Final Adjusted Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2012, 55503 [2012-22127]
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55503
Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Notices
Aggregate production quotas for all
other Schedule I and II controlled
substances included in 21 CFR 1308.11
and 1308.12 remain at zero.
Dated: August 31, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–22128 Filed 9–7–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA 353]
Final Adjusted Assessment of Annual
Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2012
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Notice.
AGENCY:
This notice establishes the
Final Adjusted 2012 Assessment of
Annual Needs for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine.
SUMMARY:
DATES:
Effective Date: September 10,
2012.
John
W. Partridge, Chief, Liaison and Policy
Section, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (202)
307–4654.
SUPPLEMENTARY INFORMATION: The 2012
Assessment of Annual Needs represents
those quantities of ephedrine,
pseudoephedrine, and
phenylpropanolamine which may be
manufactured domestically and
imported into the United States in 2012
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 of
such chemicals. Section 306 of the
Controlled Substances Act (CSA) (21
U.S.C. 826) requires that the Attorney
General establish an assessment of
annual needs for ephedrine,
pseudoephedrine, and
phenylpropanolamine. This
responsibility has been delegated to the
Administrator of the DEA by 28 CFR
0.100.
On July 18, 2012, a notice entitled
‘‘Proposed Adjustment of the
Assessment of Annual Needs for the List
I Chemicals Ephedrine,
Pseudoephedrine, and
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Mar<15>2010
16:57 Sep 07, 2012
Jkt 226001
Phenylpropanolamine for 2012’’ was
published in the Federal Register (77
FR 42333). That notice proposed to
adjust the 2012 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 proposed
assessments on or before August 17,
2012.
Comments Received
DEA did not receive any comments to
the proposed adjustment of the
assessment of annual needs for
ephedrine (for sale), ephedrine (for
conversion), pseudoephedrine (for sale),
phenylpropanolamine (for sale), and
phenylpropanolamine (for conversion).
Conclusion
In determining the adjusted 2012
assessments, DEA used the calculation
methodology previously described in
the 2010 and 2011 assessment of annual
needs (74 FR 60294 and 75 FR 79407
respectively). DEA considered changes
in demand, changes in the national rate
of net disposal, and changes in the rate
of net disposal by the registrants
holding individual manufacturing or
import quotas for the chemical; whether
any increased demand or changes in the
national and/or individual rates of net
disposal are temporary, short term, or
long term; whether any increased
demand could be met through existing
inventories, increased individual
manufacturing quotas, or increased
importation without increasing the
assessment of annual needs; whether
any decreased demand would result in
excessive inventory accumulation by all
persons registered to handle the
particular chemical; and other factors
affecting the medical, scientific,
research, industrial, and importation
needs in the United States, lawful
export requirements, and reserve stocks,
as found relevant.
Other factors that DEA considered
include trends as derived from
information provided in applications for
import, manufacturing, and
procurement quotas and in import and
export declarations. The inventory,
acquisition (purchases), and disposition
(sales) data as provided by DEAregistered manufacturers and importers
reflects the most current information
available to DEA at the time of
publication of this Notice. The
underlying data used to determine the
final 2012 assessment of annual needs is
the same as that used in determining the
proposed 2012 assessment of annual
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
needs, as published on September 14,
2011, at 76 FR 56809.
In accordance with 21 U.S.C. 826(a)
and 21 CFR 1315.13, the Administrator
hereby orders that the 2012 assessment
of annual needs for ephedrine,
pseudoephedrine, and
phenylpropanolamine, expressed in
kilograms of anhydrous acid or base, is
adjusted and established as follows:
List I chemical
Final 2012
assessment of
annual needs
(kg)
Ephedrine (for sale) ..............
Phenylpropanolamine (for
sale) ..................................
Pseudoephedrine (for sale) ..
Phenylpropanolamine (for
conversion) ........................
Ephedrine (for conversion) ...
4,300
5,800
278,000
26,200
12,000
Dated: August 31, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–22127 Filed 9–7–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Cambrex
Charles City, Inc.
By Notice dated June 18, 2012, and
published in the Federal Register on
June 26, 2012, 77 FR 38085, Cambrex
Charles City, Inc., 1205 11th Street,
Charles City, Iowa 50616–3466, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
Drug
4-Anilino-N-phenethyl-4-piperidine
(8333).
Phenylacetone (8501) ..................
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
Schedule
II
II
II
II
The company plans to import the
listed controlled substances for internal
use, and to manufacture bulk
intermediates for sale to its customers.
No comments or objections have been
received. Comments and requests for
hearings on applications to import
narcotic raw material are not
appropriate. 72 FR 3417 (2007).
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
E:\FR\FM\10SEN1.SGM
10SEN1
]]>Agencies
[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Notices]
[Page 55503]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22127]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA 353]
Final Adjusted Assessment of Annual Needs for the List I
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2012
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice establishes the Final Adjusted 2012 Assessment of
Annual Needs for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: Effective Date: September 10, 2012.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and
Policy Section, Drug Enforcement Administration, 8701 Morrissette
Drive, Springfield, VA 22152, Telephone: (202) 307-4654.
SUPPLEMENTARY INFORMATION: The 2012 Assessment of Annual Needs
represents those quantities of ephedrine, pseudoephedrine, and
phenylpropanolamine which may be manufactured domestically and imported
into the United States in 2012 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 of such chemicals.
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826)
requires that the Attorney General establish an assessment of annual
needs for ephedrine, pseudoephedrine, and phenylpropanolamine. This
responsibility has been delegated to the Administrator of the DEA by 28
CFR 0.100.
On July 18, 2012, a notice entitled ``Proposed Adjustment of the
Assessment of Annual Needs for the List I Chemicals Ephedrine,
Pseudoephedrine, and Phenylpropanolamine for 2012'' was published in
the Federal Register (77 FR 42333). That notice proposed to adjust the
2012 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 proposed assessments on or
before August 17, 2012.
Comments Received
DEA did not receive any comments to the proposed adjustment of the
assessment of annual needs for ephedrine (for sale), ephedrine (for
conversion), pseudoephedrine (for sale), phenylpropanolamine (for
sale), and phenylpropanolamine (for conversion).
Conclusion
In determining the adjusted 2012 assessments, DEA used the
calculation methodology previously described in the 2010 and 2011
assessment of annual needs (74 FR 60294 and 75 FR 79407 respectively).
DEA considered changes in demand, changes in the national rate of net
disposal, and changes in the rate of net disposal by the registrants
holding individual manufacturing or import quotas for the chemical;
whether any increased demand or changes in the national and/or
individual rates of net disposal are temporary, short term, or long
term; whether any increased demand could be met through existing
inventories, increased individual manufacturing quotas, or increased
importation without increasing the assessment of annual needs; whether
any decreased demand would result in excessive inventory accumulation
by all persons registered to handle the particular chemical; and other
factors affecting the medical, scientific, research, industrial, and
importation needs in the United States, lawful export requirements, and
reserve stocks, as found relevant.
Other factors that DEA considered include trends as derived from
information provided in applications for import, manufacturing, and
procurement quotas and in import and export declarations. The
inventory, acquisition (purchases), and disposition (sales) data as
provided by DEA-registered manufacturers and importers reflects the
most current information available to DEA at the time of publication of
this Notice. The underlying data used to determine the final 2012
assessment of annual needs is the same as that used in determining the
proposed 2012 assessment of annual needs, as published on September 14,
2011, at 76 FR 56809.
In accordance with 21 U.S.C. 826(a) and 21 CFR 1315.13, the
Administrator hereby orders that the 2012 assessment of annual needs
for ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in
kilograms of anhydrous acid or base, is adjusted and established as
follows:
------------------------------------------------------------------------
Final 2012
assessment of
List I chemical annual needs
(kg)
------------------------------------------------------------------------
Ephedrine (for sale).................................... 4,300
Phenylpropanolamine (for sale).......................... 5,800
Pseudoephedrine (for sale).............................. 278,000
Phenylpropanolamine (for conversion).................... 26,200
Ephedrine (for conversion).............................. 12,000
------------------------------------------------------------------------
Dated: August 31, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-22127 Filed 9-7-12; 8:45 am]
BILLING CODE 4410-09-P
