Importer of Controlled Substances; Notice of Application Meridian Medical Technologies, 19716-19717 [2012-7755]
Download as PDF
<![CDATA[
mstockstill on DSK4VPTVN1PROD with NOTICES
19716
Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices
and, if known, an estimate of the
percentage of total U.S. imports of
Subject Merchandise from the Subject
Country accounted for by your firm’s(s’)
imports;
(b) the quantity and value (f.o.b. U.S.
port, including antidumping
countervailing duties) of U.S.
commercial shipments of Subject
Merchandise imported from the Subject
Country; and
(c) the quantity and value (f.o.b. U.S.
port, including antidumping
countervailing duties) of U.S. internal
consumption/company transfers of
Subject Merchandise imported from the
Subject Country.
(11) If you are a producer, an exporter,
or a trade/business association of
producers or exporters of the Subject
Merchandise in the Subject Country,
provide the following information on
your firm’s(s’) operations on that
product during calendar year 2011
(report quantity data in pieces and value
data in U.S. dollars, landed and dutypaid at the U.S. port but not including
antidumping duties). If you are a trade/
business association, provide the
information, on an aggregate basis, for
the firms which are members of your
association.
(a) Production (quantity) and, if
known, an estimate of the percentage of
total production of Subject Merchandise
in the Subject Country accounted for by
your firm’s(s’) production;
(b) Capacity (quantity) of your firm to
produce the Subject Merchandise in the
Subject Country (i.e., the level of
production that your establishment(s)
could reasonably have expected to
attain during the year, assuming normal
operating conditions (using equipment
and machinery in place and ready to
operate), normal operating levels (hours
per week/weeks per year), time for
downtime, maintenance, repair, and
cleanup, and a typical or representative
product mix); and
(c) The quantity and value of your
firm’s(s’) exports to the United States of
Subject Merchandise and, if known, an
estimate of the percentage of total
exports to the United States of Subject
Merchandise from the Subject Country
accounted for by your firm’s(s’) exports.
(12) Identify significant changes, if
any, in the supply and demand
conditions or business cycle for the
Domestic Like Product that have
occurred in the United States or in the
market for the Subject Merchandise in
the Subject Country after 2005, and
significant changes, if any, that are
likely to occur within a reasonably
foreseeable time. Supply conditions to
consider include technology;
production methods; development
VerDate Mar<15>2010
17:42 Mar 30, 2012
Jkt 226001
efforts; ability to increase production
(including the shift of production
facilities used for other products and the
use, cost, or availability of major inputs
into production); and factors related to
the ability to shift supply among
different national markets (including
barriers to importation in foreign
markets or changes in market demand
abroad). Demand conditions to consider
include end uses and applications; the
existence and availability of substitute
products; and the level of competition
among the Domestic Like Product
produced in the United States, Subject
Merchandise produced in the Subject
Country, and such merchandise from
other countries.
(13) (Optional) A statement of
whether you agree with the above
definitions of the Domestic Like Product
and Domestic Industry; if you disagree
with either or both of these definitions,
please explain why and provide
alternative definitions.
Authority: This review is being conducted
under authority of title VII of the Tariff Act
of 1930; this notice is published pursuant to
section 207.61 of the Commission=s rules.
By order of the Commission.
Issued: March 27, 2012.
James R. Holbein,
Secretary to the Commission.
[FR Doc. 2012–7794 Filed 3–30–12; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Notice of Filing of Consent Decree
Pursuant to the Clean Air Act, CERCLA
and EPCRA
Notice is hereby given that on March
26, 2012, a proposed Consent Decree in
United States and State of Kansas v.
National Cooperative Refinery
Association, No. 6:12-cv-01110–EFM–
JPO, was filed with the United States
District Court for the District of Kansas.
The Consent Decree settles the claims of
the United States’ and the State of
Kansas set forth in the complaint for
civil penalties and injunctive relief
against the National Cooperative
Refinery Association relating to its
refinery in McPherson, Kansas, and its
related storage facility in Conway,
Kansas, based on violations of the
refinery’s Clean Air Act Title V permit,
the CAA’s New Source Performance
Standards (NSPS), and Risk
Management Plan regulations, and
CERCLA and EPCRA release notification
requirements. Under the terms of the
Consent Decree NCRA shall pay
$700,000 in penalty, spend
approximately $730,000 in performing
PO 00000
Frm 00107
Fmt 4703
Sfmt 4703
Supplemental Environmental Projects
and implement injunctive relief directed
primarily at insuring future compliance
with the Risk Management Program
requirements for these facilities.
$225,000 of this penalty will be paid to
the State of Kansas.
The Department of Justice will receive
for a period of thirty (30) days from the
date of this publication comments
relating to the Consent Decree.
Comments should be addressed to the
Assistant Attorney General,
Environment and Natural Resources
Division, and either emailed to
pubcomment-ees.enrd@usdoj.gov or
mailed to P.O. Box 7611, U.S.
Department of Justice, Washington, DC
20044–7611, and should refer to United
States and State of Kansas v. National
Cooperative Refinery Association, No.
6:12-cv-01110–EFM–JPO (D. Kansas),
Department of Justice Case Number
90–5–1–1–06025/3.
During the public comment period,
the Consent Decree may be examined at
the Office of the United States Attorney,
District of Kansas, 301 North Main St.
Wichita, Kansas, 67212. The Settlement
Agreement may also be examined on the
following Department of Justice Web
site, https://www.usdoj.gov/enrd/
Consent_Decrees.html. A copy of the
Consent Decree may also be obtained by
mail from the Consent Decree Library,
P.O. Box 7611, U.S. Department of
Justice, Washington, DC 20044–7611 or
by faxing or emailing a request to
‘‘Consent Decree Copy’’
(eescdcopy.enrd@usdoj.gov), fax no.
(202) 514–0097, phone confirmation
number (202) 514–5271. In requesting a
copy from the Consent Decree Library,
please enclose a check in the amount of
$22.75 (25 cents per page reproduction
cost) payable to the U.S. Treasury.
Maureen Katz,
Assistant Section Chief.
[FR Doc. 2012–7714 Filed 3–30–12; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application Meridian Medical
Technologies
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
E:\FR\FM\02APN1.SGM
02APN1
19717
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices
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 January
4, 2012, Meridian Medical
Technologies, 2555 Hermelin Drive, St.
Louis, Missouri 63144, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of
Morphine (9300), a basic class of
controlled substance listed in schedule
II.
The company manufactures a product
containing morphine in the United
States. The company exports this
product to customers around the world,
including in Europe. The company has
been asked to ensure that its product
sold to European customers meets
standards established by the European
Pharmacopeia, which is administered
by the Directorate for the Quality of
Medicines (EDQM). In order to ensure
that its product will meet European
specifications, the company seeks to
import morphine supplied by EDQM to
use as reference standards. This is the
sole purpose for which the company
will be authorized by DEA to import
morphine.
Any bulk manufacturer who is
presently, or is 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 May 2, 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 43745–46, 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.
VerDate Mar<15>2010
17:42 Mar 30, 2012
Jkt 226001
Dated: March 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–7755 Filed 3–30–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration Mallinckrodt
LLC
By Notice dated January 23, 2012, and
published in the Federal Register on
January 31, 2012, 77 FR 4831,
Mallinckrodt LLC, 3600 North Second
Street, St. Louis, Missouri 63147, 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
Phenylacetone (8501) ..................
Coca Leaves (9040) .....................
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
II
II
II
II
The company plans to import the
listed controlled substances to
manufacture bulk controlled substances
for distribution to its customers, and for
research and analytical standards.
The company has withdrawn its
application for registration to import the
following drug codes: Methylphenidate
(1724), Oxycodone (9143),
Hydromorphone (9150), Hydrocodone
(9193), Morphine (9300), and Fentanyl
(9801).
Comments and requests for hearings
on applications to import narcotic raw
material are not appropriate, 72 FR 3417
(2007). Regarding all other basic classes
of controlled substances, 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 Mallinckrodt LLC, 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
Mallinckrodt LLC 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
PO 00000
Frm 00108
Fmt 4703
Sfmt 4703
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.
Dated: March 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–7758 Filed 3–30–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application;
Cerilliant Corporation
Pursuant to § 1301.33(a), Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on February 17, 2012,
Cerilliant Corporation, 811 Paloma
Drive, Suite A, Round Rock, Texas
78665–2402, made application by letter
to the Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Drug
4-methyl-N-methylcathinone
(1248).
3,4-methylenedioxypyrovalerone
(7535).
3,4-methylenedioxy-Nmethylcathinone (7540).
Desomorphine (9055) ...................
Schedule
I
I
I
I
The company plans to manufacture
small quantities of the listed controlled
substances to make reference standards
which will be distributed to their
customers.
Any other such applicant, and any
person who is presently registered with
DEA to manufacture such substances,
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
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 June 1, 2012.
E:\FR\FM\02APN1.SGM
02APN1
]]>Agencies
[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Notices]
[Pages 19716-19717]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7755]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application Meridian
Medical Technologies
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
[[Page 19717]]
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 January 4, 2012, Meridian Medical Technologies, 2555 Hermelin
Drive, St. Louis, Missouri 63144, made application by renewal to the
Drug Enforcement Administration (DEA) to be registered as an importer
of Morphine (9300), a basic class of controlled substance listed in
schedule II.
The company manufactures a product containing morphine in the
United States. The company exports this product to customers around the
world, including in Europe. The company has been asked to ensure that
its product sold to European customers meets standards established by
the European Pharmacopeia, which is administered by the Directorate for
the Quality of Medicines (EDQM). In order to ensure that its product
will meet European specifications, the company seeks to import morphine
supplied by EDQM to use as reference standards. This is the sole
purpose for which the company will be authorized by DEA to import
morphine.
Any bulk manufacturer who is presently, or is 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 May 2, 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 43745-46, all applicants
for registration to import a basic class of any controlled substance in
schedule I or II are, and will continue to be, required to demonstrate
to the Deputy Assistant Administrator, Office of Diversion Control,
Drug Enforcement Administration, that the requirements for such
registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR
1301.34(b), (c), (d), (e), and (f) are satisfied.
Dated: March 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-7755 Filed 3-30-12; 8:45 am]
BILLING CODE 4410-09-P
