Cancellation of Customs Broker License Due to Death of the License Holder, 15868-15869 [05-6105]
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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Draft Guidance for Industry on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availability of a draft guidance entitled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draft guidance is intended to provide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comments on the draft guidance by June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single copies of the draft guidance to the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comments on the draft guidance to the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 https://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electronic access to the draft guidance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a draft guidance for industry entitled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 https://
www.fda.gov/ohrms/dockets/
default.htm or https://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 .......................................................................................................................................................
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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.
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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
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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 https://
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
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[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.
-----------------------------------------------------------------------
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.
------------------------------------------------------------------------
[[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
