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U.S. Department of Health and Human Services

Emergency Preparedness and Response

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MCM-Related Legislation

 Federal Legislation: gavel and law booksSince 9/11, critical federal legislation has been enacted to strengthen the Nation’s preparedness for responding to public health emergencies involving chemical, biological, radiological, and nuclear (CBRN) as well as emerging infectious disease threats.  

Links to this relevant legislation and a brief overview can be found below.

Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) disclaimer icon (PDF, 284.20 KB)

PAHPRA was enacted in March 2013 to sustain and strengthen our country's preparedness for public health emergencies involving CBRN and infectious disease threats. The law reauthorizes provisions of the Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA), including the Special Reserve Fund, and establishes new authorities and response flexibilities. PAHPRA also recognizes the key role FDA plays in emergency preparedness and response by including provisions that further FDA’s mission of fostering the development and availability of medical countermeasures (MCMs) for use in these emergencies. PAHPRA also codifies and builds on FDA’s ongoing efforts to augment review processes and advance regulatory science for MCM development. You can find more information about PAHPRA’s MCM-related provisions on MCMi's web page 
Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA) disclaimer icon (PDF, 248.78 KB)

PAHPA was enacted in December 2006 to improve the nation’s public health and medical preparedness and response capabilities for emergencies, whether deliberate, accidental, or natural. Among other things, PAHPA amended the Public Health Service (PHS) Act to establish within the Department of Health and Human Services (HHS) a new Assistant Secretary for Preparedness and Response (ASPR). PAHPA also provided new authorities for programs like the Public Readiness and Emergency Preparedness Act of 2005 (PREP Act) disclaimer icon (PDF, 584.06 KB)

Enacted in December 2005, the PREP Act authorizes the Secretary of HHS (Secretary) to issue a declaration (called a PREP Act declaration) that provides immunity from tort liability (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures. A PREP Act declaration is specifically for the purpose of providing immunity from tort liability, and is different from, and not dependent on, other emergency declarations. The PREP Act also established a program to provide compensation for serious countermeasure injuries. For additional information about the PREP Act, click heredisclaimer icon. For additional information about the compensation program, click here disclaimer icon

Project BioShield Act of 2004 disclaimer icon (PDF, 191.70)

The Project BioShield Act of 2004 was designed to provide additional and more flexible authorities and funding to financially support the development and procurement of MCMs against CBRN threats. It also gave the FDA Commissioner the authority to issue Emergency Use Authorizations (EUAs) to authorize the use of unapproved medical products or unapproved uses of approved medical products during CBRN emergencies. These authorities were further delineated, clarified, expanded, and extended by PAHPA, which authorized the establishment of BARDA within HHS, and PAHPRA, which, among other things, reauthorized components of PAHPA and expanded the Secretary’s authorities to permit the use of unapproved products or unapproved uses of approved products during emergency.

Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)disclaimer icon

Among its provisions to strengthen the nation’s ability to respond to public health emergencies,
the Bioterrorism Act addressed the accelerated approval of priority MCMs and
the development of a final rule on animal models for when human efficacy studies are not feasible or
ethical. The Bioterrorism Act also established the Strategic National Stockpile (SNS) disclaimer icon and authorized
the Secretary of HHS, acting through FDA, to issue regulations to protect the nation's food and drug
supplies against bioterrorism and foodborne illness.




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