Established Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2012, 77252-77253 [2011-31777]
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77252
Federal Register / Vol. 76, No. 238 / Monday, December 12, 2011 / Notices
15 U.S.C. 4301 et seq. (‘‘the Act’’), Green
Seal, Inc. (‘‘Green Seal’’) has filed
written notifications simultaneously
with the Attorney General and the
Federal Trade Commission disclosing
additions or changes to its standards
development activities. The
notifications were filed for the purpose
of extending the Act’s provisions
limiting the recovery of antitrust
plaintiffs to actual damages under
specified circumstances. Specifically,
Green Seal has issued new standards for
specialty cleaning products and a
comprehensive revision to the standard
for reusable bags.
On January 26, 2011, Green Seal filed
its original notification pursuant to
Section 6(a) of the Act. The Department
of Justice published a notice in the
Federal Register pursuant to Section
6(b) of the Act on March 7, 2011 (76 FR
12370).
The last notification was filed with
the Department on June 28, 2011. A
notice was published in the Federal
Register pursuant to Section 6(b) of the
Act on August 3, 2011 (76 FR 46843).
Patricia A. Brink,
Director of Civil Enforcement, Antitrust
Division.
[FR Doc. 2011–31752 Filed 12–9–11; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–353E]
Established 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
initial 2012 assessment of annual needs
for the List I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine.
DATES:
Effective Date: December 12,
2011.
FOR FURTHER INFORMATION CONTACT: John
W. Partridge, Chief, Liaison and Policy
Section, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152, Telephone:
(202) 307–7184.
SUPPLEMENTARY INFORMATION:
Background
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 to meet the estimated medical,
scientific, research, and industrial needs
of the United States, lawful export
requirements, and the establishment
and maintenance of reserve stocks 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 September 14, 2011, a notice
entitled ‘‘Proposed Assessment of
Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2012’’ was
published in the Federal Register (76
FR 56809). That notice proposed 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 assessments
on or before October 14, 2011.
Comments Received
DEA received one comment regarding
the proposed assessment of annual
needs for pseudoephedrine. The
commenter stated that ‘‘the quotas
should be increased to cover our needs.
The appropriate DEA Form 250 will be
submitted shortly pertaining to the
items for which we submitted
comments.’’ As of October 17, 2011, the
commenter was not registered to
manufacture the chemical
pseudoephedrine and DEA had not
received the commenter’s request for
2012 quota for pseudoephedrine. DEA
will consider the commenter’s request
for quota after they become registered to
manufacture pseudoephedrine and
submit a quota application pursuant to
21 CFR 1315.22.
Conclusion
In determining the 2012 assessments,
DEA took into account the criteria that
DEA is required to consider in
accordance with 21 U.S.C. 826(a) and 21
CFR 1315.11. DEA has increased the
assessment of annual need for
ephedrine (for sale) and
pseudoephedrine (for sale) over the
proposed amount based on additional
data that was received regarding the
total net disposals (i.e. sales) of these
List I chemicals for the current and
preceding two years, actual and
estimated inventories, projected
demand (2012), industrial use, and
export requirements. The relevant
inventory, acquisition (purchases), and
disposition (sales) data was provided by
DEA registered manufacturers and
importers in procurement quota
applications (DEA 250), manufacturing
quota applications (DEA 189), import
quota applications (DEA 488), and
declarations for import and export
received by DEA as of October 17, 2011.
After reviewing the additional data,
DEA determined that an increase in the
proposed assessment of annual need for
ephedrine (for sale) and
pseudoephedrine (for sale) was
warranted. This notice reflects that
increase.
In accordance with 21 U.S.C. 826 and
21 CFR 1315.11, the Administrator
hereby determines that the 2012
assessment of annual needs for
ephedrine, pseudoephedrine, and
phenylpropanolamine, expressed in
kilograms of anhydrous acid or base, is
established as follows:
Established 2012
assessment of
annual needs
(kg)
jlentini on DSK4TPTVN1PROD with NOTICES
List I chemical
Ephedrine (for sale) .........................................................................................................................................................................
Phenylpropanolamine (for sale) .......................................................................................................................................................
Pseudoephedrine (for sale) .............................................................................................................................................................
Phenylpropanolamine (for conversion) ............................................................................................................................................
Ephedrine (for conversion) ..............................................................................................................................................................
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12DEN1
4,000
5,200
258,000
26,200
12,000
77253
Federal Register / Vol. 76, No. 238 / Monday, December 12, 2011 / Notices
The assessment of annual needs may be
adjusted at a later date pursuant to 21
CFR 1315.13.
Dated: December 1, 2011.
Michele M. Leonhart,
Administrator.
Dated: December 5, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–31776 Filed 12–9–11; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2011–31777 Filed 12–9–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Importer of Controlled Substances;
Notice of Registration
Pursuant to 21 U.S.C. 958(i), the
Attorney General shall, prior to issuing
a registration under this Section to a
bulk manufacturer of a controlled
substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
952(a)(2) authorizing the importation of
such a substance, provide
manufacturers holding registrations for
the bulk manufacture of the substance
an opportunity for a hearing.
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on October
17, 2011, Hospira Inc., 1776 North
Centennial Drive, McPherson, Kansas
67460–1247, made application by
renewal to the Drug Enforcement
Administration (DEA) to be registered as
an importer of Remifentanil (9739), a
basic class of controlled substance listed
in schedule II.
The company plans to import
Remifentanil for use in dosage form
manufacturing.
Any bulk manufacturers who are
presently, or are applying to be,
registered with DEA to manufacture
such basic class of controlled substance
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.
Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than January 11, 2012.
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, 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
By Notice dated September 27, 2011,
and published in the Federal Register
on October 7, 2011, 76 FR 62446, Fisher
Clinical Services, Inc., 7554 Schantz
Road Allentown, Pennsylvania 18106,
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
Schedule
jlentini on DSK4TPTVN1PROD with NOTICES
Noroxymorphone (9668) ..............
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
II
II
II
The company plans to import the
listed substances for analytical research
and clinical trials.
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
Fisher Clinical Services, 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. DEA has investigated
Fisher Clinical Services, 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.
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Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Dated: December 5, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–31766 Filed 12–9–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Pursuant to Title 21 Code of Federal
Regulations 1301.34(a), this is notice
that on September 12, 2011, Johnson
Matthey, Inc., Pharmaceutical Materials,
2003 Nolte Drive, West Deptford, New
Jersey 08066–1742, made application by
renewal to the Drug Enforcement
Administration (DEA) for registration as
an importer of the following basic
classes of controlled substances listed in
schedule II:
Drug
Coca Leaves (9040) .....................
Thebaine (9333) ...........................
Opium, raw (9600) .......................
Noroxymorphone (9668) ..............
Poppy Straw Concentrate (9670)
Schedule
II
II
II
II
II
The company plans to import the
listed controlled substances as raw
materials, to be used in the manufacture
of bulk controlled substances, for
distribution to its customers.
No comments, objections, or requests
for any hearings will be accepted on any
application for registration or reregistration to import crude opium,
poppy straw, concentrate of poppy
straw, and coca leaves. Comments and
requests for hearings on applications to
import narcotic raw material are not
appropriate, in accordance with 72 FR
3417 (2007).
In regards to the non-narcotic raw
material, the company plans to import
gram amounts to be used as reference
standards for sale to its customers. Any
bulk manufacturer who is presently, or
is applying to be, registered with DEA
to manufacture such basic classes of
controlled substances listed in schedule
I or II, which fall under the authority of
section 1002(a)(2)(B) of the Act (21
U.S.C. 952(a)(2)(B)) may, in the
circumstances set forth in 21 U.S.C.
E:\FR\FM\12DEN1.SGM
12DEN1
]]>Agencies
[Federal Register Volume 76, Number 238 (Monday, December 12, 2011)]
[Notices]
[Pages 77252-77253]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31777]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-353E]
Established 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 initial 2012 assessment of annual
needs for the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: Effective Date: December 12, 2011.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and
Policy Section, Drug Enforcement Administration, 8701 Morrissette
Drive, Springfield, Virginia 22152, Telephone: (202) 307-7184.
SUPPLEMENTARY INFORMATION:
Background
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 to meet the estimated
medical, scientific, research, and industrial needs of the United
States, lawful export requirements, and the establishment and
maintenance of reserve stocks 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 September 14, 2011, a notice entitled ``Proposed Assessment of
Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2012'' was published in the Federal Register
(76 FR 56809). That notice proposed 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 assessments on or before October 14, 2011.
Comments Received
DEA received one comment regarding the proposed assessment of
annual needs for pseudoephedrine. The commenter stated that ``the
quotas should be increased to cover our needs. The appropriate DEA Form
250 will be submitted shortly pertaining to the items for which we
submitted comments.'' As of October 17, 2011, the commenter was not
registered to manufacture the chemical pseudoephedrine and DEA had not
received the commenter's request for 2012 quota for pseudoephedrine.
DEA will consider the commenter's request for quota after they become
registered to manufacture pseudoephedrine and submit a quota
application pursuant to 21 CFR 1315.22.
Conclusion
In determining the 2012 assessments, DEA took into account the
criteria that DEA is required to consider in accordance with 21 U.S.C.
826(a) and 21 CFR 1315.11. DEA has increased the assessment of annual
need for ephedrine (for sale) and pseudoephedrine (for sale) over the
proposed amount based on additional data that was received regarding
the total net disposals (i.e. sales) of these List I chemicals for the
current and preceding two years, actual and estimated inventories,
projected demand (2012), industrial use, and export requirements. The
relevant inventory, acquisition (purchases), and disposition (sales)
data was provided by DEA registered manufacturers and importers in
procurement quota applications (DEA 250), manufacturing quota
applications (DEA 189), import quota applications (DEA 488), and
declarations for import and export received by DEA as of October 17,
2011. After reviewing the additional data, DEA determined that an
increase in the proposed assessment of annual need for ephedrine (for
sale) and pseudoephedrine (for sale) was warranted. This notice
reflects that increase.
In accordance with 21 U.S.C. 826 and 21 CFR 1315.11, the
Administrator hereby determines that the 2012 assessment of annual
needs for ephedrine, pseudoephedrine, and phenylpropanolamine,
expressed in kilograms of anhydrous acid or base, is established as
follows:
------------------------------------------------------------------------
Established 2012
assessment of
List I chemical annual needs
(kg)
------------------------------------------------------------------------
Ephedrine (for sale).................................. 4,000
Phenylpropanolamine (for sale)........................ 5,200
Pseudoephedrine (for sale)............................ 258,000
Phenylpropanolamine (for conversion).................. 26,200
Ephedrine (for conversion)............................ 12,000
------------------------------------------------------------------------
[[Page 77253]]
The assessment of annual needs may be adjusted at a later date pursuant
to 21 CFR 1315.13.
Dated: December 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-31777 Filed 12-9-11; 8:45 am]
BILLING CODE 4410-09-P
