Importer of Controlled Substances; Notice of Application, 76755 [2010-30901]
Download as PDF
<![CDATA[
76755
Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices
erowe on DSK5CLS3C1PROD with NOTICES
addition, Defendants will abate leadbased paint hazards on friction and
impact surfaces, stabilize other leadbased paint hazards, and pay an
administrative penalty of $7,500.
The Department of Justice will receive
for a period of thirty (30) days from the
date of this publication comments
relating to the Proposed Consent Decree.
Comments should be addressed to the
Assistant Attorney General,
Environment and Natural Resources
Division, and either e-mailed to
pubcomment-ees.enrd@usdoj.gov or
mailed to U.S. Department of Justice,
Washington, DC 20044–7611 P.O. Box
7611, U.S. Department of Justice,
Washington, DC 20044–7611, and
should refer to United States v.
Combined Development Co. I, LLC, et
al., D.J. Ref. # 90–5–1–1–09435.
The Proposed Consent Decree may be
examined at the Department of Housing
and Urban Development, Office of
General Counsel, 451 7th St. NW., Room
9262, Washington, DC 20410; at the
office of the United States Attorney for
the Southern District of Ohio, 303
Marconi Blvd., Suite 200, Columbus,
Ohio 43215 (Attn. Assistant United
States Attorney Andrew M. Malek); and
at U.S. EPA Region 5, 77 W. Jackson
Blvd., Chicago, IL 60604. During the
public comment period, the Consent
Decree may also be examined on the
following Department of Justice Web
site, to 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 e-mailing a request to Tonia
Fleetwood (tonia.fleetwood@usdoj.gov),
fax no. (202) 514–0097, phone
confirmation number (202) 514–1547. In
requesting a copy from the Consent
Decree Library, please enclose a check
in the amount of $9.25 (25 cents per
page reproduction cost) payable to the
U.S. Treasury or, if by e-mail or fax,
forward a check in that amount to the
Consent Decree Library at the stated
address.
Maureen Katz,
Assistant Chief, Environmental Enforcement
Section, Environment and Natural Resources
Division.
[FR Doc. 2010–30900 Filed 12–8–10; 8:45 am]
BILLING CODE 4410–15–P
VerDate Mar<15>2010
15:35 Dec 08, 2010
Jkt 223001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Pursuant to 21 U.S.C. 958(i), the
Attorney General shall, prior to issuing
a registration under this Section to a
bulk manufacturer of a controlled
substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
952(a)(2) authorizing the importation of
such a substance, provide
manufacturers holding registrations for
the bulk manufacture of the substance
an opportunity for a hearing.
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on October
19, 2010, Mylan Pharmaceuticals, Inc.,
781 Chestnut Ridge Road, Morgantown,
West Virginia 26505, 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
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Fentanyl (9801) ............................
II
II
II
II
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF. This
analysis is required to allow the
company to export domesticallymanufactured FDF to foreign markets.
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 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 10, 2011.
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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
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: November 29, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2010–30901 Filed 12–8–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated August 3, 2010, and
published in the Federal Register on
September 1, 2010, (75 FR 53719),
Alltech Associates, Inc., 2051 Waukegan
Road, Deerfield, Illinois 60015, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the basic
classes of controlled substances:
Drug
Gamma
Hydroxybutyric
Acid
(2010).
Heroin (9200) ...............................
Cocaine (9041) .............................
Codeine (9050) .............................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Methadone (9250) ........................
Morphine (9300) ...........................
Schedule
I
I
II
II
II
II
II
II
The company plans to import these
controlled substances for the
manufacture of reference standards.
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
Alltech Associates, 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 Alltech Associates, 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
E:\FR\FM\09DEN1.SGM
09DEN1
]]>Agencies
[Federal Register Volume 75, Number 236 (Thursday, December 9, 2010)]
[Notices]
[Page 76755]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30901]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application
Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to
issuing a registration under this Section to a bulk manufacturer of a
controlled substance in schedule I or II, and prior to issuing a
regulation under 21 U.S.C. 952(a)(2) authorizing the importation of
such a substance, provide manufacturers holding registrations for the
bulk manufacture of the substance an opportunity for a hearing.
Therefore, in accordance with 21 CFR 1301.34(a), this is notice
that on October 19, 2010, Mylan Pharmaceuticals, Inc., 781 Chestnut
Ridge Road, Morgantown, West Virginia 26505, 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
------------------------------------------------------------------------
Methylphenidate (1724)..................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
The company plans to import the listed controlled substances in
finished dosage form (FDF) from foreign sources for analytical testing
and clinical trials in which the foreign FDF will be compared to the
company's own domestically-manufactured FDF. This analysis is required
to allow the company to export domestically-manufactured FDF to foreign
markets.
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 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 10, 2011.
This procedure is to be conducted simultaneously with, and
independent of, the procedures described in 21 CFR Sec. 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: November 29, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2010-30901 Filed 12-8-10; 8:45 am]
BILLING CODE 4410-09-P
