Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc., 64509 [2016-22526]
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64509
Federal Register / Vol. 81, No. 182 / Tuesday, September 20, 2016 / Notices
Register pursuant to Section 6(b) of the
Act on May 18, 2016 (81 FR 31259).
Controlled substance
Noroxymorphone (9668) ..............
Patricia A. Brink,
Director of Civil Enforcement, Antitrust
Division.
Schedule
II
[Docket No. DEA–392]
The company plans to manufacture
the above-listed controlled substances
as Active Pharmaceutical Ingredient
(API) for clinical trials.
In reference to drug codes 7360
(marihuana), and 7370 (THC), the
company plans to bulk manufacture
these drugs as synthetics. No other
activities for these drug codes are
authorized for this registration.
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Manufacturing, Inc.
Dated: September 12, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–22590 Filed 9–19–16; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[FR Doc. 2016–22526 Filed 9–19–16; 8:45 am]
ACTION:
Notice of application.
BILLING CODE 4410–09–P
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration in
accordance with 21 CFR 1301.33(a) on
or before November 21, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
The
Attorney General has delegated her
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, dispensers,
importers, and exporters 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 section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on January
13, 2016, Patheon API Manufacturing,
Inc., 309 Delaware Street, Building
1106, Greenville, South Carolina 29605
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
sradovich on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Controlled substance
Schedule
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
VerDate Sep<11>2014
17:13 Sep 19, 2016
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Jkt 238001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
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, dispensers,
importers, and exporters 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 section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on April
4, 2015, R & D Systems, Inc., 614
McKinley Place NE., Minneapolis,
Minnesota 55413 applied to be
registered as an importer of the
following basic classes of controlled
substances:
Importer of Controlled Substances
Application: R & D Systems, Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration in
accordance with 21 CFR 1301.34(a) on
or before October 20, 2016. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
October 20, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/ODW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
Comments and requests for hearing on
applications to import narcotic raw
material are not appropriate. 72 FR 3417
(January 25, 2007).
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated her
DATES:
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
Controlled substance
Mephedrone
(4-Methyl-Nmethylcathinone) (1248).
JWH–018 (also known as AM678)
(1-Pentyl-3-(1-naphthoyl)
indole) (7118).
CP–47,497
(5-(1,1Dimethylheptyl)-2-[(1R,3S)-3hydroxycyclohexyl-phenol)
(7297).
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
4-Bromo-2,5dimethoxyamphetamine (7391).
3,4Methylenedioxymethamphetamine (7405).
Dimethyltryptamine (7435) ...........
Psilocyn (7438) .............................
Pentobarbital (2270) .....................
Phencyclidine (7471) ....................
Cocaine (9041) .............................
Schedule
I
I
I
I
I
I
I
I
I
II
II
II
The company plans to manufacture
bulk active pharmaceutical controlled
substances for distribution to its
customers for analytical purposes.
In reference to drug codes 7360 and
7370, the company plans to import a
synthetic cannabidiol and a synthetic
tetrahydrocannabinol. No other activity
for these drug codes is authorized for
this registration.
Dated: September 12, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–22525 Filed 9–19–16; 8:45 am]
BILLING CODE 4410–09–P
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20SEN1
]]>Agencies
[Federal Register Volume 81, Number 182 (Tuesday, September 20, 2016)]
[Notices]
[Page 64509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22526]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Patheon
API Manufacturing, Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration in accordance with 21 CFR
1301.33(a) on or before November 21, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated her
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, dispensers, importers, and exporters 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 section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on
January 13, 2016, Patheon API Manufacturing, Inc., 309 Delaware Street,
Building 1106, Greenville, South Carolina 29605 applied to be
registered as a bulk manufacturer of the following basic classes of
controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
Noroxymorphone (9668)...................... II
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances as Active Pharmaceutical Ingredient (API) for clinical
trials.
In reference to drug codes 7360 (marihuana), and 7370 (THC), the
company plans to bulk manufacture these drugs as synthetics. No other
activities for these drug codes are authorized for this registration.
Dated: September 12, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-22526 Filed 9-19-16; 8:45 am]
BILLING CODE 4410-09-P
