Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc., 22517 [2018-10301]
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22517
Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
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 April
5, 2017, Patheon API Manufacturing,
Inc., 309 Delaware Street, Building
1106, Greenville, South Carolina 29605
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Thebaine .................................
Noroxymorphone ....................
9333
9668
II
II
The company plans to manufacture
the above-listed controlled substances
as Active Pharmaceutical Ingredient
(API) for supply to its customers.
Dated: May 1, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–10303 Filed 5–14–18; 8:45 am]
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 April
18, 2018, Mylan Pharmaceuticals, Inc.,
3711 Collins Ferry Road, Morgantown,
West Virginia 26505 applied to be
registered as an importer of the
following basic classes of controlled
substances:
BILLING CODE 4410–09–P
Amphetamine ..........................
Methylphenidate ......................
Oxycodone ..............................
Hydromorphone ......................
Methadone ..............................
Morphine .................................
Fentanyl ..................................
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals,
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 June 14, 2018. Such persons
may also file a written request for a
hearing on the application on or before
June 14, 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
daltland on DSKBBV9HB2PROD with NOTICES
DATES:
VerDate Sep<11>2014
20:27 May 14, 2018
Jkt 244001
1100
1724
9143
9150
9250
9300
9801
II
II
II
II
II
II
II
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF.
This analysis is required to allow the
company to export domesticallymanufactured FDF to foreign markets.
Dated: April 25, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–10301 Filed 5–14–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Rhodes Technologies
ACTION:
Tetrahydrocannabinols ...........
Methylphenidate ......................
Oxycodone ..............................
Hydromorphone ......................
Hydrocodone ...........................
Morphine .................................
Opium, raw .............................
Oxymorphone .........................
Poppy Straw Concentrate .......
7370
1724
9143
9150
9193
9300
9600
9652
9670
I
II
II
II
II
II
II
II
II
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 June 14, 2018. Such persons
may also file a written request for a
DATES:
PO 00000
hearing on the application on or before
June 14, 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.
Comments and requests for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR
3417, (January 25, 2007).
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 April
6, 2018, Rhodes Technologies, 498
Washington Street, Coventry, Rhode
Island 02816 applied to be registered as
an importer of the following basic
classes of controlled substances:
Frm 00077
Fmt 4703
Sfmt 4703
The company plans to import opium,
raw (9600) and poppy straw concentrate
(9670) in order to bulk manufacture
controlled substances in Active
Pharmaceutical Ingredient (API) form.
The company distributes the
manufactured APIs in bulk to its
customers.
E:\FR\FM\15MYN1.SGM
15MYN1
]]>Agencies
[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Page 22517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10301]
-----------------------------------------------------------------------
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 June 14, 2018. Such
persons may also file a written request for a hearing on the
application on or before June 14, 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 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 April
18, 2018, Mylan Pharmaceuticals, Inc., 3711 Collins Ferry Road,
Morgantown, West Virginia 26505 applied to be registered as an importer
of the following basic classes of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................ 1100 II
Methylphenidate........................ 1724 II
Oxycodone.............................. 9143 II
Hydromorphone.......................... 9150 II
Methadone.............................. 9250 II
Morphine............................... 9300 II
Fentanyl............................... 9801 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances in
finished dosage form (FDF) from foreign sources for analytical testing
and clinical trials in which the foreign FDF will be compared to the
company's own domestically-manufactured FDF.
This analysis is required to allow the company to export
domestically-manufactured FDF to foreign markets.
Dated: April 25, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-10301 Filed 5-14-18; 8:45 am]
BILLING CODE 4410-09-P
