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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Records on this page
| Record | Date | Type | Pages |
|---|---|---|---|
| gates:exh:00028 | — | attachment | 54 |