Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc., 96045-96046 [2016-31641]
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96045
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
of Cupertino, CA. The complainant
requests that the Commission issue an
exclusion order and a cease and desist
order.
Proposed respondents, other
interested parties, and members of the
public are invited to file comments, not
to exceed five (5) pages in length,
inclusive of attachments, on any public
interest issues raised by the complaint
or § 210.8(b) filing. Comments should
address whether issuance of the relief
specifically requested by the
complainant in this investigation would
affect the public health and welfare in
the United States, competitive
conditions in the United States
economy, the production of like or
directly competitive articles in the
United States, or United States
consumers.
In particular, the Commission is
interested in comments that:
(i) explain how the articles potentially
subject to the requested remedial orders
are used in the United States;
(ii) identify any public health, safety,
or welfare concerns in the United States
relating to the requested remedial
orders;
(iii) identify like or directly
competitive articles that complainant,
its licensees, or third parties make in the
United States which could replace the
subject articles if they were to be
excluded;
(iv) indicate whether complainant,
complainant’s licensees, and/or third
party suppliers have the capacity to
replace the volume of articles
potentially subject to the requested
exclusion order and/or a cease and
desist order within a commercially
reasonable time; and
(v) explain how the requested
remedial orders would impact United
States consumers.
Written submissions must be filed no
later than by close of business, eight
calendar days after the date of
publication of this notice in the Federal
Register. There will be further
opportunities for comment on the
public interest after the issuance of any
final initial determination in this
investigation.
Persons filing written submissions
must file the original document
electronically on or before the deadlines
stated above and submit 8 true paper
copies to the Office of the Secretary by
noon the next day pursuant to § 210.4(f)
of the Commission’s Rules of Practice
and Procedure (19 CFR 210.4(f)).
Submissions should refer to the docket
number (‘‘Docket No. 3190’’) in a
prominent place on the cover page and/
or the first page. (See Handbook for
Electronic Filing Procedures, Electronic
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
Filing Procedures.1) 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 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 information,
including confidential business
information and documents for which
confidential treatment is properly
sought, submitted to the Commission for
purposes of this Investigation may be
disclosed to and used: (i) by the
Commission, its employees and Offices,
and contract personnel (a) for
developing or maintaining the records
of this or a related proceeding, or (b) in
internal investigations, audits, reviews,
and evaluations relating to the
programs, personnel, and operations of
the Commission including under 5
U.S.C. Appendix 3; or (ii) by U.S.
government employees and contract
personnel,2 solely for cybersecurity
purposes. All nonconfidential written
submissions will be available for public
inspection at the Office of the Secretary
and on EDIS.3
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 §§ 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 22, 2016.
Lisa R. Barton,
Secretary to the Commission.
BILLING CODE 7020–02–P
1 Handbook for Electronic Filing Procedures:
https://www.usitc.gov/documents/handbook_on_
filing_procedures.pdf.
2 All contract personnel will sign appropriate
nondisclosure agreements.
3 Electronic Document Information System
(EDIS): https://edis.usitc.gov
Frm 00090
Fmt 4703
Sfmt 4703
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Janssen
Pharmaceutical, 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 27, 2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
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 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
September 9, 2016, Janssen
Pharmaceutical, Inc., Buildings 1–5 & 7–
14, 1440 Olympic Drive, Athens,
Georgia 30601 applied to be registered
as a bulk manufacturer of the following
basic classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
[FR Doc. 2016–31435 Filed 12–28–16; 8:45 am]
PO 00000
DEPARTMENT OF JUSTICE
Methylphenidate .......
Oxycodone ................
Hydromorphone ........
Hydrocodone ............
Oripavine ..................
Thebaine ...................
Oxymorphone ...........
Tapentadol ................
Fentanyl ....................
Drug
code
1724
9143
9150
9193
9330
9333
9652
9780
9801
Schedule
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
E:\FR\FM\29DEN1.SGM
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96046
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
Dated: December 21, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016–31641 Filed 12–28–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Notice of Lodging of Proposed Second
Partial Consent Decree Under the
Clean Air Act
On December 20, 2016, the
Department of Justice lodged a proposed
Second Partial Consent Decree with the
United States District Court for the
Northern District of California in the
lawsuit entitled In re: Volkswagen
‘‘Clean Diesel’’ Marketing, Sales
Practices, and Products Liability
Litigation, Case No: MDL No. 2672 CRB
(JSC), partially resolving Clean Air Act
and various California claims (including
under the California Health and Safety
Code) against Volkswagen AG and
others, concerning certain noncompliant
3.0 liter diesel vehicles.
On January 4, 2016, the United States,
on behalf of the Environmental
Protection Agency (‘‘EPA’’) filed a
complaint against Volkswagen AG,
Volkswagen Group of America, Inc.,
Volkswagen Group of America
Chattanooga Operations, LLC, Audi AG,
Dr. Ing. h.c. F. Porsche AG, and Porsche
Cars North America, Inc. alleging that
the defendants violated Sections
203(a)(1), (2), (3)(A), and (3)(B) of the
Clean Air Act (‘‘Act’’), 42 U.S.C.
7522(a)(1), (2), (3)(A), and (3)(B), with
regard to approximately 500,000 model
year 2009 to 2015 motor vehicles
containing 2.0 liter diesel engines (2.0
Liter Subject Vehicles) and
approximately 80,000 model year 2009
to 2016 motor vehicles containing 3.0
liter diesel engines (3.0 Liter Subject
Vehicles). An amended complaint was
filed on October 7, 2016. The United
States’ complaint (initial and as
amended) alleges that each 2.0 and 3.0
Liter Subject Vehicle contains computer
algorithms that are prohibited defeat
devices that cause the emissions control
system of those vehicles to perform
differently during normal vehicle
operation and use than during
emissions testing. The complaint alleges
that the defeat devices cause the
vehicles, during normal vehicle
operation and use, to emit levels of
oxides of nitrogen (‘‘NOX’’) significantly
in excess of EPA-compliant levels. The
complaint seeks, among other things,
injunctive relief to remedy the
violations, including mitigation of
excess NOX emissions, and civil
penalties.
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
On June 27, 2016, People of the State
of California (‘‘California’’), by and
through the California Air Resources
Board (‘‘CARB’’) and the California
Attorney General filed a complaint
against defendants alleging that
defendants violated Cal. Health & Safety
Code §§ 43016, 43017, 43151, 43152,
43153, 43205, 43211, and 43212; Cal.
Code Regs. tit. 13, §§ 1903, 1961, 1961.2,
1965, 1968.2, and 2037, and 40 CFR
Sections incorporated by reference in
those California regulations; Cal. Bus. &
Prof. Code §§ 17200 et seq., 17500 et
seq., and 17580.5; Cal. Civ. Code § 3494;
and 12 U.S.C. 5531 et seq., with regard
to approximately 71,000 model year
2009 to 2015 motor vehicles containing
2.0 liter diesel engines and
approximately 16,000 model year 2009
to 2016 motor vehicles containing 3.0
liter diesel engines, for a total of
approximately 87,000 motor vehicles.
The California complaint alleges, in
relevant part, that the motor vehicles
contain prohibited defeat devices and
have resulted in, and continue to result
in, increased NOx emissions from each
such vehicle significantly in excess of
CARB requirements, that these vehicles
have resulted in the creation of a public
nuisance, and that defendants engaged
in related conduct that violated unfair
competition, false advertising, and
consumer protection laws.
On June 28, 2016, the United States
lodged a Partial Consent Decree, Dkt.
No. 1605–1 (‘‘First Partial Consent
Decree’’), concerning the 2.0 Liter
Subject Vehicles, which was entered
into by the United States, California,
and certain defendants (Volkswagen
AG, Audi AG, Volkswagen Group of
America, Inc., and Volkswagen Group of
America Chattanooga Operations, LLC).
The First Partial Consent Decree was
entered by this Court on October 25,
2016, Dkt. No. 2103, and may be viewed
here: https://www.cand.uscourts.gov/crb/
vwmdl.
This Second Partial Consent Decree
(‘‘Decree’’) is entered into between the
United States, California, and all
defendants (collectively,
‘‘Volkswagen’’). The Decree partially
resolves the governments’ claims for
injunctive relief with respect to the 3.0
Liter Subject Vehicles, by providing
remedies for the cars on the road and
the environmental harm from the
violations. It does not address plaintiffs’
claims, inter alia, for prospective
injunctive relief to prevent future
violations of the same type that are
alleged in the complaints or claims for
civil penalties.
Under the Decree, Volkswagen must
perform two vehicle recalls as follows
(with all capitalized terms as defined in
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
Appendix A of the Decree (Buyback,
Lease Termination, Vehicle
Modification, and Emissions Compliant
Recall Program):
First, for Generation 1.x 3.0 Liter
Subject Vehicles, Volkswagen must offer
all Eligible Owners and Lessees of these
vehicles the Buyback or the Lease
Termination under terms described in
Appendix A. In addition, if approved by
EPA/CARB, Volkswagen may, in
accordance with the requirements
specified in Appendix B of the Decree
(Vehicle Recall and Emissions
Modification Program for 3.0 Liter
Subject Vehicles), offer for Eligible
Vehicles the option of a modification to
substantially reduce NOX emissions in
accordance with standards established
by EPA/CARB in the Decree.
Second, for Generation 2.x 3.0 Liter
Subject Vehicles, if proposed by
Volkswagen and approved by EPA/
CARB, Volkswagen must offer an
Emissions Compliant Recall as set forth
in Appendix A to bring these vehicles
into compliance with their Certified
Exhaust Emission Standards in
accordance with the requirements
specified in Appendix B. If Volkswagen
is unable to effect a recall that meets
Certified Exhaust Emission Standards
for a particular Test Group or Groups of
Generation 2.x 3.0 Liter Subject
Vehicles in accordance with the
requirements specified in Appendix B,
Volkswagen must offer all Eligible
Owners and Lessees of such vehicles the
Buyback or Lease Termination, under
terms described in Appendix A, and
may, if proposed by Volkswagen and
approved by EPA/CARB, consistent
with the provisions in Appendix B, offer
to modify such vehicles to substantially
reduce their NOX emissions in
accordance with standards established
by EPA/CARB in this Consent Decree.
See Decree ¶¶ 9–15; Appendices A and
B.
Volkswagen must achieve a recall rate
(through the buyback, lease termination,
scrapped vehicles, the Emissions
Compliant Recall, and any other
approved vehicle modification options)
of 85% by November 30, 2019 for the
Generation 1.x 3.0 Liter Subject
Vehicles, and by May 31, 2020 for the
Generation 2.x 3.0 Liter Subject
Vehicles. If it fails to do so, Volkswagen
must augment the mitigation trust fund
discussed below by $5.5 million for
each 1% that it falls short of the 85%
rate for the Generation 1.x 3.0 Liter
Subject Vehicles, and by $21 million for
each 1% that it falls short of the 85%
rate for the Generation 2.x 3.0 Liter
Subject Vehicles. Volkswagen must also
achieve a separate 85% recall rate for
vehicles in California, and must pay to
E:\FR\FM\29DEN1.SGM
29DEN1
]]>Agencies
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96045-96046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31641]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Janssen
Pharmaceutical, 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
1301.33(a) on or before February 27, 2017.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
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 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
September 9, 2016, Janssen Pharmaceutical, Inc., Buildings 1-5 & 7-14,
1440 Olympic Drive, Athens, Georgia 30601 applied to be registered as a
bulk manufacturer of the following basic classes of controlled
substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Methylphenidate................................... 1724 II
Oxycodone......................................... 9143 II
Hydromorphone..................................... 9150 II
Hydrocodone....................................... 9193 II
Oripavine......................................... 9330 II
Thebaine.......................................... 9333 II
Oxymorphone....................................... 9652 II
Tapentadol........................................ 9780 II
Fentanyl.......................................... 9801 II
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances in bulk for distribution to its customers.
[[Page 96046]]
Dated: December 21, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016-31641 Filed 12-28-16; 8:45 am]
BILLING CODE 4410-09-P
