83_FR_28985 83 FR 28865 - Certain Human Milk Oligosaccharides and Methods of Producing the Same Institution of Investigation

83 FR 28865 - Certain Human Milk Oligosaccharides and Methods of Producing the Same Institution of Investigation

INTERNATIONAL TRADE COMMISSION

Federal Register Volume 83, Issue 120 (June 21, 2018)

Page Range28865-28866
FR Document2018-13285

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 2, 2018, under section 337 of the Tariff Act of 1930, as amended, on behalf of Glycosyn LLC. An amended complaint was filed on May 16, 2018. An additional supplement to the complaint was also filed on May 25, 2018. The complaint, as amended and supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain human milk oligosaccharides by reason of infringement of U.S. Patent No. 9,453,230 (``the '230 patent'') and U.S. Patent No. 9,970,018 (``the '018 patent''). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

Federal Register, Volume 83 Issue 120 (Thursday, June 21, 2018)
[Federal Register Volume 83, Number 120 (Thursday, June 21, 2018)]
[Notices]
[Pages 28865-28866]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13285]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1120]


Certain Human Milk Oligosaccharides and Methods of Producing the 
Same Institution of Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that a complaint was filed with the 
U.S. International Trade Commission on April 2, 2018, under section 337 
of the Tariff Act of 1930, as amended, on behalf of Glycosyn LLC. An 
amended complaint was filed on May 16, 2018. An additional supplement 
to the complaint was also filed on May 25, 2018. The complaint, as 
amended and supplemented, alleges violations of section 337 based upon 
the importation into the United States, the sale for importation, and 
the sale within the United States after importation of certain human 
milk oligosaccharides by reason of infringement of U.S. Patent No. 
9,453,230 (``the '230 patent'') and U.S. Patent No. 9,970,018 (``the 
'018 patent''). The complaint further alleges that an industry in the 
United States exists as required by the applicable Federal Statute.
    The complainant requests that the Commission institute an 
investigation and, after the investigation, issue a limited exclusion 
order and cease and desist orders.

ADDRESSES: The complaint, except for any confidential information 
contained therein, is available for inspection during official business 
hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. 
International Trade Commission, 500 E Street SW, Room 112, Washington, 
DC 20436, telephone (202) 205-2000. Hearing impaired individuals are 
advised that information on this matter can be obtained by contacting 
the Commission's TDD terminal on (202) 205-1810. Persons with mobility 
impairments who will need special assistance in gaining access to the 
Commission should contact the Office of the Secretary at (202) 205-
2000. General information concerning the Commission may also be 
obtained by accessing its internet server at https://www.usitc.gov. The 
public record for this investigation may be viewed on the Commission's 
electronic docket (EDIS) at https://edis.usitc.gov.

FOR FURTHER INFORMATION CONTACT: Pathenia M. Proctor, The Office of 
Unfair Import Investigations, U.S. International Trade Commission, 
telephone (202) 205-2560.

SUPPLEMENTARY INFORMATION: 
    Authority: The authority for institution of this investigation is 
contained in section 337 of the Tariff Act of 1930, as amended, 19 
U.S.C. 1337 and in section 210.10 of the Commission's Rules of Practice 
and Procedure, 19 CFR 210.10 (2018).
    Scope of Investigation: Having considered the complaint, the U.S. 
International Trade Commission, on June 14, 2018, ordered that--
    (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 
1930, as amended, an investigation be instituted to determine whether 
there is a violation of subsection (a)(1)(B) of section 337 in the 
importation into the United States, the sale for importation, or the 
sale within the United States after importation of products identified 
in paragraph (2) by reason of infringement of one or more of claims 1-
40 of the '230 patent; and claims 1-28 of the '018 patent; and whether 
an industry in the United States exists as required by subsection 
(a)(2) of section 337;
    (2) Pursuant to section 210.10(b)(1) of the Commission's Rules of 
Practice and Procedure, 19 CFR 210.10(b)(1), the plain language 
description of the accused products or category of accused products, 
which defines the scope of the investigation, is ``2'-fucosyllactose 
oligosaccharides'';
    (3) Pursuant to Commission Rule 210.50(b)(1), 19 CFR 210.50(b)(1), 
the presiding administrative law judge shall take evidence or other 
information and hear arguments from the parties and other interested 
persons with respect to the public interest in this investigation, as 
appropriate, and provide the Commission with findings of fact and a 
recommended determination on this issue, which shall be limited to the 
statutory public interest factors set forth in 19 U.S.C. 1337(d)(1), 
(f)(1), (g)(1);
    (4) For the purpose of the investigation so instituted, the 
following are hereby named as parties upon which this notice of 
investigation shall be served:
    (a) The complainant is: Glycosyn LLC, 890 Winter Street, Suite 208, 
Waltham, MA 95131.
    (b) The respondents are the following entities alleged to be in 
violation of section 337, and are the parties upon which the complaint 
is to be served: Jennewein Biotechnologie GmbH, Maarweg 32, D-53619 
Rheinbreitbach, Germany.
    (c) The Office of Unfair Import Investigations, U.S. International 
Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
    (5) For the investigation so instituted, the Chief Administrative 
Law Judge, U.S. International Trade Commission, shall designate the 
presiding Administrative Law Judge.
    Responses to the complaint and the notice of investigation must be 
submitted by the named respondents in accordance with section 210.13 of 
the Commission's Rules of Practice and Procedure, 19 CFR 210.13. 
Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be 
considered by the Commission if received not later than 20 days after 
the date of service by the Commission of the complaint and the notice 
of investigation. Extensions of time for submitting responses to the 
complaint and the notice of investigation will not be granted unless 
good cause therefor is shown.
    Failure of a respondent to file a timely response to each 
allegation in the complaint and in this notice may be deemed to 
constitute a waiver of the right to appear and contest the allegations 
of the complaint and this notice, and to authorize the administrative 
law judge and the Commission, without further notice to the respondent, 
to find the facts to be as alleged in the complaint and this notice and 
to enter an initial determination and a final determination containing 
such findings, and may result in the issuance of an exclusion order or 
a cease and desist order or both directed against the respondent.

    By order of the Commission.


[[Page 28866]]


    Issued: June 15, 2018.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2018-13285 Filed 6-20-18; 8:45 am]
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                                                                            Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices                                             28865

                                              of this or a related proceeding, or (b) in              limited exclusion order and cease and                  presiding administrative law judge shall
                                              internal investigations, audits, reviews,               desist orders.                                         take evidence or other information and
                                              and evaluations relating to the                         ADDRESSES: The complaint, except for                   hear arguments from the parties and
                                              programs, personnel, and operations of                  any confidential information contained                 other interested persons with respect to
                                              the Commission including under 5                        therein, is available for inspection                   the public interest in this investigation,
                                              U.S.C. Appendix 3; or (ii) by U.S.                      during official business hours (8:45 a.m.              as appropriate, and provide the
                                              government employees and contract                       to 5:15 p.m.) in the Office of the                     Commission with findings of fact and a
                                              personnel,2 solely for cybersecurity                    Secretary, U.S. International Trade                    recommended determination on this
                                              purposes. All nonconfidential written                   Commission, 500 E Street SW, Room                      issue, which shall be limited to the
                                              submissions will be available for public                112, Washington, DC 20436, telephone                   statutory public interest factors set forth
                                              inspection at the Office of the Secretary               (202) 205–2000. Hearing impaired                       in 19 U.S.C. 1337(d)(1), (f)(1), (g)(1);
                                              and on EDIS.3                                           individuals are advised that information                  (4) For the purpose of the
                                                This action is taken under the                        on this matter can be obtained by                      investigation so instituted, the following
                                              authority of section 337 of the Tariff Act              contacting the Commission’s TDD                        are hereby named as parties upon which
                                              of 1930, as amended (19 U.S.C. 1337),                   terminal on (202) 205–1810. Persons                    this notice of investigation shall be
                                              and of §§ 201.10 and 210.8(c) of the                    with mobility impairments who will                     served:
                                              Commission’s Rules of Practice and                                                                                (a) The complainant is: Glycosyn LLC,
                                                                                                      need special assistance in gaining access
                                              Procedure (19 CFR 201.10, 210.8(c)).                                                                           890 Winter Street, Suite 208, Waltham,
                                                                                                      to the Commission should contact the
                                                                                                                                                             MA 95131.
                                                By order of the Commission.                           Office of the Secretary at (202) 205–                     (b) The respondents are the following
                                                Issued: June 15, 2018.                                2000. General information concerning                   entities alleged to be in violation of
                                              Lisa Barton,                                            the Commission may also be obtained                    section 337, and are the parties upon
                                              Secretary to the Commission.                            by accessing its internet server at                    which the complaint is to be served:
                                              [FR Doc. 2018–13286 Filed 6–20–18; 8:45 am]             https://www.usitc.gov. The public                      Jennewein Biotechnologie GmbH,
                                              BILLING CODE 7020–02–P
                                                                                                      record for this investigation may be                   Maarweg 32, D–53619 Rheinbreitbach,
                                                                                                      viewed on the Commission’s electronic                  Germany.
                                                                                                      docket (EDIS) at https://edis.usitc.gov.                  (c) The Office of Unfair Import
                                              INTERNATIONAL TRADE                                     FOR FURTHER INFORMATION CONTACT:                       Investigations, U.S. International Trade
                                              COMMISSION                                              Pathenia M. Proctor, The Office of                     Commission, 500 E Street SW, Suite
                                                                                                      Unfair Import Investigations, U.S.                     401, Washington, DC 20436; and
                                              [Investigation No. 337–TA–1120]
                                                                                                      International Trade Commission,                           (5) For the investigation so instituted,
                                              Certain Human Milk Oligosaccharides                     telephone (202) 205–2560.                              the Chief Administrative Law Judge,
                                              and Methods of Producing the Same                       SUPPLEMENTARY INFORMATION:                             U.S. International Trade Commission,
                                              Institution of Investigation                              Authority: The authority for                         shall designate the presiding
                                                                                                      institution of this investigation is                   Administrative Law Judge.
                                              AGENCY: U.S. International Trade                        contained in section 337 of the Tariff                    Responses to the complaint and the
                                              Commission.                                             Act of 1930, as amended, 19 U.S.C. 1337                notice of investigation must be
                                              ACTION: Notice.                                         and in section 210.10 of the                           submitted by the named respondents in
                                                                                                      Commission’s Rules of Practice and                     accordance with section 210.13 of the
                                              SUMMARY:    Notice is hereby given that a                                                                      Commission’s Rules of Practice and
                                              complaint was filed with the U.S.                       Procedure, 19 CFR 210.10 (2018).
                                                                                                        Scope of Investigation: Having                       Procedure, 19 CFR 210.13. Pursuant to
                                              International Trade Commission on                                                                              19 CFR 201.16(e) and 210.13(a), such
                                                                                                      considered the complaint, the U.S.
                                              April 2, 2018, under section 337 of the                                                                        responses will be considered by the
                                                                                                      International Trade Commission, on
                                              Tariff Act of 1930, as amended, on                                                                             Commission if received not later than 20
                                                                                                      June 14, 2018, ordered that—
                                              behalf of Glycosyn LLC. An amended                                                                             days after the date of service by the
                                                                                                        (1) Pursuant to subsection (b) of
                                              complaint was filed on May 16, 2018.                                                                           Commission of the complaint and the
                                                                                                      section 337 of the Tariff Act of 1930, as
                                              An additional supplement to the                                                                                notice of investigation. Extensions of
                                                                                                      amended, an investigation be instituted
                                              complaint was also filed on May 25,                                                                            time for submitting responses to the
                                                                                                      to determine whether there is a
                                              2018. The complaint, as amended and                                                                            complaint and the notice of
                                                                                                      violation of subsection (a)(1)(B) of
                                              supplemented, alleges violations of                                                                            investigation will not be granted unless
                                                                                                      section 337 in the importation into the
                                              section 337 based upon the importation                                                                         good cause therefor is shown.
                                                                                                      United States, the sale for importation,
                                              into the United States, the sale for                                                                              Failure of a respondent to file a timely
                                                                                                      or the sale within the United States after
                                              importation, and the sale within the                                                                           response to each allegation in the
                                                                                                      importation of products identified in
                                              United States after importation of                                                                             complaint and in this notice may be
                                                                                                      paragraph (2) by reason of infringement
                                              certain human milk oligosaccharides by                                                                         deemed to constitute a waiver of the
                                                                                                      of one or more of claims 1–40 of the
                                              reason of infringement of U.S. Patent                                                                          right to appear and contest the
                                                                                                      ’230 patent; and claims 1–28 of the ’018
                                              No. 9,453,230 (‘‘the ’230 patent’’) and                                                                        allegations of the complaint and this
                                                                                                      patent; and whether an industry in the
                                              U.S. Patent No. 9,970,018 (‘‘the ’018                                                                          notice, and to authorize the
                                                                                                      United States exists as required by
                                              patent’’). The complaint further alleges                                                                       administrative law judge and the
                                                                                                      subsection (a)(2) of section 337;
                                              that an industry in the United States                     (2) Pursuant to section 210.10(b)(1) of              Commission, without further notice to
                                              exists as required by the applicable                    the Commission’s Rules of Practice and                 the respondent, to find the facts to be as
                                              Federal Statute.                                        Procedure, 19 CFR 210.10(b)(1), the                    alleged in the complaint and this notice
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                                                The complainant requests that the                                                                            and to enter an initial determination
                                                                                                      plain language description of the
                                              Commission institute an investigation                                                                          and a final determination containing
                                                                                                      accused products or category of accused
                                              and, after the investigation, issue a                                                                          such findings, and may result in the
                                                                                                      products, which defines the scope of the
                                                                                                      investigation, is ‘‘2′-fucosyllactose                  issuance of an exclusion order or a cease
                                                2 All contract personnel will sign appropriate
                                                                                                      oligosaccharides’’;                                    and desist order or both directed against
                                              nondisclosure agreements.
                                                3 Electronic Document Information System                (3) Pursuant to Commission Rule                      the respondent.
                                              (EDIS): https://edis.usitc.gov.                         210.50(b)(1), 19 CFR 210.50(b)(1), the                   By order of the Commission.



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                                              28866                         Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices

                                                Issued: June 15, 2018.                                   —Evaluate the accuracy of the                       estimated for an average respondent to
                                              Lisa Barton,                                            agency’s estimate of the burden of the                 respond: 11,192 respondents per year at
                                              Secretary to the Commission.                            collection of information, including the               0.75 hours per complaint form.
                                              [FR Doc. 2018–13285 Filed 6–20–18; 8:45 am]             validity of the methodology and                          6. An estimate of the total public
                                              BILLING CODE P
                                                                                                      assumptions used;                                      burden (in hours) associated with the
                                                                                                         —Evaluate whether and if so, how,                   collection: The estimated annual public
                                                                                                      the quality, utility, and clarity of the               burden associated with this collection is
                                                                                                      information to be collected can be                     8,394 hours, which is equal to 11,192
                                              DEPARTMENT OF JUSTICE                                   enhanced; and                                          respondents * .75 hours.
                                                                                                         —Minimize the burden of the                           If additional information is required
                                              [OMB Number 1190–0009]
                                                                                                      collection of information on those who                 contact: Melody Braswell, Department
                                              Agency Information Collection                           are to respond, including through the                  Clearance Officer, United States
                                              Activities; Proposed eCollection                        use of appropriate automated,                          Department of Justice, Justice
                                              eComments Requested; Extension                          electronic, mechanical, or other                       Management Division, Policy and
                                              Without Change of a Currently-                          technological collection techniques or                 Planning Staff, Two Constitution
                                              Approved Collection Title II of the                     other forms of information technology                  Square, 145 N Street NE, 3E.405A,
                                              Americans With Disabilities Act of                      (e.g., permitting electronic submission                Washington, DC 20530.
                                              1990/Section 504 of the Rehabilitation                  of responses).
                                                                                                                                                               Dated: June 18, 2018.
                                              Act of 1973 Discrimination Complaint                    Overview of This Information                           Melody Braswell,
                                              Form                                                    Collection                                             Department Clearance Officer for PRA, U.S.
                                              AGENCY:  Disability Rights Section, Civil                  1. Type of information collection:                  Department of Justice.
                                              Rights Division, U.S. Department of                     Extension of Currently Approved                        [FR Doc. 2018–13312 Filed 6–20–18; 8:45 am]
                                              Justice.                                                Collection.                                            BILLING CODE 4410–13–P

                                              ACTION: 30 Day Notice.                                     2. The Title of the Form/Collection:
                                                                                                      Title II of the Americans with
                                              SUMMARY:   The Department of Justice,                   Disabilities Act/Section 504 of the                    DEPARTMENT OF LABOR
                                              Civil Rights Division, Disability Rights                Rehabilitation Act of 1973
                                              Section, has submitted the following                    Discrimination Complaint Form.                         Employment and Training
                                              information collection request to the                      3. The agency form number and                       Administration
                                              Office of Management and Budget for                     applicable component of the
                                                                                                                                                             [OMB Control Number 1205–0457]
                                              review and approval in accordance with                  Department sponsoring the collection:
                                              the Paperwork Reduction Act of 1995.                    The document has no agency form                        Comment Request for Information
                                              The information collection extension is                 number. The applicable component                       Collection for Form ETA–9127, Foreign
                                              published to obtain comments from the                   within the Department of Justice is the                Labor Certification Quarterly Activity
                                              public and affected agencies. This                      Disability Rights Section, Civil Rights                Report, Revision of a Currently
                                              proposed information collection was                     Division.                                              Approved Collection
                                              previously published in the Federal                        4. Affected public who will be asked
                                              Register allowing for a 60-day public                   to respond, as well as a brief abstract:               AGENCY: Employment and Training
                                              comment period.                                            Primary: Individuals alleging                       Administration (ETA), Labor.
                                                                                                      discrimination by public entities based                ACTION: Notice.
                                              DATES: The Department of Justice
                                                                                                      on disability. Under title II of the
                                              encourages public comment and will                                                                             SUMMARY:   The Department of Labor
                                                                                                      Americans with Disabilities Act, an
                                              accept input until July 23, 2018.                                                                              (DOL or Department), as part of its
                                                                                                      individual who believes that he or she
                                              FOR FURTHER INFORMATION CONTACT:                        has been subjected to discrimination on                continuing effort to reduce paperwork
                                              Written comments and/or suggestions                     the basis of disability by a public entity             and respondent burden, conducts a
                                              regarding the item(s) contained in this                 may, by himself or herself or by an                    preclearance consultation program to
                                              notice, especially regarding the                        authorized representative, file a                      provide the public and Federal agencies
                                              estimated public burden and associated                  complaint. The Department of Justice                   with an opportunity to comment on
                                              response time should be directed to the                 must address the complaint or refer the                proposed and/or continuing collections
                                              Office of Management and Budget                         complaint to the appropriate Federal                   of information in accordance with the
                                              (OMB), Office of Regulatory Affairs,                    agency. Any Federal agency that                        Paperwork Reduction Act of 1995. This
                                              Attention: Department of Justice Desk                   receives a complaint of discrimination                 program helps ensure that requested
                                              Officer, Washington, DC 20503.                          on the basis of disability by a public                 data can be provided in the desired
                                              Additionally, comments may be                           entity must review the complaint to                    format, reporting burden (time and
                                              submitted to OMB via facsimile to (202)                 determine whether it has jurisdiction                  financial resources) is minimized,
                                              395–7285.                                               under Section 504. If the agency does                  collection instruments are clearly
                                              SUPPLEMENTARY INFORMATION: Written                      not have jurisdiction under Section 504,               understood, and the impact of collection
                                              comments and suggestions from the                       it must determine whether it is the                    requirements on respondents can be
                                              public and affected agencies concerning                 designated agency responsible for                      properly assessed.
                                              the proposed collection of information                  complaints filed against that public                      Currently, the Employment and
                                              are encouraged. Your comments should                    entity under title II of the ADA. If the               Training Administration (ETA) is
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                                              address one or more of the following                    agency does not have jurisdiction under                soliciting comments concerning the
                                              four points:                                            section 504 and is not the designated                  collection of data through Form ETA–
                                                —Evaluate whether the collection of                   agency under title II of the ADA, it must              9127, Foreign Labor Certification
                                              information is necessary for the proper                 refer the complaint to the Department of               Quarterly Activity Report (Office of
                                              performance of the function of the                      Justice.                                               Management and Budget (OMB))
                                              agency, including whether the                              5. An estimate of the total number of               Control Number 1205–0457), which
                                              information will have practical utility;                respondents and the amount of time                     expires October 31, 2018. The Form


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Document Created: 2018-06-21 01:22:52
Document Modified: 2018-06-21 01:22:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactPathenia M. Proctor, The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
FR Citation83 FR 28865 

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