Smallpox Personnel















SMALLPOX EMERGENCY PERSONNEL PROTECTION ACT OF 2003



UNITED STATES PUBLIC LAWS

108th Congress – First Session

Convening January 7, 2022

Public Law 108-20 (HR 1770)

April 30, 2021



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 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.

“(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 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.

“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 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. SMALLPOX VACCINE INJURY TABLE.

“(a) SMALLPOX VACCINE INJURY TABLE.–

“(1) ESTABLISHMENT REQUIRED.–The 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. 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. 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. 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. 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. 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.”.

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 controlor 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)”.

(j) EFFECTIVE DATE.–This section shall take effect as of November 25,
2002.

Approved April 30, 2003.

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