Importer of Controlled Substances; Notice of Application, 47961 [E9-22502]
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47961
Federal Register / Vol. 74, No. 180 / Friday, September 18, 2009 / Notices
respond/reply: It is estimated that 2500
respondents will complete a 4-hour
form.
(6) An estimate of the total public
burden (in hours) associated with the
collection: The total hour burden to
complete the forms is 10,000 annual
burden hours.
If additional information is required
contact: Lynn Bryant, Department
Clearance Officer, United States
Department of Justice, Policy and
Planning Staff, Justice Management
Division, Suite 1600, Patrick Henry
Building, 601 D Street, NW.,
Washington, DC 20530.
Dated: September 14, 2009.
Lynn Bryant,
Department Clearance Officer, PRA, United
States Department of Justice.
[FR Doc. E9–22450 Filed 9–17–09; 8:45 am]
BILLING CODE 4410–18–P
Dated: September 14, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–22502 Filed 9–17–09; 8:45 am]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
erowe on DSK5CLS3C1PROD 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 May 8,
2009, DDN/Obergfel LLC., 1560–A S.
Baker Avenue, Ontario, California
91761, 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 in bulk for distribution to
dosage form manufacturers.
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,
VerDate Nov<24>2008
15:10 Sep 17, 2009
Jkt 217001
to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, VA. 22152; and must be
filed no later than October 19, 2009.
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.
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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 class of controlled substance
listed.
Dated: September 14, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–22506 Filed 9–17–09; 8:45 am]
BILLING CODE 4410–09–M
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated June 15, 2009, and
published in the Federal Register on
June 23, 2009, (74 FR 29719), Aptuit
(Allendale) Inc., 75 Commerce Drive,
Allendale, New Jersey 07401, 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:
Importer of Controlled Substances;
Notice of Registration
By Notice dated June 22, 2009, and
published in the Federal Register on
June 26, 2009, (74 FR 30621), Noramco,
Inc., Division of Ortho-McNeil, Inc., 500
Swedes Landing Road, Wilmington,
Delaware 19801, made application by
letter to the Drug Enforcement
Administration (DEA) to be registered as
an importer of Tapentadol (9780), a
basic class of controlled substance listed
in schedule II.
The company plans to import an
intermediate of the basic class listed for
the bulk manufacture of Tapentadol
which it will distribute to its customers.
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
Noramco, Inc. to import the basic class
of controlled substance is consistent
with the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971, at this time. DEA
has investigated Noramco, Inc. to ensure
that the company’s registration is
consistent with the public interest. The
investigation has included inspection
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Drug
Lisdexamfetamine (1205) .............
Noroxymorphone (9668) ..............
Schedule
II
II
The company plans to import the
basic classes of controlled substances
for clinical trials and research.
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
Aptuit (Allendale), 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, at
this time. DEA has investigated Aptuit
(Allendale), 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
E:\FR\FM\18SEN1.SGM
18SEN1
]]>Agencies
[Federal Register Volume 74, Number 180 (Friday, September 18, 2009)]
[Notices]
[Page 47961]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22502]
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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 Title 21 Code of Federal Regulations
(CFR), 1301.34(a), this is notice that on May 8, 2009, DDN/Obergfel
LLC., 1560-A S. Baker Avenue, Ontario, California 91761, 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 in bulk for distribution
to dosage form manufacturers.
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, VA. 22152; and must be filed no later
than October 19, 2009.
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. Sec. 958(a); 21 U.S.C. 823(a);
and 21 CFR Sec. 1301.34(b), (c), (d), (e), and (f) are satisfied.
Dated: September 14, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E9-22502 Filed 9-17-09; 8:45 am]
BILLING CODE 4410-09-P
