Certain Pre-Filled Syringes for Intravitreal Injection and Components Thereof; Institution of Investigation, 45227-45228 [2020-16138]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 144 / Monday, July 27, 2020 / Notices 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. 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. 3475’’) 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:// 1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_ filing_procedures.pdf. VerDate Sep<11>2014 19:31 Jul 24, 2020 Jkt 250001 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. Issued: July 22, 2020. Lisa Barton, Secretary to the Commission. [FR Doc. 2020–16238 Filed 7–24–20; 8:45 am] BILLING CODE 7020–02–P INTERNATIONAL TRADE COMMISSION [Investigation No. 337–TA–1207] Certain Pre-Filled Syringes for Intravitreal Injection and Components Thereof; Institution of Investigation U.S. International Trade Commission. AGENCY: 2 All contract personnel will sign appropriate nondisclosure agreements. 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 ACTION: 45227 Notice. Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on June 19, 2020, under section 337 of the Tariff Act of 1930, as amended, on behalf of Novartis Pharma AG of Switzerland; Novartis Pharmaceuticals Corporation of East Hanover, New Jersey; and Novartis Technology LLC of East Hanover, New Jersey. A letter supplementing the complaint was filed on July 10, 2020. The complaint 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 pre-filled syringes for intravitreal injection and components thereof by reason of infringement of certain claims of U.S. Patent No. 9,220,631 (‘‘the ’631 patent’’). The complaint further alleges that an industry in the United States exists or is in the process of being established as required by the applicable Federal Statute. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and a cease and desist order. 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 by accessing its internet server at https://www.usitc.gov. FOR FURTHER INFORMATION CONTACT: Pathenia M. Proctor, The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205–2560. SUPPLEMENTARY INFORMATION: SUMMARY: 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 § 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 July 21, 2020, 2020, ordered that— (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as E:\FR\FM\27JYN1.SGM 27JYN1 jbell on DSKJLSW7X2PROD with NOTICES 45228 Federal Register / Vol. 85, No. 144 / Monday, July 27, 2020 / Notices 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 1–6 and 11–26 of the ’631 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337; (2) Pursuant to § 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 ‘‘syringes that are prefilled with ophthalmic medication, and components of such syringes, including barrels, plungers, and stoppers’’; (3) Pursuant to Commission Rule § 210.50(b)(1), 19 CFR 210.50(b)(1), the presiding administrative law judge shall take evidence or other information and hear arguments from the parties or other interested persons with respect to the public interest in this investigation, as appropriate, and provide the Commission with findings of fact and a recommended determination on this issue, which shall be limited to the statutory public interest factors set forth in 19 U.S.C. 1337(d)(1), (f)(1), (g)(1); (4) 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 complainants are: Novartis Pharma AG, Forum 1, Novartis Campus, CH–4056 Basel, Switzerland. Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey, 07936. Novartis Technology LLC, One Health Plaza, East Hanover, New Jersey, 07936. (b) The respondent is the following entity alleged to be in violation of section 337, and is the party upon which the complaint is to be served: Regeneron Pharmaceuticals, Inc., 77 Old Saw Mill River Road, Tarrytown, New York 10591. (c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and (5) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge. Responses to the complaint and the notice of investigation must be VerDate Sep<11>2014 19:31 Jul 24, 2020 Jkt 250001 submitted by the named respondent in accordance with § 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 complainants 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 the 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: July 21, 2020. Lisa Barton, Secretary to the Commission. industry in the United States within a reasonably foreseeable time. Background The Commission instituted these reviews on May 1, 2019 (84 FR 18577) and determined on August 5, 2019 that it would conduct full reviews (84 FR 44330, August 23, 2019). Notice of the scheduling of the Commission’s reviews and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the Federal Register on January 22, 2020 (85 FR 3717). Subsequently, the Commission cancelled its previously scheduled hearing following a request on behalf of the domestic interested parties (85 FR 31550, May 26, 2020). The Commission made these determinations pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)). It completed and filed its determinations in these reviews on July 22, 2020. The views of the Commission are contained in USITC Publication 5086 (July 2020), entitled Light-Walled Rectangular Pipe and Tube from China, Korea, Mexico, and Turkey: Investigation Nos. 701–TA– 449 and 731–TA–1118–1121 (Second Review). By order of the Commission. Issued: July 22, 2020. Lisa Barton, Secretary to the Commission. [FR Doc. 2020–16138 Filed 7–24–20; 8:45 am] BILLING CODE 7020–02–P [FR Doc. 2020–16236 Filed 7–24–20; 8:45 am] BILLING CODE 7020–02–P INTERNATIONAL TRADE COMMISSION DEPARTMENT OF JUSTICE [Investigation Nos. 701–TA–449 and 731– TA–1118–1121 (Second Review)] Bureau of Alcohol, Tobacco, Firearms and Explosives Light-Walled Rectangular Pipe and Tube From China, Korea, Mexico, and Turkey [OMB Number 1140–0013] Determination On the basis of the record 1 developed in the subject five-year reviews, the United States International Trade Commission (‘‘Commission’’) determines, pursuant to the Tariff Act of 1930 (‘‘the Act’’), that revocation of the countervailing duty order on lightwalled rectangular pipe and tube from China and antidumping duty orders on light-walled rectangular pipe and tube from China, Korea, Mexico, and Turkey would be likely to lead to continuation or recurrence of material injury to an 1 The record is defined in sec. 207.2(f) of the Commission’s Rules of Practice and Procedure (19 CFR 207.2(f)). PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 Agency Information Collection Activities; Proposed eCollection eComments Requested; Application for Tax-Exempt Transfer of Firearm and Registration to Special Occupational Taxpayer—ATF Form 3 (5320.3) Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice. ACTION: 30-Day notice. AGENCY: The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), 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. SUMMARY: E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 85, Number 144 (Monday, July 27, 2020)]
[Notices]
[Pages 45227-45228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16138]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1207]


Certain Pre-Filled Syringes for Intravitreal Injection and 
Components Thereof; Institution of Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that a complaint was filed with the 
U.S. International Trade Commission on June 19, 2020, under section 337 
of the Tariff Act of 1930, as amended, on behalf of Novartis Pharma AG 
of Switzerland; Novartis Pharmaceuticals Corporation of East Hanover, 
New Jersey; and Novartis Technology LLC of East Hanover, New Jersey. A 
letter supplementing the complaint was filed on July 10, 2020. The 
complaint 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 pre-filled syringes for 
intravitreal injection and components thereof by reason of infringement 
of certain claims of U.S. Patent No. 9,220,631 (``the '631 patent''). 
The complaint further alleges that an industry in the United States 
exists or is in the process of being established as required by the 
applicable Federal Statute. The complainants request that the 
Commission institute an investigation and, after the investigation, 
issue a limited exclusion order and a cease and desist order.

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

FOR FURTHER INFORMATION CONTACT: Pathenia M. Proctor, The Office of 
Unfair Import Investigations, U.S. International Trade Commission, 
telephone (202) 205-2560.

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 Sec.  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 July 21, 2020, 2020, ordered that--
    (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 
1930, as

[[Page 45228]]

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 1-6 
and 11-26 of the '631 patent, and whether an industry in the United 
States exists as required by subsection (a)(2) of section 337;
    (2) Pursuant to Sec.  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 ``syringes that are 
pre-filled with ophthalmic medication, and components of such syringes, 
including barrels, plungers, and stoppers'';
    (3) Pursuant to Commission Rule Sec.  210.50(b)(1), 19 CFR 
210.50(b)(1), the presiding administrative law judge shall take 
evidence or other information and hear arguments from the parties or 
other interested persons with respect to the public interest in this 
investigation, as appropriate, and provide the Commission with findings 
of fact and a recommended determination on this issue, which shall be 
limited to the statutory public interest factors set forth in 19 U.S.C. 
1337(d)(1), (f)(1), (g)(1);
    (4) 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 complainants are:

Novartis Pharma AG, Forum 1, Novartis Campus, CH-4056 Basel, 
Switzerland.
Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, 
New Jersey, 07936.
Novartis Technology LLC, One Health Plaza, East Hanover, New Jersey, 
07936.
    (b) The respondent is the following entity alleged to be in 
violation of section 337, and is the party upon which the complaint is 
to be served:

Regeneron Pharmaceuticals, Inc., 77 Old Saw Mill River Road, Tarrytown, 
New York 10591.
    (c) The Office of Unfair Import Investigations, U.S. International 
Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
    (5) For the investigation so instituted, the Chief Administrative 
Law Judge, U.S. International Trade Commission, shall designate the 
presiding Administrative Law Judge.
    Responses to the complaint and the notice of investigation must be 
submitted by the named respondent in accordance with Sec.  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 
complainants 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 the 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: July 21, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020-16138 Filed 7-24-20; 8:45 am]
BILLING CODE 7020-02-P