Humanitarian Resource Institute

-------- 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

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:

Declaration of a national public health emergency by HHS Acting Secretary Charles Johnson, April 26, 2009
Press release accompanying HHS declaration, April 26, 2009
Pandemic Influenza Legal Preparedness Tools
1. Case study: "Strengthening the Coordination of Public Health and Law Enforcement during an Influenza Pandemic"
2. Guide for Developing an MOU for Multi-sector Response to Pandemic Respiratory Disease
  - MOU tool for pandemic preparedness:"Coordinated Implementation of Community Response Measures (Including Social Distancing) to Control the Spread of Pandemic Respiratory Disease: A Guide for Developing an MOU for Public Health, Law Enforcement, Corrections, and the Judiciary"
  - Complete access to "Multi-sector Coordination" emergency preparedness tools
3. Pan-Flu Preparedness Legal Checklist for Healthcare Providers
  - Downloadable at: http://www2a.cdc.gov/phlp/docs/Pan-Flu08.pdf
  - Complete access to emergency legal preparedness tools
"State Swine Flu Information" posted by the Association of State and Territorial Health Officials (includes guidance to schools and providers/healthcare facilities, testing guidelines, travel advisories, fact sheets, state press releases, and state swine flu websites
Statement by WHO Director-General Dr. Margaret Chan, April 27, 2009
Article "The Swine Flu Outbreak and International Law," by David Fidler, April 27, 2009:

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:

IVPHC: Swine Flu: A/California/04/2009(H1N1) on Genbank: Humanitarian Resource Institute, 28 April 2009.
IVPHC: Swine Flu: Clinicians Biodefense Update: Humanitarian Resource Institute, 27 April 2009.
IVPHC: Swine Influenza - Mexico/US/International: Humanitarian Resource Institute, 24 April 2009.

Stephen M. Apatow
Founder, Director of Research and Development
Pathobiologics International

Humanitarian Resource Institute
.
Stephen M. Apatow
President, Director of Research and Development, Humanitarian University Consortium Graduate Studies Center for Medicine, Veterinary Medicine and Law

Tel: (203) 668-0282
Internet: www.humanitarian.net
Email: s.m.apatow@humanitarian.net

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