends in the
national rate of net disposals from sales data provided by IMS Health's
NSP database. IMS NSP data reported the average sales volume of
ephedrine for the calendar years 2007 and 2008 to be approximately
1,378 kg.
[[Page 32957]]
DEA notes that the 2008 sales figure reported by manufacturers (2,465
kg) is higher than the sales reported by IMS (1,378 kg). As previously
explained, 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 2,465 kg fairly represents the U.S.
sales of ephedrine for 2009 and that 91 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 2008 year end inventory as reported by DEA registrants in
determining the inventory allowance.
DEA calculated the ephedrine (for sale) assessment by the following
methodology:
2008 sales + reserve stock + export requirement - existing inventory =
AAN
2,465 + (50 percent * 2,465) + 91 - 423 = 3,366 kg ephedrine (for sale)
for 2009
This calculation suggests that DEA's Assessment of Annual Needs for
ephedrine can be revised to 3,400 kg rather than the 1,500 kg
established in the Interim Final Rule. DEA notes that this upward
revision is attributed to DEA's consideration of applications for 2009
quotas received as of April 1, 2009, a one-year time period since the
application due date.
Accordingly, DEA is establishing the Assessment of Annual Needs for
ephedrine (for sale) at 3,400 kg.
Comments Regarding DEA's Interim Final Assessment for
Phenylpropanolamine (For Sale)
The second commenter, a manufacturer of phenylpropanolamine
products used by veterinary professionals, urged DEA ``to consider
revising the calculation methodology for establishing quotas'' to
consider whether the market need was met in the prior year.
Additionally, the commenter suggested that there ``should be a factor
inserted in the calculation that would more accurately reflect market
need and the changing demand.'' The commenter also encouraged ``the
establishment of a safety reserve so that the DEA and manufacturers can
be responsive to the ever-changing health care needs of companion
animals.''
The third and fourth comments were received from two distributors
that sell phenylpropanolamine products used by veterinarians. These
commenters stated that ``To base quotas on last year's sales and
inventories and formulas does not allow for the increased need.'' The
commenters encouraged DEA ``to consider increasing the quotas based on
the aging of the companion animal population.'' Additionally, the
commenter encouraged DEA ``to work with individual manufacturers of PPA
in order to assure the uninterrupted supply of PPA.''
DEA Response
As a preliminary matter, this Federal Register notice establishes
the assessment of annual needs for List I chemicals and the methodology
used by the DEA to set that number. The assessment of annual needs is
different than individual quotas and this rulemaking does not address
the regulatory process for evaluating individual import, manufacturing
and procurement quotas issued to DEA registered manufacturers and
importers.
With regard to the establishment of the assessment of annual needs
for phenylpropanolamine (for sale), DEA believes that the sales
information provided in requests for quotas for the manufacture of
phenylpropanolamine products fairly represents the legitimate medical
needs of the companion animal population. Additionally, DEA notes that
the requirements of the two distributors and one manufacturer of
phenylpropanolamine were considered as part of the assessment for
phenylpropanolamine. DEA notes that there was a 3 percent increase in
reported sales of phenylpropanolamine from 2007 to 2008. For the 2009
assessment, DEA has determined that the higher 2008 sales fairly
represent the manufacturing requirements of phenylpropanolamine. In
calculating the assessment, DEA provides for quantities to support
sales of phenylpropanolamine and also for a reserve stock of 50
percent. This is not only consistent with the 50 percent inventory
allowance permitted under 21 CFR 1315.24, but also provides
manufacturers with sufficient material to account for slight increases
in demand that may occur in 2009.
Additionally, DEA notes that pursuant to 21 CFR 1315.32, DEA
registered manufacturers and importers may request adjustments to their
individual quotas at any time. This option allows the DEA and DEA
registrants to respond to the changing needs of the companion animal
population.
Considering that 2008 was the first year of implementation of
quotas for the List I chemicals, DEA is revising the 2009 assessments
to consider applications received as of April 1, 2009 (i.e. one year
after the April 1, 2008, application due date). This ensures that DEA
considered the most recent information provided by DEA registered
manufacturers and importers for 2009. A summary of the underlying data
from quota applications and other sources, as well as DEA's analysis of
that data, are provided below.
---------------------------------------------------------------------------
\3\ 2008 data represents estimated sales, imports, and
inventories as reported on applications for quotas.
---------------------------------------------------------------------------
Phenylpropanolamine (For Sale) Data
Phenylpropanolamine (for Sale) Data for 2009 Assessment of Annual Needs
[Kilograms]
----------------------------------------------------------------------------------------------------------------
Phenylpropanolamine (for sale) 2006 2007 2008 \3\ 2009 Request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)............................... 4,179 4,224 4,362 5,462
Imports ** (DEA 488)............................ 1,119 9,381 3,032 5,295
Export Declarations (DEA 486)................... 0 1,002 0 n/a
Inventory * (DEA 250)........................... 3,555 3,976 1,696 n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) and manufacturing quotas
(DEA 189) received as of April 1, 2009.
** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009.
[[Page 32958]]
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 April 1, 2009, DEA registered manufacturers of dosage form
products containing phenylpropanolamine reported sales totaling
approximately 4,224 kg in 2007 and 4,362 kg in 2008; this represents a
3 percent increase in sales reported by these firms from 2007 to 2008.
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:
2008 sales + reserve stock + export requirement - existing
inventory = AAN
4,362 + (50 percent * 4,362) + 0 - 1,696 = 4,847 kg
phenylpropanolamine (for sale) for 2009
This calculation suggests that DEA's Assessment of Annual Needs for
phenylpropanolamine (for sale) can be revised to be 4,900 kg rather
than the 4,500 kg established in the Interim Final Rule.
DEA is establishing the Assessment of Annual Needs for
phenylpropanolamine (for sale) at 4,900 kg.
Pseudoephedrine, Ephedrine (for Conversion), and Phenylpropanolamine
(for Conversion)
DEA did not receive any comments on its interim Assessment of
Annual Needs for pseudoephedrine, ephedrine (for conversion), and
phenylpropanolamine (for conversion). However, DEA is providing the
underlying data, analysis, methodology and calculation for the
establishment of the assessments for these List I chemicals. These
assessments reflect new information received from applications for
quota received as of April 1, 2009 (i.e. one year after the April 1,
2008 application due date).
Pseudoephedrine (for Sale) Data
Pseudoephedrine (for Sale) Data for 2009 Assessment of Annual Needs
[Kilograms]
----------------------------------------------------------------------------------------------------------------
Pseudoephedrine (for sale) 2006 2007 2008 \4\ 2009 Request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)............................... 232,721 215,877 262,159 273,659
Sales * (DEA 189)............................... 56,563 100,300 111,292 105,967
Imports ** (DEA 488)............................ 133,802 225,973 165,708 205,783
Export Declarations (DEA 486)................... 37,069 42,142 85,756 n/a
Inventory * (DEA 250)........................... 83,104 115,307 89,921 n/a
IMS *** (NSP)................................... 207,509 183,382 151,013 n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) and manufacturing quotas
(DEA 189) received as of April 1, 2009.
** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009.
*** IMS Health, IMS National Sales PerspectivesTM, January 2006 to December 2008, Retail and Non-Retail
Channels, Data Extracted April 1, 2009.
Pseudoephedrine (for Sale) Analysis
DEA utilized the same general methodology and calculations to
establish the assessment for pseudoephedrine (for sale) as was
described for the assessment of ephedrine (for sale), above.
---------------------------------------------------------------------------
\4\ 2008 data represents estimated sales, imports, and
inventories as reported on applications for quotas.
---------------------------------------------------------------------------
As of April 1, 2009, DEA registered manufacturers of dosage form
products containing pseudoephedrine reported sales totaling
approximately 215,877 kg in 2007 and 262,159 kg in 2008; this
represents a 21 percent increase in sales reported by these firms from
2007 to 2008. During the same period exports of pseudoephedrine
products from the United States as reported on export declarations (DEA
486) totaled 42,142 kg in 2007 and 85,756 kg in 2008; this represents a
103 percent increase from levels observed in 2007. Additionally, DEA
considered information on trends in the national rate of net disposals
from sales data provided by IMS Health. IMS NSP data reported the
average retail sales volume of pseudoephedrine for the calendar years
2007 and 2008 to be approximately 167,171 kg. DEA thus believes that
262,159 kg of sales reported by manufacturers fairly represents the
U.S. sales of pseudoephedrine for 2009 and that 85,756 kg fairly
represents the export requirements of pseudoephedrine. DEA notes that
manufacturer reported sales (262,159 kg) are higher than the retail
sales reported by IMS (167,171 kg). This is expected because a
manufacturer's reported sales include quantities which are necessary to
provide reserve stocks for distributors and retailers. DEA calculated
the pseudoephedrine (for sale) assessment by the following methodology:
2008 sales + reserve stock + export requirement - existing inventory =
AAN
262,159 + (50 percent * 262,159) + 85,756 - 89,921 = 389,074 kg
pseudoephedrine (for sale) for 2009
This calculation suggests that based on quota applications received
as of April 1, 2009, DEA's Assessment of Annual Needs for
pseudoephedrine (for sale) should be established at 390,000 kg rather
than the 380,000 kg established in the December 29, 2008 Interim Final
Rule. DEA is establishing the Assessment of Annual Needs for
pseudoephedrine (for sale) at 390,000 kg.
Phenylpropanolamine (for Conversion) Data
[[Page 32959]]
Phenylpropanolamine (for Conversion) Data for 2009 Assessment of Annual Needs
[Kilograms]
----------------------------------------------------------------------------------------------------------------
Phenylpropanolamine (for conversion) 2006 2007 2008 \5\ 2009 Request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)............................... 8,004 9,991 15,498 13,606
Imports ** (DEA 488)............................ 14,476 9,370 15,776 14,175
Export Declarations (DEA 486)................... 0 0 0 n/a
Inventory * (DEA 250)........................... 4,863 3,742 4,566 n/a
APQ Amphetamine ***............................. 17,000 22,000 22,000 n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) received as of April 1,
2009.
** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009.
*** Amphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.htm.
Phenylpropanolamine (for Conversion) Analysis
As of April 1, 2009, DEA registered manufacturers of
phenylpropanolamine (for conversion) requested the authority to
purchase a total of 13,606 kg phenylpropanolamine (for conversion).
Additionally, DEA registered importers of phenylpropanolamine (for
conversion) requested the authority to import a total of 14,175 kg of
phenylpropanolamine (for conversion). DEA had not received any requests
to synthesize phenylpropanolamine in 2009.
---------------------------------------------------------------------------
\5\ 2008 data represents estimated sales, imports, and
inventories as reported on applications for quotas.
---------------------------------------------------------------------------
DEA has determined that 13,606 kg of phenylpropanolamine (for
conversion) would be insufficient to meet the requirements for
phenylpropanolamine for the production of amphetamine as established by
DEA as the Aggregate Production Quota (APQ) for amphetamine (i.e.,
22,000 kg for 2008). 13,606 kg would be sufficient to manufacture only
30 percent of the APQ of amphetamine. DEA further considered
manufacturer's conversion yields of phenylpropanolamine to amphetamine
of 50 percent in its calculation of the phenylpropanolamine assessment.
DEA calculated the phenylpropanolamine (for conversion) assessment by
the following methodology:
(2008 APQ/50 percent yield) + reserve stock - inventory = AAN
(22,000/50 percent yield) + 50 percent * (22,000/50 percent yield) -
4,566 = 61,434 kg PPA (for conversion) for 2009
This calculation suggests that DEA's Assessment of Annual Needs for
phenylpropanolamine (for conversion) should be established as 62,000
kg, as established in the Interim Final Rule.
DEA is establishing the Assessment of Annual Needs for
phenylpropanolamine (for conversion) at 62,000 kg.
Ephedrine (for Conversion) Data
Ephedrine (for Conversion) Data for 2009 Assessment of Annual Needs
[Kilograms]
----------------------------------------------------------------------------------------------------------------
Ephedrine (for conversion) 2006 2007 2008 \6\ 2009 Request
----------------------------------------------------------------------------------------------------------------
Sales * (DEA 250)............................... 49,973 100,093 133,209 112,277
Imports ** (DEA 488)............................ 43,612 107,230 122,683 111,365
Inventory * (DEA 250)........................... 77 28 10 n/a
APQ Methamphetamine ***......................... 3,130 3,130 3,130 n/a
----------------------------------------------------------------------------------------------------------------
* Reported sales and inventory from applications for 2009 procurement quotas (DEA 250) and manufacturing quotas
(DEA 189) received as of April 1, 2009.
** Reported imports from applications for 2009 import quotas (DEA 488) received as of April 1, 2009.
*** Methamphetamine Aggregate Production Quota History https://www.deadiversion.usdoj.gov/quotas/quota_history.htm
Ephedrine (for Conversion) Analysis
For ephedrine (for conversion), DEA utilized the same general
methodology and calculation as was described for the assessment of
phenylpropanolamine (for conversion), above.
---------------------------------------------------------------------------
\6\ 2008 data represents estimated sales, imports, and
inventories as reported on applications for quotas.
---------------------------------------------------------------------------
As of April 1, 2009, DEA registered manufacturers of ephedrine (for
conversion) requested the authority to purchase a total of 112,277 kg
ephedrine (for conversion) for the manufacture of two substances:
methamphetamine and pseudoephedrine.
DEA in its methodology considered the ephedrine (for conversion)
requirements for the manufacture of these two substances:
methamphetamine and pseudoephedrine. DEA has determined 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. The assessment of need for
pseudoephedrine was determined by DEA as the estimated sales of
pseudoephedrine as referenced in the 2008 Annual Assessment of Need
(AAN) 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. These firms reported a conversion yield of 39 percent for
the synthesis of methamphetamine. 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
The calculation for the ephedrine (for conversion) requirement for
the
[[Page 32960]]
manufacture of methamphetamine is as follows:
(2008 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) - 35 =
12,003 kg
The calculation for the ephedrine (for conversion) requirement for
the manufacture of pseudoephedrine leads to a result of 106,424 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
12,003 + 106,424 = 118,427 kg ephedrine (for conversion) for 2009
This calculation suggests that based on applications received as of
April 1, 2009, DEA's Assessment of Annual Needs for ephedrine (for
conversion) should be established as 120,000 kg rather than the 110,000
kg established on an interim basis in the December 29, 2008, notice.
Under this rulemaking, DEA is establishing the Assessment of Annual
Needs for ephedrine (for conversion) as 120,000 kg.
Conclusion
DEA has carefully considered the comments received in connection
with the 2009 Assessment of Annual Needs. Based on information provided
in the comments, along with information provided by DEA-registered
manufacturers and importers of these List I chemicals on applications
for individual import, manufacturing, and procurement quotas pursuant
to DEA regulations, DEA has fully addressed the relevant issues set
forth in the comments. 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 Section 0.100, and
redelegated to the Deputy Administrator pursuant to 28 CFR Section
0.104, the Deputy Administrator hereby orders that the 2009 Assessment
of Annual Needs for ephedrine, pseudoephedrine, and
phenylpropanolamine, expressed in kilograms of anhydrous acid or base,
be established as follows:
------------------------------------------------------------------------
Established
2009
List I chemical Assessment of
Annual Needs
------------------------------------------------------------------------
Ephedrine (for sale).................................... 3,400
Ephedrine (for conversion).............................. 120,000
Pseudoephedrine (for sale).............................. 390,000
Phenylpropanolamine (for sale).......................... 4,900
Phenylpropanolamine (for conversion).................... 62,000
------------------------------------------------------------------------
The Office of Management and Budget has determined that notices of
quotas are not subject to centralized review under Executive Order
12866.
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 any federalism implications
warranting the application of Executive Order 13132.
The Deputy Administrator hereby certifies that this action will not
have a significant economic impact upon a substantial number of small
entities whose interests must be considered under the Regulatory
Flexibility Act, 5 U.S.C. 601-612. The establishment of 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.
This action meets the applicable standards set forth in Sections
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
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 (adjusted for inflation) 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.
This action is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). 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 26, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-16152 Filed 7-8-09; 8:45 am]
BILLING CODE 4410-09-P