Federal Register:
January 28, 2003 (Volume 68, Number 18)
Notices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Declaration Regarding Administration of Smallpox Countermeasures
ACTION: Notice.
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 Determinations
(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 states 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 Page 4213 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.
U.S. Department of Health and Human Services