Smallpox Emergency Personnel Protection Act of 2003
PL 108-20 (H.R.1770), enacted 04/30/2003

117 STAT. 638
PUBLIC LAW 108–20—APR. 30, 2003
Public Law 108–20
108th Congress
An Act
To provide benefits and other compensation for certain individuals with injuries
resulting from administration of smallpox countermeasures, and for other purposes.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. 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. 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 per-
sonnel 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 Sec-
retary 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 pursu-
ant 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)
42 USC 239.
42 USC 201 note.
Smallpox
Emergency
Personnel
Protection Act of
2003.
Apr. 30, 2003
[H.R. 1770]
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117 STAT. 639
PUBLIC LAW 108–20—APR. 30, 2003
determined, pursuant to the procedures established under sec-
tion 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 Declara-
tion; 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 Dec-
laration Regarding Administration of Smallpox Counter-
measures 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.
‘‘(b) VOLUNTARY PROGRAM.—The Secretary shall ensure that
a State, local, or Department of Health and Human Services plan
to vaccinate individuals that is approved by the Secretary estab-
lishes 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 surveil-
lance 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.
Procedures.
Applicability.
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117 STAT. 640
PUBLIC LAW 108–20—APR. 30, 2003
‘‘SEC. 262. DETERMINATION OF ELIGIBILITY AND BENEFITS.
‘‘(a) IN GENERAL.—The 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 certifi-
cation, 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 speci-
fied 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 preponder-
ance of the evidence standard and take into consideration all
relevant medical and scientific evidence presented for consider-
ation, 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 manifesta-
tion 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 Sec-
retary 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.—
Procedures.
42 USC 239a.
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117 STAT. 641
PUBLIC LAW 108–20—APR. 30, 2003
‘‘(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 Sec-
retary 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 posses-
sion thereof, shall have subject matter jurisdiction to review,
whether by mandamus or otherwise, any action by the Sec-
retary 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. SMALLPOX VACCINE INJURY TABLE.
‘‘(a) SMALLPOX VACCINE INJURY TABLE.—
‘‘(1) ESTABLISHMENT REQUIRED.—The Secretary shall estab-
lish by interim final regulation a table identifying adverse
effects (including injuries, disabilities, illnesses, conditions, and
deaths) that shall be presumed to result from the administra-
tion 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 amend-
ment 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. 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
42 USC 239c.
Regulations.
42 USC 239b.
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117 STAT. 642
PUBLIC LAW 108–20—APR. 30, 2003
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. 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 662⁄3 percent of the relevant pay period
(weekly, monthly, or otherwise), except as provided in para-
graph (2).
‘‘(2) AUGMENTED COMPENSATION FOR DEPENDENTS.—If an
eligible individual has one or more dependents, the basic com-
pensation for loss of employment income as described in para-
graph (1) shall be augmented at the rate of 81⁄3 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 pur-
poses 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 govern-
mental entity, private insurance carrier, or employer),
under any other law or contractual agreement, to pay com-
pensation 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 indi-
vidual 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
42 USC 239d.
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117 STAT. 643
PUBLIC LAW 108–20—APR. 30, 2003
received in a single year. The Secretary may, in the discre-
tion 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 limita-
tion under subparagraph (A)(ii) does not apply in the case
of an eligible individual who is determined to have a cov-
ered 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 compensa-
tion 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. 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
42 USC 239e.
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117 STAT. 644
PUBLIC LAW 108–20—APR. 30, 2003
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 para-
graph (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’ Bene-
fits 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 APPRO-
PRIATIONS FOR DISABILITY BENEFITS UNDER PSOB.—In the
event that disability benefits available to an eligible indi-
vidual 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 pay-
ments 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 sub-
section (a) of section 265, with the rate augmented in accord-
ance with subsection (b)(2) of such section and with such indi-
vidual considered to be an eligible individual described in sub-
section (c)(3)(B) of such section.
‘‘(3) LIMITATIONS.—
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117 STAT. 645
PUBLIC LAW 108–20—APR. 30, 2003
‘‘(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 agree-
ment, 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 pay-
ment is made, such payment shall, for purposes of
this subparagraph, be deemed to be received over mul-
tiple years rather than received in a single year. The
Secretary may, in the discretion of the Secretary, deter-
mine 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. ADMINISTRATION.
‘‘(a) ADMINISTRATION BY AGREEMENT WITH OTHER AGENCY OR
AGENCIES.—The Secretary may administer any or all of the provi-
sions 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 regu-
lations may be interim final regulations.
‘‘SEC. 268. 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. 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.’’.
42 USC 239h.
42 USC 239g.
42 USC 239f.
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PUBLIC LAW 108–20—APR. 30, 2003
SEC. 3. AMENDMENTS TO PROVISION REGARDING TORT LIABILITY
FOR 
ADMINISTRATION 
OF 
SMALLPOX 
COUNTER-
MEASURES.
(a) AMENDMENT TO ACCIDENTAL VACCINIA INOCULATION PROVI-
SION.—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 indi-
vidual 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 employ-
ment 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 require-
ments 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 bene-
fits provided under part C of this title for an incident
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117 STAT. 647
PUBLIC LAW 108–20—APR. 30, 2003
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.—Sec-
tion 224(p)(5) of such Act (42 U.S.C. 233(p)(5)) is amended in
the caption by striking ‘‘DEFENDANT’’ and inserting ‘‘COVERED PER-
SON’’.
(e) AMENDMENT
TO
DEFINITION
OF
COVERED
COUNTER-
MEASURE.—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 mon-
itored, 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 offi-
cial has established requirements, provided policy guid-
ance, supplied technical or scientific advice or assist-
ance, or otherwise supervised or administered a pro-
gram with respect to administration of such counter-
measures;
‘‘(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 para-
graph (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);
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‘‘(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 other-
wise authorized to provide health care under the aus-
pices 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 COV-
ERED 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 condi-
tions, an individual should receive a covered counter-
measure;
‘‘(ii) obtaining informed consent of an individual
to the administration of a covered countermeasure;
‘‘(iii) monitoring, management, or care of an imme-
diate site of administration on the body of a covered
countermeasure, or evaluation of whether the adminis-
tration of the countermeasure has been effective; or
‘‘(iv) transmission of vaccinia virus by an indi-
vidual 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)’’.
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LEGISLATIVE HISTORY—H.R. 1770:
CONGRESSIONAL RECORD, Vol. 149 (2003):
Apr. 11, considered and passed House and Senate.
(j) EFFECTIVE DATE.—This section shall take effect as of
November 25, 2002.
Approved April 30, 2003.
42 USC 233 note.
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