HHS Legal Authorities Related to Disasters and Emergencies

Forms the foundation of HHS’ legal authority for responding to public health emergencies; it authorizes the HHS Secretary to lead all Federal public health and medical response 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.

Amendments:

• Project BioShield Act of 2004
• Public Readiness and Emergency Preparedness (PREP) Act of 2005
• Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA)
• Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013
• 21st Century Cures Act of 2016
• Pandemic and All Hazards Preparedness and Advancing Innovation Act (PAHPAIA) of 2019

At the request of the Governor of an affected State, or a Chief Executive of an affected Indian Tribe, 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.
A Stafford Act declaration allows Federal assistance to be mobilized and directed in support of State, Tribal, and jurisdictional response efforts, among other things. 
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 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.

When the President declares a major disaster or an emergency under the Stafford Act or an emergency under the National Emergencies Act, and the HHS Secretary declares a  public health emergency, the Secretary is authorized to take certain actions in addition to his regular authorities under section 1135 of the Social Security Act.  He may waive or modify certain Medicare, Medicaid, Children’s Health Insurance Program (CHIP) and Health Insurance Portability and Accountability Act (HIPAA) requirements as necessary to ensure to the maximum extent feasible that, in an emergency area during an emergency period, sufficient health care items and services are available to meet the needs of individuals enrolled in Social Security Act (SSA) programs and that providers of such services in good faith who are unable to comply with certain statutory requirements are reimbursed and exempted from sanctions for noncompliance other than fraud or abuse.

The primary source of Presidential authorities used to expedite and expand the supply of critical resources (materials, services and facilities) from the private sector to support approved Homeland Security Programs.  Priority contracting, via priority contract ratings, helps ensure a timely response from the private sector in times of emergency.

The Federal Food, Drug, and Cosmetic Act is the foundation for FDA’s authority and responsibility to protect and promote the public health by, among other things, ensuring  the safety and effectiveness of human and veterinary drugs, biological products, and medical devices; and ensuring the safety and security of our nation’s food supply. 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, Emergency Use Authorization.