Cancellation of Customs Broker License Due to Death of the License Holder, 15868-15869 [05-6105]

Download as PDF 15868 Federal Register / Vol. 70, No. 59 / Tuesday, March 29, 2005 / Notices Administration, 9201 Corporate Blvd., suite N316, Rockville, MD 20850, 301–827–2090; or Jeffrey N. Siegel, Center for Drug Evaluation and Research (HFD– 108), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594– 5667. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0106] Draft Guidance for Industry on Systemic Lupus Erythematosus— Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Systemic Lupus Erythematosus— Developing Drugs for Treatment.’’ The draft guidance is intended to provide recommendations for industry on developing drugs for the treatment of systemic lupus erythematosus (SLE). Specific topics include measurement of lupus disease activity and clinical outcomes, reduction in disease activity and flares, treatment of organ-specific disease, trial design issues and analysis, surrogate markers as endpoints, and risk-benefit assessment. DATES: Submit written or electronic comments on the draft guidance by June 27, 2005. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Submit written comments on the draft guidance to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ ecomments. Send one self-addressed adhesive label to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Joel Schiffenbauer, Center for Drug Evaluation and Research (HFD– 550), Food and Drug I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Systemic Lupus Erythematosus— Developing Drugs for Treatment.’’ SLE is a chronic disease characterized by protean manifestations often demonstrating a waxing and waning course. In the past, a diagnosis of SLE often implied a decreased life span due to internal organ system involvement or to toxic effects of therapy. However, recent improvements in care have dramatically enhanced the survival of SLE patients with the most severe and life-threatening manifestations. Unfortunately, current treatments for SLE remain inadequate as many patients have incompletely controlled the disease, progression to end-stage organ involvement continues, and current therapies carry potential risks of debilitating side effects. Therefore, it is important to clearly describe acceptable endpoints for approval to facilitate the development of novel therapeutic agents which have the potential to be more effective and/or less toxic. This draft guidance provides a general discussion of outcomes and measurements of lupus disease activity including the use of disease activity indices, flares, and organ-specific outcomes. It presents the indications that the agency may be willing to approve at present for new drug therapies for lupus. It also presents general trial design issues, discusses the use of surrogate endpoints in relation to lupus, presents the overall risk-benefit assessment that should be addressed for any new therapy of lupus, and presents some issues related to lupus and pharmacokinetics. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the draft guidance. Two copies of any mailed comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at http:// www.fda.gov/ohrms/dockets/ default.htm or http://www.fda.gov/cder/ guidance/index.htm. Dated: March 22, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–6085 Filed 3–28–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection Cancellation of Customs Broker License Due to Death of the License Holder Bureau of Customs and Border Protection, Department of Homeland Security. ACTION: General notice. AGENCY: SUMMARY: Notice is hereby given that, pursuant to Title 19 of the Code of Federal Regulations § 111.51(a), the following individual Customs broker licenses and any and all permits have been cancelled due to the death of the broker: Name License No. Enoch Van Hoesen ..................................................................................................................................................... Manuel A. Gonzalez ................................................................................................................................................... Sherry A. Ireland ......................................................................................................................................................... Joan P. Shindledecker ................................................................................................................................................ Robert E. Finley, Sr. ................................................................................................................................................... Gabe S. Fountain ....................................................................................................................................................... VerDate jul<14>2003 17:01 Mar 28, 2005 Jkt 205001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\29MRN1.SGM 29MRN1 2528 05742 22657 9808 3448 9170 Port name New York. Miami. Detroit. Baltimore. Mobile. Mobile. Federal Register / Vol. 70, No. 59 / Tuesday, March 29, 2005 / Notices Dated: March 18, 2005. William S. Heffelfinger III, Acting Assistant Commissioner, Office of Field Operations. [FR Doc. 05–6105 Filed 3–28–05; 8:45 am] DEPARTMENT OF HOMELAND SECURITY BILLING CODE 4820–02–P Notice of Cancellation of Customs Broker Permit Bureau of Customs and Border Protection ACTION: 15869 General Notice. SUMMARY: Pursuant to section 641 of the Tariff Act of 1930, as amended, (19 U.S.C. 1641) and the Customs Regulations (19 CFR 111.51), the following Customs broker local permits are canceled without prejudice. Bureau of Customs and Border Protection, U.S. Department of Homeland Security. AGENCY: Name Permit No. Issuing port Godwin Shipping Company, Inc ................................................................................................................................. Kamino International Transport, Inc ........................................................................................................................... Steven Hsien-Lin Wang dba WHL Customs Broker Services ................................................................................... Dynamic Ocean Services International, Inc ............................................................................................................... James P. Cesped ....................................................................................................................................................... Marvin Madden ........................................................................................................................................................... David Meth .................................................................................................................................................................. Robert Conyers ........................................................................................................................................................... 19–03–H39 00–014 200108 94–2101–1 26–02–WSK 19–03–J20 DF5 52–03–AUR Mobile. Houston. Los Angeles. Houston. Nogales. Mobile. Miami. Miami. Dated: March 18, 2005. William S. Heffelfinger III, Acting Assistant Commissioner, Office of Field Operations. [FR Doc. 05–6104 Filed 3–28–05; 8:45 am] BILLING CODE 4820–02–P DEPARTMENT OF THE INTERIOR Indian Arts and Craft Board Proposed Renewal of Information Collection for Source Directory Publication; Comment Request AGENCY: Indian Arts and Crafts Board, Interior. Notice. ACTION: SUMMARY: The Indian Arts and Crafts Board collects information to identify and revise listings for the Source Directory of American Indian and Alaska native owned and operated arts and crafts businesses. Comments on renewal of this collection are requested from the public. After the public review, we will submit the information collection to OMB–OIRA for review and re-approval as required by the Paperwork Reduction Act of 1995. DATES: Submit comments on or before May 3, 2005. ADDRESSES: Send your written comments to Attention: Indian Arts and Crafts Board, U.S. Department of the Interior, 1849 C Street, NW., MS–2058 MIB, Washington, DC 20240. If you wish to submit comments by facsimile, the number is (202) 208–5196, or you may send them by e-mail to ‘‘iacb@ios.doi.gov.’’ Please mention that your comments concern the Source Directory. VerDate jul<14>2003 17:01 Mar 28, 2005 Jkt 205001 FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the Source Directory application or renewal forms, i.e., the information collection instruments, should be directed to Meridith Z. Stanton, Director, Indian Arts and Crafts Board, 1849 C Street, NW., MS 2058 MIB, Washington, DC 20240. You may also call (202) 208–3773 (not a toll free call), or send you request by e-mail to ‘‘iacb@ios.doi.gov’’ or by facsimile to (202) 208–5196. SUPPLEMENTARY INFORMATION: I. Abstract The Source Directory of American Indian and Alaska Native owned and operated arts and craft enterprises is a program of the Indian Arts and Crafts Board that promotes American Indian and Alaska Native arts and crafts. The Source Directory is a forty-one page fullcolor illustrated publication featuring fine examples of contemporary American Indian and Alaska Native art from the major cultural areas in the United States. The Source Directory also comes with a listing of American Indian and Alaska native owned and operated arts and crafts businesses. This listing is included as an insert in the back cover of the Source Directory. The service of being listed in this publication is provided free-of-charge to members of federally recognized tribes. Businesses listed in the Source Directory include American Indian and Alaska Native artists and craftspeople, cooperatives, tribal arts and crafts enterprises, businesses privately-ownedand-operated by American Indian and Alaska native artists, designers, and craftspeople, and businesses privately owned-and-operated by American PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Indian and Alaska Native merchants who retail and/or wholesale authentic Indian and Alaska native arts and crafts. Business listings in the Source Directory are arranged alphabetically by State. The Source Directory may be ordered from either the Oklahoma Arts and Crafts Cooperative, P.O. Box 966, Anadarko, Oklahoma 73005 or the Sioux Indian Museum, 222 New York Street, Rapid City, South Dakota 57701, for a cost of $11.50 which includes shipping and handling. The business listings are also available on the Board’s Web site located at http:// www.iacb.doi.gov. The Director of the Board uses this information to determine whether an individual or business applying to be listed in the Source Directory meets the requirements for listing. The approved application will be printed in the Source Directory. The Source Directory is updated annually to include new businesses and to update existing information. II. Method of Collection To be listed in the Source Directory, interested individuals and businesses must submit: (1) A letter requesting an entry in the Source Directory, (2) a draft of their business information in a format like the other Source Directory listings, (3) a copy of the individual’s or business owner’s tribal enrollment card; and for businesses, proof that the business is organized under tribal, state, or federal law; and (4) a certification that the business is an American Indian or Alaska Native owned and operated cooperative, tribal enterprise, or nonprofit organization, or that the owner of the enterprise is an enrolled member of a federally recognized E:\FR\FM\29MRN1.SGM 29MRN1

Agencies

[Federal Register Volume 70, Number 59 (Tuesday, March 29, 2005)]
[Notices]
[Pages 15868-15869]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6105]


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DEPARTMENT OF HOMELAND SECURITY

Bureau of Customs and Border Protection


Cancellation of Customs Broker License Due to Death of the 
License Holder

AGENCY: Bureau of Customs and Border Protection, Department of Homeland 
Security.

ACTION: General notice.

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SUMMARY: Notice is hereby given that, pursuant to Title 19 of the Code 
of Federal Regulations Sec.  111.51(a), the following individual 
Customs broker licenses and any and all permits have been cancelled due 
to the death of the broker:

------------------------------------------------------------------------
              Name                   License No.           Port name
------------------------------------------------------------------------
Enoch Van Hoesen...............  2528                 New York.
Manuel A. Gonzalez.............  05742                Miami.
Sherry A. Ireland..............  22657                Detroit.
Joan P. Shindledecker..........  9808                 Baltimore.
Robert E. Finley, Sr...........  3448                 Mobile.
Gabe S. Fountain...............  9170                 Mobile.
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[[Page 15869]]

    Dated: March 18, 2005.
William S. Heffelfinger III,
Acting Assistant Commissioner, Office of Field Operations.
[FR Doc. 05-6105 Filed 3-28-05; 8:45 am]
BILLING CODE 4820-02-P