Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, 5275 [2018-02341]
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Federal Register / Vol. 83, No. 25 / Tuesday, February 6, 2018 / Notices
comments on or objections to the
issuance of the proposed registration on
or before April 9, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 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, 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 Assistant
Administrator of the DEA Diversion
Control Division (‘‘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 July 21,
2017, Chattem Chemicals, Inc., 3801 St.
Elmo Avenue, Chattanooga, Tennessee
37409 applied to be registered as a bulk
manufacturer for the basic classes of
controlled substances:
daltland on DSKBBV9HB2PROD with NOTICES
Controlled substance
Gamma Hydroxybutyric
Acid.
Marihuana .......................
Tetrahydrocannabinols ...
4-Methoxyamphetamine
Dihydromorphine ............
Amphetamine .................
Methamphetamine ..........
Lisdexamfetamine ..........
Methylphenidate .............
Pentobarbital ..................
Codeine ..........................
Dihydrocodeine ...............
Oxycodone .....................
Hydromorphone ..............
Hydrocodone ..................
Meperidine ......................
Meperidine intermediateA.
Meperidine intermediateB.
Meperidine intermediateC.
Methadone ......................
Methadone intermediate
Morphine .........................
Oripavine ........................
Thebaine .........................
Opium tincture ................
Opium, powdered ...........
Opium, granulated ..........
Oxymorphone .................
VerDate Sep<11>2014
Noroxymorphone ............
Alfentanil .........................
Remifentanil ....................
Sufentanil ........................
Tapentadol ......................
Fentanyl ..........................
I
7360
7370
7411
9145
1100
1105
1205
1724
2270
9050
9120
9143
9150
9193
9230
9232
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
9233
II
9234
II
9250
9254
9300
9330
9333
9630
9639
9640
9652
II
II
II
II
II
II
II
II
II
9668
9737
9739
9740
9780
9801
II
II
II
II
II
II
Dated: January 30, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–02343 Filed 2–5–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Cedarburg
Pharmaceuticals
Notice of application.
Schedule
2010
Schedule
The company plans to manufacture
the listed controlled substances in bulk
for distribution and sale to its
customers.
In reference to drug codes 7360
(marihuana) and 7370
(tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
ACTION:
Drug
code
Drug
code
Controlled substance
19:02 Feb 05, 2018
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 on
or before April 9, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
Jkt 244001
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, 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 Assistant
Administrator of the DEA Diversion
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Control Division (‘‘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 August
29, 2017, Cedarburg Pharmaceuticals,
Inc., A Division of Albany Molecular
Research Inc. (AMRI), 870 Badger
Circle, Grafton, Wisconsin 53024
applied to be registered as a bulk
manufacturer the following basic classes
of controlled substances:
Controlled substance
Marihuana .......................
Tetrahydrocannabinols ...
Lisdexamfetamine ..........
Pentobarbital ..................
Nabilone .........................
4-Anilino-N-phenethyl-4piperidine (ANPP).
Remifentanil ....................
Fentanyl ..........................
Drug
code
Schedule
7360
7370
1205
2270
7379
8333
I
I
II
II
II
II
9739
9801
II
II
The company plans to manufacture
the above listed controlled substances in
bulk for distribution to its customers. In
reference to drug codes 7360 marihuana,
the company plans to bulk manufacture
cannabidiol as a synthetic intermediate.
The company plans to manufacture bulk
active pharmaceutical ingredients (API)
for distribution to its customers. This
controlled substance will be further
synthesized to bulk manufacture a
synthetic tetrahydrocannabinols 7370.
No other activity for this drug code is
authorized for this registration.
Dated: January 30, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–02341 Filed 2–5–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Notice of Proposed Settlement
Agreement and Draft Restoration Plan
Under The Oil Pollution Act of 1990,
and The Clean Water Act
Notice is hereby given that the United
States of America, on behalf of the
Department of the Interior (‘‘DOI’’)
acting through the Fish and Wildlife
Service and the National Park Service,
the District of Columbia, on behalf of
the Department of Energy and
Environment, and the Commonwealth
of Virginia, acting through the Virginia
Department of Environmental Quality
(collectively ‘‘Trustees’’), are providing
an opportunity for public comment on
a proposed Settlement Agreement
(‘‘Settlement Agreement’’) among the
DOI, the District of Columbia, the
Commonwealth of Virginia, and
E:\FR\FM\06FEN1.SGM
06FEN1
]]>Agencies
[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)]
[Notices]
[Page 5275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02341]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Cedarburg
Pharmaceuticals
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 on or before April 9, 2018.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
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, 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 Assistant Administrator of the DEA Diversion Control Division
(``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 August
29, 2017, Cedarburg Pharmaceuticals, Inc., A Division of Albany
Molecular Research Inc. (AMRI), 870 Badger Circle, Grafton, Wisconsin
53024 applied to be registered as a bulk manufacturer the following
basic classes of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
Lisdexamfetamine....................... 1205 II
Pentobarbital.......................... 2270 II
Nabilone............................... 7379 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Remifentanil........................... 9739 II
Fentanyl............................... 9801 II
------------------------------------------------------------------------
The company plans to manufacture the above listed controlled
substances in bulk for distribution to its customers. In reference to
drug codes 7360 marihuana, the company plans to bulk manufacture
cannabidiol as a synthetic intermediate. The company plans to
manufacture bulk active pharmaceutical ingredients (API) for
distribution to its customers. This controlled substance will be
further synthesized to bulk manufacture a synthetic
tetrahydrocannabinols 7370. No other activity for this drug code is
authorized for this registration.
Dated: January 30, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-02341 Filed 2-5-18; 8:45 am]
BILLING CODE 4410-09-P
