Importer of Controlled Substances Application: Actavis Laboratories FL., Inc., 54602-54603 [2016-19438]
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54602
Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices
In accordance with 21 CFR
1301.34(a), this is notice that on June
29, 2016, ALMAC Clinical Services
Incorp (ACSI), 25 Fretz Road,
Souderton, Pennsylvania 18964 applied
to be registered as an importer of the
following basic classes of controlled
substances:
development and preparation of
stability batches.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–19434 Filed 8–15–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: ALMAC Clinical Services
Incorp (ACSI)
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 1301.34(a) on
or before September 15, 2016. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
September 15, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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/ODW, 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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
18:36 Aug 15, 2016
Jkt 238001
Schedule
Oxycodone (9143) ................
Hydromorphone (9150) ........
Morphine (9300) ...................
Tapentadol (9780) ................
Fentanyl (9801) ....................
II
II
II
II
II
The company plans to import the
listed controlled substances in dosage
form for clinical trial only. 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.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–19439 Filed 8–15–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Cody Laboratories, 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
1301.34(a) on or before September 15,
2016. Such persons may also file a
written request for a hearing on the
application pursuant to 21 CFR 1301.43
on or before September 15, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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,
SUMMARY:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Attn: DEA Federal Register
Representative/ODW, 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 May 18,
2016, Cody Laboratories, Inc., 601
Yellowstone Avenue, Barry Baldwin,
Controlled Substances Manager, Cody,
Wyoming 82414–9321 applied to be
registered as an importer of the
following basic classes of controlled
substances:
Schedule
Phenylacetone (8501) ..........
Poppy Straw Concentrate
(9670) ................................
Tapentadol (9780) ................
II
II
II
The company plans to import narcotic
raw materials to manufacture bulk
controlled substances for distribution to
its customers. The company plans to
import an intermediate form of
tapentadol (9780), to bulk manufacture
tapentadol for distribution to its
customers.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–19435 Filed 8–15–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Actavis Laboratories FL.,
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
DATES:
E:\FR\FM\16AUN1.SGM
16AUN1
Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices
issuance of the proposed registration in
accordance with 21 CFR 1301.34(a) on
or before September 15, 2016. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
September 15, 2016.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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/ODW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
clinical trials, research and analytical
purposes.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–19438 Filed 8–15–16; 8:45 am]
BILLING CODE 4410–09–P
ADDRESSES:
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 June 2,
2016, Actavis Laboratories FL., Inc.,
4955 Orange Drive, Davie, Florida 33314
applied to be registered as an importer
of the following basic classes of
controlled substances:
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Controlled substance
Schedule
Amphetamine (1100) ............
Methylphenidate (1724) ........
Oxycodone (9143) ................
Hydromorphone (9150) ........
Hydrocodone (9193) .............
Fentanyl (9801) ....................
II
II
II
II
II
II
The company plans to import the
above-listed controlled substances for
VerDate Sep<11>2014
18:36 Aug 15, 2016
Jkt 238001
54603
In accordance with 21 CFR
1301.34(a), this is notice that on April
18, 2016, Bellwyck Clinical Services,
8946 Global Way, West Chester, Ohio
45069 applied to be registered as an
importer of the following basic classes
of controlled substances:
Controlled substance
Schedule
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Bellwyck Clinical Services
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
1301.34(a) on or before September 15,
2016. Such persons may also file a
written request for a hearing on the
application pursuant to 21 CFR 1301.43
on or before September 15, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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/ODW, 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.
SUMMARY:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Methylphenidate (1724) ........
Oxycodone (9143) ................
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.
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–19437 Filed 8–15–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: AMRI Rensselaer, 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
1301.34(a) on or before September 15,
2016. Such persons may also file a
written request for a hearing on the
application pursuant to 21 CFR 1301.43
on or before September 15, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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,
SUMMARY:
E:\FR\FM\16AUN1.SGM
16AUN1
]]>Agencies
[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Pages 54602-54603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19438]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Actavis
Laboratories FL., 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
[[Page 54603]]
issuance of the proposed registration in accordance with 21 CFR
1301.34(a) on or before September 15, 2016. Such persons may also file
a written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before September 15, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
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/ODW, 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 June
2, 2016, Actavis Laboratories FL., Inc., 4955 Orange Drive, Davie,
Florida 33314 applied to be registered as an importer of the following
basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Amphetamine (1100)...................................... II
Methylphenidate (1724).................................. II
Oxycodone (9143)........................................ II
Hydromorphone (9150).................................... II
Hydrocodone (9193)...................................... II
Fentanyl (9801)......................................... II
------------------------------------------------------------------------
The company plans to import the above-listed controlled substances
for clinical trials, research and analytical purposes.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-19438 Filed 8-15-16; 8:45 am]
BILLING CODE 4410-09-P
