Certain Botulinum Toxin Products and Processes for Manufacturing or Relating to Same; Notice of Request for Submissions on the Public Interest, 51548-51549 [2024-13333]
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lotter on DSK11XQN23PROD with NOTICES1
51548
Federal Register / Vol. 89, No. 118 / Tuesday, June 18, 2024 / Notices
Comments that you submit in
response to this notice are a matter of
public record. Before including your
address, phone number, email address,
or other personal identifying
information in your comment, you
should be aware that your entire
comment—including your personal
identifying information—may be made
publicly available at any time. While
you can ask us in your comment to
withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
Abstract: The BIE provides standards
for the appropriate use of lands and
facilities by third parties under 25 CFR
part 48. These standards address the
following: the execution of lease
agreements; the establishment and
administration of mechanisms for the
acceptance of consideration for the use
and benefit of a Bureau-operated school;
the assurance of ethical conduct; and
monitoring the amount and terms of
consideration received, the manner in
which the consideration is used, and
any results achieved by such use.
Title of Collection: Use of BureauOperated Schools by Third Parties.
OMB Control Number: 1076–0187.
Form Number: None.
Type of Review: Extension of a
currently approved collection.
Respondents/Affected Public:
Individuals and private sector.
Total Estimated Number of Annual
Respondents: 17.
Total Estimated Number of Annual
Responses: 24.
Estimated Completion Time per
Response: One to three hours.
Total Estimated Number of Annual
Burden Hours: 68 hours.
Respondent’s Obligation: Required to
Obtain a Benefit.
Frequency of Collection: Annually.
Total Estimated Annual Nonhour
Burden Cost: $0.
An agency may not conduct or
sponsor and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number.
The authority for this action is the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Steven Mullen,
Information Collection Clearance Officer,
Office of Regulatory Affairs and Collaborative
Action—Indian Affairs.
[FR Doc. 2024–13403 Filed 6–17–24; 8:45 am]
BILLING CODE 4337–15–P
VerDate Sep<11>2014
17:57 Jun 17, 2024
Jkt 262001
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
U.S. International Trade
Commission.
ACTION: Notice.
AGENCY:
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
EDIS3Help@usitc.gov. 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
SUMMARY:
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Sfmt 4703
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 thirdparty 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.
E:\FR\FM\18JNN1.SGM
18JNN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 118 / Tuesday, June 18, 2024 / Notices
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),
VerDate Sep<11>2014
17:57 Jun 17, 2024
Jkt 262001
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
INTERNATIONAL TRADE
COMMISSION
[Investigation No. 337–TA–1377]
Certain Products Containing
Tirzepatide and Products Purporting
To Contain Tirzepatide; Notice of a
Commission Determination Not To
Review an Initial Determination
Granting a Motion To Amend the
Complaint and Notice of Investigation
International Trade
Commission.
ACTION: Notice.
AGENCY:
Notice is hereby given that
the U.S. International Trade
Commission (‘‘Commission’’) has
determined not to review an initial
determination (‘‘ID’’) (Order No. 16) of
the presiding administrative law judge
(‘‘ALJ’’) granting a motion to amend the
complaint and notice of investigation to
name an additional respondent.
FOR FURTHER INFORMATION CONTACT:
Edward S. Jou, Esq., Office of the
General Counsel, U.S. International
Trade Commission, 500 E Street SW,
Washington, DC 20436, telephone (202)
205–3316. 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
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, telephone
(202) 205–1810.
SUPPLEMENTARY INFORMATION: The
Commission instituted this investigation
on November 27, 2023, based upon a
complaint filed on behalf of Eli Lilly
and Company (‘‘Eli Lilly’’) of
Indianapolis, Indiana. 88 FR 82914–15
(Nov. 27, 2023). The complaint, as
supplemented, alleges violations of
section 337 based upon the importation
into the United States and the sale of
certain products containing tirzepatide
or purporting to contain tirzepatide by
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
51549
reason of false designation of source and
false and misleading advertising, the
threat or effect of which is to destroy or
substantially injure an industry in the
United States, and based upon the
importation into the United States, the
sale for importation, and the sale within
the United States after importation of
certain products containing tirzepatide
or purporting to contain tirzepatide by
reason of infringement of U.S.
Trademark No. 6,809,369. Id. The
complaint also alleges that a domestic
industry exists pursuant to subsection
(a)(2) of section 337. Id.
The Commission’s notice of
investigation named as respondents
Arctic Peptides LLC of Akeny, Iowa;
Audrey Beauty Co. of Hong Kong,
China; Biolabshop Limited of Lancaster,
United Kingdom; Mew Mews Company
Limited of Hong Kong, China; Strate
Labs LLC of Spring, Texas; Steroide
Kaufen of Bialystok, Poland; Super
Human Store of Barcelona, Spain;
Supopeptide of Cedar Grove, New
Jersey; Triggered Supplements LLC of
Clearwater, Florida; Unewlife of Cedar
Grove, New Jersey; and Xiamen
Austronext Trading Co., Ltd. of Fujian,
China. Id. at 82915. The Office of Unfair
Import Investigations (‘‘OUII’’) is also
named as a party in this investigation.
Id.
Respondents Unewlife, Supopeptide,
and Steroide Kaufen were terminated
pursuant to withdrawal of the
complaint. See Order No. 8 (Mar. 7,
2024), unreviewed by Comm’n Notice
(Mar. 21, 2024). Respondents Arctic
Peptides LLC; Audrey Beauty Co., Ltd.;
Biolabshop Limited; Mew Mews Co.
Ltd.; Strate Labs LLC; Super Human
Store; Triggered Supplements LLC (d/b/
a The Triggered Brand); and Xiamen
Austronext Trading Co., Ltd. (d/b/a
AustroPeptide) have been found in
default. See Order No. 13 (Apr. 22,
2024), unreviewed by Comm’n Notice
(May 15, 2024).
On May 21, 2024, the complaint and
notice of investigation were amended to
add two respondents: Fibonacci
Sequence LLC d/b/a GenX Peptides of
Houston, Texas; and Paradigm Peptides
of Michigan City, Indiana. Order No. 12
(Apr. 22, 2024), unreviewed by Comm’n
Notice (May 21, 2024), 89 FR 46159–60
(May 28, 2024).
On May 8, 2024, Eli Lilly filed a
motion to amend the complaint and
notice of investigation to name an
additional respondent, Total
Compounding Pharmaceuticals of
Australia. On that same date, Eli Lilly
filed a motion for leave to serve Total
Compounding Pharmaceuticals by
alternative service via email, which was
granted pursuant to Order No. 14 (May
E:\FR\FM\18JNN1.SGM
18JNN1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
