Certain X-Ray Breast Imaging Devices and Components Thereof; Notice of a Commission Determination To Review the Final Initial Determination In-Part; Extension of the Target Date, 54608-54610 [2018-23618]

Download as PDF 54608 Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices Notice elicited no comments. Accordingly, no changes have been made to the Collections. FOR FURTHER INFORMATION CONTACT: Information Collection Request Title: Bridge Permit Application Guide. OMB Control Number: 1625–0015. Summary: The collection of information is a request for a bridge permit submitted as an application for approval by the Coast Guard of any proposed bridge project. An applicant must submit to the Coast Guard a letter of application along with letter-size drawings (plans) and maps showing the proposed project and its location. Need: 33 U.S.C. 401, 491, and 525 authorize the Coast Guard to approve plans and locations for all bridges and causeways that go over navigable waters of the United States. Forms: None. Respondents: Public and private owners of bridges over navigable waters of the United States. Frequency: On occasion. Hour Burden Estimate: The estimated burden has increased from 12,354 hours to 17,607 hours a year due to the increase in the annual number of respondents. Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. DEPARTMENT OF THE INTERIOR Bureau of Safety and Environmental Enforcement [19XE8370SD//EEGG600000// ED1OS0000.JR0000] Notice of Public Meeting Bureau of Safety and Environmental Enforcement (BSEE), Interior. ACTION: Notice of public meeting. AGENCY: The Bureau of Safety and Environmental Enforcement (BSEE) is hosting a public meeting to discuss advancement of a low-emission spray combustion unit for responding to oil spills. khammond on DSK30JT082PROD with NOTICES SUMMARY: This public meeting will be held on December 10, 2018 from 9 to 11 a.m. ADDRESSES: The meeting will be held in Room 121 at 1201 Elmwood Park Blvd., New Orleans, LA 70123. Jkt 247001 BILLING CODE 4310–VH–P INTERNATIONAL TRADE COMMISSION [Inv. No. 337–TA–1063] Certain X-Ray Breast Imaging Devices and Components Thereof; Notice of a Commission Determination To Review the Final Initial Determination In-Part; Extension of the Target Date Notice is hereby given that the U.S. International Trade Commission has determined to review the final initial determination (‘‘ID’’) inpart and extend the target date for completion of the investigation until January 25, 2019. FOR FURTHER INFORMATION CONTACT: Amanda Pitcher Fisherow, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205–2737. Copies of non-confidential documents filed in connection with this investigation are or will be 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, Washington, DC 20436, telephone (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. Hearing-impaired persons are advised that information on this matter can be obtained by SUMMARY: BILLING CODE 9110–04–P 17:34 Oct 29, 2018 [FR Doc. 2018–23709 Filed 10–29–18; 8:45 am] U.S. International Trade Commission. ACTION: Notice. [FR Doc. 2018–23638 Filed 10–29–18; 8:45 am] VerDate Sep<11>2014 Dated: October 24, 2018. Scott A. Angelle, Director, Bureau of Safety and Environmental Enforcement. AGENCY: Dated: October 25, 2018. James D. Roppel, Acting Chief, U.S. Coast Guard, Office of Information Management. DATES: Karen N. Stone, (703) 787–1810 or email karen.stone@bsee.gov. SUPPLEMENTARY INFORMATION: This notice is to inform the interested public that BSEE, Oil Spill Preparedness Division (OSPD), Response Research Branch will be conducting a public meeting to discuss advancement of a low-emission spray combustion unit being designed to burn water-in-oil emissions. System integration including platform/barge configurations will be discussed to ready the unit towards use in oil spill cleanup operations. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 contacting the Commission’s TDD terminal on (202) 205–1810. SUPPLEMENTARY INFORMATION: The Commission instituted this investigation on August 1, 2017, based on a complaint and supplement, filed on behalf of Hologic, Inc. of Marlborough, Massachusetts (‘‘Hologic’’). 82 FR 35829–24 (Aug. 1, 2017). 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 x-ray breast imaging and components thereof by reason of infringement of certain claims of U.S. Patent No. 7,831,296 (‘‘the ’296 patent’’); U.S. Patent No. 8,452,379 (‘‘the ’379 patent’’); U.S. Patent No. 7,688,940 (‘‘the ’940 patent’’); U.S. Patent No. 7,986,765 (‘‘the ’765 patent’’); and U.S. Patent No. 7,123,684 (‘‘the ’684 patent’’). The complaint further alleges that an industry in the United States exists as required by section 337. The Notice of Investigation named FUJIFILM Corporation of Tokyo, Japan; FUJIFILM Medical Systems USA, Inc. of Stamford, Connecticut; and FUJIFILM Techno Products Co., Ltd. of Hanamaki-Shi Iwate, Japan (collectively, ‘‘Fujifilm’’) as respondents. The Office of Unfair Import Investigations (‘‘OUII’’) was named as a party. On January 18, 2018, the ’765 patent was terminated in its entirety from the investigation. See Order No. 18 (Jan. 18, 2018) (unreviewed). On July 26, 2018, the ALJ issued the final ID and found a violation of section 337 has occurred. On August 8, 2018, Fujifilm and OUII each filed petitions for review of the final ID. On August 16, 2018, OUII and Hologic filed responses to the petitions for review. Having examined the record of this investigation, including the ALJ’s final ID, the petitions for review, and the responses thereto, the Commission has determined to review the final ID in part. Specifically, the Commission has determined to review the ID’s findings on (1) in rem jurisdiction and importation; (2) all findings concerning infringement; (3) claim construction of the ‘‘dose’’ limitations of the ’379 and ’296 patents; (3) claim construction of the limitations including terms of degree (i.e., similar, substantially less, much less, and substantially higher) in the ’379 and ’296 patents; (4) the ‘‘control’’/‘‘motion control’’ and ‘‘processor’’ limitations of the ’379 and ’296 patents; (5) the technical prong of domestic industry for the ’379 and ’296 patents; (6) claim construction of the ‘‘control’’ limitations of the ’940 patent; E:\FR\FM\30OCN1.SGM 30OCN1 Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices khammond on DSK30JT082PROD with NOTICES (7) anticipation by the Kopans 2000 Army Report for the ’379 and ’296 patents; (8) anticipation by MGH/GE Prototype #2 for the ’379 and ’296 patents; (9) obviousness based on the publicly available MGH/GE References related to the MGH/GE Prototypes for the ’379 and ’296 patents; (10) anticipation by GE Senographe 2000D System and/or Manual for the ’940 patent; (11) obviousness based on GE Senographe 2000D System and/or Manual with Dornheim for the ’940 patent; (12) obviousness based on Niklason article, the GE Senographe DMR System and Dornheim for the ’940 patent; and (13) indefiniteness under 35 U.S.C. 112 for the ’940 patent. In connection with its review, the Commission is interested in responses to the following questions: 1. Was the argument that ‘‘conventional mammogram,’’ as used in the ’379 and ’296 patents, should be construed to include diagnostic images waived? See, e.g., OUII Petition for Review at 9–12; Complainant’s Resp. to OUII Petition at 2–3. 2. Does the claimed ‘‘dose’’ for a ‘‘conventional mammogram,’’ as used in the ’379 and ’296 patents, meet the indefiniteness standard set forth in Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014). The Commission is most interested in a discussion of the relevant Federal Circuit precedent. 3. To what extent are the ID’s findings on whether the ‘‘dose’’ for a conventional mammogram has changed over time necessary in establishing whether the ‘‘dose’’ for conventional mammogram is definite/ indefinite? See ID at 60–61. 4. Please discuss whether the terms of degree, as used in the asserted claims of ’379 and ’296 patents, are indefinite. The Commission is interested in evidence that would provide an understanding of the terms to a person of ordinary skill in the art and the relevant case law. 5. The asserted claims of the ’379 and ’296 patents require a comparison of different xray doses and in particular, to a dose used for a conventional mammogram. Does the specification, claims, prosecution history, or extrinsic record shed light on whether the comparison is made to a conventional twodimensional system or whether the comparison is made to the two-dimensional mode on a device that performs both twodimensional and three-dimensional imaging? See, e.g., Fujifilm Petition for Review at 17. 6. Would claims 1, 2, and 22 of the ’940 patent be anticipated by the GE Senographe 2000D System and/or Manual if the Commission were to find that the claims allow for the anti-scatter grid to be completely removed? See, e.g., Fujifilm Petition for Review at 55–59. The parties are requested to brief only the discrete issues above, with reference to the applicable law and evidentiary record. The parties are not to brief other issues on review, which are adequately presented in the parties’ existing filings. VerDate Sep<11>2014 17:34 Oct 29, 2018 Jkt 247001 In connection with the final disposition of this investigation, the Commission may (1) issue an order that could result in the exclusion of the subject articles from entry into the United States, and/or (2) issue one or more cease and desist orders that could result in the respondents 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 (December 1994) (Commission Opinion). If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order and/or cease and desist orders 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 or disapprove the Commission’s action. 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. The Commission has also determined to extend the target date for completion of this investigation until January 25, 2019. Written Submissions: The parties to the investigation are requested to file written submissions on the issues identified in this notice. Parties to the PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 54609 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. Such submissions should address the recommended determination by the ALJ on public interest, remedy, and bonding. Complainant and the OUII are requested to submit proposed remedial orders for the Commission’s consideration. Complainant is also requested to state the date that the subject patents expire and the HTSUS numbers under which the accused products are imported. Complainant is further requested to supply the names of known importers of the Respondents’ products at issue in this investigation. Also specifically, with respect to the public interest, the Commission requests briefing on the following issue: Please discuss whether the accused Fujifilm products have been proven to be more effective in screening for breast cancer than comparable systems available in the United States (e.g., systems from Hologic, Siemens, or GE). Please include evidence to support your position. The written submissions and proposed remedial orders must be filed no later than close of business on November 5, 2018. Reply submissions must be filed no later than the close of business on November 13, 2018. Opening submissions are limited to 75 pages. Reply submissions are limited to 50 pages. No further submissions on any of 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 and submit eight true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) Of the Commission’s Rules of Practice and Procedure (19 CFR 2.10.4(f)). Submissions should refer to the investigation number (‘‘Inv. No. 337–TA–1063’’) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, http://www.usitc.gov/ secretary/fed_reg_notices/rules/ handbook_on_electronic_filing.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. 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 E:\FR\FM\30OCN1.SGM 30OCN1 54610 Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices 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 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel,1 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on 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: October 24, 2018. Jessica Mullan, Attorney Advisor. [FR Doc. 2018–23618 Filed 10–29–18; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Cambrex High Point, Inc. ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on July 16, DATES: 2018, Cambrex High Point, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265–8017 applied to be registered as an importer of the following basic class of controlled substance: Controlled substance Poppy Straw Concentrate. [FR Doc. 2018–23699 Filed 10–29–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration ACTION: Notice of registration. The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as an importer of schedule I or schedule II controlled substances. SUMMARY: SUPPLEMENTARY INFORMATION: The company listed below applied to be registered as an importer of various basic classes of controlled substances. Information on the previously published notice is listed in the table below. No comments or objections were submitted and no requests for hearing were submitted for this notice. khammond on DSK30JT082PROD with NOTICES Cody Laboratories, Inc. ........................................................................................................................................ 83 FR 37524 17:34 Oct 29, 2018 Jkt 247001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Published August 1, 2018. local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule II controlled substances to the above listed company. 1 All contract personnel will sign appropriate nondisclosure agreements. VerDate Sep<11>2014 II Dated: October 22, 2018. John J. Martin, Assistant Administrator. FR Docket treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and 9670 Schedule The company plans to import the listed controlled substance for clinical trial narcotic material for bulk manufacture. Company The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrant to import the applicable basic classes of schedule I or II controlled substances is consistent with the public interest and with United States obligations under international Drug code E:\FR\FM\30OCN1.SGM 30OCN1

Agencies

[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54608-54610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23618]


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INTERNATIONAL TRADE COMMISSION

[Inv. No. 337-TA-1063]


Certain X-Ray Breast Imaging Devices and Components Thereof; 
Notice of a Commission Determination To Review the Final Initial 
Determination In-Part; Extension of the Target Date

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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

SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has determined to review the final initial determination 
(``ID'') in-part and extend the target date for completion of the 
investigation until January 25, 2019.

FOR FURTHER INFORMATION CONTACT: Amanda Pitcher Fisherow, Esq., Office 
of the General Counsel, U.S. International Trade Commission, 500 E 
Street SW, Washington, DC 20436, telephone (202) 205-2737. Copies of 
non-confidential documents filed in connection with this investigation 
are or will be 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, Washington, DC 20436, 
telephone (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. 
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 instituted this investigation 
on August 1, 2017, based on a complaint and supplement, filed on behalf 
of Hologic, Inc. of Marlborough, Massachusetts (``Hologic''). 82 FR 
35829-24 (Aug. 1, 2017). 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 x-ray breast imaging and components 
thereof by reason of infringement of certain claims of U.S. Patent No. 
7,831,296 (``the '296 patent''); U.S. Patent No. 8,452,379 (``the '379 
patent''); U.S. Patent No. 7,688,940 (``the '940 patent''); U.S. Patent 
No. 7,986,765 (``the '765 patent''); and U.S. Patent No. 7,123,684 
(``the '684 patent''). The complaint further alleges that an industry 
in the United States exists as required by section 337. The Notice of 
Investigation named FUJIFILM Corporation of Tokyo, Japan; FUJIFILM 
Medical Systems USA, Inc. of Stamford, Connecticut; and FUJIFILM Techno 
Products Co., Ltd. of Hanamaki-Shi Iwate, Japan (collectively, 
``Fujifilm'') as respondents. The Office of Unfair Import 
Investigations (``OUII'') was named as a party. On January 18, 2018, 
the '765 patent was terminated in its entirety from the investigation. 
See Order No. 18 (Jan. 18, 2018) (unreviewed).
    On July 26, 2018, the ALJ issued the final ID and found a violation 
of section 337 has occurred. On August 8, 2018, Fujifilm and OUII each 
filed petitions for review of the final ID. On August 16, 2018, OUII 
and Hologic filed responses to the petitions for review.
    Having examined the record of this investigation, including the 
ALJ's final ID, the petitions for review, and the responses thereto, 
the Commission has determined to review the final ID in part. 
Specifically, the Commission has determined to review the ID's findings 
on (1) in rem jurisdiction and importation; (2) all findings concerning 
infringement; (3) claim construction of the ``dose'' limitations of the 
'379 and '296 patents; (3) claim construction of the limitations 
including terms of degree (i.e., similar, substantially less, much 
less, and substantially higher) in the '379 and '296 patents; (4) the 
``control''/``motion control'' and ``processor'' limitations of the 
'379 and '296 patents; (5) the technical prong of domestic industry for 
the '379 and '296 patents; (6) claim construction of the ``control'' 
limitations of the '940 patent;

[[Page 54609]]

(7) anticipation by the Kopans 2000 Army Report for the '379 and '296 
patents; (8) anticipation by MGH/GE Prototype #2 for the '379 and '296 
patents; (9) obviousness based on the publicly available MGH/GE 
References related to the MGH/GE Prototypes for the '379 and '296 
patents; (10) anticipation by GE Senographe 2000D System and/or Manual 
for the '940 patent; (11) obviousness based on GE Senographe 2000D 
System and/or Manual with Dornheim for the '940 patent; (12) 
obviousness based on Niklason article, the GE Senographe DMR System and 
Dornheim for the '940 patent; and (13) indefiniteness under 35 U.S.C. 
112 for the '940 patent.
    In connection with its review, the Commission is interested in 
responses to the following questions:

    1. Was the argument that ``conventional mammogram,'' as used in 
the '379 and '296 patents, should be construed to include diagnostic 
images waived? See, e.g., OUII Petition for Review at 9-12; 
Complainant's Resp. to OUII Petition at 2-3.
    2. Does the claimed ``dose'' for a ``conventional mammogram,'' 
as used in the '379 and '296 patents, meet the indefiniteness 
standard set forth in Nautilus, Inc. v. Biosig Instruments, Inc., 
134 S. Ct. 2120 (2014). The Commission is most interested in a 
discussion of the relevant Federal Circuit precedent.
    3. To what extent are the ID's findings on whether the ``dose'' 
for a conventional mammogram has changed over time necessary in 
establishing whether the ``dose'' for conventional mammogram is 
definite/indefinite? See ID at 60-61.
    4. Please discuss whether the terms of degree, as used in the 
asserted claims of '379 and '296 patents, are indefinite. The 
Commission is interested in evidence that would provide an 
understanding of the terms to a person of ordinary skill in the art 
and the relevant case law.
    5. The asserted claims of the '379 and '296 patents require a 
comparison of different x-ray doses and in particular, to a dose 
used for a conventional mammogram. Does the specification, claims, 
prosecution history, or extrinsic record shed light on whether the 
comparison is made to a conventional two-dimensional system or 
whether the comparison is made to the two-dimensional mode on a 
device that performs both two-dimensional and three-dimensional 
imaging? See, e.g., Fujifilm Petition for Review at 17.
    6. Would claims 1, 2, and 22 of the '940 patent be anticipated 
by the GE Senographe 2000D System and/or Manual if the Commission 
were to find that the claims allow for the anti-scatter grid to be 
completely removed? See, e.g., Fujifilm Petition for Review at 55-
59.

    The parties are requested to brief only the discrete issues above, 
with reference to the applicable law and evidentiary record. The 
parties are not to brief other issues on review, which are adequately 
presented in the parties' existing filings.
    In connection with the final disposition of this investigation, the 
Commission may (1) issue an order that could result in the exclusion of 
the subject articles from entry into the United States, and/or (2) 
issue one or more cease and desist orders that could result in the 
respondents 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 (December 1994) 
(Commission Opinion).
    If the Commission contemplates some form of remedy, it must 
consider the effects of that remedy upon the public interest. The 
factors the Commission will consider include the effect that an 
exclusion order and/or cease and desist orders 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 
or disapprove the Commission's action. 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.
    The Commission has also determined to extend the target date for 
completion of this investigation until January 25, 2019.
    Written Submissions: The parties to the investigation are requested 
to file written submissions on the issues identified in this notice. 
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. Such 
submissions should address the recommended determination by the ALJ on 
public interest, remedy, and bonding. Complainant and the OUII are 
requested to submit proposed remedial orders for the Commission's 
consideration. Complainant is also requested to state the date that the 
subject patents expire and the HTSUS numbers under which the accused 
products are imported. Complainant is further requested to supply the 
names of known importers of the Respondents' products at issue in this 
investigation. Also specifically, with respect to the public interest, 
the Commission requests briefing on the following issue:

    Please discuss whether the accused Fujifilm products have been 
proven to be more effective in screening for breast cancer than 
comparable systems available in the United States (e.g., systems 
from Hologic, Siemens, or GE). Please include evidence to support 
your position.

    The written submissions and proposed remedial orders must be filed 
no later than close of business on November 5, 2018. Reply submissions 
must be filed no later than the close of business on November 13, 2018. 
Opening submissions are limited to 75 pages. Reply submissions are 
limited to 50 pages. No further submissions on any of 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 and submit eight 
true paper copies to the Office of the Secretary by noon the next day 
pursuant to section 210.4(f) Of the Commission's Rules of Practice and 
Procedure (19 CFR 2.10.4(f)). Submissions should refer to the 
investigation number (``Inv. No. 337-TA-1063'') in a prominent place on 
the cover page and/or the first page. (See Handbook for Electronic 
Filing Procedures, http://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.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. 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

[[Page 54610]]

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 U.S.C. Appendix 3; or (ii) by U.S. 
government employees and contract personnel,\1\ solely for 
cybersecurity purposes. All nonconfidential written submissions will be 
available for public inspection at the Office of the Secretary and on 
EDIS.
---------------------------------------------------------------------------

    \1\ All contract personnel will sign appropriate nondisclosure 
agreements.
---------------------------------------------------------------------------

    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: October 24, 2018.

Jessica Mullan,
Attorney Advisor.
[FR Doc. 2018-23618 Filed 10-29-18; 8:45 am]
 BILLING CODE 7020-02-P