Public Health Emergency - Leading a Nation Prepared
The PHS Act forms the foundation of HHS’ legal authority for responding to public health emergencies. Among other things, it authorizes the HHS Secretary to lead all Federal public health and medical response to public health emergencies and incidents covered by the National Response Framework; to direct the U.S. PHS and other components of the Department to respond to a public health emergency; to declare a public health emergency (PHE) and take such actions as may be appropriate to respond to the PHE consistent with existing authorities; to assist states in meeting health emergencies; to control communicable diseases; to maintain the Strategic National Stockpile; to provide for the operation of the National Disaster Medical System; to establish and maintain a Medical Reserve Corps; and to potentially provide targeted immunity for covered countermeasures to manufacturers, distributors, certain classes of people involved in the administration of a program to deliver covered treatments to patients, and their employees. The PHS Act was amended recently by the Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA) which has broad implications for the Department’s preparedness and response activities.
The Social Security Act authorizes Medicare, Medicaid, State Children’s Health Insurance (SCHIP), and social services programs of the Department. Among other things, it authorizes the Secretary to temporarily modify or waive certain Medicare, Medicaid, SCHIP, and HIPAA requirements when the Secretary has declared a public health emergency and the President has declared an emergency or a major disaster.
Federal Food, Drug and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act is the foundation for the HHS Secretary’s and FDA’s responsibility for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. Among other things, when certain conditions have occurred, it authorizes the Secretary to declare an emergency justifying emergency use authorization (EUA) of unapproved drugs, devices, or biological products, or emergency use authorization of approved drugs, devices, or biological products for an unapproved use. For more information about EUA, please see Food and Drug Administration Guidance, Emergency Use Authorization of Medical Products.
Robert T. Stafford Disaster Relief and Emergency Assistance Act
At the request of the Governor of an affected State, the President may declare a major disaster or emergency if an event is beyond the combined response capabilities of the State, Tribal, and jurisdictional governments. Among other things, this declaration allows Federal assistance to be mobilized and directed in support of State, Tribal, and jurisdictional response efforts. Under the Stafford Act (42 USC Chapter 68), the President can also declare an emergency without a Gubernatorial request if primary responsibility for response rests with the Federal Government because the emergency involves a subject area for which the United States exercises exclusive responsibility and authority. In addition, in the absence of a specific request, the President may provide accelerated Federal assistance and Federal support where necessary to save lives, prevent human suffering, or mitigate severe damage, and notify the State of that activity.
Learn more about Related Preparedness and Response Guidance >>
Learn more about the Secretary's Legal Authorities with and without a declaration >>
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