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The book provides a thorough review of the U.S. health care system, including its organization and financing, care delivery, recent reforms, and an evaluation of the system's performance.
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
The National Protection Framework describes what the whole community should do to safeguard against acts of terrorism, natural disasters, and other threats or hazards. It describes the core capabilities; roles and responsibilities; and coordinating structures that facilitate the protection of individuals, communities, and the Nation. This Framework is focused on actions to protect against the greatest risks in a manner that allows American interests, aspirations, and way of life to thrive. The Federal Government works collaboratively with local, state, tribal, and territorial governments; the private sector; and nongovernmental organizations (NGOs) to develop and deliver Protection core capabilities. Protection core capabilities are applied in varying degrees to achieve successful implementation of the Protection mission area. The 11 core capabilities described in the National Protection Framework are Planning; Public Information and Warning; Operational Coordination; Access Control and Identity Verification; Cybersecurity; Intelligence and Information Sharing; Interdiction and Disruption; Physical Protective Measures; Risk Management for Protection Programs and Activities; Screening, Search and Detection; and Supply Chain Integrity and Security. The following principles guide the development and support the execution and deployment of Protection core capabilities. These guiding principles are resilience and scalability; risk-informed culture; and shared responsibility.