[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72995-72996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27811]


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INTERNATIONAL TRADE COMMISSION


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

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has received a complaint entitled Certain Adalimumab, 
Processes for Manufacturing or Relating to Same, and Products 
Containing Same, DN 3585; 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 AbbVie Inc.; AbbVie 
Biotechnology Ltd.; and AbbVie Operations Singapore Pte. Ltd. on 
December 17, 2021. 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 adalimumab, processes for 
manufacturing or relating to same, and products containing same. The 
complainant names as respondents: Alvotech hf. of Iceland; Alvotech 
Germany GmbH of Germany; Alvotech Swiss AG of Switzerland; Alvotech USA 
Inc. of Arlington, VA; Teva Pharmaceutical Industries Ltd. of Israel; 
Teva Pharmaceuticals USA Inc. of North Wales, PA; and Ivers-Lee AG of 
Switzerland. 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, and members of the 
public 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. 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. 3585'') 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].
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    \1\ Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf.
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    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

[[Page 72996]]

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\
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    \2\ All contract personnel will sign appropriate nondisclosure 
agreements.
    \3\ Electronic Document Information System (EDIS): https://edis.usitc.gov.
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    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: December 17, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021-27811 Filed 12-22-21; 8:45 am]
BILLING CODE 7020-02-P