Bulk Manufacturer of Controlled Substances Application: Organix, Inc., 150-151 [2017-28269]

Download as PDF daltland on DSKBBV9HB2PROD with NOTICES 150 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, VerDate Sep<11>2014 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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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: E:\FR\FM\02JAN1.SGM 02JAN1 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 VerDate Sep<11>2014 19:54 Dec 29, 2017 Jkt 244001 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 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 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. E:\FR\FM\02JAN1.SGM 02JAN1

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]


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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
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