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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
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          Medical Countermeasures Initiative (MCMi)
          MCM Legal, Regulatory and Policy Framework
          Availability of Regulatory Management PlansMCM Legal, Regulatory and Policy Framework Availability of Regulatory Management Plans
  
  					Section 565(f) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 360bbb–4(f))
	
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Introduction to RMPs
	Process for submission and timing of response
	Information required for submission of a request
	Types of developmental milestones and performance targets
	MCMs eligible for RMPs
	Contact informationIntroduction to RMPs

The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as amended by the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA), furthered FDA’s mission of fostering the development and availability of medical countermeasures (MCMs) by codifying the development of Regulatory Management Plans (RMPs) for certain high-priority MCMs.

Under section 565(f) of the FD&C Act, sponsors or applicants of eligible MCMs can request an RMP, setting forth a formal process for obtaining scientific feedback and agency interactions regarding the development and regulatory review of eligible MCMs. Eligible MCMs are those for which the Biomedical Advanced Research and Development Authority (BARDA) has:

entered into a procurement contract under section 319F-2(c) of the Public Health Service (PHS) Act; or
	provided funding under section 319L of the PHS Act for advanced research and development.Process for submission and timing of response

Sponsors or applicants of eligible MCMs may submit a request for an RMP after the eligible MCM has an investigational new drug (IND) or investigational device exemption (IDE) in effect. A request for an RMP should be submitted as a filing to the IND or IDE.

Upon receipt of the request, FDA will work with the sponsor or applicant to agree on an RMP within a reasonable time not to exceed 90 days. If FDA determines that no plan can be agreed upon, FDA will provide to the sponsor or applicant, in writing, the scientific or regulatory rationale why such agreement cannot be reached.

Information required for submission of a request

Requests for an RMP that are submitted to FDA must include a proposed RMP with information sufficient to facilitate agreement. An agreed-upon RMP must include:

an agreement between FDA and the sponsor or applicant regarding developmental milestones that will trigger FDA responses;
	performance targets and goals for timely and appropriate FDA responses, including meetings between FDA and the sponsor or applicant, written feedback, decisions by FDA, and other activities carried out as part of the development and review process; and
	an agreement on how to modify the plan, if needed.Types of developmental milestones and performance targets

The developmental milestones and performance targets and goals within an RMP must include:

feedback from FDA regarding the data required to support the approval, clearance, or licensure of the eligible MCM;
	feedback from FDA regarding the data necessary to inform any authorization for emergency use;
	feedback from FDA regarding the data necessary to support the positioning and delivery of the eligible MCM, including to the Strategic National Stockpile;
	feedback from FDA regarding the data necessary to support the submission of protocols for review;
	feedback from FDA regarding any gaps in scientific knowledge that will need resolution prior to approval, licensure, or clearance of the eligible MCM and plans for conducting the necessary scientific research;
	identification of the population for which the MCM sponsor or applicant seeks approval, licensure, or clearance and the population for which desired labeling would not be appropriate, if known; and
	as necessary and appropriate, and to the extent practicable, a plan for demonstrating safety and effectiveness in pediatric populations, and for developing pediatric dosing, formulation, and administration with respect to the eligible MCM, provided that such plan would not delay authorization for emergency use, approval, licensure, or clearance for adults.MCMs eligible for RMPs

Under PAHPRA, MCMs eligible for RMPs are:

security countermeasures with respect to which the Secretary of HHS has entered into a procurement contract under section 319F-2(c) of the PHS Act (42 USCS § 247d-6b(c)); or
	MCMs with respect to which the Biomedical Advanced Research and Development Authority (BARDA) has provided funding under section 319L of the PHS Act (42 USCS § 247d-7e) for advanced research and development. (FD&C Act Sec. 565(f); 21 U.S.C. § 360bbb-4(f)).While RMPs are to be established for all security countermeasures for which they are requested, the Director of BARDA, in consultation with the FDA Commissioner, prioritizes which otherwise eligible MCMs may receive RMPs if resources are not available to establish RMPs for all eligible MCMs for which requests are submitted. (FD&C Act Sec. 565(f)(7); 21 U.S.C. § 360bbb-4(f))(7).

Contact information

To submit an RMP request, or for additional information related to the RMP request process, please contact your point of contact for the IND or IDE filing within the relevant Center, or the Office of Counterterrorism and Emerging Threats (OCET) at AskMCMi@fda.hhs.gov.

                                                                                  Content current as of:
      11/30/2022
              
              
Topic(s)
			  Terrorism
				    				       				    				       Radiological
				       				    				       Chemical
				       				    				       BiologicalLaw(s) & Regulation(s)
			  Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
			    			       			    			       Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
			       			    			       Federal Food, Drug & Cosmetic ActMCM 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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