In the Matter of Certain Products and Pharmaceutical Compositions Containing Recombinant Human Erythropoietin; Notice of Investigation, 27742-27743 [E6-7307]

Download as PDF 27742 Federal Register / Vol. 71, No. 92 / Friday, May 12, 2006 / Notices Clinics, 301 Business Loop 70 West, Suite 208, Columbia, MO 65203, 573– 882–1273. Toxicology Testing Service, Inc., 5426 N.W. 79th Ave., Miami, FL 33166, 305–593– 2260. US Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., Fort George G. Meade, MD 20755–5235, 301–677– 7085. The following laboratory’s certification was suspended on November 14, 2005, with an effective date of November 15, 2005, and then revoked on February 8, 2006: Sciteck Clinical Laboratories, Inc., 317 Rutledge Road, Fletcher, NC 28732, 828– 650–0409. * The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. HHS, with the HHS’ NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do. Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory (Federal Register, July 16, 1996) as meeting the minimum standards of the Mandatory Guidelines published in the Federal Register on April 13, 2004 (69 FR 19644). After receiving DOT certification, the laboratory will be included in the monthly list of HHScertified laboratories and participate in the NLCP certification maintenance program. Anna Marsh, Director, Office Program Services, SAMHSA. [FR Doc. E6–7316 Filed 5–11–06; 8:45 am] BILLING CODE 4160–20–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT sroberts on PROD1PC70 with NOTICES [Docket No. FR–5045–N–19] Federal Property Suitable as Facilities To Assist the Homeless Office of the Assistant Secretary for Community Planning and Development, HUD. AGENCY: VerDate Aug<31>2005 16:54 May 11, 2006 Jkt 208001 ACTION: Notice. SUMMARY: This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless. DATES: Effective Date: May 12, 2006. FOR FURTHER INFORMATION CONTACT: Kathy Ezzell, Department of Housing and Urban Development, Room 7262, 451 Seventh Street SW., Washington, DC 20410; telephone (202) 708–1234; TTY number for the hearing- and speech-impaired (202) 708–2565, (these telephone numbers are not toll-free), or call the toll-free title V information line at 1–800–927–7588. SUPPLEMENTARY INFORMATION: In accordance with the December 12, 1988 court order in National Coalition for the Homeless v. Veterans Administration, No. 88–2503–OG (D.D.C.), HUD publishes a Notice, on a weekly basis, identifying unutilized, underutilized, excess and surplus Federal buildings and real property that HUD has reviewed for suitability for use to assist the homeless. Today’s Notice is for the purpose of announcing that no additional properties have been determined suitable or unsuitable this week. Dated: May 4, 2006. Mark R. Johnston, Acting Deputy Assistant Secretary for Special Needs. [FR Doc. 06–4318 Filed 5–11–06; 8:45am] 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 U.S. International Trade Commission. ACTION: Institution of investigation pursuant to 19 U.S.C. 1337. AGENCY: 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 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 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 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: 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 E:\FR\FM\12MYN1.SGM 12MYN1 sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 71, No. 92 / Friday, May 12, 2006 / Notices 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 VerDate Aug<31>2005 16:54 May 11, 2006 Jkt 208001 (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 30-Day notice of information collection under review: Federal firearms licensee firearms inventory theft/loss report. ACTION: 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 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 27743 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 E:\FR\FM\12MYN1.SGM 12MYN1

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INTERNATIONAL TRADE COMMISSION

[Federal Register Volume 71, Number 92 (Friday, May 12, 2006)]
[Notices]
[Pages 27742-27743]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7307]


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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 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: 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

[[Page 27743]]

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

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