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 In this section:

                MCM Legal, Regulatory and Policy Framework

MCM Legal, Regulatory and Policy Framework

                        Emergency Use Authorization
          Expiration Dating Extension
          MCM Emergency Use Authorities
          MCM-Related Counterterrorism Legislation
          MCM-Related Legal and Policy Presentations, Publications and Q&As
          State, Tribal, Local, and Territorial Public Health Preparedness
          Guidance and Other Information of Special Interest to MCM Stakeholders
          MCM-Related Cooperative Arrangements
          Availability of Regulatory Management Plans
          Vaccine EUA Questions and Answers for Stakeholders
          FAQs: What happens to EUAs when a public health emergency ends? Home
          Emergency Preparedness and Response
          Counterterrorism and Emerging Threats
          Medical Countermeasures Initiative (MCMi)
          MCM Legal, Regulatory and Policy Framework
          Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)MCM Legal, Regulatory and Policy Framework Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
  
  	
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    PrintThe Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) contains key legal authorities to sustain and strengthen our Nation's preparedness for public health emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, as well as emerging infectious disease threats.

The law also recognizes the key role FDA plays in public health emergency preparedness and response. Its provisions further FDA’s mission of fostering the development and availability of  drugs, vaccines, and devices (also referred to as medical countermeasures, or MCMs) for use in these emergencies. PAHPRA also builds on FDA’s ongoing efforts to enhance review processes and advance regulatory science for MCM development.

Together, these authorities for FDA not only support and facilitate government partners’ pre-event planning efforts and pre-positioning of MCMs, but also help to facilitate MCM development and the efficient and rapid deployment of these medical products in the event of a CBRN emergency or emerging disease health threat. FDA is implementing PAHPRA's MCM-related provisions to support our nation’s preparedness and response capabilities, and continues to provide the highest quality and most timely guidance possible to all stakeholders engaged in MCM product development.

PAHPRA Legislative Information

Public Law 113-5 (PDF, 284 KB)
	Summary of PAHPRA’s MCM provisions
	PAHPRA Questions and Answers(Archived - PDF, 250 KB)
	PAHPRA information from the HHS Assistant Secretary for Preparedness and ResponseEmergency Use of MCMs

MCM emergency use authorities
	Current Emergency Use Authorizations
	Summary of process for EUA issuance
	Emergency use of approved MCMsPAHPRA Authorities Related to MCM Development

Animal Rule informationRelated Links

MCMi Program Update (most recent report)
	MCMi Publications and Reports(including previous program updates)
	Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA)
	21st Century Cures Act: MCM-Related Cures Provisions
	Public Readiness and Emergency Preparedness (PREP) Act

                                                                                  Content current as of:
      12/19/2022
              
              
Topic(s)
			  Emergency Response
				    				       				    				       Emergencies
				       				    				       Terrorism
				       				    				       Radiological
				       				    				       Outbreak
				       				    				       Chemical
				       				    				       BiologicalLaw(s) & Regulation(s)
			  Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)MCM Legal, Regulatory and Policy Framework

          
                        Emergency Use Authorization
          Expiration Dating Extension
          MCM Emergency Use Authorities
          MCM-Related Counterterrorism Legislation
          MCM-Related Legal and Policy Presentations, Publications and Q&As
          State, Tribal, Local, and Territorial Public Health Preparedness
          Guidance and Other Information of Special Interest to MCM Stakeholders
          MCM-Related Cooperative Arrangements
          Availability of Regulatory Management Plans
          Vaccine EUA Questions and Answers for Stakeholders
          FAQs: What happens to EUAs when a public health emergency ends?
 
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