[108th Congress Public Law 20]
[From the U.S. Government Printing Office]


[DOCID: f:publ020.108]

[[Page 637]]

           SMALLPOX EMERGENCY PERSONNEL PROTECTION ACT OF 2003

[[Page 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 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 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 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 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 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 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 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 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 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 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 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.

                                  <all>