83_FR_22609 83 FR 22515 - Certain Radio Frequency Micro-Needle Dermatological Treatment Devices and Components Thereof; Institution of Investigation

83 FR 22515 - Certain Radio Frequency Micro-Needle Dermatological Treatment Devices and Components Thereof; Institution of Investigation

INTERNATIONAL TRADE COMMISSION

Federal Register Volume 83, Issue 94 (May 15, 2018)

Page Range22515-22516
FR Document2018-10240

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 9, 2018, under section 337 of the Tariff Act of 1930, as amended, on behalf of Syneron Medical Ltd. of Israel; Candela Corporation of Wayland, Massachusetts; and Massachusetts General Hospital of Boston, Massachusetts. A supplement was filed on April 27, 2018. The complaint, as 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 radio frequency micro-needle dermatological treatment devices and components thereof by reason of infringement of certain claims of U.S. Patent No. 9,510,899 (``the '899 patent'') and U.S. Patent No. 9,095,357 (``the '357 patent''). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainants request 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 94 (Tuesday, May 15, 2018)
[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22515-22516]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10240]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1112]


Certain Radio Frequency Micro-Needle Dermatological Treatment 
Devices and Components Thereof; Institution of Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that a complaint was filed with the 
U.S. International Trade Commission on April 9, 2018, under section 337 
of the Tariff Act of 1930, as amended, on behalf of Syneron Medical 
Ltd. of Israel; Candela Corporation of Wayland, Massachusetts; and 
Massachusetts General Hospital of Boston, Massachusetts. A supplement 
was filed on April 27, 2018. The complaint, as 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 radio frequency micro-needle 
dermatological treatment devices and components thereof by reason of 
infringement of certain claims of U.S. Patent No. 9,510,899 (``the '899 
patent'') and U.S. Patent No. 9,095,357 (``the '357 patent''). The 
complaint further alleges that an industry in the United States exists 
as required by the applicable Federal Statute.
    The complainants request that the Commission institute an 
investigation and, after the investigation, issue a limited exclusion 
order and cease and desist orders.

ADDRESSES: The complaint, as supplemented, 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

[[Page 22516]]

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: Katherine Hiner, Office of the 
Secretary, Docket Services Division, U.S. International Trade 
Commission, telephone (202) 205-1802.

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 (2017).

    Scope of Investigation: Having considered the complaint, the U.S. 
International Trade Commission, on May 9, 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 certain radio 
frequency micro-needle dermatological treatment devices and components 
thereof by reason of infringement of one or more of claims 1, 2, 4, 9-
11, 15, 20, and 21 of the '899 patent and claims 1, 2, 4, 9-12, 17, and 
18 of the '357 patent, and whether an industry in the United States 
exists as required by subsection (a)(2) of section 337;
    (2) 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 complainants are:

Syneron Medical Ltd., Tavor Building, Industrial Zone, Yokneam lllit, 
20692, Israel
Candela Corporation, 530 Boston Post Road, Wayland, MA 01778
General Hospital Corporation d/b/a, Massachusetts General Hospital, 55 
Fruit Street, Boston, MA 02114

    (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:

Invasix, Inc., 21084 Bake Parkway, Suite 106, Lake Forest, CA 92618
Invasix, Ltd., Apolo Building, Shaar Yokneam, Yokneam, 20692, Israel
Inmode Md, Ltd., 20996 Bake Parkway, Suite 106, Lake Forest, CA 92630
Ilooda Co., Ltd., 37-1 Imok-dong, Imok-dong, Jangan-gu, Suwon-si, 
Gyeonggi-do, Republic of Korea
Cutera, Inc., 3240 Bayshore Boulevard, Brisbane, CA 94005
Emvera Technologies, LLC, 641 10th Street, Cedartown, GA 30125
Rohrer Aesthetics, LLC, 105 Citation Court, Homewood, AL 35209
Lutronic, Corp., Lutronic Center, 219 Sowon-ro, Deogyang-gu, Goyang-si, 
Geonggi-do, Republic of Korea
Lutronic, Inc., 19 Fortune Drive, Billerica, MA 01821
Endymed Medical Inc., 790 Madison Avenue, Suite 402, New York, NY 10065
Endymed Medical Ltd., 12 Leshem Street, North Industrial Park, 
Caesarea, 30889 Israel
Sung Hwan E&B Co., Ltd. d/b/a SHEnB Co., Ltd., 148 Seongsui-Ro, 
Soengdong-Gu, Seoul 04796, Republic of Korea
Aesthetics Biomedical, Inc., 4602 N 16th Street, Suite 300, Phoenix, AZ 
85016
Cartessa Aesthetics, 210 Peoples Way, Hockessin, DE 19707-1904
Jeisys Medical, Inc., 307 Daeryung Techno Town 8th, Gamasan-ro 96, 
Geumcheon-Gu, Seoul, 153-775, Republic of Korea
Perigee Medical LLC, 2227 N Macarthur Dr., Tracy, CA 95376-2830
Lumenis Ltd., Yokneam Industrial Park, Hakidma 6, Yokneam 2069204, 
Israel
Pollogen Ltd., 6 Kaufman Yehezkel, Tel Aviv-Jaffa, 6801298, Israel

    (3) For the investigation so instituted, the Chief Administrative 
Law Judge, U.S. International Trade Commission, shall designate the 
presiding Administrative Law Judge.
    The Office of Unfair Import Investigations will not participate as 
a party in this investigation.
    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.

    Issued: May 9, 2018.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2018-10240 Filed 5-14-18; 8:45 am]
 BILLING CODE 7020-02-P



                                                                              Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices                                                   22515

                                               the Office of Surface Mining                            enhance the quality, utility, and clarity               Respondent’s Obligation: Voluntary.
                                               Reclamation and Enforcement (OSMRE)                     of the information to be collected; and                 Frequency of Collection: One time.
                                               are proposing to renew an information                   (4) how might OSMRE minimize the                        Total Estimated Annual Nonhour
                                               collection for the Excellence in Surface                burden of this collection on the                      Burden Cost: $2,500.
                                               Coal Mining Reclamation Award and                       respondents, including through the use                  An agency may not conduct or
                                               the Abandoned Mine Land Reclamation                     of information technology.                            sponsor and a person is not required to
                                               Awards. These awards have been                             Comments that you submit in                        respond to a collection of information
                                               established to give well-earned public                  response to this notice are a matter of               unless it displays a currently valid OMB
                                               recognition to those responsible for the                public record. Before including your                  control number.
                                               nation’s highest achievements in                        address, phone number, email address,                   The authority for this action is the
                                               abandoned mine land reclamation, and                    or other personal identifying                         Paperwork Reduction Act of 1995 (44
                                               who have developed innovative                           information in your comment, you                      U.S.C. 3501 et seq.).
                                               reclamation techniques or who have                      should be aware that your entire                      John A. Trelease,
                                               completed reclamation that resulted in                  comment—including your personal                       Acting Chief, Division of Regulatory Support.
                                               outstanding on-the-ground performance.                  identifying information—may be made
                                                                                                                                                             [FR Doc. 2018–10278 Filed 5–14–18; 8:45 am]
                                               DATES: Interested persons are invited to                publicly available at any time. While
                                                                                                                                                             BILLING CODE 4310–05–P
                                               submit comments on or before June 14,                   you can ask us in your comment to
                                               2018.                                                   withhold your personal identifying
                                               ADDRESSES: Send written comments on                     information from public review, we
                                                                                                       cannot guarantee that we will be able to              INTERNATIONAL TRADE
                                               this information collection request (ICR)
                                                                                                       do so.                                                COMMISSION
                                               to the Office of Management and
                                               Budget’s Desk Officer for the                              Title: Reclamation Awards—Call for                 [Investigation No. 337–TA–1112]
                                               Department of the Interior by email at                  Nominations.
                                               OIRA_Submission@omb.eop.gov; or via                        OMB Control Number: 1029–0129.                     Certain Radio Frequency Micro-Needle
                                               facsimile to (202) 395–5806. Please                        Abstract: This information collection              Dermatological Treatment Devices and
                                               provide a copy of your comments to                      clearance package is being submitted by               Components Thereof; Institution of
                                               John Trelease, Office of Surface Mining                 the Office of Surface Mining                          Investigation
                                               Reclamation and Enforcement, 1849 C.                    Reclamation and Enforcement (OSMRE)
                                                                                                       for renewed approval to collect                       AGENCY: U.S. International Trade
                                               Street NW, Mail Stop 4559, Washington,                                                                        Commission.
                                               DC 20240; or by email to jtrelease@                     information for our annual call for
                                                                                                       nominations for our Excellence in                     ACTION: Notice.
                                               osmre.gov. Please reference OMB
                                               Control Number 1029–0039 in the                         Surface Coal Mining Reclamation
                                                                                                                                                             SUMMARY:    Notice is hereby given that a
                                               subject line of your comments.                          Awards and Abandoned Mine Land
                                                                                                                                                             complaint was filed with the U.S.
                                               FOR FURTHER INFORMATION CONTACT: To
                                                                                                       Reclamation Awards. Since 1986, the
                                                                                                                                                             International Trade Commission on
                                               request additional information about                    Office of Surface Mining has presented
                                                                                                                                                             April 9, 2018, under section 337 of the
                                               this ICR, contact John Trelease by email                awards to coal mine operators who
                                                                                                                                                             Tariff Act of 1930, as amended, on
                                               at jtrelease@osmre.gov, or by telephone                 completed exemplary active
                                                                                                                                                             behalf of Syneron Medical Ltd. of Israel;
                                               at (202) 208–2783. You may also view                    reclamation. A parallel award program
                                                                                                                                                             Candela Corporation of Wayland,
                                               the ICR at http://www.reginfo.gov/                      for abandoned mine land reclamation
                                                                                                                                                             Massachusetts; and Massachusetts
                                               public/do/PRAMain.                                      began in 1992. The objective is to give
                                                                                                                                                             General Hospital of Boston,
                                                                                                       public recognition to those responsible
                                               SUPPLEMENTARY INFORMATION: In                                                                                 Massachusetts. A supplement was filed
                                                                                                       for the nation’s most outstanding
                                               accordance with the Paperwork                                                                                 on April 27, 2018. The complaint, as
                                                                                                       achievement in environmentally sound
                                               Reduction Act of 1995, we provide the                                                                         supplemented, alleges violations of
                                                                                                       surface mining and land reclamation
                                               general public and other Federal                                                                              section 337 based upon the importation
                                                                                                       and to encourage the exchange and
                                               agencies with an opportunity to                                                                               into the United States, the sale for
                                                                                                       transfer of successful reclamation
                                               comment on new, proposed, revised,                                                                            importation, and the sale within the
                                                                                                       technology. This collection request
                                               and continuing collections of                                                                                 United States after importation of
                                                                                                       seeks a three-year term of approval.
                                               information. This helps us assess the                                                                         certain radio frequency micro-needle
                                                                                                          Form Number: None.
                                               impact of our information collection                       Type of Review: Extension of a                     dermatological treatment devices and
                                               requirements and minimize the public’s                  currently approved collection.                        components thereof by reason of
                                               reporting burden. It also helps the                        Respondents/Affected Public:                       infringement of certain claims of U.S.
                                               public understand our information                       Industry and state/tribal nominees for                Patent No. 9,510,899 (‘‘the ’899 patent’’)
                                               collection requirements and provides                    reclamation awards and state/tribal                   and U.S. Patent No. 9,095,357 (‘‘the ’357
                                               the requested data in the desired format.               reviewers and judges.                                 patent’’). The complaint further alleges
                                                  A Federal Register notice with a 60-                    Total Estimated Number of Annual                   that an industry in the United States
                                               day public comment period soliciting                    Respondents: 14 active mine                           exists as required by the applicable
                                               comments on this collection of                          respondents, 11 abandoned mine land                   Federal Statute.
                                               information was published on January                    state/tribal respondents, and 40 state                  The complainants request that the
                                               31, 2018 (83 FR 4514). No comments                      and tribal reviewers and judges.                      Commission institute an investigation
                                               were received.                                             Total Estimated Number of Annual                   and, after the investigation, issue a
                                                  We are again soliciting comments on                  Responses: 65.                                        limited exclusion order and cease and
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                                               the proposed ICR that is described                         Estimated Completion Time per                      desist orders.
                                               below. We are especially interested in                  Response: An average of 17 hours per                  ADDRESSES: The complaint, as
                                               public comment addressing the                           coal producer, 67 hours per State/Tribal              supplemented, except for any
                                               following issues: (1) Is the collection                 nominee, and 2 hours to 8 hours per                   confidential information contained
                                               necessary to the proper functions of                    State/Tribe to judge responses.                       therein, is available for inspection
                                               OSMRE; (2) is the estimate of burden                       Total Estimated Number of Annual                   during official business hours (8:45 a.m.
                                               accurate; (3) how might OSMRE                           Burden Hours: 1,211 hours.                            to 5:15 p.m.) in the Office of the


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                                               22516                          Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices

                                               Secretary, U.S. International Trade                        (b) The respondents are the following              notice of investigation. Extensions of
                                               Commission, 500 E Street SW, Room                       entities alleged to be in violation of                time for submitting responses to the
                                               112, Washington, DC 20436, telephone                    section 337, and are the parties upon                 complaint and the notice of
                                               (202) 205–2000. Hearing impaired                        which the complaint is to be served:                  investigation will not be granted unless
                                               individuals are advised that information                Invasix, Inc., 21084 Bake Parkway, Suite              good cause therefor is shown.
                                               on this matter can be obtained by                          106, Lake Forest, CA 92618                            Failure of a respondent to file a timely
                                               contacting the Commission’s TDD                         Invasix, Ltd., Apolo Building, Shaar                  response to each allegation in the
                                               terminal on (202) 205–1810. Persons                        Yokneam, Yokneam, 20692, Israel                    complaint and in this notice may be
                                               with mobility impairments who will                      Inmode Md, Ltd., 20996 Bake Parkway,                  deemed to constitute a waiver of the
                                               need special assistance in gaining access                  Suite 106, Lake Forest, CA 92630                   right to appear and contest the
                                               to the Commission should contact the                    Ilooda Co., Ltd., 37–1 Imok-dong, Imok-               allegations of the complaint and this
                                               Office of the Secretary at (202) 205–                      dong, Jangan-gu, Suwon-si, Gyeonggi-               notice, and to authorize the
                                               2000. General information concerning                       do, Republic of Korea                              administrative law judge and the
                                               the Commission may also be obtained                     Cutera, Inc., 3240 Bayshore Boulevard,                Commission, without further notice to
                                               by accessing its internet server at                        Brisbane, CA 94005                                 the respondent, to find the facts to be as
                                               https://www.usitc.gov. The public                       Emvera Technologies, LLC, 641 10th                    alleged in the complaint and this notice
                                               record for this investigation may be                       Street, Cedartown, GA 30125                        and to enter an initial determination
                                               viewed on the Commission’s electronic                   Rohrer Aesthetics, LLC, 105 Citation                  and a final determination containing
                                               docket (EDIS) at https://edis.usitc.gov.                   Court, Homewood, AL 35209                          such findings, and may result in the
                                               FOR FURTHER INFORMATION CONTACT:                        Lutronic, Corp., Lutronic Center, 219                 issuance of an exclusion order or a cease
                                               Katherine Hiner, Office of the Secretary,                  Sowon-ro, Deogyang-gu, Goyang-si,                  and desist order or both directed against
                                               Docket Services Division, U.S.                             Geonggi-do, Republic of Korea                      the respondent.
                                               International Trade Commission,                         Lutronic, Inc., 19 Fortune Drive,                       By order of the Commission.
                                               telephone (202) 205–1802.                                  Billerica, MA 01821                                  Issued: May 9, 2018.
                                               SUPPLEMENTARY INFORMATION:
                                                                                                       Endymed Medical Inc., 790 Madison                     Lisa Barton,
                                                                                                          Avenue, Suite 402, New York, NY
                                                 Authority: The authority for institution of                                                                 Secretary to the Commission.
                                                                                                          10065
                                               this investigation is contained in section 337          Endymed Medical Ltd., 12 Leshem                       [FR Doc. 2018–10240 Filed 5–14–18; 8:45 am]
                                               of the Tariff Act of 1930, as amended, 19                                                                     BILLING CODE 7020–02–P
                                               U.S.C. 1337 and in section 210.10 of the
                                                                                                          Street, North Industrial Park,
                                               Commission’s Rules of Practice and                         Caesarea, 30889 Israel
                                               Procedure, 19 CFR 210.10 (2017).                        Sung Hwan E&B Co., Ltd. d/b/a SHEnB
                                                                                                          Co., Ltd., 148 Seongsui-Ro,                        DEPARTMENT OF JUSTICE
                                                  Scope of Investigation: Having                          Soengdong-Gu, Seoul 04796, Republic
                                               considered the complaint, the U.S.                         of Korea                                           Drug Enforcement Administration
                                               International Trade Commission, on                      Aesthetics Biomedical, Inc., 4602 N                   [Docket No. DEA–392]
                                               May 9, 2018, Ordered that—                                 16th Street, Suite 300, Phoenix, AZ
                                                  (1) Pursuant to subsection (b) of                       85016                                              Bulk Manufacturer of Controlled
                                               section 337 of the Tariff Act of 1930, as               Cartessa Aesthetics, 210 Peoples Way,                 Substances Application: Patheon API
                                               amended, an investigation be instituted                    Hockessin, DE 19707–1904                           Manufacturing, Inc.
                                               to determine whether there is a                         Jeisys Medical, Inc., 307 Daeryung
                                               violation of subsection (a)(1)(B) of                       Techno Town 8th, Gamasan-ro 96,                    ACTION:   Notice of application.
                                               section 337 in the importation into the                    Geumcheon-Gu, Seoul, 153–775,
                                               United States, the sale for importation,                   Republic of Korea                                  DATES:  Registered bulk manufacturers of
                                               or the sale within the United States after              Perigee Medical LLC, 2227 N Macarthur                 the affected basic classes, and
                                               importation of certain radio frequency                     Dr., Tracy, CA 95376–2830                          applicants therefore, may file written
                                               micro-needle dermatological treatment                   Lumenis Ltd., Yokneam Industrial Park,                comments on or objections to the
                                               devices and components thereof by                          Hakidma 6, Yokneam 2069204, Israel                 issuance of the proposed registration on
                                               reason of infringement of one or more of                Pollogen Ltd., 6 Kaufman Yehezkel, Tel                or before July 16, 2018.
                                               claims 1, 2, 4, 9–11, 15, 20, and 21 of                    Aviv-Jaffa, 6801298, Israel                        ADDRESSES: Written comments should
                                               the ’899 patent and claims 1, 2, 4, 9–12,                  (3) For the investigation so instituted,           be sent to: Drug Enforcement
                                               17, and 18 of the ’357 patent, and                      the Chief Administrative Law Judge,                   Administration, Attention: DEA Federal
                                               whether an industry in the United                       U.S. International Trade Commission,                  Register Representative/DRW, 8701
                                               States exists as required by subsection                 shall designate the presiding                         Morrissette Drive, Springfield, Virginia
                                               (a)(2) of section 337;                                  Administrative Law Judge.                             22152.
                                                  (2) For the purpose of the                              The Office of Unfair Import                        SUPPLEMENTARY INFORMATION:      The
                                               investigation so instituted, the following              Investigations will not participate as a              Attorney General has delegated his
                                               are hereby named as parties upon which                  party in this investigation.                          authority under the Controlled
                                               this notice of investigation shall be                      Responses to the complaint and the                 Substances Act to the Administrator of
                                               served:                                                 notice of investigation must be                       the Drug Enforcement Administration
                                                  (a) The complainants are:                            submitted by the named respondents in                 (DEA), 28 CFR 0.100(b). Authority to
                                               Syneron Medical Ltd., Tavor Building,                   accordance with section 210.13 of the                 exercise all necessary functions with
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                                                  Industrial Zone, Yokneam lllit, 20692,               Commission’s Rules of Practice and                    respect to the promulgation and
                                                  Israel                                               Procedure, 19 CFR 210.13. Pursuant to                 implementation of 21 CFR part 1301,
                                               Candela Corporation, 530 Boston Post                    19 CFR 201.16(e) and 210.13(a), such                  incident to the registration of
                                                  Road, Wayland, MA 01778                              responses will be considered by the                   manufacturers, distributors, dispensers,
                                               General Hospital Corporation d/b/a,                     Commission if received not later than 20              importers, and exporters of controlled
                                                  Massachusetts General Hospital, 55                   days after the date of service by the                 substances (other than final orders in
                                                  Fruit Street, Boston, MA 02114                       Commission of the complaint and the                   connection with suspension, denial, or


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Document Created: 2018-05-15 00:33:36
Document Modified: 2018-05-15 00:33:36
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.
ContactKatherine Hiner, Office of the Secretary, Docket Services Division, U.S. International Trade Commission, telephone (202) 205-1802.
FR Citation83 FR 22515 

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