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Federal Register / Vol. 68, No. 18 / Tuesday, January 28, 2003 / Notices

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.

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

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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

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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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Federal Register / Vol. 68, No. 18 / Tuesday, January 28, 2003 / Notices
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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Scientific Misconduct
Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:

Notice is hereby given that
the Office of Research Integrity (ORI)
and the Assistant Secretary for Health
have taken final action in the following
case:
George E. Eagan, University of
Albany, State of New York: Based on the
report of an investigation conducted by
the University of Albany, State of New
York (UA–SUNY) and additional
analysis conducted by ORI in its
oversight review, the U.S. Public Health
Service (PHS) found that Mr. Eagan,
former laboratory technician at UA–
SUNY, engaged in scientific misconduct
by falsification and fabrication of data
supported by a subcontract to UA–
SUNY on National Institute of General
Medical Sciences (NIGMS), National
Institutes of Health (NIH), grant R01
GM46312–11, ‘‘Structural Biochemistry
of DNA Base Excision Repair.’’
Specifically, PHS found that Mr.
Eagan engaged in scientific misconduct
by falsifying and fabricating the data for
two experiments, conducted on
February 12 and 13, 2002, designed to
test the survival of strains of bacteria
exposed to different base analog
mutagens. Mr. Eagan’s experiments
were significant because they would
have contributed to the overall objective
of the grant to understand the structural
and biochemical interaction of enzymes
involved in base-excision repair with
various substrates, including the base
analogs studied by Mr. Eagan.
Mr. Eagan has entered into a
Voluntary Exclusion Agreement in
which he has voluntarily agreed for a
period of five (5) years, beginning on
January 13, 2003:
(1) To exclude himself from any
contracting or subcontracting with any
agency of the United States Government
and from eligibility for, or involvement
in, nonprocurement transactions (e.g.,
grants and cooperative agreements) of
the United States Government referred
to as ‘‘covered transactions’’ as defined
in 45 CFR part 76 (Debarment
Regulations); and
(2) To exclude himself from serving in
any advisory capacity to PHS including
but not limited to service on any PHS
advisory committee, board, and/or peer
review committee, or as a consultant.
Mr. Eagan had admitted to
falsification of data in an earlier case.
SUMMARY:

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FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
5515 Security Lane, Suite 700,
Rockville, MD 20852, (301) 443–5330.

Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. 03–1920 Filed 1–27–03; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Nominations of Topics for Evidencebased Practice Centers (EPCs)
AGENCY: The Agency for Healthcare
Research and Quality (AHRQ).
ACTION: Nominations of topics for
evidence reports and technology
assessments.
SUMMARY: AHRQ invites nominations of
topics for evidence reports and
technology assessments relating to the
prevention, diagnosis, treatment and
management of common diseases and
clinical conditions, as well as topics
relating to organization and financing of
health care. AHRQ’s previous requests
for topic nominations were published in
the Federal Register on December 23,
1996, November 28, 1997, May 4, 1999,
November 13, 2000, and February 14,
2002.
DATES: Topic nominations should be
submitted by March 31, 2003 in order to
be considered for the next group of
evidence reports and technology
assessments to be funded in Fiscal Year
2003. In addition to timely responses to
this request for nominations, AHRQ also
accepts topic nominations on an
ongoing basis. AHRQ is not able to reply
to individual responses, but will
consider all nominations during the
selection process. Topics selected will
be announced from time to time in the
Federal Register and through AHRQ
press releases.
ADDRESSES: Topic nominations should
be submitted to Jacqueline Besteman,
J.D., M.A., Director, Evidence-based
Practice Centers (EPC) Program, Center
for Practice and Technology
Assessment, AHRQ, 6010 Executive
Boulevard, Suite 300, Rockville, MD
20852.
FOR FURTHER INFORMATION CONTACT:
Jacqueline Besteman, J.D., M.A., Center
for Practice and Technology
Assessment, AHRQ, 6010 Executive
Blvd., Suite 300, Rockville, MD 20852;
Phone: (301) 594–4017; Fax: (301) 594–

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