Bulk Manufacturer of Controlled Substances Application: Organix, Inc., 150-151 [2017-28269]
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Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices
known related parties and the nature of
the relationship as defined in section
771(4)(B) of the Act (19 U.S.C.
1677(4)(B)).
(6) A list of all known and currently
operating U.S. importers of the Subject
Merchandise and producers of the
Subject Merchandise in the Subject
Country that currently export or have
exported Subject Merchandise to the
United States or other countries after
2011.
(7) A list of 3–5 leading purchasers in
the U.S. market for the Domestic Like
Product and the Subject Merchandise
(including street address, World Wide
Web address, and the name, telephone
number, fax number, and Email address
of a responsible official at each firm).
(8) A list of known sources of
information on national or regional
prices for the Domestic Like Product or
the Subject Merchandise in the U.S. or
other markets.
(9) If you are a U.S. producer of the
Domestic Like Product, provide the
following information on your firm’s
operations on that product during
calendar year 2017, except as noted
(report quantity data in short tons and
value data in U.S. dollars, f.o.b. plant).
If you are a union/worker group or
trade/business association, provide the
information, on an aggregate basis, for
the firms in which your workers are
employed/which are members of your
association.
(a) Production (quantity) and, if
known, an estimate of the percentage of
total U.S. production of the Domestic
Like Product accounted for by your
firm’s(s’) production;
(b) Capacity (quantity) of your firm to
produce the Domestic Like Product (that
is, the level of production that your
establishment(s) could reasonably have
expected to attain during the year,
assuming normal operating conditions
(using equipment and machinery in
place and ready to operate), normal
operating levels (hours per week/weeks
per year), time for downtime,
maintenance, repair, and cleanup, and a
typical or representative product mix);
(c) the quantity and value of U.S.
commercial shipments of the Domestic
Like Product produced in your U.S.
plant(s);
(d) the quantity and value of U.S.
internal consumption/company
transfers of the Domestic Like Product
produced in your U.S. plant(s); and
(e) the value of (i) net sales, (ii) cost
of goods sold (COGS), (iii) gross profit,
(iv) selling, general and administrative
(SG&A) expenses, and (v) operating
income of the Domestic Like Product
produced in your U.S. plant(s) (include
both U.S. and export commercial sales,
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19:54 Dec 29, 2017
Jkt 244001
internal consumption, and company
transfers) for your most recently
completed fiscal year (identify the date
on which your fiscal year ends).
(10) If you are a U.S. importer or a
trade/business association of U.S.
importers of the Subject Merchandise
from the Subject Country, provide the
following information on your firm’s(s’)
operations on that product during
calendar year 2017 (report quantity data
in short tons and value data in U.S.
dollars). If you are a trade/business
association, provide the information, on
an aggregate basis, for the firms which
are members of your association.
(a) The quantity and value (landed,
duty-paid but not including
antidumping duties) of U.S. imports
and, if known, an estimate of the
percentage of total U.S. imports of
Subject Merchandise from the Subject
Country accounted for by your firm’s(s’)
imports;
(b) the quantity and value (f.o.b. U.S.
port, including antidumping duties) of
U.S. commercial shipments of Subject
Merchandise imported from the Subject
Country; and
(c) the quantity and value (f.o.b. U.S.
port, including antidumping duties) of
U.S. internal consumption/company
transfers of Subject Merchandise
imported from the Subject Country.
(11) If you are a producer, an exporter,
or a trade/business association of
producers or exporters of the Subject
Merchandise in the Subject Country,
provide the following information on
your firm’s(s’) operations on that
product during calendar year 2017
(report quantity data in short tons and
value data in U.S. dollars, landed and
duty-paid at the U.S. port but not
including antidumping duties). If you
are a trade/business association, provide
the information, on an aggregate basis,
for the firms which are members of your
association.
(a) Production (quantity) and, if
known, an estimate of the percentage of
total production of Subject Merchandise
in the Subject Country accounted for by
your firm’s(s’) production;
(b) Capacity (quantity) of your firm(s)
to produce the Subject Merchandise in
the Subject Country (that is, the level of
production that your establishment(s)
could reasonably have expected to
attain during the year, assuming normal
operating conditions (using equipment
and machinery in place and ready to
operate), normal operating levels (hours
per week/weeks per year), time for
downtime, maintenance, repair, and
cleanup, and a typical or representative
product mix); and
(c) the quantity and value of your
firm’s(s’) exports to the United States of
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Subject Merchandise and, if known, an
estimate of the percentage of total
exports to the United States of Subject
Merchandise from the Subject Country
accounted for by your firm’s(s’) exports.
(12) Identify significant changes, if
any, in the supply and demand
conditions or business cycle for the
Domestic Like Product that have
occurred in the United States or in the
market for the Subject Merchandise in
the Subject Country after 2011, and
significant changes, if any, that are
likely to occur within a reasonably
foreseeable time. Supply conditions to
consider include technology;
production methods; development
efforts; ability to increase production
(including the shift of production
facilities used for other products and the
use, cost, or availability of major inputs
into production); and factors related to
the ability to shift supply among
different national markets (including
barriers to importation in foreign
markets or changes in market demand
abroad). Demand conditions to consider
include end uses and applications; the
existence and availability of substitute
products; and the level of competition
among the Domestic Like Product
produced in the United States, Subject
Merchandise produced in the Subject
Country, and such merchandise from
other countries.
(13) (OPTIONAL) A statement of
whether you agree with the above
definitions of the Domestic Like Product
and Domestic Industry; if you disagree
with either or both of these definitions,
please explain why and provide
alternative definitions.
Authority: This proceeding is being
conducted under authority of title VII of the
Tariff Act of 1930; this notice is published
pursuant to section 207.61 of the
Commission’s rules.
By order of the Commission.
Issued: December 26, 2017.
Katherine M. Hiner,
Supervisory Attorney.
[FR Doc. 2017–28237 Filed 12–29–17; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Organix, 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. 83, No. 1 / Tuesday, January 2, 2018 / Notices
comments on or objections to the
issuance of the proposed registration on
or before March 5, 2018.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
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 6, 2017, Organix, Inc., 240
Salem Street, Woburn, Massachusetts
01801 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled
substance
Drug code
daltland on DSKBBV9HB2PROD with NOTICES
Gamma Hydroxybutyric Acid.
Lysergic acid
diethylamide.
Marihuana .........
Tetrahydrocannabinols.
Dimethyltryptamine.
Psilocybin .........
Psilocyn ............
Heroin ...............
Morphine ...........
Schedule
2010
I
7315
I
7360
7370
I
I
7435
I
7437
7438
9200
9300
I
I
I
II
The company plans to manufacture
reference standards for distribution to
its research and forensic customers. In
reference to drug code 7360 (marihuana)
and 7370 (THC) the company plans to
manufacture these drugs as synthetic.
No other activities for these drug codes
are authorized for this registration.
Dated: December 26, 2017.
Neil Doherty,
Deputy Assistant Administrator.
[FR Doc. 2017–28269 Filed 12–29–17; 8:45 am]
BILLING CODE 4410–09–P
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DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the Clean Water
Act, Clean Air Act, Emergency
Planning and Community Right-ToKnow Act, and Resource Conservation
and Recovery Act
On December 22, 2017, the
Department of Justice filed an amended
complaint and lodged a revised
proposed consent decree with the
United States District Court for the
Western District of Pennsylvania in the
lawsuit entitled United States and
Territory of American Samoa v. StarKist
Co. and Starkist Samoa Co., Civil
Action No. 2:17–cv–01190–DSC. The
amended complaint and revised
proposed consent decree supersede the
complaint and proposed consent decree
filed by the Department of Justice in this
action on September 12, 2017 and
noticed for public comment in 82 FR
43,573 (Sept. 18, 2017).
In addition to the allegations in the
original complaint, the amended
complaint, which is filed by the United
States and the Territory of American
Samoa, alleges three new violations of
the Clean Water Act (‘‘CWA’’) related to
unpermitted discharges from Starkist’s
facility to Pago Pago Harbor. First, the
amended complaint alleges that Starkist
discharged stormwater associated with
industrial activity without a permit
between June 2, 2015 and the present.
Second, the amended complaint alleges
that Starkist discharged a milky-white
substance that contained pollutants
from its facility through a stormwater
outfall on 5 occasions between July 13,
2017 and October 30, 2017. Finally, the
amended complaint alleges that Starkist
discharged pollutants from a sewage lift
station overflow pipe at its facility into
the harbor on September 20, 2017. For
each of these violations, the amended
complaint seeks injunctive relief and
civil penalties.
The amended complaint also adds a
claim for relief by the Territory for
violations of the American Samoa
Environmental Quality Act and its
implementing regulations based on the
same facts underlying the United States’
claims for relief. In particular, the
amended complaint alleges that
Starkist’s unauthorized discharges and
its discharges that exceeded effluent
limitations in its NPDES permit violated
the requirement in the American Samoa
Environmental Quality Commission
Rules that such discharges comply with
NPDES rules and regulations. In
addition, the amended complaint
alleges that each of Starkist’s violations
of Section 112(r) of the Clean Air Act
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151
related to the handling of ammonia,
butane, and chlorine at the facility
violated the American Samoa
Environmental Quality Commission
Rules requirement to comply with the
federal Clean Air Act. For each of these
violations, the Territory seeks civil
penalties.
The revised proposed consent decree
requires the defendants to perform
injunctive relief, and pay an increased
civil penalty of $6,500,000 (an increase
of $200,000) to resolve the additional
CWA violations alleged in the amended
complaint, as well as the original
alleged violations. Starkist must pay
$3,900,000 to the United States and
$2,600,000 to the Territory.
The revised proposed consent decree
requires the defendants to perform the
injunctive relief included in the
previously-lodged consent decree, as
well as to address the additional CWA
violations. It requires Starkist to obtain
authorization to discharge stormwater
from the facility, to implement best
management practices, and prepare a
plan to reduce, minimize, and eliminate
pollutants in stormwater discharges
from the facility. The decree also
requires Starkist to identify and
eliminate any connections between the
facility’s industrial processes and its
stormwater collection system. Finally,
the revised proposed Consent Decree
formalizes the role of the Territory in
the implementation of the revised
Consent Decree. The revised consent
decree also replaces the process flow
diagram in Appendix C to include an
updated diagram.
The publication of this notice opens
a period for public comment on the
proposed consent decree. Comments
should be addressed to the Assistant
Attorney General, Environment and
Natural Resources Division, and should
refer to United States v. StarKist Co. and
Starkist Samoa Co., D.J. Ref. No. 90–5–
1–1–11357. 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 .........
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.
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]]>Agencies
[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Pages 150-151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28269]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Organix,
Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written
[[Page 151]]
comments on or objections to the issuance of the proposed registration
on or before March 5, 2018.
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 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 6, 2017, Organix, Inc., 240 Salem Street, Woburn,
Massachusetts 01801 applied to be registered as a bulk manufacturer of
the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.......... 2010 I
Lysergic acid diethylamide......... 7315 I
Marihuana.......................... 7360 I
Tetrahydrocannabinols.............. 7370 I
Dimethyltryptamine................. 7435 I
Psilocybin......................... 7437 I
Psilocyn........................... 7438 I
Heroin............................. 9200 I
Morphine........................... 9300 II
------------------------------------------------------------------------
The company plans to manufacture reference standards for
distribution to its research and forensic customers. In reference to
drug code 7360 (marihuana) and 7370 (THC) the company plans to
manufacture these drugs as synthetic. No other activities for these
drug codes are authorized for this registration.
Dated: December 26, 2017.
Neil Doherty,
Deputy Assistant Administrator.
[FR Doc. 2017-28269 Filed 12-29-17; 8:45 am]
BILLING CODE 4410-09-P
