Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc., 23373 [2014-09563]
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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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request and payment to: Consent Decree
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7611, Washington, DC 20044–7611.
Please enclose a check or money order
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reproduction cost) payable to the United
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]
BILLING CODE 4410–09–P
[FR Doc. 2014–09531 Filed 4–25–14; 8:45 am]
DEPARTMENT OF JUSTICE
BILLING CODE 4410–15–P
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
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DATES:
VerDate Mar<15>2010
17:06 Apr 25, 2014
Jkt 232001
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) ....................
E:\FR\FM\28APN1.SGM
28APN1
Schedule
II
II
II
II
]]>Agencies
[Federal Register Volume 79, Number 81 (Monday, April 28, 2014)]
[Notices]
[Page 23373]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09563]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Patheon
Pharmaceuticals, Inc.
ACTION: Notice of application with opportunity for comment.
-----------------------------------------------------------------------
DATES: 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
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]
BILLING CODE 4410-09-P
