81 FR 37640 - Certain Recombinant Factor VIII Products
INTERNATIONAL TRADE COMMISSION Federal Register Volume 81, Issue 112 (June 10, 2016)
Federal Register Volume 81, Issue 112 (June 10, 2016)
| Page Range | 37640-37641 | |
| FR Document | 2016-13688 |
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)] [Notices] [Pages 37640-37641] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13688] ======================================================================= ----------------------------------------------------------------------- INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-956] Certain Recombinant Factor VIII Products AGENCY: U.S. International Trade Commission. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: Notice is hereby given that the presiding administrative law judge (ALJ) has issued a final initial determination on May 27, 2016, and a recommended determination on remedy and bonding on June 3, 2016. The ALJ found no violation of Section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337). Should the Commission, however, find a violation of Section 337, the ALJ recommends that the Commission issue a limited exclusion order that excludes from importation into the United States certain recombinant factor VIII products manufactured by processes that infringe certain claims of U.S. Patent Nos. 6,100,061 and 8,084,252. The respondents are Novo Nordisk A/S of Bagsvaerd, Denmark, and Novo Nordisk Inc. of Plainsboro, N.J. Upon a finding of a violation, the ALJ further recommends that cease and desist orders issue to respondents and be directed to respondents' domestic inventories. This notice is soliciting public interest comments only from the public. Parties are to file public interest submissions pursuant to 19 CFR 210.50(a)(4) within 30 days from service of the recommended determination. FOR FURTHER INFORMATION CONTACT: Ron Traud, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, (202) 205-3427. The public version of the complaint can be accessed on the Commission's electronic docket (EDIS) at http://edis.usitc.gov, and 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, (202) 205-2000. General information concerning the Commission may also be obtained at http://www.usitc.gov. The public record for this investigation may be viewed on EDIS at http://edis.usitc.gov. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal at (202) 205-1810. SUPPLEMENTARY INFORMATION: Section 337 of the Tariff Act of 1930 provides that if the Commission finds a violation it shall exclude the articles concerned from the United States: unless, after considering the effect of such exclusion upon the public health and welfare, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, and United States consumers, it finds that such articles should not be excluded from entry. 19 U.S.C. 1337(d)(1). A similar provision applies to cease and desist orders. 19 U.S.C. 1337(f)(1). Therefore, the Commission is interested in further developing the record on the public interest in this investigation. Accordingly, members of the public are invited to file submissions of no more than five pages, inclusive of attachments, concerning the [[Page 37641]] public interest in light of the ALJ's recommended determination on remedy and bonding issued in this investigation on June 3, 2016. Comments should address whether the issuance of a limited exclusion order and cease and desist order would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers. In particular, the Commission is interested in comments that: (i) Explain how the articles potentially subject to the recommended orders are used in the United States; (ii) identify any public health, safety, or welfare concerns in the United States relating to the recommended orders; (iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded; (iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the recommended exclusion order and/or a cease and desist order within a commercially reasonable time; and (v) explain how the limited exclusion order and cease and desist order would impact consumers in the United States. Written submissions must be filed no later than by close of business on June 29, 2016. 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 210.4(f)). Submissions should refer to the investigation number (Inv. No. 337-TA-956) in a prominent place on the cover page, the first page, or both. 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 at (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 Commission is properly sought will be treated accordingly. A redacted non-confidential version of the document must also be filed simultaneously with any confidential filing. All non-confidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS. This action is taken under the authority of Section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10, 210.46, and 210.50 of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.46, 210.50). By order of the Commission. Issued: June 6, 2016. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2016-13688 Filed 6-9-16; 8:45 am] BILLING CODE 7020-02-P
![37640 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices
Copper River, near the village of application and its supporting rationale. that the Commission issue a limited
Tazlina, Alaska. This notice is intended A final decision on the merits of the exclusion order that excludes from
to notify the public of the Archdiocese’s Archdiocese’s application will not be importation into the United States
application and its supporting rationale. made before September 8, 2016. During certain recombinant factor VIII products
DATES: All comments to this action the 90-day period, interested parties manufactured by processes that infringe
should be received on or before may comment on the Archdiocese’s certain claims of U.S. Patent Nos.
September 8, 2016. application, AA–094010, and 6,100,061 and 8,084,252. The
ADDRESSES: Written comments on the supporting evidence. Interested parties respondents are Novo Nordisk A/S of
Archdiocese’s application or the BLM may comment during this time on the Bagsvaerd, Denmark, and Novo Nordisk
Draft Summary Report for the BLM’s Draft Summary Report for the Inc. of Plainsboro, N.J. Upon a finding
Corporation of Archbishop of Corporation of Archbishop of of a violation, the ALJ further
Anchorage, Inc. (Archdiocese of Anchorage, Inc. (Archdiocese of recommends that cease and desist
Anchorage) application for RDI must be Anchorage) Application for Recordable orders issue to respondents and be
filed with the RDI Program Manager Disclaimer of Interest. directed to respondents’ domestic
(AK–942), Division of Lands and Comments, including names and inventories.
Cadastral, BLM Alaska State Office, 222 street addresses, will be available for This notice is soliciting public
West Seventh Avenue, #13, Anchorage, public review at the Alaska State Office interest comments only from the public.
AK 99513. (see ADDRESSES above), during regular Parties are to file public interest
business hours, 7:30 a.m. to 4:30 p.m., submissions pursuant to 19 CFR
FOR FURTHER INFORMATION CONTACT:
Monday through Friday, except Federal 210.50(a)(4) within 30 days from service
Angie Nichols, RDI Program Manager, at holidays. of the recommended determination.
222 West 7th Avenue, #13, Anchorage, Before including your address, phone FOR FURTHER INFORMATION CONTACT: Ron
AK 99513; 907- 271–3359; or anichols@ number, email address, or other
blm.gov; or visit the BLM RDI Web site Traud, Office of the General Counsel,
personal identifying information in your U.S. International Trade Commission,
at http://www.blm.gov/ak/st/en/prog/ comment, you should be aware that
rdi.html. Persons who use a 500 E Street SW., Washington, DC
your entire comment—including your 20436, (202) 205–3427. The public
telecommunications device for the deaf personal identifying information—may
(TDD) may call the Federal Information version of the complaint can be
be made publicly available at any time. accessed on the Commission’s
Relay System (FIRS) at 1–800–877–8339 While you can ask us in your comment
to contact the above individual during electronic docket (EDIS) at http://
to withhold your personal identifying edis.usitc.gov, and will be available for
normal business hours. The FIRS is information from public review, we
available 24 hours of a day, seven days inspection during official business
cannot guarantee that we will be able to hours (8:45 a.m. to 5:15 p.m.) in the
a week, to leave a message or question do so.
with the above individual. You will Office of the Secretary, U.S.
If the evidence is sufficient to find a International Trade Commission, 500 E
receive a reply during normal business favorable determination and neither the
hours. Street SW., Washington, DC 20436,
records nor a valid objection disclose a (202) 205–2000.
SUPPLEMENTARY INFORMATION: The reason not to disclaim, then the General information concerning the
Archdiocese has filed an application for application may be approved. Commission may also be obtained at
an RDI pursuant to Section 315 of the Authority: 43 CFR 1864. http://www.usitc.gov. The public record
Federal Land Policy and Management for this investigation may be viewed on
Act of 1976 (43 U.S.C. 1745), as Erika L. Reed,
EDIS at http://edis.usitc.gov. Hearing-
amended, and the regulations contained Acting Deputy State Director, Division of impaired persons can obtain
in 43 CFR subpart 1864 for the surface Lands and Cadastral.
information on this matter by contacting
estate of the following lands: [FR Doc. 2016–13763 Filed 6–9–16; 8:45 am]
the Commission’s TDD terminal at (202)
BILLING CODE 4310–JA–P 205–1810.
Copper River Meridian, Alaska
T. 3 N., R. 1 W., SUPPLEMENTARY INFORMATION: Section
Sec. 10, lots 6 and 7, NW1⁄4SW1⁄4, 337 of the Tariff Act of 1930 provides
INTERNATIONAL TRADE that if the Commission finds a violation
S1⁄2SW1⁄4;
Sec. 15, lots 2, 3, 4, 7, and 8, N1⁄2NW1⁄4, COMMISSION it shall exclude the articles concerned
SE1⁄4NW1⁄4. [Investigation No. 337–TA–956] from the United States:
The areas described aggregate 461.67 acres. unless, after considering the effect of such
In the application, the Archdiocese asserts Certain Recombinant Factor VIII exclusion upon the public health and
that the United States has no interest in the Products welfare, competitive conditions in the United
property. States economy, the production of like or
AGENCY: U.S. International Trade
The lands were patented under directly competitive articles in the United
Commission. States, and United States consumers, it finds
Private Law 151. Both the law and ACTION: Notice. that such articles should not be excluded
patent have language stating that the
from entry.
land is for use as a mission school. The SUMMARY: Notice is hereby given that
Archdiocese believes that the clause for the presiding administrative law judge 19 U.S.C. 1337(d)(1). A similar
use as a mission school casts a cloud on (ALJ) has issued a final initial provision applies to cease and desist
asabaliauskas on DSK3SPTVN1PROD with NOTICES
the title and believes that cloud serves determination on May 27, 2016, and a orders. 19 U.S.C. 1337(f)(1).
as an impediment to any future use or recommended determination on remedy Therefore, the Commission is
sale of the land. If the BLM approves the and bonding on June 3, 2016. interested in further developing the
application and issues an RDI, it would The ALJ found no violation of Section record on the public interest in this
confirm that the United States has no 337 of the Tariff Act of 1930, as investigation. Accordingly, members of
valid interest in the subject lands. amended (19 U.S.C. 1337). Should the the public are invited to file
By this notice the BLM is informing Commission, however, find a violation submissions of no more than five pages,
the public of the Archdiocese’s of Section 337, the ALJ recommends inclusive of attachments, concerning the
VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1](https://thefederalregister.org/doc/81_FR_37752/page/1.svg)
![Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices 37641
public interest in light of the ALJ’s for which confidential treatment by the 22041; telephone: (703) 305–0470.
recommended determination on remedy Commission is properly sought will be Written comments and/or suggestions
and bonding issued in this investigation treated accordingly. A redacted non- can also be directed to the Office of
on June 3, 2016. Comments should confidential version of the document Management and Budget, Office of
address whether the issuance of a must also be filed simultaneously with Information and Regulatory Affairs,
limited exclusion order and cease and any confidential filing. All non- Attention Department of Justice Desk
desist order would affect the public confidential written submissions will be Officer, Washington, DC 20503 or sent
health and welfare in the United States, available for public inspection at the to OIRA_submissions@omb.eop.gov.
competitive conditions in the United Office of the Secretary and on EDIS. SUPPLEMENTARY INFORMATION: Written
States economy, the production of like This action is taken under the comments and suggestions from the
or directly competitive articles in the authority of Section 337 of the Tariff Act public and affected agencies concerning
United States, or United States of 1930, as amended (19 U.S.C. 1337), the proposed collection of information
consumers. and of sections 201.10, 210.46, and are encouraged. Your comments should
In particular, the Commission is 210.50 of the Commission’s Rules of address one or more of the following
interested in comments that: Practice and Procedure (19 CFR 201.10, four points:
(i) Explain how the articles 210.46, 210.50).
potentially subject to the recommended —Evaluate whether the proposed
By order of the Commission. collection of information is necessary
orders are used in the United States;
(ii) identify any public health, safety, Issued: June 6, 2016. for the proper performance of the
or welfare concerns in the United States Lisa R. Barton, functions of the Executive Office for
relating to the recommended orders; Secretary to the Commission. Immigration Review, including
(iii) identify like or directly [FR Doc. 2016–13688 Filed 6–9–16; 8:45 am] whether the information will have
competitive articles that complainant, BILLING CODE 7020–02–P practical utility;
its licensees, or third parties make in the —Evaluate the accuracy of the agency’s
United States which could replace the estimate of the burden of the
subject articles if they were to be DEPARTMENT OF JUSTICE proposed collection of information,
excluded; including the validity of the
(iv) indicate whether complainant, Executive Office for Immigration methodology and assumptions used;
complainant’s licensees, and/or third Review —Evaluate whether and if so how the
party suppliers have the capacity to quality, utility, and clarity of the
[OMB 1125–0002]
replace the volume of articles information to be collected can be
potentially subject to the recommended Agency Information Collection enhanced; and
exclusion order and/or a cease and Activities; Proposed eCollection; —Minimize the burden of the collection
desist order within a commercially eComments Requested;Notice of of information on those who are to
reasonable time; and Appeal From a Decision of an respond, including through the use of
(v) explain how the limited exclusion Immigration Judge (EOIR–26) appropriate automated, electronic,
order and cease and desist order would mechanical, or other technological
impact consumers in the United States. AGENCY: Executive Office for collection techniques or other forms
Written submissions must be filed no Immigration Review, Department of of information technology, e.g.,
later than by close of business on June Justice. permitting electronic submission of
29, 2016. ACTION: 30-Day notice. responses.
Persons filing written submissions
must file the original document SUMMARY: The Department of Justice Overview of This Information
electronically on or before the deadlines (DOJ), Executive Office for Immigration Collection
stated above and submit eight true paper Review, will be submitting the 1. Type of Information Collection:
copies to the Office of the Secretary by following information collection request Extension of a currently approved
noon the next day pursuant to section to the Office of Management and Budget collection.
210.4(f) of the Commission’s Rules of (OMB) for review and approval in 2. The Title of the Form/Collection:
Practice and Procedure (19 CFR accordance with the Paperwork Notice of Appeal from a Decision of an
210.4(f)). Submissions should refer to Reduction Act of 1995. This proposed Immigration Judge.
the investigation number (Inv. No. 337– collection was previously published in 3. The agency form number, if any,
TA–956) in a prominent place on the Federal Register at 81 FR 19639, on and the applicable component of the
cover page, the first page, or both. See April 5, 2016, allowing for a 60 day Department sponsoring the collection:
Handbook for Electronic Filing comment period. The form number is EOIR–26, Executive
Procedures, http://www.usitc.gov/ DATES: Comments are encouraged and Office for Immigration Review, United
secretary/fed_reg_notices/rules/ will be accepted for an additional 30 States Department of Justice.
handbook_on_electronic_filing.pdf. days until July 11, 2016. 4. Affected public who will be asked
Persons with questions regarding filing FOR FURTHER INFORMATION CONTACT: If or required to respond, as well as a brief
should contact the Secretary at (202) you have additional comments abstract: A party (either the U.S.
205–2000. especially on the estimated public Immigration and Customs Enforcement
Any person desiring to submit a burden or associated response time, of the Department of Homeland Security
asabaliauskas on DSK3SPTVN1PROD with NOTICES
document to the Commission in suggestions, or need a copy of the or the respondent/applicant) who
confidence must request confidential proposed information collection appeals a decision of an Immigration
treatment. All such requests should be instrument with instructions or Judge to the Board of Immigration
directed to the Secretary to the additional information, please contact Appeals (Board). A party affected by a
Commission and must include a full Jean King, General Counsel, Executive decision of an Immigration Judge may
statement of the reasons why the Office for Immigration Review, U.S. appeal that decision to the Board,
Commission should grant such Department of Justice, Suite 2600, 5107 provided that the Board has jurisdiction
treatment. See 19 CFR 201.6. Documents Leesburg Pike, Falls Church, Virginia pursuant to 8 CFR 1003.1(b). An appeal
VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1](https://thefederalregister.org/doc/81_FR_37752/page/2.svg)
Document Created: 2018-02-08 07:35:49
Document Modified: 2018-02-08 07:35:49
| 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 | Ron Traud, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, (202) 205-3427. The public version of the complaint can be accessed on the Commission's electronic docket (EDIS) at http://edis.usitc.gov, and 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, (202) 205-2000. | |
| FR Citation | 81 FR 37640 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR