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Statement of Need: The quarantine or isolation of persons believed to be infected with or exposed to a communicable disease are public health prevention measures that have been used effectively to contain the spread of disease. As diseases evolve due to natural occurrences or man-made events, it is important to ensure that prevention procedures reflect new threats and uniform ways to contain them. Recent experiences with emerging infectious diseases such as West Nile Virus, SARS, and monkeypox have illustrated both the rapidity with which disease may spread throughout the world and the impact that communicable diseases, when left unchecked, may have on the global economy. Stopping an outbreak—whether it is naturally occurring or intentionally caused—requires the use of the most rapid and effective public health tools available. Two of these tools are isolation and quarantine. Isolation refers to the separation or restriction of movement of ill persons with an infectious disease in order to prevent transmission to those who are not ill. Quarantine refers to the separation and restriction of movement of persons who, while not yet ill, have been exposed to an infectious agent and therefore may become infectious. Isolation and quarantine of ill and exposed persons may be one of the best initial strategies to prevent the uncontrolled spread of highly dangerous biologic agents—especially when combined with other health strategies such as vaccination, prophylactic drug treatment, and other appropriate infection control measures.

Summary of the Legal Basis: These regulations would be proposed under the authority of 25 U.S.C. 198, 231, 2001; 42 U.S.C. 243, 264 to 271. In addition, section 361(b) of the Public Health Service Act (42 U.S.C. 264(b)) authorizes the “apprehension, detention, or conditional release” of persons to prevent the introduction, transmission, and spread of specified communicable diseases from foreign countries into the United States and from one State or possession into another. Among other public health powers, the lawful ability to inspect property, to medically examine and monitor persons, and to detain or quarantine exists in current regulations. Acknowledging the critical importance of protecting the public’s health, long-standing court decisions uphold the ability of Congress and State legislatures to enact quarantine and other public health laws and to have them executed by public health officials.

Alternatives: These regulations are necessary to ensure that HHS has the tools it needs to respond to public health emergencies and disease threats. Any less stringent alternatives would prevent the Department from the most effective possible pursuit of this objective.

Anticipated Costs and Benefits: The primary cost impact of the proposed rule would be data collection, transmission, storage and retrieval, and costs associated with contact tracing. The benefits of this rule will offer procedures that more completely describe the 21st century implementation of disease containment measures such as isolation and quarantine. These procedures are expected to expedite and improve CDC operations by allowing immediate medical follow-up of potentially infected passengers and their contacts. The benefits of the rule would be measured in terms of the number of deaths and illnesses prevented by rapid intervention.

Risks: Failure to move forward with this rulemaking would hinder the Nation’s ability to use the most rapid and effective public health tools available when responding to public health emergencies and disease threats.