Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals, Inc., 55205-55206 [2018-24006]
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55205
Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Notices
Cambridge, UK; Clear Scientific, LLC,
Cambridge, MA; Cornerstone
Government Affairs, Inc., Washington,
DC; DePuy Synthes Products, Inc.,
Raynham, MA; Dignitas Technologies,
Orlando, FL; ECM Therapeutics, Inc.,
Warrendale, PA; ElMindA Ltd.,
Herzliya, Israel; Family Health
International DBA FHI 360, Durham,
NC; Hypatia Project, Reston, VA;
Institutes for Behavior Resources, Inc.
(IBR), Baltimore, MD; Integrated
MicroSciences, LLC, Frederick, MD; J.
Craig Venter Institute (JCVI), Rockville,
MD; KaloCyte, Inc., St. Louis, MO;
Lieber Institute, Inc., Baltimore, MD;
NanoDirect, LLC, Baltimore, MD;
OXYVITA, Inc., Middletown, NY;
Parsons Government Services, Inc.,
Pasadena, CA; Protocentral, Inc.,
Woburn, MA; Q2Pharma, Haifa, Israel;
RAIN Scientific, Inc., Asheville, NC;
Rehat, LLC, Pittsburgh, PA; Research
Foundation for Mental Hygiene, Inc.
(NYSPI), New York, NY; Responde2
Corporation, Mountain View, CA; Saint
Barnabas Medical Center (SBMC),
Livingston, NJ; San Diego Blood Bank,
San Diego, CA; SmartMD Systems, Inc.,
Manchester Center, VT; Sonica LLC,
Evanston, IL; Spire, San Francisco, CA;
Syracuse University, Syracuse, NY; The
Charles Stark Draper Laboratory, Inc.
(Draper), Cambridge, MA; The
University of Arizona, Defense and
Security Research Institute (DSRI),
Tucson, AZ; Trauma Insight, LLC, San
Antonio, TX; Trustees of Boston
University, Boston, MA; University of
Central Florida Research Foundation,
Inc., Orlando, FL; University of
Houston—Cullen College of
Engineering, Houston, TX; Vivonics,
Inc., Bedford, MA; and Washington
State University, Pullman, WA; have
been added as parties to this venture.
No other changes have been made in
either the membership or planned
activity of the group research project.
Membership in this group research
project remains open, and MTEC
intends to file additional written
notifications disclosing all changes in
membership.
On May 9, 2014, MTEC filed its
original notification pursuant to Section
6(a) of the Act. The Department of
Justice published a notice in the Federal
Register pursuant to Section 6(b) of the
Act on June 9, 2014 (79 FR 32999).
The last notification was filed with
the Department on May 3, 2018. A
notice was published in the Federal
VerDate Sep<11>2014
17:57 Nov 01, 2018
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Register pursuant to Section 6(b) of the
Act on June 19, 2018 (83 FR 28448).
Suzanne Morris,
Chief, Premerger and Division Statistics Unit
Antitrust Division.
Dated: October 24, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–24005 Filed 11–1–18; 8:45 am]
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[FR Doc. 2018–23989 Filed 11–1–18; 8:45 am]
BILLING CODE 4410–11–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Registration
ACTION:
The registrants listed below
have applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as bulk
manufacturers of various classes of
schedule I and II controlled substances.
SUMMARY:
The
companies listed below applied to be
registered as bulk manufacturers of
various basic classes of controlled
substances. Information on previously
published notices is listed in the table
below. No comments or objections were
submitted for these notices.
SUPPLEMENTARY INFORMATION:
FR citation
Chemtos,
83 FR 37520
LLC.
Johnson
83 FR 34880
Matthey Inc.
AMRI
83 FR 38179
Rensselaer,
Inc.
Published
August 1,
2018.
July 23,
2018.
August 3,
2018.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of these registrants to
manufacture the applicable 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 each of the company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed companies.
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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 January 2, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
Notice of registration.
Company
Bulk Manufacturer of Controlled
Substances Application: Janssen
Pharmaceuticals, Inc.
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
1301.33(a), this is notice that on
September 13, 2018, Janssen
Pharmaceuticals, 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
Drug
code
Schedule
Methylphenidate ...............
Hydromorphone ................
Hydrocodone ....................
Oripavine ..........................
Thebaine ...........................
Tapentadol ........................
1724
9150
9193
9330
9333
9780
II
II
II
II
II
II
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55206
Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Notices
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
Dated: October 24, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–24006 Filed 11–1–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Amended Consent Decree Under the
Clean Air Act
On October 25, 2018, the Department
of Justice lodged a proposed Amended
Consent Decree with the United States
District Court of the Virgin Islands in
the lawsuit entitled United States of
America v. Virgin Islands Water and
Power Authority, Civil Action No. 3:14–
cv–00086.
The original Consent Decree resolved
the Clean Air Act violations as alleged
in the Complaint filed by the United
States on October 30, 2014. The
violations alleged in the Complaint with
respect to VIWAPA’s St. Thomas facility
include VIWAPA’s failure to properly
operate and/or maintain its water
injection systems on its gas turbine
units, failure to operate in compliance
with NOX, sulfuric acid mist, particulate
matter and VOC emission limits, failure
to operate in compliance with opacity
limits, failure to perform required audits
and maintain required quality data
availability, failure to properly operate
and calibrate the continuous emission
monitoring systems (CEMS) for NOX
and CO, failure to conduct stack testing
every 30 months, and failure to properly
report non-compliance. The violations
alleged in the Complaint with respect to
VIWAPA’s St. John facility concern
VIWAPA’s failure to comply with the
RICE NESHAP regulations, failure to
timely submit a Title V renewal
application and operation without a
Title V permit, and failure to conduct
stack testing every 30 months.
The Consent Decree, entered by the
Court on September 30, 2016, requires
VIWAPA to generate a high percentage
of its KWh from liquid propane gas or
liquid natural gas and renewables, to
implement a spare parts inventory
program, to control NOX emissions
through improved operation of its water
injection system, to maintain and
operate continuous emissions
monitoring systems on specified units,
to operate a video camera system for
visible emissions, to perform stack
testing, and to conduct targeted selfaudits and third party audits given its
long term compliance problems. The
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17:57 Nov 01, 2018
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Consent Decree also required a
$1,300,000 penalty, which VIWAPA has
paid. The proposed Amended Consent
Decree makes certain changes to the
Consent Decree, including: Updating
references to current operating units;
adding new units called reciprocating
internal combustion engines to the
requirements of Paragraph 13 and any
requirements associated with the
requirements of Paragraph 13; updating
aspects of the Consent Decree that have
become outdated and are no longer
relevant to its enforcement; addressing
the current status of the St. John Unit;
edits to Paragraph 21 regarding the
Atomizer on Unit 14; and adding a date
certain for the performance of a stack
test.
The Department of Justice will
receive, for a period of thirty (30) days
from the date of this publication,
comments relating to the Consent
Decree. Comments should be addressed
to the Assistant Attorney General for the
Environmental and Natural Resources
Division, and should refer to United
States v. Virgin Islands Water and
Power Authority, DOJ Ref. # 90–5–2–1–
10424. All comments must be submitted
no later than thirty 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 e-mail ......
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ—ENRD, P.O.
Box 7611, Washington, DC
20044–7611.
By mail .........
During the public comment period,
the Consent Decree may be examined
and downloaded at this Justice
Department website: 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 $22.75 (25 cents per page
reproduction cost) payable to the United
States Treasury.
Robert Maher,
Assistant Section Chief, Environmental
Enforcement Section, Environment & Natural
Resources Division.
[FR Doc. 2018–23985 Filed 11–1–18; 8:45 am]
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DEPARTMENT OF JUSTICE
U.S. Marshals Service
[OMB Number 1105–0096]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Extension
With No Changes, of a Previously
Approved Collection; Sequestered
Juror Information Form
U.S. Marshals Service,
Department of Justice.
ACTION: 30-Day notice.
AGENCY:
The Department of Justice
(DOJ), U.S. Marshals Service (USMS),
will submit the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
The proposed information collection
was previously published in the Federal
Register on August 29, 2018, allowing
for a 60-day comment period.
DATES: Comments are encouraged and
will be accepted for an additional 30
days until December 3, 2018.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments,
particularly with respect to the
estimated public burden or associated
response time, have suggestions, need a
copy of the proposed information
collection instrument with instructions,
or desire any other additional
information, please contact Nicole
Timmons either by mail at CG–3, 10th
Floor, Washington, DC 20530–0001, by
email at Nicole.Timmons@usdoj.gov, or
by telephone at 202–236–2646. Written
comments and/or suggestions can also
be directed to the Office of Management
and Budget, Office of Information and
Regulatory Affairs, Attention
Department of Justice Desk Officer,
Washington, DC 20503 or sent to OIRA_
submissions@omb.eop.gov.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
address one or more of the following
four points:
—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
—Evaluate the accuracy of the agency’s
estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)]
[Notices]
[Pages 55205-55206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24006]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Janssen
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 January 2, 2019.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
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 1301.33(a), this is notice that on
September 13, 2018, Janssen Pharmaceuticals, 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:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methylphenidate......................... 1724 II
Hydromorphone........................... 9150 II
Hydrocodone............................. 9193 II
Oripavine............................... 9330 II
Thebaine................................ 9333 II
Tapentadol.............................. 9780 II
------------------------------------------------------------------------
[[Page 55206]]
The company plans to manufacture the above-listed controlled
substances in bulk for distribution to its customers.
Dated: October 24, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-24006 Filed 11-1-18; 8:45 am]
BILLING CODE 4410-09-P
