Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc., 76709-76710 [2015-31073]
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76709
Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices
Filing Procedures 4). Persons with
questions regarding filing should
contact the Secretary (202–205–2000).
Any person desiring to submit a
document to the Commission in
confidence must request confidential
treatment. All such requests should be
directed to the Secretary to the
Commission and must include a full
statement of the reasons why the
Commission should grant such
treatment. See 19 CFR. 201.6.
Documents for which confidential
treatment by the Commission is
properly sought will be treated
accordingly. All nonconfidential written
submissions will be available for public
inspection at the Office of the Secretary
and on EDIS.5
This action is taken under the
authority of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337),
and of sections 201.10 and 210.8(c) of
the Commission’s Rules of Practice and
Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
Issued: December 7, 2015.
Lisa R. Barton,
Secretary to the Commission.
Controlled substance
[FR Doc. 2015–31151 Filed 12–9–15; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer 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 1301.33(a) on
or before February 8, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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
mstockstill on DSK4VPTVN1PROD with NOTICES
DATES:
4 Handbook
for Electronic Filing Procedures:
https://www.usitc.gov/secretary/fed_reg_notices/
rules/handbook_on_electronic_filing.pdf.
5 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
VerDate Sep<11>2014
19:33 Dec 09, 2015
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
1301.33(a), this is notice that on
September 3, 2015, Cody Laboratories,
Inc., 601 Yellowstone Avenue, Cody,
Wyoming 82414 applied to be registered
as a bulk manufacturer of the following
basic classes of controlled substances:
Jkt 238001
Dihydromorphine (9145) ...............
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Methylphenidate (1724) ................
Amobarbital (2125) .......................
Pentobarbital (2270) .....................
Secobarbital (2315) ......................
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
Schedule
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers.
Dated: December 4, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–31074 Filed 12–9–15; 8:45 am]
BILLING CODE 4410–09–P
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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 in
accordance with 21 CFR 1301.34(a) on
or before January 11, 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 11, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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
19, 2015, 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:
DATES:
Controlled substance
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
E:\FR\FM\10DEN1.SGM
10DEN1
Schedule
II
II
II
II
II
II
76710
Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices
Controlled substance
Schedule
Hydrocodone (9193) .....................
Levorphanol (9220) ......................
Methadone (9250) ........................
Morphine (9300) ...........................
Oxymorphone (9652) ...................
Remifentanil (9739) ......................
Fentanyl (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.
there. Aloha will also install improved
containment liners at five of its other
facilities.
The publication of this notice opens
a period for public comment on the
consent decree. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and should refer to
United States v. Aloha Petroleum, Ltd.,
D.J. Ref. No. 90–5–2–1–10467. All
comments must be submitted no later
than thirty (30) days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
Send them to:
By email .......
Dated: December 4, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
To submit
comments:
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ—ENRD, P.O.
Box 7611, Washington, DC
20044–7611.
By mail .........
[FR Doc. 2015–31073 Filed 12–9–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
mstockstill on DSK4VPTVN1PROD with NOTICES
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act and Clean Water Act
On December 2, 2015, the Department
of Justice lodged a proposed consent
decree with the United States District
Court for the District of Hawaii in the
lawsuit entitled United States v. Aloha
Petroleum, Ltd., Civil Action No. CV
15–00498 HG–BMK.
The United States’ Complaint asserts
claims against Aloha under Section
113(b) of the Clean Air Act (‘‘CAA’’), 42
U.S.C. 7413(b) and section 311(b) of the
Clean Water Act (‘‘CWA’’), 33 U.S.C.
1321(b). Aloha operates a bulk gasoline
terminal in Hilo, Hawaii (the
‘‘Terminal’’). The Terminal receives
petroleum products via pipelines
connected to the local marine port and
stores the products in large tanks prior
to transfer into tank trucks at the
Terminal’s loading rack. The Complaint
alleges that Aloha failed to install a
vapor collection system, limit
emissions, and conduct a performance
test, as required by 40 CFR part 60,
subpart XX. Under the CWA, the
Complaint alleges that Aloha failed to
construct a secondary containment
structure that is sufficiently impervious
to contain oil, or to hold oil until
cleanup can occur. 40 CFR 112.7(c),
112.8(c)(2).
Under the Consent Decree, Aloha will
pay a civil penalty of $650,000, will
‘‘permanently close’’ the Terminal as
defined in 40 CFR 112.2, and certify that
it has ceased operating the loading racks
VerDate Sep<11>2014
19:33 Dec 09, 2015
Jkt 238001
During the public comment period,
the consent decree may be examined
and downloaded at this Justice
Department Web site: https://
www.justice.gov/enrd/consent-decrees.
We will provide a paper copy of the
consent decree upon written request
and payment of reproduction costs.
Please mail your request and payment
to: Consent Decree Library, U.S. DOJ—
ENRD, P.O. Box 7611, Washington, DC
20044–7611.
Please enclose a check or money order
for $8.75 (25 cents per page
reproduction cost) payable to the United
States Treasury.
Henry Friedman,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. 2015–31077 Filed 12–9–15; 8:45 am]
BILLING CODE 4410–CW–P
DEPARTMENT OF JUSTICE
Notice of Filing of Proposed
Settlement Agreement Under the
Comprehensive Environmental
Response, Compensation, and Liability
Act and the Resource Conservation
and Recovery Act
On December 1, 2015, a proposed
Settlement Agreement was filed with
the United States Bankruptcy Court for
the District of Delaware in the
bankruptcy proceeding entitled In re
Energy Future Holdings Corp., et al.,
Case No. 14–10979 (CSS).
The Settlement Agreement resolves a
claim against debtor Energy Future
Competitive Holdings Company
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
(‘‘EFCH’’), as the alleged corporate
successor to former mine operators,
asserted by the United States on behalf
of the Environmental Protection Agency
(‘‘EPA’’) under the Comprehensive
Environmental Response,
Compensation, and Liability Act, 42
U.S.C. 9601–9675 (‘‘CERCLA’’). The
claim sought to recover costs incurred
and expected to be incurred in the
future by the United States in response
to releases and threats of releases of
hazardous substances at or in
connection with the Faith, Hope, Doris,
and Isabella Uranium Mine Sites,
located in McKinley County, New
Mexico (‘‘New Mexico Sites’’).
Under the Settlement Agreement, EPA
will receive either (1) a distribution of
$2,000,000 upon confirmation and
consummation of EFCH’s and other
affiliated debtors’ Sixth Amended Joint
Plan of Reorganization of In re Energy
Future Holdings Corp., et al., pursuant
to Chapter 11 of the Bankruptcy Code,
or (2) $1,000,000 on the effective date of
an alternate restructuring approved by
the Bankruptcy Court. The Settlement
Agreement contains covenants not to
sue by the United States on behalf of
EPA in favor of the debtors, the
reorganized debtors, or any successors
in interest under Sections 106 and 107
of CERCLA, 42 U.S.C. 9606, 9607 and
Section 7003 of the Resource
Conservation and Recovery Act, 42
U.S.C. 6973, with respect to the EPA
claim or the New Mexico Sites.
The publication of this notice opens
a period for public comment on the
Settlement Agreement. Comments
should be addressed to the Assistant
Attorney General, Environment and
Natural Resources Division, and should
refer to In re Energy Future Holdings
Corp., et al., Case No. 14–10979 (CSS),
D.J. Ref. No. 90–5–2–1–09894/2. All
comments must be submitted no later
than thirty (30) days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
To submit
comments:
Send them to:
By email .......
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ—ENRD, P.O.
Box 7611, Washington, DC
20044–7611.
By mail .........
Under section 7003(d) of RCRA, a
commenter may request an opportunity
for a public meeting in the affected area.
During the public comment period,
the Settlement Agreement may be
examined and downloaded at this
Justice Department Web site: https://
E:\FR\FM\10DEN1.SGM
10DEN1
]]>Agencies
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Pages 76709-76710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31073]
-----------------------------------------------------------------------
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 in accordance with 21 CFR
1301.34(a) on or before January 11, 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 11, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
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 19, 2015, 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:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Amphetamine (1100)......................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
Pentobarbital (2270)....................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
[[Page 76710]]
Hydrocodone (9193)......................... II
Levorphanol (9220)......................... II
Methadone (9250)........................... II
Morphine (9300)............................ II
Oxymorphone (9652)......................... II
Remifentanil (9739)........................ 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: December 4, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-31073 Filed 12-9-15; 8:45 am]
BILLING CODE 4410-09-P
