COVID-19 Records

Gates Package — page 54

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additional training and to get their questions answered from CDC experts. Clinicians can get updates on these events at www.cde.gov/Ebola, Training and educational sessions over the next month will include at least seven regional or national meetings/conferences calls, a major national web-based training event, and ongoing calls and webinars with partners to promote improved understanding of appropriate protocols and practices for the safe management of patients with Ebola in U.S. hospitals, Additionally, CDC is setting up a dedicated CDC Response Team that could be on the ground within a few hours at any hospital that receives a confirmed patient with Ebola, The CDC Response Team would provide in-person, expert support and training on infection control, healthcare safety, medical treatment, contact tracing, waste and decontamination, public education and other issues, The CDC Response Team would help ensure that clinicians, and state and local public health practitioners, consistently follow strict standards of protocol to ensure safety of the patient and health care workers, CDC is providing Public Health Emergency Preparedness cooperative agreement funding and assistance to state and local health departments for all-hazards preparedness, including infectious disease outbreaks, This funding and assistance helps public health departments develop capabilities that are applicable to responding to many public health threats, including Ebola, In regard to travel safety, CDC is working closely with the U.S. Department of Homeland Security's Customs and Border Protection (CBP) and other partners at U.S. ports of entry-- primarily international airports--to use enhanced screening measures to identify travelers who show signs of infectious disease. CBP is now conducting entry screening at five U.S. airports that receive over 94 percent of travelers from the Ebola-affected nations of Guinea, Liberia, and Sierra Leone, Additionally, CDC has been working with the U.S, Department of Transportation on guidance for the transportation and handling of Ebola-infected medical waste. The U.S. Food and Drug Administration (FDA) FDA is actively working to help advance the development of treatments, vaccines, and diagnostic tests with the potential to help bring the Ebola epidemic under control as quickly as possible, These efforts include providing scientific and regulatory advice to U.S. government agencies that support medical product development--including the National Institutes of Health, the Office of the Assistant Secretary for Preparedness and Response, CDC, and DoD--to help accelerate product development programs. Specific activities include: © Working with medical product sponsors to clarify regulatory requirements, review and provide input on pre-clinical and clinical trial designs (including studies that can potentially be conducted in West Africa), and expediting the regulatory review of data as it is received from product developers. This includes expediting the review of Investigational New Drug (IND) applications, which are required for FDA-regulated clinical trials of drugs and vaccines to proceed. For example, FDA rapidly reviewed IND applications for two investigational Ebola vaccines and, after such review, allowed them to proceed. © Collaborating with the World Health Organization (WHO) and other international regulatory counterparts--including the European Medicines Agency, Health Canada, and others--to

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