[Federal Register Volume 68, Number 18 (Tuesday, January 28, 2003)]
[Notices]
[Pages 4212-4213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2012]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Declaration Regarding Administration of Smallpox Countermeasures

AGENCY: Office of the Secretary (OS), HHS.

ACTION: Notice.

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SUMMARY: The Secretary of the Department of Health and Human Services 
is issuing this notice pursuant to section 224(p)(2)(A) of the Public 
Health Service Act to make a declaration regarding administration of 
smallpox countermeasures. The Secretary provides policy determinations 
regarding administration of countermeasures, and declares that a 
potential bioterrorist incident makes it advisable to administer, on a 
voluntary basis, covered countermeasures specified in the declaration 
for prevention or treatment of smallpox or control or treatment of 
adverse events related to smallpox vaccination to categories of 
individuals named in the declaration who may be involved in a wide 
range of activities associated with the administration of 
countermeasures against smallpox. Effective dates of the declaration, 
and relevant definitions are also provided.

DATES: This Notice and the attached declaration are effective as of 
January 24, 2003.

FOR FURTHER INFORMATION CONTACT: Jerome S. Hauer, Acting Assistant 
Secretary for Public Health Emergency Preparedness, (202) 205-2882.

SUPPLEMENTARY INFORMATION: The Secretary issues the following 
declaration pursuant to section 224(p)(2)(A) of the Public Health 
Service Act, 42 U.S.C. 233(p)(2)(A):

I. Policy Derterminations

    (1) The attacks of September and October 2001 have 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.
    (2) In light of these concerns, and in order to advance the public 
health and national security, the President announced the smallpox 
vaccination program on December 13, 2002.
    (3) Given the potential for a bioterrorist incident, administration 
of smallpox countermeasures is advisable within the terms of this 
declaration.
    (4) Smallpox vaccine is currently recommended domestically only for 
smallpox response teams, health care workers, and emergency response 
workers.
    (5) The U.S. Government is making smallpox countermeasures 
available to personnel associated with certain U.S. facilities abroad 
and administration of these countermeasures to such personnel is 
advisable within the terms of this declaration.
    (6) Liability protections for manufacturers and distributors of 
smallpox countermeasures and the hospitals, health care facilities, and 
health care workers who will receive them and treat potentially 
infected smallpox cases are integral to ensuring maximum participation 
in the vaccination program.
    (7) Section 304 of the Homeland Security Act (Pub. L. 107-296) is 
intended to alleviate liability concerns and therefore ensure that 
vaccine is available if necessary to protect the public health.
    (8) Administration of a countermeasure such as smallpox vaccine is 
necessarily more involved than the act of placing a drop of vaccine on 
a two-pronged needle and inoculating a person's arm. Determining who is 
contraindicated; monitoring, management, and care of the countermeasure 
site; evaluation of countermeasure ``takes;'' and contact transmission 
of vaccinia, among other things, all arise out of and are directly 
related to and part of the administration of the countermeasure. All 
such acts also potentially give rise to legal liability that, without 
sufficient protections, may significantly discourage participation in 
the smallpox vaccination program.
    (9) Under current domestic planning, many health care entities will 
designate individuals to receive countermeasures at a hospital or 
vaccination clinic determined by the state. To achieve a successful 
vaccination program and because it is impractical to have 
countermeasures administered at every health care entity involved in 
the program, it is critical that health care entities participate in 
this manner and that their personnel be protected while acting within 
their scope of employment.
    (10) It is important to the successful implementation of the 
vaccination program that those workers employed by health care entities 
under whose auspices a countermeasure is administered be protected by 
section 304 while acting within the scope of their employment.
    (11) Health care entities use numerous staffing arrangements to 
carry out daily functions. Individuals designated to receive covered 
countermeasures and subsequently treat potential smallpox cases may 
fall into any of these arrangements. Liability protection for these 
individuals, to the extent described below, is necessary to encourage 
participation in the smallpox vaccination program.
    (12) Based upon scientific data from animal model studies examining 
Cidofivir's effectiveness in treating lethal pox virus infections that 
are similar to smallpox, Cidofivir may be useful in treating smallpox 
in humans.

II. Declaration

    I, Tommy G. Thompson, Secretary of the Department of Health and 
Human Services, have concluded, in accordance with 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 administer, on a 
voluntary basis, covered countermeasures specified in this declaration 
for prevention or treatment of smallpox or control or treatment of 
adverse events related to smallpox vaccination, to categories of 
individuals named in this declaration. The countermeasures set forth 
below shall be considered to be administered pursuant to this 
declaration when used for prevention or treatment of smallpox, or to 
control or treat the adverse effects of smallpox vaccination.
    This declaration may be amended as circumstances require.

III. Covered Countermeasures

    Countermeasures to be administered pursuant to this declaration 
are:
    (1) Vaccinia (Smallpox) Vaccines, including the Dryvax vaccine;
    (2) Cidofivir and derivatives thereof;
    (3) Vaccinia Immune Globulin (VIG).

IV. Individuals Covered by this Declaration

    Individuals to whom it is advisable to administer the covered 
countermeasures specified above are:
    (1) Health care workers who may be called upon to monitor or treat 
any persons who are either (a) covered by this declaration or (b) are 
deemed to be individuals to whom a covered countermeasure was 
administered by a qualified person, whether domestically or abroad, 
pursuant to section 224(p)(2)(C) of the Public Health Service Act;
    (2) Any person who is a member of a smallpox response team or teams 
identified by state[s] or local government entities or the United 
States Department of Health and Human Services;
    (3) Public safety personnel, including, but not limited to, law 
enforcement

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officers, firefighters, security, and emergency medical personnel who 
may be called upon to assist smallpox response teams specified in 
paragraph IV(2) above; and
    (4) Personnel associated with certain U.S. Government facilities 
abroad.

V. Effective Dates

    The declaration is effective January 24, 2003 until and including 
January 23, 2004. The effective period may be extended or shortened by 
subsequent amendment to this declaration.

VI. Definitions

    For the purposes of this declaration, including any claim brought 
against the United States pursuant to section 224 of the Public Health 
Service Act (''PHS''), as amended by section 304 of the Homeland 
Security Act, the following definitions will be used:
    (1) ``Administration of a covered countermeasure'' as used in 
section 224(p)(1) of the PHS Act includes, but is not limited to, the 
physical administration of a covered countermeasure; education and 
screening of covered countermeasure recipients; monitoring, management, 
and care of the covered countermeasure site; evaluation of covered 
countermeasure ``takes;'' and contact transmission of vaccinia.
    (2) ``Health care entity under whose auspices such countermeasure 
was administered'' as used in section 224(p)(7)(B)(ii) of the PHS Act, 
includes but is not limited to, hospitals, clinics, state and local 
health departments, health care entities, and contractors of any of 
those entities that (a) Administer covered countermeasures; (b) 
designate officials, agents, or employees to receive or administer 
covered countermeasures; or (c) are identified by state or local 
government entities or the United States Department of Health and Human 
Services to participate in the vaccination program, whether that 
participation is in the United States or abroad.
    (3) ``Official, agent, or employee'' as used in section 
224(p)(7)(B)(iv) of the PHS Act and with respect to health care 
entities under whose auspices covered countermeasures are administered, 
includes health care workers who share any employment or other staffing 
relationship with the health care entity.

    Dated: January 24, 2003.
Tommy G. Thompson,
Secretary.
[FR Doc. 03-2012 Filed 1-24-03; 12:00 am]
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