Importer of Controlled Substances Application: Janssen Pharmaceuticals, Inc., 2214-2215 [2018-00508]
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Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices
argument that a different standard of
proof should apply.
B. In any enforcement proceeding in
which the Court finds that TransDigm
has violated this Final Judgment, the
United States may apply to the Court for
a one-time extension of this Final
Judgment, together with such other
relief as may be appropriate. TransDigm
agrees to reimburse the United States for
any attorneys’ fees, experts’ fees, and
costs incurred in connection with any
effort to enforce this Final Judgment.
XVI. Expiration of Final Judgment
Unless this Court grants an extension,
this Final Judgment shall expire ten (10)
years from the date of its entry, except
that after five (5) years from the date of
its entry, this Final Judgment may be
terminated upon notice by the United
States to the Court and TransDigm that
the divestiture has been completed and
that the continuation of the Final
Judgment no longer is necessary or in
the public interest.
XVII. Public Interest Determination
Entry of this Final Judgment is in the
public interest. The parties have
complied with the requirements of the
Antitrust Procedures and Penalties Act,
15 U.S.C. 16, including making copies
available to the public of this Final
Judgment, the Competitive Impact
Statement, and any comments thereon
Facility name
1371 SW 8th Street, Pompano Beach, FL ......
APPENDIX A: Real Property
(Owned and Leased)
SCHROTH U.S. Leased Real Property
Address
Pompano Beach .................................................
and the United States’ responses to
comments. Based upon the record
before the Court, which includes the
Competitive Impact Statement and any
comments and response to comments
filed with the Court, entry of this Final
Judgment is in the public interest.
Date: llllllllllllllll
Court approval subject to procedures
of Antitrust Procedures and Penalties
Act, 15 U.S.C. 16.
llllllllllllllllll
l
United States District Judge.
Type of facility
Manufacturing Plant, Office, and Warehouse.
SCHROTH Germany Leased Real
Property
Facility name
Address
Type of facility
Headquarters ‘‘Im Ohl’’ .......................................
Im Ohl 14, 59757, Arnsberg, Germany ...........
Parking Area ‘‘Im Ohl’’ ........................................
Im Ohl 14, 59757, Arnsberg, Germany ...........
Manufacturing
quarters).
Parking Area.
Plant
and
Office
(Head-
SCHROTH Germany Owned Real
Property
Facility name
Address
Warehouse ‘‘Im Ohl’’ ..........................................
Im Ohl 14, 59757, Arnsberg, Germany; Land
Register of Neheim-Husten of the local
court of Arnsberg; Page 13024; Plot 5, Parcel 390.
Im Ohl 14, 59757, Arnsberg, Germany; Land
Register of Neheim-Husten of the local
court of Arnsberg; Page 9777; Plot 5, Parcel 88.
Warehouse ‘‘Im Ohl’’ ..........................................
persons may also file a written request
for a hearing on the application
pursuant on or before February 15,
2018.
[FR Doc. 2018–00544 Filed 1–12–18; 8:45 am]
BILLING CODE 4410–11–P
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
daltland on DSKBBV9HB2PROD with NOTICES
Importer of Controlled Substances
Application: Janssen Pharmaceuticals,
Inc.
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 February 15, 2018. Such
DATES:
VerDate Sep<11>2014
22:48 Jan 12, 2018
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 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
ADDRESSES:
Drug Enforcement Administration
ACTION:
Jkt 244001
Type of facility
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
Warehouse.
Warehouse.
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16JAN1.SGM
16JAN1
2215
Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices
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
September 19, 2017, Janssen
Pharmaceuticals Inc., 1400 Olympic
Drive, BLDGS 1–5 & 7–14, Athens,
Georgia 30601 applied to be registered
as an importer of the following basic
classes of controlled substances:
Controlled substance
Tapentadol ....................
Thebaine .......................
Concentrated Poppy
Straw.
Drug
code
9780
9333
9670
Schedule
II
II
II
Dated: January 4, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–00508 Filed 1–12–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Catalent Pharma
Solutions, LLC
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 February 15, 2018. Such
persons may also file a written request
for a hearing on the application
February 15, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
daltland on DSKBBV9HB2PROD with NOTICES
DATES:
VerDate Sep<11>2014
22:48 Jan 12, 2018
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
1301.34(a), this is notice that on October
13, 2017, Catalent Pharma Solutions,
LLC, 1100 Enterprise Drive, Winchester,
KY 40391 applied to be registered as an
importer for Gamma Hydroxybutyric
Acid (2010) the basic class of controlled
substances.
The company plans to import the
listed controlled substance in finished
dosage form for analytical purposes
only. No other activity for these drug
codes is authorized for this registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under to 21 U.S.C.
952(a)(2). Authorization will not extend
to the import of FDA approved or nonapproved finished dosage forms for
commercial sale.
SUPPLEMENTARY INFORMATION:
The company plans to import an
intermediate form of tapentadol (9780)
to bulk manufacture tapentadol for
distribution to its customers. The
company plans to import thebaine
derivatives (9333) as reference
standards. The company plans to import
concentrated poppy straw to
manufacture other controlled
substances. No other activity for these
drug codes is authorized for this
registration. Approval of permit
applications will occur only when the
registrant’s business activity is
consistent with what is authorized
under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
ACTION:
Register Representative/DRW, 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/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
Jkt 244001
Dated: January 4, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–00507 Filed 1–12–18; 8:45 am]
BILLING CODE 4410–09–P
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Johnson
Matthey 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 March 19, 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 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 0, appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on
November 10, 2017, Johnson Matthey
Inc., Pharmaceuticals Materials, 900
River Road, Conshohocken,
Pennsylvania 19428 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
DATES:
Controlled substance
Gamma Hydroxybutyric
Acid.
Amphetamine ...............
Methylphenidate ...........
Codeine ........................
Oxycodone ...................
Diphenoxylate ...............
Hydrocodone ................
Meperidine ....................
Methadone ....................
Methadone intermediate
Morphine .......................
Thebaine .......................
Opium tincture ..............
E:\FR\FM\16JAN1.SGM
16JAN1
Drug
code
Schedule
2010
I
1100
1724
9050
9143
9170
9193
9230
9250
9254
9300
9333
9630
II
II
II
II
II
II
II
II
II
II
II
II
]]>Agencies
[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Pages 2214-2215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00508]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Janssen
Pharmaceuticals, 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 on or before February 15, 2018.
Such persons may also file a written request for a hearing on the
application pursuant on or before February 15, 2018.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
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/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
[[Page 2215]]
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
September 19, 2017, Janssen Pharmaceuticals Inc., 1400 Olympic Drive,
BLDGS 1-5 & 7-14, Athens, Georgia 30601 applied to be registered as an
importer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Tapentadol............................. 9780 II
Thebaine............................... 9333 II
Concentrated Poppy Straw............... 9670 II
------------------------------------------------------------------------
The company plans to import an intermediate form of tapentadol
(9780) to bulk manufacture tapentadol for distribution to its
customers. The company plans to import thebaine derivatives (9333) as
reference standards. The company plans to import concentrated poppy
straw to manufacture other controlled substances. No other activity for
these drug codes is authorized for this registration. Approval of
permit applications will occur only when the registrant's business
activity is consistent with what is authorized under 21 U.S.C.
952(a)(2).
Authorization will not extend to the import of FDA approved or non-
approved finished dosage forms for commercial sale.
Dated: January 4, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-00508 Filed 1-12-18; 8:45 am]
BILLING CODE 4410-09-P
