    [United States Statutes at Large, Volume 117, 108th Congress, 1st Session]
    [From the U.S. Government Publishing 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.