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[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1770 Received in Senate (RDS)]

  1st Session
                                H. R. 1770

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             April 11, 2003

                                Received

_______________________________________________________________________

                                 AN ACT

 
To provide benefits and other compensation for certain individuals with 
injuries resulting from administration of smallpox countermeasures, and 
                          for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Smallpox Emergency Personnel 
Protection Act of 2003''.

 SEC. 2. SMALLPOX EMERGENCY PERSONNEL PROTECTION.

    Title II of the Public Health Service Act (42 U.S.C. 202 et seq.) 
is amended by adding at the end the following part:

           ``Part C--Smallpox Emergency Personnel Protection

``SEC. 261. GENERAL PROVISIONS.

    ``(a) Definitions.--For purposes of this part:
            ``(1) Covered countermeasure.--The term `covered 
        countermeasure' means a covered countermeasure as specified in 
        a Declaration made pursuant to section 224(p).
            ``(2) Covered individual.--The term `covered individual' 
        means an individual--
                    ``(A) who is a health care worker, law enforcement 
                officer, firefighter, security personnel, emergency 
                medical personnel, other public safety personnel, or 
                support personnel for such occupational specialities;
                    ``(B) who is or will be functioning in a role 
                identified in a State, local, or Department of Health 
                and Human Services smallpox emergency response plan (as 
                defined in paragraph (7)) approved by the Secretary;
                    ``(C) who has volunteered and been selected to be a 
                member of a smallpox emergency response plan described 
                in subparagraph (B) prior to the time at which the 
                Secretary publicly announces that an active case of 
                smallpox has been identified either within or outside 
                of the United States; and
                    ``(D) to whom a smallpox vaccine is administered 
                pursuant to such approved plan during the effective 
                period of the Declaration (including the portion of 
                such period before the enactment of this part).
            ``(3) Covered injury.--The term `covered injury' means an 
        injury, disability, illness, condition, or death (other than a 
        minor injury such as minor scarring or minor local reaction) 
        determined, pursuant to the procedures established under 
        section 262, to have been sustained by an individual as the 
        direct result of--
                    ``(A) administration to the individual of a covered 
                countermeasure during the effective period of the 
                Declaration; or
                    ``(B) accidental vaccinia inoculation of the 
                individual in circumstances in which--
                            ``(i) the vaccinia is contracted during the 
                        effective period of the Declaration or within 
                        30 days after the end of such period;
                            ``(ii) smallpox vaccine has not been 
                        administered to the individual; and
                            ``(iii) the individual has been in contact 
                        with an individual who is (or who was 
                        accidentally inoculated by) a covered 
                        individual.
            ``(4) Declaration.--The term `Declaration' means the 
        Declaration Regarding Administration of Smallpox 
        Countermeasures issued by the Secretary on January 24, 2003, 
        and published in the Federal Register on January 28, 2003.
            ``(5) Effective period of the declaration.--The term 
        `effective period of the Declaration' means the effective 
        period specified in the Declaration, unless extended by the 
        Secretary.
            ``(6) Eligible individual.--The term `eligible individual' 
        means an individual who is (as determined in accordance with 
        section 262)--
                    ``(A) a covered individual who sustains a covered 
                injury in the manner described in paragraph (3)(A); or
                    ``(B) an individual who sustains a covered injury 
                in the manner described in paragraph (3)(B).
            ``(7) Smallpox emergency response plan.--The term `smallpox 
        emergency response plan' or `plan' means a response plan 
        detailing actions to be taken in preparation for a possible 
        smallpox-related emergency during the period prior to the 
        identification of an active case of smallpox either within or 
        outside the United States.
    ``(b) Voluntary Program.--The Secretary shall ensure that a State, 
local, or Department of Health and Human Services plan to vaccinate 
individuals that is approved by the Secretary establishes procedures to 
ensure, consistent with the Declaration and any applicable guidelines 
of the Centers for Disease Control and Prevention, that--
            ``(1) potential participants are educated with respect to 
        contraindications, the voluntary nature of the program, and the 
        availability of potential benefits and compensation under this 
        part;
            ``(2) there is voluntary screening provided to potential 
        participants that can identify health conditions relevant to 
        contraindications; and
            ``(3) there is appropriate post-inoculation medical 
        surveillance that includes an evaluation of adverse health 
        effects that may reasonably appear to be due to such vaccine 
        and prompt referral of, or the provision of appropriate 
        information to, any individual requiring health care as a 
        result of such adverse health event.

``SEC. 262. DETERMINATION OF ELIGIBILITY AND BENEFITS.

    ``(a) In General.--The Secretary shall establish procedures for 
determining, as applicable with respect to an individual--
            ``(1) whether the individual is an eligible individual;
            ``(2) whether an eligible individual has sustained a 
        covered injury or injuries for which medical benefits or 
        compensation may be available under sections 264 and 265, and 
        the amount of such benefits or compensation; and
            ``(3) whether the covered injury or injuries of an eligible 
        individual caused the individual's death for purposes of 
        benefits under section 266.
    ``(b) Covered Individuals.--The Secretary may accept a 
certification, by a Federal, State, or local government entity or 
private health care entity participating in the administration of 
covered countermeasures under the Declaration, that an individual is a 
covered individual.
    ``(c) Criteria for Reimbursement.--
            ``(1) Injuries specified in injury table.--In any case 
        where an injury or other adverse effect specified in the injury 
        table established under section 263 as a known effect of a 
        vaccine manifests in an individual within the time period 
        specified in such table, such injury or other effect shall be 
        presumed to have resulted from administration of such vaccine.
            ``(2) Other determinations.--In making determinations other 
        than those described in paragraph (1) as to the causation or 
        severity of an injury, the Secretary shall employ a 
        preponderance of the evidence standard and take into 
        consideration all relevant medical and scientific evidence 
        presented for consideration, and may obtain and consider the 
        views of qualified medical experts.
    ``(d) Deadline for Filing Request.--The Secretary shall not 
consider any request for a benefit under this part with respect to an 
individual, unless--
            ``(1) in the case of a request based on the administration 
        of the vaccine to the individual, the individual files with the 
        Secretary an initial request for benefits or compensation under 
        this part not later than one year after the date of 
        administration of the vaccine; or
            ``(2) in the case of a request based on accidental vaccinia 
        inoculation, the individual files with the Secretary an initial 
        request for benefits or compensation under this part not later 
        than two years after the date of the first symptom or 
        manifestation of onset of the adverse effect.
    ``(e) Structured Settlements at Secretary's Option.--In any case in 
which there is a reasonable likelihood that compensation or payment 
under section 264, 265, or 266(b) will be required for a period in 
excess of one year from the date an individual is determined eligible 
for such compensation or payment, the Secretary shall have the 
discretion to make a lump-sum payment, purchase an annuity or medical 
insurance policy, or execute an appropriate structured settlement 
agreement, provided that such payment, annuity, policy, or agreement is 
actuarially determined to have a value equal to the present value of 
the projected total amount of benefits or compensation that the 
individual is eligible to receive under such section or sections.
    ``(f) Review of Determination.--
            ``(1) Secretary's review authority.--The Secretary may 
        review a determination under this section at any time on the 
        Secretary's own motion or on application, and may affirm, 
        vacate, or modify such determination in any manner the 
        Secretary deems appropriate. The Secretary shall develop a 
        process by which an individual may file a request for 
        reconsideration of any determination made by the Secretary 
        under this section.
            ``(2) Judicial and administrative review.--No court of the 
        United States, or of any State, District, territory or 
        possession thereof, shall have subject matter jurisdiction to 
        review, whether by mandamus or otherwise, any action by the 
        Secretary under this section. No officer or employee of the 
        United States shall review any action by the Secretary under 
        this section (unless the President specifically directs 
        otherwise).

``SEC. 263. SMALLPOX VACCINE INJURY TABLE.

    ``(a) Smallpox Vaccine Injury Table.--
            ``(1) Establishment required.--The Secretary shall 
        establish by interim final regulation a table identifying 
        adverse effects (including injuries, disabilities, illnesses, 
        conditions, and deaths) that shall be presumed to result from 
        the administration of (or exposure to) a smallpox vaccine, and 
        the time period in which the first symptom or manifestation of 
        onset of each such adverse effect must manifest in order for 
        such presumption to apply.
            ``(2) Amendments.--The Secretary may by regulation amend 
        the table established under paragraph (1). An amendment to the 
        table takes effect on the date of the promulgation of the final 
        rule that makes the amendment, and applies to all requests for 
        benefits or compensation under this part that are filed on or 
        after such date or are pending as of such date. In addition, 
        the amendment applies retroactively to an individual who was 
        not with respect to the injury involved an eligible individual 
        under the table as in effect before the amendment but who with 
        respect to such injury is an eligible individual under the 
        table as amended. With respect to a request for benefits or 
        compensation under this part by an individual who becomes an 
        eligible individual as described in the preceding sentence, the 
        Secretary may not provide such benefits or compensation unless 
        the request (or amendment to a request, as applicable) is filed 
        before the expiration of one year after the effective date of 
        the amendment to the table in the case of an individual to whom 
        the vaccine was administered and before the expiration of two 
        years after such effective date in the case of a request based 
        on accidental vaccinia inoculation.

``SEC. 264. MEDICAL BENEFITS.

    ``(a) In General.--Subject to the succeeding provisions of this 
section, the Secretary shall make payment or reimbursement for medical 
items and services as reasonable and necessary to treat a covered 
injury of an eligible individual, including the services, appliances, 
and supplies prescribed or recommended by a qualified physician, which 
the Secretary considers likely to cure, give relief, reduce the degree 
or the period of disability, or aid in lessening the amount of monthly 
compensation.
    ``(b) Benefits Secondary to Other Coverage.--Payment or 
reimbursement for services or benefits under subsection (a) shall be 
secondary to any obligation of the United States or any third party 
(including any State or local governmental entity, private insurance 
carrier, or employer) under any other provision of law or contractual 
agreement, to pay for or provide such services or benefits.

``SEC. 265. COMPENSATION FOR LOST EMPLOYMENT INCOME.

    ``(a) In General.--Subject to the succeeding provisions of this 
section, the Secretary shall provide compensation to an eligible 
individual for loss of employment income (based on such income at the 
time of injury) incurred as a result of a covered injury, at the rate 
specified in subsection (b).
    ``(b) Amount of Compensation.--
            ``(1) In general.--Compensation under subsection (a) shall 
        be at the rate of 66 2/3 percent of the relevant pay period 
        (weekly, monthly, or otherwise), except as provided in 
        paragraph (2).
            ``(2) Augmented compensation for dependents.--If an 
        eligible individual has one or more dependents, the basic 
        compensation for loss of employment income as described in 
        paragraph (1) shall be augmented at the rate of 8 1/3 percent.
            ``(3) Consideration of other programs.--
                    ``(A) In general.--The Secretary may consider the 
                provisions of sections 8114, 8115, and 8146a of title 
                5, United States Code, and any implementing 
                regulations, in determining the amount of payment under 
                subsection (a) and the circumstances under which such 
                payments are reasonable and necessary.
                    ``(B) Minors.--With respect to an eligible 
                individual who is a minor, the Secretary may consider 
                the provisions of section 8113 of title 5, United 
                States Code, and any implementing regulations, in 
                determining the amount of payment under subsection (a) 
                and the circumstances under which such payments are 
                reasonable and necessary.
            ``(4) Treatment of self-employment income.--For purposes of 
        this section, the term `employment income' includes income from 
        self-employment.
    ``(c) Limitations.--
            ``(1) Benefits secondary to other coverage.--
                    ``(A) In general.--Any compensation under 
                subsection (a) shall be secondary to the obligation of 
                the United States or any third party (including any 
                State or local governmental entity, private insurance 
                carrier, or employer), under any other law or 
                contractual agreement, to pay compensation for loss of 
                employment income or to provide disability or 
                retirement benefits.
                    ``(B) Relation to other obligations.--Compensation 
                under subsection (a) shall not be made to an eligible 
                individual to the extent that the total of amounts paid 
                to the individual under such subsection and under the 
                other obligations referred to in subparagraph (A) is an 
                amount that exceeds the rate specified in subsection 
                (b)(1). If under any such other obligation a lump-sum 
                payment is made, such payment shall, for purposes of 
                this paragraph, be deemed to be received over multiple 
                years rather than received in a single year. The 
                Secretary may, in the discretion of the Secretary, 
                determine how to apportion such payment over multiple 
                years.
            ``(2) No benefits in case of death.--No payment shall be 
        made under subsection (a) in compensation for loss of 
        employment income subsequent to the receipt, by the survivor or 
        survivors of an eligible individual, of benefits under section 
        266 for death.
            ``(3) Limit on total benefits.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B)--
                            ``(i) total compensation paid to an 
                        individual under subsection (a) shall not 
                        exceed $50,000 for any year; and
                            ``(ii) the lifetime total of such 
                        compensation for the individual may not exceed 
                        an amount equal to the amount authorized to be 
                        paid under section 266.
                    ``(B) Permanent and total disability.--The 
                limitation under subparagraph (A)(ii) does not apply in 
                the case of an eligible individual who is determined to 
                have a covered injury or injuries meeting the 
                definition of disability in section 216(i) of the 
                Social Security Act (42 U.S.C. 416(i)).
            ``(4) Waiting period.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), an eligible individual shall not be 
                provided compensation under this section for the first 
                5 work days of loss of employment income.
                    ``(B) Exception.--Subparagraph (A) does not apply 
                if the period of loss of employment income of an 
                eligible individual is 10 or more work days.
            ``(5) Termination of benefits.--No payment shall be made 
        under subsection (a) in compensation for loss of employment 
        income once the eligible individual involves reaches the age of 
        65.
    ``(d) Benefit in Addition to Medical Benefits.--A benefit under 
subsection (a) shall be in addition to any amounts received by an 
eligible individual under section 264.

``SEC. 266. PAYMENT FOR DEATH.

    ``(a) Death Benefit.--
            ``(1) In general.--The Secretary shall pay, in the case of 
        an eligible individual whose death is determined to have 
        resulted from a covered injury or injuries, a death benefit in 
        the amount determined under paragraph (2) to the survivor or 
        survivors in the same manner as death benefits are paid 
        pursuant to the Public Safety Officers' Benefits Program under 
        subpart 1 of part L of title I of the Omnibus Crime Control and 
        Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) with respect 
        to an eligible deceased (except that in the case of an eligible 
        individual who is a minor with no living parent, the legal 
        guardian shall be considered the survivor in the place of the 
        parent).
            ``(2) Benefit amount.--
                    ``(A) In general.--The amount of the death benefit 
                under paragraph (1) in a fiscal year shall equal the 
                amount of the comparable benefit calculated under the 
                Public Safety Officers' Benefits Program under subpart 
                1 of part L of title I of the Omnibus Crime Control and 
                Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) in 
                such fiscal year, without regard to any reduction 
                attributable to a limitation on appropriations, but 
                subject to subparagraph (B).
                    ``(B) Reduction for payments for lost employment 
                income.--The amount of the benefit as determined under 
                subparagraph (A) shall be reduced by the total amount 
                of any benefits paid under section 265 with respect to 
                lost employment income.
            ``(3) Limitations.--
                    ``(A) In general.--No benefit is payable under 
                paragraph (1) with respect to the death of an eligible 
                individual if--
                            ``(i) a disability benefit is paid with 
                        respect to such individual under the Public 
                        Safety Officers' Benefits Program under subpart 
                        1 of part L of title I of the Omnibus Crime 
                        Control and Safe Streets Act of 1968 (42 U.S.C. 
                        3796 et seq.); or
                            ``(ii) a death benefit is paid or payable 
                        with respect to such individual under the 
                        Public Safety Officers' Benefits Program under 
                        subpart 1 of part L of title I of the Omnibus 
                        Crime Control and Safe Streets Act of 1968 (42 
                        U.S.C. 3796 et seq.).
                    ``(B) Exception in the case of a limitation on 
                appropriations for disability benefits under psob.--In 
                the event that disability benefits available to an 
                eligible individual under the Public Safety Officers' 
                Benefits Program under subpart 1 of part L of title I 
                of the Omnibus Crime Control and Safe Streets Act of 
                1968 (42 U.S.C. 3796 et seq.) are reduced because of a 
                limitation on appropriations, and such reduction would 
                affect the amount that would be payable under 
                subparagraph (A) without regard to this subparagraph, 
                benefits shall be available under paragraph (1) to the 
                extent necessary to ensure that the survivor or 
                survivors of such individual receives a total amount 
                equal to the amount described in paragraph (2).
    ``(b) Election in Case of Dependents.--
            ``(1) In general.--In the case of an eligible individual 
        whose death is determined to have resulted from a covered 
        injury or injuries, if the individual had one or more 
        dependents under the age of 18, the legal guardian of the 
        dependents may, in lieu of the death benefit under subsection 
        (a), elect to receive on behalf of the aggregate of such 
        dependents payments in accordance with this subsection. An 
        election under the preceding sentence is effective in lieu of a 
        request under subsection (a) by an individual who is not the 
        legal guardian of such dependents.
            ``(2) Amount of payments.--Payments under paragraph (1) 
        with respect to an eligible individual described in such 
        paragraph shall be made as if such individual were an eligible 
        individual to whom compensation would be paid under subsection 
        (a) of section 265, with the rate augmented in accordance with 
        subsection (b)(2) of such section and with such individual 
        considered to be an eligible individual described in subsection 
        (c)(3)(B) of such section.
            ``(3) Limitations.--
                    ``(A) Age of dependents.--No payments may be made 
                under paragraph (1) once the youngest of the dependents 
                involved reaches the age of 18.
                    ``(B) Benefits secondary to other coverage.--
                            ``(i) In general.--Any payment under 
                        paragraph (1) shall be secondary to the 
                        obligation of the United States or any third 
                        party (including any State or local 
                        governmental entity, private insurance carrier, 
                        or employer), under any other law or 
                        contractual agreement, to pay compensation for 
                        loss of employment income or to provide 
                        disability benefits, retirement benefits, life 
                        insurance benefits on behalf of dependents 
                        under the age of 18, or death benefits.
                            ``(ii) Relation to other obligations.--
                        Payments under paragraph (1) shall not be made 
                        to with respect to an eligible individual to 
                        the extent that the total of amounts paid with 
                        respect to the individual under such paragraph 
                        and under the other obligations referred to in 
                        clause (i) is an amount that exceeds the rate 
                        of payment that applies under paragraph (2). If 
                        under any such other obligation a lump-sum 
                        payment is made, such payment shall, for 
                        purposes of this subparagraph, be deemed to be 
                        received over multiple years rather than 
                        received in a single year. The Secretary may, 
                        in the discretion of the Secretary, determine 
                        how to apportion such payment over multiple 
                        years.
    ``(c) Benefit in Addition to Medical Benefits.--A benefit under 
subsection (a) or (b) shall be in addition to any amounts received by 
an eligible individual under section 264.

``SEC. 267. ADMINISTRATION.

    ``(a) Administration by Agreement With Other Agency or Agencies.--
The Secretary may administer any or all of the provisions of this part 
through Memorandum of Agreement with the head of any appropriate 
Federal agency.
    ``(b) Regulations.--The head of the agency administering this part 
or provisions thereof (including any agency head administering such Act 
or provisions through a Memorandum of Agreement under subsection (a)) 
may promulgate such implementing regulations as may be found necessary 
and appropriate. Initial implementing regulations may be interim final 
regulations.

``SEC. 268. AUTHORIZATION OF APPROPRIATIONS.

    ``For the purpose of carrying out this part, there are authorized 
to be appropriated such sums as may be necessary for each of the fiscal 
years 2003 through 2007, to remain available until expended, including 
administrative costs and costs of provision and payment of benefits. 
The Secretary's payment of any benefit under section 264, 265, or 266 
shall be subject to the availability of appropriations under this 
section.

``SEC. 269. RELATIONSHIP TO OTHER LAWS.

    ``Except as explicitly provided herein, nothing in this part shall 
be construed to override or limit any rights an individual may have to 
seek compensation, benefits, or redress under any other provision of 
Federal or State law.''.

SEC. 3. AMENDMENTS TO PROVISION REGARDING TORT LIABILITY FOR 
              ADMINISTRATION OF SMALLPOX COUNTERMEASURES.

    (a) Amendment to Accidental Vaccinia Inoculation Provision.--
Section 224(p)(2)(C)(ii)(II) of such Act (42 U.S.C. 
233(p)(2)(C)(ii)(II)) is amended by striking ``resides or has resided 
with'' and inserting ``has resided with, or has had contact with,''.
    (b) Deeming Acts and Omissions To Be Within Scope of Employment.--
Section 224(p)(2) of such Act (42 U.S.C. 233(p)(2)) is amended by 
adding at the end the following new subparagraph:
                    ``(D) Acts and omissions deemed to be within scope 
                of employment.--
                            ``(i) In general.--In the case of a claim 
                        arising out of alleged transmission of vaccinia 
                        from an individual described in clause (ii), 
                        acts or omissions by such individual shall be 
                        deemed to have been taken within the scope of 
                        such individual's office or employment for 
                        purposes of--
                                    ``(I) subsection (a); and
                                    ``(II) section 1346(b) and chapter 
                                171 of title 28, United States Code.
                            ``(ii) Individuals to whom deeming 
                        applies.--An individual is described by this 
                        clause if--
                                    ``(I) vaccinia vaccine was 
                                administered to such individual as 
                                provided by subparagraph (B); and
                                    ``(II) such individual was within a 
                                category of individuals covered by a 
                                declaration under subparagraph 
                                (A)(i).''.
    (c) Exhaustion; Exclusivity; Offset.--Section 224(p)(3) of such Act 
(42 U.S.C. 233(p)(3)) is amended to read as follows:
            ``(3) Exhaustion; exclusivity; offset.--
                    ``(A) Exhaustion.--
                            ``(i) In general.--A person may not bring a 
                        claim under this subsection unless such person 
                        has exhausted such remedies as are available 
                        under part C of this title, except that if the 
                        Secretary fails to make a final determination 
                        on a request for benefits or compensation filed 
                        in accordance with the requirements of such 
                        part within 240 days after such request was 
                        filed, the individual may seek any remedy that 
                        may be available under this section.
                            ``(ii) Tolling of statute of limitations.--
                        The time limit for filing a claim under this 
                        subsection, or for filing an action based on 
                        such claim, shall be tolled during the pendency 
                        of a request for benefits or compensation under 
                        part C of this title.
                            ``(iii) Construction.--This subsection 
                        shall not be construed as superseding or 
                        otherwise affecting the application of a 
                        requirement, under chapter 171 of title 28, 
                        United States Code, to exhaust administrative 
                        remedies.
                    ``(B) Exclusivity.--The remedy provided by 
                subsection (a) shall be exclusive of any other civil 
                action or proceeding for any claim or suit this 
                subsection encompasses, except for a proceeding under 
                part C of this title.
                    ``(C) Offset.--The value of all compensation and 
                benefits provided under part C of this title for an 
                incident or series of incidents shall be offset against 
                the amount of an award, compromise, or settlement of 
                money damages in a claim or suit under this subsection 
                based on the same incident or series of incidents.''.
    (d) Requirement To Cooperate With United States.--Section 224(p)(5) 
of such Act (42 U.S.C. 233(p)(5)) is amended in the caption by striking 
``Defendant'' and inserting ``Covered person''.
    (e) Amendment to Definition of Covered Countermeasure.--Section 
224(p)(7)(A)(i)(II) of such Act (42 U.S.C. 233(p)(7)(A)(i)(II)) is 
amended to read as follows:
                                    ``(II) used to 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);
                            ``(vii) a contractor of, or a volunteer 
                        working for, a person described in clause (i), 
                        (ii), or (iv), if the contractor or volunteer 
                        performs a function for which a person 
                        described in clause (i), (ii), or (iv) is a 
                        covered person; or
                            ``(viii) an individual who has privileges 
                        or is otherwise authorized to provide health 
                        care under the auspices of an entity described 
                        in clause (ii) or (v)(II).''.
    (g) Amendment to Definition of Qualified Person.--Section 
224(p)(7)(C) of such Act (42 U.S.C. 233(p)(7)(C)) is amended--
            (1) by designating ``is authorized to'' and all that 
        follows as clause (i) and indenting accordingly;
            (2) by striking ``individual who'' and inserting 
        ``individual who--''; and
            (3) by striking the period and inserting ``; or
                            ``(ii) is otherwise authorized by the 
                        Secretary to administer such countermeasure.''.
    (h) Definition of ``Arising Out of Administration of a Covered 
Countermeasure''.--Section 224(p)(7) of such Act (42 U.S.C. 233(p)(7)) 
is amended by adding at the end the following new subparagraph:
                    ``(D) Arising out of administration of a covered 
                countermeasure.--The term `arising out of 
                administration of a covered countermeasure', when used 
                with respect to a claim or liability, includes a claim 
                or liability arising out of--
                            ``(i) determining whether, or under what 
                        conditions, an individual should receive a 
                        covered countermeasure;
                            ``(ii) obtaining informed consent of an 
                        individual to the administration of a covered 
                        countermeasure;
                            ``(iii) monitoring, management, or care of 
                        an immediate site of administration on the body 
                        of a covered countermeasure, or evaluation of 
                        whether the administration of the 
                        countermeasure has been effective; or
                            ``(iv) transmission of vaccinia virus by an 
                        individual to whom vaccinia vaccine was 
                        administered as provided by paragraph 
                        (2)(B).''.
    (i) Technical Correction.--Section 224(p)(2)(A)(ii) of such Act (42 
U.S.C. 233(p)(2)(A)(ii)) is amended by striking ``paragraph (8)(A)'' 
and inserting ``paragraph (7)(A)''.
    (j) Effective Date.--This section shall take effect as of November 
25, 2002.

            Passed the House of Representatives April 11, 2003.

            Attest:

                                                 JEFF TRANDAHL,

                                                                 Clerk.
```