Certain Gabapentin Immunoassay Kits and Test Strips, Components Thereof, and Methods Therefor; Institution of Investigation, 6918-6919 [2021-01548]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES 6918 Federal Register / Vol. 86, No. 14 / Monday, January 25, 2021 / Notices exclusion order, a cease and desist order and impose a bond upon respondents’ alleged infringing articles during the 60day Presidential review period pursuant to 19 U.S.C. 1337(j). Proposed respondents, other interested parties, and members of the public are invited to file comments 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 on the public interest 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. Any written submissions on other issues must also be filed by no later than the close of business, eight calendar days after publication of this notice in the Federal Register. Complainant may file replies to any written submissions no later than three calendar days after the date on which any initial submissions were due. Any submissions and replies filed in response to this Notice are limited to five (5) pages in length, inclusive of attachments. VerDate Sep<11>2014 18:31 Jan 22, 2021 Jkt 253001 Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (‘‘Docket No. 3525’’) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, Electronic Filing Procedures 1). Please note the Secretary’s Office will accept only electronic filings during this time. Filings must be made through the Commission’s Electronic Document Information System (EDIS, https:// edis.usitc.gov.) No in-person paperbased filings or paper copies of any electronic filings will be accepted until further notice. Persons with questions regarding filing should contact the Secretary at EDIS3Help@usitc.gov. 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 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. 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. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Issued: January 19, 2021. William Bishop, Supervisory Hearings and Information Officer. [FR Doc. 2021–01504 Filed 1–22–21; 8:45 am] BILLING CODE 7020–02–P INTERNATIONAL TRADE COMMISSION [Inv. No. 337–TA–1239] Certain Gabapentin Immunoassay Kits and Test Strips, Components Thereof, and Methods Therefor; Institution of Investigation U.S. International Trade Commission. ACTION: Notice. AGENCY: Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on December 2, 2020, under section 337 of the Tariff Act of 1930, as amended, on behalf of ARK Diagnostics, Inc. of Fremont, California. A supplement to the complaint was filed on December 2, 2020 and an amended complaint was filed on December 23, 2020. The complaint, as amended, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain gabapentin immunoassay kits and test strips, components thereof, and methods therefor by reason of infringement of certain claims of U.S. Patent No. 8,828,665 (‘‘the ’665 patent’’) and U.S. Patent No. 10,203,345 (‘‘the ’345 patent’’). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders. ADDRESSES: The complaint, except for any confidential information contained therein, may be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email EDIS3Help@usitc.gov. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission’s TDD terminal on (202) 205–1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205– 2000. General information concerning the Commission may also be obtained SUMMARY: E:\FR\FM\25JAN1.SGM 25JAN1 Federal Register / Vol. 86, No. 14 / Monday, January 25, 2021 / Notices by accessing its internet server at https://www.usitc.gov. jbell on DSKJLSW7X2PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Katherine Hiner, Office of Docket Services, U.S. International Trade Commission, telephone (202) 205–1802. SUPPLEMENTARY INFORMATION: Authority: The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in section 210.10 of the Commission’s Rules of Practice and Procedure, 19 CFR 210.10 (2020). Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on January 19, 2021, ordered that— (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1–3, 6, 7, 9, 14, 17, 18, 20, and 21 of the ’665 patent; and claims 1, 2, 7, 8, 11, 12, 19, 20, 26, and 27 of the ’345 patent; and whether an industry in the United States exists as required by subsection (a)(2) of section 337; (2) Pursuant to section 210.10(b)(1) of the Commission’s Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is ‘‘gabapentin immunoassays kits, gabapentin-specific test strips, multi-drug test kits and strips that test for gabapentin among other drugs, and components of such kits and test strips’’; (3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served: (a) The complainant is: ARK Diagnostics, Inc., 48089 Fremont Boulevard, Fremont, CA 94538. (b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served: Hangzhou AllTest Biotech Co., Ltd., No. 550, Yinhai Street, Hangzhou Economy and Technology Development Area, Hangzhou, China 210018. Shanghai Chemtron Biotech Co., Ltd., No. 518, Qingdai Rd., International Medical Park, Pudong 201318, Shanghai, China. VerDate Sep<11>2014 18:31 Jan 22, 2021 Jkt 253001 Chemtron Biotech Co., Ltd., 9425 Brown Deer Road, Suite B, San Diego, CA 92121. Zhejiang Orient Gene Biotech Co., Ltd., #3787 East Yangguang Ave., Dipu St., Anji 313300, Huzhou, Zhejiang, China. Healgen Scientific, LLC, 3818 Fuqua Street, Houston, TX 77047. Kappa City Biotech, SAS, 32 Rue Danton, 03100 Montlucon, France. 12PanelMedical, Inc., 846 Wee Burn Street, Apt. E306, Sarasota, FL 34243. Acro Biotech, Inc., 9500 7th Street, Unit M, Rancho Cucamonga, CA 91730. AlcoPro, Inc., 2547 Sutherland Ave., Knoxville, TN 37919. American Screening, LLC, 9742 St. Vincent Ave., Ste. 100, Shreveport, LA 71106. Confirm Biosciences, Inc., 10123 Carroll Canyon Road, San Diego, CA 92131. Mercedes Medical, LLC, 12210 Rangeland Parkway, Lakewood Ranch, FL 34211. TransMed Co., LLC, 1887 McFarland Parkway, Alpharetta, GA 30005. Transmetron, Inc., 1476 S Major Street (50 East), Salt Lake City, UT 84115. (4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge. The Office of Unfair Import Investigations will not participate as a party in this investigation. Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission’s Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainant of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown. Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 6919 such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent. By order of the Commission. Issued: January 19, 2021. William Bishop, Supervisory Hearings and Information Officer. [FR Doc. 2021–01548 Filed 1–22–21; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Air Act On January 14, 2021, the Department of Justice lodged a proposed consent decree with the United States District Court for the Middle District of North Carolina in United States v. Pilkington North America, Inc., Civil Action No. 1:21–cv–00040. The United States filed a complaint under Clean Air Act (CAA) Sections 113(b) and 167, 42 U.S.C. 7413(b) and 7477, seeking injunctive relief for the Defendant’s alleged failure to (1) obtain appropriate permits before modifying and subsequently operating Furnace No. 1 at its glass manufacturing facility in Laurinburg, North Carolina, and (2) install and employ the best available control technology (BACT) to control emissions of nitrogen oxides (NOX), sulfur dioxide (SO2), and particulate matter (PM) from Furnace No. 1, as required by the CAA. The United States simultaneously lodged a consent decree that would settle the claims in the complaint. Under the proposed decree, the Defendant will have to (1) install equipment on Furnace No. 1 to control emissions of NOX, SO2, and PM from the furnace; (2) install equipment on Furnace No. 1 to continuously monitor NOX and SO2 emissions from the furnace and perform annual stack tests to monitor PM emissions from the furnace; (3) meet interim and final limits for emissions of NOX, SO2, and PM from Furnace No. 1; (4) incorporate certain requirements of the decree into a permit; and (5) perform a project to mitigate excess PM emissions from the Laurinburg facility. 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. Pilkington North America, Inc., D.J. Ref. No. 90–5– 2–1–10328. All comments must be E:\FR\FM\25JAN1.SGM 25JAN1

Agencies

[Federal Register Volume 86, Number 14 (Monday, January 25, 2021)]
[Notices]
[Pages 6918-6919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01548]


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INTERNATIONAL TRADE COMMISSION

[Inv. No. 337-TA-1239]


Certain Gabapentin Immunoassay Kits and Test Strips, Components 
Thereof, and Methods Therefor; Institution of Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that a complaint was filed with the 
U.S. International Trade Commission on December 2, 2020, under section 
337 of the Tariff Act of 1930, as amended, on behalf of ARK 
Diagnostics, Inc. of Fremont, California. A supplement to the complaint 
was filed on December 2, 2020 and an amended complaint was filed on 
December 23, 2020. The complaint, as amended, alleges violations of 
section 337 based upon the importation into the United States, the sale 
for importation, and the sale within the United States after 
importation of certain gabapentin immunoassay kits and test strips, 
components thereof, and methods therefor by reason of infringement of 
certain claims of U.S. Patent No. 8,828,665 (``the '665 patent'') and 
U.S. Patent No. 10,203,345 (``the '345 patent''). The complaint further 
alleges that an industry in the United States exists as required by the 
applicable Federal Statute. The complainant requests that the 
Commission institute an investigation and, after the investigation, 
issue a limited exclusion order and cease and desist orders.

ADDRESSES: The complaint, except for any confidential information 
contained therein, may be viewed on the Commission's electronic docket 
(EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email 
[email protected]. Hearing impaired individuals are advised that 
information on this matter can be obtained by contacting the 
Commission's TDD terminal on (202) 205-1810. Persons with mobility 
impairments who will need special assistance in gaining access to the 
Commission should contact the Office of the Secretary at (202) 205-
2000. General information concerning the Commission may also be 
obtained

[[Page 6919]]

by accessing its internet server at https://www.usitc.gov.

FOR FURTHER INFORMATION CONTACT: Katherine Hiner, Office of Docket 
Services, U.S. International Trade Commission, telephone (202) 205-
1802.

SUPPLEMENTARY INFORMATION: 
    Authority: The authority for institution of this investigation is 
contained in section 337 of the Tariff Act of 1930, as amended, 19 
U.S.C. 1337, and in section 210.10 of the Commission's Rules of 
Practice and Procedure, 19 CFR 210.10 (2020).
    Scope of Investigation: Having considered the complaint, the U.S. 
International Trade Commission, on January 19, 2021, ordered that--
    (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 
1930, as amended, an investigation be instituted to determine whether 
there is a violation of subsection (a)(1)(B) of section 337 in the 
importation into the United States, the sale for importation, or the 
sale within the United States after importation of certain products 
identified in paragraph (2) by reason of infringement of one or more of 
claims 1-3, 6, 7, 9, 14, 17, 18, 20, and 21 of the '665 patent; and 
claims 1, 2, 7, 8, 11, 12, 19, 20, 26, and 27 of the '345 patent; and 
whether an industry in the United States exists as required by 
subsection (a)(2) of section 337;
    (2) Pursuant to section 210.10(b)(1) of the Commission's Rules of 
Practice and Procedure, 19 CFR 210.10(b)(1), the plain language 
description of the accused products or category of accused products, 
which defines the scope of the investigation, is ``gabapentin 
immunoassays kits, gabapentin-specific test strips, multi-drug test 
kits and strips that test for gabapentin among other drugs, and 
components of such kits and test strips'';
    (3) For the purpose of the investigation so instituted, the 
following are hereby named as parties upon which this notice of 
investigation shall be served:
    (a) The complainant is:

ARK Diagnostics, Inc., 48089 Fremont Boulevard, Fremont, CA 94538.
    (b) The respondents are the following entities alleged to be in 
violation of section 337, and are the parties upon which the complaint 
is to be served:

Hangzhou AllTest Biotech Co., Ltd., No. 550, Yinhai Street, Hangzhou 
Economy and Technology Development Area, Hangzhou, China 210018.
Shanghai Chemtron Biotech Co., Ltd., No. 518, Qingdai Rd., 
International Medical Park, Pudong 201318, Shanghai, China.
Chemtron Biotech Co., Ltd., 9425 Brown Deer Road, Suite B, San Diego, 
CA 92121.
Zhejiang Orient Gene Biotech Co., Ltd., #3787 East Yangguang Ave., Dipu 
St., Anji 313300, Huzhou, Zhejiang, China.
Healgen Scientific, LLC, 3818 Fuqua Street, Houston, TX 77047.
Kappa City Biotech, SAS, 32 Rue Danton, 03100 Montlucon, France.
12PanelMedical, Inc., 846 Wee Burn Street, Apt. E306, Sarasota, FL 
34243.
Acro Biotech, Inc., 9500 7th Street, Unit M, Rancho Cucamonga, CA 
91730.
AlcoPro, Inc., 2547 Sutherland Ave., Knoxville, TN 37919.
American Screening, LLC, 9742 St. Vincent Ave., Ste. 100, Shreveport, 
LA 71106.
Confirm Biosciences, Inc., 10123 Carroll Canyon Road, San Diego, CA 
92131.
Mercedes Medical, LLC, 12210 Rangeland Parkway, Lakewood Ranch, FL 
34211.
TransMed Co., LLC, 1887 McFarland Parkway, Alpharetta, GA 30005.
Transmetron, Inc., 1476 S Major Street (50 East), Salt Lake City, UT 
84115.

    (4) For the investigation so instituted, the Chief Administrative 
Law Judge, U.S. International Trade Commission, shall designate the 
presiding Administrative Law Judge.
    The Office of Unfair Import Investigations will not participate as 
a party in this investigation.
    Responses to the complaint and the notice of investigation must be 
submitted by the named respondents in accordance with section 210.13 of 
the Commission's Rules of Practice and Procedure, 19 CFR 210.13. 
Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 
(March 19, 2020), such responses will be considered by the Commission 
if received not later than 20 days after the date of service by the 
complainant of the complaint and the notice of investigation. 
Extensions of time for submitting responses to the complaint and the 
notice of investigation will not be granted unless good cause therefor 
is shown.
    Failure of a respondent to file a timely response to each 
allegation in the complaint and in this notice may be deemed to 
constitute a waiver of the right to appear and contest the allegations 
of the complaint and this notice, and to authorize the administrative 
law judge and the Commission, without further notice to the respondent, 
to find the facts to be as alleged in the complaint and this notice and 
to enter an initial determination and a final determination containing 
such findings, and may result in the issuance of an exclusion order or 
a cease and desist order or both directed against the respondent.

    By order of the Commission.

    Issued: January 19, 2021.
William Bishop,
Supervisory Hearings and Information Officer.
[FR Doc. 2021-01548 Filed 1-22-21; 8:45 am]
BILLING CODE 7020-02-P
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