[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Notices]
[Pages 11096-11098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04080]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1239]


Certain Gabapentin Immunoassay Kits and Test Strips, Components 
Thereof, and Methods Therefor; Commission Determination Not To Review 
an Initial Determination Terminating a Final Respondent Based on 
Settlement; Request for Written Submissions on Remedy, the Public 
Interest, and Bonding

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 determined not to review an initial determination 
(``ID'') (Order No. 29) terminating the final, non-defaulting 
respondent, Shanghai Chemtron Biotech Co. Ltd., in the above-captioned 
investigation based on settlement. The Commission has further 
determined to find that the complainants' declaration seeking immediate 
relief against a respondent previously found to be in default is moot. 
The Commission also requests written submissions from the parties, 
interested government agencies, and interested persons on remedy, the 
public interest, and bonding concerning the defaulted respondent.

FOR FURTHER INFORMATION CONTACT: Lynde Herzbach, Office of the General 
Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 205-3228. 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: On January 25, 2021, 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 ARK Diagnostics, Inc. of Fremont, California 
(``ARK''). See 86 FR 6918-19. The complaint, as supplemented, alleges a 
violation of section 337 based upon the importation into the United 
States, sale for importation, or sale after importation into the United 
States of certain gabapentin immunoassay kits and test strips, 
components thereof, and methods therefor by reason of infringement of 
certain claims of U.S. Patent Nos. 8,828,665 and 10,203,345. Id. The 
complaint further alleges that a domestic industry exists. Id. The 
notice of investigation names fourteen respondents, including Shanghai 
Chemtron Biotech Co., Ltd. of Shanghai, China (``Shanghai Chemtron'') 
and Kappa City Biotech, SAS of Montlucon, France (``Kappa City''). See 
id. The complaint and notice of investigation were later amended to add 
two respondents. Order No. 8 (March 9, 2021), unreviewed by 86 FR 
16640-41 (March 30, 2021).
    The Commission previously terminated six respondents based on 
consent orders. Order Nos. 11 and 12 (Mar. 31, 2021), unreviewed by 
Comm'n Notice (Apr. 15, 2021); Order No. 14 (April 9, 2021), unreviewed 
by Comm'n Notice (Apr. 22, 2021); Order No. 15 (April 12, 2021), 
unreviewed by Comm'n Notice (May 12, 2021). The Commission also 
previously terminated three respondents based on settlement agreements. 
Order No. 13 (Apr. 5, 2021), unreviewed by Comm'n Notice (Apr. 19, 
2021); Order No. 17 (May 5, 2021),

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unreviewed by Comm'n Notice (May 18, 2021); Order No. 18 (May 20, 
2021), unreviewed by Comm'n Notice (June 21, 2021). The Commission also 
terminated five respondents based on partial withdrawal of the 
complaint. Order No. 20 (June 4, 2021), unreviewed by Comm'n Notice 
(June 28, 2021); Order No. 21 (June 14, 2021), unreviewed by Comm'n 
Notice (July 1, 2021).
    On May 18, 2021, the Commission determined not to review an initial 
determination (Order No. 16) finding Kappa City in default. Order No. 
16 (Apr. 30, 2021), unreviewed by Comm'n Notice (May 18, 2021).
    On December 7, 2021, ARK filed a declaration seeking immediate 
entry of a limited exclusion order and cease and desist order against 
Kappa City.
    On January 20, 2022, ARK filed a motion to terminate this 
investigation with respect to Shanghai Chemtron based on a settlement.
    On January 31, 2022, the presiding administrative law judge issued 
the subject ID granting the motion to terminate Shanghai Chemtron based 
on settlement. See Order No. 29 (Jan. 31, 2022). The subject ID finds 
that the motion complies with Commission Rule 210.21(b)(1) (19 CFR 
210.21(b)) and that no extraordinary circumstances prevent denying the 
motion. The subject ID further finds that termination of Shanghai 
Chemtron based on settlement would not be contrary to the public 
interest.
    No party petitioned for review of the subject ID.
    The Commission has determined not to review the subject ID (Order 
No. 29). Shanghai Chemtron is terminated from the investigation.
    The Commission has further determined that ARK's declaration is now 
moot given the termination of the final remaining non-defaulting 
respondent in this investigation. The Commission has also determined to 
request briefing on the issues of remedy, bonding, and the public 
interest.
    In connection with the final disposition of this investigation, the 
statute authorizes issuance of, inter alia, (1) an exclusion order that 
could result in the exclusion of the subject articles from entry into 
the United States; and/or (2) a cease and desist order that could 
result in the respondent being required to cease and desist from 
engaging in unfair acts in the importation and sale of such articles. 
Accordingly, the Commission is interested in receiving written 
submissions that address the form of remedy, if any, that should be 
ordered. If a party seeks exclusion of an article from entry into the 
United States for purposes other than entry for consumption, the party 
should so indicate and provide information establishing that activities 
involving other types of entry either are adversely affecting it or 
likely to do so. For background, see Certain Devices for Connecting 
Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 
2843, Comm'n Op. at 7-10 (Dec. 1994).
    The statute requires the Commission to consider the effects of that 
remedy upon the public interest. The public interest factors the 
Commission will consider include the effect that an exclusion order and 
cease and desist order would have on: (1) The public health and 
welfare, (2) competitive conditions in the U.S. economy, (3) U.S. 
production of articles that are like or directly competitive with those 
that are subject to investigation, and (4) U.S. consumers. The 
Commission is therefore interested in receiving written submissions 
that address the aforementioned public interest factors in the context 
of this investigation.
    If the Commission orders some form of remedy, the U.S. Trade 
Representative, as delegated by the President, has 60 days to approve, 
disapprove, or take no action on the Commission's determination. See 
Presidential Memorandum of July 21, 2005, 70 FR 43251 (July 26, 2005). 
During this period, the subject articles would be entitled to enter the 
United States under bond, in an amount determined by the Commission and 
prescribed by the Secretary of the Treasury. The Commission is 
therefore interested in receiving submissions concerning the amount of 
the bond that should be imposed if a remedy is ordered.
    Written Submissions: Parties to the investigation, interested 
government agencies, and any other interested parties are encouraged to 
file written submissions on the issues of remedy, the public interest, 
and bonding.
    ARK is requested to submit proposed remedial orders for the 
Commission's consideration. ARK is further requested to state the dates 
that the Asserted Patents expire, to provide the HTSUS subheadings 
under which the accused products are imported, and to supply the 
identification information for all known importers of the products at 
issue in this investigation. The initial written submissions and 
proposed remedial orders must be filed no later than close of business 
on March 8, 2022. Reply submissions must be filed no later than the 
close of business on March 15, 2022. No further submissions on these 
issues will be permitted unless otherwise ordered by the Commission.
    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 (March 19, 2020). Submissions should refer to the 
investigation number (Inv. No. 337-TA-1239) 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. A redacted 
non-confidential version of the document must also be filed 
simultaneously with any confidential filing. 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.
    The Commission vote for this determination took place on February 
22, 2022.
    While temporary remote operating procedures are in place in 
response to COVID-19, the Office of the Secretary is not able to serve 
parties that have not retained counsel or otherwise provided a point of 
contact for electronic service. Accordingly, pursuant to Commission 
Rules 201.16(a) and 210.7(a)(1) (19 CFR 201.16(a), 210.7(a)(1)), the 
Commission orders that the complainant complete service for any party/
parties without a

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method of electronic service noted on the attached Certificate of 
Service and shall file proof of service on the Electronic Document 
Information System (EDIS).
    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.

    Issued: February 22, 2022.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2022-04080 Filed 2-25-22; 8:45 am]
BILLING CODE 7020-02-P