Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc., 95647-95648 [2016-31283]
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95647
Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices
Controlled substance
Drug code
Meperidine ...............................................................................................................................................................
Meperidine intermediate-B .......................................................................................................................................
Methadone ...............................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ......................................................................................................
Morphine ..................................................................................................................................................................
Thebaine ..................................................................................................................................................................
Oxymorphone ..........................................................................................................................................................
Alfentanil ..................................................................................................................................................................
Remifentanil .............................................................................................................................................................
Sufentanil .................................................................................................................................................................
Carfentanil ................................................................................................................................................................
Tapentadol ...............................................................................................................................................................
Fentanyl ...................................................................................................................................................................
The company plans to manufacture
bulk controlled substances for use in
product development of analytical
reference standards, for distribution to
its customers.
Drug Enforcement Administration
[Docket No. DEA–392]
SUPPLEMENTARY INFORMATION:
ACTION:
[FR Doc. 2016–31285 Filed 12–27–16; 8:45 am]
Notice of registration.
Registrants listed below have
applied for and been granted
registration by the Drug Enforcement
SUMMARY:
BILLING CODE 4410–09–P
Company
sradovich on DSK3GMQ082PROD with NOTICES
Rhodes Technologies ...........................................................
Bellwyck Clinical Services ....................................................
Cerilliant Corporation ............................................................
Noramco, Inc ........................................................................
Cody Laboratories, Inc .........................................................
AMRI Rensselaer, Inc ..........................................................
ALMAC Clinical Services Incorp (ACSI) ..............................
Fresenius Kabi USA, LLC ....................................................
Akorn, Inc .............................................................................
Actavis Laboratories FL, Inc ................................................
Unither Manufacturing LLC ..................................................
Cambrex Charles City ..........................................................
United States Pharmacopeial Convention ...........................
R & D Systems, Inc ..............................................................
Catalent CTS, LLC ...............................................................
VerDate Sep<11>2014
18:54 Dec 27, 2016
Jkt 241001
The companies listed below applied
to be registered as importers of various
basic classes of controlled substances.
Information on previously published
notices is listed in the table below. No
comments or objections were submitted
and no requests for hearing were
submitted for these notices.
FR docket
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of the
listed registrants to import the
applicable basic classes of schedule I or
II 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 each company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
II.
II.
II.
II.
II.
II.
II.
II.
II.
II.
II.
II.
II.
Administration (DEA) as importers of
various classes of schedule I or II
controlled substances.
DEPARTMENT OF JUSTICE
Importer of Controlled Substances
Registration
Dated: December 20, 2016.
Louis J. Milione,
Assistant Administrator.
9230
9233
9250
9273
9300
9333
9652
9737
9739
9740
9743
9780
9801
Schedule
81
81
81
81
81
81
81
81
81
81
81
81
81
81
81
FR
FR
FR
FR
FR
FR
FR
FR
FR
FR
FR
FR
FR
FR
FR
46956
54603
57933
57932
54602
54603
54602
54601
57935
54602
61250
63222
63220
64509
66081
Published
........................................................................
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........................................................................
........................................................................
........................................................................
........................................................................
........................................................................
........................................................................
........................................................................
........................................................................
........................................................................
........................................................................
........................................................................
........................................................................
........................................................................
granted a registration as an importer for
schedule I or II controlled substances to
the above listed persons.
Dated: December 19, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016–31273 Filed 12–27–16; 8:45 am]
July 19, 2016.
August 16, 2016.
August 24, 2016.
August 24, 2016.
August 16, 2016.
August 16, 2016.
August 16, 2016.
August 16, 2016.
August 24, 2016.
August 16, 2016.
September 6, 2016.
September 14, 2016.
September 14, 2016.
September 20, 2016.
September 26, 2016.
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 27, 2017.
DATES:
Drug Enforcement Administration
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
[Docket No. DEA–392]
SUPPLEMENTARY INFORMATION:
ADDRESSES:
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: Johnson
Matthey Inc.
ACTION:
PO 00000
Notice of application.
Frm 00093
Fmt 4703
Sfmt 4703
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
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95648
Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices
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
September 5, 2016, 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:
Controlled substance
Drug code
Gamma Hydroxybutyric Acid ...........................................................................................................................................
Amphetamine ...................................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Codeine ...........................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Diphenoxylate ..................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Methadone .......................................................................................................................................................................
Methadone intermediate ..................................................................................................................................................
Morphine ..........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Opium tincture .................................................................................................................................................................
The company plans to manufacture
the listed controlled substances in bulk
for distribution and sale to its
customers. Thebaine (9333) will be used
to manufacture other controlled
substances for sale in bulk to its
customers.
Dated: December 20, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016–31283 Filed 12–27–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Office of the Secretary
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Request
for State or Federal Workers’
Compensation Information
ACTION:
Notice.
The Department of Labor
(DOL) is submitting the Office of
Workers’ Compensation Programs
(OWCP) sponsored information
collection request (ICR) revision titled,
‘‘Request for State or Federal Workers’
Compensation Information,’’ to the
Office of Management and Budget
(OMB) for review and approval for use
in accordance with the Paperwork
Reduction Act (PRA) of 1995 (44 U.S.C.
3501 et seq.).
DATES: Submit comments on or before
January 27, 2017.
ADDRESSES: A copy of this ICR with
applicable supporting documentation;
including a description of the likely
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:54 Dec 27, 2016
Jkt 241001
respondents, proposed frequency of
response, and estimated total burden
may be obtained free of charge from the
RegInfo.gov Web site at https://
www.reginfo.gov/public/do/
PRAViewICR?ref_nbr=201607-1240-002
(this link will only become active on the
day following publication of this notice)
or by contacting Michel Smyth by
telephone at 202–693–4129 (this is not
a toll-free number) or sending an email
to DOL_PRA_PUBLIC@dol.gov.
Submit comments about this request
to the Office of Information and
Regulatory Affairs, Attn: OMB Desk
Officer for DOL–OWCP, Office of
Management and Budget, Room 10235,
725 17th Street NW., Washington, DC
20503, Fax: 202–395–6881 (this is not a
toll-free number), email: OIRA_
submission@omb.eop.gov. Commenters
are encouraged, but not required, to
send a courtesy copy of any comments
to the U.S. Department of LaborOASAM, Office of the Chief Information
Officer, Attn: Compliance Management
Program, Room N1301, 200 Constitution
Avenue NW., Washington, DC 20210,
email: DOL_PRA_PUBLIC@dol.gov.
FOR FURTHER INFORMATION CONTACT:
Contact Michel Smyth by telephone at
202–693–4129 (this is not a toll-free
number) or by email at DOL_PRA_
PUBLIC@dol.gov.
Authority: 44 U.S.C. 3507(a)(1)(D).
This ICR
seeks approval under the PRA for
revisions to the Request for State or
Federal Workers’ Compensation
Information (Form CM–905) information
collection. Form CM–905 collects
information to process a claim under the
Black Lung Benefits Act (30 U.S.C. 901
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00094
Fmt 4703
Sfmt 4703
2010
1100
1724
9050
9143
9170
9193
9230
9250
9254
9300
9333
9630
Schedule
I
II
II
II
II
II
II
II
II
II
II
II
II
et seq.). The information collected helps
determine compensation benefits
awarded for pneumoconiosis. The
information collection has been
classified as a revision, because the
OWCP proposes to make a series of
cosmetic and minor changes to Form
CM–905. The changes provide clearer
language, so that Federal/State workers’
compensation officials clearly
understand which portion of the form
they should complete and what
information to provide. Other changes
update the form to reflect current
organizational structure within the DOL.
For additional substantive information
about this ICR, see the related notice
published in the Federal Register on
July 27, 2016 (81 FR 49270).
This information collection is subject
to the PRA. A Federal agency generally
cannot conduct or sponsor a collection
of information, and the public is
generally not required to respond to an
information collection, unless it is
approved by the OMB under the PRA
and displays a currently valid OMB
Control Number. In addition,
notwithstanding any other provisions of
law, no person shall generally be subject
to penalty for failing to comply with a
collection of information that does not
display a valid Control Number. See 5
CFR 1320.5(a) and 1320.6. The DOL
obtains OMB approval for this
information collection under Control
Number 1240–0032. The current
approval for this collection is scheduled
to expire on December 31, 2016;
however, the DOL notes that existing
information collection requirements
submitted to the OMB receive a monthto-month extension while they undergo
E:\FR\FM\28DEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Pages 95647-95648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31283]
-----------------------------------------------------------------------
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 27, 2017.
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 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
[[Page 95648]]
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
September 5, 2016, 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:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.......... 2010 I
Amphetamine........................ 1100 II
Methylphenidate.................... 1724 II
Codeine............................ 9050 II
Oxycodone.......................... 9143 II
Diphenoxylate...................... 9170 II
Hydrocodone........................ 9193 II
Meperidine......................... 9230 II
Methadone.......................... 9250 II
Methadone intermediate............. 9254 II
Morphine........................... 9300 II
Thebaine........................... 9333 II
Opium tincture..................... 9630 II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for distribution and sale to its customers. Thebaine (9333)
will be used to manufacture other controlled substances for sale in
bulk to its customers.
Dated: December 20, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016-31283 Filed 12-27-16; 8:45 am]
BILLING CODE 4410-09-P
