80 FR 29745 - Certain Recombinant Factor VIII Products; Institution of Investigation

INTERNATIONAL TRADE COMMISSION

Federal Register Volume 80, Issue 99 (May 22, 2015)

Page Range		29745-29746
FR Document		2015-12390

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 16, 2015, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Baxter International Inc. of Deerfield, Illinois; Baxter Healthcare Corporation of Deerfield, Illinois; and Baxter Healthcare SA, of Switzerland. Letters supplementing the complaint were filed on April 21, 2015; May 1, 2015; and May 4, 2015. The complaint 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 recombinant factor VIII products by reason of infringement of certain claims of U.S. Patent No. 6,100,061 (``the '061 patent''); U.S. Patent No. 6,936,441 (``the '441 patent''); and U.S. Patent No. 8,084,252 (``the '252 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. 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 80 Issue 99 (Friday, May 22, 2015)

[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29745-29746]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12390]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-956]


Certain Recombinant Factor VIII Products; 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 16, 2015, under section 
337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of 
Baxter International Inc. of Deerfield, Illinois; Baxter Healthcare 
Corporation of Deerfield, Illinois; and Baxter Healthcare SA, of 
Switzerland. Letters supplementing the complaint were filed on April 
21, 2015; May 1, 2015; and May 4, 2015. The complaint 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 recombinant factor VIII products by reason 
of infringement of certain claims of U.S. Patent No. 6,100,061 (``the 
'061 patent''); U.S. Patent No. 6,936,441 (``the '441 patent''); and 
U.S. Patent No. 8,084,252 (``the '252 patent''). The complaint further 
alleges that an industry in the United States exists as required by 
subsection (a)(2) of section 337.
    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, 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 http://www.usitc.gov. The 
public record for this investigation may be viewed on the Commission's 
electronic docket (EDIS) at http://edis.usitc.gov.

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


[[Page 29746]]


    Authority:  The authority for institution of this investigation 
is contained in section 337 of the Tariff Act of 1930, as amended, 
and in section 210.10 of the Commission's Rules of Practice and 
Procedure, 19 CFR 210.10 (2015).

    Scope of Investigation: Having considered the complaint, the U.S. 
International Trade Commission, on May 15, 2015, 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 recombinant 
factor VIII products by reason of infringement of one or more of claims 
19-21, 36, 37, and 39 of the '061 patent; claims 20 and 21 of the '441 
patent; claims 1, 5, 8, 10, 14, and 18 of the '252 patent, and whether 
an industry in the United States exists as required by subsection 
(a)(2) of section 337;
    (2) 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)
    (3) 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:

Baxter International Inc., One Baxter Parkway, Deerfield, IL 60015-
4625.
Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015-
4625.
Baxter Healthcare SA, Thursgauerstrasse 130, Glattpark 
(Opfikon),Switzerland.

    (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:

Novo Nordisk A/S, Novo All[eacute], 2880 Bagsvaerd, Denmark.
Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536.

    (c) The Office of Unfair Import Investigations, U.S. International 
Trade Commission, 500 E Street SW., Suite 401, Washington, DC 20436; 
and
    (4) 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.

    Issued: May 18, 2015.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2015-12390 Filed 5-21-15; 8:45 am]
BILLING CODE 7020-02-P

Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices 29745

BURDEN TABLE
Non-hour cost burdens
NTL—Gulf of Mexico OCS
region—GPS for MODUs Average number of
Hour burden Annual burden hours
annual responses

1—Notify BSEE with tracking/locator data access and supporting information; no- 15 mins ....... 1 rig * ......................... 1 hour (rounded).
tify BSEE Hurricane Response Team as soon as operator is aware a rig has 15 mins ....... 1 notification * ............
moved off location.

2—Purchase and install tracking/locator devices—(these are replacement GPS 20 devices per year for replacement and/or new × $325.00 =
devices or new rigs). $6,500
3—Pay monthly tracking fee for GPS devices already placed on MODUs/rig ....... 40 rigs at $50/month = $600/year = $24,000
4—Rent GPS devices and pay monthly tracking fee per rig .................................. 40 rigs @$1,800 per year = $72,000

Total burden ...................................................................................................... ..................... 102 responses ........... 1 hour.

Estimated Reporting and We will summarize written responses May 4, 2015. The complaint alleges
Recordkeeping Non-Hour Cost Burden: to this notice and address them in our violations of section 337 based upon the
We have identified three non-hour cost submission for OMB approval. As a importation into the United States, the
burdens for this collection, which are result of your comments, we will make sale for importation, and the sale within
described and shown in the table. We any necessary adjustments to the burden the United States after importation of
have not identified any other non-hour in our submission to OMB. certain recombinant factor VIII products
cost burdens associated with this Public Comment Procedures: Before by reason of infringement of certain
collection of information. including your address, phone number, claims of U.S. Patent No. 6,100,061
email address, or other personal (‘‘the ’061 patent’’); U.S. Patent No.
Public Disclosure Statement: The PRA
identifying information in your 6,936,441 (‘‘the ’441 patent’’); and U.S.
(44 U.S.C. 3501, et seq.) provides that an
comment, you should be aware that Patent No. 8,084,252 (‘‘the ’252 patent’’).
agency may not conduct or sponsor a
your entire comment–including your The complaint further alleges that an
collection of information unless it
personal identifying information–may industry in the United States exists as
displays a currently valid OMB control
be made publicly available at any time. required by subsection (a)(2) of section
number. Until OMB approves a
While you can ask us in your comment 337.
collection of information, you are not
to withhold your personal identifying The complainants request that the
obligated to respond.
information from public review, we Commission institute an investigation
Comments: Before submitting an ICR cannot guarantee that we will be able to and, after the investigation, issue a
to OMB, PRA section 3506(c)(2)(A) do so. limited exclusion order and cease and
requires each agency ‘‘. . . to provide Dated: May 14, 2015. desist orders.
notice . . . and otherwise consult with
Douglas W. Morris,
members of the public and affected ADDRESSES: The complaint, except for
Chief, Office of Offshore Regulatory Programs. any confidential information contained
agencies concerning each proposed
collection of information . . .’’. [FR Doc. 2015–12303 Filed 5–21–15; 8:45 am] therein, is available for inspection
Agencies must specifically solicit BILLING CODE 4310–VH–P during official business hours (8:45 a.m.
comments to: (a) Evaluate whether the to 5:15 p.m.) in the Office of the
collection is necessary or useful; (b) Secretary, U.S. International Trade
evaluate the accuracy of the burden of INTERNATIONAL TRADE Commission, 500 E Street SW., Room
the proposed collection of information; COMMISSION 112, Washington, DC 20436, telephone
(c) enhance the quality, usefulness, and [Investigation No. 337–TA–956] (202) 205–2000. Hearing impaired
clarity of the information to be individuals are advised that information
collected; and (d) minimize the burden Certain Recombinant Factor VIII on this matter can be obtained by
on the respondents, including the use of Products; Institution of Investigation contacting the Commission’s TDD
technology. terminal on (202) 205–1810. Persons
AGENCY: U.S. International Trade with mobility impairments who will
Agencies must also estimate the non- Commission.
hour paperwork cost burdens to need special assistance in gaining access
ACTION: Notice. to the Commission should contact the
respondents or recordkeepers resulting
from the collection of information. SUMMARY: Notice is hereby given that a Office of the Secretary at (202) 205–
Therefore, if you have other than hour complaint was filed with the U.S. 2000. General information concerning
burden costs to generate, maintain, and International Trade Commission on the Commission may also be obtained
disclose this information, you should April 16, 2015, under section 337 of the by accessing its internet server at
asabaliauskas on DSK5VPTVN1PROD with NOTICES

comment and provide your total capital Tariff Act of 1930, as amended, 19 http://www.usitc.gov. The public record
and startup cost components or annual U.S.C. 1337, on behalf of Baxter for this investigation may be viewed on
operation, maintenance, and purchase International Inc. of Deerfield, Illinois; the Commission’s electronic docket
of service components. For further Baxter Healthcare Corporation of (EDIS) at http://edis.usitc.gov.
information on this burden, refer to 5 Deerfield, Illinois; and Baxter FOR FURTHER INFORMATION CONTACT: The
CFR 1320.3(b)(1) and (2), or contact the Healthcare SA, of Switzerland. Letters Office of Unfair Import Investigations,
Bureau representative listed previously supplementing the complaint were filed U.S. International Trade Commission,
in this notice. on April 21, 2015; May 1, 2015; and telephone (202) 205–2560.

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29746 Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices

Authority: The authority for institution of shall designate the presiding FOR FURTHER INFORMATION CONTACT: If
this investigation is contained in section 337 Administrative Law Judge. you have additional comments
of the Tariff Act of 1930, as amended, and Responses to the complaint and the especially on the estimated public
in section 210.10 of the Commission’s Rules notice of investigation must be burden or associated response time,
of Practice and Procedure, 19 CFR 210.10
(2015).
submitted by the named respondents in suggestions, or need a copy of the
accordance with section 210.13 of the proposed information collection
Scope of Investigation: Having Commission’s Rules of Practice and instrument with instructions or
considered the complaint, the U.S. Procedure, 19 CFR 210.13. Pursuant to additional information, please contact
International Trade Commission, on 19 CFR 201.16(e) and 210.13(a), such Tracey Robertson,
May 15, 2015, ordered that— responses will be considered by the Tracey.Robertson@atf.gov, Chief,
(1) Pursuant to subsection (b) of Commission if received not later than 20 Federal Firearms Licensing Center, 244
section 337 of the Tariff Act of 1930, as days after the date of service by the Needy Road, Martinsburg, WV 25405.
amended, an investigation be instituted Commission of the complaint and the SUPPLEMENTARY INFORMATION: Written
to determine whether there is a notice of investigation. Extensions of comments and suggestions from the
violation of subsection (a)(1)(B) of time for submitting responses to the public and affected agencies concerning
section 337 in the importation into the complaint and the notice of the proposed collection of information
United States, the sale for importation, investigation will not be granted unless are encouraged. Your comments should
or the sale within the United States after good cause therefor is shown. address one or more of the following
importation of certain recombinant Failure of a respondent to file a timely four points:
factor VIII products by reason of response to each allegation in the • Evaluate whether the proposed
infringement of one or more of claims complaint and in this notice may be collection of information is necessary
19–21, 36, 37, and 39 of the ’061 patent; deemed to constitute a waiver of the for the proper performance of the
claims 20 and 21 of the ’441 patent; right to appear and contest the functions of the agency, including
claims 1, 5, 8, 10, 14, and 18 of the ’252 allegations of the complaint and this whether the information will have
patent, and whether an industry in the notice, and to authorize the practical utility;
United States exists as required by administrative law judge and the • Evaluate the accuracy of the
subsection (a)(2) of section 337; Commission, without further notice to agency’s estimate of the burden of the
(2) Pursuant to Commission Rule the respondent, to find the facts to be as proposed collection of information,
210.50(b)(1), 19 CFR 210.50(b)(1), the alleged in the complaint and this notice including the validity of the
presiding administrative law judge shall and to enter an initial determination methodology and assumptions used;
take evidence or other information and and a final determination containing • Evaluate whether and if so how the
hear arguments from the parties and such findings, and may result in the quality, utility, and clarity of the
other interested persons with respect to issuance of an exclusion order or a cease information to be collected can be
the public interest in this investigation, and desist order or both directed against enhanced; and
as appropriate, and provide the the respondent. • Minimize the burden of the
Commission with findings of fact and a By order of the Commission. collection of information on those who
recommended determination on this Issued: May 18, 2015. are to respond, including through the
issue, which shall be limited to the use of appropriate automated,
Lisa R. Barton,
statutory public interest factors set forth electronic, mechanical, or other
in 19 U.S.C. 1337(d)(1), (f)(1), (g)(1) Secretary to the Commission.
technological collection techniques or
(3) For the purpose of the [FR Doc. 2015–12390 Filed 5–21–15; 8:45 am]
other forms of information technology,
investigation so instituted, the following BILLING CODE 7020–02–P
e.g., permitting electronic submission of
are hereby named as parties upon which responses.
this notice of investigation shall be Overview of this information
served: DEPARTMENT OF JUSTICE collection 1140–0061:
(a) The complainants are: 1. Type of Information Collection:
Baxter International Inc., One Baxter [OMB Number 1140–0061]
Extension of an existing collection.
Parkway, Deerfield, IL 60015–4625. 2. The Title of the Form/Collection:
Agency Information Collection
Baxter Healthcare Corporation, One Certification of Compliance.
Activities; Proposed eCollection
Baxter Parkway, Deerfield, IL 60015– 3. The agency form number, if any,
eComments Requested; Certification
4625. and the applicable component of the
Baxter Healthcare SA, Thursgauerstrasse of Compliance
Department sponsoring the collection:
130, Glattpark (Opfikon),Switzerland. AGENCY: Bureau of Alcohol, Tobacco, Form number: ATF Form 5330.20.
(b) The respondents are the following Firearms and Explosives, Department of Component: Bureau of Alcohol,
entities alleged to be in violation of Justice. Tobacco, Firearms and Explosives, U.S.
section 337, and are the parties upon ACTION: 60-day notice. Department of Justice.
which the complaint is to be served: 4. Affected public who will be asked
Novo Nordisk A/S, Novo Allé, 2880 SUMMARY: The Department of Justice or required to respond, as well as a brief
Bagsvaerd, Denmark. (DOJ), Bureau of Alcohol, Tobacco, abstract:
Novo Nordisk Inc., 800 Scudders Mill Firearms and Explosives (ATF), will Primary: Business or other for-profit.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Road, Plainsboro, NJ 08536. submit the following information Other: None.
(c) The Office of Unfair Import collection request to the Office of Abstract: The law at 18 U.S.C.
Investigations, U.S. International Trade Management and Budget (OMB) for 922(g)(5)(B) makes it unlawful for any
Commission, 500 E Street SW., Suite review and approval in accordance with nonimmigrant alien to ship or transport
401, Washington, DC 20436; and the Paperwork Reduction Act of 1995. in interstate commerce, or possess in or
(4) For the investigation so instituted, DATES: Comments are encouraged and affecting commerce, any firearm,
the Chief Administrative Law Judge, will be accepted for 60 days until July ammunition, which has been shipped or
U.S. International Trade Commission, 21, 2015. transported in interstate or foreign

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Document Created: 2015-12-15 15:46:06
Document Modified: 2015-12-15 15:46:06

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
FR Citation		80 FR 29745