Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest, 54856-54857 [2024-14523]

Download as PDF 54856 Federal Register / Vol. 89, No. 127 / Tuesday, July 2, 2024 / Notices PENNSYLVANIA Cambria County Johnstown Flood National Memorial, 733 Lake Road, Adams, SG100010579 Authority: Section 60.13 of 36 CFR part 60. Sherry A. Frear, Chief, National Register of Historic Places/ National Historic Landmarks Program. [FR Doc. 2024–14506 Filed 7–1–24; 8:45 am] BILLING CODE 4312–52–P INTERNATIONAL TRADE COMMISSION Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest International Trade Commission. ACTION: Notice. AGENCY: Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Photodynamic Therapy Systems, Components Thereof, and Pharmaceutical Products Used in Combination with the Same, DN 3758; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant’s filing pursuant to the Commission’s Rules of Practice and Procedure. FOR FURTHER INFORMATION CONTACT: Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205–2000. The public version of the complaint can be accessed on the Commission’s Electronic Document Information System (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email EDIS3Help@usitc.gov. General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission’s Electronic Document Information System (EDIS) at https://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission’s TDD terminal on (202) 205–1810. SUPPLEMENTARY INFORMATION: The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission’s Rules of Practice and Procedure filed on behalf of Sun Pharmaceutical Industries, Inc. on June lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:34 Jul 01, 2024 Jkt 262001 26, 2024. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain photodynamic therapy systems, components thereof, and pharmaceutical products used in combination with the same. The complaint names as respondents: Biofrontera Inc. of Woburn, MA; Biofrontera Pharma GMBH of Germany; Biofrontera Bioscience GMBH of Germany; and Biofrontera AG of Germany. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders, 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, members of the public, and interested government agencies 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 PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 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, notwithstanding § 201.14(a) of the Commission’s Rules of Practice and Procedure. No other submissions will be accepted, unless requested by the Commission. 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. 3758’’) 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 1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_ filing_procedures.pdf. E:\FR\FM\02JYN1.SGM 02JYN1 Federal Register / Vol. 89, No. 127 / Tuesday, July 2, 2024 / Notices 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: June 26, 2024. Lisa Barton, Secretary to the Commission. [FR Doc. 2024–14523 Filed 7–1–24; 8:45 am] BILLING CODE 7020–02–P INTERNATIONAL TRADE COMMISSION [Investigation No. 337–TA–1344] Certain Bio-Layer Interferometers and Components Thereof; Notice of Commission Decision To Review in Part, and on Review To Affirm With Modification a Final Initial Determination Finding No Violation of Section 337; Termination of the Investigation International Trade Commission. ACTION: Notice. AGENCY: Notice is hereby given that the U.S. International Trade Commission has determined to review in part a final initial determination (‘‘FID’’) of the presiding Administrative Law Judge (‘‘ALJ’’) finding no violation of section 337, and on review, to affirm the FID with modification. Accordingly, the investigation is terminated with a finding of no violation of section 337. FOR FURTHER INFORMATION CONTACT: Houda Morad, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 708–4716. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email EDIS3Help@usitc.gov. General information concerning the Commission may also be obtained by accessing its lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: 2 All contract personnel will sign appropriate nondisclosure agreements. 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. VerDate Sep<11>2014 17:34 Jul 01, 2024 Jkt 262001 internet server at https://www.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission’s TDD terminal on (202) 205–1810. SUPPLEMENTARY INFORMATION: On November 29, 2022, the Commission instituted this investigation under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (‘‘section 337’’), based on a complaint filed by Sartorius Bioanalytical Instruments, Inc. (‘‘Sartorius’’) of Bohemia, New York. See 87 FR 73329–30 (Nov. 29, 2022). The complaint, as supplemented, alleges a violation 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 bio-layer interferometers and components thereof by reason of the infringement of certain claims of U.S. Patent Nos. 7,445,887 (‘‘the ’887 patent’’); 7,394,547 (‘‘the ’547 patent’’); 7,728,982 (‘‘the ’982 patent); and 8,305,585 (‘‘the ’585 patent’’). See id. The notice of investigation names Gator Bio, Inc. (‘‘Gator Bio’’) of Palo Alto, California as the sole respondent in the investigation. Id. The Office of Unfair Import Investigations (‘‘OUII’’) is also a party to the investigation. Id. The Commission previously terminated the investigation as to the ’547, ’982, and ’585 patents and claims 1–5, 7, 9–14, and 16–18 of the ’887 patent based on the withdrawal of the complaint as to those patents and claims. See Order No. 14 (May 15, 2023), unreviewed by Comm’n Notice (June 9, 2023); Order No. 26 (June 29, 2023), unreviewed by Comm’n Notice (July 20, 2023); Order No. 37 (Oct. 26, 2023), unreviewed by Comm’n Notice (Nov. 27, 2023). On March 8, 2024, the ALJ issued the FID finding no violation of section 337. Specifically, the FID finds that the accused products do not infringe claim 8 of the ’887 patent, and that the domestic industry products do not practice that claim, thus finding that the technical prong of the domestic industry requirement is not satisfied. The FID also finds that claim 8 of the ’887 patent is not invalid. The FID further finds, should the Commission find that the technical prong is satisfied, that the economic prong of the domestic industry requirement is satisfied with respect to the ’887 patent. On March 22, 2024, Sartorius petitioned for Commission review of the FID’s finding of no violation of section 337. Specifically, Sartorius requests Commission review of certain findings of the FID including with respect to: (1) PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 54857 importation and in rem jurisdiction; (2) whether the accused instruments are ‘‘articles that infringe’’; (3) claim construction; (4) non-infringement; and (5) non-satisfaction of the technical prong of the domestic industry requirement. On the same day, Gator Bio filed a contingent petition for review requesting review of certain FID’s findings including with respect to: (1) infringement; (2) invalidity; and (3) the domestic industry requirement (economic prong and technical prong). On April 3, 2024, the parties, including OUII, filed responses to the parties’ petitions. Having examined the record of this investigation, including the FID and the parties’ submissions, the Commission has determined to review in part and on review, to affirm with modification the FID’s determination of no violation of section 337. Specifically, as explained in the Commission Opinion filed concurrently herewith, the Commission has determined to review certain findings of the FID and, on review to: (1) take no position on the FID’s findings of no importation with respect to Gator Bio’s probes and kits; (2) vacate the FID’s findings of no in rem jurisdiction with respect to Gator Bio’s probes and kits; (3) find that Gator Bio’s instruments are not ‘‘articles that infringe’’ because the accused products do not infringe the asserted claim; (4) modify the claim construction of the preamble of claim 8, ‘‘assaying enzyme activity,’’ and the claim term ‘‘air gap’’; (5) affirm with modification the FID’s finding that the accused products do not infringe claim 8 of the ’887 patent; (6) affirm with modification the FID’s finding that the domestic industry products do not practice claim 8 of the ’887 patent, and thus Sartorius does not satisfy the technical prong of the domestic industry requirement; and (7) take no position as to the FID’s finding that Sartorius satisfies the economic prong of the domestic industry requirement. The Commission has determined not to review the remainder of the FID. Accordingly, the investigation is terminated with a finding of no violation of section 337. The Commission’s vote for this determination took place on June 26, 2024. The authority for the Commission’s determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission’s Rules of Practice and Procedure (19 CFR part 210). By order of the Commission. E:\FR\FM\02JYN1.SGM 02JYN1

Agencies

[Federal Register Volume 89, Number 127 (Tuesday, July 2, 2024)]
[Notices]
[Pages 54856-54857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14523]


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INTERNATIONAL TRADE COMMISSION


Notice of Receipt of Complaint; Solicitation of Comments Relating 
to the Public Interest

AGENCY: International Trade Commission.

ACTION: Notice.

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

SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has received a complaint entitled Certain Photodynamic 
Therapy Systems, Components Thereof, and Pharmaceutical Products Used 
in Combination with the Same, DN 3758; the Commission is soliciting 
comments on any public interest issues raised by the complaint or 
complainant's filing pursuant to the Commission's Rules of Practice and 
Procedure.

FOR FURTHER INFORMATION CONTACT: Lisa R. Barton, Secretary to the 
Commission, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 205-2000. The public version of 
the complaint can be accessed on the Commission's Electronic Document 
Information System (EDIS) at https://edis.usitc.gov. For help accessing 
EDIS, please email [email protected].
    General information concerning the Commission may also be obtained 
by accessing its internet server at United States International Trade 
Commission (USITC) at https://www.usitc.gov. The public record for this 
investigation may be viewed on the Commission's Electronic Document 
Information System (EDIS) at https://edis.usitc.gov. Hearing-impaired 
persons are advised that information on this matter can be obtained by 
contacting the Commission's TDD terminal on (202) 205-1810.

SUPPLEMENTARY INFORMATION: The Commission has received a complaint and 
a submission pursuant to Sec.  210.8(b) of the Commission's Rules of 
Practice and Procedure filed on behalf of Sun Pharmaceutical 
Industries, Inc. on June 26, 2024. The complaint alleges violations of 
section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the 
importation into the United States, the sale for importation, and the 
sale within the United States after importation of certain photodynamic 
therapy systems, components thereof, and pharmaceutical products used 
in combination with the same. The complaint names as respondents: 
Biofrontera Inc. of Woburn, MA; Biofrontera Pharma GMBH of Germany; 
Biofrontera Bioscience GMBH of Germany; and Biofrontera AG of Germany. 
The complainant requests that the Commission issue a limited exclusion 
order, cease and desist orders, and impose a bond upon respondents' 
alleged infringing articles during the 60-day Presidential review 
period pursuant to 19 U.S.C. 1337(j).
    Proposed respondents, other interested parties, members of the 
public, and interested government agencies are invited to file comments 
on any public interest issues raised by the complaint or Sec.  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, notwithstanding Sec.  201.14(a) 
of the Commission's Rules of Practice and Procedure. No other 
submissions will be accepted, unless requested by the Commission. 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. 3758'') 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 paper-based filings or paper copies of any electronic filings 
will be accepted until further notice. Persons with questions regarding 
filing should contact the Secretary at [email protected].
---------------------------------------------------------------------------

    \1\ Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf.
---------------------------------------------------------------------------

    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

[[Page 54857]]

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\
---------------------------------------------------------------------------

    \2\ All contract personnel will sign appropriate nondisclosure 
agreements.
    \3\ Electronic Document Information System (EDIS): https://edis.usitc.gov.
---------------------------------------------------------------------------

    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 Sec. Sec.  
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: June 26, 2024.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2024-14523 Filed 7-1-24; 8:45 am]
BILLING CODE 7020-02-P
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