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Saturday, August 16, 2014



August 16, 2014:  New York, NY
By: Scott Anthony

Project BioShield is only one piece of the federal efforts to develop and acquire medical countermeasures to protect against CBRN (Chemical, Biological, Radiological & Nuclear) attacks. Homeland Security Presidential Directive 18 (HSPD-18), Medical Countermeasures Against Weapons of Mass Destruction, and Homeland Security Presidential Directive 21 (HSPD-21), Public Health and Medical Preparedness, provide the overall policy framework and strategy for federal efforts to develop and acquire CBRN countermeasures.

Implementation of the federal countermeasure strategy requires coordinated activities by several separate agencies. The interagency working group, the Public Health and Emergency Medical Countermeasure Enterprise (PHEMCE), is responsible for coordinating these activities to ensure federal countermeasure needs are addressed efficiently. The PHEMCE is headed by the HHS Assistant Secretary for Preparedness and Response and includes representatives from the FDA, Centers for Disease Control and Prevention, National Institutes of Health, Department of Defense, Department of Homeland Security, Department of Agriculture, and Department of Veterans Affairs.

As part of the Office of the Assistant Secretary for Preparedness and Response, the Biomedical Advanced Research and Development Authority (BARDA) manages and executes Project BioShield contracts. The Pandemic and All-Hazards Preparedness Act (P.L. 109-417 / 42 U.S.C. 300hh– 11
 et seq.) established BARDA to develop and procure medical countermeasures against CBRN agents, pandemic influenza, and emerging infectious diseases. In addition to supporting countermeasure development through Project BioShield, BARDA can contract with companies to develop and commercialize potential countermeasures. These contracts specify development activities for the company to perform and may extend multiple years. 

The BARDA typically uses such contracts to support advanced development of CBRN countermeasures that it has determined are not yet mature enough for a Project BioShield acquisition contract. Thus, BARDA has two separate mechanisms to support CBRN countermeasure advanced development and commercialization: countermeasure advanced development contracts and Project BioShield acquisition contracts with developmental milestone payments.

In theory, HHS can contribute to all phases of a countermeasure’s development: basic research supported by the National Institutes of Health and advanced development and commercialization supported by BARDA. HHS can purchase countermeasures using Project BioShield funds (through BARDA) or the Strategic National Stockpile funds (through the Centers for Disease Control and Prevention). 


Here are the facts, as presented by the CDC in an easy-to-digest format... I will also supply links to other laws, statutes and legislation that may or may not have been passed as suggested, but will give you an idea as to the thinking of our Legislative and Executive Branches here in the US:

Isolation and quarantine are public health practices used to stop or limit the spread of disease.
Isolation is used to separate ill persons who have a communicable disease from those who are healthy. Isolation restricts the movement of ill persons to help stop the spread of certain diseases. For example, hospitals use isolation for patients with infectious tuberculosis.
Quarantine is used to separate and restrict the movement of well persons who may have been exposed to a communicable disease to see if they become ill. These people may have been exposed to a disease and do not know it, or they may have the disease but do not show symptoms. Quarantine can also help limit the spread of communicable disease.
Isolation and quarantine are used to protect the public by preventing exposure to infected persons or to persons who may be infected.
In addition to serving as medical functions, isolation and quarantine also are “police power” functions, derived from the right of the state to take action affecting individuals for the benefit of society.

Federal isolation and quarantine are authorized for these communicable diseases:

  • Cholera
  • Diphtheria
  • Infectious tuberculosis
  • Plague
  • Smallpox
  • Yellow fever
  • Viral hemorrhagic fevers
  • Severe acute respiratory syndromes
  • Flu that can cause a pandemic

Federal isolation and quarantine are authorized by Executive Order of the President. The President can revise this list by Executive Order.

Federal Law

The federal government derives its authority for isolation and quarantine from the Commerce Clause of the U.S. Constitution.
Under section 361 of the Public Health Service Act (42 U.S. Code § 264), the U.S. Secretary of Health and Human Services is authorized to take measures to prevent the entry and spread of communicable diseases from foreign countries into the United States and between states.
The authority for carrying out these functions on a daily basis has been delegated to the Centers for Disease Control and Prevention (CDC).

CDC’s Role

Under 42 Code of Federal Regulations parts 70 and 71, CDC is authorized to detain, medically examine, and release persons arriving into the United States and traveling between states who are suspected of carrying these communicable diseases.
As part of its federal authority, CDC routinely monitors persons arriving at U.S. land border crossings and passengers and crew arriving at U.S. ports of entry for signs or symptoms of  communicable diseases.
When alerted about an ill passenger or crew  member by the pilot of a plane or captain of a ship, CDC may detain passengers and crew as  necessary to investigate whether the cause of the illness on board is a communicable disease.

State, Local, and Tribal Law

States have police power functions to protect the health, safety, and welfare of persons within their borders. To control the spread of disease within their borders, states have laws to enforce the use of isolation and quarantine.
These laws can vary from state to state and can be  specific or broad. In some states, local health authorities implement state law. In most states, breaking a quarantine order is a criminal misdemeanor.
Tribes also have police power authority to take actions that promote the health, safety, and welfare of their own tribal members. Tribal health authorities may enforce their own isolation and quarantine laws within tribal lands, if such laws exist.

Who Is in Charge

The federal government

  • Acts to prevent the entry of communicable diseases into the United States. Quarantine and isolation may be used at U.S. ports of entry.
  • Is authorized to take measures to prevent the spread of communicable diseases between states.
  • May accept state and local assistance in enforcing federal quarantine.
  • May assist state and local authorities in preventing the spread of communicable diseases.

State, local, and tribal authorities

  • Enforce isolation and quarantine within their borders.
It is possible for federal, state, local, and tribal health authorities to have and use all at the same time separate but coexisting legal quarantine power in certain events. In the event of a conflict, federal law is supreme.


If a quarantinable disease is suspected or identified, CDC may issue a federal isolation or quarantine order.
Public health authorities at the federal, state, local, and tribal levels may sometimes seek help from police or other law enforcement officers to enforce a public health order.  
U.S. Customs and Border Protection and U.S. Coast Guard officers are authorized to help enforce federal quarantine orders.
Breaking a federal quarantine order is punishable by fines and imprisonment.
Federal law allows the conditional release of persons from quarantine if they comply with medical monitoring and surveillance.

Federal Quarantine Rarely used

Large-scale isolation and quarantine was last enforced during the influenza (“Spanish Flu”) pandemic in 1918–1919. In recent history, only a few public health events have prompted federal isolation or quarantine orders.


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