Importer of Controlled Substances; Notice of Application; Almac Clinical Services, Inc., (ACSI), 23373-23374 [2014-09567]
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Federal Register / Vol. 79, No. 81 / Monday, April 28, 2014 / Notices
3. All comments must be submitted no
later than thirty (30) days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
To submit
comments:
Send them to:
By email .......
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General
U.S. DOJ—ENRD
P.O. Box 7611
Washington, DC 20044–7611.
By mail .........
During the public comment period,
the Consent Decree may be examined
and downloaded at this Justice
Department Web site: https://
www.usdoj.gov/enrd/Consent_
Decrees.html. We will provide a paper
copy of the Consent Decree upon
written request and payment of
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States Treasury.
Susan M. Akers,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, and
dispensers of controlled substances
(other than final orders in connection
with suspension, denial, or revocation
of registration) has been redelegated to
the Deputy Assistant Administrator of
the DEA Office of Diversion Control
(‘‘Deputy Assistant Administrator’’)
pursuant to sec. 7(g) of 28 CFR part 0,
subpart R, App.
In accordance with 21 CFR
1301.33(a), this is notice that on January
8, 2014, Patheon Pharmaceuticals, Inc.,
2110 E. Galbraith Road, Cincinnati,
Ohio 45237, made application by
renewal to the DEA to be registered as
a bulk manufacturer of Gamma
Hydroxybutyric Acid (2010), a basic
class of nonnarcotic controlled
substances in schedule I.
The company plans to manufacture
the listed controlled substance for
distribution to its customers.
Dated: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014–09563 Filed 4–25–14; 8:45 am]
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DEPARTMENT OF JUSTICE
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Drug Enforcement Administration
DEPARTMENT OF JUSTICE
Importer of Controlled Substances;
Notice of Application; Research
Triangle Institute
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Patheon
Pharmaceuticals, Inc.
Notice of application with
opportunity for comment.
ACTION:
Registered bulk manufacturers of
the affected basic classes and applicants
therefore may file written comments or
objections to the issuance of the
proposed registration in accordance
with 21 CFR 1301.33(a) on or before
June 27, 2014.
ADDRESSES: Written comments should
be sent via regular or express mail to:
Drug Enforcement Administration,
Attention: DEA Federal Register
Representative/ODW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
tkelley on DSK3SPTVN1PROD with NOTICES
DATES:
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Pursuant to 21 CFR 1301.34(a), this is
notice that on February 12, 2014,
Research Triangle Institute, Poonam G.
Pande, Ph.D. RPH, RAC, Hermann
Building, East Institute Drive, P.O. Box
12194, Research Triangle Park, North
Carolina 27709, made application by
written correspondence to the Drug
Enforcement Administration (DEA) for
registration as an importer of
Noroxymorphone (9668) a basic class of
controlled substance listed in schedule
II.
The company plans to import small
quantities of the listed controlled
substances for the National Institute on
Drug Abuse (NIDA) for research
activities.
Any bulk manufacturer who is
presently, or is applying to be,
registered with the DEA to manufacture
such basic class of controlled substance
listed in schedule I or II, which fall
under the authority of section
1002(a)(2)(B) of the Act (21 U.S.C.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
23373
952(a)(2)(B)) may, in the circumstances
set forth in 21 U.S.C. 958(i), 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
(ODW), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than May 28, 2014.
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: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2014–09561 Filed 4–25–14; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Almac Clinical
Services, Inc., (ACSI)
Pursuant to 21 CFR 1301.34 (a), this
is notice that on March 5, 2014, Almac
Clinical Services, Inc., (ACSI), 25 Fretz
Road, Souderton, Pennsylvania 18964,
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
Oxycodone (9143) ................
Hydromorphone (9150) ........
Tapentadol (9780) ................
Fentanyl (9801) ....................
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Schedule
II
II
II
II
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Federal Register / Vol. 79, No. 81 / Monday, April 28, 2014 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
The company plans to import small
quantities of the listed controlled
substances in dosage form to conduct
clinical trials.
The import of the above listed basic
classes of controlled substances will be
granted only for analytical testing and
clinical trials. This authorization does
not extend to the import of finished
FDA approved or non-approved dosage
forms for commercial distribution in the
United States.
Any bulk manufacturer who is
presently, or is applying to be,
registered with the DEA to manufacture
such basic classes of controlled
substances listed in schedule II, which
falls 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. 958(i), 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
(ODW), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than May 28, 2014.
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 substances in schedules
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: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2014–09567 Filed 4–25–14; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Meridian Medical
Technologies
Pursuant to 21 CFR 1301.34(a), this is
notice that on January 3, 2014, Meridian
Medical Technologies, 2555 Hermelin
Drive, St. Louis, Missouri 63144, made
application by renewal to the Drug
Enforcement Administration (DEA) for
registration 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.
The company has been asked to ensure
that its product, which is sold to
European customers, meets the
standards established by the European
Pharmacopeia, 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 for
use as reference standards.
This is the sole purpose for which the
company will be authorized by the DEA
to import morphine.
Any bulk manufacturer who is
presently, or is applying to be,
registered with the DEA to manufacture
such basic class of controlled substance
listed in schedules 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. 958(i), 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
(ODW), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than May 28, 2014.
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 schedules I
or II are, and will continue to be,
required to demonstrate to the Deputy
PO 00000
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Fmt 4703
Sfmt 4703
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: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2014–09571 Filed 4–25–14; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; S & B Pharma,
Inc.
By Notice dated January 15, 2014, and
published in the Federal Register on
February 4, 2014, 79 FR 6630, S & B
Pharma, Inc., DBA Norac Pharma, 405 S.
Motor Avenue, Azusa, California
91702–3232, made application to the
Drug Enforcement Administration
(DEA) to be registered as an importer of
the following basic classes of controlled
substances:
Drug
4-Anilino-N-phenethyl-4-piperidine
(8333).
Tapentadol (9780) ........................
Schedule
II
II
The company plans to import the
listed controlled substances for internal
use, and to manufacture bulk
intermediates for sale to its customers.
On February 10, 2014, S & B Pharma,
Inc., withdrew its request for the
addition of Fentanyl (9801) to this
registration.
No comments or objections have been
received. The DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a),
and determined that the registration of
S & B Pharma, Inc. to import the basic
classes of controlled substances is
consistent with the public interest and
in accordance with United States
obligations under international treaties,
conventions, or protocols in effect on
May 1, 1971. The DEA has investigated
S & B Pharma, 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.
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[Federal Register Volume 79, Number 81 (Monday, April 28, 2014)]
[Notices]
[Pages 23373-23374]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09567]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application; Almac
Clinical Services, Inc., (ACSI)
Pursuant to 21 CFR 1301.34 (a), this is notice that on March 5,
2014, Almac Clinical Services, Inc., (ACSI), 25 Fretz Road, Souderton,
Pennsylvania 18964, 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
------------------------------------------------------------------------
Oxycodone (9143)........................................ II
Hydromorphone (9150).................................... II
Tapentadol (9780)....................................... II
Fentanyl (9801)......................................... II
------------------------------------------------------------------------
[[Page 23374]]
The company plans to import small quantities of the listed
controlled substances in dosage form to conduct clinical trials.
The import of the above listed basic classes of controlled
substances will be granted only for analytical testing and clinical
trials. This authorization does not extend to the import of finished
FDA approved or non-approved dosage forms for commercial distribution
in the United States.
Any bulk manufacturer who is presently, or is applying to be,
registered with the DEA to manufacture such basic classes of controlled
substances listed in schedule II, which falls 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. 958(i), 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 (ODW), 8701
Morrissette Drive, Springfield, Virginia 22152; and must be filed no
later than May 28, 2014.
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 substances
in schedules 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: April 21, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2014-09567 Filed 4-25-14; 8:45 am]
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