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

The summary for the Strengthening Processes and Building Capacity to Facilitate Regulatory Review and Approval of Medical Countermeasures During Public Health Emergencies with the World Health Organization grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Assistant Secretary for Preparedness and Response, which is the U.S. government agency offering this grant.
Strengthening Processes and Building Capacity to Facilitate Regulatory Review and Approval of Medical Countermeasures During Public Health Emergencies with the World Health Organization: This funding opportunity announcement (FOA)€“ Strengthening Processes and Building Capacity to Facilitate Emergency Regulatory Review and Approval of Medical Countermeasures During Public Health Emergencies with the World Health Organization is a request for a sole-source application from the World Health Organization (WHO) a cooperative agreement between ASPR and the WHO for fiscal years 2017-2019. The envisioned ASPR-WHO collaborative agreement continues the long-standing collaborations between the United States and the WHO aimed at safeguarding all countries from public health threats, and 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.
Federal Grant Title: Strengthening Processes and Building Capacity to Facilitate Regulatory Review and Approval of Medical Countermeasures During Public Health Emergencies with the World Health Organization
Federal Agency Name: Assistant Secretary for Preparedness and Response (HHS-OS-ASPR)
Grant Categories: Health Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: EP-IDS-17-006
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.019
CFDA Descriptions: Information not provided
Current Application Deadline: September 18th, 2017
Original Application Deadline: September 18th, 2017
Posted Date: July 19th, 2017
Creation Date: July 19th, 2017
Archive Date: October 18th, 2017
Total Program Funding: $200,000
Maximum Federal Grant Award: $500,000
Minimum Federal Grant Award: $75,000
Expected Number of Awards: 1
Cost Sharing or Matching: No
Last Updated: July 19th, 2017
Applicants Eligible for this Grant
For-profit organizations other than small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on Eligibility
Other private organizations; Health and Medical organizations.
Link to Full Grant Announcement
Strengthening Processes and Building Capacity to Facilitate Regulatory Review and Approval of Medical Countermeasures During Public Health Emergencies with the World Health Organization
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