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<!-- From DocTemplateOld.txt -->
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<TITLE>NOT-OD-02-013: FEDERAL GOVERNMENT CLEARANCES FOR RECEIPT OF INTERNATIONAL SHIPMENT OF HUMAN EMBRYONIC STEM CELLS</TITLE>
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: FEDERAL GOVERNMENT CLEARANCES FOR RECEIPT OF INTERNATIONAL SHIPMENT OF HUMAN EMBRYONIC STEM CELLS NOT-OD-02-013. NIH">
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<META NAME="Keywords" CONTENT="NOT-OD-02-013: FEDERAL GOVERNMENT CLEARANCES FOR RECEIPT OF INTERNATIONAL SHIPMENT OF HUMAN EMBRYONIC STEM CELLS">
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FEDERAL GOVERNMENT CLEARANCES FOR RECEIPT OF INTERNATIONAL SHIPMENT OF HUMAN
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EMBRYONIC STEM CELLS
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Release Date: November 16, 2001
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NOTICE: NOT-OD-02-013
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National Institutes of Health
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Many of the sources of human embryonic stem cells are located in countries
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other than the United States. For investigators wishing to conduct federal
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research using human embryonic stem cells, permission may be required for
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their importation. Several U.S. federal government agencies have policies in
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place for the importation of biological specimens. This document explains
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them and provides agency contacts and additional information. Some countries
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may have additional requirements for exportation, but NIH does not know of
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specific cases at the present time. Therefore, this issue is not addressed in
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this document.
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The primary concern about importation of human embryonic stem cells pertains
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to their potential infectious properties, such as bovine spongiform
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encephalopathy (BSE) i.e., mad cow disease. All of the sources of human
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embryonic stem cells known to the NIH are aware of the Federal government
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needs for permits for importation. Specific requirements pertain to the use
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of bovine serum albumin products that were used in human embryonic stem cell
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research in foreign countries that may have BSE. Federal agencies require
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information about the certified sources of bovine serum albumin that originate
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from sources in countries that may have BSE.
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All investigators receiving human embryonic stem cells from international
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sources should consider obtaining the following:
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o United States Department of Agriculture (USDA) Permits to Import or
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Transport Controlled Material or Organisms or Vectors (Forms 16-3 and
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16-7).
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o Background information regarding importation requirements, forms, and
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fees can be obtained at the following website:
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http://www.aphis.usda.gov/ncie/. On-line applications can be completed
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at this site or the forms can be downloaded from this site (both form
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16-3 and the supplemental form16-7 are required.
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<a href="http://www.aphis.usda.gov/forms/vs16-3.pdf">http://www.aphis.usda.gov/forms/vs16-3.pdf</a>
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<a href="http://www.aphis.usda.gov/forms/vs16-7s.pdf">http://www.aphis.usda.gov/forms/vs16-7s.pdf</a>
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o Additional information can be obtained by contacting Dr. Linda Kahn,
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NCIE-Import Products Veterinary Services, National Center for Import and
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Export, 4700 River Road, Unit 40, Riverdale, MD 20737-1232. Tel: (301)
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734-3277, fax (301) 723-8226.
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Some investigators receiving human embryonic stem cells from international
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sources may wish to apply for additional permits for the receipt of cells and
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tissues that may harbor agents or vectors of human disease.
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o The Centers for Disease Control and Prevention has a separate policy and
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permit process for importation of biologic products that may harbor
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etiologic agents that cause human disease. Information about this process
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may be obtained from the Office of Health and Safety Information (Ohasis)
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<a href="https://www.cdc.gov/od/ohs/">http://www.cdc.gov/od/ohs/</a>
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The CDC application for permit for import or transport of agents or
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vectors of human disease is document #101000 and can be found at
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<a href="https://www.cdc.gov/od/ohs/biosfty/imprtper.htm">http://www.cdc.gov/od/ohs/biosfty/imprtper.htm</a>
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Additional information can be obtained by contacting Dr. Jonathan Y.
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Richmond at the Centers for Disease Control and Prevention, Office of
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Health and Safety, 1600 Clifton Road, N.E., Mail Stop F05 Atlanta, GA
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30333.
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o The U.S. Food and Drug Administration (FDA) does not issue importation
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permits for cell lines. However, for clinical research applications
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that involve the use of human embryonic stem cells, the agency
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recommends that sponsors contact the FDA regarding policies for the
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manufacture of biological products. Contact information about these
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policies can be obtained from:
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FDA Office of Regulatory Affairs, Associate Commissioner for Regulatory
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Affairs, tel: (301) 827-3101 or <a href="http://www.fda.gov/ora">http://www.fda.gov/ora</a> , Joyce Frey-
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Vasconsells, Ph.D., Deputy Director, Center for Biologics Evaluation and
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Research/FDA, tel: (301) 827-5102 or email: <a href="/cdn-cgi/l/email-protection#7c0a1d0f1f13121f1910100f3c1f1e190e521a181d521b130a"><span class="__cf_email__" data-cfemail="81f7e0f2e2eeefe2e4ededf2c1e2e3e4f3afe7e5e0afe6eef7">[email protected]</span></a>, or
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Eda Bloom, Ph.D., Coordinator, Xenotransplantation Working Group,
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Division of Cell and Gene Therapy, Center for Biologics Evaluation and
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Research/FDA, tel: (301) 827-0452 or email: <a href="/cdn-cgi/l/email-protection#97f5fbf8f8fad7f4f5f2e5b9f1f3f6b9f0f8e1"><span class="__cf_email__" data-cfemail="f1939d9e9e9cb192939483df979590df969e87">[email protected]</span></a>.
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</pre>
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<P><HR><P>
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<A HREF="/grants/guide/WeeklyIndex.cfm?WeekEnding=11-16-01">Weekly TOC for this Announcement</A><br>
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<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
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