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