[Federal Register Volume 89, Number 118 (Tuesday, June 18, 2024)]
[Notices]
[Pages 51548-51549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13333]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1313]


Certain Botulinum Toxin Products and Processes for Manufacturing 
or Relating to 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 June 10, 2024, the presiding 
administrative law judge (``ALJ'') issued an Initial Determination on 
Violation of Section 337. On June 10, 2024, 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: Michael Liberman, Esq., Office of the 
General Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 205-3115. 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 
[email protected]. General information concerning the Commission may 
also be obtained by accessing its 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: 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: (1) a limited exclusion order directed to 
certain botulinum toxin products and processes for manufacturing or 
relating to same imported, sold for importation, and/or sold after 
importation by respondents Hugel, Inc. of Seoul, Republic of Korea; 
Hugel America, Inc. of Irvine, California; and Croma Pharma GmbH of 
Leobendorf, Austria; and (2) a cease and desist order directed to 
certain botulinum toxin products and processes for manufacturing or 
relating to same imported, sold for importation, and/or sold after 
importation by respondent Hugel America, Inc. of Irvine, California. 
Parties are to file public interest submissions pursuant to 19 CFR 
210.50(a)(4).
    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 
June 10, 2024. 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.

[[Page 51549]]

    Written submissions must be filed no later than by close of 
business on July 12, 2024.
    Persons filing written submissions must file the original document 
electronically on or before the deadlines stated above. The 
Commission's paper filing requirements in 19 CFR 210.4(f) are currently 
waived. 85 FR 15798 (Mar. 19, 2020). Submissions should refer to the 
investigation number (``Inv. No. 337-TA-1313'') in a prominent place on 
the cover page and/or the first page. (See Handbook for Electronic 
Filing Procedures, https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf.). 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: June 12, 2024.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2024-13333 Filed 6-17-24; 8:45 am]
BILLING CODE 7020-02-P