Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc., 78765-78766 [2015-31665]
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78765
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices
requested, the Commission will provide
its advice to USTR by May 24, 2016.
Written Submissions: No public
hearing is planned. However, interested
parties are invited to file written
submissions concerning this
investigation. All written submissions
should be addressed to the Secretary,
and all such submissions should be
received not later than 5:15 p.m.,
January 25, 2016. All written
submissions must conform with the
provisions of section 201.8 of the
Commission’s Rules of Practice and
Procedure (19 CFR 201.8). Section 201.8
and the Commission’s Handbook on
Filing Procedures require that interested
parties file documents electronically on
or before the filing deadline and submit
eight (8) true paper copies by 12:00 p.m.
eastern time on the next business day.
In the event that confidential treatment
of a document is requested, interested
parties must file, at the same time as the
eight paper copies, at least four (4)
additional true paper copies in which
the confidential information must be
deleted (see the following paragraph for
further information regarding
confidential business information).
Persons with questions regarding
electronic filing should contact the
Secretary (202–205–2000).
Any submissions that contain
confidential business information must
also conform with the requirements of
section 201.6 of the Commission’s Rules
of Practice and Procedure (19 CFR
201.6). Section 201.6 of the rules
requires that the cover of the document
and the individual pages be clearly
marked as to whether they are the
‘‘confidential’’ or ‘‘non-confidential’’
version, and that the confidential
business information be clearly
identified by means of brackets. All
written submissions, except for
confidential business information, will
be made available for inspection by
interested parties. The Commission may
include some or all of the confidential
business information submitted in the
course of this investigation in the report
it sends to the USTR and the President.
As requested, the Commission will issue
a public version of its report, with any
confidential business information
deleted, shortly after it transmits its
report.
Summaries of Written Submissions:
The Commission intends to publish
summaries of the positions of interested
persons in an appendix to its report.
Persons wishing to have a summary of
their position included in the appendix
should include a summary with their
written submission. The summary may
not exceed 500 words, should be in
MSWord format or a format that can be
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16:53 Dec 16, 2015
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easily converted to MSWord, and
should not include any confidential
business information. The summary will
be published as provided if it meets
these requirements and is germane to
the subject matter of the investigation.
In the appendix the Commission will
identify the name of the organization
furnishing the summary, and will
include a link to the Commission’s
Electronic Document Information
System (EDIS) where the full written
submission can be found.
By order of the Commission.
Dated: December 14, 2015.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2015–31734 Filed 12–16–15; 8:45 am]
BILLING CODE 7020–02–P
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Schedule
I
I
The company plans to manufacture
bulk synthetic active pharmaceutical
ingredients (APIs) for product
development and distribution to its
customers. No other activity for these
drug codes are authorized for this
registration.
Dated: December 9, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–31667 Filed 12–16–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
Drug Enforcement Administration
Manufacturer of Controlled
Substances Registration: Austin
Pharma LLC
ACTION:
Notice of registration.
Austin Pharma LLC applied
to be registered as a manufacturer of
certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Austin
Pharma LLC registration as a
manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION: By notice
dated August 10, 2015, and published in
the Federal Register on August 18,
2015, 80 FR 50043, Austin Pharma LLC,
811 Paloma Drive, Suite C, Round Rock,
Texas 78665–2402 applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
No comments or objections were
submitted for this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Austin Pharma LLC to
manufacture the basic classes of
controlled substances is consistent with
the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
[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 in
accordance with 21 CFR 1301.33(a) on
or before February 16, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 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
DATES:
E:\FR\FM\17DEN1.SGM
17DEN1
78766
Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices
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
September 3, 2015, Johnson Matthey,
Inc., Custom Pharmaceuticals
Department, 2003 Nolte Drive, West
Deptford, New Jersey 08066–1742
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Schedule
Gamma
Hydroxybutyric
Acid
(2010).
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Dihydromorphine (9145) ...............
Difenoxin (9168) ...........................
Propiram (9649) ...........................
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Nabilone (7379) ............................
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
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I
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II
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asabaliauskas on DSK5VPTVN1PROD with NOTICES
The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers.
In reference to drug codes 7360
(marihuana) and 7370 (THC), the
company plans to bulk manufacture
these drugs as synthetic. No other
activities for these drug codes are
authorized for this registration.
Dated: December 9, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Fisher Clinical Services,
Inc.
ACTION:
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 January 19, 2016. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
January 19, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 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
1301.34(a), this is notice that on August
26, 2015, Fisher Clinical Services, Inc.
7554 Schantz Road, Allentown,
Pennsylvania 18106 applied to be
registered as an importer of the
following basic classes of controlled
substances:
DATES:
Controlled substance
[FR Doc. 2015–31665 Filed 12–16–15; 8:45 am]
BILLING CODE 4410–09–P
VerDate Sep<11>2014
16:53 Dec 16, 2015
Notice of application.
Methylphenidate (1724) ................
Levorphanol (9220) ......................
Noroxymorphone (9668) ..............
Tapentadol (9780) ........................
Jkt 238001
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Schedule
II
II
II
II
The company plans to import the
listed substances for analytical research,
testing, and clinical trials. This
authorization does not extend to the
import of a finished FDA approved or
non-approved dosage form for
commercial distribution in the United
States.
The company plans to import an
intermediate form of tapentadol (9780)
to bulk manufacture tapentadol for
distribution to its customers. Placement
of these (this) drug code (s) onto the
company’s registration does not
translate into automatic approval of
subsequent permit applications to
import controlled substances. 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.
Dated: December 9, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–31672 Filed 12–16–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: National
Center for Natural Products Research
(NIDA MPROJECT)
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 1301.33(a) on
or before February 16, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearing should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 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
DATES:
E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Pages 78765-78766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31665]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Johnson
Matthey, 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 February 16, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152. Request for
hearings should be sent to: Drug Enforcement Administration, Attention:
Hearing Clerk/LJ, 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
[[Page 78766]]
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
September 3, 2015, Johnson Matthey, Inc., Custom Pharmaceuticals
Department, 2003 Nolte Drive, West Deptford, New Jersey 08066-1742
applied to be registered as a bulk manufacturer of the following basic
classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)........... I
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
Dihydromorphine (9145)..................... I
Difenoxin (9168)........................... I
Propiram (9649)............................ I
Amphetamine (1100)......................... II
Methamphetamine (1105)..................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
Nabilone (7379)............................ II
Cocaine (9041)............................. II
Codeine (9050)............................. II
Dihydrocodeine (9120)...................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Diphenoxylate (9170)....................... II
Ecgonine (9180)............................ II
Hydrocodone (9193)......................... II
Meperidine (9230).......................... II
Methadone (9250)........................... II
Methadone intermediate (9254).............. II
Morphine (9300)............................ II
Thebaine (9333)............................ II
Oxymorphone (9652)......................... II
Noroxymorphone (9668)...................... II
Alfentanil (9737).......................... II
Remifentanil (9739)........................ II
Sufentanil (9740).......................... II
Tapentadol (9780).......................... II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for sale to its customers.
In reference to drug codes 7360 (marihuana) and 7370 (THC), the
company plans to bulk manufacture these drugs as synthetic. No other
activities for these drug codes are authorized for this registration.
Dated: December 9, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-31665 Filed 12-16-15; 8:45 am]
BILLING CODE 4410-09-P
