04-1631. Amendment To Extend the January 24, 2003, Declaration Regarding Administration of Smallpox Countermeasures

AGENCY:

Office of the Secretary (OS), Department of Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

Concern that terrorists may have access to the smallpox virus and attempt to use it against the American public and United States Government facilities abroad continues to exist. The January 24, 2003, declaration regarding administration of smallpox countermeasures is revised to incorporate statutory definitions from the Smallpox Emergency Personnel Protection Act of 2003 and extended for one year until and including January 23, 2005.

DATES:

This notice and the attached amendment are effective as of January 24, 2004.

FOR FURTHER INFORMATION CONTACT:

William F. Raub, PhD, Acting Assistant Secretary for the Office of Public Health Emergency Preparedness, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue, SW., Washington, DC 20201, Telephone [phone] (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

Section 224(p) of the Public Health Service Act, which was established by section 304 of the Homeland Security Act of 2002 and amended by section 3 of the Smallpox Emergency Personnel Protection Act of 2003 (“SEPPA”), is intended to alleviate certain liability concerns associated with administration of smallpox countermeasures and, therefore, ensure that the countermeasures are available and can be administered in the event of a smallpox-related actual or potential public health emergency such as a bioterrorist incident.

On January 24, 2003, due to concerns that terrorists may have access to the smallpox virus and attempt to use it against the American public and U.S. Government facilities abroad, the Secretary issued a declaration making section 224's legal protections available. The declaration was effective until and including January 23, 2004; it included in section VI a number of definitions, which are no longer appropriate because of the statutory amendments in section 3 of SEPPA. The Secretary issues the amendment below to: (1) Delete the section VI definitions, and (2) extend the January 24, 2003, declaration pursuant to section 224(p)(2)(A) of the Public Health Service Act. In deleting the definitions, the Secretary does not intend to adopt an interpretation of the statutory amendments as limiting or denying the remedy of section 224(a) in any situation where it would have been available under the statute as originally enacted and the January 24, 2003, declaration.

Amendment To Extend January 24, 2003 Declaration Regarding Administration of Smallpox Countermeasures

I. Policy Determination: The underlying policy determinations of the January 24, 2003 declaration continue to exist, including the heightened concern that terrorists may have access to the smallpox virus and attempt to use it against the American public and U.S. Government facilities abroad.

II. Amendment of Declaration: I, Tommy G. Thompson, Secretary of the Department of Health and Human Services, have concluded, in accordance with the authority vested in me under section 224(p)(2)(A) of the Public Health Service Act, that a potential bioterrorist incident makes it advisable to extend the January 24, 2003 declaration regarding administration of smallpox countermeasures until and including January 23, 2005. The January 24, 2003, declaration as hereby amended may be further amended as circumstances require.

III. Definitions: The definitions of the January 24, 2003 declaration are deleted; terms that are used in the declaration and that are defined in section 224(p) of the Public Health Service Act shall have the meanings given in those definitions.

IV. Effective Dates: This extension is effective January 24, 2004 until and including January 23, 2005. The effective period may be extended or shortened by subsequent amendment to the January 24, 2003, declaration as hereby amended.

Dated: January 21, 2004.

Tommy G. Thompson,

Secretary.