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Code · REGISTER · 2006-05-12 · U.S. International Trade Commission · Notices

Notices. Institution of investigation pursuant to 19 U

1,712 words·~8 min read·/register/2006/05/12/06-4431

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BILLING CODE 4210-67-M INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-568] In the Matter of Certain Products and Pharmaceutical Compositions Containing Recombinant Human Erythropoietin; Notice of Investigation AGENCY: U.S. International Trade Commission. ACTION: Institution of investigation pursuant to 19 U.S.C. 1337. SUMMARY: Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 11, 2006, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Amgen Inc. of Thousand Oaks, California.
Amgen filed an amended complaint and a supplement on April 27, 2006. The amended complaint alleges violations of section 337 in the importation into the United States of certain products and pharmaceutical compositions containing recombinant human erythropoietin by reason of infringement of claims 1 and 2 of U.S. Patent No. 5,441,868, claims 3, 4, 5, and 11 of U.S. Patent No. 5,547,933, claims 4-9 of U.S. Patent No. 5,618,698, claims 4 and 6 of U.S. Patent No. 5,621,080, claim 7 of U.S.
Patent No. 5,756,349, and claim 1 of U.S. Patent No. 5,955,422. The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainant requests that the Commission institute an investigation and, after the investigation, issue a permanent exclusion order and permanent cease and desist orders. ADDRESSES: The amended 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: Anne Goalwin, Office of Unfair Import Investigations, U.S. International Trade Commission, telephone
(202)205-2574. 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 (2005). *Scope of Investigation:* Having considered the complaint, the U.S. International Trade Commission, on May 8, 2006, *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 products and pharmaceutical compositions containing recombinant human erythropoietin by reason of infringement of one or more of claims 1 and 2 of U.S. Patent No. 5,441,868, claims 3, 4, 5, and 11 of U.S. Patent No. 5,547,933, claims 4-9 of U.S. Patent No. 5,618,698, claims 4 and 6 of U.S. Patent No. 5,621,080, claim 7 of U.S. Patent No. 5,756,349, and claim 1 of U.S. Patent No. 5,955,422, and whether an industry in the United States exists as required by subsection (a)(2) of section 337.
(2)In instituting this investigation, the Commission is mindful of the provision of 35 U.S.C. 271(e), which states that “[i]t shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention * * * solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs * * *.” Accordingly, the Commission directs the presiding administrative law judge to consider at an early date any motions for summary determination based upon 35 U.S.C. 271(e). Any decision granting or denying such motions should be issued in the form of an initial determination
(ID)under Rule 210.42(c), 19 CFR 210.42(c). The ID will become the Commission's final determination 45 days after the date of service of the ID unless the Commission determines to review the ID. Any such review will be conducted in accordance with Commission Rules 210.43, 210.44 and 210.45, 19 CFR 210.43, 210.44, and 210.45.
(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 complainant is— Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320.
(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: Roche Holding Ltd., Grenzacherstrasse 124, CH-4070, Basel, Switzerland. F. Hoffmann-La Roche, Ltd., Grenzacherstrasse 124, CH-4070, Basel, Switzerland. Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305, Mannheim, Germany. Hoffmann La Roche, Inc., 340 Kingsland Street, Nutley, New Jersey 07110.
(c)The Commission investigative attorney, party to this investigation, is Anne Goalwin, Esq., 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 Honorable Paul J. Luckern is designated as 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(d) 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 respondents, to find the facts to be as alleged in the complaint and this notice and to enter a final determination containing such findings, and may result in the issuance of a limited exclusion order or cease and desist order or both directed against the respondent. Issued: May 9, 2006. By order of the Commission. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E6-7307 Filed 5-11-06; 8:45 am] BILLING CODE 7020-02-P DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms and Explosives Agency Information Collection Activities: Proposed Collection; Comments Requested ACTION: 30-Day notice of information collection under review: Federal firearms licensee firearms inventory theft/loss report. The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives
(ATF)has submitted the following information collection request to the Office of Management and Budget
(OMB)for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the **Federal Register** volume 71, number 48, pages 12713-12714 on March 13, 2006, allowing for a 60 day comment period. The purpose of this notice is to allow for an additional 30 days for public comment until June 12, 2006. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to The Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503. Additionally, comments may be submitted to OMB VIA FACSIMILE TO
(202)395-5806. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Enhance the quality, utility, and clarity of the information to be collected; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection
(1)*Type of Information Collection:* Extension of a currently approved collection.
(2)*Title of the Form/Collection:* Federal Firearms Licensee Firearms Inventory Theft/Loss Report.
(3)*Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection:* Form Number: ATF F 3310.11. Bureau of Alcohol, Tobacco, Firearms and Explosives.
(4)* Affected public who will be asked or required to respond, as well as a brief abstract: * Primary: Individuals or households. Other: Business or other for-profit. Authorization of this form is requested as the Violent Crime Control and Law Enforcement Act requires Federal firearms licensees to report to the Bureau of Alcohol, Tobacco, Firearms and Explosives and to the appropriate local authorities any theft or loss of a firearm from the licensee's inventory or collection within a specific time frame after the theft or loss is discovered.
(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* There will be an estimated 4,000 respondents, who will complete the form within approximately 24 minutes.
(6)*An estimate of the total burden (in hours) associated with the collection:* There are an estimated 1,600 total burden hours associated with this collection. If additional information is required contact: Lynn Bryant, Deputy Clearance Officer, United States Department of Justice, Policy and Planning Staff, Justice Management Division, Suite 1600, Patrick Henry Building, 601 D Street, NW., Washington, DC 20530. Dated: May 8, 2006. Lynn Bryant, Department Deputy Clearance Officer, United States Department of Justice. [FR Doc. 06-4431 Filed 5-11-06; 8:45 am]
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