Strengthening Processes and Building Capacity to Facilitate Regulatory Review and Approval of Medical Countermeasures During Public Health Emergencies with the World Health Organization

fulfilling the goals of the International Health Regulations (2005) (IHR). The goals of this cooperative agreement are to strengthen the WHO processes to develop regulatory capacities at the national and/or regional level to review and be able to provide access to medical countermeasures during public health emergencies and foster stakeholder engagement and alignment of regulatory activities established. The International Health Regulations (2005) established the current global framework for health security collaboration and response coordination and states, in Article 44.1(a), that “States Parties shall undertake to collaborate with each other, to the extent possible, in the provision or facilitation of technical cooperation and logistical support, and the detection and assessment of, and response to, events as provided under these Regulations. The international deployment of medical countermeasures may be a critical component of response to the deliberate use or accidental release of chemical, biological, radiological, or nuclear (CBRN) agents or the spread of naturally occurring (including newly emerging) infectious diseases, such as pandemic influenza, in an increasingly interconnected world where these threats know no borders. As recognized by the after action review the WHO 2009 H1N1 Vaccine Deployment Initiative which highlighted that each recipient country had a unique regulatory process for ensuring that the vaccines were legally imported and distributed, ranging from one-time waivers to clinical trials for registration. A harmonized regulatory approach for emergencies would help to avoid bottlenecks related to regulatory processes. The experiences deploying diagnostics, vaccines, and medicines during other recent public health emergencies of international concern such as the Ebola virus disease and the Zika virus, ensuring that there are global frameworks to support the regulatory review of medical countermeasures during public health emergencies is critical to ensure deployment, distribution, and use in a timely manner. This FOA seeks to build upon the WHO Emergency Use Assessment and Listing (EUAL) procedures that the WHO developed for Ebola IVDs, vaccines and medicines, and Zika IVDs and laboratory technologies. The work accomplished under the 2014-2016 ASPR cooperative agreement to develop processes to facilitate the regulatory review and recommendation of using smallpox vaccine work accomplished under the 2014-2016 ASPR/WHO cooperative agreement to develop processes to facilitate the regulatory review and recommendation of using smallpox vaccine. This builds on recommendations from the WHO informal consultation on options to improve regulatory preparedness to address public health emergencies to strengthen global processes and capacities for the review and approval of medical countermeasures during public health emergencies. This FOA recognizes the unique and irreplaceable roles and responsibilities of the WHO to establish processes to support the development of global capacities for emergency regulatory review and process for provision of medical countermeasures within appropriate political and legal considerations aimed at enhancing international public health emergency preparedness, response, and recovery. This FOA calls for a proposal for a cooperative agreement that spans a wide range of collaborative activities with the potential to meet the strategic objectives of the United States Government, the U.S. Department of Health and Human Services (HHS), ASPR, and the WHO.