Importer of Controlled Substances Application: Mylan Technologies, Inc., 75688-75689 [2015-30555]
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Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices
nonnative vegetation management
easement adjacent to the entire length of
the exchange corridor. The fee for fee
land exchange would be subject to terms
and conditions that are to be agreed
upon between NPS and FPL and
incorporated into a binding exchange
agreement. FPL would be required to
allow the United States the perpetual
right, power, and privilege to flood and
submerge the exchange corridor
consistent with hydrologic restoration
requirements. The construction scenario
associated with this alternative assumes
that FPL would build the transmission
lines in the exchange corridor.
This alternative has been revised from
the Draft EIS to the Final EIS due to
updated transmission line siting
requirements included in the state site
certification process, which were not
available in time for the Draft EIS. The
final order directed FPL to avoid siting
any transmission lines in the park and
pursue the use of the West Consensus
Corridor as the primary corridor for
siting transmission lines. The FPL West
Preferred Corridor (which includes the
NPS exchange lands) would only be
used for transmission lines if FPL
cannot secure an adequate right-of-way
within the FPL West Consensus
Corridor (outside of the park boundary)
in a timely manner and at a reasonable
cost. FPL’s success in acquiring interests
in the West Consensus Corridor would
minimize or eliminate the amount of
property in the exchange corridor
required for these transmission lines.
In the Final EIS, this alternative now
includes a commitment that FPL shall
reconvey to the NPS all acreage in the
exchange corridor that is determined to
be unneeded by FPL to build the
transmission lines. FPL would not
develop land within the exchange
corridor until completing the
requirements of the site certification
process and determining land
ownership needs. The park boundary
would be adjusted after the
reconveyance, so that it reflects the
actual final land ownership between
FPL and NPS. These commitments
would be identified in a binding
exchange agreement between the two
parties.
Alternative 4, Easement for Fee Land
Exchange: the NPS would acquire fee
title to the FPL property through an
exchange for an easement on NPS
property. This is similar to alternative 3,
except that NPS would grant FPL an
easement for potential transmission line
construction (not fee title) over the
lands along the eastern boundary of the
EEEA, in accordance with the terms and
conditions developed for this easement
for fee exchange. The NPS would retain
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ownership of the corridor, but would no
longer have unencumbered use of it.
The NPS would also convey a 90-footwide perpetual nonnative vegetation
management easement to FPL adjacent
to the entire length of the exchange
corridor. The easement for fee land
exchange would be subject to terms and
conditions that are to be agreed upon
between NPS and FPL and incorporated
into a binding exchange agreement.
Similar to alternative 3, the FPL
easement corridor would be subject to a
perpetual flowage easement.
Alternative 5, Perpetual Flowage
Easement on FPL Property: the NPS
would acquire a perpetual flowage
easement on FPL’s property within the
EEEA through purchase, condemnation,
or donation by FPL. FPL would retain
ownership of its corridor in the park
during the term of the easement and
could seek to site transmission lines
there. The flowage allowed under this
easement would allow sufficient water
flow over this area to support ecosystem
restoration projects. The construction
scenario associated with this alternative
would be the same as the one for
alternative 1B (FPL construction of
transmission lines on its existing land in
the park).
The Final EIS responds to, and
incorporates, agency and public
comments received on the Draft EIS.
The Draft EIS was available for public
review and comment for 60 days from
January 17, 2014, through March 18,
2014. During the comment period, 275
pieces of correspondence were received.
Two of these were petitions or letters
containing 14,075 total signatures; a
third form letter contained 178
signatures and 70 individual pieces of
correspondence, which are included in
the 275 total comments received.
Alternative 2 is the environmentally
preferable alternative and alternative 3
is the NPS preferred alternative.
The responsible official for this EIS is
the Regional Director, NPS Southeast
Region, 100 Alabama Street SW., 1924
Building, Atlanta, Georgia 30303.
Dated: November 18, 2015.
Shawn Benge,
Deputy Regional Director, Southeast Region.
[FR Doc. 2015–30580 Filed 12–2–15; 8:45 am]
BILLING CODE 4310–JD–P
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INTERNATIONAL TRADE
COMMISSION
[USITC SE–15–041]
Government in the Sunshine Act
Meeting Notice
United
States International Trade Commission.
TIME AND DATE: December 11, 2015 at
11:00 a.m.
PLACE: Room 101, 500 E Street SW.,
Washington, DC 20436, Telephone:
(202) 205–2000.
STATUS: Open to the public.
MATTERS TO BE CONSIDERED:
1. Agendas for future meetings: None.
2. Minutes.
3. Ratification List.
4. Vote in Inv. Nos. 701–TA–549 and
731–TA–1299–1303 (Preliminary)
(Circular Welded Carbon-Quality Steel
Pipe from Oman, Pakistan, the
Philippines, the United Arab Emirates,
and Vietnam). The Commission is
currently scheduled to complete and file
its determinations on December 14,
2015; views of the Commission are
currently scheduled to be completed
and filed on December 21, 2015.
5. Vote in Inv. Nos. 701–TA–550 and
731–TA–1304–1305 (Preliminary)
(Certain Iron Mechanical Transfer Drive
Components from Canada and China).
The Commission is currently scheduled
to be completed and filed on December
14, 2015; views of the Commission are
currently scheduled to be completed
and filed on December 21, 2015.
6. Outstanding action jackets: None.
In accordance with Commission
policy, subject matter listed above, not
disposed of at the scheduled meeting,
may be carried over to the agenda of the
following meeting.
AGENCY HOLDING THE MEETING:
By order of the Commission.
Issued: November 30, 2015.
William R. Bishop,
Supervisory Hearings and Information
Officer.
[FR Doc. 2015–30634 Filed 12–1–15; 11:15 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Mylan Technologies, Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
DATES:
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Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices
comments on or objections to the
issuance of the proposed registration in
accordance with 21 CFR 1301.34(a) on
or before January 4, 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 4,
2016.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/OD/D, 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.
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 October
29, 2015, Mylan Technologies, Inc., 110
Lake Street, Saint Albans, Vermont
05478 applied to be registered as an
importer of the following basic classes
of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Schedule
Lhorne on DSK5TPTVN1PROD with NOTICES
Methylphenidate (1724) ................
Fentanyl (9801) ............................
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: November 27, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–392]
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Fresenius Kabi USA, LLC
ACTION:
Fresenius Kabi USA, LLC
applied to be registered as an importer
of a certain basic class of controlled
substance. The Drug Enforcement
Administration (DEA) grants Fresenius
Kabi USA, LLC registration as an
importer of this controlled substance.
SUMMARY:
By notice
dated September 16, 2015, and
published in the Federal Register on
September 23, 2015, 80 FR 57389
Fresenius Kabi USA, LLC, 3159 Staley
Road, Grand Island, New York 14072
applied to be registered as an importer
of a certain basic class of controlled
substance. No comments or objections
were submitted for this notice.
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of
Fresenius Kabi USA, LLC to import the
basic class of controlled substance 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.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the above-named
company is granted registration as an
importer of remifentanil (9739), a basic
class of controlled substance listed in
schedule II.
The company plans to import the
listed controlled substance for product
development and preparation of
stability batches.
SUPPLEMENTARY INFORMATION:
Dated: November 27, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–30556 Filed 12–2–15; 8:45 am]
[FR Doc. 2015–30555 Filed 12–2–15; 8:45 am]
BILLING CODE 4410–09–P
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ACTION:
Notice of registration.
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Importer of Controlled Substances
Registration: United States
Pharmacopeial Convention
Notice of registration.
United States Pharmacopeial
Convention applied to be registered as
an importer of certain basic classes of
controlled substances. The Drug
Enforcement Administration (DEA)
grants United States Pharmacopeial
Convention registration as an importer
of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated June 25, 2015, and published in
the Federal Register on July 6, 2015, 80
FR 38466, United States Pharmacopeial
Convention, 12601 Twinbrook Parkway,
Rockville, Maryland 20852 applied to be
registered as an importer 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, 952(a) and 958(a) and
determined that the registration of
United States Pharmacopeial
Convention to import 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.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the above-named
company is granted registration as an
importer of the basic classes of
controlled substances:
SUMMARY:
Controlled substance
Cathinone (1235) ..........................
Methaqualone (2565) ...................
Lysergic acid diethylamide (7315)
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
4-Methyl-2,5dimethoxyamphetamine (7395).
3,4-Methylenedioxyamphetamine
(7400).
Codeine-N-oxide (9053) ...............
Difenoxin (9168) ...........................
Heroin (9200) ...............................
Morphine-N-oxide (9307) .............
Norlevorphanol (9634) ..................
Amphetamine (1100) ....................
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[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Notices]
[Pages 75688-75689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30555]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Mylan
Technologies, Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written
[[Page 75689]]
comments on or objections to the issuance of the proposed registration
in accordance with 21 CFR 1301.34(a) on or before January 4, 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 4, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/OD/D,
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
October 29, 2015, Mylan Technologies, Inc., 110 Lake Street, Saint
Albans, Vermont 05478 applied to be registered as an importer of the
following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Methylphenidate (1724)..................... 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: November 27, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-30555 Filed 12-2-15; 8:45 am]
BILLING CODE 4410-09-P
