Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc., 64158-64159 [2018-27036]
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64158
ACTION:
DATES:
Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices
Notice.
December 7, 2018.
Eric
Mozie, Director of Human Resources, or
Ronald Johnson, Senior Human
Resources Specialist, U.S. International
Trade Commission (202) 205–2651.
SUPPLEMENTARY INFORMATION: The
Chairman of the U.S. International
Trade Commission has appointed the
following individuals to serve on the
Commission’s Performance Review
Board (PRB):
FOR FURTHER INFORMATION CONTACT:
Chair of the PRB: Commissioner Irving
A. Williamson
Vice-Chair of the PRB: Commissioner
Meredith Broadbent
Member—John Ascienzo
Member—Dominic Bianchi
Member—Nannette Christ
Member—Catherine DeFilippo
Member—James Holbein
Member—Margaret Macdonald
Member—Stephen A. McLaughlin
Member—William Powers
Authority: This notice is published in the
Federal Register pursuant to the requirement
of 5 U.S.C. 4314(c)(4). Hearing impaired
individuals are advised that information on
this matter can be obtained by contacting our
TDD terminal on (202) 205–1810.
By order of the Commission.
Issued: December 4, 2018.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2018–26742 Filed 12–12–18; 8:45 am]
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for 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: 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
November 05, 2018, Siegfried USA,
LLC, 33 Industrial Park Road,
Pennsville, New Jersey 08070 applied to
be registered as an importer of the
following basic classes of controlled
substances:
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances
Application: Siegfried USA, 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 January 14, 2019. Such
persons may also file a written request
for a hearing on the application on or
before January 14, 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 hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
amozie on DSK3GDR082PROD with NOTICES1
DATES:
VerDate Sep<11>2014
17:12 Dec 12, 2018
Jkt 247001
Drug
code
Schedule
Opium, raw .......................
Poppy Straw Concentrate
9600
9670
II
II
The company plans to import the
listed controlled substances to
manufacture bulk active pharmaceutical
ingredients (API) for distribution to its
customers.
[Docket No. DEA–392]
ACTION:
Controlled
substance
Dated: December 3, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–27032 Filed 12–12–18; 8:45 am]
BILLING CODE 4410–09–P
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 14, 2019. Such
persons may also file a written request
for a hearing on the application on or
before January 14, 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 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/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: 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
10, 2018, Mylan Pharmaceuticals Inc.,
2898 Manufacturers Road, Greensboro,
North Carolina 27406–4600 applied to
be registered as an importer of the
following basic class of controlled
substance:
DATES:
Controlled substance
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals
Inc.
ACTION:
PO 00000
Notice of application.
Frm 00062
Fmt 4703
Sfmt 4703
Nabilone ........................
Drug
code
7379
Schedule
II
The company plans to import the
FDA approved drug product in finished
dosage form for distribution to its
customers. 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).
E:\FR\FM\13DEN1.SGM
13DEN1
64159
Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices
Dated: December 3, 2018.
John J. Martin,
Assistant Administrator.
Cocaine .........................
Codeine .........................
Dihydrocodeine ..............
Oxycodone ....................
Hydromorphone .............
Ecgonine ........................
Hydrocodone .................
Morphine ........................
Thebaine ........................
[FR Doc. 2018–27036 Filed 12–12–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Eli-Elsohly
Laboratories
ACTION:
Drug
code
Controlled substance
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 11, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
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
November 22, 2017, Eli-Elsohly
Laboratories, Mahmoud A. Elsohly
Ph.D., 5 Industrial Park Drive, Oxford,
Mississippi 38655 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
9041
9050
9120
9143
9150
9180
9193
9300
9333
Schedule
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances for
product development and reference
standards. In reference to drug codes
7360 (marihuana) and 7370 (THC), the
company plans to isolate these
controlled substances from procured
7350 (marihuana extract). In reference to
drug code 7360 (marihuana), no
cultivation activities are authorized for
this registration. No other activities for
these drug codes are authorized for this
registration.
Dated: December 3, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–27029 Filed 12–12–18; 8:45 am]
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 16,
2018, Cambrex High Point Inc., 4180
Mendenhall Oaks Parkway, High Point,
North Carolina 27265 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
Controlled
substances
Oxymorphone ................
Noroxymorphone ...........
Drug
code
9652
9668
Schedule
II
II
The company plans to manufacture
the above listed controlled substances in
bulk for distribution to its customers.
Dated: December 3, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–27039 Filed 12–12–18; 8:45 am]
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
amozie on DSK3GDR082PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
Controlled substance
Marihuana Extract .........
Marihuana ......................
Tetrahydrocannabinols ..
Dihydromorphine ...........
Amphetamine ................
Methamphetamine .........
VerDate Sep<11>2014
Drug
code
7350
7360
7370
9145
1100
1105
17:12 Dec 12, 2018
Schedule
I
I
I
I
II
II
Jkt 247001
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Cambrex
High Point, Inc.
ACTION:
Notice of application.
Frm 00063
Fmt 4703
Sfmt 4703
Importer of Controlled Substances
Application: Noramco 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 14, 2019. Such
persons may also file a written request
for a hearing on the application on or
before January 14, 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 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/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
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 11, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 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
DATES:
PO 00000
Drug Enforcement Administration
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Notices]
[Pages 64158-64159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27036]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Mylan
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 January 14, 2019.
Such persons may also file a written request for a hearing on the
application on or before January 14, 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
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/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: 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 10, 2018, Mylan Pharmaceuticals Inc., 2898 Manufacturers Road,
Greensboro, North Carolina 27406-4600 applied to be registered as an
importer of the following basic class of controlled substance:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Nabilone............................... 7379 II
------------------------------------------------------------------------
The company plans to import the FDA approved drug product in
finished dosage form for distribution to its customers. 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).
[[Page 64159]]
Dated: December 3, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-27036 Filed 12-12-18; 8:45 am]
BILLING CODE 4410-09-P
