Notice2025-19447
Certain Photodynamic Therapy Systems, Components Thereof, and Pharmaceutical Products Used in Combination With the Same; Notice of Request for Submissions on the Public Interest
Primary source
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Published
October 3, 2025
Issuing agencies
International Trade Commission
Abstract
Notice is hereby given that on September 30, 2025, the presiding administrative law judge ("ALJ") issued an Initial Determination on Violation of Section 337. The ALJ also issued a Recommended Determination on remedy and bonding should a violation be found in the above-captioned investigation. The Commission is soliciting submissions on public interest issues raised by the recommended relief should the Commission find a violation. This notice is soliciting comments from the public and interested government agencies only.
Full Text
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<title>Federal Register, Volume 90 Issue 190 (Friday, October 3, 2025)</title>
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[Federal Register Volume 90, Number 190 (Friday, October 3, 2025)]
[Notices]
[Pages 48057-48058]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19447]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1411]
Certain Photodynamic Therapy Systems, Components Thereof, and
Pharmaceutical Products Used in Combination With the Same; Notice of
Request for Submissions on the Public Interest
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
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SUMMARY: Notice is hereby given that on September 30, 2025, the
presiding administrative law judge (``ALJ'') issued an Initial
Determination on Violation of Section 337. The ALJ also issued a
Recommended Determination on remedy and bonding should a violation be
found in the above-captioned investigation. The Commission is
soliciting submissions on public interest issues raised by the
recommended relief should the Commission find a violation. This notice
is soliciting comments from the public and interested government
agencies only.
FOR FURTHER INFORMATION CONTACT: B. Rashmi Borah, Esq., Office of the
General Counsel, U.S. International Trade Commission, 500 E Street SW,
Washington, DC 20436, telephone (202) 205-2518. Copies of non-
confidential documents filed in connection with this investigation may
be viewed on the Commission's electronic docket (EDIS) at <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. For help accessing EDIS, please email
<a href="/cdn-cgi/l/email-protection#71343538224239141d013104021805125f161e07"><span class="__cf_email__" data-cfemail="98dddcd1cbabd0fdf4e8d8edebf1ecfbb6fff7ee">[email protected]</span></a>. General information concerning the Commission may
also be obtained by accessing its internet server at <a href="https://www.usitc.gov">https://www.usitc.gov</a>. 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: Section 337 of the Tariff Act of 1930
provides that, if the Commission finds a violation, it shall exclude
the articles concerned from the United States unless, after considering
the effect of such exclusion upon the public health and welfare,
competitive conditions in the United States economy, the production of
like or directly competitive articles in the United States, and United
States consumers, it finds that such articles should not be excluded
from entry. (19 U.S.C. 1337(d)(1)). A similar provision applies to
cease and desist orders. (19 U.S.C. 1337(f)(1)).
The Commission is soliciting submissions on public interest issues
raised by the recommended relief should the Commission find a
violation, specifically: a limited exclusion order directed to certain
photodynamic therapy systems, components thereof, and pharmaceutical
products used in combination with the same imported, sold for
importation, and/or sold after importation by respondents Biofrontera
Inc. of Woburn, Massachusetts; Biofrontera Pharma GmbH of Leverkusen,
Germany; Biofrontera Bioscience GmbH of Leverkusen, Germany; and
Biofrontera AG of Leverkusen, Germany (collectively, ``Respondents'');
and cease and desist orders directed to Respondents. Parties are to
file public interest submissions pursuant to 19 CFR 210.50(a)(4).
[[Page 48058]]
The Commission is interested in further development of the record
on the public interest in this investigation. Accordingly, members of
the public and interested government agencies are invited to file
submissions of no more than five (5) pages, inclusive of attachments,
concerning the public interest in light of the ALJ's Recommended
Determination on Remedy and Bonding issued in this investigation on
September 30, 2025. Comments should address whether issuance of the
recommended remedial orders in this investigation, should the
Commission find a violation, 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 recommended
remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the
United States relating to the recommended 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 recommended orders within a
commercially reasonable time; and
(v) explain how the recommended orders would impact consumers in
the United States.
Written submissions must be filed no later than by close of
business on October 30, 2025.
Persons filing written submissions must file the original document
electronically on or before the deadlines stated above pursuant to 19
CFR 210.4(f). Submissions should refer to the investigation number
(``Inv. No. 337-TA-1411'') in a prominent place on the cover page and/
or the first page. (See Handbook for Electronic Filing Procedures,
<a href="https://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.pdf">https://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.pdf</a>). Persons with questions regarding
filing should contact the Secretary (202-205-2000).
Any person desiring to submit a document to the Commission in
confidence must request confidential treatment by marking each document
with a header indicating that the document contains confidential
information. This marking will be deemed to satisfy the request
procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b)
& 210.5(e)(2)). Documents for which confidential treatment by the
Commission is properly sought will be treated accordingly. Any non-
party wishing to submit comments containing confidential information
must serve those comments on the parties to the investigation pursuant
to the applicable Administrative Protective Order. A redacted non-
confidential version of the document must also be filed simultaneously
with any confidential filing and must be served in accordance with
Commission Rule 210.4(f)(7)(ii)(A) (19 CFR 210.4(f)(7)(ii)(A)). 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, solely for cybersecurity
purposes. All contract personnel will sign appropriate nondisclosure
agreements. All nonconfidential written submissions will be available
for public inspection on EDIS.
This action is taken under the authority of 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.
Issued: September 30, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025-19447 Filed 10-2-25; 8:45 am]
BILLING CODE 7020-02-P
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