Importer of Controlled Substances Application: Fresenius Kabi USA, LLC, 64562-64563 [2019-25403]
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64562
Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
Issued: November 20, 2019.
William Bishop,
Supervisory Hearings and Information
Officer.
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 December 23, 2019. Such
persons may also file a written request
for a hearing on the application on or
before December 23, 2019.
DATES:
[FR Doc. 2019–25500 Filed 11–20–19; 11:15 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
[Docket No. DEA–550]
Importer of Controlled Substances
Application: Janssen Pharmaceuticals,
Inc.
ACTION:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
ADDRESSES:
Drug Enforcement Administration
Notice of application.
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
In
accordance with 21 CFR 1301.34(a), this
is notice that on October 9, 2019,
Janssen Pharmaceuticals, Inc., 1440
Olympic Drive, Athens, Georgia 30601–
1645 applied to be registered as an
importer of the following basic classes
of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Thebaine ..................................................................................................................................................................
Concentrate of Poppy Straw ...................................................................................................................................
Tapentadol ...............................................................................................................................................................
The company plans to import
intermediate forms of tapentadol (9780)
and thebaine (9333) for further
manufacturing prior to distribution to
its customers. The company plans to
import concentrate of poppy straw
(9670) to bulk manufacture other
controlled substances. No other activity
for these drug codes is authorized for
this registration.
Dated: November 8, 2019.
William T. McDermott,
Assistant Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–551]
Controlled
substance
Importer of Controlled Substances
Application: Epic Pharma, LLC
khammond on DSKJM1Z7X2PROD with NOTICES
Methadone
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 on
or before December 23, 2019. Such
persons may also file a written request
for a hearing on the application on or
before December 23, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
DATES:
VerDate Sep<11>2014
16:57 Nov 21, 2019
Jkt 250001
Drug code
[Docket No. DEA–528]
Importer of Controlled Substances
Application: Fresenius Kabi USA, LLC
ACTION:
II
The company plans to import the
listed controlled substance for research
and analytical purposes.
Dated: November 8, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019–25406 Filed 11–21–19; 8:45 am]
BILLING CODE 4410–09–P
PO 00000
Frm 00110
Fmt 4703
Sfmt 4703
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 on
or before December 23, 2019. Such
persons may also file a written request
for a hearing on the application on or
before December 23, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on August 7, 2019
Fresenius Kabi USA, LLC, 3159 Staley
Road, Grand Island, New York 14072–
DATES:
Schedule
9250
II
II
II
Drug Enforcement Administration
In
accordance with 21 CFR 1301.34(a), this
is notice that on September 13, 2019,
Epic Pharma, LLC, 227–15 North
Conduit Avenue, Laurelton, New York
11413, applied to be registered as an
importer of the following basic class of
controlled substance:
BILLING CODE 4410–09–P
9333
9670
9780
DEPARTMENT OF JUSTICE
SUPPLEMENTARY INFORMATION:
[FR Doc. 2019–25407 Filed 11–21–19; 8:45 am]
ACTION:
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
Schedule
E:\FR\FM\22NON1.SGM
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64563
Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
2028 applied to be registered as an
importer of the following basic classes
of controlled substances:
Controlled substance
Drug code
Schedule
Remifentanil .............................................................................................................................................................
9739
II
Dated: October 23, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019–25403 Filed 11–21–19; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2019–25404 Filed 11–21–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
In
accordance with 21 CFR 1301.34(a), this
is notice that on July 15, 2019, GE
Healthcare, 3350 North Ridge Avenue,
Arlington Heights, Illinois 60004–1412
applied to be registered as an importer
of the following basic class of controlled
substance:
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–538]
Importer of Controlled Substances
Application: GE Healthcare
ACTION:
Dated: November 7, 2019.
William T. McDermott,
Assistant Administrator.
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
The company plans to import the
listed controlled substance for bulk
manufacture.
[Docket No. DEA–529]
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Manufacturing, 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 on
or before January 21, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
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 on
or before December 23, 2019. Such
persons may also file a written request
for a hearing on the application on or
before December 23, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
DATES:
Controlled
substance
Drug code
Cocaine .....
Schedule
9041
II
The company plans to import small
quantities of Ioflupane, in the form of
three separate analogues of cocaine, to
validate production and quality control
systems, for a reference standard, and
for producing material for a future
investigational new drug (IND)
submission. Supplies of this particular
controlled substance are not available in
the form needed within the current
domestic supply of the United States.
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 15, 2019,
Patheon API Manufacturing, Inc., 309
Delaware Street, Greenville, South
Carolina 29605 applied to be registered
as a bulk manufacturer of the following
basic classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Thebaine ..................................................................................................................................................................
Noroxymorphone .....................................................................................................................................................
Gamma Hydroxybutyric Acid ...................................................................................................................................
Alpha-methyltryptamine ...........................................................................................................................................
khammond on DSKJM1Z7X2PROD with NOTICES
The company plans to bulk
manufacture the listed controlled
substances as an Active Pharmaceutical
Ingredient for supply to its customers.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–545]
[FR Doc. 2019–25401 Filed 11–21–19; 8:45 am]
Bulk Manufacturer of Controlled
Substances Application: S&B Pharma,
Inc.
ACTION:
BILLING CODE 4410–09–P
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
DATES:
16:57 Nov 21, 2019
9333
9668
2010
7432
II
II
I
I
applicants therefore, may file written
comments on or objections to the
issuance of the proposed on or before
January 21, 2020.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
Dated: November 5, 2019.
William T. McDermott,
Assistant Administrator.
VerDate Sep<11>2014
Schedule
Jkt 250001
PO 00000
Frm 00111
Fmt 4703
Sfmt 4703
In
accordance with 21 CFR 1301.33(a), this
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22NON1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64562-64563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25403]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-528]
Importer of Controlled Substances Application: Fresenius Kabi
USA, LLC
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 December 23, 2019.
Such persons may also file a written request for a hearing on the
application on or before December 23, 2019.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for a hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on August 7, 2019 Fresenius Kabi USA, LLC, 3159 Staley
Road, Grand Island, New York 14072-
[[Page 64563]]
2028 applied to be registered as an importer of the following basic
classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Remifentanil.......................... 9739 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance for
bulk manufacture.
Dated: October 23, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-25403 Filed 11-21-19; 8:45 am]
BILLING CODE 4410-09-P
