[United States Statutes at Large, Volume 117, 108th Congress, 1st Session]
[From the U.S. Government Printing Office, www.gpo.gov]


117 STAT. 638]]

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. [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)

[[Page 639]]

117 STAT. 639

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 [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.

[[Page 640]]

117 STAT. 640

``SEC. 262. [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.--

[[Page 641]]

117 STAT. 641

``(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

[[Page 642]]

117 STAT. 642

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

[[Page 643]]

117 STAT. 643

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

[[Page 644]]

117 STAT. 644

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.--

[[Page 645]]

117 STAT. 645

``(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.''.

[[Page 646]]

117 STAT. 646

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

[[Page 647]]

117 STAT. 647

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);

[[Page 648]]

117 STAT. 648

``(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)''.

[[Page 649]]

117 STAT. 649

(j) 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.