Manufacturer of Controlled Substances; Notice of Application, 60719 [E8-24310]
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Federal Register / Vol. 73, No. 199 / Tuesday, October 14, 2008 / Notices
Dated: October 8, 2008.
Lynn Bryant,
Department Clearance Officer, PRA, United
States Department of Justice.
[FR Doc. E8–24284 Filed 10–10–08; 8:45 am]
BILLING CODE 4410–FY–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
jlentini on PROD1PC65 with NOTICES
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 August
26, 2008, Hospira Inc., 1776 North
Centennial Drive, McPherson, Kansas
67460–1247, made application 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 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.
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 November 13, 2008.
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,
VerDate Aug<31>2005
15:37 Oct 10, 2008
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60719
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21 USC
958(a); 21 U.S.C. 823(a); and 21 CFR
1301.34(b), (c), (d), (e), and (f) are
satisfied.
DEPARTMENT OF JUSTICE
Dated: October 6, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E8–24308 Filed 10–10–08; 8:45 am]
On October 3, 2008, the Drug
Enforcement Administration (DEA)
published an order in the Federal
Register (73 FR 57655) that, among
other things, revoked the registration of
Sunny Wholesale, Inc. In the order
taking this action, the DEA Certificate of
Registration was incorrectly cited. The
correct Certificate of Registration for
Sunny Wholesale, Inc., 120 Forest
Parkway, Forest Park, Georgia, is
004550SLY.
Therefore, the Certificate of
Registration referenced at 73 FR 57668,
first column, sixth line down, is
corrected to read ‘‘004550SLY.’’
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application
Pursuant to § 1301.33(a) of Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on May 13, 2008, Halo
Pharmaceutical Inc., 30 North Jefferson
Road, Whippany, New Jersey 07981,
made application to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
the basic classes of controlled
substances listed in schedules I and II:
Drug
Schedule
Drug Enforcement Administration
[Docket Nos. 05–13 and 05–45]
Sunny Wholesale, Inc. Revocation of
Registration and Denial of Application;
Correction
Dated: October 6, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8–24305 Filed 10–10–08; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Office of Justice Programs
[OMB Number 1121–NEW]
Dihydromorphine (9145) ...............
Hydromorphone (9150) ................
I
II
Dihydromorphine is an intermediate
in the manufacture of Hydromorphone
and is not for commercial distribution.
The company plans to manufacture
Hydromorphone HCL for sale to other
manufacturers and for the manufacture
of other controlled substance dosage
units for distribution to its 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 December 15, 2008.
Dated: October 7, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E8–24310 Filed 10–10–08; 8:45 am]
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Agency Information Collection
Activities: New Information Collection,
Comments Requested
30-Day Notice of Information
Collection Under Review: NICS Act
State Record Estimates Data Collection.
ACTION:
The Department of Justice (DOJ),
Office of Justice Programs, Bureau of
Justice Statistics (BJS), will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
The proposed information collection is
published to obtain comments from the
public and affected agencies. This
proposed information collection was
previously published in the Federal
Register Volume 73, Number 150, page
45245 on August 4, 2008, allowing for
a 60 day comment period.
The purpose of this notice is to allow
for an additional 30 days for public
comment until November 13, 2008. This
process is conducted in accordance with
5 CFR 1320.10.
The proposed information collection
is available online at https://
www.ojp.usdoj.gov/bjs/niaa.htm.
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[Federal Register Volume 73, Number 199 (Tuesday, October 14, 2008)]
[Notices]
[Page 60719]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24310]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Application
Pursuant to Sec. 1301.33(a) of Title 21 of the Code of Federal
Regulations (CFR), this is notice that on May 13, 2008, Halo
Pharmaceutical Inc., 30 North Jefferson Road, Whippany, New Jersey
07981, made application to the Drug Enforcement Administration (DEA) to
be registered as a bulk manufacturer of the basic classes of controlled
substances listed in schedules I and II:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Dihydromorphine (9145)..................... I
Hydromorphone (9150)....................... II
------------------------------------------------------------------------
Dihydromorphine is an intermediate in the manufacture of
Hydromorphone and is not for commercial distribution. The company plans
to manufacture Hydromorphone HCL for sale to other manufacturers and
for the manufacture of other controlled substance dosage units for
distribution to its 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 December 15, 2008.
Dated: October 7, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E8-24310 Filed 10-10-08; 8:45 am]
BILLING CODE 4410-09-P
