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15868 Federal Register / Vol. 70, No.

59 / Tuesday, March 29, 2005 / Notices

DEPARTMENT OF HEALTH AND Administration, 9201 Corporate on this topic. It does not create or confer
HUMAN SERVICES Blvd., suite N316, Rockville, MD any rights for or on any person and does
20850, 301–827–2090; or not operate to bind FDA or the public.
Food and Drug Administration Jeffrey N. Siegel, Center for Drug An alternative approach may be used if
Evaluation and Research (HFD– such approach satisfies the
[Docket No. 2005D–0106]
108), Food and Drug requirements of the applicable statutes
Draft Guidance for Industry on Administration, 5600 Fishers Lane, and regulations.
Systemic Lupus Erythematosus— Rockville, MD 20857, 301–594–
5667. II. Comments
Developing Drugs for Treatment;
Availability SUPPLEMENTARY INFORMATION: Interested persons may submit to the
Division of Dockets Management (see
AGENCY: Food and Drug Administration, I. Background ADDRESSES) written or electronic
HHS. FDA is announcing the availability of comments on the draft guidance. Two
ACTION: Notice. a draft guidance for industry entitled copies of any mailed comments are to be
‘‘Systemic Lupus Erythematosus— submitted, except that individuals may
SUMMARY: The Food and Drug Developing Drugs for Treatment.’’ SLE submit one copy. Comments are to be
Administration (FDA) is announcing the is a chronic disease characterized by identified with the docket number
availability of a draft guidance entitled protean manifestations often found in brackets in the heading of this
‘‘Systemic Lupus Erythematosus— demonstrating a waxing and waning document. The draft guidance and
Developing Drugs for Treatment.’’ The course. In the past, a diagnosis of SLE received comments may be seen in the
draft guidance is intended to provide often implied a decreased life span due Division of Dockets Management
recommendations for industry on to internal organ system involvement or between 9 a.m. and 4 p.m., Monday
developing drugs for the treatment of to toxic effects of therapy. However, through Friday.
systemic lupus erythematosus (SLE). recent improvements in care have
Specific topics include measurement of III. Electronic Access
dramatically enhanced the survival of
lupus disease activity and clinical SLE patients with the most severe and Persons with access to the Internet
outcomes, reduction in disease activity life-threatening manifestations. may obtain the document at http://
and flares, treatment of organ-specific Unfortunately, current treatments for www.fda.gov/ohrms/dockets/
disease, trial design issues and analysis, SLE remain inadequate as many patients default.htm or http://www.fda.gov/cder/
surrogate markers as endpoints, and have incompletely controlled the guidance/index.htm.
risk-benefit assessment. disease, progression to end-stage organ Dated: March 22, 2005.
DATES: Submit written or electronic involvement continues, and current Jeffrey Shuren,
comments on the draft guidance by June therapies carry potential risks of
Assistant Commissioner for Policy.
27, 2005. General comments on agency debilitating side effects. Therefore, it is
important to clearly describe acceptable [FR Doc. 05–6085 Filed 3–28–05; 8:45 am]
guidance documents are welcome at any
time. endpoints for approval to facilitate the BILLING CODE 4160–01–S

ADDRESSES: Submit written requests for development of novel therapeutic agents


single copies of the draft guidance to the which have the potential to be more
Division of Drug Information (HFD– effective and/or less toxic.
This draft guidance provides a general DEPARTMENT OF HOMELAND
240), Center for Drug Evaluation and SECURITY
Research, Food and Drug discussion of outcomes and
measurements of lupus disease activity
Administration, 5600 Fishers Lane, Bureau of Customs and Border
including the use of disease activity
Rockville, MD 20857. Submit written Protection
indices, flares, and organ-specific
comments on the draft guidance to the
outcomes. It presents the indications Cancellation of Customs Broker
Division of Dockets Management (HFA–
that the agency may be willing to License Due to Death of the License
305), Food and Drug Administration,
approve at present for new drug Holder
5630 Fishers Lane, rm. 1061, Rockville,
therapies for lupus. It also presents
MD 20852. Submit electronic comments
general trial design issues, discusses the AGENCY: Bureau of Customs and Border
to http://www.fda.gov/dockets/
use of surrogate endpoints in relation to Protection, Department of Homeland
ecomments. Send one self-addressed
lupus, presents the overall risk-benefit Security.
adhesive label to assist the office in
assessment that should be addressed for ACTION: General notice.
processing your requests. See the
any new therapy of lupus, and presents
SUPPLEMENTARY INFORMATION section for
some issues related to lupus and SUMMARY: Notice is hereby given that,
electronic access to the draft guidance pursuant to Title 19 of the Code of
pharmacokinetics.
document. This draft guidance is being issued Federal Regulations § 111.51(a), the
FOR FURTHER INFORMATION CONTACT: consistent with FDA’s good guidance following individual Customs broker
Joel Schiffenbauer, Center for Drug practices regulation (21 CFR 10.115). licenses and any and all permits have
Evaluation and Research (HFD– The draft guidance, when finalized, will been cancelled due to the death of the
550), Food and Drug represent the agency’s current thinking 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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Federal Register / Vol. 70, No. 59 / Tuesday, March 29, 2005 / Notices 15869

Dated: March 18, 2005. DEPARTMENT OF HOMELAND ACTION: General Notice.


William S. Heffelfinger III, SECURITY
Acting Assistant Commissioner, Office of SUMMARY: Pursuant to section 641 of the
Field Operations. Bureau of Customs and Border Tariff Act of 1930, as amended, (19
[FR Doc. 05–6105 Filed 3–28–05; 8:45 am]
Protection U.S.C. 1641) and the Customs
BILLING CODE 4820–02–P Regulations (19 CFR 111.51), the
Notice of Cancellation of Customs
Broker Permit following Customs broker local permits
are canceled without prejudice.
AGENCY: Bureau of Customs and Border
Protection, U.S. Department of
Homeland Security.

Name Permit No. Issuing port

Godwin Shipping Company, Inc ................................................................................................................................. 19–03–H39 Mobile.


Kamino International Transport, Inc ........................................................................................................................... 00–014 Houston.
Steven Hsien-Lin Wang dba WHL Customs Broker Services ................................................................................... 200108 Los Angeles.
Dynamic Ocean Services International, Inc ............................................................................................................... 94–2101–1 Houston.
James P. Cesped ....................................................................................................................................................... 26–02–WSK Nogales.
Marvin Madden ........................................................................................................................................................... 19–03–J20 Mobile.
David Meth .................................................................................................................................................................. DF5 Miami.
Robert Conyers ........................................................................................................................................................... 52–03–AUR Miami.

Dated: March 18, 2005. FOR FURTHER INFORMATION CONTACT: Indian and Alaska Native merchants
William S. Heffelfinger III, Requests for additional information or who retail and/or wholesale authentic
Acting Assistant Commissioner, Office of copies of the Source Directory Indian and Alaska native arts and crafts.
Field Operations. application or renewal forms, i.e., the Business listings in the Source Directory
[FR Doc. 05–6104 Filed 3–28–05; 8:45 am] information collection instruments, are arranged alphabetically by State.
BILLING CODE 4820–02–P should be directed to Meridith Z. The Source Directory may be ordered
Stanton, Director, Indian Arts and Crafts from either the Oklahoma Arts and
Board, 1849 C Street, NW., MS 2058 Crafts Cooperative, P.O. Box 966,
DEPARTMENT OF THE INTERIOR MIB, Washington, DC 20240. You may Anadarko, Oklahoma 73005 or the
also call (202) 208–3773 (not a toll free Sioux Indian Museum, 222 New York
Indian Arts and Craft Board call), or send you request by e-mail to Street, Rapid City, South Dakota 57701,
‘‘iacb@ios.doi.gov’’ or by facsimile to for a cost of $11.50 which includes
Proposed Renewal of Information (202) 208–5196. shipping and handling. The business
Collection for Source Directory SUPPLEMENTARY INFORMATION: listings are also available on the Board’s
Publication; Comment Request Web site located at http://
I. Abstract
www.iacb.doi.gov.
AGENCY: Indian Arts and Crafts Board, The Source Directory of American The Director of the Board uses this
Interior. Indian and Alaska Native owned and information to determine whether an
ACTION: Notice. operated arts and craft enterprises is a individual or business applying to be
program of the Indian Arts and Crafts listed in the Source Directory meets the
SUMMARY: The Indian Arts and Crafts
Board that promotes American Indian requirements for listing. The approved
Board collects information to identify and Alaska Native arts and crafts. The application will be printed in the
and revise listings for the Source Source Directory is a forty-one page full- Source Directory. The Source Directory
Directory of American Indian and color illustrated publication featuring is updated annually to include new
Alaska native owned and operated arts fine examples of contemporary businesses and to update existing
and crafts businesses. Comments on American Indian and Alaska Native art information.
renewal of this collection are requested from the major cultural areas in the
from the public. After the public review, United States. The Source Directory also II. Method of Collection
we will submit the information comes with a listing of American Indian To be listed in the Source Directory,
collection to OMB–OIRA for review and and Alaska native owned and operated interested individuals and businesses
re-approval as required by the arts and crafts businesses. This listing is must submit: (1) A letter requesting an
Paperwork Reduction Act of 1995. included as an insert in the back cover entry in the Source Directory, (2) a draft
DATES: Submit comments on or before of the Source Directory. of their business information in a format
May 3, 2005. The service of being listed in this like the other Source Directory listings,
ADDRESSES: Send your written publication is provided free-of-charge to (3) a copy of the individual’s or business
comments to Attention: Indian Arts and members of federally recognized tribes. owner’s tribal enrollment card; and for
Crafts Board, U.S. Department of the Businesses listed in the Source businesses, proof that the business is
Interior, 1849 C Street, NW., MS–2058 Directory include American Indian and organized under tribal, state, or federal
MIB, Washington, DC 20240. If you Alaska Native artists and craftspeople, law; and (4) a certification that the
wish to submit comments by facsimile, cooperatives, tribal arts and crafts business is an American Indian or
the number is (202) 208–5196, or you enterprises, businesses privately-owned- Alaska Native owned and operated
may send them by e-mail to and-operated by American Indian and cooperative, tribal enterprise, or
‘‘iacb@ios.doi.gov.’’ Please mention that Alaska native artists, designers, and nonprofit organization, or that the
your comments concern the Source craftspeople, and businesses privately owner of the enterprise is an enrolled
Directory. owned-and-operated by American member of a federally recognized

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