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Project Bioshield Act And Pandemic And All-Hazards Preparedness Reauthorization Act Of 2013

Drareg

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Joined
Feb 18, 2016
Messages
3,819
Interesting pieces of legislation in the USA enacted in 2004 and 2013 -Project Bioshield Act - Wikipedia

"The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack.[1] This was a ten-year program to acquire medical countermeasures to biological, chemical, radiological, and nuclear agents for civilian use. A key element of the Act was to allow stockpiling and distribution of vaccines which had not been tested for safety or efficacy in humans, due to ethical concerns. Efficacy of such agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated, so testing follows the FDA Animal Rule for pivotal animal efficacy.

"Allows security countermeasures to be procured using the special reserve fund (an appropriations account set up by to this Act). A "security countermeasure" is a countermeasure that is either authorized for emergency use or that the Secretary determines is a priority, is necessary, and is an approved drug or a drug reasonably likely to be approved within eight years"

"Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to authorize the use of a drug, device, or biological product intended for emergency use, specifically allowing the use of unapproved products"

"A 2005 review reported that the project had an advanced appropriation for countermeasures—ranging from vaccines to biodosimetry to surveillance—related to biological weapons and other WMD"


Pandemic and All-Hazards Preparedness Reauthorization Act of 2013
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 - Wikipedia

"The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub.L. 113–5, H.R. 307, enacted March 13, 2013) is a law enacted by the 113th United States Congress. The Act amends the Public Health Service Act in order to extend, fund, and improve several programs designed to prepare the United States and health professionals in the event of a pandemic, epidemic, or biological, chemical, radiological, or nuclear accident or attack. The Act clarifies the authority of different American officials, makes it easier to temporarily reassign personnel to respond to emergency situations, and alters the process for testing and producing medical countermeasures. The Act is focused on improving preparedness for any public health emergency.

"Section 401 would also reauthorize the Project BioShield Special Reserve Fund (SRF), originally established in 2004. It would reauthorize the SRF at $2.8 billion for FY 2014 – 2018, which is consistent with the original appropriation of $5.6 billion over FY 2004 – 2013. The new law prohibits SRF funds from being used for anything other than medical countermeasures procurement, research and development. It requires the Secretary of Health and Human Services to provide a report to Congress when funds available in the SRF go below $1.5 billion. It would also allow the use of up to 50 percent of funds available in the SRF for advanced research and development of medical countermeasures at the Biomedical Advanced Research and Development Authority (BARDA)"

"Section 402 also extends the Freedom of Information Act (FOIA) exemption for specific technical data or scientific information that is created or obtained during countermeasure and product advanced research and development under the Public Health Service Act that reveals significant and not otherwise known vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats. It likewise extends the antitrust exemption to permit meetings and consultations to discuss the development of security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products"
 

Regina

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Aug 17, 2016
Messages
3,916
Location
Chicago
Interesting pieces of legislation in the USA enacted in 2004 and 2013 -Project Bioshield Act - Wikipedia

"The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack.[1] This was a ten-year program to acquire medical countermeasures to biological, chemical, radiological, and nuclear agents for civilian use. A key element of the Act was to allow stockpiling and distribution of vaccines which had not been tested for safety or efficacy in humans, due to ethical concerns. Efficacy of such agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated, so testing follows the FDA Animal Rule for pivotal animal efficacy.

"Allows security countermeasures to be procured using the special reserve fund (an appropriations account set up by to this Act). A "security countermeasure" is a countermeasure that is either authorized for emergency use or that the Secretary determines is a priority, is necessary, and is an approved drug or a drug reasonably likely to be approved within eight years"

"Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to authorize the use of a drug, device, or biological product intended for emergency use, specifically allowing the use of unapproved products"

"A 2005 review reported that the project had an advanced appropriation for countermeasures—ranging from vaccines to biodosimetry to surveillance—related to biological weapons and other WMD"


Pandemic and All-Hazards Preparedness Reauthorization Act of 2013
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 - Wikipedia

"The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub.L. 113–5, H.R. 307, enacted March 13, 2013) is a law enacted by the 113th United States Congress. The Act amends the Public Health Service Act in order to extend, fund, and improve several programs designed to prepare the United States and health professionals in the event of a pandemic, epidemic, or biological, chemical, radiological, or nuclear accident or attack. The Act clarifies the authority of different American officials, makes it easier to temporarily reassign personnel to respond to emergency situations, and alters the process for testing and producing medical countermeasures. The Act is focused on improving preparedness for any public health emergency.

"Section 401 would also reauthorize the Project BioShield Special Reserve Fund (SRF), originally established in 2004. It would reauthorize the SRF at $2.8 billion for FY 2014 – 2018, which is consistent with the original appropriation of $5.6 billion over FY 2004 – 2013. The new law prohibits SRF funds from being used for anything other than medical countermeasures procurement, research and development. It requires the Secretary of Health and Human Services to provide a report to Congress when funds available in the SRF go below $1.5 billion. It would also allow the use of up to 50 percent of funds available in the SRF for advanced research and development of medical countermeasures at the Biomedical Advanced Research and Development Authority (BARDA)"

"Section 402 also extends the Freedom of Information Act (FOIA) exemption for specific technical data or scientific information that is created or obtained during countermeasure and product advanced research and development under the Public Health Service Act that reveals significant and not otherwise known vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats. It likewise extends the antitrust exemption to permit meetings and consultations to discuss the development of security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products"
eww. Good find.
 

Regina

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Joined
Aug 17, 2016
Messages
3,916
Location
Chicago
It's come to the point that I think all our overlords are basically this kid:


If I eliminate everyone who can see me, I won't feel shame.
 
Last edited:

Drareg

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Thread starter
Joined
Feb 18, 2016
Messages
3,819
eww. Good find.

This is big money even if the vaccines are not used , this legislation frees up money and adequate testing laws don’t have to be passed.

They will also be granted legal "immunity" if their are side effects ,indemnification.
 
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