Smallpox
Emergency Personnel Protection Act of
2003
Public Law 108-20
An
Act to provide benefits and other compensation
for certain individuals with injuries
resulting from administration of smallpox
countermeasures, and for other purposes.
NOTE:
Apr. 30, 2003 - [H.R. 1770] Be it enacted
by the Senate and House of Representatives
of the United States of America in Congress
NOTE: Smallpox Emergency
Personnel Protection Act of 2003. assembled,
SECTION 1. NOTE: 42 USC
201 note.
SHORT
TITLE. This Act may be cited
as the ``Smallpox Emergency Personnel
Protection Act of 2003''. SEC. 2. SMALLPOX
EMERGENCY PERSONNEL PROTECTION. Title
II of the Public Health Service Act (42
U.S.C. 202 et seq.) is amended by adding
at the end the following part: ``Part
C--Smallpox Emergency Personnel Protection
``SEC. 261. NOTE: 42 USC 239.
GENERAL
PROVISIONS.
``(a) Definitions.--For purposes of this
part:
``(1)
Covered countermeasure.--The
term `covered countermeasure' means
a covered countermeasure as specified
in a Declaration made pursuant to section
224(p).
``(2)
Covered individual.--The term
`covered individual' means an individual-
``(A)
who is a health care worker, law enforcement
officer, firefighter, security personnel,
emergency medical personnel, other
public safety personnel, or support
personnel for such occupational specialities;
``(B) who is or will be functioning
in a role identified in a State, local,
or Department of Health and Human
Services smallpox emergency response
plan (as defined in paragraph (7))
approved by the Secretary;
``(C) who has volunteered and been
selected to be a member of a smallpox
emergency response plan described
in subparagraph (B) prior to the time
at which the Secretary publicly announces
that an active case of smallpox has
been identified either within or outside
of the United States; and
``(D) to whom a smallpox vaccine is
administered pursuant to such approved
plan during the effective period of
the Declaration (including the portion
of such period before the enactment
of this part).
``(3)
Covered injury.--The term `covered
injury' means an injury, disability,
illness, condition, or death (other
than a minor injury such as minor scarring
or minor local reaction) determined,
pursuant to the procedures established
under section 262, to have been sustained
by an individual as the direct result
of--
``(A)
administration to the individual of
a covered countermeasure during the
effective period of the Declaration;
or
``(B)
accidental vaccinia inoculation of
the individual in circumstances in
which--
``(i)
the vaccinia is contracted during
the effective period of the Declaration
or within 30 days after the end
of such period;
``(ii) smallpox vaccine has not
been administered to the individual;
and
``(iii) the individual has been
in contact with an individual who
is (or who was accidentally inoculated
by) a covered individual.
``(4)
Declaration.--The term `Declaration'
means the Declaration Regarding Administration
of Smallpox Countermeasures issued by
the Secretary on January 24, 2003, and
published in the Federal Register on
January 28, 2003.
``(5)
Effective period of the declaration.--The
term `effective period of the Declaration'
means the effective period specified
in the Declaration, unless extended
by the Secretary.
``(6)
Eligible individual.--The term
`eligible individual' means an individual
who is (as determined in accordance
with section 262)--
``(A)
a covered individual who sustains
a covered injury in the manner described
in paragraph (3)(A); or
``(B) an individual who sustains a
covered injury in the manner described
in paragraph (3)(B).
``(7)
Smallpox emergency response plan.--The
term `smallpox emergency response plan'
or `plan' means a response plan detailing
actions to be taken in preparation for
a possible smallpox-related emergency
during the period prior to the identification
of an active case of smallpox either
within or outside the United States.
NOTE:
Procedures.
Applicability. Secretary
shall ensure that a State, local, or Department
of Health and Human Services plan to vaccinate
individuals that is approved by the Secretary
establishes procedures to ensure, consistent
with the Declaration and any applicable
guidelines of the Centers for Disease
Control and Prevention, that--
``(1)
potential participants are educated
with respect to contraindications, the
voluntary nature of the program, and
the availability of potential benefits
and compensation under this part;
``(2)
there is voluntary screening provided
to potential participants that can identify
health conditions relevant to contraindications;
and
``(3) there is appropriate post-inoculation
medical surveillance that includes an
evaluation of adverse health effects
that may reasonably appear to be due
to such vaccine and prompt referral
of, or the provision of appropriate
information to, any individual requiring
health care as a result of such adverse
health event.
NOTE:
42 USC 239a.
DETERMINATION OF ELIGIBILITY AND BENEFITS.
``(a) In General.--The NOTE:
Procedures. Secretary shall establish
procedures for determining, as applicable
with respect to an individual--
``(1)
whether the individual is an eligible
individual;
``(2)
whether an eligible individual has sustained
a covered injury or injuries for which
medical benefits or compensation may
be available under sections 264 and
265, and the amount of such benefits
or compensation; and
``(3) whether the covered injury or
injuries of an eligible individual caused
the individual's death for purposes
of benefits under section 266.
``(b)
Covered Individuals.--The
Secretary may accept a certification,
by a Federal, State, or local government
entity or private health care entity
participating in the administration
of covered countermeasures under the
Declaration, that an individual is
a covered individual.
``(c) Criteria for Reimbursement.--
``(1)
Injuries specified in injury table.--In
any case where an injury or other
adverse effect specified in the
injury table established under section
263 as a known effect of a vaccine
manifests in an individual within
the time period specified in such
table, such injury or other effect
shall be presumed to have resulted
from administration of such vaccine.
``(2) Other determinations.--In
making determinations other than
those described in paragraph (1)
as to the causation or severity
of an injury, the Secretary shall
employ a preponderance of the evidence
standard and take into consideration
all relevant medical and scientific
evidence presented for consideration,
and may obtain and consider the
views of qualified medical experts.
``(d)
Deadline for Filing Request.--The
Secretary shall not consider any request
for a benefit under this part with
respect to an individual, unless--
``(1)
in the case of a request based on
the administration of the vaccine
to the individual, the individual
files with the Secretary an initial
request for benefits or compensation
under this part not later than one
year after the date of administration
of the vaccine; or
``(2) in the case of a request based
on accidental vaccinia inoculation,
the individual files with the Secretary
an initial request for benefits
or compensation under this part
not later than two years after the
date of the first symptom or manifestation
of onset of the adverse effect.
``(e)
Structured Settlements at
Secretary's Option.--In any
case in which there is a reasonable
likelihood that compensation or payment
under section 264, 265, or 266(b)
will be required for a period in excess
of one year from the date an individual
is determined eligible for such compensation
or payment, the Secretary shall have
the discretion to make a lump-sum
payment, purchase an annuity or medical
insurance policy, or execute an appropriate
structured settlement agreement, provided
that such payment, annuity, policy,
or agreement is actuarially determined
to have a value equal to the present
value of the projected total amount
of benefits or compensation that the
individual is eligible to receive
under such section or sections.
``(f)
Review of Determination.--
``(1)
Secretary's review authority.--The
Secretary may review a determination
under this section at any time on
the Secretary's own motion or on
application, and may affirm, vacate,
or modify such determination in
any manner the Secretary deems appropriate.
The Secretary shall develop a process
by which an individual may file
a request for reconsideration of
any determination made by the Secretary
under this section.
``(2)
Judicial and administrative review.--No
court of the United States, or of
any State, District, territory or
possession thereof, shall have subject
matter jurisdiction to review, whether
by mandamus or otherwise, any action
by the Secretary under this section.
No officer or employee of the United
States shall review any action by
the Secretary under this section
(unless the President specifically
directs otherwise).
``SEC.
263. NOTE: 42 USC 239b.
SMALLPOX VACCINE INJURY TABLE.
``(a)
Smallpox Vaccine Injury Table.--
``(1)
Establishment required.--
The NOTE: Regulations. Secretary shall
establish by interim final regulation
a table identifying adverse effects
(including injuries, disabilities, illnesses,
conditions, and deaths) that shall be
presumed to result from the administration
of (or exposure to) a smallpox vaccine,
and the time period in which the first
symptom or manifestation of onset of
each such adverse effect must manifest
in order for such presumption to apply.
``(2) Amendments.--The
Secretary may by regulation amend the
table established under paragraph (1).
An amendment to the table takes effect
on the date of the promulgation of the
final rule that makes the amendment,
and applies to all requests for benefits
or compensation under this part that
are filed on or after such date or are
pending as of such date. In addition,
the amendment applies retroactively
to an individual who was not with respect
to the injury involved an eligible individual
under the table as in effect before
the amendment but who with respect to
such injury is an eligible individual
under the table as amended. With respect
to a request for benefits or compensation
under this part by an individual who
becomes an eligible individual as described
in the preceding sentence, the Secretary
may not provide such benefits or compensation
unless the request (or amendment to
a request, as applicable) is filed before
the expiration of one year after the
effective date of the amendment to the
table in the case of an individual to
whom the vaccine was administered and
before the expiration of two years after
such effective date in the case of a
request based on accidental vaccinia
inoculation.
`SEC.
264. NOTE: 42 USC 239c.
MEDICAL BENEFITS.
``(a) In General.--Subject to the succeeding
provisions of this section, the Secretary
shall make payment or reimbursement for
medical items and services as reasonable
and necessary to treat a covered injury
of an eligible individual, including the
services, appliances, and supplies prescribed
or recommended by a qualified physician,
which the Secretary considers likely to
cure, give relief, reduce the degree or
the period of disability, or aid in lessening
the amount of monthly compensation.
``(b) Benefits Secondary to Other Coverage.--Payment
or reimbursement for services or benefits
under subsection
(a)
shall be secondary to any obligation
of the United States or any third party
(including any State or local governmental
entity, private insurance carrier, or
employer) under any other provision
of law or contractual agreement, to
pay for or provide such services or
benefits.
``SEC. 265. NOTE: 42
USC 239d. COMPENSATION FOR LOST
EMPLOYMENT INCOME.
``(a)
In General.--Subject to the succeeding
provisions of this section, the Secretary
shall provide compensation to an eligible
individual for loss of employment income
(based on such income at the time of injury)
incurred as a result of a covered injury,
at the rate specified in subsection (b).
``(b) Amount of Compensation.--
``(1)
In general.--Compensation under subsection
(a) shall be at the rate of 66\2/3\
percent of the relevant pay period (weekly,
monthly, or otherwise), except as provided
in paragraph (2).
``(2)
Augmented compensation for dependents.--If
an eligible individual has one or more
dependents, the basic compensation for
loss of employment income as described
in paragraph (1) shall be augmented
at the rate of 8\1/3\ percent.
``(3) Consideration of other programs.--
``(A)
In general.--The Secretary may consider
the provisions of sections 8114, 8115,
and 8146a of title 5, United States
Code, and any implementing regulations,
in determining the amount of payment
under subsection (a) and the circumstances
under which such payments are reasonable
and necessary.
``(B) Minors.--With respect to an
eligible individual who is a minor,
the Secretary may consider the provisions
of section 8113 of title 5, United
States Code, and any implementing
regulations, in determining the amount
of payment under subsection (a) and
the circumstances under which such
payments are reasonable and necessary.
``(4)
Treatment of self-employment income.--For
purposes of this section, the term `employment
income' includes income from self-employment.
``(c)
Limitations.--
``(1)
Benefits secondary to other coverage.--
``(A)
In general.--Any compensation under
subsection (a) shall be secondary
to the obligation of the United States
or any third party (including any
State or local governmental entity,
private insurance carrier, or employer),
under any other law or contractual
agreement, to pay compensation for
loss of employment income or to provide
disability or retirement benefits.
``(B) Relation to other obligations.--Compensation
under subsection (a) shall not be
made to an eligible individual to
the extent that the total of amounts
paid to the individual under such
subsection and under the other obligations
referred to in subparagraph (A) is
an amount that exceeds the rate specified
in subsection (b)(1). If under any
such other obligation a lump-sum payment
is made, such payment shall, for purposes
of this paragraph, be deemed to be
received over multiple years rather
than received in a single year. The
Secretary may, in the discretion of
the Secretary, determine how to apportion
such payment over multiple years.
``(2)
No benefits in case of death.--No payment
shall be made under subsection (a) in
compensation for loss of employment
income subsequent to the receipt, by
the survivor or survivors of an eligible
individual, of benefits under section
266 for death.
``(3)
Limit on total benefits.--
``(A)
In general.--Except as provided in
subparagraph
(B)-- ``(i) total compensation paid
to an individual under subsection
(a) shall not exceed $50,000 for any
year; and ``(ii) the lifetime total
of such compensation for the individual
may not exceed an amount equal to
the amount authorized to be paid under
section 266. ``(B) Permanent and total
disability.--The limitation under
subparagraph (A)(ii) does not apply
in the case of an eligible individual
who is determined to have a covered
injury or injuries meeting the definition
of disability in section 216(i) of
the Social Security Act (42 U.S.C.
416(i)).
``(4)
Waiting period.--
``(A)
In general.--Except as provided in
subparagraph (B), an eligible individual
shall not be provided compensation
under this section for the first 5
work days of loss of employment income.
``(B) Exception.--Subparagraph (A)
does not apply if the period of loss
of employment income of an eligible
individual is 10 or more work days.
``(5)
Termination of benefits.--No payment
shall be made under subsection (a) in
compensation for loss of employment
income once the eligible individual
involves reaches the age of 65.
``(d)
Benefit in Addition to Medical
Benefits.--A benefit under subsection
(a) shall be in addition to any amounts
received by an eligible individual under
section 264.
``SEC.
266. NOTE: 42 USC 239e.
PAYMENT FOR DEATH.
``(a) Death Benefit.--
``(1)
In general.--The Secretary shall pay,
in the case of an eligible individual
whose death is determined to have resulted
from a covered injury or injuries, a
death benefit in the amount determined
under paragraph (2) to the survivor
or survivors in the same manner as death
benefits are paid pursuant to the Public
Safety Officers' Benefits Program under
subpart 1 of part L of title I of the
Omnibus Crime Control and Safe Streets
Act of 1968 (42 U.S.C. 3796 et seq.)
with respect to an eligible deceased
(except that in the case of an eligible
individual who is a minor with no living
parent, the legal guardian shall be
considered the survivor in the place
of the parent).
``(2) Benefit amount.-- ``(A) In general.--The
amount of the death benefit under paragraph
(1) in a fiscal year shall equal the
amount of the comparable benefit calculated
under the Public Safety Officers' Benefits
Program under subpart 1 of part L of
title I of the Omnibus Crime Control
and Safe Streets Act of 1968 (42 U.S.C.
3796 et seq.) in such fiscal year, without
regard to any reduction attributable
to a limitation on appropriations, but
subject to subparagraph (B).
``(B)
Reduction for payments for lost employment
income.--The amount of the benefit
as determined under subparagraph (A)
shall be reduced by the total amount
of any benefits paid under section
265 with respect to lost employment
income.
``(3)
Limitations.--
``(A)
In general.--No benefit is payable
under paragraph (1) with respect to
the death of an eligible individual
if-- ``(i) a disability benefit is
paid with respect to such individual
under the Public Safety Officers'
Benefits Program under subpart 1 of
part L of title I of the Omnibus Crime
Control and Safe Streets Act of 1968
(42 U.S.C. 3796 et seq.); or ``(ii)
a death benefit is paid or payable
with respect to such individual under
the Public Safety Officers' Benefits
Program under subpart 1 of part L
of title I of the Omnibus Crime Control
and Safe Streets Act of 1968 (42 U.S.C.
3796 et seq.). ``(B) Exception in
the case of a limitation on appropriations
for disability benefits under psob.--In
the event that disability benefits
available to an eligible individual
under the Public Safety Officers'
Benefits Program under subpart 1 of
part L of title I of the Omnibus Crime
Control and Safe Streets Act of 1968
(42 U.S.C. 3796 et seq.) are reduced
because of a limitation on appropriations,
and such reduction would affect the
amount that would be payable under
subparagraph (A) without regard to
this subparagraph, benefits shall
be available under paragraph (1) to
the extent necessary to ensure that
the survivor or survivors of such
individual receives a total amount
equal to the amount described in paragraph
(2).
``(b)
Election in Case of Dependents.--
``(1)
In general.--In the case of an eligible
individual whose death is determined
to have resulted from a covered injury
or injuries, if the individual had one
or more dependents under the age of
18, the legal guardian of the dependents
may, in lieu of the death benefit under
subsection (a), elect to receive on
behalf of the aggregate of such dependents
payments in accordance with this subsection.
An election under the preceding sentence
is effective in lieu of a request under
subsection (a) by an individual who
is not the legal guardian of such dependents.
``(2) Amount of payments.--Payments
under paragraph (1) with respect to
an eligible individual described in
such paragraph shall be made as if such
individual were an eligible individual
to whom compensation would be paid under
subsection (a) of section 265, with
the rate augmented in accordance with
subsection (b)(2) of such section and
with such individual considered to be
an eligible individual described in
subsection (c)(3)(B) of such section.
``(3) Limitations.--
``(A)
Age of dependents.--No payments may
be made under paragraph (1) once the
youngest of the dependents involved
reaches the age of 18.
``(B) Benefits secondary to other
coverage.--
``(i)
In general.--Any payment under paragraph
(1) shall be secondary to the obligation
of the United States or any third
party (including any State or local
governmental entity, private insurance
carrier, or employer), under any
other law or contractual agreement,
to pay compensation for loss of
employment income or to provide
disability benefits, retirement
benefits, life insurance benefits
on behalf of dependents under the
age of 18, or death benefits.
``(ii) Relation to other obligations.--
Payments under paragraph (1) shall
not be made to with respect to an
eligible individual to the extent
that the total of amounts paid with
respect to the individual under
such paragraph and under the other
obligations referred to in clause
(i) is an amount that exceeds the
rate of payment that applies under
paragraph (2). If under any such
other obligation a lump-sum payment
is made, such payment shall, for
purposes of this subparagraph, be
deemed to be received over multiple
years rather than received in a
single year. The Secretary may,
in the discretion of the Secretary,
determine how to apportion such
payment over multiple years.
``(c)
Benefit in Addition to Medical Benefits.--A
benefit under subsection (a) or (b)
shall be in addition to any amounts
received by an eligible individual
under section 264.
``SEC.
267. NOTE: 42 USC 239f.
ADMINISTRATION.
``(a) Administration by Agreement With
Other Agency or Agencies.-- The Secretary
may administer any or all of the provisions
of this part through Memorandum of Agreement
with the head of any appropriate Federal
agency.
``(b) Regulations.--The head of the agency
administering this part or provisions
thereof (including any agency head administering
such Act or provisions through a Memorandum
of Agreement under subsection (a)) may
promulgate such implementing regulations
as may be found necessary and appropriate.
Initial implementing regulations may be
interim final regulations.
``SEC. 268. NOTE: 42 USC 239g.
AUTHORIZATION OF APPROPRIATIONS.
``For the purpose of carrying out this
part, there are authorized to be appropriated
such sums as may be necessary for each
of the fiscal years 2003 through 2007,
to remain available until expended, including
administrative costs and costs of provision
and payment of benefits. The Secretary's
payment of any benefit under section 264,
265, or 266 shall be subject to the availability
of appropriations under this section.
``SEC. 269. NOTE: 42 USC 239h.
RELATIONSHIP TO OTHER LAWS.
``Except as explicitly provided herein,
nothing in this part shall be construed
to override or limit any rights an individual
may have to seek compensation, benefits,
or redress under any other provision of
Federal or State law.''.
SEC.
3.
AMENDMENTS
TO PROVISION REGARDING TORT LIABILITY
FOR ADMINISTRATION OF SMALLPOX COUNTERMEASURES.
(a) Amendment to Accidental Vaccinia Inoculation
Provision.--Section 224(p)(2)(C)(ii)(II)
of such Act (42 U.S.C. 233(p)(2)(C)(ii)(II))
is amended by striking ``resides or has
resided with'' and inserting ``has resided
with, or has had contact with,''.
(b) Deeming Acts and Omissions to be Within
Scope of Employment.-- Section 224(p)(2)
of such Act (42 U.S.C. 233(p)(2)) is amended
by adding at the end the following new
subparagraph:
``(D)
Acts and omissions deemed to be within
scope of employment.--
``(i)
In general.--In the case of a claim
arising out of alleged transmission
of vaccinia from an individual described
in clause (ii), acts or omissions
by such individual shall be deemed
to have been taken within the scope
of such individual's office or employment
for purposes of-- ``(I) subsection
(a); and ``(II) section 1346(b) and
chapter 171 of title 28, United States
Code.
``(ii) Individuals to whom deeming
applies.-- An individual is described
by this clause if--
``(I)
vaccinia vaccine was administered
to such individual as provided by
subparagraph (B); and
``(II)
such individual was within a category
of individuals covered by a declaration
under subparagraph (A)(i).''.
(c)
Exhaustion; Exclusivity; Offset.--Section
224(p)(3) of such Act (42 U.S.C. 233(p)(3))
is amended to read as follows: ``(3) Exhaustion;
exclusivity; offset.--
``(A)
Exhaustion.--
``(i)
In general.--A person may not bring
a claim under this subsection unless
such person has exhausted such remedies
as are available under part C of this
title, except that if the Secretary
fails to make a final determination
on a request for benefits or compensation
filed in accordance with the requirements
of such part within 240 days after
such request was filed, the individual
may seek any remedy that may be available
under this section. ``(ii) Tolling
of statute of limitations.--The time
limit for filing a claim under this
subsection, or for filing an action
based on such claim, shall be tolled
during the pendency of a request for
benefits or compensation under part
C of this title.
``(iii) Construction.--This subsection
shall not be construed as superseding
or otherwise affecting the application
of a requirement, under chapter 171
of title 28, United States Code, to
exhaust administrative remedies.
``(B) Exclusivity.--The remedy provided
by subsection (a) shall be exclusive
of any other civil action or proceeding
for any claim or suit this subsection
encompasses, except for a proceeding
under part C of this title. `
`(C) Offset.--The value of all compensation
and benefits provided under part C of
this title for an incident or series
of incidents shall be offset against
the amount of an award, compromise,
or settlement of money damages in a
claim or suit under this subsection
based on the same incident or series
of incidents.''. (d) Requirement to
Cooperate With United States.
--Section
224(p)(5) of such Act (42 U.S.C. 233(p)(5))
is amended in the caption by striking
``Defendant'' and inserting ``Covered
person''. (e) Amendment to Definition
of Covered Countermeasure.--Section 224(p)(7)(A)(i)(II)
of such Act (42 U.S.C. 233(p)(7)(A)(i)(II))
is amended to read as follows:
``(II)
used to control or treat the adverse
effects of vaccinia inoculation or of
administration of another covered countermeasure;
and''.
(f)
Amendment to Definition of Covered Person.--Section
224(p)(7)(B) of such Act (42 U.S.C. 233(p)(7)(B))
is amended--
(1) by striking ``includes any person''
and inserting ``means a person'';
(2) in clause (ii)-- (A) by striking ``auspices''
and inserting ``auspices--''; (B) by redesignating
``such countermeasure'' and all that follows
as clause (I) and indenting accordingly;
and (C) by adding at the end the following:
``(II) a determination was made as to
whether, or under what circumstances,
an individual should receive a covered
countermeasure; ``(III) the immediate
site of administration on the body of
a covered countermeasure was monitored,
managed, or cared for; or ``(IV) an evaluation
was made of whether the administration
of a countermeasure was effective;'';
(3) in clause (iii) by striking ``or'';
(4) by striking clause (iv) and inserting
the following: ``(iv) a State, a political
subdivision of a State, or an agency or
official of a State or of such a political
subdivision, if such State, subdivision,
agency, or official has established requirements,
provided policy guidance, supplied technical
or scientific advice or assistance, or
otherwise supervised or administered a
program with respect to administration
of such countermeasures; ``(v) in the
case of a claim arising out of alleged
transmission of vaccinia from an individual--
``(I)
the individual who allegedly transmitted
the vaccinia, if vaccinia vaccine was
administered to such individual as provided
by paragraph (2)(B) and such individual
was within a category of individuals
covered by a declaration under paragraph
(2)(A)(i); or
` `(II) an entity that employs an individual
described by clause (I) or where such
individual has privileges or is otherwise
authorized to provide health care; ``(vi)
an official, agent, or employee of a
person described in clause (i), (ii),
(iii), or (iv); ``(vii) a contractor
of, or a volunteer working for, a person
described in clause (i), (ii), or (iv),
if the contractor or volunteer performs
a function for which a person described
in clause (i), (ii), or (iv) is a covered
person; or ``(viii) an individual who
has privileges or is otherwise authorized
to provide health care under the auspices
of an entity described in clause (ii)
or (v)(II).''. (g) Amendment to Definition
of Qualified Person.--Section 224(p)(7)(C)
of such Act (42 U.S.C. 233(p)(7)(C))
is amended-- (1) by designating ``is
authorized to'' and all that follows
as clause (i) and indenting accordingly;
(2) by striking ``individual who'' and
inserting ``individual who--''; and
(3) by striking the period and inserting
``; or ``(ii) is otherwise authorized
by the Secretary to administer such
countermeasure.''. (h) Definition of
``Arising Out of Administration of a
Covered Countermeasure''.--Section 224(p)(7)
of such Act (42 U.S.C. 233(p)(7)) is
amended by adding at the end the following
new subparagraph: ``(D) Arising out
of administration of a covered countermeasure.--The
term `arising out of administration
of a covered countermeasure', when used
with respect to a claim or liability,
includes a claim or liability arising
out of-- ``(i) determining whether,
or under what conditions, an individual
should receive a covered countermeasure;
``(ii) obtaining informed consent of
an individual to the administration
of a covered countermeasure; ``(iii)
monitoring, management, or care of an
immediate site of administration on
the body of a covered countermeasure,
or evaluation of whether the administration
of the countermeasure has been effective;
or ``(iv) transmission of vaccinia virus
by an individual to whom vaccinia vaccine
was administered as provided by paragraph
(2)(B).''. (i) Technical Correction.--Section
224(p)(2)(A)(ii) of such Act (42 U.S.C.
233(p)(2)(A)(ii)) is amended by striking
``paragraph (8)(A)'' and inserting ``paragraph
(7)(A)''.
Effective
Date. This NOTE: 42 USC 233 note.
section shall take effect as of November
25, 2002. Approved April 30, 2003.
LEGISLATIVE
HISTORY--H.R. 1770: CONGRESSIONAL
RECORD, Vol. 149 (2003): Apr. 11, considered
and passed House and Senate.
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