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-------- Original Message --------
Subject: [Fwd: Federal Public Health Emergency Law - IHR]
Date: Tues, 28 Apr 2009 09:41:05 -0700
From: "Stephen M. Apatow" <s.m.apatow@pathobiologics.org>
To: ivphc.wg@pathobiologics.org


28 April 2009

Contact: Stephen M. Apatow
Founder, Director of Research & Development
Humanitarian Resource Institute (UN:NGO:DESA)
Humanitarian University Consortium Graduate Studies
Center for Medicine, Veterinary Medicine & Law
Phone: 203-668-0282
Email: s.m.apatow@humanitarian.net
Internet: www.humanitarian.net

Pathobiologics International
Internet: www.pathobiologics.org


IDIN: Pathobiologics International: Biodefense Threat Analysis & Communication Center
Subject: Pandemic Influenza: Contingency Planning Discussion

Dear Colleagues:

An immediate need has been presented for rapid diagnostics tools for H1N1, see:  Testing for swine flu no easy feat, expert says, Reuters, 28 April 2009.

Note: Emergency Use of Investigational Drugs (EUA) (CDC COCA Conference: Federal Public Health Emergency Law - Implications for State and Local Preparedness and Response, ppt, pg. 43):
  • The Secretary may authorize use of unapproved new drugs, unlicensed biological products, or unapproved/not cleared medical devices to respond to an emergency involving a chemical, biological, radiological, or nuclear agent .
  • Serious or Life-Threatening Disease or Condition .
  • Reasonable to believe product may be effective, known and potential benefits outweigh potential risks, no adequate, approved, available alternative.
  • Applies to unapproved products and unapproved uses of approved products, FFDCA 564.
As per requests for Swine Flu Legal Preparedness materials available through the CDC: Public Health Law Program web site:

Note: Following 2003 SARS, the World Health Organization (WHO) revised the International Health Regulations (IHR) that provide an operational definition of a “public health emergency of international concern” that triggers increased control responsibilities for nations.

Related:

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